[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3448 Enrolled Bill (ENR)]

        H.R.3448

                      One Hundred Seventh Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

         Begun and held at the City of Washington on Wednesday,
          the twenty-third day of January, two thousand and two


                                 An Act


 
To improve the ability of the United States to prevent, prepare for, and 
      respond to bioterrorism and other public health emergencies.

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

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:

Sec. 1. Short title; table of contents.

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

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

Sec. 101. National preparedness and response.
Sec. 102. Assistant Secretary for Public Health Emergency Preparedness; 
          National Disaster Medical System.
Sec. 103. Improving ability of Centers for Disease Control and 
          Prevention.
Sec. 104. Advisory committees and communications; study regarding 
          communications abilities of public health agencies.
Sec. 105. Education of health care personnel; training regarding 
          pediatric issues.
Sec. 106. Grants regarding shortages of certain health professionals.
Sec. 107. Emergency system for advance registration of health 
          professions volunteers.
Sec. 108. Working group.
Sec. 109. Antimicrobial resistance.
Sec. 110. Supplies and services in lieu of award funds.
Sec. 111. Additional amendments.

   Subtitle B--Strategic National Stockpile; Development of Priority 
                             Countermeasures

Sec. 121. Strategic national stockpile.
Sec. 122. Accelerated approval of priority countermeasures.
Sec. 123. Issuance of rule on animal trials.
Sec. 124. Security for countermeasure development and production.
Sec. 125. Accelerated countermeasure research and development.
Sec. 126. Evaluation of new and emerging technologies regarding 
          bioterrorist 
          attack and other public health emergencies.
Sec. 127. Potassium iodide.

 Subtitle C--Improving State, Local, and Hospital Preparedness for and 
      Response to Bioterrorism and Other Public Health Emergencies

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

        Subtitle D--Emergency Authorities; Additional Provisions

Sec. 141. Reporting deadlines.
Sec. 142. Streamlining and clarifying communicable disease quarantine 
          provisions.
Sec. 143. Emergency waiver of Medicare, Medicaid, and SCHIP 
          requirements.
Sec. 144. Provision for expiration of public health emergencies.

                    Subtitle E--Additional Provisions

Sec. 151. Designated State public emergency announcement plan.
Sec. 152. Expanded research by Secretary of Energy.
Sec. 153. Expanded research on worker health and safety.
Sec. 154. Enhancement of emergency preparedness of Department of 
          Veterans 
          Affairs.
Sec. 155. Reauthorization of existing program.
Sec. 156. Sense of Congress.
Sec. 157. General Accounting Office report.
Sec. 158. Certain awards.
Sec. 159. Public access defibrillation programs and public access 
          defibrillation 
          demonstration projects.

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

           Subtitle A--Department of Health and Human Services

Sec. 201. Regulation of certain biological agents and toxins.
Sec. 202. Implementation by Department of Health and Human Services.
Sec. 203. Effective dates.
Sec. 204. Conforming amendment.

                  Subtitle B--Department of Agriculture

Sec. 211. Short title.
Sec. 212. Regulation of certain biological agents and toxins.
Sec. 213. Implementation by Department of Agriculture.

Subtitle C--Interagency Coordination Regarding Overlap Agents and Toxins

Sec. 221. Interagency coordination.

 Subtitle D--Criminal Penalties Regarding Certain Biological Agents and 
                                 Toxins

Sec. 231. Criminal penalties.

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

                  Subtitle A--Protection of Food Supply

Sec. 301. Food safety and security strategy.
Sec. 302. Protection against adulteration of food.
Sec. 303. Administrative detention.
Sec. 304. Debarment for repeated or serious food import violations.
Sec. 305. Registration of food facilities.
Sec. 306. Maintenance and inspection of records for foods.
Sec. 307. Prior notice of imported food shipments.
Sec. 308. Authority to mark articles refused admission into United 
          States.
Sec. 309. Prohibition against port shopping.
Sec. 310. Notices to States regarding imported food.
Sec. 311. Grants to States for inspections.
Sec. 312. Surveillance and information grants and authorities.
Sec. 313. Surveillance of zoonotic diseases.
Sec. 314. Authority to commission other Federal officials to conduct 
          inspections.
Sec. 315. Rule of construction.

                  Subtitle B--Protection of Drug Supply

Sec. 321. Annual registration of foreign manufacturers; shipping 
          information; drug and device listing.
Sec. 322. Requirement of additional information regarding import 
          components 
          intended for use in export products.

   Subtitle C--General Provisions Relating to Upgrade of Agricultural 
                                Security

Sec. 331. Expansion of Animal and Plant Health Inspection Service 
          activities.
Sec. 332. Expansion of Food Safety Inspection Service activities.
Sec. 333. Biosecurity upgrades at the Department of Agriculture.
Sec. 334. Agricultural biosecurity.
Sec. 335. Agricultural bioterrorism research and development.
Sec. 336. Animal enterprise terrorism penalties.

              TITLE IV--DRINKING WATER SECURITY AND SAFETY

Sec. 401. Terrorist and other intentional acts.
Sec. 402. Other Safe Drinking Water Act amendments.
Sec. 403. Miscellaneous and technical amendments.

                     TITLE V--ADDITIONAL PROVISIONS

                 Subtitle A--Prescription Drug User Fees

Sec. 501. Short title.
Sec. 502. Findings.
Sec. 503. Definitions.
Sec. 504. Authority to assess and use drug fees.
Sec. 505. Accountability and reports.
Sec. 506. Reports of postmarketing studies.
Sec. 507. Savings clause.
Sec. 508. Effective date.
Sec. 509. Sunset clause.

  Subtitle B--Funding Provisions Regarding Food and Drug Administration

Sec. 521. Office of Drug Safety.
Sec. 522. Division of Drug Marketing, Advertising, and Communications.
Sec. 523. Office of Generic Drugs.

                    Subtitle C--Additional Provisions

Sec. 531. Transition to digital television.
Sec. 532. 3-year delay in lock in procedures for Medicare+Choice plans; 
          change in Medicare+Choice reporting deadlines and annual, 
          coordinated election period for 2003, 2004, and 2005.

TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH 
                              EMERGENCIES
Subtitle A--National Preparedness and Response Planning, Coordinating, 
                             and Reporting

SEC. 101. NATIONAL PREPAREDNESS AND RESPONSE.

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

``TITLE XXVIII--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC 
                           HEALTH EMERGENCIES
      ``Subtitle A--National Preparedness and Response Planning, 
                      Coordinating, and Reporting

``SEC. 2801. NATIONAL PREPAREDNESS PLAN.

