[Congressional Record Volume 148, Number 66 (Tuesday, May 21, 2002)]
[House]
[Pages H2685-H2732]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          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--

[[Page H2686]]

       ``(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.

                              {time}  1215

  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

[[Page H2687]]

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.

[[Page H2688]]

  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.

                              {time}  1230

  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

[[Page H2689]]

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.

[[Page H2690]]

  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:

[[Page H2691]]

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.

[[Page H2692]]

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

[[Page H2693]]

     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,

[[Page H2694]]

     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.

[[Page H2695]]

       ``(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

[[Page H2696]]

     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.

[[Page H2697]]

       (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

[[Page H2698]]

     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.

[[Page H2699]]

       ``(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.--

[[Page H2700]]

       (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.

[[Page H2701]]

       (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

[[Page H2702]]

     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

[[Page H2703]]

       ``(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

[[Page H2704]]

     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).

[[Page H2705]]

       ``(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

[[Page H2706]]

     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

[[Page H2707]]

     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

[[Page H2708]]

     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

[[Page H2709]]

     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.''.

[[Page H2710]]

     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

[[Page H2711]]

     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);

[[Page H2712]]

       ``(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:

[[Page H2713]]

       ``(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.

[[Page H2714]]

       (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.

[[Page H2715]]

       ``(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

[[Page H2716]]

     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

[[Page H2717]]

       (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

[[Page H2718]]

     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

[[Page H2719]]

     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

[[Page H2720]]

     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.

[[Page H2721]]

       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

[[Page H2722]]

     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

[[Page H2723]]

     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,

[[Page H2724]]

     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

[[Page H2725]]

     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

[[Page H2726]]

     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

[[Page H2727]]

     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

[[Page H2728]]

     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 

[[Page H2729]]

     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

[[Page H2730]]

     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

[[Page H2731]]

     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.

[[Page H2732]]

     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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