Congressional Record publishes “ENCOURAGING WORK AND SUPPORTING MARRIAGE ACT OF 2002” on May 21, 2002

Volume 148, No. 66 covering the 2nd Session of the 107th Congress (2001 - 2002) was published by the Congressional Record.

The Congressional Record is a unique source of public documentation. It started in 1873, documenting nearly all the major and minor policies being discussed and debated.

“ENCOURAGING WORK AND SUPPORTING MARRIAGE ACT OF 2002” mentioning the Environmental Protection Agency was published in the House of Representatives section on pages H2685-H2732 on May 21, 2002.

The publication is reproduced in full below:

ENCOURAGING WORK AND SUPPORTING MARRIAGE ACT OF 2002

Mr. WELLER. Mr. Speaker, I move to suspend the rules and pass the bill (H.R. 4626) to amend the Internal Revenue Code of 1986 to accelerate the marriage penalty relief in the standard deduction and to modify the work opportunity credit and the welfare-to-work credit, as amended.

The Clerk read as follows:

H.R. 4626

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ``Encouraging Work and Supporting Marriage Act of 2002''.

TITLE I--ACCELERATION OF MARRIAGE PENALTY RELIEF

SEC. 101. ACCELERATION OF INCREASE IN STANDARD DEDUCTION FOR

JOINT RETURNS.

(a) In General.--Paragraph (7) of section 63(c) of the Internal Revenue Code of 1986, as amended by section 301 of the Economic Growth and Tax Relief Reconciliation Act of 2001, is amended to read as follows:

``(7) Applicable percentage.--For purposes of paragraph

(2), the applicable percentage shall be determined in accordance with the following table:

``For taxable years beginning in calendarThe applicable percentage is--

2003 or 2004.................................................170

2005.........................................................174

2006.........................................................184

2007.........................................................187

2008.........................................................190

2009 and thereafter.......................................200.''.

(b) Conforming Amendment.--Subsection (d) of section 301 of the Economic Growth and Tax Relief Reconciliation Act of 2001 is amended by striking ``December 31, 2004'' and inserting

``December 31, 2002''.

(c) Effective Date.--The amendments made by this section shall apply to taxable years beginning after December 31, 2002.

TITLE II--MODIFICATIONS TO WORK OPPORTUNITY CREDIT AND WELFARE-TO-WORK

CREDIT

SEC. 201. MODIFICATIONS TO WORK OPPORTUNITY CREDIT AND

WELFARE-TO-WORK CREDIT.

(a) Eligibility of Ex-Felons Determined Without Regard to Family Income.--Paragraph (4) of section 51(d) of the Internal Revenue Code of 1986 is amended by adding ``and'' at the end of subparagraph (A), by striking ``, and'' at the end of subparagraph (B) and inserting a period, and by striking all that follows subparagraph (B).

(b) Increase in Maximum Age for Eligibility of Food Stamp Recipients.--Clause (i) of section 51(d)(8)(A) of such Code is amended by striking ``25'' and inserting ``30''.

(c) Clarification of Treatment of Individuals Under Individual Work Plans.--Subparagraph (B) of section 51(d)(6) of such Code (relating to vocational rehabilitation referral) is amended by striking ``or'' at the end of clause (i), by striking the period at the end of clause (ii) and inserting

``, or'', and by adding at the end the following new clause:

``(iii) an individual work plan developed and implemented by an employment network pursuant to subsection (g) of section 1148 of the Social Security Act with respect to which the requirements of such subsection are met.''

(d) Effective Date.--The amendments made by this section shall apply to individuals who begin work for the employer after December 31, 2002.

SEC. 202. CONSOLIDATION OF WORK OPPORTUNITY CREDIT WITH

WELFARE-TO-WORK CREDIT.

(a) In General.--Paragraph (1) of section 51(d) of the Internal Revenue Code of 1986 is amended by striking ``or'' at the end of subparagraph (G), by striking the period at the end of subparagraph (H) and inserting ``, or'', and by adding at the end the following new subparagraph:

``(I) a long-term family assistance recipient.''

(b) Long-Term Family Assistance Recipient.--Subsection (d) of section 51 of such Code is amended by redesignating paragraphs (10) through (12) as paragraphs (11) through (13), respectively, and by inserting after paragraph (9) the following new paragraph:

``(10) Long-term family assistance recipient.--The term

`long-term family assistance recipient' means any individual who is certified by the designated local agency--

``(A) as being a member of a family receiving assistance under a IV-A program (as defined in paragraph (2)(B)) for at least the 18-month period ending on the hiring date,

``(B)(i) as being a member of a family receiving such assistance for 18 months beginning after August 5, 1997, and

``(ii) as having a hiring date which is not more than 2 years after the end of the earliest such 18-month period, or

``(C)(i) as being a member of a family which ceased to be eligible for such assistance by reason of any limitation imposed by Federal or State law on the maximum period such assistance is payable to a family, and

``(ii) as having a hiring date which is not more than 2 years after the date of such cessation.''

(c) Increased Credit for Employment of Long-Term Family Assistance Recipients.--Section 51 of such Code is amended by inserting after subsection (d) the following new subsection:

``(e) Credit for Second-Year Wages for Employment of Long-Term Family Assistance Recipients.--

``(1) In general.--With respect to the employment of a long-term family assistance recipient--

``(A) the amount of the work opportunity credit determined under this section for the taxable year shall include 40 percent of the qualified second-year wages for such year, and

``(B) in lieu of applying subsection (b)(3), the amount of the qualified first-year wages, and the amount of qualified second-year wages, which may be taken into account with respect to such a recipient shall not exceed $10,000 per year.

``(2) Qualified second-year wages.--For purposes of this subsection, the term `qualified second-year wages' means qualified wages--

``(A) which are paid to a long-term family assistance recipient, and

``(B) which are attributable to service rendered during the 1-year period beginning on the day after the last day of the 1-year period with respect to such recipient determined under subsection (b)(2).

``(3) Special rules for agricultural and railway labor.--If such recipient is an employee to whom subparagraph (A) or (B) of subsection (h)(1) applies, rules similar to the rules of such subparagraphs shall apply except that--

``(A) such subparagraph (A) shall be applied by substituting `$10,000' for `$6,000', and

``(B) such subparagraph (B) shall be applied by substituting `$833.33' for `$500'.''

(d) Repeal of Separate Welfare-to-Work Credit.--

(1) In general.--Section 51A of such Code is hereby repealed.

(2) Clerical amendment.--The table of sections for subpart F of part IV of subchapter A of chapter 1 of such Code is amended by striking the item relating to section 51A.

(e) Effective Date.--The amendments made by this section shall apply to individuals who begin work for the employer after December 31, 2002.

The SPEAKER pro tempore. Pursuant to the rule, the gentleman from Illinois (Mr. Weller) and the gentleman from Massachusetts (Mr. Neal) each will control 20 minutes.

The Chair recognizes the gentleman from Illinois (Mr. Weller).

Mr. WELLER. Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I bring H.R. 4626, legislation sponsored by my friend, the gentleman from New York (Mr. Houghton) and myself, legislation called the Encouraging Work and Supporting Marriage Act of 2002 to the floor today.

This is important legislation because it helps American families in two ways. First, it makes marriage penalty relief more quickly available to 21 million low and moderate income married working couples. Second, it facilitates the transition from welfare to work by simplifying the work opportunity and welfare-to-work tax credits and making them easier for employers as well as employees to use.

This past year, in what we know as the Bush tax cut, last year's tax law, which President Bush signed into law June of 2001, it phased out the marriage tax penalty for 43 million married working couples. It included a phaseout of marriage penalty relief particularly targeted to low and moderate income married couples which we include in today's legislation which resulted from the doubling of the standard deduction which was to begin in the year 2005.

This legislation before us today accelerates this relief for low and moderate income married working couples by increasing the standard deduction for joint filers to twice that for singles and reducing the marriage penalty by many low and middle income Americans beginning next year in 2003. It is estimated that 9 million American married couples currently use the standard deduction. With this legislation they will begin to see marriage tax relief next year instead of in 2005 as originally planned.

H.R. 4626 will also help simplify the tax code. With an earlier phaseout of the marriage tax penalty, 300,000 married working couples who now use the standard deduction instead of itemizing their taxes next year will be able to use the standard deduction and no longer need to itemize. Again, 300,000 married working couples will see their taxes simplified as a result of this marriage tax penalty relief in this legislation.

Besides affecting the marriage taxes penalty, H.R. 4626 will also help simplify the work opportunity and welfare-to-work tax credits, two very successful programs which have given hundreds of thousands of low income Americans the opportunity to go back to work. As we have often said in this House Chamber, the best solution to welfare is a job.

And I would also note that President Bush recently traveled to Chicago, to my home State, and visited a United Parcel Services facility to highlight the success of this program which has given tens of thousands of Chicago area residents the opportunity to have a job, to have a chance to go to work and get off welfare. Current law provides a work opportunity tax credit to employers who hire individuals from 8 target groups that are considered hard to hire. Employers who hire long term TANF recipients can claim a separate welfare-to-work tax credit. The proposal would simplify the tax code to combine the 2 tax credits and conform most of their rules, making the credits easier for employers to use.

Additionally, this bill eliminates the family income tax for ex-

felons under work opportunity tax credit. Under current law, employers can claim the work opportunity tax credit for hiring ex-felons only if he or she meets a complicated family income test which requires a State to document the income of all members in the ex-felon's household.

H.R. 4626 eliminates the family income tax for this group, thus simplifying the work opportunity tax credit and helping ex-felons transition into the workplace.

Finally, H.R. 4626 increases eligibility age limit for food stamp recipients. Under current law, employers can claim the work opportunity tax credit for hiring certain food stamp recipients between the ages of 18 to 25.

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This proposal would increase the age to 3 and give more low-income individuals the opportunity to go to work.

Mr. Speaker, H.R. 4626 is a good bill. It has bipartisan support, and I would note that this legislation passed the House Committee on Ways and Means on a unanimous voice vote.

This legislation encourages the values we hold most dear: marriage, family, and hard work. I encourage my colleagues to vote for this bill to eliminate the marriage tax penalty more quickly for low-income and moderate-income married working couples and also help facilitate an easier transition from welfare to work.

Mr. Speaker, I reserve the balance of my time.

Mr. NEAL of Massachusetts. Mr. Speaker, I yield myself such time as I may consume.

I want to agree with what the gentleman from Illinois (Mr. Weller) said a couple of moments ago, that this measure did indeed pass through the Committee on Ways and Means on a unanimous vote. So for the purpose of this moment, I think that we are really discussing the benefits of this legislation for the American citizenry.

What we should be debating, as opposed to just discussing here, is how we are going to pay for this tax relief. I am a supporter of the measure that is in front of us, and indeed the Committee on Ways and Means voted for it as well. But what we are not voting on here today, Mr. Speaker, and what we should be voting on here today, and what we have been prohibited from voting on for the last few weeks is a way to ensure that while providing for this tax relief that we do not steal from the Social Security and Medicare trust funds. That is what this House has to have a debate about, not simply a discussion.

Last week, the Republican leadership in the House withdrew consideration of this very important legislation, in my judgment, to protect a certain group that has been characterized as being financial traitors. We wanted to pay for this legislation, because we agree with the merit of what has been offered by the gentleman from Illinois (Mr. Weller), by implementing provisions of H.R. 3884, the Corporate Patriot Enforcement Act, a bill authored by myself and the gentleman from Connecticut (Mr. Maloney).

Knowing that this House would vote overwhelmingly to stop the exodus of American corporations to tax havens, the leadership of this House opted to impose procedural barriers to preclude our amendment.

Mr. Speaker, once again the New York Times highlighted yesterday morning on its front page what precisely is happening. The leadership in this institution continues to procrastinate. Our constituents around the country want Congress to act now to stop these corporations from shelving their patriotism to save a few bucks. And as we discovered yesterday, not only to save what they have claimed to be money for the shareholders, but we have now discovered what will happen to the salaries of the executives once they leave. It is unconscionable to have this occur at the same time when we could be taking a vigorous and measured response to end it.

The Neal-Maloney Corporate Patriot Enforcement Act would immediately and permanently shut down the exodus of American corporations to tax havens, and end benefits for those who set up shell headquarters in island countries to avoid U.S. corporate income taxes.

Again, the gentleman from Illinois (Mr. Weller) is right. Hardworking American families are entitled to tax relief, but I am sure these families do not want to burden their children by placing our Social Security and Medicare trust funds and our budget at risk.

Let us pay up front for the Marriage Penalty Relief Act. Let us stop the procedural games and pass the Neal-Maloney bill to stop the corporate expatriates.

Mr. Speaker, I reserve the balance of my time.

Mr. WELLER. Mr. Speaker, I yield myself such time as I may consume.

Briefly, in response to my friend from Massachusetts, I would note today's legislation before us is about giving welfare recipients the opportunity to go to work and providing greater marriage tax relief.

The issue of inversions that the gentleman from Massachusetts (Mr. Neal) has brought up is an issue of bipartisan concern. I particularly want to commend my colleague, the gentlewoman from Connecticut (Mrs. Johnson), for her leadership on this issue and sponsorship of H.R. 4756.

I would note the flaws in the gentleman from Massachusetts' (Mr. Neal) proposal, some suggest may even promote foreign takeover of U.S. companies under the proposal that he has offered, and that is why out of fairness a hearing has been scheduled by the House Committee on Ways and Means on June 13. Also, as part of that hearing, we will be looking at a Treasury review and study which was released this past Friday.

Mr. Speaker, I yield 3 minutes to the gentleman from New York (Mr. Houghton), one of the leaders of the welfare-to-work initiative.

Mr. HOUGHTON. Mr. Speaker, I would like to rise in support of H.R. 4626, and I would like to thank the gentleman from Illinois (Mr. Weller) for all the great work he has done and also thank the gentleman from California (Mr. Thomas) for his support and the whole broad parameter of encouraging work and supporting marriage.

This is a very simple and a straightforward piece of legislation. It improves the Work and Opportunity Act. It reduces the marriage penalty for lower-middle income people, and this is it. There are lots of things I would have gone over, but the gentleman from Illinois (Mr. Weller) has described those very eloquently, and I will not try to duplicate his words. However, I would just like to mention several facts.

First of all, this bill combines the work and opportunity and the welfare-to-work credit, and while it increases the welfare-to-work credit from 35 to 40 percent, for the first year, very, very important feature here, it would also extend this 40 percent credit into the second year for employers who retain the workers. Also, it would expand incentives for vocational rehabilitation.

This is important. It would eliminate family income tests for ex-

felons, which the gentleman from Illinois (Mr. Weller) mentioned, and the test is a really significant impediment to hiring ex-felons.

Finally, the legislation would increase the age limitation for food stamps recipients from 25 to 30; and what this is going to do, it is going to assist many people, many men who should be taking advantage of the work opportunity tax credit, but where the current age limit prevents their eligibility.

So, Mr. Speaker, let me say this legislation is a good piece of work. It will increase the opportunity for those who want to work and the need to save and leave welfare for steady, long-term employment.

I appreciate my colleagues' understanding of this, and I appreciate the gentleman from Illinois' (Mr. Weller) leadership.

Mr. NEAL of Massachusetts. Mr. Speaker, I yield 3 minutes to the gentleman from Michigan (Mr. Levin), who has been a leader on this issue and question as well.

(Mr. LEVIN asked and was given permission to revise and extend his remarks.)

Mr. LEVIN. Mr. Speaker, I want to congratulate the gentleman from Massachusetts (Mr. Neal) for bringing up this issue of how we pay for this legislation and urging that we use the Neal-Maloney bill to pay for it.

Once again, the Republican majority has come forth with an idea, in this case a good one, without paying for it except to divert Social Security and Medicare moneys. That is how they are paying for everything. As we dip more and more into debt, we use more and more moneys that are payroll taxes for Social Security and Medicare.

So what the gentleman from Massachusetts (Mr. Neal) has suggested is let us pay for it with a good idea, and that is the Neal-Maloney bill; but my colleagues abuse our House rules by not letting us bring it up.

Once again, what they are saying is we will bring it up on suspension so there is no way to propose a good pay-for for a good idea. So they have a bad pay-for for a good idea. Why? They do not want up and down votes on these issues. They are going to do the same apparently or try to do the same on debt relief.

Look, we do not really need hearings. My colleagues have not held many hearings on many of these issues in the Committee on Ways and Means, and now the dodge for not taking up Neal-Maloney is let us hold a hearing. What I suggest is let us have some action.

The gentleman from Connecticut (Mr. Maloney) has been out on the streets working this issue, right? The gentleman from Massachusetts

(Mr. Neal) has been talking about this issue for how long? A long time. It is time for action.

These are paper reincorporations, purely filing some paper to duck paying taxes to the United States of America. So if my colleagues really care about the American taxpayer, as they claim, they will let us bring up this proposal and it will pass; but instead, to kind of help out some people who are escaping taxes, they delay action on this, and it hurts the American taxpayer, the people that we represent.

So I want to salute the gentleman from Massachusetts (Mr. Neal) and the gentleman from Connecticut (Mr. Maloney) for pressing this issue. Ultimately, we will prevail.

Mr. WELLER. Mr. Speaker, I yield myself such time as I may consume.

I would remind my colleagues that today we are focusing on eliminating the marriage tax penalty and giving welfare recipients the opportunity to go back to work.

I would also note this legislation is paid for through the budget which the House has adopted which allows for an additional $28 billion in tax provisions. It is estimated this provision will cost $1 billion or less. So it fits well within those parameters and does not need to be paid for under the House-adopted budget.

Mr. Speaker, I yield 4 minutes to the gentleman from Arizona (Mr. Hayworth), one of our leaders on the Committee on Ways and Means, a distinguished gentleman who has been a real leader on bringing tax fairness to those married working couples, as well as giving opportunity to those who need to work.

Mr. HAYWORTH. Mr. Speaker, I thank the gentleman from Illinois (Mr. Weller) for the recognition.

Listening with interest to the debate; and indeed those who may join us, either in the gallery, Mr. Speaker, or electronically across the country, and indeed, around the world, may view with curiosity the debate thus far.

Announcement by the Speaker Pro Tempore

The SPEAKER pro tempore (Mr. Linder). The gentleman will suspend. The gentleman will refrain from referencing the gallery or the TV audience.

Mr. HAYWORTH. Mr. Speaker, I apologize. Those who listen to our debate, and I thank the gentleman. It was not intentional to violate House rules. I thank the Speaker for his attention to discourse, and I will return to it right now.

Perhaps as the Speaker listens to the debate and as our colleagues in the Chamber listen to the debate, they might be mystified that what we have done is transform a debate on expanding opportunities for welfare to work and to lift the burden of the marriage tax penalty on those who need that help and thereby help bolster the institution of marriage to be caught up in the debate on other bills and other issues that we indeed will address in the days ahead. It is an interesting concept to focus on process in the House rather than content of the legislation.

The legislation before us today helps us simplify the Tax Code. It increases the standard deduction for married couples, 300,000 married couples, would allow them to claim the standard deduction on their tax return rather than itemize. That, in itself, is a major simplification.

It seems to me, Mr. Speaker, that we should work to emphasize policies that are family friendly, policies that would support marriage when we offer this economic incentive. It allows us to accelerate the lifting of the burdensome marriage tax penalty. It accelerates relief for 21 million married couples, and that is vitally important to offer them access to the American dream.

My friend from New York was here just moments ago in this Chamber, Mr. Speaker, addressing the entire concept of welfare to work, indeed to complement the legislation passed last week, to build upon a major success over the last half decade. We need to offer opportunities for people to get to work.

My colleague from Illinois said it best. The best social program, the best opportunity to lift the burden of poverty is to offer people jobs, to get them into the workforce, and enhancing the welfare-to-work tax credit increases an employer's incentive to hire long-term recipients of the temporary assistance to needy families.

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This allows us to put people back to work.

Mr. Speaker, I would be remiss if I did not address something that has been repeated here time and again. It is important to clear up any misconception that may have been offered on the floor by my friends on the other side of the aisle. I appreciate their newfound adherence to what they believe to be sound fiscal policy, but the fact is this reasonable, rational, bipartisan reduction in taxes is allowed for in our House-passed budget resolution. Indeed, the budget resolution allows for a $28 billion reduction in taxation. We are not taking a penny, nor a dollar, nor a quarter nor a nickel, we are not going into Social Security and Medicare revenues to pay for this.

Indeed, as disturbing as it is, if that indeed is the charge, would our friends on the other side vote ``no'' to expand this tax relief, an opportunity for those who look to seize it? I hope that would not be the case.

I would hope, Mr. Speaker, that at the end of the day, they will rise and join us in support of this legislation.

Mr. NEAL of Massachusetts. Mr. Speaker, the previous speaker is quite correct. He did use the word welfare. It occurred to me that you will not catch that bunch that are currently moving to Bermuda sleeping on the grates when they get there. You can bet on that. The point that we raised earlier is this is merely a discussion of the issue, but we want, as Democrats, to have a substantive debate about these companies that are moving to Bermuda to avoid taxes, and who better to speak about it than the distinguished gentleman from Washington (Mr. McDermott) to whom I yield 3 minutes.

Mr. McDERMOTT. Mr. Speaker, I was glad to come out here and join in the preparing the press-release-of-the-week event. The Republicans say, well, every week we have got to have something to put out in the press to confuse the public, so let us go vote another tax cut. It reminds me of that old saying, ``Tonight we drink, tomorrow we'll fix the truck.''

What are you drinking from? You are drinking from the tax cut cup. You are putting another billion dollars in the hole. And for anybody to get up at that other side of the well and say that that does not come out of Social Security means he has paid no attention to the fact that we are going to end this year $300 billion in debt.

Why add one more? Well, we have to have the press release, right? Even more, though, let me tell you what is going on here. The reason this is out here on the suspension calendar, with no hearings in the committee, just out on the suspension calendar, is because they did not want to bring it to the committee. They did not want to give the gentleman from Massachusetts (Mr. Neal) the opportunity to raise the question of the runaway companies and paying for this particular option. There is no payment in here. This is just taken out of the Social Security. So the leadership on the Committee on Ways and Means said, I know how we can get around this uncomfortable situation that the gentleman from Massachusetts is going to put us in, forcing us to vote about whether we want people running away, creating paper companies and taking tremendous profits because they are no longer an American company. Why, one of them even in Connecticut, just recently, makes hand tools. They decided they would go to Bermuda, create a paper company. As luck would have it, there might be a member on the Committee on Ways and Means who would be embarrassed by having to vote on that issue. So the chairman said, ``Don't worry, we'll never let it come up in the committee. We will send this directly to the floor.''

At some point, somebody has got to talk seriously out here. You cannot blame the fact that a tool company goes to Bermuda on 9/11 or on the war on terrorism. Why would they be moving from Connecticut to Bermuda? Is it to get away from the terror in this country? They went there for tax purposes and everybody knows it. I could give you a list as long as my arm of companies doing it all the time to avoid paying taxes in this country. They want the protection of the United States, they want the military, they want us patrolling the oceans so that they can send their exports everywhere, but they do not want to pay for it.

I wish that I would hear the President of the United States say, ``We all have to make a sacrifice, we all have to pay taxes,'' and that he would say it to his friends in Bermuda, ``Come on home. Pay your share.''

This is a terrible bill.

Mr. WELLER. Mr. Speaker, I yield myself such time as I may consume.

Responding briefly to my colleague from Washington State, a friend of mine on my committee, being a member of the House Committee on Ways and Means, I would note that today's debate is whether or not we more quickly phase out the marriage tax penalty, and do we make it easier for those on welfare to go to work. I realize that with a hearing coming up on June 13 that the gentleman from Massachusetts (Mr. Neal) requested and agreed to and, of course, on an issue that the gentlewoman from Connecticut (Mrs. Johnson) has been a leader on, that we are planning to have plenty of debate and discussion of the issue that they are raising. The bottom line is today we want to eliminate the marriage tax penalty, and today we want to help those who are on welfare go to work.

Mr. Speaker, I reserve the balance of my time.

Mr. NEAL of Massachusetts. Mr. Speaker, I yield 2 minutes to the gentleman from Massachusetts (Mr. Lynch), a worthy successor to McCormick and O'Neill, newly elected here from South Boston.

Mr. LYNCH. Mr. Speaker, in response to my esteemed colleague from Arizona, I think this is a perfect time to talk about correct tax policy in this country. I think you will find widespread agreement that there is support for reducing the marriage penalty. It is a sensible adjustment to our tax code. However, I think you will also find widespread agreement here that stopping American companies from avoiding their fair share of taxes by incorporating into offshore tax havens is also a sensible adjustment to our tax code.

Mr. Speaker, I rise in support of the gentleman from Massachusetts

(Mr. Neal) and the gentleman from Connecticut (Mr. Maloney) and their recommendation entitled the Corporate Patriot Enforcement Act. Unfortunately, the Republican leadership is not allowing us to debate that bill today. We quite frankly are in a time of great challenge in this country. It is a time when we should set aside our partisan squabbling and pull together and do what is necessary, do what is right for this country.

There are some Americans, however, Mr. Speaker, who seem to feel that the burden of defending our country should fall rather lightly on them. In the last few years, we have seen a growing epidemic of companies voting to, quote, unquote, reincorporate themselves in Bermuda, in Barbados, in offshore tax havens, asking us to believe that buying a post office box in Bermuda or Barbados is a legitimate way to avoid paying to support our efforts against terrorism, paying to support our troops overseas. Profits and jobs are shipped abroad by this process. Those profits are not reinvested in the United States. And it leaves their share, these runaway corporations, it leaves their share of the tax burden to fall unfairly on those companies and individuals who are too honest and are too patriotic to engage in these kinds of schemes.

Mr. Speaker, the executives of these companies have practically dared Congress to shut down their offshore tax schemes. I believe we should take them up on that challenge.

Mr. WELLER. Mr. Speaker, I yield myself such time as I may consume.

To briefly respond to my friend and colleague from Massachusetts, again today's debate is about do we more quickly eliminate the marriage tax penalty, and do we give thousands, if not millions, more of those who are on welfare the opportunity to go to work? I would note that the issue that has been raised, of course, has been an issue that has been led on by the gentlewoman from Connecticut (Mrs. Johnson), and as the gentleman from Massachusetts (Mr. Neal) and the gentlewoman from Connecticut (Mrs. Johnson) have both requested, the committee will be addressing this on June 13.

Mr. Speaker, I reserve the balance of my time.

Mr. NEAL of Massachusetts. Mr. Speaker, I yield myself such time as I may consume.

They won't give us a vote in this institution on this measure, the Corporate Patriot Enforcement Act. This is the way we have to do it. I will assure the folks on the other side of the aisle this is the way we are going to continue to do it until we get an up-or-down vote on this question.

Mr. Speaker, I yield 3 minutes to the gentleman from Connecticut (Mr. Maloney) who has been a leader on this issue. He knows it firsthand and indeed has been a passionate critic of what these corporations are doing in an effort to scheme to avoid taxes.

Mr. MALONEY of Connecticut. Mr. Speaker, I rise in support of H.R. 4626, the legislation before us today. It is a good measure, but it could be substantially better. This debate is about our tax policy. Tax policy very much is in question. Last month while citizens of this country were paying their income taxes, some of America's largest corporations decided they no longer wanted to pay their fair share of U.S. taxes. Instead, they sought out a loophole and are trying to exploit it for their own gain. For little more than the cost of a post office box in an offshore tax haven like Bermuda, U.S. companies are trying to avoid millions of dollars in Federal taxes. The tax dodgers may set up paper headquarters in Bermuda, but they continue to operate in the United States. They still receive Federal, State and local services such as police, fire and schools and, of course, they still rely on the protection of our courageous armed services here at home and around the world. The only difference is they now get it all for free while U.S. citizens and loyal U.S. companies continue to pay the bill. This is unpatriotic, especially in light of our current economic situation. We are now seeing a major growing budget deficit, expected to be as much as $100 billion this year. The huge Federal surplus we had only a year ago has been entirely wiped out, mostly because of erroneous, irresponsible tax policy. So critical programs like Social Security and Medicare are in serious jeopardy just as the largest generation in the history of this country is getting ready to retire.

Stanley Works in Connecticut, which has been alluded to previously, stamps ``USA'' on its products while at the same time ships its jobs overseas, ships its corporate entity to Bermuda, and will end up evading virtually all of its U.S. taxes. But that is not the end of the outrage that we face. I had previously noted that the U.S. Treasury and small shareholders will have to bear the brunt of this unfair tax scheme. In fact, if this tax dodge goes through, individual Stanley shareholders will have to pay an estimated $150 million in additional capital gains taxes. But yesterday's New York Times reported on the real scope of this outrage, and I quote:

``Even if their shares rose 11.5 percent, they, the shareholders, will barely break even after taxes. At Stanley Works, the CEO stands to pocket an amount equal to 58 cents of each dollar the company would save in corporate income taxes in the first year.''

That is $17.4 million of an estimated $30 million in savings out of the Treasury into the CEO's individual pocket. Additionally, the CEO, if he receives all of the options he is eligible for under the current plan, would gain $385 million by exercising those options. The CEO is raiding the U.S. Treasury at a time of war at the expense of the taxpayers of this country and the shareholders that the CEO is supposed to represent. The gentleman from Massachusetts (Mr. Neal) and I have offered legislation on this issue. We call on the majority to allow it to be brought forward for a vote.

Mr. WELLER. Mr. Speaker, I yield myself such time as I may consume.

I would briefly like to remind the gentleman from Connecticut that the Committee on Ways and Means will be conducting a hearing on this subject which he raises. I also note that the gentlewoman from his home State Connecticut (Mrs. Johnson) has been a leader on this issue with the legislation that she has offered, H.R. 4756. That legislation, as well as the gentleman from Massachusetts' legislation, will be the subject of the Committee on Ways and Means hearing on June 13.

Mr. Speaker, I reserve the balance of my time.

Mr. NEAL of Massachusetts. Mr. Speaker, I yield myself such time as I may consume.

We have a request for $48 billion more for national defense which the President is going to largely get, $38 billion more for homeland security, and these corporations are moving to Bermuda rather than joining in with the rest of the American family and paying their share.

Mr. Speaker, I yield 3 minutes to the gentleman from Texas (Mr. Doggett).

Mr. DOGGETT. Mr. Speaker, the tragedy of September 11 really brought out the best of the American spirit, with so many people across this country asking, ``What can I do to help my country? What can I do to help my neighbors?'' But unfortunately that spirit did not extend to some of the larger multinationals in this country. Recognizing that there would be additional costs for national security, for homeland security, their first concern seems to have been, ``What can I do to dodge my fair share of the cost of additional security, which, as a multinational operating around the globe, I particularly need?

{time} 1245

So we have seen a series of companies decide that their sacrifice for America would be buying a mailbox in Bermuda or some other country and would shift the responsibility of paying for our enhanced national security needs on to ordinary taxpaying families.

Stanley Tool Company, which the gentleman from Connecticut (Mr. Maloney) and the gentleman from Massachusetts (Mr. Neal) have taken the lead in focusing attention on the problem and demanding action now. Our Republican colleagues prefer studying the problem until so many corporations have departed.

Stanley Tool Company has hammered the American taxpayer. Who do you think is going to pick up the cost of this additional national security? It will not be Stanley Tool. They renounced their American citizenship like these other companies and decided they would go abroad, or at least send their mailbox abroad.

For our Republican colleagues, who never seem to have met an abusive tax shelter that they did not like, this is only one of many types of corporate tax shelters that are abusive and they have avoided taking any action on, but instead tell us that what we need is a study. Well, I have here the study that the Treasury Department just completed on Friday, and if you look in the fine print of that study, you will find one very significant conclusion. The conclusion of the Treasury Department is that we ought to keep multinational corporations from having to send their mailbox abroad by awarding further corporate tax breaks. Treasury's answer is, cut Stanley Tool Company's taxes here so they do not have to pay for a mailbox abroad.

That is not sharing the sacrifice. ``Study'' has been an excuse for inaction, and the call for study this morning invites more inaction. If we keep studying, as they recommend, the only appropriate legislation for this Congress to enact would call to erect a big sign that says:

``Let the last multinational flip off the lights in America.''

I would say that the gentleman from Illinois (Mr. Weller) is absolutely right about saying that today this debate is about the marriage penalty. It is about the marriage penalty that all of America suffers when the House Republican leadership and this Administration are married to special interests, even to the extent that they let them totally dodge their tax responsibility and instead turn to the Social Security and Medicare trust funds to pick up the tab. That is wrong. That is the kind of a marriage penalty we need to be addressing today by adopting the Neal-Maloney legislation.

Mr. WELLER. Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, briefly responding to the dialogue of my colleague and member of the Committee on Ways and Means, I would note again that he is absolutely right. Today's debate is about eliminating the marriage tax penalty, simplifying the Tax Code for low- and moderate-income working married couplings.

This debate is also about whether or not we give hundreds of thousands, if not millions, of welfare recipients the opportunity to have a job, to have a chance. That is what this debate is about.

I realize there are some who came here to practice campaign rhetoric; it is a campaign season. And the Committee on Ways and Means is conducting a hearing on the issue that the gentlemen and women on the other side have raised this morning.

Mr. Speaker, I reserve the balance of my time.

Mr. NEAL of Massachusetts. Mr. Speaker, I yield myself the balance of my time to close.

The SPEAKER pro tempore (Mr. Linder). The gentleman from Massachusetts is recognized for 1\1/2\ minutes.

Mr. NEAL of Massachusetts. Mr. Speaker, an editorial from the Hartford Courant on May 14 said: ``Guess who will wind up picking up the tab as a result of Stanley's tax avoidance? Other American taxpayers, of course.''

The New York Times on May 13 wrote: ``Even in the best of times, it is outrageous for companies to engage in offshore shenanigans to avoid paying their fair share of taxes. Doing so after the Enron scandal, in dire fiscal times and when the Nation is at war is unconscionable.''

How about the Houston Chronicle on May 9 which stated: ``American companies that have no headquarters, no employees or operations in foreign tax havens should not be able to lower their taxes by acquiring an island post office box. Basic fairness to American companies that remain incorporated in America is at stake.''

How about the Springfield Union News editorial on May 7: ``When a U.S.-based corporation decides to reincorporate, basing its operations in, say, the Cayman Islands when the company has little more than a mailbox there, it can legally avoid millions of dollars in taxes, there will come no better moment than this one as an opportunity to right a wrong. We look forward to a floor vote on this matter.''

How about Paul Krugman writing in the New York Times: ``Flying the flag of convenience and seeking rewards.''

Or columnist Jeff Brown in the Philadelphia Inquirer: ``Yet Stanley won't have to pay its fair share for the good life and safe business climate that we have created for all of them. It shouldn't be allowed to get away with this.''

And one might ask, will it play in Peoria? Let us try the editorial from the Peoria Journal Star as well: ``Tax policy of this sort is outrageously offensive, if not masochistic. It penalizes businesses that have ethically and responsibly done their part and rewards those that do not.''

Mr. Speaker, we would like a vote on our side on the question of these companies moving to Bermuda in this time of war. We want an opportunity to voice to the American people the concerns that they have expressed to us through a vote in this Chamber to stop corporate expatriation.

Mr. WELLER. Mr. Speaker, I yield myself the balance of my time.

Mr. Speaker, I rise in support of the Encouraging Work and Supporting Marriage Act of 2002, legislation that accomplishes two goals, that is, a quicker phase-out of the marriage tax penalty for low- and moderate-

income workers, and increasing the opportunity for those who are on welfare to have a chance to have a job. That is what this debate is all about.

I know there are other issues that have been raised by some that are in the ``excuse caucus'' of the Democratic Party, who believe there is always an excuse not to do these things. But today we wanted to eliminate the marriage tax penalty. Today we want to increase the opportunity to help those who are on welfare go to work.

Let me give you an example of a couple from the district that I represent who suffer the marriage tax penalty, a result of the complicated Tax Code that we have had and, until President Bush became President, was in place, and thanks to President Bush and the Republican leadership as well as Republican majority in this House of Representatives, we eliminated the marriage tax penalty. Unfortunately, it had to be phased out, we could not do it all at once; but we passed legislation to accomplish that.

Jose and Magdalena Castillo are two laborers from Joliet, Illinois. They are both in the workforce. Because they are married, they file their taxes jointly, it pushes them into a higher tax bracket, they pay the marriage tax penalty, about $1,150 in higher taxes just because they are married. But thanks to the Bush tax cut, which resulted from a Republican majority in this House, Jose and Magdalena Castillo no longer pay the marriage tax penalty.

Today we want to help millions of couples such as Jose and Magdalena Castillo by phasing out the marriage tax penalty more quickly. For those who are low- and moderate-income taxpayers, those who do not itemize, in the phase-in they were not going to receive the full impact of the elimination of the marriage tax penalty to them until 2005.

What we have before us today is legislation that eliminates the marriage tax penalty for low- and moderate-income taxpayers in 2003, next year. As a result of that, 9 million married couples will receive immediate relief, and I will note that 300,000 low- and moderate-income married working couples will no longer have to itemize their taxes as a result of this legislation. That is progress, and I am proud to say this is good legislation.

I would also note that this legislation helps hundreds of thousands of other hard-working, low-income families. This legislation simplifies the Work Opportunity and Welfare-to-Work tax credits. President Bush was in my home area of Chicago just this past week. President Bush went to a facility, it was a UPS, United Parcel Service, facility. They are one of the leading companies in helping those on welfare with an opportunity to go to work. The President highlighted the Work Opportunity Tax Credit, how it has been a successful tool in our effort to give those on welfare a chance, a chance for a job.

Well, the President drew attention to a very successful program that we need to continue to improve. Today's legislation simplifies the Work Opportunity and Welfare-to-Work tax credits. In fact, it combines the two so there is only one, to make it much more simple for those that use, the private business that hires and gives opportunities for welfare recipients.

But also I would note that this legislation gives more low-income welfare recipients the opportunity to participate. If they have a criminal past and they are trying to make right, if they have been an ex-felon, we give greater opportunity because they want to do the right thing and go to work. If they are on food stamps, we raise the eligibility age limit for those on food stamps to participate in the Work Opportunity Tax Credit. We also expand incentives for vocational rehabilitation referrals, again giving more opportunity for low-income individuals to have a chance to go to work and get off of welfare.

This is good legislation, and regardless of some of the rhetoric we have heard today, it is about two things: eliminating the marriage tax penalty and giving those on welfare an opportunity to go to work. Those are two very noble goals, and I am proud to say that this legislation passed the Committee on Ways and Means unanimously. Regardless of the rhetoric we have heard from the other side from the ``excuses caucus,'' it passed unanimously. They voted for it. My hope is they will vote for it again, because this legislation to eliminate the marriage tax penalty, to give those on welfare a chance, an opportunity to go to work, deserves bipartisan support.

Mr. Speaker, I ask for bipartisan support for this legislation.

Mr. Speaker, I yield back the balance of my time.

The SPEAKER pro tempore. The question is on the motion offered by the gentleman from Illinois (Mr. Weller) that the House suspend the rules and pass the bill, H.R. 4626, as amended.

The question was taken.

The SPEAKER pro tempore. In the opinion of the Chair, two-thirds of those present have voted in the affirmative.

Mr. WELLER. Mr. Speaker, on that I demand the yeas and nays.

The yeas and nays were ordered.

The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the Chair's prior announcement, further proceedings on this motion will be postponed.

Conference Report (H. Rept. 107-481)

The committee of conference on the disagreeing votes of the two Houses on the amendment of the Senate to the bill (H.R. 3448), to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies, having met, after full and free conference, have agreed to recommend and do recommend to their respective Houses as follows:

That the House recede from its disagreement to the amendment of the Senate and agree to the same with an amendment as follows:

In lieu of the matter proposed to be inserted by the Senate amendment, insert the following:

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.--This Act may be cited as the ``Public Health Security and Bioterrorism Preparedness and Response Act of 2002''.

(b) Table of Contents.--The table of contents of the Act is as follows:

TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH

EMERGENCIES

Subtitle A--National Preparedness and Response Planning, Coordinating, and Reporting

Sec. 101. National preparedness and response.

Sec. 102. Assistant Secretary for Public Health Emergency Preparedness;

National Disaster Medical System.

Sec. 103. Improving ability of Centers for Disease Control and

Prevention.

Sec. 104. Advisory committees and communications; study regarding communications abilities of public health agencies.

Sec. 105. Education of health care personnel; training regarding pediatric issues.

Sec. 106. Grants regarding shortages of certain health professionals.

Sec. 107. Emergency system for advance registration of health professions volunteers.

Sec. 108. Working group.

Sec. 109. Antimicrobial resistance.

Sec. 110. Supplies and services in lieu of award funds.

Sec. 111. Additional amendments.

Subtitle B--Strategic National Stockpile; Development of Priority

Countermeasures

Sec. 121. Strategic national stockpile.

Sec. 122. Accelerated approval of priority countermeasures.

Sec. 123. Issuance of rule on animal trials.

Sec. 124. Security for countermeasure development and production.

Sec. 125. Accelerated countermeasure research and development.

Sec. 126. Evaluation of new and emerging technologies regarding bioterrorist attack and other public health emergencies.

Sec. 127. Potassium iodide.

Subtitle C--Improving State, Local, and Hospital Preparedness for and

Response to Bioterrorism and Other Public Health Emergencies

Sec. 131. Grants to improve State, local, and hospital preparedness for and response to bioterrorism and other public health emergencies.

Subtitle D--Emergency Authorities; Additional Provisions

Sec. 141. Reporting deadlines.

Sec. 142. Streamlining and clarifying communicable disease quarantine provisions.

Sec. 143. Emergency waiver of Medicare, Medicaid, and SCHIP requirements.

Sec. 144. Provision for expiration of public health emergencies.

Subtitle E--Additional Provisions

Sec. 151. Designated State public emergency announcement plan.

Sec. 152. Expanded research by Secretary of Energy.

Sec. 153. Expanded research on worker health and safety.

Sec. 154. Enhancement of emergency preparedness of Department of

Veterans Affairs.

Sec. 155. Reauthorization of existing program.

Sec. 156. Sense of Congress.

Sec. 157. General Accounting Office report.

Sec. 158. Certain awards.

Sec. 159. Public access defibrillation programs and public access defibrillation demonstration projects.

TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS

Subtitle A--Department of Health and Human Services

Sec. 201. Regulation of certain biological agents and toxins.

Sec. 202. Implementation by Department of Health and Human Services.

Sec. 203. Effective dates.

Sec. 204. Conforming amendment.

Subtitle B--Department of Agriculture

Sec. 211. Short title.

Sec. 212. Regulation of certain biological agents and toxins.

Sec. 213. Implementation by Department of Agriculture.

Subtitle C--Interagency Coordination Regarding Overlap Agents and

Toxins

Sec. 221. Interagency coordination.

Subtitle D--Criminal Penalties Regarding Certain Biological Agents and

Toxins

Sec. 231. Criminal penalties.

TITLE III--PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG SUPPLY

Subtitle A--Protection of Food Supply

Sec. 301. Food safety and security strategy.

Sec. 302. Protection against adulteration of food.

Sec. 303. Administrative detention.

Sec. 304. Debarment for repeated or serious food import violations.

Sec. 305. Registration of food facilities.

Sec. 306. Maintenance and inspection of records for foods.

Sec. 307. Prior notice of imported food shipments.

Sec. 308. Authority to mark articles refused admission into United

States.

Sec. 309. Prohibition against port shopping.

Sec. 310. Notices to States regarding imported food.

Sec. 311. Grants to States for inspections.

Sec. 312. Surveillance and information grants and authorities.

Sec. 313. Surveillance of zoonotic diseases.

Sec. 314. Authority to commission other Federal officials to conduct inspections.

Sec. 315. Rule of construction.

Subtitle B--Protection of Drug Supply

Sec. 321. Annual registration of foreign manufacturers; shipping information; drug and device listing.

Sec. 322. Requirement of additional information regarding import components intended for use in export products.

Subtitle C--General Provisions Relating to Upgrade of Agricultural

Security

Sec. 331. Expansion of Animal and Plant Health Inspection Service activities.

Sec. 332. Expansion of Food Safety Inspection Service activities.

Sec. 333. Biosecurity upgrades at the Department of Agriculture.

Sec. 334. Agricultural biosecurity.

Sec. 335. Agricultural bioterrorism research and development.

Sec. 336. Animal enterprise terrorism penalties.

TITLE IV--DRINKING WATER SECURITY AND SAFETY

Sec. 401. Terrorist and other intentional acts.

Sec. 402. Other Safe Drinking Water Act amendments.

Sec. 403. Miscellaneous and technical amendments.

TITLE V--ADDITIONAL PROVISIONS

Subtitle A--Prescription Drug User Fees

Sec. 501. Short title.

Sec. 502. Findings. Sec. 503. Definitions.

Sec. 504. Authority to assess and use drug fees.

Sec. 505. Accountability and reports.

Sec. 506. Reports of postmarketing studies.

Sec. 507. Savings clause.

Sec. 508. Effective date.

Sec. 509. Sunset clause.

Subtitle B--Funding Provisions Regarding Food and Drug Administration

Sec. 521. Office of Drug Safety.

Sec. 522. Division of Drug Marketing, Advertising, and Communications.

Sec. 523. Office of Generic Drugs.