    ``(a) In General.--
        ``(1) Preparedness and response regarding public health 
    emergencies.--The Secretary shall further develop and implement a 
    coordinated strategy, building upon the core public health 
    capabilities established pursuant to section 319A, for carrying out 
    health-related activities to prepare for and respond effectively to 
    bioterrorism and other public health emergencies, including the 
    preparation of a plan under this section. The Secretary shall 
    periodically thereafter review and, as appropriate, revise the 
    plan.
        ``(2) National approach.--In carrying out paragraph (1), the 
    Secretary shall collaborate with the States toward the goal of 
    ensuring that the activities of the Secretary regarding 
    bioterrorism and other public health emergencies are coordinated 
    with activities of the States, including local governments.
        ``(3) Evaluation of progress.--The plan under paragraph (1) 
    shall provide for specific benchmarks and outcome measures for 
    evaluating the progress of the Secretary and the States, including 
    local governments, with respect to the plan under paragraph (1), 
    including progress toward achieving the goals specified in 
    subsection (b).
    ``(b) Preparedness Goals.--The plan under subsection (a) should 
include provisions in furtherance of the following:
        ``(1) Providing effective assistance to State and local 
    governments in the event of bioterrorism or other public health 
    emergency.
        ``(2) Ensuring that State and local governments have 
    appropriate capacity to detect and respond effectively to such 
    emergencies, including capacities for the following:
            ``(A) Effective public health surveillance and reporting 
        mechanisms at the State and local levels.
            ``(B) Appropriate laboratory readiness.
            ``(C) Properly trained and equipped emergency response, 
        public health, and medical personnel.
            ``(D) Health and safety protection of workers responding to 
        such an emergency.
            ``(E) Public health agencies that are prepared to 
        coordinate health services (including mental health services) 
        during and after such emergencies.
            ``(F) Participation in communications networks that can 
        effectively disseminate relevant information in a timely and 
        secure manner to appropriate public and private entities and to 
        the public.
        ``(3) Developing and maintaining medical countermeasures (such 
    as drugs, vaccines and other biological products, medical devices, 
    and other supplies) against biological agents and toxins that may 
    be involved in such emergencies.
        ``(4) Ensuring coordination and minimizing duplication of 
    Federal, State, and local planning, preparedness, and response 
    activities, including during the investigation of a suspicious 
    disease outbreak or other potential public health emergency.
        ``(5) Enhancing the readiness of hospitals and other health 
    care facilities to respond effectively to such emergencies.
    ``(c) Reports to Congress.--
        ``(1) In general.--Not later than one year after the date of 
    the enactment of the Public Health Security and Bioterrorism 
    Preparedness and Response Act of 2002, and biennially thereafter, 
    the Secretary shall submit to the Committee on Energy and Commerce 
    of the House of Representatives, and the Committee on Health, 
    Education, Labor, and Pensions of the Senate, a report concerning 
    progress with respect to the plan under subsection (a), including 
    progress toward achieving the goals specified in subsection (b).
        ``(2) Additional authority.--Reports submitted under paragraph 
    (1) by the Secretary (other than the first report) shall make 
    recommendations concerning--
            ``(A) any additional legislative authority that the 
        Secretary determines is necessary for fully implementing the 
        plan under subsection (a), including meeting the goals under 
        subsection (b); and
            ``(B) any additional legislative authority that the 
        Secretary determines is necessary under section 319 to protect 
        the public health in the event of an emergency described in 
        section 319(a).
    ``(d) Rule of Construction.--This section may not be construed as 
expanding or limiting any of the authorities of the Secretary that, on 
the day before the date of the enactment of the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002, were in effect 
with respect to preparing for and responding effectively to 
bioterrorism and other public health emergencies.''.
    (b) Other Reports.--
        (1) In general.--Not later than one year after the date of the 
    enactment of this Act, the Secretary of Health and Human Services 
    (referred to in this subsection as the ``Secretary'') shall submit 
    to the Committee on Energy and Commerce of the House of 
    Representatives, and the Committee on Health, Education, Labor, and 
    Pensions of the Senate, a report concerning--
            (A) the recommendations and findings of the National 
        Advisory Committee on Children and Terrorism under section 
        319F(c)(2) of the Public Health Service Act;
            (B) the recommendations and findings of the EPIC Advisory 
        Committee under section 319F(c)(3) of such Act;
            (C) the characteristics that may render a rural community 
        uniquely vulnerable to a biological attack, including distance, 
        lack of emergency transport, hospital or laboratory capacity, 
        lack of integration of Federal or State public health networks, 
        workforce deficits, or other relevant characteristics;
            (D) the characteristics that may render areas or 
        populations designated as medically underserved populations (as 
        defined in section 330 of such Act) uniquely vulnerable to a 
        biological attack, including significant numbers of low-income 
        or uninsured individuals, lack of affordable and accessible 
        health care services, insufficient public and primary health 
        care resources, lack of integration of Federal or State public 
        health networks, workforce deficits, or other relevant 
        characteristics;
            (E) the recommendations of the Secretary with respect to 
        additional legislative authority that the Secretary determines 
        is necessary to effectively strengthen rural communities, or 
        medically underserved populations (as defined in section 330 of 
        such Act); and
            (F) the need for and benefits of a National Disaster 
        Response Medical Volunteer Service that would be a private-
        sector, community-based rapid response corps of medical 
        volunteers.
        (2) Study regarding local emergency response methods.--The 
    Secretary shall conduct a study of effective methods for the 
    provision of emergency response services through local governments 
    (including through private response contractors and volunteers of 
    such governments) in a consistent manner in response to acts of 
    bioterrorism or other public health emergencies. Not later than 180 
    days after the date of the enactment of this Act, the Secretary 
    shall submit to the Committee on Energy and Commerce of the House 
    of Representatives, and the Committee on Health, Education, Labor, 
    and Pensions of the Senate, a report describing the findings of the 
    study.

SEC. 102. ASSISTANT SECRETARY FOR PUBLIC HEALTH EMERGENCY PREPAREDNESS; 
              NATIONAL DISASTER MEDICAL SYSTEM.

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

           ``Subtitle B--Emergency Preparedness and Response

``SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO 
              BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES.