Subtitle C--Additional Provisions

Sec. 531. Transition to digital television.

Sec. 532. 3-year delay in lock in procedures for Medicare+Choice plans; change in Medicare+Choice reporting deadlines and annual, coordinated election period for 2003, 2004, and 2005.

TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH

EMERGENCIES

Subtitle A--National Preparedness and Response Planning, Coordinating, and Reporting

SEC. 101. NATIONAL PREPAREDNESS AND RESPONSE.

(a) In General.--The Public Health Service Act (42 U.S.C. 201 et seq.) is amended by adding at the end the following title:

``TITLE XXVIII--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC

HEALTH EMERGENCIES

``Subtitle A--National Preparedness and Response Planning,

Coordinating, and Reporting

``SEC. 2801. NATIONAL PREPAREDNESS PLAN.

``(a) In General.--

``(1) Preparedness and response regarding public health emergencies.--The Secretary shall further develop and implement a coordinated strategy, building upon the core public health capabilities established pursuant to section 319A, for carrying out health-related activities to prepare for and respond effectively to bioterrorism and other public health emergencies, including the preparation of a plan under this section. The Secretary shall periodically thereafter review and, as appropriate, revise the plan.

``(2) National approach.--In carrying out paragraph (1), the Secretary shall collaborate with the States toward the goal of ensuring that the activities of the Secretary regarding bioterrorism and other public health emergencies are coordinated with activities of the States, including local governments.

``(3) Evaluation of progress.--The plan under paragraph (1) shall provide for specific benchmarks and outcome measures for evaluating the progress of the Secretary and the States, including local governments, with respect to the plan under paragraph (1), including progress toward achieving the goals specified in subsection (b).

``(b) Preparedness Goals.--The plan under subsection (a) should include provisions in furtherance of the following:

``(1) Providing effective assistance to State and local governments in the event of bioterrorism or other public health emergency.

``(2) Ensuring that State and local governments have appropriate capacity to detect and respond effectively to such emergencies, including capacities for the following:

``(A) Effective public health surveillance and reporting mechanisms at the State and local levels.

``(B) Appropriate laboratory readiness.

``(C) Properly trained and equipped emergency response, public health, and medical personnel.

``(D) Health and safety protection of workers responding to such an emergency.

``(E) Public health agencies that are prepared to coordinate health services (including mental health services) during and after such emergencies.

``(F) Participation in communications networks that can effectively disseminate relevant information in a timely and secure manner to appropriate public and private entities and to the public.

``(3) Developing and maintaining medical countermeasures

(such as drugs, vaccines and other biological products, medical devices, and other supplies) against biological agents and toxins that may be involved in such emergencies.

``(4) Ensuring coordination and minimizing duplication of Federal, State, and local planning, preparedness, and response activities, including during the investigation of a suspicious disease outbreak or other potential public health emergency.

``(5) Enhancing the readiness of hospitals and other health care facilities to respond effectively to such emergencies.

``(c) Reports to Congress.--

``(1) In general.--Not later than one year after the date of the enactment of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and biennially thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report concerning progress with respect to the plan under subsection (a), including progress toward achieving the goals specified in subsection (b).

``(2) Additional authority.--Reports submitted under paragraph (1) by the Secretary (other than the first report) shall make recommendations concerning--

``(A) any additional legislative authority that the Secretary determines is necessary for fully implementing the plan under subsection (a), including meeting the goals under subsection (b); and

``(B) any additional legislative authority that the Secretary determines is necessary under section 319 to protect the public health in the event of an emergency described in section 319(a).

``(d) Rule of Construction.--This section may not be construed as expanding or limiting any of the authorities of the Secretary that, on the day before the date of the enactment of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, were in effect with respect to preparing for and responding effectively to bioterrorism and other public health emergencies.''.

(b) Other Reports.--

(1) In general.--Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the

``Secretary'') shall submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report concerning--

(A) the recommendations and findings of the National Advisory Committee on Children and Terrorism under section 319F(c)(2) of the Public Health Service Act;

(B) the recommendations and findings of the EPIC Advisory Committee under section 319F(c)(3) of such Act;

(C) the characteristics that may render a rural community uniquely vulnerable to a biological attack, including distance, lack of emergency transport, hospital or laboratory capacity, lack of integration of Federal or State public health networks, workforce deficits, or other relevant characteristics;

(D) the characteristics that may render areas or populations designated as medically underserved populations

(as defined in section 330 of such Act) uniquely vulnerable to a biological attack, including significant numbers of low-income or uninsured individuals, lack of affordable and accessible health care services, insufficient public and primary health care resources, lack of integration of Federal or State public health networks, workforce deficits, or other relevant characteristics;

(E) the recommendations of the Secretary with respect to additional legislative authority that the Secretary determines is necessary to effectively strengthen rural communities, or medically underserved populations (as defined in section 330 of such Act); and

(F) the need for and benefits of a National Disaster Response Medical Volunteer Service that would be a private-sector, community-based rapid response corps of medical volunteers.

(2) Study regarding local emergency response methods.--The Secretary shall conduct a study of effective methods for the provision of emergency response services through local governments (including through private response contractors and volunteers of such governments) in a consistent manner in response to acts of bioterrorism or other public health emergencies. Not later than 180 days after the date of the enactment of this Act, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report describing the findings of the study.

SEC. 102. ASSISTANT SECRETARY FOR PUBLIC HEALTH EMERGENCY

PREPAREDNESS; NATIONAL DISASTER MEDICAL SYSTEM.

(a) In General.--Title XXVIII of the Public Health Service Act, as added by section 101 of this Act, is amended by adding at the end the following subtitle:

``Subtitle B--Emergency Preparedness and Response

``SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO

BIOTERRORISM AND OTHER PUBLIC HEALTH

EMERGENCIES.

``(a) Assistant Secretary for Public Health Emergency Preparedness.--

``(1) In general.--There is established within the Department of Health and Human Services the position of Assistant Secretary for Public Health Emergency Preparedness. The President shall appoint an individual to serve in such position. Such Assistant Secretary shall report to the Secretary.

``(2) Duties.--Subject to the authority of the Secretary, the Assistant Secretary for Public Health Emergency Preparedness shall carry out the following duties with respect to bioterrorism and other public health emergencies:

``(A) Coordinate on behalf of the Secretary--

``(i) interagency interfaces between the Department of Health and Human Services (referred to in this paragraph as the `Department') and other departments, agencies, and offices of the United States; and

``(ii) interfaces between the Department and State and local entities with responsibility for emergency preparedness.

``(B) Coordinate the operations of the National Disaster Medical System and any other emergency response activities within the Department of Health and Human Services that are related to bioterrorism and other public health emergencies.

``(C) Coordinate the efforts of the Department to bolster State and local emergency preparedness for a bioterrorist attack or other public health emergency, and evaluate the progress of such entities in meeting the benchmarks and other outcome measures contained in the national plan and in meeting the core public health capabilities established pursuant to 319A.

``(D) Any other duties determined appropriate by the Secretary.

``(b) National Disaster Medical System.--

``(1) In general.--The Secretary shall provide for the operation in accordance with this section of a system to be known as the National Disaster Medical System. The Secretary shall designate the Assistant Secretary for Public Health Emergency Preparedness as the head of the National Disaster Medical System, subject to the authority of the Secretary.

``(2) Federal and state collaborative system.--

``(A) In general.--The National Disaster Medical System shall be a coordinated effort by the Federal agencies specified in subparagraph (B), working in collaboration with the States and other appropriate public or private entities, to carry out the purposes described in paragraph (3).

``(B) Participating federal agencies.--The Federal agencies referred to in subparagraph (A) are the Department of Health and Human Services, the Federal Emergency Management Agency, the Department of Defense, and the Department of Veterans Affairs.

``(3) Purpose of system.--

``(A) In general.--The Secretary may activate the National Disaster Medical System to--

``(i) provide health services, health-related social services, other appropriate human services, and appropriate auxiliary services to respond to the needs of victims of a public health emergency (whether or not determined to be a public health emergency under section 319); or

``(ii) be present at locations, and for limited periods of time, specified by the Secretary on the basis that the Secretary has determined that a location is at risk of a public health emergency during the time specified.

``(B) Ongoing activities.--The National Disaster Medical System shall carry out such ongoing activities as may be necessary to prepare for the provision of services described in subparagraph (A) in the event that the Secretary activates the National Disaster Medical System for such purposes.

``(C) Test for mobilization of system.--During the one-year period beginning on the date of the enactment of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Secretary shall conduct an exercise to test the capability and timeliness of the National Disaster Medical System to mobilize and otherwise respond effectively to a bioterrorist attack or other public health emergency that affects two or more geographic locations concurrently. Thereafter, the Secretary may periodically conduct such exercises regarding the National Disaster Medical System as the Secretary determines to be appropriate.

``(c) Criteria.--

``(1) In general.--The Secretary shall establish criteria for the operation of the National Disaster Medical System.

``(2) Participation agreements for non-federal entities.--In carrying out paragraph (1), the Secretary shall establish criteria regarding the participation of States and private entities in the National Disaster Medical System, including criteria regarding agreements for such participation. The criteria shall include the following:

``(A) Provisions relating to the custody and use of Federal personal property by such entities, which may in the discretion of the Secretary include authorizing the custody and use of such property to respond to emergency situations for which the National Disaster Medical System has not been activated by the Secretary pursuant to subsection (b)(3)(A). Any such custody and use of Federal personal property shall be on a reimbursable basis.

``(B) Provisions relating to circumstances in which an individual or entity has agreements with both the National Disaster Medical System and another entity regarding the provision of emergency services by the individual. Such provisions shall address the issue of priorities among the agreements involved.

``(d) Intermittent Disaster-Response Personnel.--

``(1) In general.--For the purpose of assisting the National Disaster Medical System in carrying out duties under this section, the Secretary may appoint individuals to serve as intermittent personnel of such System in accordance with applicable civil service laws and regulations.

``(2) Liability.--For purposes of section 224(a) and the remedies described in such section, an individual appointed under paragraph (1) shall, while acting within the scope of such appointment, be considered to be an employee of the Public Health Service performing medical, surgical, dental, or related functions. With respect to the participation of individuals appointed under paragraph (1) in training programs authorized by the Assistant Secretary for Public Health Emergency Preparedness or a comparable official of any Federal agency specified in subsection (b)(2)(B), acts of individuals so appointed that are within the scope of such participation shall be considered within the scope of the appointment under paragraph (1) (regardless of whether the individuals receive compensation for such participation).

``(e) Certain Employment Issues Regarding Intermittent Appointments.--

``(1) Intermittent disaster-response appointee.--For purposes of this subsection, the term `intermittent disaster-response appointee' means an individual appointed by the Secretary under subsection (d).

``(2) Compensation for work injuries.--An intermittent disaster-response appointee shall, while acting in the scope of such appointment, be considered to be an employee of the Public Health Service performing medical, surgical, dental, or related functions, and an injury sustained by such an individual shall be deemed `in the performance of duty', for purposes of chapter 81 of title 5, United States Code, pertaining to compensation for work injuries. With respect to the participation of individuals appointed under subsection

(d) in training programs authorized by the Assistant Secretary for Public Health Emergency Preparedness or a comparable official of any Federal agency specified in subsection (b)(2)(B), injuries sustained by such an individual, while acting within the scope of such participation, also shall be deemed `in the performance of duty' for purposes of chapter 81 of title 5, United States Code (regardless of whether the individuals receive compensation for such participation). In the event of an injury to such an intermittent disaster-response appointee, the Secretary of Labor shall be responsible for making determinations as to whether the claimant is entitled to compensation or other benefits in accordance with chapter 81 of title 5, United States Code.

``(3) Employment and reemployment rights.--

``(A) In general.--Service as an intermittent disaster-response appointee when the Secretary activates the National Disaster Medical System or when the individual participates in a training program authorized by the Assistant Secretary for Public Health Emergency Preparedness or a comparable official of any Federal agency specified in subsection

(b)(2)(B) shall be deemed `service in the uniformed services' for purposes of chapter 43 of title 38, United States Code, pertaining to employment and reemployment rights of individuals who have performed service in the uniformed services (regardless of whether the individual receives compensation for such participation). All rights and obligations of such persons and procedures for assistance, enforcement, and investigation shall be as provided for in chapter 43 of title 38, United States Code.

``(B) Notice of absence from position of employment.--Preclusion of giving notice of service by necessity of Service as an intermittent disaster-response appointee when the Secretary activates the National Disaster Medical System shall be deemed preclusion by `military necessity' for purposes of section 4312(b) of title 38, United States Code, pertaining to giving notice of absence from a position of employment. A determination of such necessity shall be made by the Secretary, in consultation with the Secretary of Defense, and shall not be subject to judicial review.

``(4) Limitation.--An intermittent disaster-response appointee shall not be deemed an employee of the Department of Health and Human Services for purposes other than those specifically set forth in this section.

``(f) Rule of Construction Regarding Use of Commissioned Corps.--If the Secretary assigns commissioned officers of the Regular or Reserve Corps to serve with the National Disaster Medical System, such assignments do not affect the terms and conditions of their appointments as commissioned officers of the Regular or Reserve Corps, respectively

(including with respect to pay and allowances, retirement, benefits, rights, privileges, and immunities).

``(g) Definition.--For purposes of this section, the term

`auxiliary services' includes mortuary services, veterinary services, and other services that are determined by the Secretary to be appropriate with respect to the needs referred to in subsection (b)(3)(A).

``(h) Authorization of Appropriations.--For the purpose of providing for the Assistant Secretary for Public Health Emergency Preparedness and the operations of the National Disaster Medical System, other than purposes for which amounts in the Public Health Emergency Fund under section 319 are available, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2002 through 2006.''.

(b) Sense of Congress Regarding Resources of National Disaster Medical System.--It is the sense of the Congress that the Secretary of Health and Human Services should provide sufficient resources to entities tasked to carry out the duties of the National Disaster Medical System for reimbursement of expenses, operations, purchase and maintenance of equipment, training, and other funds expended in furtherance of the National Disaster Medical System.

SEC. 103. IMPROVING ABILITY OF CENTERS FOR DISEASE CONTROL

AND PREVENTION.

Section 319D of the Public Health Service Act (42 U.S.C. 247d-4) is amended to read as follows:

``SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND

PREVENTION.

``(a) Facilities; Capacities.--

``(1) Findings.--Congress finds that the Centers for Disease Control and Prevention has an essential role in defending against and combatting public health threats and requires secure and modern facilities, and expanded and improved capabilities related to bioterrorism and other public health emergencies, sufficient to enable such Centers to conduct this important mission.

``(2) Facilities.--

``(A) In general.--The Director of the Centers for Disease Control and Prevention may design, construct, and equip new facilities, renovate existing facilities (including laboratories, laboratory support buildings, scientific communication facilities, transshipment complexes, secured and isolated parking structures, office buildings, and other facilities and infrastructure), and upgrade security of such facilities, in order to better conduct the capacities described in section 319A, and for supporting public health activities.

``(B) Multiyear contracting authority.--For any project of designing, constructing, equipping, or renovating any facility under subparagraph (A), the Director of the Centers for Disease Control and Prevention may enter into a single contract or related contracts that collectively include the full scope of the project, and the solicitation and contract shall contain the clause `availability of funds' found at section 52.232-18 of title 48, Code of Federal Regulations.

``(3) Improving the capacities of the centers for disease control and prevention.--The Secretary, taking into account evaluations under section 319B(a), shall expand, enhance, and improve the capabilities of the Centers for Disease Control and Prevention relating to preparedness for and responding effectively to bioterrorism and other public health emergencies. Activities that may be carried out under the preceding sentence include--

``(A) expanding or enhancing the training of personnel;

``(B) improving communications facilities and networks, including delivery of necessary information to rural areas;

``(C) improving capabilities for public health surveillance and reporting activities, taking into account the integrated system or systems of public health alert communications and surveillance networks under subsection (b); and

``(D) improving laboratory facilities related to bioterrorism and other public health emergencies, including increasing the security of such facilities.

``(b) National Communications and Surveillance Networks.--

``(1) In general.--The Secretary, directly or through awards of grants, contracts, or cooperative agreements, shall provide for the establishment of an integrated system or systems of public health alert communications and surveillance networks between and among--

``(A) Federal, State, and local public health officials;

``(B) public and private health-related laboratories, hospitals, and other health care facilities; and

``(C) any other entities determined appropriate by the Secretary.

``(2) Requirements.--The Secretary shall ensure that networks under paragraph (1) allow for the timely sharing and discussion, in a secure manner, of essential information concerning bioterrorism or another public health emergency, or recommended methods for responding to such an attack or emergency.

``(3) Standards.--Not later than one year after the date of the enactment of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Secretary, in cooperation with health care providers and State and local public health officials, shall establish any additional technical and reporting standards (including standards for interoperability) for networks under paragraph (1).

``(c) Authorization of Appropriations.--

``(1) Facilities; capacities.--

``(A) Facilities.--For the purpose of carrying out subsection (a)(2), there are authorized to be appropriated

$300,000,000 for each of the fiscal years 2002 and 2003, and such sums as may be necessary for each of the fiscal years 2004 through 2006.

``(B) Mission; Improving capacities.--For the purposes of achieving the mission of the Centers for Disease Control and Prevention described in subsection (a)(1), for carrying out subsection (a)(3), for better conducting the capacities described in section 319A, and for supporting public health activities, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2002 through 2006.

``(2) National communications and surveillance networks.--For the purpose of carrying out subsection (b), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2002 through 2006.''.

SEC. 104. ADVISORY COMMITTEES AND COMMUNICATIONS; STUDY

REGARDING COMMUNICATIONS ABILITIES OF PUBLIC

HEALTH AGENCIES.

(a) In General.--Section 319F of the Public Health Service Act (42 U.S.C. 247d-6) is amended--

(1) by striking subsections (b) and (i);

(2) by redesignating subsections (c) through (h) as subsections (e) through (j), respectively; and

(3) by inserting after subsection (a) the following subsections:

``(b) Advice to the Federal Government.--

``(1) Required advisory committees.--In coordination with the working group under subsection (a), the Secretary shall establish advisory committees in accordance with paragraphs

(2) and (3) to provide expert recommendations to assist such working groups in carrying out their respective responsibilities under subsections (a) and (b).

``(2) National advisory committee on children and terrorism.--

``(A) In general.--For purposes of paragraph (1), the Secretary shall establish an advisory committee to be known as the National Advisory Committee on Children and Terrorism

(referred to in this paragraph as the `Advisory Committee').

``(B) Duties.--The Advisory Committee shall provide recommendations regarding--

``(i) the preparedness of the health care (including mental health care) system to respond to bioterrorism as it relates to children;

``(ii) needed changes to the health care and emergency medical service systems and emergency medical services protocols to meet the special needs of children; and

``(iii) changes, if necessary, to the national stockpile under section 121 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 to meet the emergency health security of children.

``(C) Composition.--The Advisory Committee shall be composed of such Federal officials as may be appropriate to address the special needs of the diverse population groups of children, and child health experts on infectious disease, environmental health, toxicology, and other relevant professional disciplines.

``(D) Termination.--The Advisory Committee terminates one year after the date of the enactment of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

``(3) Emergency public information and communications advisory committee.--

``(A) In general.--For purposes of paragraph (1), the Secretary shall establish an advisory committee to be known as the Emergency Public Information and Communications Advisory Committee (referred to in this paragraph as the

`EPIC Advisory Committee').

``(B) Duties.--The EPIC Advisory Committee shall make recommendations to the Secretary and the working group under subsection (a) and report on appropriate ways to communicate public health information regarding bioterrorism and other public health emergencies to the public.

``(C) Composition.--The EPIC Advisory Committee shall be composed of individuals representing a diverse group of experts in public health, medicine, communications, behavioral psychology, and other areas determined appropriate by the Secretary.

``(D) Dissemination.--The Secretary shall review the recommendations of the EPIC Advisory Committee and ensure that appropriate information is disseminated to the public.

``(E) Termination.--The EPIC Advisory Committee terminates one year after the date of the enactment of Public Health Security and Bioterrorism Preparedness and Response Act of 2002.

``(c) Strategy for Communication of Information Regarding Bioterrorism and Other Public Health Emergencies.--In coordination with working group under subsection (a), the Secretary shall develop a strategy for effectively communicating information regarding bioterrorism and other public health emergencies, and shall develop means by which to communicate such information. The Secretary may carry out the preceding sentence directly or through grants, contracts, or cooperative agreements.

``(d) Recommendation of Congress Regarding Official Federal Internet Site on Bioterrorism.--It is the recommendation of Congress that there should be established an official Federal Internet site on bioterrorism, either directly or through provision of a grant to an entity that has expertise in bioterrorism and the development of websites, that should include information relevant to diverse populations

(including messages directed at the general public and such relevant groups as medical personnel, public safety workers, and agricultural workers) and links to appropriate State and local government sites.''.

(b) Study Regarding Communications Abilities of Public Health Agencies.--The Secretary of Health and Human Services, in consultation with the Federal Communications Commission, the National Telecommunications and Information Administration, and other appropriate Federal agencies, shall conduct a study to determine whether local public health entities have the ability to maintain communications in the event of a bioterrorist attack or other public health emergency. The study shall examine whether redundancies are required in the telecommunications system, particularly with respect to mobile communications, for public health entities to maintain systems operability and connectivity during such emergencies. The study shall also include recommendations to industry and public health entities about how to implement such redundancies if necessary.

SEC. 105. EDUCATION OF HEALTH CARE PERSONNEL; TRAINING

REGARDING PEDIATRIC ISSUES.

Section 319F(g) of the Public Health Service Act, as redesignated by section 104(a)(2) of this Act, is amended to read as follows:

``(g) Education; Training Regarding Pediatric Issues.--

``(1) Materials; core curriculum.--The Secretary, in collaboration with members of the working group described in subsection (b), and professional organizations and societies, shall--

``(A) develop materials for teaching the elements of a core curriculum for the recognition and identification of potential bioweapons and other agents that may create a public health emergency, and for the care of victims of such emergencies, recognizing the special needs of children and other vulnerable populations, to public health officials, medical professionals, emergency physicians and other emergency department staff, laboratory personnel, and other personnel working in health care facilities (including poison control centers);

``(B) develop a core curriculum and materials for community-wide planning by State and local governments, hospitals and other health care facilities, emergency response units, and appropriate public and private sector entities to respond to a bioterrorist attack or other public health emergency;

``(C) develop materials for proficiency testing of laboratory and other public health personnel for the recognition and identification of potential bioweapons and other agents that may create a public health emergency; and

``(D) provide for dissemination and teaching of the materials described in subparagraphs (A) through (C) by appropriate means, which may include telemedicine, long-distance learning, or other such means.

``(2) Certain entities.--The entities through which education and training activities described in paragraph (1) may be carried out include Public Health Preparedness Centers, the Public Health Service's Noble Training Center, the Emerging Infections Program, the Epidemic Intelligence Service, the Public Health Leadership Institute, multi-State, multi-institutional consortia, other appropriate educational entities, professional organizations and societies, private accrediting organizations, and other nonprofit institutions or entities meeting criteria established by the Secretary.

``(3) Grants and contracts.--In carrying out paragraph (1), the Secretary may carry out activities directly and through the award of grants and contracts, and may enter into interagency cooperative agreements with other Federal agencies.

``(4) Health-related assistance for emergency response personnel training.--The Secretary, in consultation with the Attorney General and the Director of the Federal Emergency Management Agency, may provide technical assistance with respect to health-related aspects of emergency response personnel training carried out by the Department of Justice and the Federal Emergency Management Agency.''.

SEC. 106. GRANTS REGARDING SHORTAGES OF CERTAIN HEALTH

PROFESSIONALS.

Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319G the following section:

``SEC. 319H. GRANTS REGARDING TRAINING AND EDUCATION OF

CERTAIN HEALTH PROFESSIONALS.

``(a) In General.--The Secretary may make awards of grants and cooperative agreements to appropriate public and nonprofit private health or educational entities, including health professions schools and programs as defined in section 799B, for the purpose of providing low-interest loans, partial scholarships, partial fellowships, revolving loan funds, or other cost-sharing forms of assistance for the education and training of individuals in any category of health professions for which there is a shortage that the Secretary determines should be alleviated in order to prepare for or respond effectively to bioterrorism and other public health emergencies.

``(b) Authority Regarding Non-Federal Contributions.--The Secretary may require as a condition of an award under subsection (a) that a grantee under such subsection provide non-Federal contributions toward the purpose described in such subsection.

``(c) Authorization of Appropriations.--For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2002 through 2006.''.

SEC. 107. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF HEALTH

PROFESSIONS VOLUNTEERS.

Part B of title III of the Public Health Service Act, as amended by section 106 of this Act, is amended by inserting after section 319H the following section:

``SEC. 319I. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF

HEALTH PROFESSIONS VOLUNTEERS.

``(a) In General.--The Secretary shall, directly or through an award of a grant, contract, or cooperative agreement, establish and maintain a system for the advance registration of health professionals for the purpose of verifying the credentials, licenses, accreditations, and hospital privileges of such professionals when, during public health emergencies, the professionals volunteer to provide health services (referred to in this section as the `verification system'). In carrying out the preceding sentence, the Secretary shall provide for an electronic database for the verification system.

``(b) Certain Criteria.--The Secretary shall establish provisions regarding the promptness and efficiency of the system in collecting, storing, updating, and disseminating information on the credentials, licenses, accreditations, and hospital privileges of volunteers described in subsection

(a).

``(c) Other Assistance.--The Secretary may make grants and provide technical assistance to States and other public or nonprofit private entities for activities relating to the verification system developed under subsection (a).

``(d) Coordination Among States.--The Secretary may encourage each State to provide legal authority during a public health emergency for health professionals authorized in another State to provide certain health services to provide such health services in the State.

``(e) Rule of Construction.--This section may not be construed as authorizing the Secretary to issue requirements regarding the provision by the States of credentials, licenses, accreditations, or hospital privileges.

``(f) Authorization of Appropriations.--For the purpose of carrying out this section, there are authorized to be appropriated $2,000,000 for fiscal year 2002, and such sums as may be necessary for each of the fiscal years 2003 through 2006.''.

SEC. 108. WORKING GROUP.

Section 319F of the Public Health Service Act, as amended by section 104(a), is amended by striking subsection (a) and inserting the following:

``(a) Working Group on Bioterrorism and Other Public Health Emergencies.--

``(1) In general.--The Secretary, in coordination with the Secretary of Agriculture, the Attorney General, the Director of Central Intelligence, the Secretary of Defense, the Secretary of Energy, the Administrator of the Environmental Protection Agency, the Director of the Federal Emergency Management Agency, the Secretary of Labor, the Secretary of Veterans Affairs, and with other similar Federal officials as determined appropriate, shall establish a working group on the prevention, preparedness, and response to bioterrorism and other public health emergencies. Such joint working group, or subcommittees thereof, shall meet periodically for the purpose of consultation on, assisting in, and making recommendations on--

``(A) responding to a bioterrorist attack, including the provision of appropriate safety and health training and protective measures for medical, emergency service, and other personnel responding to such attacks;

``(B) prioritizing countermeasures required to treat, prevent, or identify exposure to a biological agent or toxin pursuant to section 351A;

``(C) facilitation of the awarding of grants, contracts, or cooperative agreements for the development, manufacture, distribution, supply-chain management, and purchase of priority countermeasures;

``(D) research on pathogens likely to be used in a biological threat or attack on the civilian population;

``(E) development of shared standards for equipment to detect and to protect against biological agents and toxins;

``(F) assessment of the priorities for and enhancement of the preparedness of public health institutions, providers of medical care, and other emergency service personnel

(including firefighters) to detect, diagnose, and respond

(including mental health response) to a biological threat or attack;

``(G) in the recognition that medical and public health professionals are likely to provide much of the first response to such an attack, development and enhancement of the quality of joint planning and training programs that address the public health and medical consequences of a biological threat or attack on the civilian population between--

``(i) local firefighters, ambulance personnel, police and public security officers, or other emergency response personnel; and

``(ii) hospitals, primary care facilities, and public health agencies;

``(H) development of strategies for Federal, State, and local agencies to communicate information to the public regarding biological threats or attacks;

``(I) ensuring that the activities under this subsection address the health security needs of children and other vulnerable populations;

``(J) strategies for decontaminating facilities contaminated as a result of a biological attack, including appropriate protections for the safety of workers conducting such activities;

``(K) subject to compliance with other provisions of Federal law, clarifying the responsibilities among Federal officials for the investigation of suspicious outbreaks of disease and other potential public health emergencies, and for related revisions of the interagency plan known as the Federal response plan; and

``(L) in consultation with the National Highway Traffic Safety Administration and the U.S. Fire Administration, ways to enhance coordination among Federal agencies involved with State, local, and community based emergency medical services, including issuing a report that--

``(i) identifies needs of community-based emergency medical services; and

``(ii) identifies ways to streamline and enhance the process through which Federal agencies support community-based emergency medical services.

``(2) Consultation with experts.--In carrying out subparagraphs (B) and (C) of paragraph (1), the working group under such paragraph shall consult with the pharmaceutical, biotechnology, and medical device industries, and other appropriate experts.

``(3) Use of subcommittees regarding consultation requirements.--With respect to a requirement under law that the working group under paragraph (1) be consulted on a matter, the working group may designate an appropriate subcommittee of the working group to engage in the consultation.

``(4) Discretion in exercise of duties.--Determinations made by the working group under paragraph (1) with respect to carrying out duties under such paragraph are matters committed to agency discretion for purposes of section 701(a) of title 5, Unites States Code.

``(5) Rule of construction.--This subsection may not be construed as establishing new regulatory authority for any of the officials specified in paragraph (1), or as having any legal effect on any other provision of law, including the responsibilities and authorities of the Environmental Protection Agency.''.

SEC. 109. ANTIMICROBIAL RESISTANCE.

Section 319E of the Public Health Service Act (42 U.S.C. 247d-5) is amended--

(1) in subsection (b)--

(A) by striking ``shall conduct and support'' and inserting

``shall directly or through awards of grants or cooperative agreements to public or private entities provide for the conduct of''; and

(B) by amending paragraph (4) to read as follows:

``(4) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens (as determined by the Director of the National Institutes of Health in consultation with the task force established under subsection (a)), in collaboration and coordination with the activities of the Department of Defense and the Joint Genome Institute of the Department of Energy; and'';

(2) in subsection (e)(2), by inserting after ``societies,'' the following: ``schools or programs that train medical laboratory personnel,''; and

(3) in subsection (g), by striking ``and such sums'' and all that follows and inserting the following: ``$25,000,000 for each of the fiscal years 2002 and 2003, and such sums as may be necessary for each of the fiscal years 2004 through 2006.''.

SEC. 110. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS.

Part B of title III of the Public Health Service Act, as amended by section 107 of this Act, is amended by inserting after section 319I the following section:

``SEC. 319J. SUPPLIES AND SERVICES IN LIEU OF AWARD FUNDS

``(a) In General.--Upon the request of a recipient of an award under any of sections 319 through 319I or section 319K, the Secretary may, subject to subsection (b), provide supplies, equipment, and services for the purpose of aiding the recipient in carrying out the purposes for which the award is made and, for such purposes, may detail to the recipient any officer or employee of the Department of Health and Human Services.

``(b) Corresponding Reduction in Payments.--With respect to a request described in subsection (a), the Secretary shall reduce the amount of payments under the award involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.''.

SEC. 111. ADDITIONAL AMENDMENTS.

Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq) is amended--

(1) in section 319A(a)(1), by striking ``10 years'' and inserting ``five years'';

(2) in section 319B(a), in the first sentence, by striking

``10 years'' and inserting ``five years''; and

(3) in section 391F(e)(2), as redesignated by section 104(a)(2) of this Act--

(A) by striking ``or'' after ``clinic,''; and

(B) by inserting before the period following: ``, professional organization or society, school or program that trains medical laboratory personnel, private accrediting organization, or other nonprofit private institution or entity meeting criteria established by the Secretary''.

Subtitle B--Strategic National Stockpile; Development of Priority

Countermeasures

SEC. 121. STRATEGIC NATIONAL STOCKPILE.

(a) Strategic National Stockpile.--

(1) In general.--The Secretary of Health and Human Services

(referred to in this section as the ``Secretary''), in coordination with the Secretary of Veterans Affairs, shall maintain a stockpile or stockpiles of drugs, vaccines and other biological products, medical devices, and other supplies in such numbers, types, and amounts as are determined by the Secretary to be appropriate and practicable, taking into account other available sources, to provide for the emergency health security of the United States, including the emergency health security of children and other vulnerable populations, in the event of a bioterrorist attack or other public health emergency.

(2) Procedures.--The Secretary, in managing the stockpile under paragraph (1), shall--

(A) consult with the working group under section 319F(a) of the Public Health Service Act;

(B) ensure that adequate procedures are followed with respect to such stockpile for inventory management and accounting, and for the physical security of the stockpile;

(C) in consultation with Federal, State, and local officials, take into consideration the timing and location of special events;

(D) review and revise, as appropriate, the contents of the stockpile on a regular basis to ensure that emerging threats, advanced technologies, and new countermeasures are adequately considered;

(E) devise plans for the effective and timely supply-chain management of the stockpile, in consultation with appropriate Federal, State and local agencies, and the public and private health care infrastructure; and

(F) ensure the adequate physical security of the stockpile.

(b) Smallpox Vaccine Development.--

(1) In general.--The Secretary shall award contracts, enter into cooperative agreements, or carry out such other activities as may reasonably be required in order to ensure that the stockpile under subsection (a) includes an amount of vaccine against smallpox as determined by the Secretary to be sufficient to meet the health security needs of the United States.

(2) Rule of construction.--Nothing in this section shall be construed to limit the private distribution, purchase, or sale of vaccines from sources other than the stockpile described in subsection (a).

(c) Disclosures.--No Federal agency shall disclose under section 552, United States Code, any information identifying the location at which materials in the stockpile under subsection (a) are stored.

(d) Definition.--For purposes of subsection (a), the term

``stockpile'' includes--

(1) a physical accumulation (at one or more locations) of the supplies described in subsection (a); or

(2) a contractual agreement between the Secretary and a vendor or vendors under which such vendor or vendors agree to provide to the Secretary supplies described in subsection

(a).

(e) Authorization of Appropriations.--

(1) Strategic national stockpile.--For the purpose of carrying out subsection (a), there are authorized to be appropriated $640,000,000 for fiscal year 2002, and such sums as may be necessary for each of fiscal years 2003 through 2006.

(2) Smallpox vaccine development.--For the purpose of carrying out subsection (b), there are authorized to be appropriated $509,000,000 for fiscal year 2002, and such sums as may be necessary for each of fiscal years 2003 through 2006.

SEC. 122. ACCELERATED APPROVAL OF PRIORITY COUNTERMEASURES.

(a) In General.--The Secretary of Health and Human Services may designate a priority countermeasure as a fast-track product pursuant to section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) or as a device granted review priority pursuant to section 515(d)(5) of such Act (21 U.S.C. 360e(d)(5)). Such a designation may be made prior to the submission of--

(1) a request for designation by the sponsor or applicant; or

(2) an application for the investigation of the drug under section 505(i) of such Act or section 351(a)(3) of the Public Health Service Act.Nothing in this subsection shall be construed to prohibit a sponsor or applicant from declining such a designation.

(b) Use of Animal Trials.--A drug for which approval is sought under section 505(b) of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act on the basis of evidence of effectiveness that is derived from animal studies pursuant to section 123 may be designated as a fast track product for purposes of this section.

(c) Priority Review of Drugs and Biological Products.--A priority countermeasure that is a drug or biological product shall be considered a priority drug or biological product for purposes of performance goals for priority drugs or biological products agreed to by the Commissioner of Food and Drugs.

(d) Definitions.--For purposes of this title:

(1) The term ``priority countermeasure'' has the meaning given such term in section 319F(h)(4) of the Public Health Service Act.

(2) The term ``priority drugs or biological products'' means a drug or biological product that is the subject of a drug or biologics application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997.

SEC. 123. ISSUANCE OF RULE ON ANIMAL TRIALS.

Not later than 90 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall complete the process of rulemaking that was commenced under authority of section 505 of the Federal Food, Drug, and Cosmetic Act and section 351 of the Public Health Service Act with the issuance of the proposed rule entitled ``New Drug and Biological Drug Products; Evidence Needed to Demonstrate Efficacy of New Drugs for Use Against Lethal or Permanently Disabling Toxic Substances When Efficacy Studies in Humans Ethically Cannot be Conducted'' published in the Federal Register on October 5, 1999 (64 Fed. Reg. 53960), and shall promulgate a final rule.

SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND

PRODUCTION.

Part B of title III of the Public Health Service Act, as amended by section 110 of this Act, is amended by inserting after section 319J the following section:

``SEC. 319K. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND

PRODUCTION.

``(a) In General.--The Secretary, in consultation with the Attorney General and the Secretary of Defense, may provide technical or other assistance to provide security to persons or facilities that conduct development, production, distribution, or storage of priority countermeasures (as defined in section 319F(h)(4)).

``(b) Guidelines.--The Secretary may develop guidelines to enable entities eligible to receive assistance under subsection (a) to secure their facilities against potential terrorist attack.''.

SEC. 125. ACCELERATED COUNTERMEASURE RESEARCH AND

DEVELOPMENT.

Section 319F(h) of the Public Health Service Act, as redesignated by section 104(a)(2) of this Act, is amended to read as follows:

``(h) Accelerated Research and Development on Priority Pathogens and Countermeasures.--

``(1) In general.--With respect to pathogens of potential use in a bioterrorist attack, and other agents that may cause a public health emergency, the Secretary, taking into consideration any recommendations of the working group under subsection (a), shall conduct, and award grants, contracts, or cooperative agreements for, research, investigations, experiments, demonstrations, and studies in the health sciences relating to--

``(A) the epidemiology and pathogenesis of such pathogens;

``(B) the sequencing of the genomes, or other DNA analysis, or other comparative analysis, of priority pathogens (as determined by the Director of the National Institutes of Health in consultation with the working group established in subsection (a)), in collaboration and coordination with the activities of the Department of Defense and the Joint Genome Institute of the Department of Energy;

``(C) the development of priority countermeasures; and

``(D) other relevant areas of research;with consideration given to the needs of children and other vulnerable populations.

``(2) Priority.--The Secretary shall give priority under this section to the funding of research and other studies related to priority countermeasures.

``(3) Role of department of veterans affairs.--In carrying out paragraph (1), the Secretary shall consider using the biomedical research and development capabilities of the Department of Veterans Affairs, in conjunction with that Department's affiliations with health-professions universities. When advantageous to the Government in furtherance of the purposes of such paragraph, the Secretary may enter into cooperative agreements with the Secretary of Veterans Affairs to achieve such purposes.

``(4) Priority countermeasures.--For purposes of this section, the term `priority countermeasure' means a drug, biological product, device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that the Secretary determines to be--

``(A) a priority to treat, identify, or prevent infection by a biological agent or toxin listed pursuant to section 351A(a)(1), or harm from any other agent that may cause a public health emergency; or

``(B) a priority to diagnose conditions that may result in adverse health consequences or death and may be caused by the administering of a drug, biological product, device, vaccine, vaccine adjuvant, antiviral, or diagnostic test that is a priority under subparagraph (A).''.

SEC. 126. EVALUATION OF NEW AND EMERGING TECHNOLOGIES

REGARDING BIOTERRORIST ATTACK AND OTHER PUBLIC

HEALTH EMERGENCIES.

(a) In General.--The Secretary of Health and Human Services

(referred to in this section as the ``Secretary'') shall promptly carry out a program to periodically evaluate new and emerging technologies that, in the determination of the Secretary, are designed to improve or enhance the ability of public health or safety officials to conduct public health surveillance activities relating to a bioterrorist attack or other public health emergency.

(b) Certain Activities.--In carrying out this subsection, the Secretary shall, to the extent practicable--

(1) survey existing technology programs funded by the Federal Government for potentially useful technologies;

(2) promptly issue a request, as necessary, for information from non-Federal public and private entities for ongoing activities in this area; and

(3) evaluate technologies identified under paragraphs (1) and (2) pursuant to subsection (c).

(c) Consultation and Evaluation.--In carrying out subsection (b)(3), the Secretary shall consult with the working group under section 319F(a) of the Public Health Service Act, as well as other appropriate public, nonprofit, and private entities, to develop criteria for the evaluation of such technologies and to conduct such evaluations.

(d) Report.--Not later than 180 days after the date of the enactment of this Act, and periodically thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report on the activities under this section.

SEC. 127. POTASSIUM IODIDE.

(a) In General.--Through the national stockpile under section 121, the President, subject to subsections (b) and

(c), shall make available to State and local governments potassium iodide tablets for stockpiling and for distribution as appropriate to public facilities, such as schools and hospitals, in quantities sufficient to provide adequate protection for the population within 20 miles of a nuclear power plant.

(b) State and Local Plans.--

(1) In general.--Subsection (a) applies with respect to a State or local government, subject to paragraph (2), if the government involved meets the following conditions:

(A) Such government submits to the President a plan for the stockpiling of potassium iodide tablets, and for the distribution and utilization of potassium iodide tablets in the event of a nuclear incident.

(B) The plan is accompanied by certifications by such government that the government has not already received sufficient quantities of potassium iodide tablets from the Federal Government.

(2) Local governments.--Subsection (a) applies with respect to a local government only if, in addition to the conditions described in paragraph (1), the following conditions are met:

(A) The State in which the locality involved is located--

(i) does not have a plan described in paragraph (1)(A); or

(ii) has a plan described in such paragraph, but the plan does not address populations at a distance greater than 10 miles from the nuclear power plant involved.

(B) The local government has petitioned the State to modify the State plan to address such populations, not exceeding 20 miles from such plant, and 60 days have elapsed without the State modifying the State plan to address populations at the full distance sought by the local government through the petition.

(C) The local government has submitted its local plan under paragraph (1)(A) to the State, and the State has approved the plan and certified that the plan is not inconsistent with the State emergency plan.

(c) Guidelines.--Not later than one year after the date of the enactment of this Act, the President, in consultation with individuals representing appropriate Federal, State, and local agencies, shall establish guidelines for the stockpiling of potassium iodide tablets, and for the distribution and utilization of potassium iodide tablets in the event of a nuclear incident. Such tablets may not be made available under subsection (a) until such guidelines have been established.

(d) Information.--The President shall carry out activities to inform State and local governments of the program under this section.

(e) Reports.--

(1) President.--Not later than six months after the date on which the guidelines under subsection (c) are issued, the President shall submit to the Congress a report--

(A) on whether potassium iodide tablets have been made available under subsection (a) or other Federal, State, or local programs, and the extent to which State and local governments have established stockpiles of such tablets; and

(B) the measures taken by the President to implement this section.

(2) National academy of sciences.--

(A) In general.--The President shall request the National Academy of Sciences to enter into an agreement with the President under which the Academy conducts a study to determine what is the most effective and safe way to distribute and administer potassium iodide tablets on a mass scale. If the Academy declines to conduct the study, the President shall enter into an agreement with another appropriate public or nonprofit private entity to conduct the study.

(B) Report.--The President shall ensure that, not later than six months after the date of the enactment of this Act, the study required in subparagraph (A) is completed and a report describing the findings made in the study is submitted to the Congress.

(f) Applicability.--Subsections (a) and (d) cease to apply as requirements if the President determines that there is an alternative and more effective prophylaxis or preventive measures for adverse thyroid conditions that may result from the release of radionuclides from nuclear power plants.

Subtitle C--Improving State, Local, and Hospital Preparedness for and

Response to Bioterrorism and Other Public Health Emergencies

SEC. 131. GRANTS TO IMPROVE STATE, LOCAL, AND HOSPITAL

PREPAREDNESS FOR AND RESPONSE TO BIOTERRORISM

AND OTHER PUBLIC HEALTH EMERGENCIES.

(a) In General.--Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319C the following sections:

``SEC. 319C-1. GRANTS TO IMPROVE STATE, LOCAL, AND HOSPITAL

PREPAREDNESS FOR AND RESPONSE TO BIOTERRORISM

AND OTHER PUBLIC HEALTH EMERGENCIES.

``(a) In General.--To enhance the security of the United States with respect to bioterrorism and other public health emergencies, the Secretary shall make awards of grants or cooperative agreements to eligible entities to enable such entities to conduct the activities described in subsection

(d).

``(b) Eligible Entities.--

``(1) In general.--To be eligible to receive an award under subsection (a), an entity shall--

``(A)(i) be a State; and

``(ii) prepare and submit to the Secretary an application at such time, and in such manner, and containing such information as the Secretary may require, including an assurance that the State--

``(I) has completed an evaluation under section 319B(a), or an evaluation that is substantially equivalent to an evaluation described in such section (as determined by the Secretary);

``(II) has prepared, or will (within 60 days of receiving an award under this section) prepare, a Bioterrorism and Other Public Health Emergency Preparedness and Response Plan in accordance with subsection (c);

``(III) has established a means by which to obtain public comment and input on the plan prepared under subclause (II), and on the implementation of such plan, that shall include an advisory committee or other similar mechanism for obtaining comment from the public at large as well as from other State and local stakeholders;

``(IV) will use amounts received under the award in accordance with the plan prepared under subclause (II), including making expenditures to carry out the strategy contained in the plan; and

``(V) with respect to the plan prepared under subclause

(II), will establish reasonable criteria to evaluate the effective performance of entities that receive funds under the award and include relevant benchmarks in the plan; or

``(B)(i) be a political subdivision of a State or a consortium of 2 or more such subdivisions; and

``(ii) prepare and submit to the Secretary an application at such time, and in such manner, and containing such information as the Secretary may require.

``(2) Coordination with statewide plans.--An award under subsection (a) to an eligible entity described in paragraph

(1)(B) may not be made unless the application of such entity is in coordination with, and consistent with, applicable Statewide plans described in subsection (d)(1).

``(c) Bioterrorism and Other Public Health Emergency Preparedness and Response Plan.--Not later than 60 days after receiving amounts under an award under subsection (a), an eligible entity described in subsection (b)(1)(A) shall prepare and submit to the Secretary a Bioterrorism and Other Public Health Emergency Preparedness and Response Plan. Recognizing the assessment of public health needs conducted under section 319B, such plan shall include a description of activities to be carried out by the entity to address the needs identified in such assessment (or an equivalent assessment).

``(d) Use of Funds.--An award under subsection (a) may be expended for activities that may include the following and similar activities:

``(1) To develop Statewide plans (including the development of the Bioterrorism and Other Public Health Emergency Preparedness and Response Plan required under subsection

(c)), and community-wide plans for responding to bioterrorism and other public health emergencies that are coordinated with the capacities of applicable national, State, and local health agencies and health care providers, including poison control centers.

``(2) To address deficiencies identified in the assessment conducted under section 319B.

``(3) To purchase or upgrade equipment (including stationary or mobile communications equipment), supplies, pharmaceuticals or other priority countermeasures to enhance preparedness for and response to bioterrorism or other public health emergencies, consistent with the plan described in subsection (c).

``(4) To conduct exercises to test the capability and timeliness of public health emergency response activities.

``(5) To develop and implement the trauma care and burn center care components of the State plans for the provision of emergency medical services.

``(6) To improve training or workforce development to enhance public health laboratories.

``(7) To train public health and health care personnel to enhance the ability of such personnel--

``(A) to detect, provide accurate identification of, and recognize the symptoms and epidemiological characteristics of exposure to a biological agent that may cause a public health emergency; and

``(B) to provide treatment to individuals who are exposed to such an agent.

``(8) To develop, enhance, coordinate, or improve participation in systems by which disease detection and information about biological attacks and other public health emergencies can be rapidly communicated among national, State, and local health agencies, emergency response personnel, and health care providers and facilities to detect and respond to a bioterrorist attack or other public health emergency, including activities to improve information technology and communications equipment available to health care and public health officials for use in responding to a biological threat or attack or other public health emergency.

``(9) To enhance communication to the public of information on bioterrorism and other public health emergencies, including through the use of 2-1-1 call centers.

``(10) To address the health security needs of children and other vulnerable populations with respect to bioterrorism and other public health emergencies.

``(11) To provide training and develop, enhance, coordinate, or improve methods to enhance the safety of workers and workplaces in the event of bioterrorism.

``(12) To prepare and plan for contamination prevention efforts related to public health that may be implemented in the event of a bioterrorist attack, including training and planning to protect the health and safety of workers conducting the activities described in this paragraph.

``(13) To prepare a plan for triage and transport management in the event of bioterrorism or other public health emergencies.

``(14) To enhance the training of health care professionals to recognize and treat the mental health consequences of bioterrorism or other public health emergencies.

``(15) To enhance the training of health care professionals to assist in providing appropriate health care for large numbers of individuals exposed to a bioweapon.

``(16) To enhance training and planning to protect the health and safety of personnel, including health care professionals, involved in responding to a biological attack.

``(17) To improve surveillance, detection, and response activities to prepare for emergency response activities including biological threats or attacks, including training personnel in these and other necessary functions and including early warning and surveillance networks that use advanced information technology to provide early detection of biological threats or attacks.

``(18) To develop, enhance, and coordinate or improve the ability of existing telemedicine programs to provide health care information and advice as part of the emergency public health response to bioterrorism or other public health emergencies.

Nothing in this subsection may be construed as establishing new regulatory authority or as modifying any existing regulatory authority.

``(e) Priorities in Use of Grants.--

``(1) In general.--

``(A) Priorities.--Except as provided in subparagraph (B), the Secretary shall, in carrying out the activities described in this section, address the following hazards in the following priority:

``(i) Bioterrorism or acute outbreaks of infectious diseases.

``(ii) Other public health threats and emergencies.

``(B) Determination of the secretary.--In the case of the hazard involved, the degree of priority that would apply to the hazard based on the categories specified in clauses (i) and (ii) of subparagraph (A) may be modified by the Secretary if the following conditions are met:

``(i) The Secretary determines that the modification is appropriate on the basis of the following factors:

``(I) The extent to which eligible entities are adequately prepared for responding to hazards within the category specified in clause (i) of subparagraph (A).

``(II) There has been a significant change in the assessment of risks to the public health posed by hazards within the category specified in clause (ii) of such subparagraph.

``(ii) Prior to modifying the priority, the Secretary notifies the appropriate committees of the Congress of the determination of the Secretary under clause (i) of this subparagraph.

``(2) Areas of emphasis within categories.--The Secretary shall determine areas of emphasis within the category of hazards specified in clause (i) of paragraph (1)(A), and shall determine areas of emphasis within the category of hazards specified in clause (ii) of such paragraph, based on an assessment of the risk and likely consequences of such hazards and on an evaluation of Federal, State, and local needs, and may also take into account the extent to which receiving an award under subsection (a) will develop capacities that can be used for public health emergencies of varying types.

``(f) Certain Activities.--In administering activities under section 319C(c)(4) or similar activities, the Secretary shall, where appropriate, give priority to activities that include State or local government financial commitments, that seek to incorporate multiple public health and safety services or diagnostic databases into an integrated public health entity, and that cover geographic areas lacking advanced diagnostic and laboratory capabilities.

``(g) Coordination with Local Medical Response System.--An eligible entity and local Metropolitan Medical Response Systems shall, to the extent practicable, ensure that activities carried out under an award under subsection (a) are coordinated with activities that are carried out by local Metropolitan Medical Response Systems.

``(h) Coordination of Federal Activities.--In making awards under subsection (a), the Secretary shall--

``(1) annually notify the Director of the Federal Emergency Management Agency, the Director of the Office of Justice Programs, and the Director of the National Domestic Preparedness Office, as to the amount, activities covered under, and status of such awards; and

``(2) coordinate such awards with other activities conducted or supported by the Secretary to enhance preparedness for bioterrorism and other public health emergencies.

``(i) Definition.--For purposes of this section, the term

`eligible entity' means an entity that meets the conditions described in subparagraph (A) or (B) of subsection (b)(1).

``(j) Funding.--

``(1) Authorizations of appropriations.--

``(A) Fiscal year 2003.--

``(i) Authorizations.--For the purpose of carrying out this section, there is authorized to be appropriated

$1,600,000,000 for fiscal year 2003, of which--

``(I) $1,080,000,000 is authorized to be appropriated for awards pursuant to paragraph (3) (subject to the authority of the Secretary to make awards pursuant to paragraphs (4) and

(5)); and

``(II) $520,000,000 is authorized to be appropriated--

``(aa) for awards under subsection (a) to States, notwitstanding the eligibility conditions under subsection

(b), for the purpose of enhancing the preparedness of hospitals (including children's hospitals), clinics, health centers, and primary care facilities for bioterrorism and other public health emergencies; and

``(bb) for Federal, State, and local planning and administrative activities related to such purpose.

``(ii) Contingent additional authorization.--If a significant change in circumstances warrants an increase in the amount authorized to be appropriated under clause (i) for fiscal year 2003, there are authorized to be appropriated such sums as may be necessary for such year for carrying out this section, in addition to the amount authorized in clause

(i).

``(B) Other fiscal years.--For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2004 through 2006.

``(2) Supplement not supplant.--Amounts appropriated under paragraph (1) shall be used to supplement and not supplant other State and local public funds provided for activities under this section.

``(3) State bioterrorism and other public health emergency preparedness and response block grant for fiscal year 2003.--

``(A) In general.--For fiscal year 2003, the Secretary shall, in an amount determined in accordance with subparagraphs (B) through (D), make an award under subsection

(a) to each State, notwithstanding the eligibility conditions described in subsection (b), that submits to the Secretary an application for the award that meets the criteria of the Secretary for the receipt of such an award and that meets other implementation conditions established by the Secretary for such awards. No other awards may be made under subsection

(a) for such fiscal year, except as provided in paragraph

(1)(A)(i)(II) and paragraphs (4) and (5).

``(B) Base amount.--In determining the amount of an award pursuant to subparagraph (A) for a State, the Secretary shall first determine an amount the Secretary considers appropriate for the State (referred to in this paragraph as the `base amount'), except that such amount may not be greater than the minimum amount determined under subparagraph (D).

``(C) Increase on basis of population.--After determining the base amount for a State under subparagraph (B), the Secretary shall increase the base amount by an amount equal to the product of--

``(i) the amount appropriated under paragraph (1)(A)(i)(I) for the fiscal year, less an amount equal to the sum of all base amounts determined for the States under subparagraph

(B), and less the amount, if any, reserved by the Secretary under paragraphs (4) and (5); and

``(ii) subject to paragraph (4)(C), the percentage constituted by the ratio of an amount equal to the population of the State over an amount equal to the total population of the States (as indicated by the most recent data collected by the Bureau of the Census).

``(D) Minimum amount.--Subject to the amount appropriated under paragraph (1)(A)(i)(I), an award pursuant to subparagraph (A) for a State shall be the greater of the base amount as increased under subparagraph (C), or the minimum amount under this subparagraph. The minimum amount under this subparagraph is--

``(i) in the case of each of the several States, the District of Columbia, and the Commonwealth of Puerto Rico, an amount equal to the lesser of--

``(I) $5,000,000; or

``(II) if the amount appropriated under paragraph

(1)(A)(i)(I) is less than $667,000,000, an amount equal to 0.75 percent of the amount appropriated under such paragraph, less the amount, if any, reserved by the Secretary under paragraphs (4) and (5); or

``(ii) in the case of each of American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, and the Virgin Islands, an amount determined by the Secretary to be appropriate, except that such amount may not exceed the amount determined under clause (i).

``(4) Certain political subdivisions.--

``(A) In general.--For fiscal year 2003, the Secretary may, before making awards pursuant to paragraph (3) for such year, reserve from the amount appropriated under paragraph

(1)(A)(i)(I) for the year an amount determined necessary by the Secretary to make awards under subsection (a) to political subdivisions that have a substantial number of residents, have a substantial local infrastructure for responding to public health emergencies, and face a high degree of risk from bioterrorist attacks or other public health emergencies. Not more than three political subdivisions may receive awards pursuant to this subparagraph.

``(B) Coordination with statewide plans.--An award pursuant to subparagraph (A) may not be made unless the application of the political subdivision involved is in coordination with, and consistent with, applicable Statewide plans described in subsection (c)(1).

``(C) Relationship to formula grants.--In the case of a State that will receive an award pursuant to paragraph (3), and in which there is located a political subdivision that will receive an award pursuant to subparagraph (A), the Secretary shall, in determining the amount under paragraph

(3)(B) for the State, subtract from the population of the State an amount equal to the population of such political subdivision.

``(D) Continuity of funding.--In determining whether to make an award pursuant to subparagraph (A) to a political subdivision, the Secretary may consider, as a factor indicating that the award should be made, that the political subdivision received public health funding from the Secretary for fiscal year 2002.

``(5) Significant unmet needs; degree of risk.--

``(A) In general.--For fiscal year 2003, the Secretary may, before making awards pursuant to paragraph (3) for such year, reserve from the amount appropriated under paragraph

(1)(A)(i)(I) for the year an amount determined necessary by the Secretary to make awards under subsection (a) to eligible entities that--

``(i) have a significant need for funds to build capacity to identify, detect, monitor, and respond to a bioterrorist or other threat to the public health, which need will not be met by awards pursuant to paragraph (3); and

``(ii) face a particularly high degree of risk of such a threat.

``(B) Recipients of grants.--Awards pursuant to subparagraph (A) may be supplemental awards to States that receive awards pursuant to paragraph (3), or may be awards to eligible entities described in subsection (b)(1)(B) within such States.

``(C) Finding with respect to district of columbia.--The Secretary shall consider the District of Columbia to have a significant unmet need for purposes of subparagraph (A), and to face a particularly high degree of risk for such purposes, on the basis of the concentration of entities of national significance located within the District.

``(6) Funding of local entities.--For fiscal year 2003, the Secretary shall in making awards under this section ensure that appropriate portions of such awards are made available to political subdivisions, local departments of public health, hospitals (including children's hospitals), clinics, health centers, or primary care facilities, or consortia of such entities.

``SEC. 319C-2. PARTNERSHIPS FOR COMMUNITY AND HOSPITAL

PREPAREDNESS.

``(a) Grants.--The Secretary shall make awards of grants or cooperative agreements to eligible entities to enable such entities to improve community and hospital preparedness for bioterrorism and other public health emergencies.

``(b) Eligibility.--To be eligible for an award under subsection (a), an entity shall--

``(1) be a partnership consisting of--

``(A) one or more hospitals (including children's hospitals), clinics, health centers, or primary care facilities; and

``(B)(i) one or more political subdivisions of States;

``(ii) one or more States; or

``(iii) one or more States and one or more political subdivisions of States; and

``(2) prepare, in consultation with the Chief Executive Officer of the State, District, or territory in which the hospital, clinic, health center, or primary care facility described in paragraph (1)(A) is located, and submit to the Secretary, an application at such time, in such manner, and containing such information as the Secretary may require.

``(c) Regional Coordination.--In making awards under subsection (a), the Secretary shall give preference to eligible entities that submit applications that, in the determination of the Secretary, will--

``(1) enhance coordination--

``(A) among the entities described in subsection (b)(1)(A); and

``(B) between such entities and the entities described in subsection (b)(1)(B); and

``(2) serve the needs of a defined geographic area.

``(d) Consistency of Planned Activities.--An entity described in subsection (b)(1) shall utilize amounts received under an award under subsection (a) in a manner that is coordinated and consistent, as determined by the Secretary, with an applicable State Bioterrorism and Other Public Health Emergency Preparedness and Response Plan.

``(e) Use of Funds.--An award under subsection (a) may be expended for activities that may include the following and similar activities--

``(1) planning and administration for such award;

``(2) preparing a plan for triage and transport management in the event of bioterrorism or other public health emergencies;

``(3) enhancing the training of health care professionals to improve the ability of such professionals to recognize the symptoms of exposure to a potential bioweapon, to make appropriate diagnosis, and to provide treatment to those individuals so exposed;

``(4) enhancing the training of health care professionals to recognize and treat the mental health consequences of bioterrorism or other public health emergencies;

``(5) enhancing the training of health care professionals to assist in providing appropriate health care for large numbers of individuals exposed to a bioweapon;

``(6) enhancing training and planning to protect the health and safety of personnel involved in responding to a biological attack;

``(7) developing and implementing the trauma care and burn center care components of the State plans for the provision of emergency medical services; or

``(8) conducting such activities as are described in section 319C-1(d) that are appropriate for hospitals

(including children's hospitals), clinics, health centers, or primary care facilities.

``(f) Limitation on Awards.--A political subdivision of a State shall not participate in more than one partnership described in subsection (b)(1).

``(g) Priorities in Use of Grants.--

``(1) In general.--

``(A) Priorities.--Except as provided in subparagraph (B), the Secretary shall, in carrying out the activities described in this section, address the following hazards in the following priority:

``(i) Bioterrorism or acute outbreaks of infectious diseases.

``(ii) Other public health threats and emergencies.

``(B) Determination of the secretary.--In the case of the hazard involved, the degree of priority that would apply to the hazard based on the categories specified in clauses (i) and (ii) of subparagraph (A) may be modified by the Secretary if the following conditions are met:

``(i) The Secretary determines that the modification is appropriate on the basis of the following factors:

``(I) The extent to which eligible entities are adequately prepared for responding to hazards within the category specified in clause (i) of subparagraph (A).

``(II) There has been a significant change in the assessment of risks to the public health posed by hazards within the category specified in clause (ii) of such subparagraph.

``(ii) Prior to modifying the priority, the Secretary notifies the appropriate committees of the Congress of the determination of the Secretary under clause (i) of this subparagraph.

``(2) Areas of emphasis within categories.--The Secretary shall determine areas of emphasis within the category of hazards specified in clause (i) of paragraph (1)(A), and shall determine areas of emphasis within the category of hazards specified in clause (ii) of such paragraph, based on an assessment of the risk and likely consequences of such hazards and on an evaluation of Federal, State, and local needs, and may also take into account the extent to which receiving an award under subsection (a) will develop capacities that can be used for public health emergencies of varying types.

``(h) Coordination with Local Medical Response System.--An eligible entity and local Metropolitan Medical Response Systems shall, to the extent practicable, ensure that activities carried out under an award under subsection (a) are coordinated with activities that are carried out by local Metropolitan Medical Response Systems.

``(i) Authorization of Appropriations.--For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2004 through 2006.''.

(b) Certain Grants.--Section 319C of the Public Health Service Act (42 U.S.C. 247d-3) is amended by striking subsection (f).

Subtitle D--Emergency Authorities; Additional Provisions

SEC. 141. REPORTING DEADLINES.

Section 319 of the Public Health Service Act (42 U.S.C. 247d) is amended by adding at the end the following:

``(d) Data Submittal and Reporting Deadlines.--In any case in which the Secretary determines that, wholly or partially as a result of a public health emergency that has been determined pursuant to subsection (a), individuals or public or private entities are unable to comply with deadlines for the submission to the Secretary of data or reports required under any law administered by the Secretary, the Secretary may, notwithstanding any other provision of law, grant such extensions of such deadlines as the circumstances reasonably require, and may waive, wholly or partially, any sanctions otherwise applicable to such failure to comply. Before or promptly after granting such an extension or waiver, the Secretary shall notify the Congress of such action and publish in the Federal Register a notice of the extension or waiver.''.

SEC. 142. STREAMLINING AND CLARIFYING COMMUNICABLE DISEASE

QUARANTINE PROVISIONS.

(a) Elimination of Prerequisite for National Advisory Health Council Recommendation Before Issuing Quarantine Rules.--

(1) Executive orders specifying diseases subject to individual detentions.--Section 361(b) of the Public Health Act (42 U.S.C. 264(b)) is amended by striking ``Executive orders of the President upon the recommendation of the National Advisory Health Council and the Surgeon General'' and inserting ``Executive orders of the President upon the recommendation of the Secretary, in consultation with the Surgeon General,''.

(2) Regulations providing for apprehension of individuals.--Section 361(d) of the Public Health Act (42 U.S.C. 264(d)) is amended by striking ``On recommendation of the National Advisory Health Council, regulations'' and inserting ``Regulations''.

(3) Regulations providing for apprehension of individuals in wartime.--Section 363 of the Public Health Act (42 U.S.C. 266) is amended by striking ``the Surgeon General, on recommendation of the National Advisory Health Council,'' and inserting ``the Secretary, in consultation with the Surgeon General,''.

(b) Apprehension Authority To Apply in Cases of Exposure to Disease.--

(1) Regulations providing for apprehension of individuals.--Section 361(d) of the Public Health Act (42 U.S.C. 264(d)), as amended by subsection (a)(2), is further amended--

(A) by striking ``(1)'' and ``(2)'' and inserting ``(A)'' and ``(B)'', respectively;

(B) by striking ``(d)'' and inserting ``(d)(1)'';

(C) in paragraph (1) (as designated by subparagraph (B) of this paragraph), in the first sentence, by striking ``in a communicable stage'' each place such term appears and inserting ``in a qualifying stage''; and

(D) by adding at the end the following paragraph:

``(2) For purposes of this subsection, the term `qualifying stage', with respect to a communicable disease, means that such disease--

``(A) is in a communicable stage; or

``(B) is in a precommunicable stage, if the disease would be likely to cause a public health emergency if transmitted to other individuals.''.

(2) Regulations providing for apprehension of individuals in wartime.--Section 363 of the Public Health Act (42 U.S.C. 266), as amended by subsection (a)(3), is further amended by striking ``in a communicable stage''

(c) State Authority.--Section 361 of the Public Health Act

(42 U.S.C. 264) is amended by adding at the end the following:

``(e) Nothing in this section or section 363, or the regulations promulgated under such sections, may be construed as superseding any provision under State law (including regulations and including provisions established by political subdivisions of States), except to the extent that such a provision conflicts with an exercise of Federal authority under this section or section 363.''.

SEC. 143. EMERGENCY WAIVER OF MEDICARE, MEDICAID, AND SCHIP

REQUIREMENTS.

(a) Waiver Authority.--Title XI of the Social Security Act

(42 U.S.C. 1301 et seq.) is amended by inserting after section 1134 the following new section:

``authority to waive requirements during national emergencies

``Sec. 1135. (a) Purpose.--The purpose of this section is to enable the Secretary to ensure to the maximum extent feasible, in any emergency area and during an emergency period (as defined in subsection (g)(1))--

``(1) that sufficient health care items and services are available to meet the needs of individuals in such area enrolled in the programs under titles XVIII, XIX, and XXI; and

``(2) that health care providers (as defined in subsection

(g)(2)) that furnish such items and services in good faith, but that are unable to comply with one or more requirements described in subsection (b), may be reimbursed for such items and services and exempted from sanctions for such noncompliance, absent any determination of fraud or abuse.

``(b) Secretarial Authority.--To the extent necessary to accomplish the purpose specified in subsection (a), the Secretary is authorized, subject to the provisions of this section, to temporarily waive or modify the application of, with respect to health care items and services furnished by a health care provider (or classes of health care providers) in any emergency area (or portion of such an area) during any portion of an emergency period, the requirements of titles XVIII, XIX, or XXI, or any regulation thereunder (and the requirements of this title other than this section, and regulations thereunder, insofar as they relate to such titles), pertaining to--

``(1)(A) conditions of participation or other certification requirements for an individual health care provider or types of providers,

``(B) program participation and similar requirements for an individual health care provider or types of providers, and

``(C) pre-approval requirements;

``(2) requirements that physicians and other health care professionals be licensed in the State in which they provide such services, if they have equivalent licensing in another State and are not affirmatively excluded from practice in that State or in any State a part of which is included in the emergency area;

``(3) sanctions under section 1867 (relating to examination and treatment for emergency medical conditions and women in labor) for a transfer of an individual who has not been stabilized in violation of subsection (c) of such section if the transfer arises out of the circumstances of the emergency;

``(4) sanctions under section 1877(g) (relating to limitations on physician referral);

``(5) deadlines and timetables for performance of required activities, except that such deadlines and timetables may only be modified, not waived; and

``(6) limitations on payments under section 1851(i) for health care items and services furnished to individuals enrolled in a Medicare+Choice plan by health care professionals or facilities not included under such plan.

Insofar as the Secretary exercises authority under paragraph

(6) with respect to individuals enrolled in a Medicare+Choice plan, to the extent possible given the circumstances, the Secretary shall reconcile payments made on behalf of such enrollees to ensure that the enrollees do not pay more than would be required had they received services from providers within the network of the plan and may reconcile payments to the organization offering the plan to ensure that such organization pays for services for which payment is included in the capitation payment it receives under part C of title XVIII.

``(c) Authority for Retroactive Waiver.--A waiver or modification of requirements pursuant to this section may, at the Secretary's discretion, be made retroactive to the beginning of the emergency period or any subsequent date in such period specified by the Secretary.

``(d) Certification to Congress.--The Secretary shall provide a certification and advance written notice to the Congress at least two days before exercising the authority under this section with respect to an emergency area. Such a certification and notice shall include--

``(1) a description of--

``(A) the specific provisions that will be waived or modified;

``(B) the health care providers to whom the waiver or modification will apply;

``(C) the geographic area in which the waiver or modification will apply; and

``(D) the period of time for which the waiver or modification will be in effect; and

``(2) a certification that the waiver or modification is necessary to carry out the purpose specified in subsection

(a).

``(e) Duration of Waiver.--

``(1) In general.--A waiver or modification of requirements pursuant to this section terminates upon--

``(A) the termination of the applicable declaration of emergency or disaster described in subsection (g)(1)(A);

``(B) the termination of the applicable declaration of public health emergency described in subsection (g)(1)(B); or

``(C) subject to paragraph (2), the termination of a period of 60 days from the date the waiver or modification is first published (or, if applicable, the date of extension of the waiver or modification under paragraph (2)).

``(2) Extension of 60-day periods.--The Secretary may, by notice, provide for an extension of a 60-day period described in paragraph (1)(C) (or an additional period provided under this paragraph) for additional period or periods (not to exceed, except as subsequently provided under this paragraph, 60 days each), but any such extension shall not affect or prevent the termination of a waiver or modification under subparagraph (A) or (B) of paragraph (1).

``(f) Report to Congress.--Within one year after the end of the emergency period in an emergency area in which the Secretary exercised the authority provided under this section, the Secretary shall report to the Congress regarding the approaches used to accomplish the purposes described in subsection (a), including an evaluation of such approaches and recommendations for improved approaches should the need for such emergency authority arise in the future.

``(g) Definitions.--For purposes of this section:

``(1) Emergency area; emergency period.--An `emergency area' is a geographical area in which, and an `emergency period' is the period during which, there exists--

``(A) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Robert T. Stafford Disaster Relief and Emergency Assistance Act; and

``(B) a public health emergency declared by the Secretary pursuant to section 319 of the Public Health Service Act.

``(2) Health care provider.--The term `health care provider' means any entity that furnishes health care items or services, and includes a hospital or other provider of services, a physician or other health care practitioner or professional, a health care facility, or a supplier of health care items or services.''.

(b) Effective Date.--The amendment made by subsection (a) shall be effective on and after September 11, 2001.

SEC. 144. PROVISION FOR EXPIRATION OF PUBLIC HEALTH

EMERGENCIES.

(a) In General.--Section 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)), is amended by adding at the end the following new sentence: ``Any such determination of a public health emergency terminates upon the Secretary declaring that the emergency no longer exists, or upon the expiration of the 90-day period beginning on the date on which the determination is made by the Secretary, whichever occurs first. Determinations that terminate under the preceding sentence may be renewed by the Secretary (on the basis of the same or additional facts), and the preceding sentence applies to each such renewal. Not later than 48 hours after making a determination under this subsection of a public health emergency (including a renewal), the Secretary shall submit to the Congress written notification of the determination.''.

(b) Applicability.--The amendment made by subsection (a) applies to any public health emergency under section 319(a) of the Public Health Service Act, including any such emergency that was in effect as of the day before the date of the enactment of this Act. In the case of such an emergency that was in effect as of such day, the 90-day period described in such section with respect to the termination of the emergency is deemed to begin on such date of enactment.

Subtitle E--Additional Provisions

SEC. 151. DESIGNATED STATE PUBLIC EMERGENCY ANNOUNCEMENT

PLAN.

Section 613(b) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5196b(b)) is amended--

(1) in paragraph (5), by striking ``and'' at the end;

(2) in paragraph (6), by striking the period and inserting

``; and''; and

(3) by adding at the end the following:

``(7) include a plan for providing information to the public in a coordinated manner.''.

SEC. 152. EXPANDED RESEARCH BY SECRETARY OF ENERGY.

(a) Detection and Identification Research.--

(1) In general.--In conjunction with the working group under section 319F(a) of the Public Health Service Act, the Secretary of Energy and the Administrator of the National Nuclear Security Administration shall expand, enhance, and intensify research relevant to the rapid detection and identification of pathogens likely to be used in a bioterrorism attack or other agents that may cause a public health emergency.

(2) Authorized activities.--Activities carried out under paragraph (1) may include--

(A) the improvement of methods for detecting biological agents or toxins of potential use in a biological attack and the testing of such methods under variable conditions;

(B) the improvement or pursuit of methods for testing, verifying, and calibrating new detection and surveillance tools and techniques; and

(C) carrying out other research activities in relevant areas.

(3) Report.--Not later than 180 days after the date of the enactment of this Act, the Administrator of the National Nuclear Security Administration shall submit to the Committee on Energy and Natural Resources and the Committee on Armed Services of the Senate, and the Committee on Energy and Commerce and the Committee on Armed Services of the House of Representatives, a report setting forth the programs and projects that will be funded prior to the obligation of funds appropriated under subsection (b).

(b) Authorization.--For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary in each of fiscal years 2002 through 2006.

SEC. 153. EXPANDED RESEARCH ON WORKER HEALTH AND SAFETY.

The Secretary of Health and Human Services (referred to in this section as the ``Secretary''), acting through the Director of the National Institute of Occupational Safety and Health, shall enhance and expand research as deemed appropriate on the health and safety of workers who are at risk for bioterrorist threats or attacks in the workplace, including research on the health effects of measures taken to treat or protect such workers for diseases or disorders resulting from a bioterrorist threat or attack. Nothing in this section may be construed as establishing new regulatory authority for the Secretary or the Director to issue or modify any occupational safety and health rule or regulation.

SEC. 154. ENHANCEMENT OF EMERGENCY PREPAREDNESS OF DEPARTMENT

OF VETERANS AFFAIRS.

(a) Readiness of Department Medical Center.--(1) The Secretary of Veterans Affairs shall take appropriate actions to enhance the readiness of Department of Veterans Affairs medical centers to protect the patients and staff of such centers from chemical or biological attack or otherwise to respond to such an attack and so as to enable such centers to fulfil their obligations as part of the Federal response to public health emegencies.

(2) Actions under paragraph (1) shall include--

(A) the provision of decontamination equipment and personal protection equipment at Department medical centers; and

(B) the provision of training in the use of such equipment to staff of such centers.

(b) Security at Department Medical and Research Facilities.--(1) Not later than 180 days after the date of the enactment of this Act, the Secretary shall carry out an evaluation of the security needs at Department medical centers and research facilities. The evaluation shall address the following needs:

(A) Needs for the protection of patients and medical staff during emergencies, including a chemical or biological attack or other terrorist attack.

(B) Needs, if any, for screening personnel engaged in research relating to biological pathogens or agents, including work associated with such research.

(C) Needs for securing laboratories or other facilities engaged in research relating to biological pathogens or agents.

(D) Any other needs the Secretary considers appropriate.

(2) The Secretary shall take appropriate actions to enhance the security of Department medical centers and research facilities, including staff and patients at such centers and facilities. In taking such actions, the Secretary shall take into account the results of the evaluation required by paragraph (1).

(c) Tracking of Pharmaceuticals and Medical Supplies and Equipment.--The Secretary shall develop and maintain a centralized system for tracking the current location and availability of pharmaceuticals, medical supplies, and medical equipment throughout the Department health care system in order to permit the ready identification and utilization of such pharmaceuticals, supplies, and equipment for a variety of purposes, including response to a chemical or biological attack or other terrorist attack.

(d) Training.--The Secretary shall ensure that the Department medical centers, in consultation with the accredited medical school affiliates of such medical centers, develop and implement curricula to train resident physicians and health care personnel in medical matters relating to biological, chemical, or radiological attacks.

(e) Participation in National Disaster Medical System.--(1) The Secretary shall, in consultation with the Secretary of Defense, the Secretary of Health and Human Services, and the Director of the Federal Emergency Management Agency, establish and maintain a training program to facilitate the participation of the staff of Department medical centers, and of the community partners of such centers, in the National Disaster Medical System.

(2) The Secretary shall establish and maintain the training program under paragraph (1) in accordance with the recommendations of the working group under section 319F(a) of the Public Health Service Act.

(f) Mental Health Counseling.--(1) With respect to activities conducted by personnel serving at Department medical centers, the Secretary shall, in consultation with the Secretary of Health and Human Services, the American Red Cross, and the working group under section 319F(a) of the Public Health Service Act, develop and maintain various strategies for providing mental health counseling and assistance, including counseling and assistance for post-traumatic stress disorder, to local and community emergency response providers, veterans, active duty military personnel, and individuals seeking care at Department medical centers following a bioterrorist attack or other public health emergency.

(2) The strategies under paragraph (1) shall include the following:

(A) Training and certification of providers of mental health counseling and assistance.

(B) Mechanisms for coordinating the provision of mental health counseling and assistance to emergency response providers referred to in that paragraph.

(g) Authorization of Appropriations.--There is hereby authorized to be appropriated for the Department of Veterans Affairs amounts as follows:

(1) To carry out activities required by subsection (a)--

(A) $100,000,000 for fiscal year 2002; and

(B) such sums as may be necessary for each of fiscal years 2003 through 2006.

(2) To carry out activities required by subsections (b) through (f)--

(A) $33,000,000 for fiscal year 2002; and

(B) such sums as may be necessary for each of fiscal years 2003 through 2006.

SEC. 155. REAUTHORIZATION OF EXISTING PROGRAM.

Section 582(f) of the Public Health Service Act (42 U.S.C. 290hh-1(f)) is amended by striking ``2002 and 2003'' and inserting ``2003 through 2006''.

SEC. 156. SENSE OF CONGRESS.

It is the sense of the Congress that--

(1) many excellent university-based programs are already functioning and developing important biodefense products and solutions throughout the United States;

(2) accelerating the crucial work done at university centers and laboratories will contribute significantly to the United States capacity to defend against any biological threat or attack;

(3) maximizing the effectiveness of, and extending the mission of, established university programs would be one appropriate use of the additional resources provided for in this Act and the amendments made by this Act; and

(4) the Secretary of Health and Human Services should, as appropriate, recognize the importance of existing public and private university-based research, training, public awareness, and safety related biological defense programs when the Secretary makes awards of grants and contracts in accordance with this Act and the amendments made by this Act.

SEC. 157. GENERAL ACCOUNTING OFFICE REPORT.

(a) In General.--The Comptroller General shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, and to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, a report that describes--

(1) Federal activities primarily related to research on, preparedness for, and the management of the public health and medical consequences of a bioterrorist attack against the civilian population;

(2) the coordination of the activities described in paragraph (1);

(3) the effectiveness of such efforts in preparing national, State, and local authorities to address the public health and medical consequences of a potential bioterrorist attack against the civilian population;

(4) the activities and costs of the Civil Support Teams of the National Guard in responding to biological threats or attacks against the civilian population;

(5) the activities of the working group under subsection

(a) and the efforts made by such group to carry out the activities described in such subsection; and

(6) the ability of private sector contractors to enhance governmental responses to biological threats or attacks.

SEC. 158. CERTAIN AWARDS.

Section 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)) is amended in the matter after and below paragraph

(2) by striking ``grants and'' and inserting ``grants, providing awards for expenses, and''

SEC. 159. PUBLIC ACCESS DEFIBRILLATION PROGRAMS AND PUBLIC

ACCESS DEFIBRILLATION DEMONSTRATION PROJECTS.

(a) Short Title.--This section may be cited as the

``Community Access to Emergency Defibrillation Act of 2002''.

(b) Findings.--Congress makes the following findings:

(1) Over 220,000 Americans die each year from cardiac arrest. Every 2 minutes, an individual goes into cardiac arrest in the United States.

(2) The chance of successfully returning to a normal heart rhythm diminishes by 10 percent each minute following sudden cardiac arrest.

(3) Eighty percent of cardiac arrests are caused by ventricular fibrillation, for which defibrillation is the only effective treatment.

(4) Sixty percent of all cardiac arrests occur outside the hospital. The average national survival rate for out-of-hospital cardiac arrest is only 5 percent.

(5) Communities that have established and implemented public access defibrillation programs have achieved average survival rates for out-of-hospital cardiac arrest as high as 50 percent.

(6) According to the American Heart Association, wide use of defibrillators could save as many as 50,000 lives nationally each year.

(7) Successful public access defibrillation programs ensure that cardiac arrest victims have access to early 911 notification, early cardiopulmonary resuscitation, early defibrillation, and early advanced care.

(c) Public Access Defibrillation Programs and Projects.--Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.), as amended by Public Law 106-310, is amended by adding after section 311 the following:

``SEC. 312. PUBLIC ACCESS DEFIBRILLATION PROGRAMS.

``(a) In General.--The Secretary shall award grants to States, political subdivisions of States, Indian tribes, and tribal organizations to develop and implement public access defibrillation programs--

``(1) by training and equipping local emergency medical services personnel, including firefighters, police officers, paramedics, emergency medical technicians, and other first responders, to administer immediate care, including cardiopulmonary resuscitation and automated external defibrillation, to cardiac arrest victims;

``(2) by purchasing automated external defibrillators, placing the defibrillators in public places where cardiac arrests are likely to occur, and training personnel in such places to administer cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims;

``(3) by setting procedures for proper maintenance and testing of such devices, according to the guidelines of the manufacturers of the devices;

``(4) by providing training to members of the public in cardiopulmonary resuscitation and automated external defibrillation;

``(5) by integrating the emergency medical services system with the public access defibrillation programs so that emergency medical services personnel, including dispatchers, are informed about the location of automated external defibrillators in their community; and

``(6) by encouraging private companies, including small businesses, to purchase automated external defibrillators and provide training for their employees to administer cardiopulmonary resuscitation and external automated defibrillation to cardiac arrest victims in their community.

``(b) Preference.--In awarding grants under subsection (a), the Secretary shall give a preference to a State, political subdivision of a State, Indian tribe, or tribal organization that--

``(1) has a particularly low local survival rate for cardiac arrests, or a particularly low local response rate for cardiac arrest victims; or

``(2) demonstrates in its application the greatest commitment to establishing and maintaining a public access defibrillation program.

``(c) Use of Funds.--A State, political subdivision of a State, Indian tribe, or tribal organization that receives a grant under subsection (a) may use funds received through such grant to--

``(1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and Drug Administration;

``(2) provide automated external defibrillation and basic life support training in automated external defibrillator usage through nationally recognized courses;

``(3) provide information to community members about the public access defibrillation program to be funded with the grant;

``(4) provide information to the local emergency medical services system regarding the placement of automated external defibrillators in public places;

``(5) produce materials to encourage private companies, including small businesses, to purchase automated external defibrillators; and

``(6) further develop strategies to improve access to automated external defibrillators in public places.

``(d) Application.--

``(1) In general.--To be eligible to receive a grant under subsection (a), a State, political subdivision of a State, Indian tribe, or tribal organization shall prepare and submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require.

``(2) Contents.--An application submitted under paragraph

(1) shall--

``(A) describe the comprehensive public access defibrillation program to be funded with the grant and demonstrate how such program would make automated external defibrillation accessible and available to cardiac arrest victims in the community;

``(B) contain procedures for implementing appropriate nationally recognized training courses in performing cardiopulmonary resuscitation and the use of automated external defibrillators;

``(C) contain procedures for ensuring direct involvement of a licensed medical professional and coordination with the local emergency medical services system in the oversight of training and notification of incidents of the use of the automated external defibrillators;

``(D) contain procedures for proper maintenance and testing of the automated external defibrillators, according to the labeling of the manufacturer;

``(E) contain procedures for ensuring notification of local emergency medical services system personnel, including dispatchers, of the location and type of devices used in the public access defibrillation program; and

``(F) provide for the collection of data regarding the effectiveness of the public access defibrillation program to be funded with the grant in affecting the out-of-hospital cardiac arrest survival rate.

``(e) Authorization of Appropriations.--For the purpose of carrying out this section, there are authorized to be appropriated $25,000,000 for fiscal year 2003, and such sums as may be necessary for each of the fiscal years 2004 through 2006. Not more than 10 percent of amounts received under a grant awarded under this section may be used for administrative expenses.

``SEC. 313. PUBLIC ACCESS DEFIBRILLATION DEMONSTRATION

PROJECTS.

``(a) In General.--The Secretary shall award grants to political subdivisions of States, Indian tribes, and tribal organizations to develop and implement innovative, comprehensive, community-based public access defibrillation demonstration projects that--

``(1) provide cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims in unique settings;

``(2) provide training to community members in cardiopulmonary resuscitation and automated external defibrillation; and

``(3) maximize community access to automated external defibrillators.

``(b) Use of Funds.--A recipient of a grant under subsection (a) shall use the funds provided through the grant to--

``(1) purchase automated external defibrillators that have been approved, or cleared for marketing, by the Food and Drug Administration;

``(2) provide basic life training in automated external defibrillator usage through nationally recognized courses;

``(3) provide information to community members about the public access defibrillation demonstration project to be funded with the grant;

``(4) provide information to the local emergency medical services system regarding the placement of automated external defibrillators in the unique settings; and

``(5) further develop strategies to improve access to automated external defibrillators in public places.

``(c) Application.--

``(1) In general.--To be eligible to receive a grant under subsection (a), a political subdivision of a State, Indian tribe, or tribal organization shall prepare and submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require.

``(2) Contents.--An application submitted under paragraph

(1) may--

``(A) describe the innovative, comprehensive, community-based public access defibrillation demonstration project to be funded with the grant;

``(B) explain how such public access defibrillation demonstration project represents innovation in providing public access to automated external defibrillation; and

``(C) provide for the collection of data regarding the effectiveness of the demonstration project to be funded with the grant in--

``(i) providing emergency cardiopulmonary resuscitation and automated external defibrillation to cardiac arrest victims in the setting served by the demonstration project; and

``(ii) affecting the cardiac arrest survival rate in the setting served by the demonstration project.

``(d) Authorization of Appropriations.--There is authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2002 through 2006. Not more than 10 percent of amounts received under a grant awarded under this section may be used for administrative expenses.''.

TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS

Subtitle A--Department of Health and Human Services

SEC. 201. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.

(a) Biological Agents Provisions of the Antiterrorism and Effective Death Penalty Act of 1996; Codification in the Public Health Service Act, With Amendments.--Subpart 1 of part F of title III of the Public Health Service Act (42 U.S.C. 262 et seq.) is amended by inserting after section 351 the following:

``SEC. 351A. ENHANCED CONTROL OF DANGEROUS BIOLOGICAL AGENTS

AND TOXINS.

``(a) Regulatory Control of Certain Biological Agents and Toxins.--

``(1) List of biological agents and toxins.--

``(A) In general.--The Secretary shall by regulation establish and maintain a list of each biological agent and each toxin that has the potential to pose a severe threat to public health and safety.

``(B) Criteria.--In determining whether to include an agent or toxin on the list under subparagraph (A), the Secretary shall--

``(i) consider--

``(I) the effect on human health of exposure to the agent or toxin;

``(II) the degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans;

``(III) the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or toxin; and

``(IV) any other criteria, including the needs of children and other vulnerable populations, that the Secretary considers appropriate; and

``(ii) consult with appropriate Federal departments and agencies and with scientific experts representing appropriate professional groups, including groups with pediatric expertise.

``(2) Biennial review.--The Secretary shall review and republish the list under paragraph (1) biennially, or more often as needed, and shall by regulation revise the list as necessary in accordance with such paragraph.

``(b) Regulation of Transfers of Listed Agents and Toxins.--The Secretary shall by regulation provide for--

``(1) the establishment and enforcement of safety procedures for the transfer of listed agents and toxins, including measures to ensure--

``(A) proper training and appropriate skills to handle such agents and toxins; and

``(B) proper laboratory facilities to contain and dispose of such agents and toxins;

``(2) the establishment and enforcement of safeguard and security measures to prevent access to such agents and toxins for use in domestic or international terrorism or for any other criminal purpose;

``(3) the establishment of procedures to protect the public safety in the event of a transfer or potential transfer of such an agent or toxin in violation of the safety procedures established under paragraph (1) or the safeguard and security measures established under paragraph (2); and

``(4) appropriate availability of biological agents and toxins for research, education, and other legitimate purposes.

``(c) Possession and Use of Listed Agents and Toxins.--The Secretary shall by regulation provide for the establishment and enforcement of standards and procedures governing the possession and use of listed agents and toxins, including the provisions described in paragraphs (1) through (4) of subsection (b), in order to protect the public health and safety.

``(d) Registration; Identification; Database.--

``(1) Registration.--Regulations under subsections (b) and

(c) shall require registration with the Secretary of the possession, use, and transfer of listed agents and toxins, and shall include provisions to ensure that persons seeking to register under such regulations have a lawful purpose to possess, use, or transfer such agents and toxins, including provisions in accordance with subsection (e)(6).

``(2) Identification; database.--Regulations under subsections (b) and (c) shall require that registration include (if available to the person registering) information regarding the characterization of listed agents and toxins to facilitate their identification, including their source. The Secretary shall maintain a national database that includes the names and locations of registered persons, the listed agents and toxins such persons are possessing, using, or transferring, and information regarding the characterization of such agents and toxins.

``(e) Safeguard and Security Requirements for Registered Persons.--

``(1) In general.--Regulations under subsections (b) and

(c) shall include appropriate safeguard and security requirements for persons possessing, using, or transferring a listed agent or toxin commensurate with the risk such agent or toxin poses to public health and safety (including the risk of use in domestic or international terrorism). The Secretary shall establish such requirements in consultation with the Attorney General, and shall ensure compliance with such requirements as part of the registration system under such regulations.