    ``(a) Assistant Secretary for Public Health Emergency 
Preparedness.--
        ``(1) In general.--There is established within the Department 
    of Health and Human Services the position of Assistant Secretary 
    for Public Health Emergency Preparedness. The President shall 
    appoint an individual to serve in such position. Such Assistant 
    Secretary shall report to the Secretary.
        ``(2) Duties.--Subject to the authority of the Secretary, the 
    Assistant Secretary for Public Health Emergency Preparedness shall 
    carry out the following duties with respect to bioterrorism and 
    other public health emergencies:
            ``(A) Coordinate on behalf of the Secretary--
                ``(i) interagency interfaces between the Department of 
            Health and Human Services (referred to in this paragraph as 
            the `Department') and other departments, agencies, and 
            offices of the United States; and
                ``(ii) interfaces between the Department and State and 
            local entities with responsibility for emergency 
            preparedness.
            ``(B) Coordinate the operations of the National Disaster 
        Medical System and any other emergency response activities 
        within the Department of Health and Human Services that are 
        related to bioterrorism and other public health emergencies.
            ``(C) Coordinate the efforts of the Department to bolster 
        State and local emergency preparedness for a bioterrorist 
        attack or other public health emergency, and evaluate the 
        progress of such entities in meeting the benchmarks and other 
        outcome measures contained in the national plan and in meeting 
        the core public health capabilities established pursuant to 
        319A.
            ``(D) Any other duties determined appropriate by the 
        Secretary.
    ``(b) National Disaster Medical System.--
        ``(1) In general.--The Secretary shall provide for the 
    operation in accordance with this section of a system to be known 
    as the National Disaster Medical System. The Secretary shall 
    designate the Assistant Secretary for Public Health Emergency 
    Preparedness as the head of the National Disaster Medical System, 
    subject to the authority of the Secretary.
        ``(2) Federal and state collaborative system.--
            ``(A) In general.--The National Disaster Medical System 
        shall be a coordinated effort by the Federal agencies specified 
        in subparagraph (B), working in collaboration with the States 
        and other appropriate public or private entities, to carry out 
        the purposes described in paragraph (3).
            ``(B) Participating federal agencies.--The Federal agencies 
        referred to in subparagraph (A) are the Department of Health 
        and Human Services, the Federal Emergency Management Agency, 
        the Department of Defense, and the Department of Veterans 
        Affairs.
        ``(3) Purpose of system.--
            ``(A) In general.--The Secretary may activate the National 
        Disaster Medical System to--
                ``(i) provide health services, health-related social 
            services, other appropriate human services, and appropriate 
            auxiliary services to respond to the needs of victims of a 
            public health emergency (whether or not determined to be a 
            public health emergency under section 319); or
                ``(ii) be present at locations, and for limited periods 
            of time, specified by the Secretary on the basis that the 
            Secretary has determined that a location is at risk of a 
            public health emergency during the time specified.
            ``(B) Ongoing activities.--The National Disaster Medical 
        System shall carry out such ongoing activities as may be 
        necessary to prepare for the provision of services described in 
        subparagraph (A) in the event that the Secretary activates the 
        National Disaster Medical System for such purposes.
            ``(C) Test for mobilization of system.--During the one-year 
        period beginning on the date of the enactment of the Public 
        Health Security and Bioterrorism Preparedness and Response Act 
        of 2002, the Secretary shall conduct an exercise to test the 
        capability and timeliness of the National Disaster Medical 
        System to mobilize and otherwise respond effectively to a 
        bioterrorist attack or other public health emergency that 
        affects two or more geographic locations concurrently. 
        Thereafter, the Secretary may periodically conduct such 
        exercises regarding the National Disaster Medical System as the 
        Secretary determines to be appropriate.
    ``(c) Criteria.--
        ``(1) In general.--The Secretary shall establish criteria for 
    the operation of the National Disaster Medical System.
        ``(2) Participation agreements for non-federal entities.--In 
    carrying out paragraph (1), the Secretary shall establish criteria 
    regarding the participation of States and private entities in the 
    National Disaster Medical System, including criteria regarding 
    agreements for such participation. The criteria shall include the 
    following:
            ``(A) Provisions relating to the custody and use of Federal 
        personal property by such entities, which may in the discretion 
        of the Secretary include authorizing the custody and use of 
        such property to respond to emergency situations for which the 
        National Disaster Medical System has not been activated by the 
        Secretary pursuant to subsection (b)(3)(A). Any such custody 
        and use of Federal personal property shall be on a reimbursable 
        basis.
            ``(B) Provisions relating to circumstances in which an 
        individual or entity has agreements with both the National 
        Disaster Medical System and another entity regarding the 
        provision of emergency services by the individual. Such 
        provisions shall address the issue of priorities among the 
        agreements involved.
    ``(d) Intermittent Disaster-Response Personnel.--
        ``(1) In general.--For the purpose of assisting the National 
    Disaster Medical System in carrying out duties under this section, 
    the Secretary may appoint individuals to serve as intermittent 
    personnel of such System in accordance with applicable civil 
    service laws and regulations.
        ``(2) Liability.--For purposes of section 224(a) and the 
    remedies described in such section, an individual appointed under 
    paragraph (1) shall, while acting within the scope of such 
    appointment, be considered to be an employee of the Public Health 
    Service performing medical, surgical, dental, or related functions. 
    With respect to the participation of individuals appointed under 
    paragraph (1) in training programs authorized by the Assistant 
    Secretary for Public Health Emergency Preparedness or a comparable 
    official of any Federal agency specified in subsection (b)(2)(B), 
    acts of individuals so appointed that are within the scope of such 
    participation shall be considered within the scope of the 
    appointment under paragraph (1) (regardless of whether the 
    individuals receive compensation for such participation).
    ``(e) Certain Employment Issues Regarding Intermittent 
Appointments.--
        ``(1) Intermittent disaster-response appointee.--For purposes 
    of this subsection, the term `intermittent disaster-response 
    appointee' means an individual appointed by the Secretary under 
    subsection (d).
        ``(2) Compensation for work injuries.--An intermittent 
    disaster-response appointee shall, while acting in the scope of 
    such appointment, be considered to be an employee of the Public 
    Health Service performing medical, surgical, dental, or related 
    functions, and an injury sustained by such an individual shall be 
    deemed `in the performance of duty', for purposes of chapter 81 of 
    title 5, United States Code, pertaining to compensation for work 
    injuries. With respect to the participation of individuals 
    appointed under subsection (d) in training programs authorized by 
    the Assistant Secretary for Public Health Emergency Preparedness or 
    a comparable official of any Federal agency specified in subsection 
    (b)(2)(B), injuries sustained by such an individual, while acting 
    within the scope of such participation, also shall be deemed `in 
    the performance of duty' for purposes of chapter 81 of title 5, 
    United States Code (regardless of whether the individuals receive 
    compensation for such participation). In the event of an injury to 
    such an intermittent disaster-response appointee, the Secretary of 
    Labor shall be responsible for making determinations as to whether 
    the claimant is entitled to compensation or other benefits in 
    accordance with chapter 81 of title 5, United States Code.
        ``(3) Employment and reemployment rights.--
            ``(A) In general.--Service as an intermittent disaster-
        response appointee when the Secretary activates the National 
        Disaster Medical System or when the individual participates in 
        a training program authorized by the Assistant Secretary for 
        Public Health Emergency Preparedness or a comparable official 
        of any Federal agency specified in subsection (b)(2)(B) shall 
        be deemed `service in the uniformed services' for purposes of 
        chapter 43 of title 38, United States Code, pertaining to 
        employment and reemployment rights of individuals who have 
        performed service in the uniformed services (regardless of 
        whether the individual receives compensation for such 
        participation). All rights and obligations of such persons and 
        procedures for assistance, enforcement, and investigation shall 
        be as provided for in chapter 43 of title 38, United States 
        Code.
            ``(B) Notice of absence from position of employment.--
        Preclusion of giving notice of service by necessity of Service 
        as an intermittent disaster-response appointee when the 
        Secretary activates the National Disaster Medical System shall 
        be deemed preclusion by `military necessity' for purposes of 
        section 4312(b) of title 38, United States Code, pertaining to 
        giving notice of absence from a position of employment. A 
        determination of such necessity shall be made by the Secretary, 
        in consultation with the Secretary of Defense, and shall not be 
        subject to judicial review.
        ``(4) Limitation.--An intermittent disaster-response appointee 
    shall not be deemed an employee of the Department of Health and 
    Human Services for purposes other than those specifically set forth 
    in this section.
    ``(f) Rule of Construction Regarding Use of Commissioned Corps.--If 
the Secretary assigns commissioned officers of the Regular or Reserve 
Corps to serve with the National Disaster Medical System, such 
assignments do not affect the terms and conditions of their 
appointments as commissioned officers of the Regular or Reserve Corps, 
respectively (including with respect to pay and allowances, retirement, 
benefits, rights, privileges, and immunities).
    ``(g) Definition.--For purposes of this section, the term 
`auxiliary services' includes mortuary services, veterinary services, 
and other services that are determined by the Secretary to be 
appropriate with respect to the needs referred to in subsection 
(b)(3)(A).
    ``(h) Authorization of Appropriations.--For the purpose of 
providing for the Assistant Secretary for Public Health Emergency 
Preparedness and the operations of the National Disaster Medical 
System, other than purposes for which amounts in the Public Health 
Emergency Fund under section 319 are available, there are authorized to 
be appropriated such sums as may be necessary for each of the fiscal 
years 2002 through 2006.''.
    (b) Sense of Congress Regarding Resources of National Disaster 
Medical System.--It is the sense of the Congress that the Secretary of 
Health and Human Services should provide sufficient resources to 
entities tasked to carry out the duties of the National Disaster 
Medical System for reimbursement of expenses, operations, purchase and 
maintenance of equipment, training, and other funds expended in 
furtherance of the National Disaster Medical System.