``(2) Limiting access to listed agents and toxins.--Requirements under paragraph (1) shall include provisions to ensure that registered persons--

``(A) provide access to listed agents and toxins to only those individuals whom the registered person involved determines have a legitimate need to handle or use such agents and toxins;

``(B) submit the names and other identifying information for such individuals to the Secretary and the Attorney General, promptly after first determining that the individuals need access under subparagraph (A), and periodically thereafter while the individuals have such access, not less frequently than once every five years;

``(C) deny access to such agents and toxins by individuals whom the Attorney General has identified as restricted persons; and

``(D) limit or deny access to such agents and toxins by individuals whom the Attorney General has identified as within any category under paragraph (3)(B)(ii), if limiting or denying such access by the individuals involved is determined appropriate by the Secretary, in consultation with the Attorney General.

``(3) Submitted names; use of databases by attorney general.--

``(A) In general.--Upon the receipt of names and other identifying information under paragraph (2)(B), the Attorney General shall, for the sole purpose of identifying whether the individuals involved are within any of the categories specified in subparagraph (B), promptly use criminal, immigration, national security, and other electronic databases that are available to the Federal Government and are appropriate for such purpose.

``(B) Certain individuals.--For purposes of subparagraph

(A), the categories specified in this subparagraph regarding an individual are that--

``(i) the individual is a restricted person; or

``(ii) the individual is reasonably suspected by any Federal law enforcement or intelligence agency of--

``(I) committing a crime set forth in section 2332b(g)(5) of title 18, United States Code;

``(II) knowing involvement with an organization that engages in domestic or international terrorism (as defined in section 2331 of such title 18) or with any other organization that engages in intentional crimes of violence; or

``(III) being an agent of a foreign power (as defined in section 1801 of title 50, United States Code).

``(C) Notification by attorney general regarding submitted names.--After the receipt of a name and other identifying information under paragraph (2)(B), the Attorney General shall promptly notify the Secretary whether the individual is within any of the categories specified in subparagraph (B).

``(4) Notifications by secretary.--The Secretary, after receiving notice under paragraph (3) regarding an individual, shall promptly notify the registered person involved of whether the individual is granted or denied access under paragraph (2). If the individual is denied such access, the Secretary shall promptly notify the individual of the denial.

``(5) Expedited review.--Regulations under subsections (b) and (c) shall provide for a procedure through which, upon request to the Secretary by a registered person who submits names and other identifying information under paragraph

(2)(B) and who demonstrates good cause, the Secretary may, as determined appropriate by the Secretary--

``(A) request the Attorney General to expedite the process of identification under paragraph (3)(A) and notification of the Secretary under paragraph (3)(C); and

``(B) expedite the notification of the registered person by the Secretary under paragraph (4).

``(6) Process regarding persons seeking to register.--

``(A) Individuals.--Regulations under subsections (b) and

(c) shall provide that an individual who seeks to register under either of such subsections is subject to the same processes described in paragraphs (2) through (4) as apply to names and other identifying information submitted to the Attorney General under paragraph (2)(B). Paragraph (5) does not apply for purposes of this subparagraph.

``(B) Other persons.--Regulations under subsections (b) and

(c) shall provide that, in determining whether to deny or revoke registration by a person other than an individual, the Secretary shall submit the name of such person to the Attorney General, who shall use criminal, immigration, national security, and other electronic databases available to the Federal Government, as appropriate for the purpose of promptly notifying the Secretary whether the person, or, where relevant, the individual who owns or controls such person, is a restricted person or is reasonably suspected by any Federal law enforcement or intelligence agency of being within any category specified in paragraph (3)(B)(ii) (as applied to persons, including individuals). Such regulations shall provide that a person who seeks to register under either of such subsections is subject to the same processes described in paragraphs (2) and (4) as apply to names and other identifying information submitted to the Attorney General under paragraph (2)(B). Paragraph (5) does not apply for purposes of this subparagraph. The Secretary may exempt Federal, State, or local governmental agencies from the requirements of this subparagraph.

``(7) Review.--

``(A) Administrative review.--

``(i) In general.--Regulations under subsections (b) and

(c) shall provide for an opportunity for a review by the Secretary--

``(I) when requested by the individual involved, of a determination under paragraph (2) to deny the individual access to listed agents and toxins; and

``(II) when requested by the person involved, of a determination under paragraph (6) to deny or revoke registration for such person.

``(ii) Ex parte review.--During a review under clause (i), the Secretary may consider information relevant to the review ex parte to the extent that disclosure of the information could compromise national security or an investigation by any law enforcement agency.

``(iii) Final agency action.--The decision of the Secretary in a review under clause (i) constitutes final agency action for purposes of section 702 of title 5, United States Code.

``(B) Certain procedures.--

``(i) Submission of ex parte materials in judicial proceedings.--When reviewing a decision of the Secretary under subparagraph (A), and upon request made ex parte and in writing by the United States, a court, upon a sufficient showing, may review and consider ex parte documents containing information the disclosure of which could compromise national security or an investigation by any law enforcement agency. If the court determines that portions of the documents considered ex parte should be disclosed to the person involved to allow a response, the court shall authorize the United States to delete from such documents specified items of information the disclosure of which could compromise national security or an investigation by any law enforcement agency, or to substitute a summary of the information to which the person may respond. Any order by the court authorizing the disclosure of information that the United States believes could compromise national security or an investigation by any law enforcement agency shall be subject to the processes set forth in subparagraphs (A) and

(B)(i) of section 2339B(f)(5) of title 18, United States Code

(relating to interlocutory appeal and expedited consideration).

``(ii) Disclosure of information.--In a review under subparagraph (A), and in any judical proceeding conducted pursuant to such review, neither the Secretary nor the Attorney General may be required to disclose to the public any information that under subsection (h) shall not be disclosed under section 552 of title 5, United States Code.

``(8) Notifications regarding theft or loss of agents.--Requirements under paragraph (1) shall include the prompt notification of the Secretary, and appropriate Federal, State, and local law enforcement agencies, of the theft or loss of listed agents and toxins.

``(9) Technical assistance for registered persons.--The Secretary, in consultation with the Attorney General, may provide technical assistance to registered persons to improve security of the facilities of such persons.

``(f) Inspections.--The Secretary shall have the authority to inspect persons subject to regulations under subsection

(b) or (c) to ensure their compliance with such regulations, including prohibitions on restricted persons and other provisions of subsection (e).

``(g) Exemptions.--

``(1) Clinical or diagnostic laboratories.--Regulations under subsections (b) and (c) shall exempt clinical or diagnostic laboratories and other persons who possess, use, or transfer listed agents or toxins that are contained in specimens presented for diagnosis, verification, or proficiency testing, provided that--

``(A) the identification of such agents or toxins is reported to the Secretary, and when required under Federal, State, or local law, to other appropriate authorities; and

``(B) such agents or toxins are transferred or destroyed in a manner set forth by the Secretary by regulation.

``(2) Products.--

``(A) In general.--Regulations under subsections (b) and

(c) shall exempt products that are, bear, or contain listed agents or toxins and are cleared, approved, licensed, or registered under any of the Acts specified in subparagraph

(B), unless the Secretary by order determines that applying additional regulation under subsection (b) or (c) to a specific product is necessary to protect public health and safety.

``(B) Relevant laws.--For purposes of subparagraph (A), the Acts specified in this subparagraph are the following:

``(i) The Federal Food, Drug, and Cosmetic Act.

``(ii) Section 351 of this Act.

``(iii) The Act commonly known as the Virus-Serum-Toxin Act

(the eighth paragraph under the heading `Bureau of Animal Industry' in the Act of March 4, 1913; 21 U.S.C. 151-159).

``(iv) The Federal Insecticide, Fungicide, and Rodenticide Act.

``(C) Investigational use.--

``(i) In general.--The Secretary may exempt an investigational product that is, bears, or contains a listed agent or toxin from the applicability of provisions of regulations under subsection (b) or (c) when such product is being used in an investigation authorized under any Federal Act and the Secretary determines that applying additional regulation under subsection (b) or (c) to such product is not necessary to protect public health and safety.

``(ii) Certain processes.--Regulations under subsections

(b) and (c) shall set forth the procedures for applying for an exemption under clause (i). In the case of investigational products authorized under any of the Acts specified in subparagraph (B), the Secretary shall make a determination regarding a request for an exemption not later than 14 days after the first date on which both of the following conditions have been met by the person requesting the exemption:

``(I) The person has submitted to the Secretary an application for the exemption meeting the requirements established by the Secretary.

``(II) The person has notified the Secretary that the investigation has been authorized under such an Act.

``(3) Public health emergencies.--The Secretary may temporarily exempt a person from the applicability of the requirements of this section, in whole or in part, if the Secretary determines that such exemption is necessary to provide for the timely participation of the person in a response to a domestic or foreign public health emergency

(whether determined under section 319(a) or otherwise) that involves a listed agent or toxin. With respect to the emergency involved, such exemption for a person may not exceed 30 days, except that the Secretary, after review of whether such exemption remains necessary, may provide one extension of an additional 30 days.

``(4) Agricultural emergencies.--Upon request of the Secretary of Agriculture, after the granting by such Secretary of an exemption under section 212(g)(1)(D) of the Agricultural Bioterrorism Protection Act of 2002 pursuant to a finding that there is an agricultural emergency, the Secretary of Health and Human Services may temporarily exempt a person from the applicability of the requirements of this section, in whole or in part, to provide for the timely participation of the person in a response to the agricultural emergency. With respect to the emergency involved, the exemption under this paragraph for a person may not exceed 30 days, except that upon request of the Secretary of Agriculture, the Secretary of Health and Human Services may, after review of whether such exemption remains necessary, provide one extension of an additional 30 days.

``(h) Disclosure of Information.--

``(1) Nondisclosure of certain information.--No Federal agency specified in paragraph (2) shall disclose under section 552 of title 5, United States Code, any of the following:

``(A) Any registration or transfer documentation submitted under subsections (b) and (c) for the possession, use, or transfer of a listed agent or toxin; or information derived therefrom to the extent that it identifies the listed agent or toxin possessed, used, or transferred by a specific registered person or discloses the identity or location of a specific registered person.

``(B) The national database developed pursuant to subsection (d), or any other compilation of the registration or transfer information submitted under subsections (b) and

(c) to the extent that such compilation discloses site-specific registration or transfer information.

``(C) Any portion of a record that discloses the site-specific or transfer-specific safeguard and security measures used by a registered person to prevent unauthorized access to listed agents and toxins.

``(D) Any notification of a release of a listed agent or toxin submitted under subsections (b) and (c), or any notification of theft or loss submitted under such subsections.

``(E) Any portion of an evaluation or report of an inspection of a specific registered person conducted under subsection (f) that identifies the listed agent or toxin possessed by a specific registered person or that discloses the identity or location of a specific registered person if the agency determines that public disclosure of the information would endanger public health or safety.

``(2) Covered agencies.--For purposes of paragraph (1) only, the Federal agencies specified in this paragraph are the following:

``(A) The Department of Health and Human Services, the Department of Justice, the Department of Agriculture, and the Department of Transportation.

``(B) Any Federal agency to which information specified in paragraph (1) is transferred by any agency specified in subparagraph (A) of this paragraph.

``(C) Any Federal agency that is a registered person, or has a sub-agency component that is a registered person.

``(D) Any Federal agency that awards grants or enters into contracts or cooperative agreements involving listed agents and toxins to or with a registered person, and to which information specified in paragraph (1) is transferred by any such registered person.

``(3) Other exemptions.--This subsection may not be construed as altering the application of any exemptions to public disclosure under section 552 of title 5, United States Code, except as to subsection 552(b)(3) of such title, to any of the information specified in paragraph (1).

``(4) Rule of construction.--Except as specifically provided in paragraph (1), this subsection may not be construed as altering the authority of any Federal agency to withhold under section 552 of title 5, United States Code, or the obligation of any Federal agency to disclose under section 552 of title 5, United States Code, any information, including information relating to--

``(A) listed agents and toxins, or individuals seeking access to such agents and toxins;

``(B) registered persons, or persons seeking to register their possession, use, or transfer of such agents and toxins;

``(C) general safeguard and security policies and requirements under regulations under subsections (b) and (c); or

``(D) summary or statistical information concerning registrations, registrants, denials or revocations of registrations, listed agents and toxins, inspection evaluations and reports, or individuals seeking access to such agents and toxins.

``(5) Disclosures to congress; other disclosures.--This subsection may not be construed as providing any authority--

``(A) to withhold information from the Congress or any committee or subcommittee thereof; or

``(B) to withhold information from any person under any other Federal law or treaty.

``(i) Civil Money Penalty.--

``(1) In general.--In addition to any other penalties that may apply under law, any person who violates any provision of regulations under subsection (b) or (c) shall be subject to the United States for a civil money penalty in an amount not exceeding $250,000 in the case of an individual and $500,000 in the case of any other person.

``(2) Applicability of certain provisions.--The provisions of section 1128A of the Social Security Act (other than subsections (a), (b), (h), and (i), the first sentence of subsection (c), and paragraphs (1) and (2) of subsection (f)) shall apply to a civil money penalty under paragraph (1) in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a) of such Act. The Secretary may delegate authority under this subsection in the same manner as provided in section 1128A(j)(2) of the Social Security Act, and such authority shall include all powers as contained in section 6 of the Inspector General Act of 1978

(5 U.S.C. App.).

``(j) Notification in Event of Release.--Regulations under subsections (b) and (c) shall require the prompt notification of the Secretary by a registered person whenever a release, meeting criteria established by the Secretary, of a listed agent or toxin has occurred outside of the biocontainment area of a facility of the registered person. Upon receipt of such notification and a finding by the Secretary that the release poses a threat to public health or safety, the Secretary shall take appropriate action to notify relevant State and local public health authorities, other relevant Federal authorities, and, if necessary, other appropriate persons (including the public). If the released listed agent or toxin is an overlap agent or toxin (as defined in subsection (l)), the Secretary shall promptly notify the Secretary of Agriculture upon notification by the registered person.

``(k) Reports.--The Secretary shall report to the Congress annually on the number and nature of notifications received under subsection (e)(8) (relating to theft or loss) and subsection (j) (relating to releases).

``(l) Definitions.--For purposes of this section:

``(1) The terms `biological agent' and `toxin' have the meanings given such terms in section 178 of title 18, United States Code.

``(2) The term `listed agents and toxins' means biological agents and toxins listed pursuant to subsection (a)(1).

``(3) The term `listed agents or toxins' means biological agents or toxins listed pursuant to subsection (a)(1).

``(4) The term `overlap agents and toxins' means biological agents and toxins that--

``(A) are listed pursuant to subsection (a)(1); and

``(B) are listed pursuant to section 212(a)(1) of the Agricultural Bioterrorism Protection Act of 2002.

``(5) The term `overlap agent or toxin' means a biological agent or toxin that--

``(A) is listed pursuant to subsection (a)(1); and

``(B) is listed pursuant to section 212(a)(1) of the Agricultural Bioterrorism Protection Act of 2002.

``(6) The term `person' includes Federal, State, and local governmental entities.

``(7) The term `registered person' means a person registered under regulations under subsection (b) or (c).

``(8) The term `restricted person' has the meaning given such term in section 175b of title 18, United States Code.

``(m) Authorization of Appropriations.--For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2002 through 2007.''.

(b) Report to Congress.--Not later than one year after the date of the enactment of this Act, the Secretary of Health and Human Services, after consultation with other appropriate Federal agencies, shall submit to the Congress a report that--

(1) describes the extent to which there has been compliance by governmental and private entities with applicable regulations under section 351A of the Public Health Service Act (as added by subsection (a) of this section), including the extent of compliance before the date of the enactment of this Act, and including the extent of compliance with regulations promulgated after such date of enactment;

(2) describes the actions to date and future plans of the Secretary for updating the list of biological agents and toxins under such section 351A;

(3) describes the actions to date and future plans of the Secretary for determining compliance with regulations under such section 351A and for taking appropriate enforcement actions;

(4) evaluates the impact of such section 351A on research on biological agents and toxins listed pursuant to such section; and

(5) provides any recommendations of the Secretary for administrative or legislative initiatives regarding such section 351A.

SEC. 202. IMPLEMENTATION BY DEPARTMENT OF HEALTH AND HUMAN

SERVICES.

(a) Date Certain for Notice of Possession.--Not later than 90 days after the date of the enactment of this Act, all persons (unless exempt under subsection (g) of section 351A of the Public Health Service Act, as added by section 201 of this Act) in possession of biological agents or toxins listed under such section 351A of the Public Health Service Act shall notify the Secretary of Health and Human Services of such possession. Not later than 30 days after such date of enactment, the Secretary shall provide written guidance on how such notice is to be provided to the Secretary.

(b) Date Certain for Promulgation; Effective Date Regarding Criminal and Civil Penalties.--Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall promulgate an interim final rule for carrying out section 351A of the Public Health Service Act, subject to subsection (c). Such interim final rule shall take effect 60 days after the date on which such rule is promulgated, including for purposes of--

(1) section 175b(c) of title 18, United States Code

(relating to criminal penalties), as added by section 231(a)(5) of this Act; and

(2) section 351A(i) of the Public Health Service Act

(relating to civil penalties).

(c) Transitional Provision Regarding Current Research and Education.--The interim final rule under subsection (b) shall include time frames for the applicability of the rule that minimize disruption of research or educational projects that involve biological agents and toxins listed pursuant to section 351A(a)(1) of the Public Health Service Act and that were underway as of the effective date of such rule.

SEC. 203. EFFECTIVE DATES.

(a) In General.--Regulations promulgated by the Secretary of Health and Human Services under section 511 of the Antiterrorism and Effective Death Penalty Act of 1996 are deemed to have been promulgated under section 351A of the Public Health Service Act, as added by section 201 of this Act. Such regulations, including the list under subsection

(d)(1) of such section 511, that were in effect on the day before the date of the enactment of this Act remain in effect until modified by the Secretary in accordance with such section 351A and with section 202 of this Act.

(b) Effective Date Regarding Disclosure of Information.--Subsection (h) of section 351A of the Public Health Service Act, as added by section 201 of this Act, is deemed to have taken effect on the effective date of the Antiterrorism and Effective Death Penalty Act of 1996.

SEC. 204. CONFORMING AMENDMENT.

Subsections (d), (e), (f), and (g) of section 511 of the Antiterrorism and Effective Death Penalty Act of 1996 (42 U.S.C. 262 note) are repealed.

Subtitle B--Department of Agriculture

SEC. 211. SHORT TITLE.

This subtitle may be cited as the ``Agricultural Bioterrorism Protection Act of 2002''.

SEC. 212. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.

(a) Regulatory Control of Certain Biological Agents and Toxins.--

(1) List of biological agents and toxins.--

(A) In general.--The Secretary of Agriculture shall by regulation establish and maintain a list of each biological agent and each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant health, or to animal or plant products.

(B) Criteria.--In determining whether to include an agent or toxin on the list under subparagraph (A), the Secretary shall--

(i) consider--

(I) the effect of exposure to the agent or toxin on animal or plant health, and on the production and marketability of animal or plant products;

(II) the pathogenicity of the agent or the toxicity of the toxin and the methods by which the agent or toxin is transferred to animals or plants;

(III) the availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin; and

(IV) any other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products; and

(ii) consult with appropriate Federal departments and agencies and with scientific experts representing appropriate professional groups.

(2) Biennial review.--The Secretary shall review and republish the list under paragraph (1) biennially, or more often as needed, and shall by regulation revise the list as necessary in accordance with such paragraph.

(b) Regulation of Transfers of Listed Agents and Toxins.--The Secretary shall by regulation provide for--

(1) the establishment and enforcement of safety procedures for the transfer of listed agents and toxins, including measures to ensure--

(A) proper training and appropriate skills to handle such agents and toxins; and

(B) proper laboratory facilities to contain and dispose of such agents and toxins;

(2) the establishment and enforcement of safeguard and security measures to prevent access to such agents and toxins for use in domestic or international terrorism or for any other criminal purpose;

(3) the establishment of procedures to protect animal and plant health, and animal and plant products, in the event of a transfer or potential transfer of such an agent or toxin in violation of the safety procedures established under paragraph (1) or the safeguard and security measures established under paragraph (2); and

(4) appropriate availability of biological agents and toxins for research, education, and other legitimate purposes.

(c) Possession and Use of Listed Agents and Toxins.--The Secretary shall by regulation provide for the establishment and enforcement of standards and procedures governing the possession and use of listed agents and toxins, including the provisions described in paragraphs (1) through (4) of subsection (b), in order to protect animal and plant health, and animal and plant products.

(d) Registration; Identification; Database.--

(1) Registration.--Regulations under subsections (b) and

(c) shall require registration with the Secretary of the possession, use, and transfer of listed agents and toxins, and shall include provisions to ensure that persons seeking to register under such regulations have a lawful purpose to possess, use, or transfer such agents and toxins, including provisions in accordance with subsection (e)(6).

(2) Identification; database.--Regulations under subsections (b) and (c) shall require that registration include (if available to the person registering) information regarding the characterization of listed agents and toxins to facilitate their identification, including their source. The Secretary shall maintain a national database that includes the names and locations of registered persons, the listed agents and toxins such persons are possessing, using, or transferring, and information regarding the characterization of such agents and toxins.

(e) Safeguard and Security Requirements for Registered Persons.--

(1) In general.--Regulations under subsections (b) and (c) shall include appropriate safeguard and security requirements for persons possessing, using, or transferring a listed agent or toxin commensurate with the risk such agent or toxin poses to animal and plant health, and animal and plant products

(including the risk of use in domestic or international terrorism). The Secretary shall establish such requirements in consultation with the Attorney General, and shall ensure compliance with such requirements as part of the registration system under such regulations.

(2) Limiting access to listed agents and toxins.--Requirements under paragraph (1) shall include provisions to ensure that registered persons--

(A) provide access to listed agents and toxins to only those individuals whom the registered person involved determines have a legitimate need to handle or use such agents and toxins;

(B) submit the names and other identifying information for such individuals to the Secretary and the Attorney General, promptly after first determining that the individuals need access under subparagraph (A), and periodically thereafter while the individuals have such access, not less frequently than once every five years; and

(C)(i) in the case of listed agents and toxins that are not overlap agents and toxins (as defined in subsection

(g)(1)(A)(ii)), limit or deny access to such agents and toxins by individuals whom the Attorney General has identified as within any category under paragraph (3)(B), if limiting or denying such access by the individuals involved is determined appropriate by the Secretary, in consultation with the Attorney General; and

(ii) in the case of listed agents and toxins that are overlap agents--

(I) deny access to such agents and toxins by individuals whom the Attorney General has identified as within any category referred to in paragraph (3)(B)(i); and

(II) limit or deny access to such agents and toxins by individuals whom the Attorney General has identified as within any category under paragraph (3)(B)(ii), if limiting or denying such access by the individuals involved is determined appropriate by the Secretary, in consultation with the Attorney General.

(3) Submitted names; use of databases by attorney general.--

(A) In general.--Upon the receipt of names and other identifying information under paragraph (2)(B), the Attorney General shall, for the sole purpose of identifying whether the individuals involved are within any of the categories specified in subparagraph (B), promptly use criminal, immigration, national security, and other electronic databases that are available to the Federal Government and are appropriate for such purpose.

(B) Certain individuals.--For purposes of subparagraph (A), the categories specified in this subparagraph regarding an individual are that--

(i) the individual is within any of the categories described in section 175b(d)(1) of title 18, United States Code (relating to restricted persons); or

(ii) the individual is reasonably suspected by any Federal law enforcement or intelligence agency of--

(I) committing a crime set forth in section 2332b(g)(5) of title 18, United States Code;

(II) knowing involvement with an organization that engages in domestic or international terrorism (as defined in section 2331 of such title 18) or with any other organization that engages in intentional crimes of violence; or

(III) being an agent of a foreign power (as defined in section 1801 of title 50, United States Code).

(C) Notification by attorney general regarding submitted names.--After the receipt of a name and other identifying information under paragraph (2)(B), the Attorney General shall promptly notify the Secretary whether the individual is within any of the categories specified in subparagraph (B).

(4) Notifications by secretary.--The Secretary, after receiving notice under paragraph (3) regarding an individual, shall promptly notify the registered person involved of whether the individual is granted or denied access under paragraph (2). If the individual is denied such access, the Secretary shall promptly notify the individual of the denial.

(5) Expedited review.--Regulations under subsections (b) and (c) shall provide for a procedure through which, upon request to the Secretary by a registered person who submits names and other identifying information under paragraph

(2)(B) and who demonstrates good cause, the Secretary may, as determined appropriate by the Secretary--

(A) request the Attorney General to expedite the process of identification under paragraph (3)(A) and notification of the Secretary under paragraph (3)(C); and

(B) expedite the notification of the registered person by the Secretary under paragraph (4).

(6) Process regarding persons seeking to register.--

(A) Individuals.--Regulations under subsections (b) and (c) shall provide that an individual who seeks to register under either of such subsections is subject to the same processes described in paragraphs (2) through (4) as apply to names and other identifying information submitted to the Attorney General under paragraph (2)(B). Paragraph (5) does not apply for purposes of this subparagraph.

(B) Other persons.--Regulations under subsections (b) and

(c) shall provide that, in determining whether to deny or revoke registration by a person other than an individual, the Secretary shall submit the name of such person to the Attorney General, who shall use criminal, immigration, national security, and other electronic databases available to the Federal Government, as appropriate for the purpose of promptly notifying the Secretary whether the person, or, where relevant, the individual who owns or controls such person, is within any of the categories described in section 175b(d)(1) of title 18, United States Code (relating to restricted persons), or is reasonably suspected by any Federal law enforcement or intelligence agency of being within any category specified in paragraph (3)(B)(ii) (as applied to persons, including individuals). Such regulations shall provide that a person who seeks to register under either of such subsections is subject to the same processes described in paragraphs (2) and (4) as apply to names and other identifying information submitted to the Attorney General under paragraph (2)(B). Paragraph (5) does not apply for purposes of this subparagraph. The Secretary may exempt Federal, State, or local governmental agencies from the requirements of this subparagraph.

(7) Review.--

(A) Administrative review.--

(i) In general.--Regulations under subsections (b) and (c) shall provide for an opportunity for a review by the Secretary--

(I) when requested by the individual involved, of a determination under paragraph (2) to deny the individual access to listed agents and toxins; and

(II) when requested by the person involved, of a determination under under paragraph (6) to deny or revoke registration for such person.

(ii) Ex parte review.--During a review under clause (i), the Secretary may consider information relevant to the review ex parte to the extent that disclosure of the information could compromise national security or an investigation by any law enforcement agency.

(iii) Final agency action.--The decision of the Secretary in a review under clause (i) constitutes final agency action for purposes of section 702 of title 5, United States Code.

(B) Certain procedures.--

(i) Submission of ex parte materials in judicial proceedings.--When reviewing a decision of the Secretary under subparagraph (A), and upon request made ex parte and in writing by the United States, a court, upon a sufficient showing, may review and consider ex parte documents containing information the disclosure of which could compromise national security or an investigation by any law enforcement agency. If the court determines that portions of the documents considered ex parte should be disclosed to the person involved to allow a response, the court shall authorize the United States to delete from such documents specified items of information the disclosure of which could compromise national security or an investigation by any law enforcement agency, or to substitute a summary of the information to which the person may respond. Any order by the court authorizing the disclosure of information that the United States believes could compromise national security or an investigation by any law enforcement agency shall be subject to the processes set forth in subparagraphs (A) and

(B)(i) of section 2339B(f)(5) of title 18, United States Code

(relating to interlocutory appeal and expedited consideration).

(ii) Disclosure of information.--In a review under subparagraph (A), and in any judical proceeding conducted pursuant to such review, neither the Secretary nor the Attorney General may be required to disclose to the public any information that under subsection (h) shall not be disclosed under section 552 of title 5, United States Code.

(8) Notifications regarding theft or loss of agents.--Requirements under paragraph (1) shall include the prompt notification of the Secretary, and appropriate Federal, State, and local law enforcement agencies, of the theft or loss of listed agents and toxins.

(9) Technical assistance for registered persons.--The Secretary, in consultation with the Attorney General, may provide technical assistance to registered persons to improve security of the facilities of such persons.

(f) Inspections.--The Secretary shall have the authority to inspect persons subject to regulations under subsection (b) or (c) to ensure their compliance with such regulations, including prohibitions on restricted persons and other provisions of subsection (e).

(g) Exemptions.--

(1) Overlap agents and toxins.--

(A) In general.--

(i) Limitation.--In the case of overlap agents and toxins, exemptions from the applicability of provisions of regulations under subsection (b) or (c) may be granted only to the extent provided in this paragraph.

(ii) Definitions.--For purposes of this section:

(I) The term ``overlap agents and toxins'' means biological agents and toxins that--

(aa) are listed pursuant to subsection (a)(1); and

(bb) are listed pursuant to section 315A(a)(1) of the Public Health Service Act.

(II) The term ``overlap agent or toxin'' means a biological agent or toxin that--

(aa) is listed pursuant to subsection (a)(1); and

(bb) is listed pursuant to section 315A(a)(1) of the Public Health Service Act.

(B) Clinical or diagnostic laboratories.--Regulations under subsections (b) and (c) shall exempt clinical or diagnostic laboratories and other persons who possess, use, or transfer overlap agents or toxins that are contained in specimens presented for diagnosis, verification, or proficiency testing, provided that--

(i) the identification of such agents or toxins is reported to the Secretary, and when required under Federal, State, or local law, to other appropriate authorities; and

(ii) such agents or toxins are transferred or destroyed in a manner set forth by the Secretary by regulation.

(C) Products.--

(i) In general.--Regulations under subsections (b) and (c) shall exempt products that are, bear, or contain overlap agents or toxins and are cleared, approved, licensed, or registered under any of the Acts specified in clause (ii), unless the Secretary by order determines that applying additional regulation under subsection (b) or (c) to a specific product is necessary to protect animal or plant health, or animal or plant products.

(ii) Relevant laws.--For purposes of clause (i), the Acts specified in this clause are the following:

(I) The Federal Food, Drug, and Cosmetic Act.

(II) Section 351 of the Public Health Service Act.

(III) The Act commonly known as the Virus-Serum-Toxin Act

(the eighth paragraph under the heading `Bureau of Animal Industry' in the Act of March 4, 1913; 21 U.S.C. 151-159).

(IV) The Federal Insecticide, Fungicide, and Rodenticide Act.

(iii) Investigational use.--

(I) In general.--The Secretary may exempt an investigational product that is, bears, or contains an overlap agent or toxin from the applicability of provisions of regulations under subsection (b) or (c) when such product is being used in an investigation authorized under any Federal Act and the Secretary determines that applying additional regulation under subsection (b) or (c) to such product is not necessary to protect animal and plant health, and animal and plant products.

(II) Certain processes.--Regulations under subsections (b) and (c) shall set forth the procedures for applying for an exemption under subclause (I). In the case of investigational products authorized under any of the Acts specified in clause

(ii), the Secretary shall make a determination regarding a request for an exemption not later than 14 days after the first date on which both of the following conditions have been met by the person requesting the exemption:

(aa) The person has submitted to the Secretary an application for the exemption meeting the requirements established by the Secretary.

(bb) The person has notified the Secretary that the investigation has been authorized under such an Act.

(D) Agricultural emergencies.-- The Secretary may temporarily exempt a person from the applicability of the requirements of this section with respect to an overlap agent or toxin, in whole or in part, if the Secretary determines that such exemption is necessary to provide for the timely participation of the person in a response to a domestic or foreign agricultural emergency that involves such an agent or toxin. With respect to the emergency involved, the exemption under this subparagraph for a person may not exceed 30 days, except that the Secretary, after review of whether such exemption remains necessary, may provide one extension of an additional 30 days.

(E) Public health emergencies.--Upon request of the Secretary of Health and Human Services, after the granting by such Secretary of an exemption under 351A(g)(3) of the Public Health Service Act pursuant to a finding that there is a public health emergency, the Secretary of Agriculture may temporarily exempt a person from the applicability of the requirements of this section with respect to an overlap agent or toxin, in whole or in part, to provide for the timely participation of the person in a response to the public health emergency. With respect to the emergency involved, such exemption for a person may not exceed 30 days, except that upon request of the Secretary of Health and Human Services, the Secretary of Agriculture may, after review of whether such exemption remains necessary, provide one extension of an additional 30 days.

(2) General authority for exemptions not involving overlap agents or toxins.--In the case of listed agents or toxins that are not overlap agents or toxins, the Secretary may grant exemptions from the applicability of provisions of regulations under subsection (b) or (c) if the Secretary determines that such exemptions are consistent with protecting animal and plant health, and animal and plant products.

(h) Disclosure of Information.--

(1) Nondisclosure of certain information.--No Federal agency specified in paragraph (2) shall disclose under section 552 of title 5, United States Code, any of the following:

(A) Any registration or transfer documentation submitted under subsections (b) and (c), or permits issued prior to the date of the enactment of this Act, for the possession, use or transfer of a listed agent or toxin; or information derived therefrom to the extent that it identifies the listed agent or toxin possessed, used or transferred by a specific person or discloses the identity or location of a specific person.

(B) The national database developed pursuant to subsection

(d), or any other compilation of the registration or transfer information submitted under subsections (b) and (c) to the extent that such compilation discloses site-specific registration or transfer information.

(C) Any portion of a record that discloses the site-specific or transfer-specific safeguard and security measures used by a registered person to prevent unauthorized access to listed agents and toxins.

(D) Any notification of a release of a listed agent or toxin submitted under subsections (b) and (c), or any notification of theft or loss submitted under such subsections.

(E) Any portion of an evaluation or report of an inspection of a specific registered person conducted under subsection

(f) that identifies the listed agent or toxin possessed by a specific registered person or that discloses the identity or location of a specific registered person if the agency determines that public disclosure of the information would endanger animal or plant health, or animal or plant products.

(2) Covered agencies.--For purposes of paragraph (1) only, the Federal agencies specified in this paragraph are the following:

(A) The Department of Health and Human Services, the Department of Justice, the Department of Agriculture, and the Department of Transportation.

(B) Any Federal agency to which information specified in paragraph (1) is transferred by any agency specified in subparagraph (A) of this paragraph.

(C) Any Federal agency that is a registered person, or has a sub-agency component that is a registered person.

(D) Any Federal agency that awards grants or enters into contracts or cooperative agreements involving listed agents and toxins to or with a registered person, and to which information specified in paragraph (1) is transferred by any such registered person.

(3) Other exemptions.--This subsection may not be construed as altering the application of any exemptions to public disclosure under section 552 of title 5, United States Code, except as to subsection 552(b)(3) of such title, to any of the information specified in paragraph (1).

(4) Rule of construction.--Except as specifically provided in paragraph (1), this subsection may not be construed as altering the authority of any Federal agency to withhold under section 552 of title 5, United States Code, or the obligation of any Federal agency to disclose under section 552 of title 5, United States Code, any information, including information relating to--

(A) listed agents and toxins, or individuals seeking access to such agents and toxins;

(B) registered persons, or persons seeking to register their possession, use, or transfer of such agents and toxins;

(C) general safeguard and security policies and requirements under regulations under subsections (b) and (c); or

(D) summary or statistical information concerning registrations, registrants, denials or revocations of registrations, listed agents and toxins, inspection evaluations and reports, or individuals seeking access to such agents and toxins.

(5) Disclosures to congress; other disclosures.--This subsection may not be construed as providing any authority--

(A) to withhold information from the Congress or any committee or subcommittee thereof; or

(B) to withhold information from any person under any other Federal law or treaty.

(i) Civil Money Penalty.--

(1) In general.--In addition to any other penalties that may apply under law, any person who violates any provision of regulations under subsection (b) or (c) shall be subject to the United States for a civil money penalty in an amount not exceeding $250,000 in the case of an individual and $500,000 in the case of any other person.

(2) Applicability of certain provisions.--The provisions of sections 423 and 425(2) of the Plant Protection Act (7 U.S.C. 7733 and 7735(2) shall apply to a civil money penalty or activity under paragraph (1) in the same manner as such provisions apply to a penalty or activity under the Plant Protection Act.

(j) Notification in Event of Release.--Regulations under subsections (b) and (c) shall require the prompt notification of the Secretary by a registered person whenever a release, meeting criteria established by the Secretary, of a listed agent or toxin has occurred outside of the biocontainment area of a facility of the registered person. Upon receipt of such notification and a finding by the Secretary that the release poses a threat to animal or plant health, or animal or plant products, the Secretary shall take appropriate action to notify relevant Federal, State, and local authorities, and, if necessary, other appropriate persons

(including the public). If the released listed agent or toxin is an overlap agent or toxin, the Secretary shall promptly notify the Secretary of Health and Human Services upon notification by the registered person.

(k) Reports.--The Secretary shall report to the Congress annually on the number and nature of notifications received under subsection (e)(8) (relating to theft or loss) and subsection (j) (relating to releases).

(l) Definitions.--For purposes of this section:

(1) The terms ``biological agent'' and ``toxin'' have the meanings given such terms in section 178 of title 18, United States Code.

(2) The term ``listed agents and toxins'' means biological agents and toxins listed pursuant to subsection (a)(1).

(3) The term ``listed agents or toxins'' means biological agents or toxins listed pursuant to subsection (a)(1).

(4) The terms ``overlap agents and toxins'' and ``overlap agent or toxin'' have the meaning given such terms in subsection (g)(1)(A)(ii).

(5) The term ``person'' includes Federal, State, and local governmental entities.

(6) The term ``registered person'' means a person registered under regulations under subsection (b) or (c).

(7) The term ```Secretary'' means the Secretary of Agriculture.

(m) Authorization of Appropriations.--For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2002 through 2007, in addition to other funds that may be available.

SEC. 213. IMPLEMENTATION BY DEPARTMENT OF AGRICULTURE.

(a) Date Certain for Promulgation of List.--Not later than 60 days after the date of the enactment of this Act, the Secretary of Agriculture (referred to in this section as the

``Secretary'') shall promulgate an interim final rule that establishes the initial list under section 212(a)(1). In promulgating such rule, the Secretary shall provide written guidance on the manner in which the notice required in subsection (b) is to be provided to the Secretary.

(b) Date Certain for Notice of Possession.--Not later than 60 days after the date on which the Secretary promulgates the interim final rule under subsection (a), all persons (unless exempt under section 212(g)) in possession of biological agents or toxins included on the list referred to in subsection (a) shall notify the Secretary of such possession.

(c) Date Certain for Promulgation; Effective Date Regarding Criminal and Civil Penalties.--Not later than 180 days after the date of the enactment of this Act, the Secretary shall promulgate an interim final rule for carrying out section 212, other than for the list referred to in subsection (a) of this section (but such rule may incorporate by reference provisions promulgated pursuant to subsection (a)). Such interim final rule shall take effect 60 days after the date on which such rule is promulgated, including for purposes of--

(1) section 175b(c) of title 18, United States Code

(relating to criminal penalties), as added by section 231(a)(5) of this Act; and

(2) section 212(i) of this Act (relating to civil penalties).

(d) Transitional Provision Regarding Current Research and Education.--The interim final rule under subsection (c) shall include time frames for the applicability of the rule that minimize disruption of research or educational projects that involve biological agents and toxins listed pursuant to section 212(a)(1) and that were underway as of the effective date of such rule.

Subtitle C--Interagency Coordination Regarding Overlap Agents and

Toxins

SEC. 221. INTERAGENCY COORDINATION.

(a) In General.--

(1) Coordination.--The Secretary of Agriculture and the Secretary of Health and Human Services shall in accordance with this section coordinate activities regarding overlap agents and toxins.

(2) Overlap agents and toxins; other terms.--For purposes of this section:

(A) The term ``overlap agent or toxin'' means a biological agent or toxin that--

(i) is listed pursuant to section 315A(a)(1) of the Public Health Service Act, as added by section 201 of this Act; and

(ii) is listed pursuant to section 212(a)(1) of this Act.

(B) The term ``section 351A program'' means the program under section 351A of the Public Health Service Act.

(C) The term ``section 212 program'' means the program under section 212 of this Act.

(b) Certain Matters.--In carrying out the section 351A program and the section 212 program, the Secretary of Health and Human Services and the Secretary of Agriculture shall, to the greatest extent practicable, coordinate activities to achieve the following purposes:

(1) To minimize any conflicts between the regulations issued under, and activities carried out under, such programs.

(2) To minimize the administrative burden on persons subject to regulation under both of such programs.

(3) To ensure the appropriate availability of biological agents and toxins for legitimate biomedical, agricultural or veterinary research, education, or other such purposes.

(4) To ensure that registration information for overlap agents and toxins under the section 351A and section 212 programs is contained in both the national database under the section 351A program and the national database under the section 212 program.

(c) Memorandum of Understanding.--

(1) In general.--Promptly after the date of the enactment of this Act, the Secretary of Agriculture and the Secretary of Health and Human Services shall enter into a memorandum of understanding regarding overlap agents and toxins that is in accordance with paragraphs (2) through (4) and contains such additional provisions as the Secretary of Agriculture and the Secretary of Health and Human Services determine to be appropriate.

(2) Single registration system regarding registered persons.--The memorandum of understanding under paragraph (1) shall provide for the development and implementation of a single system of registration for persons who possess, use, or transfer overlap agents or toxins and are required to register under both the section 351A program and the section 212 program. For purposes of such system, the memorandum shall provide for the development and implementation of the following:

(A) A single registration form through which the person submitting the form provides all information that is required for registration under the section 351A program and all information that is required for registration under the section 212 program.

(B) A procedure through which a person may choose to submit the single registration form to the agency administering the section 351A program (in the manner provided under such program), or to the agency administering the section 212 program (in the manner provided under such program).

(C) A procedure through which a copy of a single registration form received pursuant to subparagraph (B) by the agency administering one of such programs is promptly provided to the agency administering the other program.

(D) A procedure through which the agency receiving the single registration form under one of such programs obtains the concurrence of the agency administering the other program that the requirements for registration under the other program have been met.

(E) A procedure through which--

(i) the agency receiving the single registration form under one of such programs informs the agency administering the other program whether the receiving agency has denied the registration; and

(ii) each of such agencies ensures that registrations are entered into the national database of registered persons that is maintained by each such agency.

(3) Process of identification.--With respect to the process of identification under the section 351A program and the section 212 program for names and other identifying information submitted to the Attorney General (relating to certain categories of individuals and entities), the memorandum of understanding under paragraph (1) shall provide for the development and implementation of the following:

(A) A procedure through which a person who is required to submit information pursuant to such process makes (in addition to the submission to the Attorney General) a submission, at the option of the person, to either the agency administering the section 351A program or the agency administering the section 212 program, but not both, which submission satisfies the requirement of submission for both of such programs.

(B) A procedure for the sharing by both of such agencies of information received from the Attorney General by one of such agencies pursuant to the submission under subparagraph (A).

(C) A procedure through which the agencies administering such programs concur in determinations that access to overlap agents and toxins will be granted.

(4) Coordination of inspections and enforcement.--The memorandum of understanding under paragraph (1) shall provide for the development and implementation of procedures under which Federal personnel under the section 351A program and the section 212 program may share responsibilities for inspections and enforcement activities under such programs regarding overlap agents and toxins. Activities carried out under such procedures by one of such programs on behalf of the other may be carried out with or without reimbursement by the agency that administers the other program.

(5) Date certain for implementation.--The memorandum of understanding under paragraph (1) shall be implemented not later than 180 days after the date of the enactment of this Act. Until the single system of registration under paragraph

(2) is implemented, persons who possess, use, or transfer overlap agents or toxins shall register under both the section 351A program and the section 212 program.

(d) Joint Regulations.--Not later than 18 months after the date on which the single system of registration under subsection (c)(2) is implemented, the Secretary of Health and Human Services and the Secretary of Agriculture shall jointly issue regulations for the possession, use, and transfer of overlap agents and toxins that meet the requirements of both the section 351A program and the section 212 program.

Subtitle D--Criminal Penalties Regarding Certain Biological Agents and

Toxins

SEC. 231. CRIMINAL PENALTIES.

(a) In General.--Section 175b of title 18, United States Code, as added by section 817 of Public Law 107-56, is amended--

(1) by striking ``(a)'' and inserting ``(a)(1)'';

(2) by transferring subsection (c) from the current placement of the subsection and inserting the subsection before subsection (b);

(3) by striking ``(c)'' and inserting ``(2);

(4) by redesignating subsection (b) as subsection (d); and

(5) by inserting before subsection (d) (as so redesignated) the following subsections:

``(b) Transfer to Unregistered Person.--

``(1) Select agents.--Whoever transfers a select agent to a person who the transferor knows or has reasonable cause to believe is not registered as required by regulations under subsection (b) or (c) of section 351A of the Public Health Service Act shall be fined under this title, or imprisoned for not more than 5 years, or both.

``(2) Certain other biological agents and toxins.--Whoever transfers a biological agent or toxin listed pursuant to section 212(a)(1) of the Agricultural Bioterrorism Protection Act of 2002 to a person who the transferor knows or has reasonable cause to believe is not registered as required by regulations under subsection (b) or (c) of section 212 of such Act shall be fined under this title, or imprisoned for not more than 5 years, or both.

``(c) Unregistered for Possession.--

``(1) Select agents.--Whoever knowingly possesses a biological agent or toxin where such agent or toxin is a select agent for which such person has not obtained a registration required by regulations under section 351A(c) of the Public Health Service Act shall be fined under this title, or imprisoned for not more than 5 years, or both.

``(2) Certain other biological agents and toxins.--Whoever knowingly possesses a biological agent or toxin where such agent or toxin is a biological agent or toxin listed pursuant to section 212(a)(1) of the Agricultural Bioterrorism Protection Act of 2002 for which such person has not obtained a registration required by regulations under section 212(c) of such Act shall be fined under this title, or imprisoned for not more than 5 years, or both.''.

(b) Conforming Amendments.--Chapter 10 of title 18, United States Code, is amended--

(1) in section 175b (as added by section 817 of Public Law 107-56 and amended by subsection (a) of this section)--

(A) in subsection (d)(1), by striking ``The term'' and all that follows through ``does not include'' and inserting the following: ``The term `select agent' means a biological agent or toxin to which subsection (a) applies. Such term

(including for purposes of subsection (a)) does not include''; and

(B) in the heading for the section, by striking

``Possession by restricted persons'' and inserting ``Select agents; certain other agents''; and

(2) in the chapter analysis, in the item relating to section 175b, by striking ``Possession by restricted persons.'' and inserting ``Select agents; certain other agents.''.

(c) Technical Corrections.--Chapter 10 of title 18, United States Code, as amended by section 817 of Public Law 107-56 and subsections (a) and (b) of this section, is amended--

(1) in section 175(c), by striking ``protective'' and all that follows and inserting ``protective, bona fide research, or other peaceful purposes.'';

(2) in section 175b--

(A) in subsection (a)(1), by striking ``described in subsection (b)'' and all that follows and inserting the following: ``shall ship or transport in or affecting interstate or foreign commerce, or possess in or affecting interstate or foreign commerce, any biological agent or toxin, or receive any biological agent or toxin that has been shipped or transported in interstate or foreign commerce, if the biological agent or toxin is listed as a select agent in Appendix A of part 72 of title 42, Code of Federal Regulations, pursuant to section 351A of the Public Health Service Act, and is not exempted under subsection (h) of section 72.6, or Appendix A of part 72, of title 42, Code of Federal Regulations.''; and

(B) in subsection (d)(3), by striking ``section 1010(a)(3)'' and inserting ``section 101(a)(3)'';

(3) in section 176(a)(1)(A), by striking ``exists by reason of'' and inserting ``pertains to''; and

(4) in section 178--

(A) in paragraph (1), by striking ``means any micro-organism'' and all that follows through ``product, capable of'' and inserting the following: ``means any microorganism

(including, but not limited to, bacteria, viruses, fungi, rickettsiae or protozoa), or infectious substance, or any naturally occurring, bioengineered or synthesized component of any such microorganism or infectious substance, capable of'';

(B) in paragraph (2), by striking ``means the toxic'' and all that follows through ``including--'' and inserting the following: ``means the toxic material or product of plants, animals, microorganisms (including, but not limited to, bacteria, viruses, fungi, rickettsiae or protozoa), or infectious substances, or a recombinant or synthesized molecule, whatever their origin and method of production, and includes--''; and

(C) in paragraph (4), by striking ``recombinant molecule,'' and all that follows through ``biotechnology,'' and inserting

``recombinant or synthesized molecule,''.

(d) Additional Technical Correction.--Section 2332a of title 18, United States Code, is amended--

(1) in subsection (a), in the matter preceding paragraph

(1), by striking ``section 229F)'' and all that follows through ``section 178)--'' and inserting ``section 229F)--''; and

(2) in subsection (c)(2)(C), by striking ``a disease organism'' and inserting ``a biological agent, toxin, or vector (as those terms are defined in section 178 of this title)''.

TITLE III--PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG SUPPLY

Subtitle A--Protection of Food Supply

SEC. 301. FOOD SAFETY AND SECURITY STRATEGY.

(a) In General.--The President's Council on Food Safety (as established by Executive Order 13100) shall, in consultation with the Secretary of Transportation, the Secretary of the Treasury, other relevant Federal agencies, the food industry, consumer and producer groups, scientific organizations, and the States, develop a crisis communications and education strategy with respect to bioterrorist threats to the food supply. Such strategy shall address threat assessments; technologies and procedures for securing food processing and manufacturing facilities and modes of transportation; response and notification procedures; and risk communications to the public.

(b) Authorization of Appropriations.--For the purpose of implementing the strategy developed under subsection (a), there are authorized to be appropriated $750,000 for fiscal year 2002, and such sums as may be necessary for each subsequent fiscal year.

SEC. 302. PROTECTION AGAINST ADULTERATION OF FOOD.

(a) Increasing Inspections for Detection of Adulteration of Food.--Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following subsection:

``(h)(1) The Secretary shall give high priority to increasing the number of inspections under this section for the purpose of enabling the Secretary to inspect food offered for import at ports of entry into the United States, with the greatest priority given to inspections to detect the intentional adulteration of food.''.

(b) Improvements to Information Management Systems.--Section 801(h) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) of this section, is amended by adding at the end the following paragraph:

``(2) The Secretary shall give high priority to making necessary improvements to the information management systems of the Food and Drug Administration that contain information related to foods imported or offered for import into the United States for purposes of improving the ability of the Secretary to allocate resources, detect the intentional adulteration of food, and facilitate the importation of food that is in compliance with this Act.''.

(c) Linkages With Appropriate Public Entities.--Section 801(h) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (b) of this section, is amended by adding at the end the following paragraph:

``(3) The Secretary shall improve linkages with other regulatory agencies of the Federal Government that share responsibility for food safety, and shall with respect to such safety improve linkages with the States and Indian tribes (as defined in section 4(e) of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b(e))).''.

(d) Testing for Rapid Detection of Adulteration of Food.--Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a) of this section, is amended by adding at the end the following:

``(i)(1) For use in inspections of food under this section, the Secretary shall provide for research on the development of tests and sampling methodologies--

``(A) whose purpose is to test food in order to rapidly detect the adulteration of the food, with the greatest priority given to detect the intentional adulteration of food; and

``(B) whose results offer significant improvements over the available technology in terms of accuracy, timing, or costs.

``(2) In providing for research under paragraph (1), the Secretary shall give priority to conducting research on the development of tests that are suitable for inspections of food at ports of entry into the United States.

``(3) In providing for research under paragraph (1), the Secretary shall as appropriate coordinate with the Director of the Centers for Disease Control and Prevention, the Director of the National Institutes of Health, the Administrator of the Environmental Protection Agency, and the Secretary of Agriculture.

``(4) The Secretary shall annually submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report describing the progress made in research under paragraph (1), including progress regarding paragraph

(2).''.

(e) Assessment of Threat of Intentional Adulteration of Food.--The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall ensure that, not later than six months after the date of the enactment of this Act--

(1) the assessment that (as of such date of enactment) is being conducted on the threat of the intentional adulteration of food is completed; and

(2) a report describing the findings of the assessment is submitted to the Committee on Energy and Commerce of the House of Representatives and to the Committee on Health, Education, Labor, and Pensions of the Senate.

(f) Authorization of Appropriations.--For the purpose of carrying out this section and the amendments made by this section, there are authorized to be appropriated $100,000,000 for fiscal year 2002, and such sums as may be necessary for each of the fiscal years 2003 through 2006, in addition to other authorizations of appropriations that are available for such purpose.

SEC. 303. ADMINISTRATIVE DETENTION.

(a) Expanded Authority.--Section 304 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334) is amended by adding at the end the following subsection:

``(h) Administrative Detention of Foods.--

``(1) Detention authority.--

``(A) In general.--An officer or qualified employee of the Food and Drug Administration may order the detention, in accordance with this subsection, of any article of food that is found during an inspection, examination, or investigation under this Act conducted by such officer or qualified employee, if the officer or qualified employee has credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals.

``(B) Secretary's approval.--An article of food may be ordered detained under subparagraph (A) only if the Secretary or an official designated by the Secretary approves the order. An official may not be so designated unless the official is the director of the district under this Act in which the article involved is located, or is an official senior to such director.

``(2) Period of detention.--An article of food may be detained under paragraph (1) for a reasonable period, not to exceed 20 days, unless a greater period, not to exceed 30 days, is necessary, to enable the Secretary to institute an action under subsection (a) or section 302. The Secretary shall by regulation provide for procedures for instituting such action on an expedited basis with respect to perishable foods.

``(3) Security of detained article.--An order under paragraph (1) with respect to an article of food may require that such article be labeled or marked as detained, and shall require that the article be removed to a secure facility, as appropriate. An article subject to such an order shall not be transferred by any person from the place at which the article is ordered detained, or from the place to which the article is so removed, as the case may be, until released by the Secretary or until the expiration of the detention period applicable under such order, whichever occurs first. This subsection may not be construed as authorizing the delivery of the article pursuant to the execution of a bond while the article is subject to the order, and section 801(b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is subject to the order.

``(4) Appeal of detention order.--

``(A) In general.--With respect to an article of food ordered detained under paragraph (1), any person who would be entitled to be a claimant for such article if the article were seized under subsection (a) may appeal the order to the Secretary. Within five days after such an appeal is filed, the Secretary, after providing opportunity for an informal hearing, shall confirm or terminate the order involved, and such confirmation by the Secretary shall be considered a final agency action for purposes of section 702 of title 5, United States Code. If during such five-day period the Secretary fails to provide such an opportunity, or to confirm or terminate such order, the order is deemed to be terminated.

``(B) Effect of instituting court action.--The process under subparagraph (A) for the appeal of an order under paragraph (1) terminates if the Secretary institutes an action under subsection (a) or section 302 regarding the article of food involved.''.

(b) Prohibited Act.--Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:

``(bb) The transfer of an article of food in violation of an order under section 304(h), or the removal or alteration of any mark or label required by the order to identify the article as detained.''.

(c) Temporary Holds at Ports of Entry.--Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended by section 302(d)of this Act, is amended by adding at the end the following:

``(j)(1) If an officer or qualified employee of the Food and Drug Administration has credible evidence or information indicating that an article of food presents a threat of serious adverse health consequences or death to humans or animals, and such officer or qualified employee is unable to inspect, examine, or investigate such article upon the article being offered for import at a port of entry into the United States, the officer or qualified employee shall request the Secretary of Treasury to hold the food at the port of entry for a reasonable period of time, not to exceed 24 hours, for the purpose of enabling the Secretary to inspect, examine, or investigate the article as appropriate.

``(2) The Secretary shall request the Secretary of Treasury to remove an article held pursuant to paragraph (1) to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held.

``(3) An officer or qualified employee of the Food and Drug Administration may make a request under paragraph (1) only if the Secretary or an official designated by the Secretary approves the request. An official may not be so designated unless the official is the director of the district under this Act in which the article involved is located, or is an official senior to such director.

``(4) With respect to an article of food for which a request under paragraph (1) is made, the Secretary, promptly after the request is made, shall notify the State in which the port of entry involved is located that the request has been made, and as applicable, that such article is being held under this subsection.''. SEC. 304. DEBARMENT FOR REPEATED OR SERIOUS FOOD IMPORT

VIOLATIONS.

(a) Debarment Authority.--

(1) Permissive debarment.--Section 306(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)(1)) is amended--

(A) in subparagraph (A), by striking ``or'' after the comma at the end;

(B) in subparagraph (B), by striking the period at the end and inserting ``, or''; and

(C) by adding at the end the following subparagraph:

``(C) a person from importing an article of food or offering such an article for import into the United States.'';

(2) Amendment regarding debarment grounds.--Section 306(b)) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is amended--

(A) in paragraph (2), in the matter preceding subparagraph

(A), by inserting ``subparagraph (A) or (B) of'' before

``paragraph (1)'';

(B) by redesignating paragraph (3) as paragraph (4); and

(C) by inserting after paragraph (2) the following paragraph:

``(3) Persons subject to permissive debarment; food importation.--A person is subject to debarment under paragraph (1)(C) if--

``(A) the person has been convicted of a felony for conduct relating to the importation into the United States of any food; or

``(B) the person has engaged in a pattern of importing or offering for import adulterated food that presents a threat of serious adverse health consequences or death to humans or animals.''.

(b) Conforming Amendments.--Section 306 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a) is amended--

(1) in subsection (a), in the heading for the subsection, by striking ``Mandatory Debarment.--'' and inserting

``Mandatory Debarment; Certain Drug Applications.--'';

(2) in subsection (b)--

(A) in the heading for the subsection, by striking

``Permissive Debarment.--'' and inserting ``Permissive Debarment; Certain Drug Applications; Food Imports.--''; and

(B) in paragraph (2), in the heading for the paragraph, by striking ``permissive debarment.--'' and inserting

``permissive debarment; certain drug applications.--'';

(3) in subsection (c)(2)(A)(iii), by striking ``subsection

(b)(2)'' and inserting ``paragraph (2) or (3) of subsection

(b)'';

(4) in subsection (d)(3)--

(A) in subparagraph (A)(i), by striking ``or (b)(2)(A)'' and inserting `` or paragraph (2)(A) or (3) of subsection

(b)'';

(B) in subparagraph (A)(ii)(II), by inserting ``in applicable cases,'' before ``sufficient audits'';

(C) in subparagraph (B), in each of clauses (i) and (ii), by inserting ``or subsection (b)(3)'' after ``subsection

(b)(2)(B)''; and

(D) in subparagraph (B)(ii), by inserting before the period the following: ``or the food importation process, as the case may be''.

(c) Effective Dates.--Section 306(l)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(l)(2)) is amended--

(1) in the first sentence--

(A) by striking ``and'' after ``subsection (b)(2),''; and

(B) by inserting ``, and subsection (b)(3)(A)'' after

``subsection (b)(2)(B)''; and

(2) in the second sentence, by inserting ``, subsection

(b)(3)(B),'' after ``subsection (b)(2)(B)''.

(d) Prohibited Act.--Section 301 of the Federal Food, Drug, and Cosmetic Act, as amended by section 303(b) of this Act, is amended by adding at the end the following:

``(cc) The importing or offering for import into the United States of an article of food by, with the assistance of, or at the direction of, a person debarred under section 306(b)(3).''.

(e) Importation by Debarred Persons.--Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended by section 303(c) of this Act, is amended by adding at the end the following subsection:

``(k)(1) If an article of food is being imported or offered for import into the United States, and the importer, owner, or consignee of the article is a person who has been debarred under section 306(b)(3), such article shall be held at the port of entry for the article, and may not be delivered to such person. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.

``(2) An article of food held under paragraph (1) may be delivered to a person who is not a debarred person under section 306(b)(3) if such person affirmatively establishes, at the expense of the person, that the article complies with the requirements of this Act, as determined by the Secretary.''.

SEC. 305. REGISTRATION OF FOOD FACILITIES.

(a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amended by adding at the end the following:

``SEC. 415. REGISTRATION OF FOOD FACILITIES.

``(a) Registration.--

``(1) In general.--The Secretary shall by regulation require that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the Secretary. To be registered--

``(A) for a domestic facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary; and

``(B) for a foreign facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary and shall include with the registration the name of the United States agent for the facility.

``(2) Registration.--An entity (referred to in this section as the `registrant') shall submit a registration under paragraph (1) to the Secretary containing information necessary to notify the Secretary of the name and address of each facility at which, and all trade names under which, the registrant conducts business and, when determined necessary by the Secretary through guidance, the general food category

(as identified under section 170.3 of title 21, Code of Federal Regulations) of any food manufactured, processed, packed, or held at such facility. The registrant shall notify the Secretary in a timely manner of changes to such information.

``(3) Procedure.--Upon receipt of a completed registration described in paragraph (1), the Secretary shall notify the registrant of the receipt of such registration and assign a registration number to each registered facility.

``(4) List.--The Secretary shall compile and maintain an up-to-date list of facilities that are registered under this section. Such list and any registration documents submitted pursuant to this subsection shall not be subject to disclosure under section 552 of title 5, United States Code. Information derived from such list or registration documents shall not be subject to disclosure under section 552 of title 5, United States Code, to the extent that it discloses the identity or location of a specific registered person.

``(b) Facility.--For purposes of this section:

``(1) The term `facility' includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing as defined in section 123.3(k) of title 21, Code of Federal Regulations).

``(2) The term `domestic facility' means a facility located in any of the States or Territories.

``(3)(A) The term `foreign facility' means a facility that manufacturers, processes, packs, or holds food, but only if food from such facility is exported to the United States without further processing or packaging outside the United States.

``(B) A food may not be considered to have undergone further processing or packaging for purposes of subparagraph

(A) solely on the basis that labeling was added or that any similar activity of a de minimis nature was carried out with respect to the food.

``(c) Rule of Construction.--Nothing in this section shall be construed to authorize the Secretary to require an application, review, or licensing process.''.

(b) Prohibited Acts.--Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section 304(d) of this Act, is amended by adding at the end the following:

``(dd) The failure to register in accordance with section 415.''.

(c) Importation; Failure to Register.--Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended by section 304(e) of this Act, is amended by adding at the end the following subsection:

``(l)(1) If an article of food is being imported or offered for import into the United States, and such article is from a foreign facility for which a registration has not been submitted to the Secretary under section 415, such article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until the foreign facility is so registered. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.''.

(d) Electronic Filing.--For the purpose of reducing paperwork and reporting burdens, the Secretary of Health and Human Services may provide for, and encourage the use of, electronic methods of submitting to the Secretary registrations required pursuant to this section. In providing for the electronic submission of such registrations, the Secretary shall ensure adequate authentication protocols are used to enable identification of the registrant and validation of the data as appropriate.

(e) Rulemaking; Effective Date.--Not later than 18 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall promulgate proposed and final regulations for the requirement of registration under section 415 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a) of this section). Such requirement of registration takes effect--

(1) upon the effective date of such final regulations; or

(2) upon the expiration of such 18-month period if the final regulations have not been made effective as of the expiration of such period, subject to compliance with the final regulations when the final regulations are made effective.

SEC. 306. MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS.

(a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic Act, as amended by section 305 of this Act, is amended by inserting before section 415 the following section:

``SEC. 414. MAINTENANCE AND INSPECTION OF RECORDS.

``(a) Records Inspection.--If the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article that are needed to assist the Secretary in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. The requirement under the preceding sentence applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location.

``(b) Regulations Concerning Recordkeeping.--The Secretary, in consultation and coordination, as appropriate, with other Federal departments and agencies with responsibilities for regulating food safety, may by regulation establish requirements regarding the establishment and maintenance, for not longer than two years, of records by persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food, which records are needed by the Secretary for inspection to allow the Secretary to identify the immediate previous sources and the immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse health consequences or death to humans or animals. The Secretary shall take into account the size of a business in promulgating regulations under this section.

``(c) Protection of Sensitive Information.--The Secretary shall take appropriate measures to ensure that there are in effect effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the Secretary pursuant to this section.

``(d) Limitations.--This section shall not be construed--

``(1) to limit the authority of the Secretary to inspect records or to require establishment and maintenance of records under any other provision of this Act;

``(2) to authorize the Secretary to impose any requirements with respect to a food to the extent that it is within the exclusive jurisdiction of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq);

``(3) to have any legal effect on section 552 of title 5, United States Code, or section 1905 of title 18, United States Code; or

``(4) to extend to recipes for food, financial data, pricing data, personnel data, research data, or sales data

(other than shipment data regarding sales).''.

(b) Factory Inspection.--Section 704(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended--

(1) in paragraph (1), by inserting after the first sentence the following new sentence: ``In the case of any person

(excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 414 when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to the limitations established in section 414(d).''; and

(2) in paragraph (2), in the matter preceding subparagraph

(A), by striking ``second sentence'' and inserting ``third sentence''.

(c) Prohibited Act.--Section 301 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 331) is amended--

(1) in paragraph (e)--

(A) by striking ``by section 412, 504, or 703'' and inserting ``by section 412, 414, 504, 703, or 704(a)''; and

(B) by striking ``under section 412'' and inserting ``under section 412, 414(b)''; and

(2) in paragraph (j), by inserting ``414,'' after ``412,''.

(d) Expedited Rulemaking.--Not later than 18 months after the date of the enactment of this Act, the Secretary shall promulgate proposed and final regulations establishing recordkeeping requirements under subsection 414(b) of the Federal Food, Drug, and Cosmetic Act (as added by subsection

(a)).

SEC. 307. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.

(a) In General.--Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended by section 305(c) of this Act, is amended by adding at the end the following subsection:

``(m)(1) In the case of an article of food that is being imported or offered for import into the United States, the Secretary, after consultation with the Secretary of the Treasury, shall by regulation require, for the purpose of enabling such article to be inspected at ports of entry into the United States, the submission to the Secretary of a notice providing the identity of each of the following: The article; the manufacturer and shipper of the article; if known within the specified period of time that notice is required to be provided, the grower of the article; the country from which the article originates; the country from which the article is shipped; and the anticipated port of entry for the article. An article of food imported or offered for import without submission of such notice in accordance with the requirements under this paragraph shall be refused admission into the United States. Nothing in this section may be construed as a limitation on the port of entry for an article of food.

``(2)(A) Regulations under paragraph (1) shall require that a notice under such paragraph be provided by a specified period of time in advance of the time of the importation of the article of food involved or the offering of the food for import, which period shall be no less than the minimum amount of time necessary for the Secretary to receive, review, and appropriately respond to such notification, but may not exceed five days. In determining the specified period of time required under this subparagraph, the Secretary may consider, but is not limited to consideration of, the effect on commerce of such period of time, the locations of the various ports of entry into the United States, the various modes of transportation, the types of food imported into the United States, and any other such consideration. Nothing in the preceding sentence may be construed as a limitation on the obligation of the Secretary to receive, review, and appropriately respond to any notice under paragraph (1).

``(B)(i) If an article of food is being imported or offered for import into the United States and a notice under paragraph (1) is not provided in advance in accordance with the requirements under paragraph (1), such article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until such notice is submitted to the Secretary, and the Secretary examines the notice and determines that the notice is in accordance with the requirements under paragraph

(1). Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.

``(ii) In carrying out clause (i) with respect to an article of food, the Secretary shall determine whether there is in the possession of the Secretary any credible evidence or information indicating that such article presents a threat of serious adverse health consequences or death to humans or animals.

``(3)(A) This subsection may not be construed as limiting the authority of the Secretary to obtain information under any other provision of this Act.

``(B) This subsection may not be construed as authorizing the Secretary to impose any requirements with respect to a food to the extent that it is within the exclusive jurisdiction of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq).''.

(b) Prohibited Act.--Section 301 of the Federal Food, Drug, and Cosmetic Act, as amended by section 305(b) of this Act, is amended by adding at the end the following:

``(ee) The importing or offering for import into the United States of an article of food in violation of the requirements under section 801(m).''.

(c) Rulemaking; Effective Date.--

(1) In general.--Not later than 18 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall promulgate proposed and final regulations for the requirement of providing notice in accordance with section 801(m) of the Federal Food, Drug, and Cosmetic Act

(as added by subsection (a) of this section). Such requirement of notification takes effect--

(A) upon the effective date of such final regulations; or

(B) upon the expiration of such 18-month period if the final regulations have not been made effective as of the expiration of such period, subject to compliance with the final regulations when the final regulations are made effective.

(2) Default; minimum period of advance notice.--If under paragraph (1) the requirement for providing notice in accordance with section 801(m) of the Federal Food, Drug, and Cosmetic Act takes effect without final regulations having been made effective, then for purposes of such requirement, the specified period of time that the notice is required to be made in advance of the time of the importation of the article of food involved or the offering of the food for import shall be not fewer than eight hours and not more than five days, which shall remain in effect until the final regulations are made effective.

SEC. 308. AUTHORITY TO MARK ARTICLES REFUSED ADMISSION INTO

UNITED STATES.

(a) In General.--Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)), as amended by section 307(a) of this Act, is amended by adding at the end the following:

``(n)(1) If a food has been refused admission under subsection (a), other than such a food that is required to be destroyed, the Secretary may require the owner or consignee of the food to affix to the container of the food a label that clearly and conspicuously bears the statement: `UNITED STATES: REFUSED ENTRY'.

``(2) All expenses in connection with affixing a label under paragraph (1) shall be paid by the owner or consignee of the food involved, and in default of such payment, shall constitute a lien against future importations made by such owner or consignee.

``(3) A requirement under paragraph (1) remains in effect until the Secretary determines that the food involved has been brought into compliance with this Act.''.

(b) Misbranded Foods.--Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the following:

``(v) If--

``(1) it fails to bear a label required by the Secretary under section 801(n)(1) (relating to food refused admission into the United States);

``(2) the Secretary finds that the food presents a threat of serious adverse health consequences or death to humans or animals; and

``(3) upon or after notifying the owner or consignee involved that the label is required under section 801, the Secretary informs the owner or consignee that the food presents such a threat.''.

(c) Rule of Construction.--With respect to articles of food that are imported or offered for import into the United States, nothing in this section shall be construed to limit the authority of the Secretary of Health and Human Services or the Secretary of the Treasury to require the marking of refused articles of food under any other provision of law.

SEC. 309. PROHIBITION AGAINST PORT SHOPPING.

Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) is amended by adding at the end the following:

``(h) If it is an article of food imported or offered for import into the United States and the article of food has previously been refused admission under section 801(a), unless the person reoffering the article affirmatively establishes, at the expense of the owner or consignee of the article, that the article complies with the applicable requirements of this Act, as determined by the Secretary.''.

SEC. 310. NOTICES TO STATES REGARDING IMPORTED FOOD.

Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 391 et seq.) is amended by adding at the end the following section:

``SEC. 908. NOTICES TO STATES REGARDING IMPORTED FOOD.

``(a) In General.--If the Secretary has credible evidence or information indicating that a shipment of imported food or portion thereof presents a threat of serious adverse health consequences or death to humans or animals, the Secretary shall provide notice regarding such threat to the States in which the food is held or will be held, and to the States in which the manufacturer, packer, or distributor of the food is located, to the extent that the Secretary has knowledge of which States are so involved. In providing notice to a State, the Secretary shall request the State to take such action as the State considers appropriate, if any, to protect the public health regarding the food involved.

``(b) Rule of Construction.--Subsection (a) may not be construed as limiting the authority of the Secretary with respect to food under any other provision of this Act.''.

SEC. 311. GRANTS TO STATES FOR INSPECTIONS.

Chapter IX of the Federal Food, Drug and Cosmetic Act, as amended by section 310 of this Act, is amended by adding at the end the following section:

``SEC. 909. GRANTS TO STATES FOR INSPECTIONS.

``(a) In General.--The Secretary is authorized to make grants to States, territories, and Indian tribes (as defined in section 4(e) of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b(e))) that undertake examinations, inspections, and investigations, and related activities under section 702. The funds provided under such grants shall only be available for the costs of conducting such examinations, inspections, investigations, and related activities.

``(b) Notices Regarding Adulterated Imported Food.--The Secretary may make grants to the States for the purpose of assisting the States with the costs of taking appropriate action to protect the public health in response to notification under section 908, including planning and otherwise preparing to take such action.

``(c) Authorization of Appropriations.--For the purpose of carrying out this section, there are authorized to be appropriated $10,000,000 for fiscal year 2002, and such sums as may be necessary for each of the fiscal years 2003 through 2006.''.

SEC. 312. SURVEILLANCE AND INFORMATION GRANTS AND

AUTHORITIES.

Part B of title III of the Public Health Service Act (42 U.S.C. 243 et seq.) is amended by inserting after section 317P the following:

``SEC. 317R. FOOD SAFETY GRANTS.

``(a) In General.--The Secretary may award grants to States and Indian tribes (as defined in section 4(e) of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b(e))) to expand participation in networks to enhance Federal, State, and local food safety efforts, including meeting the costs of establishing and maintaining the food safety surveillance, technical, and laboratory capacity needed for such participation.

``(b) Authorization of Appropriations.--For the purpose of carrying out this section, there are authorized to be appropriated $19,500,000 for fiscal year 2002, and such sums as may be necessary for each of the fiscal years 2003 through 2006.''.

SEC. 313. SURVEILLANCE OF ZOONOTIC DISEASES.

The Secretary of Health and Human Services, through the Commissioner of Food and Drugs and the Director of the Centers for Disease Control and Prevention, and the Secretary of Agriculture shall coordinate the surveillance of zoonotic diseases.

SEC. 314. AUTHORITY TO COMMISSION OTHER FEDERAL OFFICIALS TO

CONDUCT INSPECTIONS.

Section 702(a) of the Federal Food, Drug and Cosmetic Act

(21 U.S.C. 372(a)) is amended--

(1) by striking ``(a)'' and inserting ``(a)(1)'';

(2) by striking ``In the case of food packed'' and inserting the following:

``(3) In the case of food packed'';

(3) by striking ``For the purposes of this subsection'' and inserting the following:

``(4) For the purposes of this subsection,''; and

(4) by inserting after paragraph (1) (as designated by paragraph (1) of this section) the following paragraph:

``(2)(A) In addition to the authority established in paragraph (1), the Secretary, pursuant to a memorandum of understanding between the Secretary and the head of another Federal department or agency, is authorized to conduct examinations and investigations for the purposes of this Act through the officers and employees of such other department or agency, subject to subparagraph (B). Such a memorandum shall include provisions to ensure adequate training of such officers and employees to conduct the examinations and investigations. The memorandum of understanding shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations or investigations performed under this section by the officers or employees of the other department or agency.

``(B) A memorandum of understanding under subparagraph (A) between the Secretary and another Federal department or agency is effective only in the case of examinations or inspections at facilities or other locations that are jointly regulated by the Secretary and such department or agency.

``(C) For any fiscal year in which the Secretary and the head of another Federal department or agency carries out one or more examinations or inspections under a memorandum of understanding under subparagraph (A), the Secretary and the head of such department or agency shall with respect to their respective departments or agencies submit to the committees of jurisdiction (authorizing and appropriating) in the House of Representatives and the Senate a report that provides, for such year--

``(i) the number of officers or employees that carried out one or more programs, projects, or activities under such memorandum;

``(ii) the number of additional articles that were inspected or examined as a result of such memorandum; and

``(iii) the number of additional examinations or investigations that were carried out pursuant to such memorandum.''.

SEC. 315. RULE OF CONSTRUCTION.

Nothing in this title, or an amendment made by this title, shall be construed to alter the jurisdiction between the Secretaries of Agriculture and of Health and Human Services, under applicable statutes and regulations.

Subtitle B--Protection of Drug Supply

SEC. 321. ANNUAL REGISTRATION OF FOREIGN MANUFACTURERS;

SHIPPING INFORMATION; DRUG AND DEVICE LISTING.

(a) Annual Registration; Listing.--Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amended--

(1) in subsection (i)(1)--

(A) by striking ``Any establishment'' and inserting ``On or before December 31 of each year, any establishment''; and

(B) by striking ``shall register'' and all that follows and inserting the following: ``shall, through electronic means in accordance with the criteria of the Secretary, register with the Secretary the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such drug or device in the United States that is known to the establishment, and the name of each person who imports or offers for import such drug or device to the United States for purposes of importation.''; and

(2) in subsection (j)(1), in the first sentence, by striking ``or (d)'' and inserting ``(d), or (i)''.

(b) Importation; Statement Regarding Registration of Manufacturer.--

(1) In general.--Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended by section 308(a) of this Act, is amended by adding at the end the following subsection:

``(o) If an article that is a drug or device is being imported or offered for import into the United States, and the importer, owner, or consignee of such article does not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of each establishment that with respect to such article is required under such section to register with the Secretary, the article may be refused admission. If the article is refused admission for failure to submit such a statement, the article shall be held at the port of entry for the article, and may not be delivered to the importer, owner, or consignee of the article, until such a statement is submitted to the Secretary. Subsection (b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is so held. The article shall be removed to a secure facility, as appropriate. During the period of time that such article is so held, the article shall not be transferred by any person from the port of entry into the United States for the article, or from the secure facility to which the article has been removed, as the case may be.''.

(2) Prohibited act.--Section 301 of the Federal Food, Drug, and Cosmetic Act, as amended by section 307(b) of this Act, is amended by adding at the end the following:

``(ff) The importing or offering for import into the United States of a drug or device with respect to which there is a failure to comply with a request of the Secretary to submit to the Secretary a statement under section 801(o).''.

(c) Effective Date.--The amendments made by this section take effect upon the expiration of the 180-day period beginning on the date of the enactment of this Act.

SEC. 322. REQUIREMENT OF ADDITIONAL INFORMATION REGARDING

IMPORT COMPONENTS INTENDED FOR USE IN EXPORT

PRODUCTS.

(a) In General.--Section 801(d)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)(3)) is amended to read as follows:

``(3)(A) Subject to subparagraph (B), no component of a drug, no component part or accessory of a device, or other article of device requiring further processing, which is ready or suitable for use for health-related purposes, and no article of a food additive, color additive, or dietary supplement, including a product in bulk form, shall be excluded from importation into the United States under subsection (a) if each of the following conditions is met:

``(i) The importer of such article of a drug or device or importer of such article of a food additive, color additive, or dietary supplement submits to the Secretary, at the time of initial importation, a statement in accordance with the following:

``(I) Such statement provides that such article is intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee, into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by the initial owner or consignee from the United States in accordance with subsection (e) or section 802, or with section 351(h) of the Public Health Service Act.

``(II) The statement identifies the manufacturer of such article and each processor, packer, distributor, or other entity that had possession of the article in the chain of possession of the article from the manufacturer to such importer of the article.

``(III) The statement is accompanied by such certificates of analysis as are necessary to identify such article, unless the article is a device or is an article described in paragraph (4).

``(ii) At the time of initial importation and before the delivery of such article to the importer or the initial owner or consignee, such owner or consignee executes a good and sufficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to regulations of the Secretary of the Treasury.

``(iii) Such article is used and exported by the initial owner or consignee in accordance with the intent described under clause (i)(I), except for any portions of the article that are destroyed.

``(iv) The initial owner or consignee maintains records on the use or destruction of such article or portions thereof, as the case may be, and submits to the Secretary any such records requested by the Secretary.

``(v) Upon request of the Secretary, the initial owner or consignee submits a report that provides an accounting of the exportation or destruction of such article or portions thereof, and the manner in which such owner or consignee complied with the requirements of this subparagraph.

``(B) Notwithstanding subparagraph (A), the Secretary may refuse admission to an article that otherwise would be imported into the United States under such subparagraph if the Secretary determines that there is credible evidence or information indicating that such article is not intended to be further processed by the initial owner or consignee, or incorporated by the initial owner or consignee, into a drug, biological product, device, food, food additive, color additive, or dietary supplement that will be exported by the initial owner or consignee from the United States in accordance with subsection (e) or section 802, or with section 351(h) of the Public Health Service Act.

``(C) This section may not be construed as affecting the responsibility of the Secretary to ensure that articles imported into the United States under authority of subparagraph (A) meet each of the conditions established in such subparagraph for importation.''.

(b) Prohibited Act.--Section 301(w) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(w)) is amended to read as follows:

``(w) The making of a knowingly false statement in any statement, certificate of analysis, record, or report required or requested under section 801(d)(3); the failure to submit a certificate of analysis as required under such section; the failure to maintain records or to submit records or reports as required by such section; the release into interstate commerce of any article or portion thereof imported into the United States under such section or any finished product made from such article or portion, except for export in accordance with section 801(e) or 802, or with section 351(h) of the Public Health Service Act; or the failure to so export or to destroy such an article or portions thereof, or such a finished product.''.

(c) Effective Date.--The amendments made by this section take effect upon the expiration of the 90-day period beginning on the date of the enactment of this Act.

Subtitle C--General Provisions Relating to Upgrade of Agricultural

Security

SEC. 331. EXPANSION OF ANIMAL AND PLANT HEALTH INSPECTION

SERVICE ACTIVITIES.

(a) In General.--The Secretary of Agriculture (referred to in this section as the ``Secretary'') may utilize existing authorities to give high priority to enhancing and expanding the capacity of the Animal and Plant Health Inspection Service to conduct activities to--

(1) increase the inspection capacity of the Service at international points of origin;

(2) improve surveillance at ports of entry and customs;

(3) enhance methods of protecting against the introduction of plant and animal disease organisms by terrorists;

(4) develop new and improve existing strategies and technologies for dealing with intentional outbreaks of plant and animal disease arising from acts of terrorism or from unintentional introduction, including--

(A) establishing cooperative agreements among Veterinary Services of the Animal and Plant Health Inspection Service, State animal health commissions and regulatory agencies for livestock and poultry health, and private veterinary practitioners to enhance the preparedness and ability of Veterinary Services and the commissions and agencies to respond to outbreaks of such animal diseases; and

(B) strengthening planning and coordination with State and local agencies, including--

(i) State animal health commissions and regulatory agencies for livestock and poultry health; and

(ii) State agriculture departments; and

(5) otherwise improve the capacity of the Service to protect against the threat of bioterrorism.

(b) Automated Recordkeeping System.--The Administrator of the Animal and Plant Health Inspection Service may implement a central automated recordkeeping system to provide for the reliable tracking of the status of animal and plant shipments, including those shipments on hold at ports of entry and customs. The Secretary shall ensure that such a system shall be fully accessible to or fully integrated with the Food Safety Inspection Service.

(c) Authorization of Appropriations.--There is authorized to be appropriated to carry out this section, $30,000,000 for fiscal year 2002, and such sums as may be necessary for each subsequent fiscal year.

SEC. 332. EXPANSION OF FOOD SAFETY INSPECTION SERVICE

ACTIVITIES.

(a) In General.--The Secretary of Agriculture may utilize existing authorities to give high priority to enhancing and expanding the capacity of the Food Safety Inspection Service to conduct activities to--

(1) enhance the ability of the Service to inspect and ensure the safety and wholesomeness of meat and poultry products;

(2) improve the capacity of the Service to inspect international meat and meat products, poultry and poultry products, and egg products at points of origin and at ports of entry;

(3) strengthen the ability of the Service to collaborate with relevant agencies within the Department of Agriculture and with other entities in the Federal Government, the States, and Indian tribes (as defined in section 4(e) of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 450b(e))) through the sharing of information and technology; and

(4) otherwise expand the capacity of the Service to protect against the threat of bioterrorism.

(b) Authorization of Appropriations.--There is authorized to be appropriated to carry out this section, $15,000,000 for fiscal year 2002, and such sums as may be necessary for each subsequent fiscal year.

SEC. 333. BIOSECURITY UPGRADES AT THE DEPARTMENT OF

AGRICULTURE.

There is authorized to be appropriated for fiscal year 2002, $180,000,000 for the purpose of enabling the Agricultural Research Service to conduct building upgrades to modernize existing facilities, of which (1) $100,000,000 shall be allocated for renovation, updating, and expansion of the Biosafety Level 3 laboratory and animal research facilities at the Plum Island Animal Disease Center

(Greenport, New York), and of which (2) $80,000,000 shall be allocated for the Agricultural Research Service/Animal and Plant Health Inspection Service facility in Ames, Iowa. There are authorized to be appropriated such sums as may be necessary for fiscal years 2003 through 2006 for the purpose described in the preceding sentence, for the planning and design of an Agricultural Research Service biocontainment laboratory for poultry research in Athens, Georgia, and for the planning, updating, and renovation of the Arthropod-Borne Animal Disease Laboratory in Laramie, Wyoming.

SEC. 334. AGRICULTURAL BIOSECURITY.

(a) Security at Colleges and Universities.--

(1) Grants.--The Secretary of Agriculture (referred to in this section as the ``Secretary'') may award grants to covered entities to review security standards and practices at their facilities in order to protect against bioterrorist attacks.

(2) Covered entities.--Covered entities under this subsection are colleges or universities that--

(A) are colleges or universities as defined in section 1404 of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3103); and

(B) have programs in food and agricultural sciences, as defined in such section.

(3) Limitation.--Each individual covered entity may be awarded one grant under paragraph (1), the amount of which shall not exceed $50,000.

(4) Contract authority.--Colleges and universities receiving grants under paragraph (1) may use such grants to enter into contracts with independent private organizations with established and demonstrated security expertise to conduct the security reviews specified in such paragraph.

(b) Guidelines for Agricultural Biosecurity.--

(1) In general.--The Secretary may award grants to associations of food producers or consortia of such associations for the development and implementation of educational programs to improve biosecurity on farms in order to ensure the security of farm facilities against potential bioterrorist attacks.

(2) Limitation.--Each individual association eligible under paragraph (1) may be awarded one grant under such paragraph, the amount of which shall not exceed $100,000. Each consortium eligible under paragraph (1) may be awarded one grant under such paragraph, the amount of which shall not exceed $100,000 per association participating in the consortium.

(3) Contract authority.--Associations of food producers receiving grants under paragraph (1) may use such grants to enter into contracts with independent private organizations with established and demonstrated expertise in biosecurity to assist in the development and implementation of educational programs to improve biosecurity specified in such paragraph.

(c) Authorization of Appropriations.--There are authorized to be appropriated to carry out this section such sums as may be necessary for each fiscal year.

SEC. 335. AGRICULTURAL BIOTERRORISM RESEARCH AND DEVELOPMENT.

(a) In General.--The Secretary of Agriculture (referred to in this section as the ``Secretary'') may utilize existing research authorities and research programs to protect the food supply of the United States by conducting and supporting research activities to--

(1) enhance the capability of the Secretary to respond in a timely manner to emerging or existing bioterrorist threats to the food and agricultural system of the United States;

(2) develop new and continue partnerships with institutions of higher education and other institutions to help form stable, long-term programs to enhance the biosecurity and food safety of the United States, including the coordination of the development, implementation, and enhancement of diverse capabilities for addressing threats to the nation's agricultural economy and food supply, with special emphasis on planning, training, outreach, and research activities related to vulnerability analyses, incident response, detection, and prevention technologies;

(3) strengthen coordination with the intelligence community to better identify research needs and evaluate materials or information acquired by the intelligence community relating to potential threats to United States agriculture;

(4) expand the involvement of the Secretary with international organizations dealing with plant and animal disease control;

(5) continue research to develop rapid detection field test kits to detect biological threats to plants and animals and to provide such test kits to State and local agencies preparing for or responding to bioterrorism;

(6) develop an agricultural bioterrorism early warning surveillance system through enhancing the capacity of and coordination between State veterinary diagnostic laboratories, Federal and State agricultural research facilities, and public health agencies; and

(7) otherwise improve the capacity of the Secretary to protect against the threat of bioterrorism.

(b) Authorization of Appropriations.--There is authorized to be appropriated to carry out this section, $190,000,000 for fiscal year 2002, and such sums as may be necessary for each subsequent fiscal year.

SEC. 336. ANIMAL ENTERPRISE TERRORISM PENALTIES.

(a) In General.--Section 43(a) of title 18, United States Code, is amended to read as follows:

``(a) Offense.--Whoever--

``(1) travels in interstate or foreign commerce, or uses or causes to be used the mail or any facility in interstate or foreign commerce for the purpose of causing physical disruption to the functioning of an animal enterprise; and

``(2) intentionally damages or causes the loss of any property (including animals or records) used by the animal enterprise, or conspires to do so,shall be punished as provided for in subsection (b).''.

(b) Penalties.--Section 43(b) of title 18, United States Code, is amended to read as follows:

``(b) Penalties.--

``(1) Economic damage.--Any person who, in the course of a violation of subsection (a), causes economic damage not exceeding $10,000 to an animal enterprise shall be fined under this title or imprisoned not more than 6 months, or both.

``(2) Major economic damage.--Any person who, in the course of a violation of subsection (a), causes economic damage exceeding $10,000 to an animal enterprise shall be fined under this title or imprisoned not more than 3 years, or both.

``(3) Serious bodily injury.--Any person who, in the course of a violation of subsection (a), causes serious bodily injury to another individual shall be fined under this title or imprisoned not more than 20 years, or both.

``(4) Death.--Any person who, in the course of a violation of subsection (a), causes the death of an individual shall be fined under this title and imprisoned for life or for any term of years.''.

(c) Restitution.--Section 43(c) of title 18, United States Code, is amended--

(1) in paragraph (1), by striking ``and'' at the end;

(2) in paragraph (2), by striking the period at the end and inserting ``; and''; and

(3) by adding at the end the following:

``(3) for any other economic damage resulting from the offense.''.

TITLE IV--DRINKING WATER SECURITY AND SAFETY

SEC. 401. TERRORIST AND OTHER INTENTIONAL ACTS.

The Safe Drinking Water Act (title XIV of the Public Health Service Act) is amended by inserting the following new section after section 1432:

``SEC. 1433. TERRORIST AND OTHER INTENTIONAL ACTS.

``(a) Vulnerability Assessments.--(1) Each community water system serving a population of greater than 3,300 persons shall conduct an assessment of the vulnerability of its system to a terrorist attack or other intentional acts intended to substantially disrupt the ability of the system to provide a safe and reliable supply of drinking water. The vulnerability assessment shall include, but not be limited to, a review of pipes and constructed conveyances, physical barriers, water collection, pretreatment, treatment, storage and distribution facilities, electronic, computer or other automated systems which are utilized by the public water system, the use, storage, or handling of various chemicals, and the operation and maintenance of such system. The Administrator, not later than August 1, 2002, after consultation with appropriate departments and agencies of the Federal Government and with State and local governments, shall provide baseline information to community water systems required to conduct vulnerability assessments regarding which kinds of terrorist attacks or other intentional acts are the probable threats to--

``(A) substantially disrupt the ability of the system to provide a safe and reliable supply of drinking water; or

``(B) otherwise present significant public health concerns.