SEC. 103. IMPROVING ABILITY OF CENTERS FOR DISEASE CONTROL AND 
              PREVENTION.

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

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

    ``(a) Facilities; Capacities.--
        ``(1) Findings.--Congress finds that the Centers for Disease 
    Control and Prevention has an essential role in defending against 
    and combatting public health threats and requires secure and modern 
    facilities, and expanded and improved capabilities related to 
    bioterrorism and other public health emergencies, sufficient to 
    enable such Centers to conduct this important mission.
        ``(2) Facilities.--
            ``(A) In general.--The Director of the Centers for Disease 
        Control and Prevention may design, construct, and equip new 
        facilities, renovate existing facilities (including 
        laboratories, laboratory support buildings, scientific 
        communication facilities, transshipment complexes, secured and 
        isolated parking structures, office buildings, and other 
        facilities and infrastructure), and upgrade security of such 
        facilities, in order to better conduct the capacities described 
        in section 319A, and for supporting public health activities.
            ``(B) Multiyear contracting authority.--For any project of 
        designing, constructing, equipping, or renovating any facility 
        under subparagraph (A), the Director of the Centers for Disease 
        Control and Prevention may enter into a single contract or 
        related contracts that collectively include the full scope of 
        the project, and the solicitation and contract shall contain 
        the clause `availability of funds' found at section 52.232-18 
        of title 48, Code of Federal Regulations.
        ``(3) Improving the capacities of the centers for disease 
    control and prevention.--The Secretary, taking into account 
    evaluations under section 319B(a), shall expand, enhance, and 
    improve the capabilities of the Centers for Disease Control and 
    Prevention relating to preparedness for and responding effectively 
    to bioterrorism and other public health emergencies. Activities 
    that may be carried out under the preceding sentence include--
            ``(A) expanding or enhancing the training of personnel;
            ``(B) improving communications facilities and networks, 
        including delivery of necessary information to rural areas;
            ``(C) improving capabilities for public health surveillance 
        and reporting activities, taking into account the integrated 
        system or systems of public health alert communications and 
        surveillance networks under subsection (b); and
            ``(D) improving laboratory facilities related to 
        bioterrorism and other public health emergencies, including 
        increasing the security of such facilities.
    ``(b) National Communications and Surveillance Networks.--
        ``(1) In general.--The Secretary, directly or through awards of 
    grants, contracts, or cooperative agreements, shall provide for the 
    establishment of an integrated system or systems of public health 
    alert communications and surveillance networks between and among--
            ``(A) Federal, State, and local public health officials;
            ``(B) public and private health-related laboratories, 
        hospitals, and other health care facilities; and
            ``(C) any other entities determined appropriate by the 
        Secretary.
        ``(2) Requirements.--The Secretary shall ensure that networks 
    under paragraph (1) allow for the timely sharing and discussion, in 
    a secure manner, of essential information concerning bioterrorism 
    or another public health emergency, or recommended methods for 
    responding to such an attack or emergency.
        ``(3) Standards.--Not later than one year after the date of the 
    enactment of the Public Health Security and Bioterrorism 
    Preparedness and Response Act of 2002, the Secretary, in 
    cooperation with health care providers and State and local public 
    health officials, shall establish any additional technical and 
    reporting standards (including standards for interoperability) for 
    networks under paragraph (1).
    ``(c) Authorization of Appropriations.--
        ``(1) Facilities; capacities.--
            ``(A) Facilities.--For the purpose of carrying out 
        subsection (a)(2), there are authorized to be appropriated 
        $300,000,000 for each of the fiscal years 2002 and 2003, and 
        such sums as may be necessary for each of the fiscal years 2004 
        through 2006.
            ``(B) Mission; Improving capacities.--For the purposes of 
        achieving the mission of the Centers for Disease Control and 
        Prevention described in subsection (a)(1), for carrying out 
        subsection (a)(3), for better conducting the capacities 
        described in section 319A, and for supporting public health 
        activities, there are authorized to be appropriated such sums 
        as may be necessary for each of the fiscal years 2002 through 
        2006.
        ``(2) National communications and surveillance networks.--For 
    the purpose of carrying out subsection (b), there are authorized to 
    be appropriated such sums as may be necessary for each of the 
    fiscal years 2002 through 2006.''.

SEC. 104. ADVISORY COMMITTEES AND COMMUNICATIONS; STUDY REGARDING 
              COMMUNICATIONS ABILITIES OF PUBLIC HEALTH AGENCIES.

    (a) In General.--Section 319F of the Public Health Service Act (42 
U.S.C. 247d-6) is amended--
        (1) by striking subsections (b) and (i);
        (2) by redesignating subsections (c) through (h) as subsections 
    (e) through (j), respectively; and
        (3) by inserting after subsection (a) the following 
    subsections:
    ``(b) Advice to the Federal Government.--
        ``(1) Required advisory committees.--In coordination with the 
    working group under subsection (a), the Secretary shall establish 
    advisory committees in accordance with paragraphs (2) and (3) to 
    provide expert recommendations to assist such working groups in 
    carrying out their respective responsibilities under subsections 
    (a) and (b).
        ``(2) National advisory committee on children and terrorism.--
            ``(A) In general.--For purposes of paragraph (1), the 
        Secretary shall establish an advisory committee to be known as 
        the National Advisory Committee on Children and Terrorism 
        (referred to in this paragraph as the `Advisory Committee').
            ``(B) Duties.--The Advisory Committee shall provide 
        recommendations regarding--
                ``(i) the preparedness of the health care (including 
            mental health care) system to respond to bioterrorism as it 
            relates to children;
                ``(ii) needed changes to the health care and emergency 
            medical service systems and emergency medical services 
            protocols to meet the special needs of children; and
                ``(iii) changes, if necessary, to the national 
            stockpile under section 121 of the Public Health Security 
            and Bioterrorism Preparedness and Response Act of 2002 to 
            meet the emergency health security of children.
            ``(C) Composition.--The Advisory Committee shall be 
        composed of such Federal officials as may be appropriate to 
        address the special needs of the diverse population groups of 
        children, and child health experts on infectious disease, 
        environmental health, toxicology, and other relevant 
        professional disciplines.
            ``(D) Termination.--The Advisory Committee terminates one 
        year after the date of the enactment of the Public Health 
        Security and Bioterrorism Preparedness and Response Act of 
        2002.
        ``(3) Emergency public information and communications advisory 
    committee.--
            ``(A) In general.--For purposes of paragraph (1), the 
        Secretary shall establish an advisory committee to be known as 
        the Emergency Public Information and Communications Advisory 
        Committee (referred to in this paragraph as the `EPIC Advisory 
        Committee').
            ``(B) Duties.--The EPIC Advisory Committee shall make 
        recommendations to the Secretary and the working group under 
        subsection (a) and report on appropriate ways to communicate 
        public health information regarding bioterrorism and other 
        public health emergencies to the public.
            ``(C) Composition.--The EPIC Advisory Committee shall be 
        composed of individuals representing a diverse group of experts 
        in public health, medicine, communications, behavioral 
        psychology, and other areas determined appropriate by the 
        Secretary.
            ``(D) Dissemination.--The Secretary shall review the 
        recommendations of the EPIC Advisory Committee and ensure that 
        appropriate information is disseminated to the public.
            ``(E) Termination.--The EPIC Advisory Committee terminates 
        one year after the date of the enactment of Public Health 
        Security and Bioterrorism Preparedness and Response Act of 
        2002.
    ``(c) Strategy for Communication of Information Regarding 
Bioterrorism and Other Public Health Emergencies.--In coordination with 
working group under subsection (a), the Secretary shall develop a 
strategy for effectively communicating information regarding 
bioterrorism and other public health emergencies, and shall develop 
means by which to communicate such information. The Secretary may carry 
out the preceding sentence directly or through grants, contracts, or 
cooperative agreements.
    ``(d) Recommendation of Congress Regarding Official Federal 
Internet Site on Bioterrorism.--It is the recommendation of Congress 
that there should be established an official Federal Internet site on 
bioterrorism, either directly or through provision of a grant to an 
entity that has expertise in bioterrorism and the development of 
websites, that should include information relevant to diverse 
populations (including messages directed at the general public and such 
relevant groups as medical personnel, public safety workers, and 
agricultural workers) and links to appropriate State and local 
government sites.''.
    (b) Study Regarding Communications Abilities of Public Health 
Agencies.--The Secretary of Health and Human Services, in consultation 
with the Federal Communications Commission, the National 
Telecommunications and Information Administration, and other 
appropriate Federal agencies, shall conduct a study to determine 
whether local public health entities have the ability to maintain 
communications in the event of a bioterrorist attack or other public 
health emergency. The study shall examine whether redundancies are 
required in the telecommunications system, particularly with respect to 
mobile communications, for public health entities to maintain systems 
operability and connectivity during such emergencies. The study shall 
also include recommendations to industry and public health entities 
about how to implement such redundancies if necessary.

SEC. 105. EDUCATION OF HEALTH CARE PERSONNEL; TRAINING REGARDING 
              PEDIATRIC ISSUES.

    Section 319F(g) of the Public Health Service Act, as redesignated 
by section 104(a)(2) of this Act, is amended to read as follows:
    ``(g) Education; Training Regarding Pediatric Issues.--
        ``(1) Materials; core curriculum.--The Secretary, in 
    collaboration with members of the working group described in 
    subsection (b), and professional organizations and societies, 
    shall--
            ``(A) develop materials for teaching the elements of a core 
        curriculum for the recognition and identification of potential 
        bioweapons and other agents that may create a public health 
        emergency, and for the care of victims of such emergencies, 
        recognizing the special needs of children and other vulnerable 
        populations, to public health officials, medical professionals, 
        emergency physicians and other emergency department staff, 
        laboratory personnel, and other personnel working in health 
        care facilities (including poison control centers);
            ``(B) develop a core curriculum and materials for 
        community-wide planning by State and local governments, 
        hospitals and other health care facilities, emergency response 
        units, and appropriate public and private sector entities to 
        respond to a bioterrorist attack or other public health 
        emergency;
            ``(C) develop materials for proficiency testing of 
        laboratory and other public health personnel for the 
        recognition and identification of potential bioweapons and 
        other agents that may create a public health emergency; and
            ``(D) provide for dissemination and teaching of the 
        materials described in subparagraphs (A) through (C) by 
        appropriate means, which may include telemedicine, long-
        distance learning, or other such means.
        ``(2) Certain entities.--The entities through which education 
    and training activities described in paragraph (1) may be carried 
    out include Public Health Preparedness Centers, the Public Health 
    Service's Noble Training Center, the Emerging Infections Program, 
    the Epidemic Intelligence Service, the Public Health Leadership 
    Institute, multi-State, multi-institutional consortia, other 
    appropriate educational entities, professional organizations and 
    societies, private accrediting organizations, and other nonprofit 
    institutions or entities meeting criteria established by the 
    Secretary.
        ``(3) Grants and contracts.--In carrying out paragraph (1), the 
    Secretary may carry out activities directly and through the award 
    of grants and contracts, and may enter into interagency cooperative 
    agreements with other Federal agencies.
        ``(4) Health-related assistance for emergency response 
    personnel training.--The Secretary, in consultation with the 
    Attorney General and the Director of the Federal Emergency 
    Management Agency, may provide technical assistance with respect to 
    health-related aspects of emergency response personnel training 
    carried out by the Department of Justice and the Federal Emergency 
    Management Agency.''.

SEC. 106. GRANTS REGARDING SHORTAGES OF CERTAIN HEALTH PROFESSIONALS.

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

``SEC. 319H. GRANTS REGARDING TRAINING AND EDUCATION OF CERTAIN HEALTH 
              PROFESSIONALS.

    ``(a) In General.--The Secretary may make awards of grants and 
cooperative agreements to appropriate public and nonprofit private 
health or educational entities, including health professions schools 
and programs as defined in section 799B, for the purpose of providing 
low-interest loans, partial scholarships, partial fellowships, 
revolving loan funds, or other cost-sharing forms of assistance for the 
education and training of individuals in any category of health 
professions for which there is a shortage that the Secretary determines 
should be alleviated in order to prepare for or respond effectively to 
bioterrorism and other public health emergencies.
    ``(b) Authority Regarding Non-Federal Contributions.--The Secretary 
may require as a condition of an award under subsection (a) that a 
grantee under such subsection provide non-Federal contributions toward 
the purpose described in such subsection.
    ``(c) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of the fiscal years 2002 through 2006.''.

SEC. 107. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF HEALTH 
              PROFESSIONS VOLUNTEERS.

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

``SEC. 319I. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF HEALTH 
              PROFESSIONS VOLUNTEERS.

    ``(a) In General.--The Secretary shall, directly or through an 
award of a grant, contract, or cooperative agreement, establish and 
maintain a system for the advance registration of health professionals 
for the purpose of verifying the credentials, licenses, accreditations, 
and hospital privileges of such professionals when, during public 
health emergencies, the professionals volunteer to provide health 
services (referred to in this section as the `verification system'). In 
carrying out the preceding sentence, the Secretary shall provide for an 
electronic database for the verification system.
    ``(b) Certain Criteria.--The Secretary shall establish provisions 
regarding the promptness and efficiency of the system in collecting, 
storing, updating, and disseminating information on the credentials, 
licenses, accreditations, and hospital privileges of volunteers 
described in subsection (a).
    ``(c) Other Assistance.--The Secretary may make grants and provide 
technical assistance to States and other public or nonprofit private 
entities for activities relating to the verification system developed 
under subsection (a).
    ``(d) Coordination Among States.--The Secretary may encourage each 
State to provide legal authority during a public health emergency for 
health professionals authorized in another State to provide certain 
health services to provide such health services in the State.
    ``(e) Rule of Construction.--This section may not be construed as 
authorizing the Secretary to issue requirements regarding the provision 
by the States of credentials, licenses, accreditations, or hospital 
privileges.
    ``(f) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $2,000,000 
for fiscal year 2002, and such sums as may be necessary for each of the 
fiscal years 2003 through 2006.''.