``(2) Each community water system referred to in paragraph

(1) shall certify to the Administrator that the system has conducted an assessment complying with paragraph (1) and shall submit to the Administrator a written copy of the assessment. Such certification and submission shall be made prior to:

``(A) March 31, 2003, in the case of systems serving a population of 100,000 or more.

``(B) December 31, 2003, in the case of systems serving a population of 50,000 or more but less than 100,000.

``(C) June 30, 2004, in the case of systems serving a population greater than 3,300 but less than 50,000.

``(3) Except for information contained in a certification under this subsection identifying the system submitting the certification and the date of the certification, all information provided to the Administrator under this subsection and all information derived therefrom shall be exempt from disclosure under section 552 of title 5 of the United States Code.

``(4) No community water system shall be required under State or local law to provide an assessment described in this section to any State, regional, or local governmental entity solely by reason of the requirement set forth in paragraph

(2) that the system submit such assessment to the Administrator.

``(5) Not later than November 30, 2002, the Administrator, in consultation with appropriate Federal law enforcement and intelligence officials, shall develop such protocols as may be necessary to protect the copies of the assessments required to be submitted under this subsection (and the information contained therein) from unauthorized disclosure. Such protocols shall ensure that--

``(A) each copy of such assessment, and all information contained in or derived from the assessment, is kept in a secure location;

``(B) only individuals designated by the Administrator may have access to the copies of the assessments; and

``(C) no copy of an assessment, or part of an assessment, or information contained in or derived from an assessment shall be available to anyone other than an individual designated by the Administrator.

At the earliest possible time prior to November 30, 2002, the Administrator shall complete the development of such protocols for the purpose of having them in place prior to receiving any vulnerability assessments from community water systems under this subsection.

``(6)(A) Except as provided in subparagraph (B), any individual referred to in paragraph (5)(B) who acquires the assessment submitted under paragraph (2), or any reproduction of such assessment, or any information derived from such assessment, and who knowingly or recklessly reveals such assessment, reproduction, or information other than--

``(i) to an individual designated by the Administrator under paragraph (5),

``(ii) for purposes of section 1445 or for actions under section 1431, or

``(iii) for use in any administrative or judicial proceeding to impose a penalty for failure to comply with this section,

shall upon conviction be imprisoned for not more than one year or fined in accordance with the provisions of chapter 227 of title 18, United States Code, applicable to class A misdemeanors, or both, and shall be removed from Federal office or employment.

``(B) Notwithstanding subparagraph (A), an individual referred to in paragraph (5)(B) who is an officer or employee of the United States may discuss the contents of a vulnerability assessment submitted under this section with a State or local official.

``(7) Nothing in this section authorizes any person to withhold any information from Congress or from any committee or subcommittee of Congress.

``(b) Emergency Response Plan.--Each community water system serving a population greater than 3,300 shall prepare or revise, where necessary, an emergency response plan that incorporates the results of vulnerability assessments that have been completed. Each such community water system shall certify to the Administrator, as soon as reasonably possible after the enactment of this section, but not later than 6 months after the completion of the vulnerability assessment under subsection (a), that the system has completed such plan. The emergency response plan shall include, but not be limited to, plans, procedures, and identification of equipment that can be implemented or utilized in the event of a terrorist or other intentional attack on the public water system. The emergency response plan shall also include actions, procedures, and identification of equipment which can obviate or significantly lessen the impact of terrorist attacks or other intentional actions on the public health and the safety and supply of drinking water provided to communities and individuals. Community water systems shall, to the extent possible, coordinate with existing Local Emergency Planning Committees established under the Emergency Planning and Community Right-to-Know Act (42 U.S.C. 11001, et seq.) when preparing or revising an emergency response plan under this subsection.

``(c) Record Maintenance.--Each community water system shall maintain a copy of the emergency response plan completed pursuant to subsection (b) for 5 years after such plan has been certified to the Administrator under this section.

``(d) Guidance to Small Public Water Systems.--The Administrator shall provide guidance to community water systems serving a population of less than 3,300 persons on how to conduct vulnerability assessments, prepare emergency response plans, and address threats from terrorist attacks or other intentional actions designed to disrupt the provision of safe drinking water or significantly affect the public health or significantly affect the safety or supply of drinking water provided to communities and individuals.

``(e) Funding.--(1) There are authorized to be appropriated to carry out this section not more than $160,000,000 for the fiscal year 2002 and such sums as may be necessary for the fiscal years 2003 through 2005.

``(2) The Administrator, in coordination with State and local governments, may use funds made available under paragraph (1) to provide financial assistance to community water systems for purposes of compliance with the requirements of subsections (a) and (b) and to community water systems for expenses and contracts designed to address basic security enhancements of critical importance and significant threats to public health and the supply of drinking water as determined by a vulnerability assessment conducted under subsection (a). Such basic security enhancements may include, but shall not be limited to the following:

``(A) the purchase and installation of equipment for detection of intruders;

``(B) the purchase and installation of fencing, gating, lighting, or security cameras;

``(C) the tamper-proofing of manhole covers, fire hydrants, and valve boxes;

``(D) the rekeying of doors and locks;

``(E) improvements to electronic, computer, or other automated systems and remote security systems;

``(F) participation in training programs, and the purchase of training manuals and guidance materials, relating to security against terrorist attacks;

``(G) improvements in the use, storage, or handling of various chemicals; and

``(H) security screening of employees or contractor support services.

Funding under this subsection for basic security enhancements shall not include expenditures for personnel costs, or monitoring, operation, or maintenance of facilities, equipment, or systems.

``(3) The Administrator may use not more than $5,000,000 from the funds made available under paragraph (1) to make grants to community water systems to assist in responding to and alleviating any vulnerability to a terrorist attack or other intentional acts intended to substantially disrupt the ability of the system to provide a safe and reliable supply of drinking water (including sources of water for such systems) which the Administrator determines to present an immediate and urgent security need.

``(4) The Administrator may use not more than $5,000,000 from the funds made available under paragraph (1) to make grants to community water systems serving a population of less than 3,300 persons for activities and projects undertaken in accordance with the guidance provided to such systems under subsection (d).

SEC. 402. OTHER SAFE DRINKING WATER ACT AMENDMENTS.

The Safe Drinking Water Act (title XIV of the Public Health Service Act) is amended by inserting the following new sections after section 1433 (as added by section 401 of this Act):

``SEC. 1434. CONTAMINANT PREVENTION, DETECTION AND RESPONSE.

``(a) In General.--The Administrator, in consultation with the Centers for Disease Control and, after consultation with appropriate departments and agencies of the Federal Government and with State and local governments, shall review

(or enter into contracts or cooperative agreements to provide for a review of) current and future methods to prevent, detect and respond to the intentional introduction of chemical, biological or radiological contaminants into community water systems and source water for community water systems, including each of the following:

``(1) Methods, means and equipment, including real time monitoring systems, designed to monitor and detect various levels of chemical, biological, and radiological contaminants or indicators of contaminants and reduce the likelihood that such contaminants can be successfully introduced into public water systems and source water intended to be used for drinking water.

``(2) Methods and means to provide sufficient notice to operators of public water systems, and individuals served by such systems, of the introduction of chemical, biological or radiological contaminants and the possible effect of such introduction on public health and the safety and supply of drinking water.

``(3) Methods and means for developing educational and awareness programs for community water systems.

``(4) Procedures and equipment necessary to prevent the flow of contaminated drinking water to individuals served by public water systems.

``(5) Methods, means, and equipment which could negate or mitigate deleterious effects on public health and the safety and supply caused by the introduction of contaminants into water intended to be used for drinking water, including an examination of the effectiveness of various drinking water technologies in removing, inactivating, or neutralizing biological, chemical, and radiological contaminants.

``(6) Biomedical research into the short-term and long-term impact on public health of various chemical, biological and radiological contaminants that may be introduced into public water systems through terrorist or other intentional acts.

``(b) Funding.--For the authorization of appropriations to carry out this section, see section 1435(e).

``SEC. 1435. SUPPLY DISRUPTION PREVENTION, DETECTION AND

RESPONSE.

``(a) Disruption of Supply or Safety.--The Administrator, in coordination with the appropriate departments and agencies of the Federal Government, shall review (or enter into contracts or cooperative agreements to provide for a review of) methods and means by which terrorists or other individuals or groups could disrupt the supply of safe drinking water or take other actions against water collection, pretreatment, treatment, storage and distribution facilities which could render such water significantly less safe for human consumption, including each of the following:

``(1) Methods and means by which pipes and other constructed conveyances utilized in public water systems could be destroyed or otherwise prevented from providing adequate supplies of drinking water meeting applicable public health standards.

``(2) Methods and means by which collection, pretreatment, treatment, storage and distribution facilities utilized or used in connection with public water systems and collection and pretreatment storage facilities used in connection with public water systems could be destroyed or otherwise prevented from providing adequate supplies of drinking water meeting applicable public health standards.

``(3) Methods and means by which pipes, constructed conveyances, collection, pretreatment, treatment, storage and distribution systems that are utilized in connection with public water systems could be altered or affected so as to be subject to cross-contamination of drinking water supplies.

``(4) Methods and means by which pipes, constructed conveyances, collection, pretreatment, treatment, storage and distribution systems that are utilized in connection with public water systems could be reasonably protected from terrorist attacks or other acts intended to disrupt the supply or affect the safety of drinking water.

``(5) Methods and means by which information systems, including process controls and supervisory control and data acquisition and cyber systems at community water systems could be disrupted by terrorists or other groups.

``(b) Alternative Sources.--The review under this section shall also include a review of the methods and means by which alternative supplies of drinking water could be provided in the event of the destruction, impairment or contamination of public water systems.

``(c) Requirements and Considerations.--In carrying out this section and section 1434--

``(1) the Administrator shall ensure that reviews carried out under this section reflect the needs of community water systems of various sizes and various geographic areas of the United States; and

``(2) the Administrator may consider the vulnerability of, or potential for forced interruption of service for, a region or service area, including community water systems that provide service to the National Capital area.

``(d) Information Sharing.--As soon as practicable after reviews carried out under this section or section 1434 have been evaluated, the Administrator shall disseminate, as appropriate as determined by the Administrator, to community water systems information on the results of the project through the Information Sharing and Analysis Center, or other appropriate means.

``(e) Funding.--There are authorized to be appropriated to carry out this section and section 1434 not more than

$15,000,000 for the fiscal year 2002 and such sums as may be necessary for the fiscal years 2003 through 2005.''.

SEC. 403. MISCELLANEOUS AND TECHNICAL AMENDMENTS.

The Safe Drinking Water Act is amended as follows:

(1) Section 1414(i)(1) is amended by inserting ``1433'' after ``1417''.

(2) Section 1431 is amended by inserting in the first sentence after ``drinking water'' the following: ``, or that there is a threatened or potential terrorist attack (or other intentional act designed to disrupt the provision of safe drinking water or to impact adversely the safety of drinking water supplied to communities and individuals), which''.

(3) Section 1432 is amended as follows:

(A) By striking ``5 years'' in subsection (a) and inserting

``20 years''.

(B) By striking ``3 years'' in subsection (b) and inserting

``10 years''.

(C) By striking ``$50,000'' in subsection (c) and inserting

``$1,000,000''.

(D) By striking ``$20,000'' in subsection (c) and inserting

``$100,000''.

(4) Section 1442 is amended as follows:

(A) By striking ``this subparagraph'' in subsection (b) and inserting ``this subsection''.

(B) By amending subsection (d) to read as follows:

``(d) There are authorized to be appropriated to carry out subsection (b) not more than $35,000,000 for the fiscal year 2002 and such sums as may be necessary for each fiscal year thereafter.''.

TITLE V--ADDITIONAL PROVISIONS

Subtitle A--Prescription Drug User Fees

SEC. 501. SHORT TITLE.

This subtitle may be cited as the ``Prescription Drug User Fee Amendments of 2002''.

SEC. 502. FINDINGS.

The Congress finds that--

(1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease;

(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for the review of human drug applications and the assurance of drug safety;

(3) the provisions added by the Prescription Drug User Fee Act of 1992, as amended by the Food and Drug Administration Modernization Act of 1997, have been successful in substantially reducing review times for human drug applications and should be--

(A) reauthorized for an additional 5 years, with certain technical improvements; and

(B) carried out by the Food and Drug Administration with new commitments to implement more ambitious and comprehensive improvements in regulatory processes of the Food and Drug Administration, including--

(i) strengthening and improving the review and monitoring of drug safety;

(ii) considering greater interaction between the agency and sponsors during the review of drugs and biologics intended to treat serious diseases and life-threatening diseases; and

(iii) developing principles for improving first-cycle reviews; and

(4) the fees authorized by amendments made in this subtitle will be dedicated towards expediting the drug development process and the process for the review of human drug applications as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the chairman of the Committee on Energy and Commerce of the House of Representatives and the chairman of the Committee on Health, Education, Labor and Pensions of the Senate, as set forth in the Congressional Record.

SEC. 503. DEFINITIONS.

Section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g) is amended--

(1) in paragraph (1), in the matter after and below subparagraph (C), by striking ``licensure, as described in subparagraph (D)'' and inserting ``licensure, as described in subparagraph (C)'';

(2) in paragraph (3)--

(A) in subparagraph (A), by striking ``and'' at the end;

(B) in subparagraph (B), by striking the period and inserting ``, and'';

(C) by inserting after subparagraph (B) the following subparagraph:

``(C) which is on the list of products described in section 505(j)(7)(A) or is on a list created and maintained by the Secretary of products approved under human drug applications under section 351 of the Public Health Service Act.''; and

(D) in the matter after and below subparagraph (C) (as added by subparagraph (C) of this paragraph), by striking

``Service Act,'' and all that follows through ``biological product'' and inserting the following: ``Service Act. Such term does not include a biological product'';

(3) in paragraph (6), by adding at the end the following subparagraph:

``(F) In the case of drugs approved after October 1, 2002, under human drug applications or supplements: collecting, developing, and reviewing safety information on the drugs, including adverse event reports, during a period of time after approval of such applications or supplements, not to exceed three years.''; and

(4) in paragraph (8)--

(A) by striking the matter after and below subparagraph

(B);

(B) by striking subparagraph (B);

(C) by striking ``is the lower of'' and all that follows through ``Consumer Price Index'' and inserting ``is the Consumer Price Index''; and

(D) by striking ``1997, or'' and inserting ``1997.''.

SEC. 504. AUTHORITY TO ASSESS AND USE DRUG FEES.

(a) Types of Fees.--Section 736(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is amended--

(1) in the matter preceding paragraph (1), by striking

``fiscal year 1998'' and inserting ``fiscal year 2003'';

(2) in paragraph (1)(A)--

(A) in each of clauses (i) and (ii), by striking ``in subsection (b)'' and inserting ``under subsection (c)(4)''; and

(B) in clause (ii), by adding at the end the following sentence: ``Such fee shall be half of the amount of the fee established under clause (i).'';

(3) in paragraph (2)(A), in the matter after and below clause (ii)--

(A) by striking ``in subsection (b)'' and inserting ``under subsection (c)(4)''; and

(B) by striking ``payable on or before January 31'' and inserting ``payable on or before October 1''; and

(4) in paragraph (3)--

(A) by amending subparagraph (A) to read as follows:

``(A) In general.--Except as provided in subparagraph (B), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay for each such prescription drug product the annual fee established under subsection (c)(4). Such fee shall be payable on or before October 1 of each year. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable.''; and

(B) in subparagraph (B), by striking ``The listing'' and all that follows through ``filed under section 505(b)(2)'' and inserting the following: ``A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is identified on the list compiled under section 505(j)(7)(A) with a potency described in terms of per 100 mL, or if such product is the same product as another product approved under an application filed under section 505(b)''.

(b) Fee Amounts.--Section 736(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows:

``(b) Fee Revenue Amounts.--Except as provided in subsections (c), (d), (f), and (g), fees under subsection (a) shall be established to generate the following revenue amounts:

----------------------------------------------------------------------------------------------------------------

Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year

``Type of Fee Revenue 2003 2004 2005 2006 2007

----------------------------------------------------------------------------------------------------------------

Application/Supplement.......... $74,300,000 $77,000,000 $84,000,000 $86,434,000 $86,434,000

Establishment................... $74,300,000 $77,000,000 $84,000,000 $86,433,000 $86,433,000

Product......................... $74,300,000 $77,000,000 $84,000,000 $86,433,000 $86,433,000

Total Fee Revenue............... $222,900,000 $231,000,000 $252,000,000 $259,300,000 $259,300,000

----------------------------------------------------------------------------------------------------------------

If, after the date of the enactment of the Prescription Drug User Fee Amendments of 2002, legislation is enacted requiring the Secretary to fund additional costs of the retirement of Federal personnel, fee revenue amounts shall be increased in each year by the amount necessary to fully fund the portion of such additional costs that are attributable to the process for the review of human drug applications.''.

(c) Adjustments.--Section 736(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(c)) is amended--

(1) in paragraph (1)--

(A) in the matter preceding subparagraph (A), by striking

``fees and total fee revenues'' and inserting ``revenues'';

(B) in subparagraph (A)--

(i) by striking ``during the preceding fiscal year''; and

(ii) by striking ``, or'' and inserting the following:

``for the 12 month period ending June 30 preceding the fiscal year for which fees are being established, or'';

(C) in subparagraph (B), by striking ``for such fiscal year'' and inserting ``for the previous fiscal year''; and

(D) in the matter after and below subparagraph (B), by striking ``fiscal year 1997''; and inserting ``fiscal year 2003'';

(2) by redesignating paragraphs (2) and (3) as paragraphs

(4) and (5), respectively;

(3) by inserting after paragraph (1) the following paragraphs:

``(2) Workload adjustment.--Beginning with fiscal year 2004, after the fee revenues established in subsection (b) are adjusted for a fiscal year for inflation in accordance with paragraph (1), the fee revenues shall be adjusted further for such fiscal year to reflect changes in the workload of the Secretary for the process for the review of human drug applications. With respect to such adjustment:

``(A) The adjustment shall be determined by the Secretary based on a weighted average of the change in the total number of human drug applications, commercial investigational new drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary. The Secretary shall publish in the Federal Register the fee revenues and fees resulting from the adjustment and the supporting methodologies.

``(B) Under no circumstances shall the adjustment result in fee revenues for a fiscal year that are less than the fee revenues for the fiscal year established in subsection (b), as adjusted for inflation under paragraph (1).

``(3) Final year adjustment.--For fiscal year 2007, the Secretary may, in addition to adjustments under paragraphs

(1) and (2), further increase the fee revenues and fees established in subsection (b) if such an adjustment is necessary to provide for not more than three months of operating reserves of carryover user fees for the process for the review of human drug applications for the first three months of fiscal year 2008. If such an adjustment is necessary, the rationale for the amount of the increase shall be contained in the annual notice establishing fee revenues and fees for fiscal year 2007. If the Secretary has carryover balances for such process in excess of three months of such operating reserves, the adjustment under this paragraph shall not be made.''; and

(4) in paragraph (4) (as redesignated by paragraph (2) of this subsection), by amending such paragraph to read as follows:

``(4) Annual fee setting.--The Secretary shall, 60 days before the start of each fiscal year that begins after September 30, 2002, establish, for the next fiscal year, application, product, and establishment fees under subsection

(a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection.''.

(d) Fee Waiver or Reduction.--Section 736(d)) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--

(1) in paragraph (1)--

(A) in subparagraph (C), by inserting ``or'' after the comma at the end;

(B) by striking subparagraph (D); and

(C) by redesignating subparagraph (E) as subparagraph (D); and

(2) in paragraph (3), in each of subparagraphs (A) and (B), by striking ``paragraph (1)(E)'' each place such term appears and inserting ``paragraph (1)(D)''.

(e) Assessment of Fees.--Section 736(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(f)) is amended--

(1) in the heading for the subsection, by striking

``Assessment of Fees.--'' and inserting ``Limitations.--''; and

(2) in paragraph (1), by striking the heading for the paragraph and all that follows through ``fiscal year beginning'' and inserting the following: ``In general.--Fees under subsection (a) shall be refunded for a fiscal year beginning''.

(f) Crediting and Availability of Fees.--

(1) In general.--Section 736(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(1)) is amended by striking ``Fees collected for a fiscal year'' and all that follows through ``fiscal year limitation.'' and inserting the following: ``Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended.''.

(2) Collections and appropriation acts.--Section 736(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(2)) is amended--

(A) by redesignating subparagraphs (A) and (B) as clauses

(i) and (ii), respectively;

(B) by striking ``(2) Collections'' and all that follows through ``the amount specified'' in clause (i) (as so redesignated) and inserting the following:

``(2) Collections and appropriation acts.--

``(A) In general.--The fees authorized by this section--

``(i) shall be retained in each fiscal year in an amount not to exceed the amount specified'';

(C) by moving clause (ii) (as so redesignated) two ems to the right; and

(D) by adding at the end the following subparagraph:

``(B) Compliance.--The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of human drug applications--

``(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or

``(ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and

``(II) such costs are not more than 5 percent below the level specified in such subparagraph.''.

(3) Authorization of appropriations.--Section 736(g)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) is amended by striking subparagraphs (A) through

(E) and inserting the following:

``(A) $222,900,000 for fiscal year 2003;

``(B) $231,000,000 for fiscal year 2004;

``(C) $252,000,000 for fiscal year 2005;

``(D) $259,300,000 for fiscal year 2006; and

``(E) $259,300,000 for fiscal year 2007;''.

SEC. 505. ACCOUNTABILITY AND REPORTS.

(a) Public Accountability.--

(1) Consultation.--In developing recommendations to the Congress for the goals and plans for meeting the goals for the process for the review of human drug applications for the fiscal years after fiscal year 2007, and for the reauthorization of sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act, the Secretary of Health and Human Services (referred to in this section as the ``Secretary'') shall consult with the Committee on Energy and Commerce of the House of Representatives, the Committee on Health, Education, Labor, and Pensions of the Senate, appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry.

(2) Recommendations.--The Secretary shall publish in the Federal Register recommendations under paragraph (1), after negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such paragraph; shall hold a meeting at which the public may present its views on such recommendations; and shall provide for a period of 30 days for the public to provide written comments on such recommendations.

(b) Performance Report.--Beginning with fiscal year 2003, not later than 60 days after the end of each fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 379g et seq.), the Secretary of Health and Human Services shall prepare and submit to the President, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 502(4) during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

(c) Fiscal Report.--Beginning with fiscal year 2003, not later than 120 days after the end of each fiscal year during which fees are collected under the part described in subsection (b), the Secretary of Health and Human Services shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.

SEC. 506. REPORTS OF POSTMARKETING STUDIES.

Section 506B of the Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 356b) is amended by adding at the end the following subsections:

``(d) Disclosure.--If a sponsor fails to complete an agreed upon study required by this section by its original or otherwise negotiated deadline, the Secretary shall publish a statement on the Internet site of the Food and Drug Administration stating that the study was not completed and, if the reasons for such failure to complete the study were not satisfactory to the Secretary, a statement that such reasons were not satisfactory to the Secretary.

``(e) Notification.--With respect to studies of the type required under section 506(b)(2)(A) or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as each of such sections was in effect on the day before the effective date of this subsection, the Secretary may require that a sponsor who, for reasons not satisfactory to the Secretary, fails to complete by its deadline a study under any of such sections of such type for a drug or biological product (including such a study conducted after such effective date) notify practitioners who prescribe such drug or biological product of the failure to complete such study and the questions of clinical benefit, and, where appropriate, questions of safety, that remain unanswered as a result of the failure to complete such study. Nothing in this subsection shall be construed as altering the requirements of the types of studies required under section 506(b)(2)(A) or under section 314.510 or 601.41 of title 21, Code of Federal Regulations, as so in effect, or as prohibiting the Secretary from modifying such sections of title 21 of such Code to provide for studies in addition to those of such type.''.

SEC. 507. SAVINGS CLAUSE.

Notwithstanding section 107 of the Food and Drug Administration Modernization Act of 1997, and notwithstanding the amendments made by this subtitle, part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this Act, continues to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that, on or after October 1, 1997, but before October 1, 2002, were accepted by the Food and Drug Administration for filing.

SEC. 508. EFFECTIVE DATE.

The amendments made by this subtitle shall take effect October 1, 2002.

SEC. 509. SUNSET CLAUSE.

The amendments made by sections 503 and 504 cease to be effective October 1, 2007, and section 505 ceases to be effective 120 days after such date.

Subtitle B--Funding Provisions Regarding Food and Drug Administration

SEC. 521. OFFICE OF DRUG SAFETY.

Of the amounts appropriated for the Food and Drug Administration for a fiscal year, the Secretary of Health and Human Services shall reserve for the Office of Drug Safety

(within such Administration), the following amounts:

(1) For fiscal year 2003, an amount equal to the sum of

$5,000,000 and the amount made available under appropriations Acts for such Office for fiscal year 2002.

(2) For fiscal year 2004, an amount equal to the sum of

$10,000,000 and the amount made available under appropriations Acts for such Office for fiscal year 2002.

(3) For each subsequent fiscal year, an amount equal to the sum of the amount made available under appropriations Acts for such Office for fiscal year 2004 and an amount sufficient to offset the effects of inflation occurring after the beginning of fiscal year 2004.

SEC. 522. DIVISION OF DRUG MARKETING, ADVERTISING, AND

COMMUNICATIONS.

For the Division of Drug Marketing, Advertising, and Communications (within the Office of Medical Policy, Food and Drug Administration), there are authorized to be appropriated the following amounts, stated as increases above the amount made available under appropriations Acts for such Division for fiscal year 2002:

(1) For fiscal year 2003, an increase of $2,500,000.

(2) For fiscal year 2004, an increase of $4,000,000.

(3) For fiscal year 2005, an increase of $5,500,000.

(4) For fiscal year 2006, an increase of $7,500,000.

(5) For fiscal year 2007, an increase of $7,500,000.

SEC. 523. OFFICE OF GENERIC DRUGS.

For the Office of Generic Drugs (within the Food and Drug Administration), there are authorized to be appropriated the following amounts, stated as increases above the amount made available under appropriations Acts for such Office for fiscal year 2002:

(1) For fiscal year 2003, an increase of $3,000,000.

(2) For fiscal year 2004, an increase of $6,000,000.

(3) For fiscal year 2005, an increase of $9,000,000.

(4) For fiscal year 2006, an increase of $12,000,000.

(5) For fiscal year 2007, an increase of $15,000,000.

Subtitle C--Additional Provisions

SEC. 531. TRANSITION TO DIGITAL TELEVISION.

(a) Pair Assignment Required.--In order to further promote the orderly transition to digital television, and to promote the equitable allocation and use of digital channels by television broadcast permittees and licensees, the Federal Communications Commission, at the request of an eligible licensee or permittee, shall, within 90 days after the date of enactment of this Act, allot, if necessary, and assign a paired digital television channel to that licensee or permittee, provided that--

(1) such channel can be allotted and assigned without further modification of the tables of allotments as set forth in sections 73.606 and 73.622 of the Commission's regulations

(47 CFR 73.606, 73.622); and

(2) such allotment and assignment is otherwise consistent with the Commission's rules (47 CFR part 73).

(b) Eligible Transition Licensee or Permittee.--For purposes of subsection (a), the term ``eligible licensee or permittee'' means only a full power television broadcast licensee or permittee (or its successor in interest) that--

(1) had an application pending for an analog television station construction permit as of October 24, 1991, which application was granted after April 3, 1997; and

(2) as of the date of enactment of this Act, is the permittee or licensee of that station.

(c) Requirements on Licensee or Permittee.--

(1) Construction deadline.--Any licensee or permittee receiving a paired digital channel pursuant to this section--

(A) shall be required to construct the digital television broadcast facility within 18 months of the date on which the Federal Communications Commission issues a construction permit therefore, and

(B) shall be prohibited from obtaining or receiving an extension of time from the Commission beyond the construction deadline established by paragraph (1).

(2) Prohibition of analog operation using digital pair.-- Any licensee or permittee receiving a paired digital channel pursuant to this section shall be prohibited from giving up its current paired analog assignment and becoming a single-channel broadcaster and operating in analog on such paired digital channel.

(d) Relief Restricted.--Any paired digital allotment and assignment made under this section shall not be available to any other applicant unless such applicant is an eligible licensee or permittee within the meaning of subsection (b).

SEC. 532. 3-YEAR DELAY IN LOCK IN PROCEDURES FOR

MEDICARE+CHOICE PLANS; CHANGE IN CERTAIN

MEDICARE+CHOICE DEADLINES AND ANNUAL,

COORDINATED ELECTION PERIOD FOR 2003, 2004, AND

2005.

(a) Lock-In Delay.--Section 1851(e) of the Social Security Act (42 U.S.C. 1395w-21(e)) is amended--

(1) in paragraph (2)(A), by striking ``through 2001'' and

``during 1998, 1999, 2000, and 2001'' and inserting ``through 2004'' and ``during the period beginning January 1, 1998, and ending on December 31, 2004'', respectively;

(2) in the heading to paragraph (2)(B), by striking

``during 2002'' and inserting ``during 2005'';

(3) in paragraphs (2)(B)(i) and (2)(C)(i), by striking

``2002'' and inserting ``2005'' each place it appears;

(4) in paragraph (2)(D), by striking ``2001'' and inserting

``2004''; and

(5) in paragraph (4), by striking ``2002'' and inserting

``2005'' each place it appears.

(b) Change in Reporting Deadline.--

(1) In general.--Section 1854(a)(1) of such Act (42 U.S.C. 1395w-24(a)(1)) is amended by striking ``Not later than July 1 of each year'' and inserting ``Not later than the second Monday in September of 2002, 2003, and 2004 (or July 1 of each other year)''.

(2) Effective date.--The amendment made by paragraph (1) shall apply to information submitted for years beginning with 2003.

(c) Delay in Annual, Coordinated Election Period.--

(1) In general.--Section 1851(e) of such Act (42 U.S.C. 1395w-21(e)) is amended--

(A) in paragraph (3)(B), by striking ``means'' and all that follows and inserting the following: ``means, with respect to a year before 2003 and after 2005, the month of November before such year and with respect to 2003, 2004, and 2005, the period beginning on November 15 and ending on December 31 of the year before such year.''; and

(B) in paragraph (6)(A), by striking ``each subsequent year

(as provided in paragraph (3))'' and inserting ``during the annual, coordinated election period under paragraph (3) for each subsequent year''.

(2) Effective date.--The amendment made by paragraph (1) shall apply to the annual, coordinated election period for years beginning with 2003.

(d) Change to Annual Announcement of Payment Rates.--

(1) In general.--Section 1853(b)(1) of such Act (42 U.S.C. 1395w-23(b)(1)) is amended by striking ``not later than March 1 before the calendar year concerned'' and inserting ``for years before 2004 and after 2005 not later than March 1 before the calendar year concerned and for 2004 and 2005 not later than the second Monday in May before the respective calendar year''.

(2) Effective date.--The amendment made by paragraph (1) shall first apply to announcements for years after 2003.

And the Senate agree to the same.

From the Committee on Energy and Commerce, for consideration of the House bill and the Senate amendment, and modifications committed to conference:Billy Tauzin,Michael Bilirakis,Paul E. Gillmor,Richard Burr,John Shimkus,John D. Dingell,Henry A. Waxman,Sherrod Brown,Provided that Mr. Pallone is appointed in lieu of Mr. Brown of Ohio for consideration of title IV of the House bill, and modifications committed to conference:Frank Pallone, Jr.,From the Committee on Agriculture, for consideration of title II of the House bill and sec. 216 and title V of the Senate amendment, and modifications committed to conference:Larry Combest,Frank D. Lucas,Saxby Chambliss,Charles Stenholm,Tim Holden,From the Committee on the Judiciary, for consideration of title II of the House bill and secs. 216 and 401 of the Senate amendment, and modifications committed to conference:F. James Sensenbrenner, Jr.,Lamar Smith,John Conyers, Jr.,

Managers on the Part of the House.

Edward Kennedy,Chris Dodd,Tom Harkin,Barbara A. Mikulski,Jim Jeffords,Judd Gregg,Bill Frist,Mike Enzi,Tim Hutchinson,

Managers on the Part of the Senate.

JOINT EXPLANATORY STATEMENT OF THE COMMITTEE OF CONFERENCE

The managers on the part of the House and the Senate at the conference on the disagreeing votes of the two Houses on the amendment of the Senate to the bill (H.R. 3448), to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies, submit the following joint statement to the House and the Senate in explanation of the effect of the action agreed upon by the managers and recommended in the accompanying conference report:

The Senate amendment struck all of the House bill after the enacting clause and inserted a substitute text.

The House recedes from its disagreement to the amendment of the Senate with an amendment that is a substitute for the House bill and the Senate amendment. The differences between the House bill, the Senate amendment, and the substitute agreed to in conference are noted below, except for clerical corrections, conforming changes made necessary by agreements reached by the conferees, and minor drafting and clerical changes.

TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH

EMERGENCIES

As approved by the conference Managers, Title I addresses core public health concerns associated with preparedness for and effective response to bioterrorism and other public health emergencies in a number of different ways. First Title I improves communications between and among all levels of government, public health officials, first responders, and health care providers and facilities during emergencies. The Managers have authorized substantial sums in FY 2002 and beyond in grants to States, local governments, and other public and private health care facilities and other entities to improve planning and preparedness activities, and educate and train health care personnel. Under Title I, the Department of Health and Human Services (HHS) will have a new focus, and improved coordination and accountability, through a new Assistant Secretary for Public Health emergency preparedness. The legislation also authorizes the National Disaster medical system, new planning and reporting provisions, training exercises, and improved communications strategies and networks. The Managers also believe that the provisions of Title I will ensure that the nation has sufficient drugs, vaccines, and other supplies for our emergency health security. The Managers intend for activities under Title I to enhance the Nation's public health infrastructure at the national, state, and local levels. The Managers believe that an effective public health system is essential to responding effectively to bioterrorism and other public health emergencies.

Subtitle A--National Preparedness and Response Planning, Coordinating, and Reporting

Section 101. National Preparedness and Response

House provision: The House provision requires the Secretary of HHS to continue the process of developing and implementing a coordinated strategy, including the preparation of a national plan for carrying out health-related activities to prepare for and respond effectively to bioterrorism and other public health emergencies. The plan would be in consultation with other Federal agencies and other appropriate public and private entities. The plan also would be coordinated with activities of State and local governments to meet preparedness goals set out under the Act. National preparedness goals include providing effective assistance to State and local governments to ensure that they and their health care facilities have adequate capacity and properly trained response personnel; a coordinated plan, effective communications networks, and laboratory readiness, training and surveillance; developing and maintaining medical countermeasures against biological agents; and effective coordination at all levels of government. There would be evaluations and reports of progress.

Senate amendment: The Senate amendment contains similar provisions.

Conference substitute: The Conference adopts the House provisions with certain modifications to clarify the provision does not expand regulatory or other authority, and to incorporate various advisory committee and study provisions. A study to emergency response services and their use during public health emergencies, formerly located in section 114 of the House bill, is now located in this section.Section 102. Assistant Secretary for Public Health Emergency

Preparedness; National Disaster Medical System

House provision: The House provision establishes the new position of Assistant Secretary for Emergency Preparedness to coordinate HHS activities under the new Act. The provision also would authorize the National Disaster Medical System, under the new Assistant Secretary to provide for further National capacity during public health emergencies.

Senate amendment: The Senate amendment contains a similar provision in section 211 of the Senate amendment.

Conference substitute: The Conference substitute uses the House language with modification. The managers believe that there is a need to increase coordination of the Department of Health and Human Services' efforts in responding to bioterrorism and other public health emergencies, and thus has provided for the creation of an Assistant Secretary for Public Health Emergency Preparedness. The substitute also formally establishes the National Disaster Medical System

(NDMS), recognizing the important role already played by the NDMS in the Federal government's response to all types of emergencies and disasters. The substitute also addresses a number of critical personnel issues within the NDMS, including liability protections, employment rights, and compensation for work injuries. In addition, the Secretary shall take into account the role and expertise of the Agency for Toxic Substances and Disease Registry.Section 103. Improving Ability of Centers for Disease Control and Prevention

House provision: The House bill provides authorization and multi-year contracting authority for the renovation, development and security at facilities for the Centers for Disease Control and Prevention (CDC). The House bill also enhances training and nationwide laboratory capacity, and the establishment of integrated, national public health communications and surveillance networks.

Senate amendment: The Senate amendment, in section 202, also contains provisions for upgrading CDC's activities and facilities.

Conference substitute: The Conference substitute adopts the House provision with modifications. The substitute recognizes the critical role played by CDC in the nation's efforts to defend against bioterrorism and other public health emergencies. The Managers are concerned by extreme disrepair at many CDC laboratories and believe that repair and modernization funds are desperately needed. To that end, the substitute has provided multi-year contracting authority for CDC and has authorized an accelerated program of facilities funding. The substitute also recognizes the central role played by CDC in maintaining robust public health alert communications and surveillance networks, and has provided for grants, contracts, and cooperative agreements to further strengthen a national network that includes public health laboratories and other health care facilities. Provisions concerning priorities for public health lab enhancements have been moved to the general grants section, section 131, of the Conference substitute.Section 104. Advisory Committees and Communications; Study

Regarding Communications Abilities of Public Health

Agencies

House provision: Section 104 of the House bill establishes an advisory committee on children and terrorism and also one on emergency public information and communications. The provision also requires a coordinated strategy on public health communications during a bioterrorism attack. Section 111 also contains a provision for a study regarding the communications ability of public health agencies and to improve telecommunications infrastructure and connectivity during public health emergencies.

Senate amendment: Section 213 of the Senate amendment contains similar provisions. Section 214 of the Senate amendment also contains a provision establishing the official Federal Internet Site on Bioterrorism.

Conference substitute: The Conference substitute adopts, with minor modification, the provisions from the House and Senate establishing an advisory committee on children and terrorism; an advisory committee on emergency public information and communications; a coordinated strategy on public health communications during a bioterrorism attack; and the official Federal Internet Site on Bioterrorism.Section 105. Education of Health Care Personnel; Training

Regarding Pediatric Issues

House provision: The House bill requires the establishment of core curriculum materials for public health emergencies, for the purpose of education and training of health care personnel.

Senate amendment: Section 105 of the Senate amendment contains a similar provision.

Conference substitute: The Conference substitute adopts the House provision with minor modification. The Managers intend that the eligible entity phrase ``other appropriate educational entities'' includes medical schools that have established departments of medical education.Section 106. Grants Regarding Shortages of Certain Health

Professionals

House provision: The House bill provides grants for training and education to certain categories of health care professionals for which there exist shortages impacting the ability to respond to bioterrorism and other public health emergencies.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference adopts the House provision without modification.Section 107. Emergency System for Advance Registration of

Health Professions Volunteers

House provision: The House bill establishes a national system to help verify the licenses, credentials and hospital privileges of health professionals who volunteer to respond during public health emergencies.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference adopts the House provision with modifications to make clear that use of the verification database is entirely voluntary, and that nothing in the section changes the roles of States in licensing or hospitals in establishing privileging requirements.Section 108. Working Groups

House provision: House section 108 makes modifications to the existing working groups in section 319 of the Public Health Service Act (PHSA).

Senate amendment: The Senate amendment also makes modifications and additions to the working group provisions. The Senate amendment also consolidates the two existing working groups in sections 319F of the Public Health Service Act.

Conference substitute: The Conference substitute adopts a single working group, but allows for subcommittees to represent the working group with respect to particular matters. The authority of the working group is limited through various savings clauses. The primary purposes of the working group are consultation, assisting in coordination, and making recommendations on a variety of topics related to preparedness for and response to bioterrorism and other public health emergencies. The Managers expect the working group to take into account the role and expertise of the Agency for Toxic Substances and Disease Registry. Additionally, the Managers encourage the working group to recognize the role of private ambulance services, especially when they may be the only ambulance services in the area.Section 109. Antimicrobial Resistance

House provision: The House bill authorizes further research and DNA analysis of priority pathogens that may be used by bioterrorists, and contains other provisions concerning antimicrobial resistance.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the House provision on antimicrobial resistance. The provision concerning priority pathogens has been moved to section 125 of the Conference substitute.Section 110. Supplies and Services in Lieu of Award Funds

House provision: The House bill provides flexibility to allow the Secretary of HHS to supply actual supplies, equipment, or services instead of, or in conjunction with, grants.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the House provision.Section 111. Additional Amendments

House provision: The House bill makes revisions to time frames to accelerate preparedness planning.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the House provision.

Subtitle B--Strategic National Stockpile; Development of Priority

Countermeasures

Section 121. Strategic National Stockpile

House provision: The House bill authorizes a national stockpile or stockpiles of drugs, vaccines, biologic products, medical devices and supplies to meet the health security needs of the United States. It requires enhanced procedures for coordination, maintenance, delivery, and distribution. House authorization language in section 151 of the House bill specifies specific sums for smallpox vaccines.

Senate amendment: Section 201 of the Senate amendment also authorizes a national stockpile, and separately has a provision under section 402 for authorizing smallpox vaccines for the stockpile.

Conferece substitute: The Conference substitute adopts the House provision with modifications and inclusion of a specific provision on smallpox vaccines. The Managers believe that antiviral products may be appropriate for the strategic national stockpile and may include antiviral products reviewed by the Food and Drug Administration (FDA) or National Institutes of Health

(NIH).Section 122. Accelerated Approval of Priority Countermeasures

House provision: The House bill clarifies certain fast-track authority for drug priority countermeasures under the Federal Food, Drug, and Cosmetic Act.

Senate amendment: Section 405 of the Senate amendment contains a similar provision.

Conference substitute: The Conference substitute adopts the Senate provision with modification.Section 123. Issuance of Rule on Animal Trials

House provision: The House bill requires the FDA to issue a final rule within six months allowing reliance on animal trials for certain priority countermeasures for public health emergencies.

Senate amendment: The Senate amendment contains a similar requirement with a 30-day time frame.

Conference substitute: The Conference substitute adopts the House provision with modifications to provide the rule within 90 days of the date of enactment.Section 124. Security for Countermeasure Development and

Production

House provision: The House bill authorizes the Secretary, in consultation with the Attorney General and Secretary of Defense, to provide technical or other assistance to enhance security at facilities that conduct development, production, distribution, or storage of priority countermeasures.

Senate amendment: Section 402 of the Senate amendment contains a similar provision and also provides for best practices guidelines.

Conference substitute: The Conference substitute adopts the House provisions without a requirement for best practices guidelines.Section 125. Accelerated Countermeasure Research and

Development

House provision: The House bill directs the Secretary to conduct an accelerated countermeasure development program, and to award grants for biomedical research, development of vaccines, and diagnostic tests for priority countermeasures.

Senate amendment: Section 404 of the Senate amendment contains similar provisions.

Conference substitute: The Conference substitute adopts the Senate provisions with modifications. The House provision concerning priority pathogens is included. The Managers encourage the Secretary to consider novel methods for detecting and identifying viral and bacterial pathogens, and developing and manufacturing effective therapeutic responses, including both vaccines and antibiotics. The Managers also encourage the Secretary to consider the use of emerging biophysical and biomanufacturing technologies that hold the promise of producing rapid detection/response programs that can achieve accelerated responses to bioterrist attacks or threats. In addition, the Managers encourage the Secretary, in coordination with the Administrator of the Environmental Protection Agency, to develop protocols for and enhance facilities for testing technologies used to decontaminate facilities contaminated as a result of bioterrorism.Section 126. Evaluation of New and Emerging Technologies

Regarding Bioterrist Attack and Other Public Health

Emergencies

House provision: The House bill requires the Secretary to evaluate new and emerging technologies to help detect, identify, diagnose, or conduct public health surveillance activities for public health emergencies, and prioritize development and deployment where warranted.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the House provision with limiting modifications.Section 127. Potassium Iodide

House provision: The House bill requires the Secretary to make potassium iodide available to States and local governments that submit a plan for local stockpile and distribution for the population within 20 miles of a nuclear power plant.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the House provision with modifications that include authority provided to the President; additional restrictions on the eligibility of local governments; and a different schedule for effective dates, and other modifications.

Subtitle C--Improving State, Local, and Hospital Preparedness for and

Response to Bioterrorism and Other Public Health Emergencies

Section 131. Grants to Improve State, Local, and Hospital

Preparedness for and Response to Bioterrorism and Other

Public Health Emergencies

House provision: The House bill modifies current authorities under section 319 of the PHSA and otherwise authorized grant funding to improve State, local, and hospital preparedness for and response to bioterrorism and other public health emergencies through the existing mechanisms of the PHSA. Authorization was provided from FY 2002-2006.

Senate amendment: The Senate amendment contains a provision for State block grants for fiscal years 2002-2003 for bioterrorism activities only, and the authorization would not continue past FY 2003. It also provides an authorization for bioterrorism medical centers with authorization from FY 2002-2006, limited to bioterrorism activities. Finally, the Senate amendment maintains and authorizes a portion of funding under section 319 for a broader list of purposes and eligible entities.

Conference substitute: The Conference substitute reflects a compromise between House and Senate approaches. For FY 2003, there is a modified State block grant provision. Beyond FY 2003, greater flexibility is provided to the Secretary to either continue the same approach or modify the approach without the restrictions of the FY 2003 formulas. The substitute also provides authorization for the purpose of enhancing the preparedness of hospitals (including children's hospitals), clinics, health centers, and primary care facilities, and for planning and administrative purposes relating to such authorizations. For FY 2004-2006, there is a new section 319 C-2.