SEC. 108. WORKING GROUP.

    Section 319F of the Public Health Service Act, as amended by 
section 104(a), is amended by striking subsection (a) and inserting the 
following:
    ``(a) Working Group on Bioterrorism and Other Public Health 
Emergencies.--
        ``(1) In general.--The Secretary, in coordination with the 
    Secretary of Agriculture, the Attorney General, the Director of 
    Central Intelligence, the Secretary of Defense, the Secretary of 
    Energy, the Administrator of the Environmental Protection Agency, 
    the Director of the Federal Emergency Management Agency, the 
    Secretary of Labor, the Secretary of Veterans Affairs, and with 
    other similar Federal officials as determined appropriate, shall 
    establish a working group on the prevention, preparedness, and 
    response to bioterrorism and other public health emergencies. Such 
    joint working group, or subcommittees thereof, shall meet 
    periodically for the purpose of consultation on, assisting in, and 
    making recommendations on--
            ``(A) responding to a bioterrorist attack, including the 
        provision of appropriate safety and health training and 
        protective measures for medical, emergency service, and other 
        personnel responding to such attacks;
            ``(B) prioritizing countermeasures required to treat, 
        prevent, or identify exposure to a biological agent or toxin 
        pursuant to section 351A;
            ``(C) facilitation of the awarding of grants, contracts, or 
        cooperative agreements for the development, manufacture, 
        distribution, supply-chain management, and purchase of priority 
        countermeasures;
            ``(D) research on pathogens likely to be used in a 
        biological threat or attack on the civilian population;
            ``(E) development of shared standards for equipment to 
        detect and to protect against biological agents and toxins;
            ``(F) assessment of the priorities for and enhancement of 
        the preparedness of public health institutions, providers of 
        medical care, and other emergency service personnel (including 
        firefighters) to detect, diagnose, and respond (including 
        mental health response) to a biological threat or attack;
            ``(G) in the recognition that medical and public health 
        professionals are likely to provide much of the first response 
        to such an attack, development and enhancement of the quality 
        of joint planning and training programs that address the public 
        health and medical consequences of a biological threat or 
        attack on the civilian population between--
                ``(i) local firefighters, ambulance personnel, police 
            and public security officers, or other emergency response 
            personnel (including private response contractors); and
                ``(ii) hospitals, primary care facilities, and public 
            health agencies;
            ``(H) development of strategies for Federal, State, and 
        local agencies to communicate information to the public 
        regarding biological threats or attacks;
            ``(I) ensuring that the activities under this subsection 
        address the health security needs of children and other 
        vulnerable populations;
            ``(J) strategies for decontaminating facilities 
        contaminated as a result of a biological attack, including 
        appropriate protections for the safety of workers conducting 
        such activities;
            ``(K) subject to compliance with other provisions of 
        Federal law, clarifying the responsibilities among Federal 
        officials for the investigation of suspicious outbreaks of 
        disease and other potential public health emergencies, and for 
        related revisions of the interagency plan known as the Federal 
        response plan; and
            ``(L) in consultation with the National Highway Traffic 
        Safety Administration and the U.S. Fire Administration, ways to 
        enhance coordination among Federal agencies involved with 
        State, local, and community based emergency medical services, 
        including issuing a report that--
                ``(i) identifies needs of community-based emergency 
            medical services; and
                ``(ii) identifies ways to streamline and enhance the 
            process through which Federal agencies support community-
            based emergency medical services.
        ``(2) Consultation with experts.--In carrying out subparagraphs 
    (B) and (C) of paragraph (1), the working group under such 
    paragraph shall consult with the pharmaceutical, biotechnology, and 
    medical device industries, and other appropriate experts.
        ``(3) Use of subcommittees regarding consultation 
    requirements.--With respect to a requirement under law that the 
    working group under paragraph (1) be consulted on a matter, the 
    working group may designate an appropriate subcommittee of the 
    working group to engage in the consultation.
        ``(4) Discretion in exercise of duties.--Determinations made by 
    the working group under paragraph (1) with respect to carrying out 
    duties under such paragraph are matters committed to agency 
    discretion for purposes of section 701(a) of title 5, Unites States 
    Code.
        ``(5) Rule of construction.--This subsection may not be 
    construed as establishing new regulatory authority for any of the 
    officials specified in paragraph (1), or as having any legal effect 
    on any other provision of law, including the responsibilities and 
    authorities of the Environmental Protection Agency.''.

SEC. 109. ANTIMICROBIAL RESISTANCE.

    Section 319E of the Public Health Service Act (42 U.S.C. 247d-5) is 
amended--
        (1) in subsection (b)--
            (A) by striking ``shall conduct and support'' and inserting 
        ``shall directly or through awards of grants or cooperative 
        agreements to public or private entities provide for the 
        conduct of''; and
            (B) by amending paragraph (4) to read as follows:
        ``(4) the sequencing of the genomes, or other DNA analysis, or 
    other comparative analysis, of priority pathogens (as determined by 
    the Director of the National Institutes of Health in consultation 
    with the task force established under subsection (a)), in 
    collaboration and coordination with the activities of the 
    Department of Defense and the Joint Genome Institute of the 
    Department of Energy; and'';
        (2) in subsection (e)(2), by inserting after ``societies,'' the 
    following: ``schools or programs that train medical laboratory 
    personnel,''; and
        (3) in subsection (g), by striking ``and such sums'' and all 
    that follows and inserting the following: ``$25,000,000 for each of 
    the fiscal years 2002 and 2003, and such sums as may be necessary 
    for each of the fiscal years 2004 through 2006.''.

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

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

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

    ``(a) In General.--Upon the request of a recipient of an award 
under any of sections 319 through 319I or section 319K, the Secretary 
may, subject to subsection (b), provide supplies, equipment, and 
services for the purpose of aiding the recipient in carrying out the 
purposes for which the award is made and, for such purposes, may detail 
to the recipient any officer or employee of the Department of Health 
and Human Services.
    ``(b) Corresponding Reduction in Payments.--With respect to a 
request described in subsection (a), the Secretary shall reduce the 
amount of payments under the award involved by an amount equal to the 
costs of detailing personnel and the fair market value of any supplies, 
equipment, or services provided by the Secretary. The Secretary shall, 
for the payment of expenses incurred in complying with such request, 
expend the amounts withheld.''.

SEC. 111. ADDITIONAL AMENDMENTS.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended--
        (1) in section 319A(a)(1), by striking ``10 years'' and 
    inserting ``five years'';
        (2) in section 319B(a), in the first sentence, by striking ``10 
    years'' and inserting ``five years''; and
        (3) in section 391F(e)(2), as redesignated by section 104(a)(2) 
    of this Act--
            (A) by striking ``or'' after ``clinic,''; and
            (B) by inserting before the period following: ``, 
        professional organization or society, school or program that 
        trains medical laboratory personnel, private accrediting 
        organization, or other nonprofit private institution or entity 
        meeting criteria established by the Secretary''.

   Subtitle B--Strategic National Stockpile; Development of Priority 
                            Countermeasures

SEC. 121. STRATEGIC NATIONAL STOCKPILE.

    (a) Strategic National Stockpile.--
        (1) In general.--The Secretary of Health and Human Services 
    (referred to in this section as the ``Secretary''), in coordination 
    with the Secretary of Veterans Affairs, shall maintain a stockpile 
    or stockpiles of drugs, vaccines and other biological products, 
    medical devices, and other supplies in such numbers, types, and 
    amounts as are determined by the Secretary to be appropriate and 
    practicable, taking into account other available sources, to 
    provide for the emergency health security of the United States, 
    including the emergency health security of children and other 
    vulnerable populations, in the event of a bioterrorist attack or 
    other public health emergency.
        (2) Procedures.--The Secretary, in managing the stockpile under 
    paragraph (1), shall--
            (A) consult with the working group under section 319F(a) of 
        the Public Health Service Act;
            (B) ensure that adequate procedures are followed with 
        respect to such stockpile for inventory management and 
        accounting, and for the physical security of the stockpile;
            (C) in consultation with Federal, State, and local 
        officials, take into consideration the timing and location of 
        special events;
            (D) review and revise, as appropriate, the contents of the 
        stockpile on a regular basis to ensure that emerging threats, 
        advanced technologies, and new countermeasures are adequately 
        considered;
            (E) devise plans for the effective and timely supply-chain 
        management of the stockpile, in consultation with appropriate 
        Federal, State and local agencies, and the public and private 
        health care infrastructure; and
            (F) ensure the adequate physical security of the stockpile.
    (b) Smallpox Vaccine Development.--
        (1) In general.--The Secretary shall award contracts, enter 
    into cooperative agreements, or carry out such other activities as 
    may reasonably be required in order to ensure that the stockpile 
    under subsection (a) includes an amount of vaccine against smallpox 
    as determined by the Secretary to be sufficient to meet the health 
    security needs of the United States.
        (2) Rule of construction.--Nothing in this section shall be 
    construed to limit the private distribution, purchase, or sale of 
    vaccines from sources other than the stockpile described in 
    subsection (a).
    (c) Disclosures.--No Federal agency shall disclose under section 
552, United States Code, any information identifying the location at 
which materials in the stockpile under subsection (a) are stored.
    (d) Definition.--For purposes of subsection (a), the term 
``stockpile'' includes--
        (1) a physical accumulation (at one or more locations) of the 
    supplies described in subsection (a); or
        (2) a contractual agreement between the Secretary and a vendor 
    or vendors under which such vendor or vendors agree to provide to 
    the Secretary supplies described in subsection (a).
    (e) Authorization of Appropriations.--
        (1) Strategic national stockpile.--For the purpose of carrying 
    out subsection (a), there are authorized to be appropriated 
    $640,000,000 for fiscal year 2002, and such sums as may be 
    necessary for each of fiscal years 2003 through 2006.
        (2) Smallpox vaccine development.--For the purpose of carrying 
    out subsection (b), there are authorized to be appropriated 
    $509,000,000 for fiscal year 2002, and such sums as may be 
    necessary for each of fiscal years 2003 through 2006.

SEC. 122. ACCELERATED APPROVAL OF PRIORITY COUNTERMEASURES.

    (a) In General.--The Secretary of Health and Human Services may 
designate a priority countermeasure as a fast-track product pursuant to 
section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) 
or as a device granted review priority pursuant to section 515(d)(5) of 
such Act (21 U.S.C. 360e(d)(5)). Such a designation may be made prior 
to the submission of--
        (1) a request for designation by the sponsor or applicant; or
        (2) an application for the investigation of the drug under 
    section 505(i) of such Act or section 351(a)(3) of the Public 
    Health Service Act.
Nothing in this subsection shall be construed to prohibit a sponsor or 
applicant from declining such a designation.
    (b) Use of Animal Trials.--A drug for which approval is sought 
under section 505(b) of the Federal Food, Drug, and Cosmetic Act or 
section 351 of the Public Health Service Act on the basis of evidence 
of effectiveness that is derived from animal studies pursuant to 
section 123 may be designated as a fast track product for purposes of 
this section.
    (c) Priority Review of Drugs and Biological Products.--A priority 
countermeasure that is a drug or biological product shall be considered 
a priority drug or biological product for purposes of performance goals 
for priority drugs or biological products agreed to by the Commissioner 
of Food and Drugs.
    (d) Definitions.--For purposes of this title:
        (1) The term ``priority countermeasure'' has the meaning given 
    such term in section 319F(h)(4) of the Public Health Service Act.
        (2) The term ``priority drugs or biological products'' means a 
    drug or biological product that is the subject of a drug or 
    biologics application referred to in section 101(4) of the Food and 
    Drug Administration Modernization Act of 1997.

SEC. 123. ISSUANCE OF RULE ON ANIMAL TRIALS.

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

SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND PRODUCTION.

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

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

    ``(a) In General.--The Secretary, in consultation with the Attorney 
General and the Secretary of Defense, may provide technical or other 
assistance to provide security to persons or facilities that conduct 
development, production, distribution, or storage of priority 
countermeasures (as defined in section 319F(h)(4)).
    ``(b) Guidelines.--The Secretary may develop guidelines to enable 
entities eligible to receive assistance under subsection (a) to secure 
their facilities against potential terrorist attack.''.

SEC. 125. ACCELERATED COUNTERMEASURE RESEARCH AND DEVELOPMENT.

    Section 319F(h) of the Public Health Service Act, as redesignated 
by section 104(a)(2) of this Act, is amended to read as follows:
    ``(h) Accelerated Research and Development on Priority Pathogens 
and Countermeasures.--
        ``(1) In general.--With respect to pathogens of potential use 
    in a bioterrorist attack, and other agents that may cause a public 
    health emergency, the Secretary, taking into consideration any 
    recommendations of the working group under subsection (a), shall 
    conduct, and award grants, contracts, or cooperative agreements 
    for, research, investigations, experiments, demonstrations, and 
    studies in the health sciences relating to--
            ``(A) the epidemiology and pathogenesis of such pathogens;
            ``(B) the sequencing of the genomes, or other DNA analysis, 
        or other comparative analysis, of priority pathogens (as 
        determined by the Director of the National Institutes of Health 
        in consultation with the working group established in 
        subsection (a)), in collaboration and coordination with the 
        activities of the Department of Defense and the Joint Genome 
        Institute of the Department of Energy;
            ``(C) the development of priority countermeasures; and
            ``(D) other relevant areas of research;
    with consideration given to the needs of children and other 
    vulnerable populations.
        ``(2) Priority.--The Secretary shall give priority under this 
    section to the funding of research and other studies related to 
    priority countermeasures.
        ``(3) Role of department of veterans affairs.--In carrying out 
    paragraph (1), the Secretary shall consider using the biomedical 
    research and development capabilities of the Department of Veterans 
    Affairs, in conjunction with that Department's affiliations with 
    health-professions universities. When advantageous to the 
    Government in furtherance of the purposes of such paragraph, the 
    Secretary may enter into cooperative agreements with the Secretary 
    of Veterans Affairs to achieve such purposes.
        ``(4) Priority countermeasures.--For purposes of this section, 
    the term `priority countermeasure' means a drug, biological 
    product, device, vaccine, vaccine adjuvant, antiviral, or 
    diagnostic test that the Secretary determines to be--
            ``(A) a priority to treat, identify, or prevent infection 
        by a biological agent or toxin listed pursuant to section 
        351A(a)(1), or harm from any other agent that may cause a 
        public health emergency; or
            ``(B) a priority to diagnose conditions that may result in 
        adverse health consequences or death and may be caused by the 
        administering of a drug, biological product, device, vaccine, 
        vaccine adjuvant, antiviral, or diagnostic test that is a 
        priority under subparagraph (A).''.