The Managers want to ensure that section 131 does not delay or disrupt the current grants and cooperative agreements that the Administration has been using in FY 2002, including those programs administered by CDC and the Health Resources and Services Administration (HRSA). It is the Managers' intent to allow the Administration to continue this approach. The Managers expect the Administration to evaluate the effectiveness of the program and make revisions where necessary to improve effectiveness and accountability.

The Managers intend that a permissible use of funds under this section includes grants to one or more centers of excellence to develop appropriate innovative technology projects--for example, the development of a web-based computerized planning application that incorporates standardized language and utilizes wireless mobile technology. The Managers intend that training programs pursuant to this section could include the use of virtual reality training methods, human patient simulators, computer-assisted training modalities, and internet-based training and modeling capabilities. One or more centers of excellence could be established to develop, deploy, and evaluate virtual and augmented reality-based, internet-ready training capabilities.

Subtitle D--Emergency Authorities; Additional Provisions

Section 141. Reporting Deadlines

House provision: The House bill provides extensions for certain reporting deadlines during a public health emergency, and for transfer authority for funds during a public health emergency.

Senate amendment: The Senate amendment contains an analogous provision on reporting deadlines and no new transfer authority.

Conference substitute: The Conference substitute adopts the Senate provision on reporting deadlines with minor modifications.Section 142. Streamlining and Clarifying Communicable Disease

Quarantine Provisions

House provision: The House bill changes existing law to expand the authority of the Secretary, in consultation with the Surgeon General, and under certain conditions, to specify diseases that are subject to individual detention orders.

Senate amendment: The senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the House provision with modifications to the standards required before the Secretary may exercise this authority.Section 143. Emergency Waiver of Medicare, Medicaid, and

SCHIP Requirements

House provision: Section 143 allows the Secretary of Health and Human Services to waive certain requirements (and related regulations) in of titles XVIII, XIX, and XXI of the Social Security Act (as well as requirements and regulations under title XI of the Social Security Act, only as necessary to effectuate the waiver of the enumerated requirements of titles XVIII, XIX, and XXI to meet the purposes of this section) in the event of an emergency or disaster in order to: (1) facilitate the provision of health services in the emergency or disaster area, and (2) ensure that health care providers who furnish care in good faith to individuals enrolled in these programs during an emergency or disaster may be reimbursed without penalty. The Secretary can waive requirements pertaining to: conditions of participation for providers; provider licensing requirements; sanctions for physician self-referral; sanctions relating to transferring patients in an emergency; and deadlines for filing reports for periods of up to 90 days.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the House provision with modifications. The Managers agree that the Secretary shall provide written notice to Congress, including a certification that a waiver is necessary. This notice shall be issued before the waiver authority is exercised. Additionally, the Secretary must report to Congress within a year evaluating the effectiveness of the approaches used during the operation of the waiver. The time frame for such waivers shall be 60 days.Section 144. Provision for Expiration of Public Health

Emergencies

House provision: The House bill provides that public health emergencies expire by announcement of the Secretary, or after 90 days. The Secretary may renew emergency declarations at his or her discretion.

Senate amendment: Section 212 of the Senate Amendment contains a similar provision, but with a 180-day expiration period.

Conference substitute: The Conference substitute adopts the House provision with amendments, including clarifying the status of any existing declaration of public health emergencies.

Subtitle--Additional Provisions

Section 151. Designated State Public Emergency Announcement

Plan

House provision: Section 135 of the House bill amends the Stafford Act to provide for coordinated communications response.

Senate amendment: Section 312 of the Senate amendment contains an identical provision.

Conference substitute: The Conference substitute adopts the identical House and Senate provisions.Section 152. Expanded Research by Secretary of Energy

House provision: The House bill expands current research at the Department of Energy (DOE) and the National Nuclear Security Administration (NNSA) on rapid detection of pathogens likely to be used in bioterrorist attacks or other agents that may cause a public health emergency.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the House provision.Section 153. Expanded Research on Worker Health and Safety

House provision: The House bill authorizes the National Institutes of Occupational Safety and Health (NIOSH) to expand research on health and safety of workers who are at risk for bioterrorist threats or attacks in the workplace.

Senate amendment: The Senate amendment contains an analogous provision.

Conference substitute: The Conference substitute adopts the Senate Amendment with minor modification.Section 154. Enhancement of Emergency Preparedness of

Department of Veterans Affairs

House provision: The House bill has no analogous provision.

Senate amendment: The Senate amendment has no analogous provision.

Conference substitute: The Conference substitute instructs the Secretary of Veterans Affairs to take appropriate actions to enhance the readiness of the Department's medical centers and research facilities for a chemical or biological attack, based on the results of an evaluation to be conducted by the Secretary on the security needs at these facilities.Section 155. Reauthorization of Existing Program

House provision: The House bill has no analogous provision.

Senate amendment: The Senate amendment has no analogous provision.

Conference substitute: The Conference substitute amends section 582(f) of the Public Health Service Act by reauthorizing a grant program through 2006 that provides awards to public and private entities, as well as Indian tribes and tribal organizations, that develop programs focusing on the behavioral and biological aspects of psychological trauma response and research that will help treat psychiatric disorders of children and youth resulting from witnessing or experiencing a traumatic event.Section 156. Sense of Congress

House provision: The House bill has no analogous provision.

Senate amendment: The Senate amendment states that Congress recognizes that many university-based programs are already functioning and developing important biodefense products and solutions. Congress should recognize the importance of supporting work done at university centers and laboratories. In addition, Congress should recognize the importance of existing public and private university-based research, training, public awareness, and safety-related biological defense programs in the awarding of grants and contracts made in accordance with this Act.

Conference substitute: The Conference substitute contains one modification to the Senate amendment, which clarifies that the Secretary of Health and Human Services may recognize the importance of existing public and private university-based efforts in grants and cooperative agreements.Section 157. General Accounting Office Report

House provision: The House bill has no analogous provision.

Senate amendment: The Senate amendment requires a General Accounting Office (GAO) report to Congress on Federal bioterrorism-related activities.

Conference substitute: The Conference substitute amends section 319F of the Public Health Service Act to require GAO to report on Federal bioterrorism-related activities, including research, preparedness, and response, to the following committees: Senate Health, Education, Labor, and Pensions; Senate Appropriations; House Energy and Commerce; and House Appropriations.Section 158. Certain Awards

House provision: The House bill has no analogous provision.

Senate amendment: The Senate amendment has no analogous provision.

Conference substitute: The Conference substitute amends section 319(a) of the Public Health Service Act by inserting after ``grants,'' ``providing awards for expenses, and.''Section 159. Public Access Defibrillation Programs and Public

Access Defibrillation Demonstration Projects

House provision: The House bill contains no such analogous provision.

Senate amendment: The Senate amendment contains no such analogous provision.

Conference substitute: The Conference substitute amends section 243 of title 42, United States Code, to enact the

``Community Access to Emergency Defibrillation Act of 2002.'' The Conference substitute directs the Secretary to establish a new grant program for States, political subdivisions of States, Indian tribes, and tribal organizations to develop and implement public access defibrillation programs. These grants may be used to purchase automated external defibrillators (AEDs), to provide automated external defibrillation and basic life support training in AED usage, to provide information to community members about the public access defibrillation program, to provide information to the local emergency medical system regarding the placement of AEDs, and to produce materials to encourage private companies to purchase AEDs. For this new grant program, the Conference substitute authorizes the appropriation of $25 million in fiscal year 2002, and such sums as may be necessary for each of the fiscal years 2004 through 2006. The Conference substitute also establishes a new grant program for political divisions of States, Indian tribes, and tribal organizations to develop and implement innovative, comprehensive, community-based public access defibrillation demonstration projects. These grants may be used to purchase AEDs, to provide basic life training in automated external defibrillator usage, to provide information to community members about the public access defibrillation demonstration project, and to provide information to the local emergency medical services system regarding the placement of AEDs. For these demonstration projects, the Conference substitute authorizes the appropriation of $5 million for fiscal years 2003 through 2006. The Managers intend that the ``Good Samaritan'' protections regarding emergency use of AEDs outlined in section 238(q) of title 42, United States Code will apply to this section. It is the intent of the Managers that this new program coordinates its activities with the Rural AED program and avoid duplication of effort.

TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS

Subtitle A--Department of Health and Human Services

Section 201. Regulation of Certain Biological Agents and

Toxins

House provision: The House bill requires all persons who possess, use or transfer ``select agents''--the 36 biological agents or toxins currently determined by the Secretary of the Department of Health and Human Services (HHS) to pose ``a severe threat to public health and safety''--to register with the Secretary and be subject to reasonable safety and security requirements and inspections. Current law requires registration only of those entities transferring such agents. The House bill also directs that the Secretary maintain a national database of all such agents, with sufficient information to facilitate their identification and traceability. The Secretary, in consultation with the Attorney General, must establish specific security requirements for registered facilities and a personnel screening protocol to ensure that access to such agents is not permitted by individuals who are ``restricted persons'' under the USA PATRIOT Act (18 U.S.C. 175b), are named in a warrant for violent criminal or terrorist activity, are under investigation for involvement in domestic or international terrorist or criminal organizations, or suspected of spying for the military or intelligence operations of a foreign nation. The Secretary is granted authority to assist public and nonprofit private entities in meeting such security requirements. The House bill also imposes civil penalties for those who violate the regulations, up to $500,000.

The House bill grants the Secretary discretion to make exemptions to the registration requirements only where those exemptions are consistent with protecting the public health and safety--for example, with respect to inactivated or attenuated strains of select agents used in vaccines or other products for legitimate medical research or use--or when the agent is presented for diagnosis, verification or proficiency testing purposes at a clinical laboratory and is promptly destroyed or transferred to a registered facility after such identification. The House bill also exempts from mandatory disclosure under the Freedom of Information Act (FOIA) site-specific or identifying information submitted under these regulations concerning registered persons, select agents, and security mechanisms.

Senate amendment: The Senate amendment is substantially similar to the House bill but differs in a few respects. First, in developing the list of select agents, the Secretary is directed to consider the needs of children and other vulnerable populations. Second, individuals who seek access to select agents are screened only to identify if they are

``restricted persons'' under the USA PATRIOT Act, or are named in a warrant for participation in a domestic or international act of terrorism. Third, the Secretary is permitted to exempt certain attenuated or inactive biological agents or toxins and certain approved medical products from the list of select agents.

Conference substitute: The Conference substitute adopts provisions of both bills, with significant modifications. The primary goals of this subtitle are to ensure the prompt reporting to the Federal government of possession of select agents (including by those who were in possession prior to April 15, 1997, the effective date for reporting transfers of select agents), to increase the security over such agents

(including access controls and screening of personnel), and to establish a comprehensive and detailed national database of the location and characterization of such agents and the identities of those in possession of them. To effectuate these goals, the substitute requires that, at a minimum, all possession of select agents (unless exempt under the provisions of this subtitle) must be registered with the Secretary. The Managers expect that most ``persons'' who register under this subtitle will be public and private entities, rather than individuals. But these provisions also will cover individuals possessing, using or transferring select agents who have not been granted authority to do so by registered persons. If an individual has not been granted such authority, then that individual would be a person required to register under this subtitle. If an individual has been granted such authority without proper authorization from the Secretary, as required by this subtitle, then the registered person is subject to any penalties provided for violation of such regulations. The Managers emphasize that the primary responsibility for registration and the screening of employees working with select agents is with the entity or employer, not the individual employee. The Secretary also is required to promulgate regulations establishing safety requirements for the possession, use, and transfer of select agents. These regulations must include procedures to protect the public safety in the event the safety requirements for possession, use or transfer are violated.

The Managers recognize that some select agents may pose a greater threat to the public health and safety than others. Accordingly, the Conference substitute amends the security requirements of both bills by adding the phrase

``commensurate with the risk such agent or toxin poses to public health and safety (including the risk of use in domestic or international terrorism).'' The Secretary will have flexibility to impose different levels of security requirements on different select agents based on his or her evaluation of the level of threat to the public, as is currently done with respect to laboratory biosafety levels. Because an agent must pose a severe threat to human health to be placed on the select agent list, the Secretary may not decide that security requirements or registration of possession are unnecessary for a particular select agent.

The substitute also modifies the existing statutory requirements for the transfer regulations by adding ``and security measures'' after ``safeguards'' in the term

``safeguards to prevent access . . . for use in domestic or international terrorism or for any other criminal purposes'' to clarify that such regulations include the imposition of security requirements. The substitute also requires that registered persons promptly notify the Secretary whenever a select agent is lost, stolen, or released outside of a biocontainment area of a facility. Current HHS regulations do not mandate such notifications.

The Conference substitute adds new provisions regarding the screening of entities and individuals seeking to register their possession, use or transfer of select agents. While both the House and Senate bills mandate screening of individuals seeking access to agents through a registered person, neither bill required screening of the registered persons themselves. The substitute provides for such screening in a similar manner to that performed for individuals working at the facilities of registered persons. Further with respect to screening, the substitute drops the provision in both bills relating to outstanding warrants, as duplicative of the fugitive provision in the restricted person categories of the USA PATRIOT Act, and adds a screening category that was in neither bill--those reasonably suspected of committing Federal crimes of terrorism. The substitute includes but makes revisions to the two additional screening categories contained in the House bill to ensure an objective basis for governmental suspicion of involvement with terrorist or criminal organizations, or with foreign powers. In the case of restricted persons, the substitute mandates that access to select agents be denied, because of the criminal prohibition on possession by such persons. In the case of persons falling within the other three specified categories, the substitute grants the Secretary and Attorney General discretion in determining how to proceed, given the law enforcement sensitivity of such situations. By making this distinction between the handling of restricted persons and other screening categories, the Managers do not intend that potential terrorists or foreign agents should be subject to a less strict screening standard than restricted persons. The substitute also clarifies that the screening performed by the Attorney General is for the sole purpose of identifying--through the use of official, electronic databases available to the Federal government--whether an individual or entity falls within any of the specified categories, and for notifying the HHS Secretary of such identification. It is the Managers' intent that the term

``electronic databases'' is not meant to preclude the use of other databases or files by the Attorney General to clarify or confirm information obtained during the electronic database search.

To address concerns within the academic and research communities about the timeliness and accuracy of the background screening process, the Conference substitute amends both bills by requiring ``prompt'' action by the Attorney General and the Secretary with respect to screening of and notification to affected individuals, and by providing for an expedited review process where good cause has been demonstrated by the registered person. The substitute also provides for a review of denials by the Secretary based on the screening process, and subsequent judicial review--with provisions to ensure that classified or sensitive law enforcement information is not compromised during such reviews. Specifically, the substitute allows for ex parte review by the Secretary in administrative proceedings, and the court during judicial review, whenever a denial is challenged. In providing the right for ex parte review, the Managers intend to protect classified and law enforcement sensitive information, including through the use of in camera proceedings. Moreover, the Managers intend that a reviewing court should not order the disclosure of any information that the United States believes may compromise national security or an ongoing law enforcement investigation without affording the United States an opportunity for further review in accordance with this subtitle. It is the Managers' overall expectation that the screening process be conducted in a timely and fair manner, and that the Secretary and the Attorney General will work closely together to effectuate such intent.

With respect to the national database of select agents that the Secretary must develop pursuant to this section, the Conference substitute slightly alters the language used in both bills with respect to the database's purpose. The object of the registration and database requirements is to provide information about all persons possessing, using or transferring select agents, and to collect sufficiently detailed characterization information on the registered select agents so that the database can differentiate between and within strains of a given agent or toxin. Such information should be in a format that public health and law enforcement officials can use to identify the origin or source of an agent or toxin that is used to cause harm to the public. Because of concerns over the potential for misconstruction, the term ``traceability''--which could imply a chain of custody or tracking requirement--was eliminated, and was replaced with the concept of ``source.''

Significant modifications were made to both bills with respect to exemptions from the statutory and regulatory requirements governing select agents. The Conference substitute establishes several exemptions from the regulatory regime for select agents, most of which are consistent with the Secretary's current regulations and practices. First, the Conference substitute adopts, with modifications, the Senate amendment's language with respect to product exemptions. The substitute directs the Secretary to exempt from such regulations products that are, bear or contain a select agent and are licensed or approved under several specified Federal laws, unless the Secretary determines that additional regulation is necessary for a specific product to ensure protection of public health and safety. The Managers intend that the Secretary will exempt by regulation categories of products, consistent with current regulations, and will act to regulate a specific product, or a particular application of a specific product, only when existing regulation under other Federal laws is inadequate. For example, HHS currently exempts the FDA-approved medical product Botox, which is the select agent botulinum toxin, when it is used by licensed physicians in the treatment of patients. However, when it is used in purely research settings or as part of early-stage clinical trials, HHS has chosen not to exempt Botox from current regulations. The Managers do not intend to alter this flexibility.

Second, the Conference substitute adds a provision granting the Secretary discretionary authority to exempt, on a case-by-case basis, investigational products when they are being used in investigational or clinical trials authorized under other Federal laws, such as the Federal Food, Drug, and Cosmetic Act. Given the time sensitivity of such trials, the substitute also includes a provision mandating a prompt determination by the Secretary of such an exemption request--within 14 days after the applicant has submitted a complete exemption request and has notified the Secretary that the investigation may proceed as authorized under Federal law.

Third, with respect to clinical or diagnostic laboratories that may come into possession of select agents when conducting specimen diagnosis, verification or proficiency testing, the substitute adopts with minor changes the comparable provisions in the House and Senate bills. The Secretary shall exempt such laboratories from registration requirements, but only if they report the identification of select agents to the Secretary and either promptly transfer the agent to a registered person or destroy the agent on site, in accordance with regulations established by the Secretary. While HHS currently exempts such laboratories, existing regulations permit them to transfer, destroy, or store the agent on site for reference purposes. The Conference substitute expressly rejects that regulatory approach, as it is inconsistent with the fundamental premise of this title--that all those who maintain possession of a select agent must register and be subject to appropriate security and safety requirements. The Secretary may not exempt laboratories that possess select agents for reference purposes, or any other clinical or diagnostic laboratories that do not qualify for an exemption under the terms of this title. In addition, the Conference substitute creates two temporary exemption authorities to deal with public health emergencies and agricultural emergencies, whether domestic or foreign.

With respect to funding, the Conference substitute authorizes such sums as may be necessary to carry out these new and expanded functions. The Managers note that, historically, HHS has had insufficient resources to properly run the existing select agent transfer program. While current regulations permit inspections, only 20 percent of all registered facilities have been inspected since the inception of the program in 1997, and virtually none of these inspections were conducted prior to registration. The Managers also note that HHS received a large increase in funding for this program in the Fiscal Year 2002 supplemental appropriations bill. Given the broader, but uncertain scope of the new regulatory regime, it is unclear whether additional funds beyond current appropriations will be necessary for Fiscal Year 2003. Once all persons possessing select agents notify the Secretary of such possession 90 days after enactment of this title, the appropriations level may need to be re-evaluated.Section 202. Implementation by Department of Health and Human

Services

House provision: The House bill requires notification to the Secretary by all persons possessing select agents within 60 days of enactment, and an interim final rule establishing a regulatory structure to be issued within 120 days of enactment.

Senate amendment: The Senate amendment requires the Secretary to issue an interim final rule within 180 days of enactment, and requires all persons possessing select agents to register within 60 days of issuance of the rule.

Conference substitute: The Conference substitute adopts the House bill with modifications. The substitute requires notification to the Secretary by all persons possessing select agents within 90 days of enactment, based on guidance issued by the Secretary within 30 days of enactment, and the issuance of an interim final rule within 180 days of enactment. The substitute also provides that the interim final rule shall include time frames for applicability of the rule that minimize disruption of research or educational projects that involves select agents and that were underway as of the effective date of such rule. The Managers note that the interim final rule and effective date provisions will result in these new regulations going into effect at approximately the same time as the National Institutes of Health (NIH) begins to award Fiscal Year 2003 grants for research, some of which will be in the select agent area. The Managers expect that the Secretary will encourage those seeking such grants to begin the registration and screening process under this title concurrently with the NIH grant process, and that the Secretary will ensure the timely registration and screening of such grantees, so as not to delay this important research.Section 203. Effective dates

House provision and Senate amendment: both the House bill and the Senate amendment provide that regulations promulgated by the Secretary under section 511 of the Antiterrorism and Effective Death Penalty Act of 1996 are deemed to have been promulgated under section 351A of the Public Health Service Act, as added by this Act. They both also provide that the FOIA exemptions apply retroactively to the effective date of the Antiterrorism and Effective Death Penalty Act of 1996.

Conference substitute: The Conference substitute adopts the same provisions.Section 204. Conforming Amendment

House provision and Senate amendment: Both the House bill and the Senate amendment repeal those provisions of the Antiterrorism and Effective Death Penalty Act of 1996 that have been codified in section 351A of the Public Health Service Act by this Act.

Conference substitute: The Conference substitute adopts the same provisions.

Subtitle B--Department of Agriculture

Section 211. Short Title

House provision and Senate amendment: Neither the House bill nor the Senate amendment contain any analogous provision.

Conference substitute: The Conference substitute includes a new subtitle, with its own short title--the Agricultural Bioterrorism Protection Act of 2002.Section 212. Regulation of Certain Biological Agents and

Toxins

House provision and Senate amendment: Neither the House bill nor the Senate amendment contain any analogous provision.

Conference substitute: The Conference substitute adopts provisions that would grant comparable regulatory authorities to the U.S. Department of Agriculture (USDA) as those granted to HHS under subtitle A of this title for the regulation of possession, use or transfer of listed biological agents and toxins that present a severe threat to plant or animal health, or animal or plant products. In an effort to minimize regulatory duplication and burden, the substitute seeks to ensure, to the greatest extent practicable, uniformity in the statutory authority that the two departments will administer. Exceptions exist in the criteria to be used by the Secretary of Agriculture in developing a list of agriculturally significant biological agents and toxins; considerations to be made in granting exemptions from regulation under the statute; procedures related to civil monetary penalties; and the time frames for promulgation of a biological agents and toxins list and the accompanying requirement that individuals who possess these agents notify the Secretary of such possession. In addition, with respect to the screening of persons registering or accessing listed agents, the substitute uses the same screening categories as are in subtitle A, but does not mandate any denials of access, given that possession of USDA-listed agents by restricted persons is not a Federal crime. Instead, the Secretary and Attorney General are granted discretion as to how to proceed in such situations.

The Managers recognize that, under provisions of current law, biologics manufacturers have had to register, maintain associated paperwork, and be subject to inspections and requirements from both USDA and HHS. Likewise, the Managers are aware that the inadequacy of the penalty provisions of the Virus-Serum-Toxin Act--enacted in 1913 and under which USDA currently regulates these dangerous agents--as well as the lack of authority for the Secretary of Agriculture to regulate possession of biological agents and toxins that pose a severe threat to plant or animal health may expose the Unite States to potential acts of bioterrorism that could have a devastating impact on animal and plant health, or the domestic agricultural economy.

The Managers intend that, in developing the list of agents and toxins to be regulated under this subtitle, the USDA Secretary shall consult with other appropriate Federal agencies. With regard to zoonotic agents, which pose a threat to both animals and humans, the Managers expect that the USDA Secretary will consult with the HHS Secretary in developing such a list. The Managers also intend that the USDA Secretary will develop the list of regulated agents and toxins based solely on the risk to animals or plants, or to animal or plant products, including consideration of the effect of exposure on the production and marketability of such products. The Managers do not intend that the USDA Secretary will include an agent or toxin on the USDA list because of the effect of that agent or toxin on human health, which is governed by the statutory provisions of section 351A of the Public Health Service Act, as amended by this title.

The Managers expect that most ``persons'' who register under this subtitle will be public and private entities, rather than individuals. But these provisions also will cover individuals possessing, using or transferring listed agents who have not been granted authority to do so by registered persons. If an individual has not been granted such authority, then that individual would be a person required to register under this subtitle. If an individual has been granted such authority without proper authorization from the Secretary, as required by this subtitle, then the registered person is subject to any penalties provided for violation of such regulations. The Managers emphasize that the primary responsibility for registration and the screening of employees working with listed agents is with the entity or employer, not the individual employee.

Procedures for the registration of persons, review of individuals, and inspection of facilities have been described in the statutory language in some detail. Of equal importance to the Managers are the regulations, to be established by the Secretary, which, to ensure compliance with this substitute, shall include provisions for the revocation and suspension of registrations for failure to maintain safe and secure facilities.Section 213. Implementation by the Department of Agriculture

House provision and Senate amendment: Neither the House bill nor the Senate amendment contain any analagous provision.

Conference substitute: The Conference substitute provides that, within 60 days of enactment, the Secretary of Agriculture shall promulgate an interim final rule that establishes an initial list of agents and toxins meeting the statutory criteria for enhanced regulation. Within 60 days of the publishing of the interim final rule, all persons (unless exempt) must notify the Secretary of such possession. Within 180 days of enactment, the Secretary shall promulgate an interim final rule for carrying out the remainder of section 212, which such rule shall include time frames that minimize disruption of ongoing research and education with listed agents and toxins.

Subtitle C--Interagency Coordination Regarding Overlap Agents and

Toxins

Section 221. Interagency Coordination

It is the Managers' intent that the two Secretaries will coordinate closely with respect to exemptions from these new regulatory regimes for overlap agents, so as to create a uniform and consistent approach. The Managers also intend that, under the Memorandum of Understanding, a regulated party will interact with one agency with respect to all matters--including registration, screening, and inspections--so as to avoid confusion and forum shopping. The Managers also expect that the two Departments will coordinate and consult with respect to overlap agent registration, screening, and exemptions in a timely manner, particularly in situations of public health or agricultural emergencies.

Within 18 months of the implementation of a Memorandum of Understanding between USDA and HHS, the Managers intend that a formal, joint regulatory system shall be implemented by the two Departments for agents and toxins that appear on both the USDA and HHS lists. Once implemented, the Managers intend that these joint regulations shall supercede the Memorandum of Understanding with respect to matters covered by such regulations.

Subtitle D--Criminal Penalties Regarding Certain Biological Agents and

Toxins

Section 231. Criminal Penalties

House provision: The House bill authorizes amendments to current law to require all persons who possess, use of transfer biological agents or toxins that have been listed as select agents by the HHS Secretary to register with the Secretary. To enforce these new regulatory provisions, subsection (a) of section 231 of the House bill provides that any person who knowingly transfers a select agent to any person without first verifying such registration with the Secretary could be fined or imprisoned up to five years, or both. The subsection also provides that any person who knowingly possesses a biological agent or toxin, where such agent or toxin is a select agent for which such person has not obtained a registration required by the Secretary, could be fined or imprisoned for up to five years, or both.

The House bill makes technical changes to 18 U.S.C. 175b to renumber current subsection (a) as (a)(1), and to redesignate subsection (c) as (a)(2). This change will result in the description of the possible penalties being placed immediately following the description of the unlawful conduct. The House bill also redesignates subsection (b) as subsection (d). The two new criminal provisions added under this bill are designated subsections (b) and (c) of section 175b. The House bill also makes conforming amendments to clarify the definition of the term ``select agent.'' The House bill also changes the title of section 175b from

``Possession by restricted persons'' to ``Select Agents.''

Senate amendment: The Senate amendment includes the same criminal provision relating to those who possess select agents without being registered, but differs with respect to the criminal penalty for unauthorized transfers. The Senate amendment criminalizes transfers to unregistered persons when the transferor has reason to believe that the recipient is not registered. The Senate amendment also differs by including the unlawful conduct in 18 U.S.C. 175, rather than 175b. The Senate amendment makes conforming changes to 18 U.S.C. 175 to make the sections technically correct and to eliminate a definition that is already provided in another section. The Senate amendment provides that current 18 U.S.C. 175(b) and (c) are redesignated as (c) and (d). New subsection (b) creates the criminal penalties referenced above. New subsection (d), which contains the definitions, amends current law to provide new definitions for the following terms: ``biological agent,'' ``for use as a weapon,'' and ``select agent.''

Conference substitute: The Conference substitute adopts the House language with regard to technical changes to 18 U.S.C. 175b, but adopts the Senate language with respect to new criminal penalties with modifications. The Conference substitute adopts the common language dealing with unlawful possession. However, the Conference substitute amends the Senate language regarding transfers to provide that any person who transfers a select agent to any person one knows or has reasonable cause to believe has not registered with the HHS Secretary could be fined or imprisoned up to five years, or both.

The Conference substitute also amends both bills by adding language that requires all persons who possess, use or transfer biological agents that have been listed as agents that pose a threat to agriculture by the Secretary of Agriculture to register with such Secretary. The Conference substitute provides that knowing possession of a biological agent or toxin, where such agent or toxin is listed by the Secretary of Agriculture under this Act and for which a required registration has not been obtained, is punishable by a fine or up to five years imprisonment, or both. Similarly, transfer of a biological agent or toxin listed by the Secretary of Agriculture to a person one knows or has reasonable cause to believe has not registered with the Secretary is punishable by a fine or up to five years imprisonment, or both.

The Conference substitute also makes additional conforming and technical amendments to title 18, including providing a comma in 18 U.S.C. 175(c); specifically describing what activities restricted persons are prohibited from engaging in under this section; referring to the correct code section for the definition of ``alien''; replacing legislative language in 176(a)(1)(A); modifying the definitions in 18 U.S.C. 178 for ``biological agent'', ``toxin'', and ``vector'' to make each more accurate; and modifying 18 U.S.C. 2332a regarding use of weapons of mass destruction to make it clear it refers to use of biological agents or toxins.

The Managers expect that most ``persons'' who register under this title will be public and private entities, rather than individuals. When an entity fails to register as required, the new criminal possession statutes will apply to that entity. These provisions also will cover individuals possessing select or listed agents who are unregistered and who have not been granted access to such agents by registered persons. If an individual has not been granted access by a registered person, then that individual would be a person required to register under this title for purposes of these criminal possession provisions. If an individual is granted access to a select or listed agent by a registered person without proper authorization from the Secretary, as required by this title, then the registered person is subject to any penalties provided for violation of such regulations. The Managers emphasize that the primary responsibility for registration and the screening of employees working with select or listed agents is with the entity or employer, not the individual employee. This same analysis applies to the criminal transfer provisions set forth in this section.

TITLE III--PROTECTING THE SAFETY AND SECURITY OF THE FOOD AND DRUG

SUPPLY

Subtitle A--Protection of Food Supply

For purposes of this Title, the term ``Secretary'' refers to the Secretary of Health and Human Services, unless otherwise indicated.Section 301. Food Safety and Security Strategy

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment expands the responsibilities of the President's Council on Food and Safety (established by Executive Order 13100) by directing the Council, with the Secretary of Commerce and the Secretary of Treasury to develop a crisis communications and education strategy with respect to bioterrorist threats to the flood supply. The Senate amendment authorizes to be appropriated

$500,000 to develop such a strategy.

Conference substitute: The Conference substitute adopts the Senate amendment with modification. The Conference substitute expands the scope of consultation between the President's Council on Food Safety and other entities to include any other relevant Federal agencies, including law enforcement and intelligence related agencies, and scientific organizations. The Conference substitute also expands the scope of the food safety and security strategy to address technologies, threat assessments, risk communication, and procedures for securing food processing and manufacturing facilities and modes of transportation. The Conference substitute increases the amount of funds that are authorized to be appropriated for fiscal year 2002 to $750,000 to develop such a strategy.Section 302. Protection Against Adulteration of Food

House provision: The House bill authorizes to be appropriated $100,000,000 for fiscal year 2002, and such sums as may be necessary for each year from fiscal year 2003 thorugh fiscal year 2006, for the Secretary to carry out increased activities to ensure the safety of the food supply. Specifically, the House bill amends section 801 of the Federal Food Drug and Cosmetic act (FFDCA) directing the Secretary to give high priority to increasing the number of food safety inspections at ports of entry, with highest priority on inspections to detect intentional adulteration of food. The House bill also directs the Secretary to give a high priority to improving the information management systems that support food safety inspection programs for the purpose of improving the ability of the Secretary to detect intentional adulteration of food and to facilitate the importation of food that is in compliance with the Act. Further, the House bill directs the Secretary to give high priority to researching and developing improved tests and sampling methods for the purpose of rapidly detecting adulterated foods, with highest priority on detection of intentional adulteration. Finally, the House bill directs the Secretary to complete an assessment of potential threats to the food supply posed by efforts to intentionally adulterate food, and to report the findings on such assessment to Congress within six months.

Senate amendment: The Senate amendment authorizes to be appropriated $59,000,000 for fiscal year 2002 and such sums as may be necessary for each year thereafter to expand the capacity of the Food and Drug Administration (FDA) to increase inspections to ensure the safety of the food supply and to improve linkages between the FDA and other Federal regulatory agencies, the States, and Indian tribes.

Conference substitute: The Conference substitute adopts the House bill with modification. The Conference substitute directs the Secretary to improve linkages with other Federal regulatory agencies that share responsibility for food safety, and directs the Secretary to improve linkages with the States and Indian tribes with respect to food safety. The Managers intend that the Secretary in making improvements to the information management systems that support food safety inspection programs, including the OASIS system, may include improvements that assist food importers and filers in providing accurate and timely information on entries filed on food import shipments. The Managers also intend that in conducting research to develop improved tests and sampling methods for the purpose of rapidly detecting adulterated foods, the Secretary may involve institutions of higher education, including such institutions that receive Federal funding to operate consortiums within the food industries, for the purpose of conducting research and development in food safety and food security. Finally, it is the understanding of the Managers that FDA already has underway (under agreement with Battelle Laboratories) an assessment of potential threats to the food supply posed by efforts to intentionally adulterate food. For purposes of this section, the requirement to conduct an assessment of potential threats to the food supply posed by efforts to intentionally adulterate food refers to such threat assessment that is already underway or very recently completed.Section 303. Administrative Detention

House provision: The House bill amends section 304 of the FFDCA by authorizing the Secretary to administratively detain an article of food that is found during an inspection, examination or investigation under this Act if the Secretary has credible evidence or information indicating that the article presents a threat of serious adverse health consequences or death to humans or animals. Such food may be detained for a reasonable period of up to 20 days, and where needed up to 30 days, for the purpose of enabling the Secretary to institute a seizure action under section 304(a) or injunctive relief under section 302, as warranted. The House bill authorizes the Secretary to move detained food from the place at which it has been detained to a secured facility, as appropriate, for the period of detention or until released by the Secretary. The House bill also authorizes a claimant of an article of food that has been detained under this section to appeal the detention of the article. In addition, where the Secretary already has credible evidence or information indicating that an imported article of food presents a threat of serious adverse health consequences or death to humans or animals, this section also requires the Secretary to request the Secretary of Treasury to temporarily hold imported food at a port of entry for up to 24 hours to enable the Secretary to inspect, examine or investigate the food. For an article of food temporarily held under this section, the Secretary is also required to notify the State in which the port of entry is located about such request or that such food is being temporarily held.

Senate amendment: The Senate amendment provides authority to administratively detain food that is similar to the House bill. The Senate amendment allows the Secretary to detain food that violates the FFDCA and that presents a threat of serious adverse health consequences or death, and requires that the Secretary provide an opportunity for a hearing (and to confirm or to revoke) a detention order within 15 days of the filing of an appeal by a claimant. Unlike the House bill, the Senate amendment does not include additional authority to temporarily hold food, nor does it require the Secretary to notify a State regarding the port of entry within such State at which food is being temporarily held.

Conference substitute: The Conference substitute adopts the House bill with modification. The Conference substitute clarifies that food that is detained under this section may not be delivered pursuant to an execution of a bond in accordance with section 801 of the FFDCA (if the detained food is imported) or otherwise (if the detained food is domestically produced), while the food is subject to the detention order, unless released by the Secretary. The Conference substitute requires the Secretary in response to an appeal filed by a claimant challenging the detention of an article of food to conduct an informal hearing and confirm or terminate a detention order within five days after an appeal is filed, at which time the Secretary's determination is subject to judicial review in accordance with section 702 of title 5, United States Code. The Conference substitute amends section 304 of the FFDCA by authorizing the Secretary to detain an article of food for the purpose of enabling the Secretary to institute a seizure action under section 304(a) or to seek injunctive relief under section 302 of the Act. This section provides a claimant of the food the right to appeal a detention order, but that right of appeal terminates if the Secretary institutes either a seizure action under section 304(a) or injunctive relief under section 302 of the Act. The Managers do not intend to terminate the claimant's right to appeal a detention order under paragraph 4(B) of such subsection, unless the basis for the seizure action instituted under section 304(a) or the injunctive relief sought under section 302 is related to the original basis for detention under this section.

The Conference substitute provides that an article of food subject to detention shall be held in a secure facility, as appropriate. Under this title, in instances where the Secretary moves food that has been refused admission to a secure facility, the Secretary should ensure that such food will be held under appropriate conditions of cleanliness, temperature, humidity and other such considerations that are necessary so as not to erode the safety and wholesomeness of the detained article.

The Managers recognize that perishable foods may be detained under this section. As a result, the Secretary is required to promulgate a rule to establish expedited procedures for instituting an action under section 304(a) or section 302 of the FFDCA for perishable foods, such as fresh produce, fresh fish and fresh seafood products. The Secretary should promptly complete such rule making.

The Conference substitute requires the Secretary to temporarily hold food for not longer than 24 hours, where the Secretary has credible evidence or information indicating that such article of food presents a threat of serious adverse health consequences or death to humans or animals. The period of temporary hold is intended to allow the Secretary time to dispatch an inspector to the port of entry in order to conduct the needed inspection, examination or investigation.Section 304. Debarment For Repeated or Serious Food Import

Violations

House provision: The House bill provides authority to the Secretary to debar from importing articles of food, any person that is convicted of a felony relating to food importation or any person that repeatedly imports food and who knew, or should have known, that such food was adulterated. The House bill treats the importation or offer for importation of an article of food by a debarred person as a prohibited act under section 301 of the FFDCA.

Senate amendment. The Senate amendment includes permissive debarment authority for food importers that is similar to the permissive debarment authority of the House bill, but replaces the standard in the House bill, allowing debarment for repeatedly importing unsafe food, with a different standard allowing debarment of food importers for engaging in a pattern of importing unsafe food. Unlike the House bill, the Senate amendment treats food that is imported by a debarred person as adulterated.

Conference substitute: The Conference substitute adopts the Senate amendment with modification. Unlike the Senate amendment, the Conference substitute does not treat food that is imported by a debarred person as adulterated solely on the basis of its importation by a debarred person. Rather the Conference substitute treats the importation or offering for importation into the United States of an article of food by, and with the assistance of, or at the direction of, a debarred person as a prohibited act under section 301 of the FFDCA. In addition, the Conference substitute requires food imported by a debarred person to be refused admission and held in a secure facility as appropriate, unless a person, other than a debarred person, affirmatively establishes that such food complies with the requirements of the FFDCA. The Conference substitute also clarifies that imported food that is refused admission may not be delivered pursuant to the execution of a bond under subsection (b) of section 801 of the FFDCA. For purposes of this section, the person other than the debarred person who may established that food, which has been refused admission under this section, is in compliance with this Act is intended to be an innocent purchaser of food, not a person that is engaged in the improper importation of food with a debarred person. In addition, the classification as a prohibited act (under section 301 of the FFDCA) of the importation or offer for importation of food ``with the assistance of'' a debarred person is not intended to include an innocent purchaser who did not have knowledge, actual or constructive, of the importer's debarred status. Finally, the Conference substitute clarifies that the Secretary has the authority to terminate the debarment of corporations or persons under this subsection.Section 305. Registration of Food Facilities

House provision: The House bill requires facilities

(excluding farms) that manufacture, process, pack or hold food for consumption in the United States to file with the Secretary, and keep up to date, a registration that contains the identity and address of the facility and, when the Secretary determines appropriate the general category of food manufactured, processed, packed or held at the facility. The House bill also authorizes the Secretary to exempt certain retail establishments only if the Secretary determines that the registration of such facilities is not needed for effective enforcement. Enforcement of this section is delayed one hundred and eighty days from the date of enactment, and this section requires the Secretary to notify and issue guidance within sixty days identifying facilities that are required to register under this section.

Senate amendment: The Senate amendment includes a requirement for certain food facilities to register with the Secretary that is similar to the registration requirement for food facilities that is contained in the House bill. The Senate amendment exempts types of farms or retail establishments but, unlike the House bill, farms can be exempted only if the Secretary determines that the registration of such facilities is not needed for effective enforcement of the FFDCA. The Senate amendment also lacks the requirements of the House bill relating to notice to those who must register and relating to electronic registration.

Conference substitute: The Conference substitute adopts the Senate amendment with modification. The Conference substitute requires the Secretary to establish registration requirements for specified food facilities by regulation not later than eighteen months after the date of enactment of this Act. If such regulations are not effective prior to the conclusion of such eighteen-month period, the requirements of this section are self-executing and enter into effect at such time and remain in effect unless superseded by such final regulations. The Managers strongly encourage the Secretary to complete this rule making in a timely manner in order to enable the efficient operation of these registration requirements.

The Conference substitute treats the failure of a specified facility to register under this section as a prohibited act under section 301 of the FFDCA. The Conference substitute requires the Secretary to refuse admission to food imported from foreign facilities that have failed to register in accordance with this section until such facility is registered, and requires the Secretary to remove such food to a secure facility, as appropriate. The Conference substitute clarifies that imported food that is refused admission under this section shall not be delivered pursuant to the execution of a bond under subsection (b) of section 801 of the FFDCA.

The Conference substitute exempts from the requirements of registration farms, restaurants, other retail food establishments, non-profit food establishments in which food is prepared for, or served directly to, the consumer, and fishing vessels not engaged in processing, as defined in section 123.3(k) of title 21, Code of Federal Regulations. The Managers intend that, for purposes of this section, the term ``retail food establishments'' includes establishments that store, prepare, package, serve or otherwise provide articles of food directly to the retail consumer for human consumption, such as grocery stores, convenience stores, cafeterias, lunch rooms, food stands, saloons, taverns, bars, lounges, catering or vending facilities, or other similar establishments that provide food directly to a retail consumer. The term does not include a warehouse that does not provide articles of food directly to a retail consumer as its primary function. The Managers intend that, for purposes of this section, the term ``non-profit food establishments'' includes not-for-profit establishments in which food is prepared for, or served directly to the consumer, such as food banks, soup kitchens, homebound food delivery services, or other similar charitable organizations that provide food or meals for human consumption. In addition, the Managers intend that, for purposes of this section,

``facility'' does not include trucks or other motor carriers, by reason of their receipt, carriage, holding, or delivery of food in the usual course of business as carriers. In addition, nothing in this section shall be construed to alter or amend the treatment of carriers under section 703 of the FFDCA.

Finally, the Conference substitute calls for one-time registration of covered facilities, rather than annual registration of such facilities. Once a facility is registered it should amend its original registration in a timely manner to reflect any changes. The Conference substitute encourages electronic registration to help reduce paperwork and reporting burden, but registration is also promitted using a paper form.Section 306. Maintenance and Inspectionse informa of Records for Foods

House provision: The House bill provides the Secretary with authority to inspect and copy all records relating to an article of food if the Secretary has credible evidence or information indicating that an article of food presents a threat of serious health consequences or death to humans or animals. The House bill contains certain limitations on the Secretary's authority, including limitations to ensure the protection of trade secrets and confidential information. The House bill provides the Secretary with the discretion to issue a regulation requiring maintenance of additional records that are needed to identify the source and chain of distribution of food, in order to address credible threats of serious adverse health consequences or death to humans or animals. The House bill excludes restaurants and farms, and the Secretary is provided the authority to take into account the size of the business when imposing any record keeping requirements.

Senate amendment: The Senate amendment includes records access authority that is similar to the records access authority granted to the Secretary in the House bill. The Senate amendment authorizes the Secretary to inspect and copy records relating to the violation when he has a reason to believe that an article of food is adulterated or misbranded and presents a threat of serious adverse health consequences or death. The Senate amendment also includes record keeping authority that is similar to the record keeping authority in the House bill. The Senate amendment requires the Secretary to issue a regulation to require the maintenance and retention of records to trace the chain and distribution of food within 18 months of enactment of the Act. In addition, the Senate amendment allows the Secretary to require maintenance and retention of records necessary to determine if a food may be adulterated or misbranded to the extent that it presents a threat of serious adverse health consequences or death. The Senate amendment limits the Secretary's authority to require the retention of either type of records for not longer than two years. The Senate amendment also criminalizes the release of trade secret information obtained by inspection of records under this section.

Conference substitute: The Conference substitute adopts the House bill with modification. The Conference substitute replaces the standard for records acccess in the House bill with a different standard that grants the Secretary records access if the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals. The Conference substitute limits access to those records relaitng to such artricle of food that are needed to assist the Secretary in determining whether food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.

The Conference substitute amends the scope of record keeping authority contained in the House bill by clarifying that the authority under this section applies to both the establishment and maintenance of records that meet the standard under this section and by limiting the record retention requirement to a period of not longer than 2 years. The Conference substitute also adopts the requirement of the Senate amendment to criminalize the disclosure of trade secrets obtained under this section.

The Conference substitute authorizes the issuance of regulations to require establishment and maintenance of chain of distribution records. This authority should not be used to require a business to maintain records regarding transactions or activities to which it was not a party. The Managers intend that those records that document the person from whom food was directly received, and to whom food was directly delivered, are adequate to enable identification of the source and distribution of food. As a result, for purposes of this section, the terms ``immediate previous sources'' and ``immediate subsequent recipients'' refer to the person from whom the food was received and the person to whom the food was delivered, respectively.

The Managers did not adopt a Senate proposal to authorize the Secretary to require the maintenance and retention of other records for inspection relating to food safety, because the Secretary has authority under section 701(a) of the FFDCA to issue regulations for the ``efficient enforcement of this Act'' and this authority, in combination with other provisions (such as section 402), gives the Secretary the authority to require appropriate record keeping in food safety regulations.Section 307. Prior Notice of Imported Food Shipments

House provision: The House bill directs the Secretary by regulation to require importers of articles of food to provide up to seventy-two hours, but not less than twenty-four hours, prior notice that food will be imported or offered for import into the United States. The House bill requires that the notice contain the following information: a description of food to be imported; the identity of the manufacturer and shipper; and, if known within the specified period of time that notice is required to be provided, the identity of the grower; the country of origin of the article; the country from which the food is being shipped; and the anticipated port of entry into the United States. In the event notice is not provided in advance of importation in accordance with the Secretary's regulation, the food shall be held at the port of entry until notice is properly provided and the Secretary determines whether there is credible evidence or information in his possession indicating that the article presents a threat of serious adverse health consequences or death to humans or animals.

Senate amendment: The Senate amendment, like the House bill, includes a requirement that food importers provide prior notice to the Secretary of incoming food imports. The Senate amendment differs from the requirement in the House bill, because the prior notice requirement in the Senate amendment is self-effectuating upon enactment of the Act and requires at least four hours minimum prior notice and no limitation on the maximum notice allowable. The Senate amendment requires that the notification contain the identity of the food, the food's country of origin, the quantity imported, and other information that the Secretary may require by regulation. Finally, if an importer fails to provide the required prior notice, under the Senate amendment the Secretary is provided with discretion to refuse admission into the United States of the food.

Conference substitute: The Conference substitute adopts the House amendment with modification. The Conference substitute requires the Secretary to establish by regulation the period of time for prior notice, that must be no less than the minimum amount of time necessary for the Secretary to receive, review, and appropriately respond to the notice, but that may not exceed five days. In determining the specified period of time for prior notice, by regulation, the Conference substitute identified several factors the Secretary may take into account, including the effect on commerce, the locations of various ports of entry, the various modes of transportation, the types of food imported into the United States, and other such considerations. Nothing in the preceding sentence may be construed as a limitation on the obligation of the Secretary to receive, review, and appropriately respond to any notice under this section.

The Conference substitute treats the failure to provide adequate prior notice under this section as a prohibited act under section 301 of the FFDCA. The Conference substitute requires the Secretary to refuse admission to food imported without properly providing prior notice in accordance with this section until such prior notice is properly provided. In addition, the Conference substitute requires the Secretary to remove such food to a secure facility, as appropriate and clarifies that imported food that is refused admission under this section shall not be delivered pursuant to the execution of a bond under subsection (b) of section 801 of the FFDCA.

The Conference substitute directs the Secretary to establish prior notice requirements for imported foods by regulation not later than eighteen months after the date of enactment of this Act. If such regulations are not effective prior to the conclusion of such eighteen-month period, the requirements of this section are self-executing and enter into effect at such time and remain in effect unless superseded by such final regulations. In addition, at the conclusion of the eighteen-month period, if such final regulations are not effective, the Conference substitute establishes a default period of time for prior notice of not less than 8 hours and not more than 5 days that remains in effect unless superseded by such final regulations. The Managers strongly encourage the Secretary to complete this rule making in a timely manner in order to enable the efficient operation of these requirements.

The Managers intend that the requirements of this section should not be construed to apply to packaging materials if, at the time of importation, such materials will not be used for, or in contact with, food as defined under section 201 of the FFDCA. Nothing in this section shall be construed to alter or amend the regulatory treatment of food packaging materials or food contact substances under the FFDCA. Also, the Conference substitute requires the importer of an article of food to provide information about the grower of the article of food, but this provision only requires the importer to provide the identity of the grower of the article of food if known during the period of time in which prior notice is required to be provided. Finally, the Secretary shall consult and coordinate with the Secretary of Treasury in developing the prior notice regulation. This section of the Conference substitute contains prior notice requirements for imported food and is not intended as a limitation on the port of entry for an article of food.Section 308. Authority to Mark Articles Refused Admission into United States

House provision: The House bill requires that food that has been refused admission to the United States, but has not been ordered destroyed, may have a label affixed to its container at the expense of the owner or consignee indicating that it has been refused admission.

Senate amendment: The Senate amendment, similar to the House bill, includes authority regarding the marking of food that has been refused admission into the United States. Unlike the House bill, the Senate amendment provides the Secretary with a broader authority than the House bill to mark foods as refused admission, including foods that have not been determined to present a threat of serious adverse health consequences or death to humans or animals. The Senate contains an enforcement provision under which food that has been refused admission but that has not been properly marked as refused admission is treated as misbranded if it is determined that it presents a threat of serious adverse health consequences or death to humans or animals.

Conference substitute: The Conference substitute adopts the House bill with modification. The Conference substitute provides the Secretary with discretionary authority to require that items that have been refused admission to the United States under section 801 of the FFDCA shall be so marked. The Conference substitute clarifies that the marking of such items may be applied to the container of the food. The Conference substitute also requires the Secretary to notify the owner or consignee of an article of food that has been refused admission and that has been required to be so marked under this section, if at some time subsequent to requirement to mark the food, the Secretary determines that the food is misbranded and presents a threat of serious adverse health consequences or death to humans or animals.

Nothing in this section shall be construed to alter or amend the authority of the Secretary to authorize the admission of an article of food that has been relabeled, reconditioned or otherwise brought into compliance with the Act in accordance with subsection (b) of section 801 of the Act.Section 309. Prohibition Against Port Shopping

House provision: The House bill requires any person attempting to re-offer for admission an article of food at a port of entry into the United States, after it has been previous refused admission at another port of entry into the United States, to affirmatively establish that the food is not adulterated.

Senate amendment: The Senate amendment contains a prohibition against port shopping that is comparable to the prohibition contained in the House bill. The Senate amendment prohibits a person from port shopping with respect to food that has been refused admission, by requiring that the person show that food that has been refused admission previously, has been brought into compliance with the applicable requirements of the FFDCA.

Conference substitute: The Conference substitute adopts the Senate amendment without modification.Section 310. Notice to States Regarding Imported Food

House provision: The House bill requires that where the Secretary has credible evidence or information indicating that an article of food presents a threat of serious adverse health consequences or death to humans or animals, the Secretary shall provide notice regarding the threat posed by such food to those States in which the food is held or will be held and shall request that such States take appropriate remedial action.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the House bill with modification. The Conference substitute clarifies the scope of the rule of construction included in subsection (b) of this section.Section 311. Grants to States for Inspections

House provision: The House bill authorizes the Secretary to make grants for increased food safety inspections, examinations, investigations and related activities and to assist States in taking appropriate actions to respond to any Federal notice received pursuant to section 309 (governing notice to States) of the House bill. The House bill authorizes to be appropriated such sums as may be necessary for fiscal year 2002 through fiscal year 2006 to establish and carry out the grants under the section.

Senate amendment: The Senate amendment authorizes the Secretary to make grants to States, territories, and Federally recognized tribes to cover the cost of food safety examinations, inspections, investigations, and related activities under section 702 of the FFDCA, and it authorizes to be appropriated $10 million in fiscal year 2002 and such sums as may be necessary for each year thereafter for such purpose.

Conference substitute: The Conference substitute adopts the House bill with modification. The Conference substitute extends the grants made available under this section to Indian tribes to the extent they undertake inspections, investigations or examinations under section 702 of the FFDCA. The Conference substitute authorizes to be appropriated $10 million in fiscal year 2002 and such sums as may be necessary for each fiscal year 2003-2006 for such purpose.Section 312. Surveillance and Information Grants and

Authorities

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment authorizes the Secretary to award grants to States to increase participation in Pulsenet, the Foodborne Diseases Active Surveillance Network, and other such networks, and authorizes to be appropriated $19.5 million in fiscal year 2002, and such sums as may be necessary each year for such purpose from fiscal year 2003 through fiscal year 2006.

Conference substitute: The Conference substitute adopts the Senate amendment with modification. The Managers intend that funds awarded under this section shall be used by States and Indian tribes to assist in meeting the costs of establishing and maintaining the food safety surveillance, technical and laboratory capacity needed to participate in programs, including Pulsenet, Foodborne Diseases Active Surveillance Network, and other networks to enhance Federal, State, and local food safety efforts.Section 313. Surveillance of Zoonotic Disease

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment requires the Secretary of Health and Human Services and the Secretary of Agriculture to develop and implement a plan for the surveillance of zoonotic and human disease.

Conference substitute: The Conference substitute adopts the Senate amendment with modification. The Conference substitute directs the Secretary, through the Commissioner of FDA and the Director of the Centers for Disease Control and Prevention (CDC), and the Secretary of Agriculture to coordinate the surveillance of zoonotic diseases.Section 314. Authority to Commission Other Federal Officials to Conduct Inspections

House provision: The House bill does contain no analogous provision.

Senate amendment: The Senate amendment includes authority that is not included in the House bill that allows the Secretary to commission officers and qualified employees of other Federal Departments or Federal agencies to conduct examinations and inspections for the Secretary under section 702 of the FFDCA.

Conference substitute: The Conference substitute adopts the Senate amendment with modification. The Conference substitute clarifies that the authority of the Secretary to commission other Federal officials to conduct inspections, examinations and investigations under section 702 of the FFDCA shall be carried out pursuant to a memorandum of understanding between the Secretary and the head of the Department or agency of such other Federal employees.Section 315. Rule of Construction

House provision: The House bill does contain no analogous provision.

Senate amendment: The Senate amendment includes a rule of construction that applies to the amendments made in Title V of the Senate amendment that provides that such amendments do not provide the FDA with additional authority over meat, poultry, and egg products, nor do such amendments limit the authority of the Department of Agriculture over such products.

Conference substitute: The Conference substitute adopts the Senate amendment with modification. The Conference substitute clarifies that nothing in this Title, or an amendment made by this Title, shall be construed to alter the jurisdiction between the Secretary and the Secretary of Agriculture, under applicable statutes and regulations.

Subtitle B--Protection of Drug Supply

Section 321. Annual Registration of Foreign Manufacturers;

Shipping Information; Drug and Device Listing

House provision: The House bill mandates annual registration of foreign manufacturers engaged in the import of drug and device products into United States. The House bill also requires that the annual registration include information on each importer or carrier transporting the foreign manufacturer's drug or device products. The House bill also directs that the registration and listing numbers be included in the declaration for the products when offered for import.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the House bill with modification. The conference substitute requires registration through electronic means. The Conference substitute deletes carrier in the annual registration and replaces with ``person who imports or offers for import.'' The Conference substitute makes non-registration a prohibited act rather than deeming it misbranded. Non-registration is a failure to comply with the Secretary's request to submit registration information. The Conference substitute provides for a non-registered drug or device to be removed to a secure facility until non-registration is cured. For purposes of this section, the Managers intend ``person who imports or offers for import'' to capture import brokers and other persons who file import-related paperwork with the U.S. Customs Service or the FDA.Section 322. Requirement of Additional Information Regarding

Import Components Intended for Use in Export Products

House provision: The House bill mandates a chain of possession identification and a customs bond for those firms that seek to import components of drugs, devices, food additives, color additives, or dietary supplements for further processing and export. The House bill requires certificates of analysis for components containing any chemical substance or biological substance intended for export.

Senate provision: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the House bill with modification. The Conference substitute deletes reference to carriers in chain of possession identification. The Conference substitute exempts devices and products covered by section 801(d)(4) of the FFDCA from the certificate of analysis requirement. The Conference substitute clarifies that the provisions permitting import-for-export do not apply to articles for which the Secretary of Health and Human Services determines that there is credible evidence or information indicating the article is not intended to be imported for export.

The Managers understand this section does not change any definitions of regulated articles or the scope of regulation of those articles as set forth in the FFDCA and its implementing regulations.

The Managers intend that this section shall not be construed to restrict or facilitate the entry of articles imported for research and development or quality assurance purposes under subsection 801(d)(3) of the FFDCA beyond the existing authority.

For the purposes of articles subject to subsection 801(d)(4) of the FFDCA, the Managers understand that the collection agency would be considered the first manufacturer under subsection 801(d)(3)(A)(i)(II) of the FFDCA, relating to the chain-of-possession.

The Managers agree that certificates of analysis are not required if the only chemical or biological component of the article imported under subsection 801(d)(3) of the FFDCA is de minimis, incidental and poses no danger to human or animal health. Further, the Managers expect that the Secretary will understand that ``certificate of analysis'' is a widely understood and utilized document to assure the identity of the substance and its components in the chemical and drug industries. However, the Secretary in consultation with other affected industries may accept documents that convey equivalent assurance as to the identity of the article and its components or substances. For example, the Secretary may determine that for an article of food additive or color additive, a document indicating specification of purity serves as the functional equivalent of a certificate of analysis and meets the requirement of a certificate analysis for purposes of this section. This section exempts devices and blood and blood products covered under subsection 801(d)(4) of the FFDCA from the certificate of analysis requirement.

The Managers do not intend the Secretary of the Treasury to engage in a new rulemaking to specify the requirement for the bonding of goods imported under subsection 801(d)(3) of FFDCA. Existing requirements for the bonding of goods imported for further processing and export should be applied.

The Managers agree that articles imported for export under this section 322 which otherwise meet the requirements of this section should be permitted entry unless the Secretary determines there is credible evidence or information that an article offered for import is not intended to be imported for export. In this regard, the Managers believe that refusal of entry should not involve shipments between known shippers and known recipients unless the Secretary has received credible evidence or information that suggests such shipments may not be legitimate. The Managers intend to permit the Secretary to refuse admission of articles if the Secretary determines there is credible evidence or information that the articles may be used as instruments of terror. Such evidence might include highly toxic or otherwise exceptionally dangerous products going to recipients unknown to the Secretary or to recipients believed to lack the capacity to further process such dangerous articles, for example, nitroglycerin imported under this section for delivery to a business other than a pharmaceutical manufacturer. Such standard may also include, for example, presentation for entry of articles not consistent with the accompanying documentation.

Subtitle C--General Provisions Relating to Upgrading of Agricultural

Security

Section 331. Expansion of Animal and Plant Health Inspection

Service Activities

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment requires the Secretary of Agriculture to enhance and expand the capacity of the Animal and Plant Health Inspection Service (APHIS) to protect against the threat of bioterrorism, including through increased inspection capacity internationally, improved surveillance at ports of entry, and enhanced protections against terrorist use of plant and animal disease organisms. The Senate amendment also requires the Secretary of Agriculture to implement and then expand a high-tech agriculture early warning and emergency response system, as well as an automated record keeping system to track animal and plant shipments. The Senate amendment authorizes the appropriation of $30 million in fiscal year 2002 and such sums in each year thereafter, as may be necessary for such purposes.

Conference substitute: The Conference substitute adopts the Senate amendment with modification. The Conference substitute clarifies that this section provides additional authorization of appropriations to the Secretary of Agriculture to utilize existing authorities to give high priority to enhancing and expanding the capacity of APHIS to conduct the specified activities and to otherwise improve the capacity of APHIS to protect against the threat of bioterrorism. The Conference substitute authorizes to be appropriated $30 million for fiscal year 2002, and such sums as may be necessary for each subsequent fiscal year.Section 332. Expansion of Food Safety Inspection Service

Activities

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment requires the Secretary of Agriculture to enhance and expand the capacity of the Food Safety Inspection Service (FSIS) to protect against the threat of bioterrorism, including through enhanced ability to inspect meat and poultry products and increased inspections of meat and meat products, poultry and poultry products, and egg products at ports of entry. The Senate amendment authorizes the appropriation of $15 million in fiscal year 2002 and such sums in each year thereafter, as may be necessary for such purposes.

Conference substitute: The Conference substitute adopts the Senate amendment with modification. The Conference substitute authorizes to be appropriated $15 million in fiscal year 2002 and such sums in each year thereafter, as may be necessary for the the purpose of providing additional authorization to the Secretary of Agriculture to utilize existing authorities to give high priority to enhancing and expanding the capacity of FSIS to conduct the specified activities and to otherwise improve the capacity of FSIS to protect against the threat of bioterrorism.Section 333. Biosecurity Upgrades at the Department of

Agriculture

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment authorizes to be appropriated $180 million in fiscal year 2002 to update, renovate, and expand the Department of Agriculture laboratory and research facilities at Plum Island Animal Disease Center and the Agricultural Research Service and Animal and Plant Health Inspection Service facility in Ames, Iowa, and also authorizes such sums as may be necessary in each year from fiscal year 2003 through fiscal year 2006, for those facilities, and for similar improvements at two other Department of Agriculture facilities, one in Athens, Georgia, and the other in Laramie, Wyoming.

Conference substitute: The Conference substitute adopts the Senate amendment without modification. In addition to the biosecurity upgrades at the Department of Agriculture authorized in this section, the Managers intend that the Secretary of Health and Human Services shall also continue to take such actions as may be necessary to secure existing facilities of the Department of Health and Human Services where potential animal and plant pathogens are housed and researched.Section 334. Agricultural Biosecurity

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment requires the Secretary of Agriculture to establish minimum security standards and award grants of up to $50,000 to land grant universities to assess security needs and plan upgrades of both security of facilities where hazardous biological agents or toxins are stored or used, and communication networks about such agents or toxins, as well as to develop a national inventory of such agents and toxins. The Senate amendment also requires the Secretary of Agriculture to provide for screening of personnel who require access at agricultural research facilities, and to develop and implement educational programs directed at biosecurity at agricultural facilities, including farms, livestock confinement operations, and crop producers, handlers, processors, and transporters, as well as educational programs related to animal quarantine and testing. The Senate amendment authorizes to be appropriated $20 million in fiscal year 2002 and such sums in each year thereafter, as may be necessary for such purposes.

Conference substitute: The Conference substitute adopts the Senate amendment with modification. The Conference substitute authorizes to be appropriated such sums as may be necessary for the Secretary of Agriculture to award grants of up to

$50,000 each, to colleges and universities that have food and agricultural science programs to review security standards and practices at their facilities in order to protect against bioterrorist threats. The Conference substitute also authorizes the Secretary of Agriculture to award grants, of up to $100,000 per association, to associations of food producers or consortia of such associations for the development and implementation of educational programs to improve bio-security on farms against bioterrorist attacks.Section 335. Agricultural Bioterrorism Research and

Development

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment requires the Secretary of Agriculture, to the maximum extent practicable, to expand research and development programs of the Agricultural Research Service and the Cooperative State Research Education and Extension Service to protect the nation's food supply from bioterrorism, including by enhancing their capability to respond to the needs of other food and agricultural regulatory agencies, continuing existing partnerships with institutions of higher education with programs related to agricultural biosecurity, and by strengthening linkages with the intelligence community. The Senate amendment authorizes the appropriation of $190 million in fiscal year 2002 and such sums in each year thereafter, as may be necessary for such purposes.

Conference substitute: The Conference substitute adopts the Senate amendment with modification. The Conference substitute authorizes to be appropriated $190 million in fiscal year 2002 and such sums in each year thereafter, as may be necessary for the Secretary of Agriculture to utilize existing research authorities and programs to protect the food supply of the United States by conducting various research activities, including developing new and continuing partnerships with institutions of higher education and other institutions to establish and enhance bio-security and food safety programs, with special emphasis on vulnerability analyses, incident response, detection and prevention technologies. The Conference substitute also authorizes the Secretary of Agriculture to continue research to develop improved rapid detection field test kits to detect biological threats to plants and animals for use in responding to bioterrorism, and to develop an agriculture bioterrorism early warning surveillance system by enhancing the capacity of and coordination between State veterinary diagnostic laboratories, Federal and State agricultural research facilities, and public health agencies.Section 336. Animal Enterprise Terrorism Penalties

House provision: The House bill contains no analogous provision.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute amends section 43(a) of title 18, United States Code, establishing a Federal criminal offense against a person traveling in interstate or foreign commerce for intentionally damaging or causing the loss of any property used by the animal enterprise, or conspiring to do such activities. The Conference substitute establishes penalties for such criminal offense and authorizes restitution for economic damage resulting from the loss.

TITLE IV--DRINKING WATER SECURITY AND SAFETY

The conference agreement builds upon title IV of the House bill to ensure that drinking water systems across the country assess their vulnerability to terrorist attack and develop emergency plans to prepare for and respond to such attacks. Americans deserve to know that the water they drink everyday is safe. The legislation will lay the groundwork for developing the necessary information, and emergency planning and response efforts that are needed to address potential terrorist attacks at drinking water systems.Section 401. Terrorist and Other Intentional Acts

House provision: The House bill requires community water systems serving over 3,300 persons to conduct vulnerability assessments. These requirements are phased-in, depending on the size of the community water system. Community water systems serving over 100,000 persons must complete a vulnerability assessment by December 31, 2002; community water systems serving over 50,000 persons must complete a vulnerability assessment by June 30, 2003; community water systems serving over 3,300 persons must complete a vulnerability assessment by December 31, 2003. Each community water system must certify to the Administrator of the Environmental Protection Agency (EPA) that they have conducted a vulnerability assessment. The Administrator of EPA is also required to provide baseline information by June 1, 2002 regarding which kinds of terrorist attacks or other intentional acts are probable threats.

The House bill also requires community water systems to prepare or revise emergency response plans that incorporate the results of the vulnerability assessments. Community water systems must certify to the Administrator of the Environmental Protection Agency within 6 months of the completion of a vulnerability assessment that they have completed an emergency response plan. To the extent possible, community water systems are to coordinate with Local Emergency Planning Committees when preparing or revising an emergency response plan. The House bill additionally requires EPA to provide guidance to community water systems serving under 3,300 persons on how to conduct vulnerability assessments and prepare emergency response plans.

In order to carry out the provisions of the section, the House bill authorized $120 million in Fiscal Year 2002 and such sums as necessary in Fiscal Years 2003 and 2004. The funds are made available for purposes of complying with vulnerability assessment and emergency response plan requirements and to address basic security enhancements of critical importance and significant threats to public health as determined by a vulnerability assessment.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the House provision with modifications. The Conference substitute extends dates for certifying that systems have completed a vulnerability assessment by three months for systems serving over 100,000 persons and by six months for all other systems. The substitute also extends the time for EPA baseline information to August 1, 2002 to reflect the passage of time between House action and conference agreement.

The Conference substitute also adds the requirement that community water systems provide a copy of their vulnerability assessment to the Administrator of the EPA. Under the conference substitute, however, information that is provided by a community water system to EPA and information that is derived thereof is exempt from disclosure under the Freedom of Information Act except for information that identifies the community water system and the date on which a community water system certifies to EPA that it has completed a vulnerability assessment. In addition, no community water system shall be required under State or local law to provide an assessment to any State, regional or local governmental authority solely by reason of the requirements to submit such assessment to the Administrator of EPA.

The Administrator of the EPA is also required, by November 30, 2002 to develop protocols to protect the assessments from unauthorized disclosure. These protocols shall ensure that all assessments and information are kept in a secure location, only individuals designated by the Administrator have access and that assessment in whole or in part or information contained or derived from such assessments shall not be available to anyone other than individuals designated by the Administrator.

The Conference substitute also provides that any individual designated by the Administrator who acquires assessments or information derived from assessments and who knowingly or recklessly reveals such information other than to an individual designated by the Administrator shall be subject to up to 1 year imprisonment, or a fine in accordance with 16 U.S.C. 227 and shall be removed from Federal office or employment unless the information is revealed for purposes of section 1445 of the Act, or actions taken under section 1431 of the Act, or for use in any administrative or judicial proceeding to impose a penalty to failure to comply with section 1433 of the bill. The substitute further provides that an individual designated by the Administrator who is an employee or officer of the United States may discuss the content of a vulnerability assessment submitted under this section with a State or local official. The Conference substitute provides that nothing authorizes any person to withhold any information from Congress.

The Conference substitute adds the requirement that each community water system maintain a copy of the emergency response plan it has completed for 5 years after it certifies to the Administrator of the EPA that it has completed such plan. The Conference agreement also increases authorized funding for Fiscal Year 2002 to $160 million and adds additional specification of basic security enhancements. The Conference Agreement also extends authorizations in this section through Fiscal year 2005. Finally, the Conference agreement provides that not more than $5,000,000 of the funds made available under the section may be used by the Administrator of EPA for immediate and urgent security needs and for grants for community water systems under 3,300 in accordance with the guidance provided by EPA under the section.Section 402. Other Safe Drinking Water Act Amendments

House provision: The House bill provides for a review of current and future methods to prevent, detect and respond to the intentional introduction of chemical, biological and radiological contaminants into community water systems and source water for community water systems. The review is to encompass methods and means to detect contaminants, to provide sufficient notice of contaminated drinking water, to negate or mitigate deleterious effects on public health and to conduct biomedical research.

The House bill also provides for a review of methods and means by which terrorists or other individuals or groups could disrupt the supply of safe drinking water or render a public water system significantly less safe for human consumption. The House bill required a review of the methods and means by which pipes, constructed conveyances, collection, pretreatment, storage or distribution facilities would be destroyed or otherwise prevented from providing adequate supplies of drinking water and methods and means by which they could be protected. The House bill also required a review of methods and means by which such items could be subjected to cross-contamination and a review of methods and means by which alternative supplies of water could be provided in the event of destruction, impairment or contamination of public water systems. The House bill authorized $15,000,000 in Fiscal Year 2002 to carry out sections 1434 and 1435 and such sums as may be necessary for Fiscal Years 2003 and 2004.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The Conference substitute adopts the House provision with modifications. The Conference substitute includes further specification in section 1434 as to the detection of various levels of contaminants and indicators of contaminants using methods, means and equipment that include real time monitoring systems. The Conference substitute additionally requires methods and means for developing education and awareness programs for community water systems.

The conference substitute also adds additional specification to the reviews undertaken under section 1435 to include methods and means by which information systems, including process controls, supervisory control and data acquisition and syber systems could be disrupted by terrorists or other groups. The Conference substitute also includes additional requirements and considerations that are applicable in the implementation of sections 1434 and 1435. These requirements and considerations include the assurance that reviews reflect the needs of various community water system sizes and geographical locations, the vulnerability of regions or service areas, including the National Capitol area, and that the Administrator of EPA disseminate certain information through the Information Sharing and Analysis Center. The Conference substitute also provides such sums as may be necessary in Fiscal Year 2005.Section 403. Miscellaneous and Technical Amendments

House provision: The House bill provides that section 1433 be included as a cross-reference in section 1414(i)(1) on the Safe Drinking Water Act (SDWA), that section 1431 of the SDWA be amended, that existing penalties for tampering with drinking water systems under section 1432 be increased and that section 1442 of the SDWA be amended to provide authorization for $35 million in Fiscal Year 2002 and such sums as may be necessary in fiscal years thereafter.

Senate amendment: The Senate amendment contains no analogous provision.

Conference substitute: The conference substitute adopts the House provisions. The conferees encourage the committees of jurisdiction in the House and Senate to develop comparable legislation covering publicly owned treatment works in this legislative session. The conferees encourage EPA to work closely with organizations representing small and rural water systems to implement the provisions of this Title.

TITLE V--ADDITIONAL PROVISIONS

The Managers agree to the following provisions.

Subtitle A--Prescription Drug User Fees

Section 501. Short Title

Designates the name of this title as the ``Prescription Drug User Fee Amendments of 2002.''Section 502. Findings

Declares the findings of Congress related to the reauthorization of prescription drug user fees.Section 503. Definitions

The following terms in section 735 of the Federal Food, Drug, and Cosmetic Act (FFD&C Act) (21 U.S.C. 379g) are modified by this section: human drug application, prescription drug product, process for the review of human drug applications, and adjustment factor. These modifications are necessary to give effect to the changes instituted by the reauthorization of the Prescription Drug User Fee Act

(PDUFA).

The term ``human drug application'' is modified to make a technical correction.

The term ``prescription drug product'' is modified to allow the Secretary to use the Prescription Drug Product List (the active portion) in the ``Approved Drug Products with Therapeutic Equivalence Evaluations,'' (the Orange Book) as the basis for identifying which products should be considered to be prescription drug products for fee assessment purposes. The Managers expect that these proposed changes will lead to a more efficient, less burdensome, billing procedure. Under current law, any prescription drug product eligible for drug listing is subject to product fees. Determining eligibility for listing is administratively complex and sometimes resource intensive. In addition, listing is often controlled by a re-packer or distributor rather than by the sponsor, but the sponsor must nonetheless pay the product fee. The Managers expect that the use of the Orange Book, which is found on FDA's Internet site, as the basis to identify products for user fee assessment purposes will not be construed to affect the legal status of the book or the products in the book. The purpose of using this method is merely a tool for the Secretary to provide a public, efficient billing process. It also provides sponsors an easier way to remove products from the list that is the basis for billing.

Also, the addition of the reference to the list of products approved under human drug applications under section 351 of the Public Health Service Act created and maintained by the Secretary refers to the current FDA method of identifying biological products considered to be prescription drug products for fee assessment determinations. The Managers do not intend this to be a change in practice; rather it documents FDA's current practice. The list is to be provided on FDA's Internet site.

A further change to the term ``prescription drug product'' deletes the clause ``does not include a large volume parenteral drug product approved before September 1, 1992.'' As a result, any large volume parenteral (LVP) product is treated as a prescription drug product and is subject to a fee. However, when coupled with a corresponding change proposed to section 736(a)(3)(B), all LVP's would be exempt from product fees in this reauthorization, including products approved after September 1, 1992. The Managers intend this change to decrease FDA's administrative burden in determining which products should be billed.

The term ``process for the review of human drug applications'' is modified to allow the use of funds, for a period of up to three years after approval, to cover risk management activities for products approved after October 1, 2002. This change is highly important to the Managers, as improving drug and biological product safety is a goal shared by all.

The term ``adjustment factor'' is modified to eliminate obsolete provisions.Section 504. Authority to Assess and Use Drug Fees

Subsection (a) of this section allows fees authorized by the Act to be assessed beginning on October 1, 2002. With respect to prescription drug establishment fees and prescription drug product fees, the subsection advances the date by which fees are payable to October 1 of each year.

Under the second Prescription Drug User Fee Act (PDUFA), prescription drug establishment and product fees, which represent two-thirds of PDUFA fees were due January 31, four months into the fiscal year. This necessitated carrying forward funds from a previous year to sustain operations for the first four months of each new fiscal year. By advancing the date for annual fees to be paid to FDA, the necessity of carrying forward these large cash surpluses from year to year is eliminated. Also, by making this change effective for FY 2003, FDA will have access to revenue as early in FY 2003 as invoices can be issued and fees collected rather than having to wait until January 31 to collect funds. This is especially important for FDA operations in FY 2003 because the agency does not expect to have any appreciable carryover funds at the end of FY 2002.

Making the fee due and payable on October 1 necessitates other changes to the FFD&C Act that are executed in subsection (e) and (f) of this section.

This section sets forth a table containing the application, establishment, and product fee revenues, and total fee revenue, for fiscal years 2003 through 2007. The subsection further authorizes an increase in fee revenue amounts to fully fund the portion of additional costs attributable to the cost of the retirement of Federal personnel. This provision would go into effect, if, after the enactment of the Prescription Drug User Fee Amendments of 2002, legislation is enacted requiring the Secretary to fund additional costs of the retirement of Federal personnel.

This section also authorizes inflation adjustments, workload adjustments, and a final year adjustment. Under present law, annual inflation adjustments were based on the higher of the federal pay raise applicable for employees in the fiscal year for which the fees were set or the CPI for the previous year. In order to collect fees on October 1, FDA will have to set fees and issue invoices in August of each year well before the pay-raise determination for the next fiscal year is made. For this reason the inflation adjustment factors have been changed to the Federal pay raise for employees in the Washington, D.C., area for the previous fiscal year or the change in the CPI for the 12 month period ending June 30, whichever is higher. Both of these figures will be available in August when fees must be set. As has been the case in the past, these inflationary changes will continue to be cumulative and compounded.

Under the workload adjustment, annual revenue adjustments are made that reflect changes in review workload, after inflation adjustments. the workload adjustment is to be determined by the Secretary based on a weighted average of the changes in the total number of (1) human drug applications, (2) commercial investigational new drug applications, (3) efficacy supplements, and (4) manufacturing supplements. The subsection provides that the Secretary shall publish in the Federal Register the fees resulting from this adjustment and the supporting methodologies. Each of the 4 components used to develop the workload adjustment is a defined category of applications that FDA currently counts. Each component will be given a weighting factor that corresponds to its percent of FDA review workload.

The workload adjustment envisioned for each component has as its base the average number of applications of each particular type that FDA received over the five-year period of current law. It requires that a rolling average of submissions also be calculated each year for the latest five-year period that ends on June 30 before the end of each fiscal year beginning on or after October 1, 2002. The percent change in the latest five-year average, compared to the base year is then multiplied by the weighting factor for that component. Then all four components of the workload adjuster are added together and the total percent that results is the workload adjuster that will be used to further adjust the inflation-adjusted statutory revenue levels each year after FY 2003. Use of five year rolling averages in this process dampens the impact of revenue fluctuations--both up and down.

Under this section, the revenue adjuster will never result in lower revenues than the inflation-adjusted statutory revenue levels. Nonetheless, in years when fee-paying applications fall below projections, FDA will automatically experience a shortfall in revenues due to the shortfall in fee-paying applications. Further downward adjustment of the revenues would over-compensate for such a decline in workload and is not authorized under the subsection. This is a lesson learned from experience during 1998 through 2002. If such a model had been in place for the past five years, revenues during PDUFA II would have been much more predictable year to year rather than exhibiting the volatility FDA experienced.

Also under this section, FDA is allowed to make a one-time increase in fees in FY 2007, if necessary, to assure that the agency will have no less than three months of operating reserves on hand at the end of FY 2007, when this legislation will expire. This final year adjustment will allow the agency sufficient fees to operate for up to 3 months in FY 2008 if there is any delay in the reauthorization of PDUFA at the end of FY 2007. Further, delaying this payment from industry until FY 2007 minimizes the need for FDA to carry large balances over from year to year, reducing industry outlays until they are necessary to support operations.

Finally, this section provides that application, product, and establishment fees are to be established 60 days before the start of the fiscal year based on the revenue amounts previously established in this section.

Under subsection (d), the waiver or fee reduction for supplements filed under section 505(b)(1) of the FFD&C Act is eliminated.

In this section the word ``assessed'' in section 736(f) of the FFD&C Act has been changed to ``retained.'' This change is part of a series of changes made to permit FDA to issue invoices and collect fees before an appropriation is actually made for the fiscal year. The change maintains the original intent of this and related provisions, however, by providing that the conditions originally specified in these sections must be fulfilled once all appropriations for the fiscal year, including any supplemental appropriations, are enacted. If the conditions are not fulfilled, FDA may not retain the fees it collects. Further, under this section, the word

``collected'' in section 736(g)(2)(A) of the FFD&C Act is changed to ``retained.'' Once again, this change is part of a series of changes made to permit FDA to issue invoices and collect fees before an appropriation is actually made for the fiscal year. The change maintains the original intent of this and related provisions by asserting that the conditions originally specified in these sections must be fulfilled once all appropriations for the fiscal year, including any supplemental appropriations, are enacted.

This section also responds to the problems associated with FDA's inability under the FFD&C Act to collect and spend fees in any year that FDA fails to spend from appropriations as much as it spend in FY 1997, adjusted for inflation. Failing to meet this obligation by as little as one dollar causes FDA to lose the authority to collect application, product and establishment fees for a given fiscal year. The consequence of failing to meet this ``trigger'' would be catastrophic. Since the trigger is based on the amount FDA spends, the agency can never identify exactly how much it has actually spend until after the end of the fiscal year. As a result, FDA consistently overspends by a substantial amount to be certain that FDA expenditures do not fall below the trigger amount and thereby cause the agency to lose the authority to collect fees.

Modifications to section 736(g)(2)(B) are proposed to provide FDA a margin of error in its effort to meet this requirement of the law. This section is being modified so that if FDA's spending is within five percent of the amount required by this section of the Act, the requirement of this section is considered to be satisfied. If FDA under-spends by three percent or less, there are no consequences. If FDA under-spends by more than three percent but not more than five percent, FDA will be required to reduce collections in the fiscal year following the subsequent fiscal year by the amount in excess of three percent by which FDA under-spent from appropriations. The intent is to relieve FDA of the need to overspend from appropriations each year, as it has done consistently since 1993 to assure that this trigger is met. Spending from appropriations on the drug review process each year is still expected to be at or very close to the amount specified by this trigger, and may never be more than five percent below the trigger amount.

This section also authorizes appropriations for fiscal years 2003 through 2007 in amounts consistent with the total fee revenue amounts set forth in subsection (b).Section 505. Accountability and Annual Reports

This section for the first time requires the agency to meet with interested public and private stakeholders when considering the reauthorization of this program before its expiration. The Managers believe that the agency will be in the best position to recognize what best serves the public health by meeting with representatives of consumer and patient advocacy groups, industry, the Congress, health care professionals, and academic experts prior to the next reauthorization of PDUFA. Further, the Managers believe that it is very important for the agency to make any recommendations to the Congress public, so this section requires that the FDA both publish the recommendations, as well as hold a public hearing at which time the agency can receive public feedback.

This section also requires an annual Performance Report and a Financial Report.Section 506. Reports of Postmarketing Studies

Under this section, the Managers intend that in instances wherein a study subject to the reporting requirements of Section 130 is not completed by the original or otherwise negotiated deadline agreed upon by the sponsor and if the reasons for such failure to complete the study were not satisfactory to the Secretary, the Secretary shall so note on the agency website. The Managers intend that the Secretary would not find the delay or termination of a study unsatisfactory if the Secretary determined that the delay or termination occurred through no fault of the sponsor (such as ethical concerns, or the study is no longer needed).

This section also empowers the Secretary to require a sponsor of a study required under section 505(b)(2)(A) or sections 314.510 or 601.41 of Title 21, Code of Federal Regulations, to notify health care practitioners who prescribe such drugs or biological products of the sponsor's failure to complete the study, and the questions of clinical benefit and, where appropriate, questions of safety, that remain unanswered as a result of such failure. The Managers intend that this authority not be utilized in cases where, through no fault of the sponsor (such as ethical concerns, or the study is no longer needed), the study has been delayed or terminated.Section 507. Savings Clause

This section authorizes user fees to be assessed and collected after October 1, 2002 for human drug applications and supplements accepted for filing prior to October 1, 2002. For example, in the event that application fees are owed but have not been collected prior to the expiration date for PDUFA II established by section 107 of the Food and Drug Administration Modernization Act (FDAMA), the section will allow these fees to be collected after October 1, 2002. The section further authorizes assessment and collection of product and establishment fees after October 1, 2002 that are owed but have not been collected.Section 508. Effective Date

Section 508 provides that the Prescription Drug User Fee Amendments of 2002 shall take effect October 1, 2002.Section 509. Sunset Clause

Section 509 provides that the amendments made by sections 503 (relating to definitions) and 504 (relating to the authority to assess and use drug fees) shall cease to be effective on October 1, 2007.

The section further provides that the amendments made by section 505 (relating to annual reports) shall cease to be effective 120 days after October 1, 2007. The additional 120 days will allow the prescription drug user fee reports for fiscal year 2007 to be prepared and submitted.

Subtitle B--Additional Authorizations of Appropriations Regarding Food and Drug Administration

Section 521. Office of Drug Safety

This section will help the FDA fulfill its vitally important role of ensuring drug safety. The Managers are highly supportive of the postmarket surveillance activities conducted by the Office of Drug Safety (ODS), and to that end other provisions in this legislation ensure for the first time that user fee monies will be available for postmarket purposes. This section complements those efforts by ensuring that not only will new user fee monies be available for this very important purpose, but so will new appropriated monies. Section 522. Division of Drug Marketing, Advertising, and

Communications

This section provides an increased authorization for the Division of Drug Marketing, Advertising, and Communications

(DDMAC) within the Office of Medical Policy, Center for Drug Evaluation and Research at the FDA. DDMAC plays a vital role in ensuring that promotional drug material is not false or misleading, and they do so on a limited budget. The authorized amounts will better ensure that DDMAC can perform its mission.Section 523. Office of Generic Drugs

This section provides an increased authorization for the Office of Generic Drugs (OGD) within the Center for Drug Evaluation and Research at the FDA. OGD is vitally important to ensuring that Americans have access to safe, effective generic drugs. This Office needs increased funding, however, due to the fact that it presently takes OGD nearly 18 months to review the typical ANDA. This section will lead to increased funding, so that these review times can be decreased without compromising health and safety.

Subtitle C--Additional Provisions

Section 531. Transition to Digital Television

In an effort to further promote the orderly transition to digital television, and to promote the equitable allocation and use of digital channels by television broadcast permittees and licensees, the Managers direct the Federal Communications Commission, at the request of an eligible licensee or permittee, to, within 90 days after the date of enactment of this Act, allot, if necessary, and assign a requested and identified paired digital television channel to that licensee or permittee. In order to avoid any undue burden to the Commission, which is required to allot and assign the paired digital television channel within a short timeframe, the Managers expect all eligible applicants to file their applications as soon as practicable after the date of enactment. The FCC shall only do this if such channel can be allotted and assigned without further modification of the tables of allotments as set forth in sections 73.606 and 73.622 of the Commission's regulations (47 CFR 73.606, 73.622) and such allotment and assignment is consistent with the Commission's technical rules (47 CFR part 73). The only licensees or permittees eligible for this digital allotment are those that are full power television broadcast licensee or permittees (or their successors in interest) that had an application pending for an analog television station construction permit as of October 24, 1991, which application was granted after April 3, 1997; and as of the date of enactment of this Act, is the permittee or licensee of that station. This provision enables such licensees or permittees an opportunity to realize their expectations created by prior FCC action to foster a digital audience during the transition period to digital television without having to terminate abruptly analog service now enjoyed by their viewers. Without this change, those broadcast licensees or permittees would be denied the flexibility to operate an analog and a digital facility simultaneously in the near term, especially in a major market. This is contrary to the Congressional goals of increasing competition and accelerating the digital television transition. The Managers are ensuring that eligible licensees or permittees will meet the intended objectives by doing two important things. First, the Managers impose an unequivocally hard 18-month deadline for the construction of the digital facility from the time of the FCC's issuance of the construction permit for the new digital channel. In this regard, eligible licensees are absolutely prohibited from obtaining or receiving an extension of time from the Commission pursuant to 47 C.F.R. 73.624(d)(3). Second, the Managers safeguard against eligible licensees from using the newly granted ``in-core'' digital channel allotment and assignment to provide analog service.Section 532. 3-Year Delay in Lock in Procedures for

Medicare+Choice Plans; Change in Medicare+Choice

Reporting Deadlines and Annual, Coordinated Election

Period for 2003, 2004, and 2005

This section changes the deadline for Medicare+Choice plans to submit information to the Secretary on Medicare benefits, premiums, cost sharing, supplemental benefits, and actuarial values of such coverage from July 1 to the second Monday in September for the years 2002, 2003, and 2004. It would also delay the annual election period for Medicare enrollees to select a M+C plan to the period of time beginning on November 15 and ending on December 31 in 2002, 2003, and 2004. This section also delays the phase in of the limitation on Medicare beneficiaries changing health plans more than once a year (the ``lock-in''). This requirement, enacted in the Balanced Budget Act of 1997, was scheduled to phase in incrementally beginning in 2002. The substitute would postpone the lock-in requirements until 2005.

From the Committee on Energy and Commerce, for consideration of the House bill and the Senate amendment, and modifications committed to conference:Billy Tauzin,Michael Bilirakis,Paul E. Gillmor,Richard Burr,John Shimkus,John D. Dingell,Henry A. Waxman,Provided that Mr. Pallone is appointed in lieu of Mr. Brown of Ohio for consideration of title IV of the House bill, and modifications committed to conference:Sherrod Brown,Frank Pallone, Jr.,From the Committee on Agriculture, for consideration of title II of the House bill and sec. 216 and title V of the Senate amendment, and modifications committed to conference:Larry Combest,Frank D. Lucas,Saxby Chambliss,Charles Stenholm,Tim Holden,From the Committee on the Judiciary, for consideration of title II of the House bill and secs. 216 and 401 of the Senate amendment, and modifications committed to conference:F. James Sensenbrenner, Jr.,Lamar Smith,John Conyers, Jr.,

Managers on the Part of the House.

Edward Kennedy,Chris Dodd,Tom Harkin,Barbara A. Mikulski,Jim Jeffords,Judd Gregg,Bill Frist,Mike Enzi,Tim Hutchinson,

Managers on the Part of the Senate.

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SOURCE: Congressional Record Vol. 148, No. 66