SEC. 126. EVALUATION OF NEW AND EMERGING TECHNOLOGIES REGARDING 
              BIOTERRORIST ATTACK AND OTHER PUBLIC HEALTH EMERGENCIES.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') shall promptly carry 
out a program to periodically evaluate new and emerging technologies 
that, in the determination of the Secretary, are designed to improve or 
enhance the ability of public health or safety officials to conduct 
public health surveillance activities relating to a bioterrorist attack 
or other public health emergency.
    (b) Certain Activities.--In carrying out this subsection, the 
Secretary shall, to the extent practicable--
        (1) survey existing technology programs funded by the Federal 
    Government for potentially useful technologies;
        (2) promptly issue a request, as necessary, for information 
    from non-Federal public and private entities for ongoing activities 
    in this area; and
        (3) evaluate technologies identified under paragraphs (1) and 
    (2) pursuant to subsection (c).
    (c) Consultation and Evaluation.--In carrying out subsection 
(b)(3), the Secretary shall consult with the working group under 
section 319F(a) of the Public Health Service Act, as well as other 
appropriate public, nonprofit, and private entities, to develop 
criteria for the evaluation of such technologies and to conduct such 
evaluations.
    (d) Report.--Not later than 180 days after the date of the 
enactment of this Act, and periodically thereafter, the Secretary shall 
submit to the Committee on Energy and Commerce of the House of 
Representatives, and the Committee on Health, Education, Labor, and 
Pensions of the Senate, a report on the activities under this section.

SEC. 127. POTASSIUM IODIDE.

    (a) In General.--Through the national stockpile under section 121, 
the President, subject to subsections (b) and (c), shall make available 
to State and local governments potassium iodide tablets for stockpiling 
and for distribution as appropriate to public facilities, such as 
schools and hospitals, in quantities sufficient to provide adequate 
protection for the population within 20 miles of a nuclear power plant.
    (b) State and Local Plans.--
        (1) In general.--Subsection (a) applies with respect to a State 
    or local government, subject to paragraph (2), if the government 
    involved meets the following conditions:
            (A) Such government submits to the President a plan for the 
        stockpiling of potassium iodide tablets, and for the 
        distribution and utilization of potassium iodide tablets in the 
        event of a nuclear incident.
            (B) The plan is accompanied by certifications by such 
        government that the government has not already received 
        sufficient quantities of potassium iodide tablets from the 
        Federal Government.
        (2) Local governments.--Subsection (a) applies with respect to 
    a local government only if, in addition to the conditions described 
    in paragraph (1), the following conditions are met:
            (A) The State in which the locality involved is located--
                (i) does not have a plan described in paragraph (1)(A); 
            or
                (ii) has a plan described in such paragraph, but the 
            plan does not address populations at a distance greater 
            than 10 miles from the nuclear power plant involved.
            (B) The local government has petitioned the State to modify 
        the State plan to address such populations, not exceeding 20 
        miles from such plant, and 60 days have elapsed without the 
        State modifying the State plan to address populations at the 
        full distance sought by the local government through the 
        petition.
            (C) The local government has submitted its local plan under 
        paragraph (1)(A) to the State, and the State has approved the 
        plan and certified that the plan is not inconsistent with the 
        State emergency plan.
    (c)  Guidelines.--Not later than one year after the date of the 
enactment of this Act, the President, in consultation with individuals 
representing appropriate Federal, State, and local agencies, shall 
establish guidelines for the stockpiling of potassium iodide tablets, 
and for the distribution and utilization of potassium iodide tablets in 
the event of a nuclear incident. Such tablets may not be made available 
under subsection (a) until such guidelines have been established.
    (d) Information.--The President shall carry out activities to 
inform State and local governments of the program under this section.
    (e) Reports.--
        (1) President.--Not later than six months after the date on 
    which the guidelines under subsection (c) are issued, the President 
    shall submit to the Congress a report--
            (A) on whether potassium iodide tablets have been made 
        available under subsection (a) or other Federal, State, or 
        local programs, and the extent to which State and local 
        governments have established stockpiles of such tablets; and
            (B) the measures taken by the President to implement this 
        section.
        (2) National academy of sciences.--
            (A) In general.--The President shall request the National 
        Academy of Sciences to enter into an agreement with the 
        President under which the Academy conducts a study to determine 
        what is the most effective and safe way to distribute and 
        administer potassium iodide tablets on a mass scale. If the 
        Academy declines to conduct the study, the President shall 
        enter into an agreement with another appropriate public or 
        nonprofit private entity to conduct the study.
            (B) Report.--The President shall ensure that, not later 
        than six months after the date of the enactment of this Act, 
        the study required in subparagraph (A) is completed and a 
        report describing the findings made in the study is submitted 
        to the Congress.
    (f) Applicability.--Subsections (a) and (d) cease to apply as 
requirements if the President determines that there is an alternative 
and more effective prophylaxis or preventive measures for adverse 
thyroid conditions that may result from the release of radionuclides 
from nuclear power plants.

 Subtitle C--Improving State, Local, and Hospital Preparedness for and 
      Response to Bioterrorism and Other Public Health Emergencies

SEC. 131. GRANTS TO IMPROVE STATE, LOCAL, AND HOSPITAL PREPAREDNESS FOR 
              AND RESPONSE TO BIOTERRORISM AND OTHER PUBLIC HEALTH 
              EMERGENCIES.

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

``SEC. 319C-1. GRANTS TO IMPROVE STATE, LOCAL, AND HOSPITAL 
              PREPAREDNESS FOR AND RESPONSE TO BIOTERRORISM AND OTHER 
              PUBLIC HEALTH EMERGENCIES.

    ``(a) In General.--To enhance the security of the United States 
with respect to bioterrorism and other public health emergencies, the 
Secretary shall make awards of grants or cooperative agreements to 
eligible entities to enable such entities to conduct the activities 
described in subsection (d).
    ``(b) Eligible Entities.--
        ``(1) In general.--To be eligible to receive an award under 
    subsection (a), an entity shall--
            ``(A)(i) be a State; and
            ``(ii) prepare and submit to the Secretary an application 
        at such time, and in such manner, and containing such 
        information as the Secretary may require, including an 
        assurance that the State--
                ``(I) has completed an evaluation under section 
            319B(a), or an evaluation that is substantially equivalent 
            to an evaluation described in such section (as determined 
            by the Secretary);
                ``(II) has prepared, or will (within 60 days of 
            receiving an award under this section) prepare, a 
            Bioterrorism and Other Public Health Emergency Preparedness 
            and Response Plan in accordance with subsection (c);
                ``(III) has established a means by which to obtain 
            public comment and input on the plan prepared under 
            subclause (II), and on the implementation of such plan, 
            that shall include an advisory committee or other similar 
            mechanism for obtaining comment from the public at large as 
            well as from other State and local stakeholders;
                ``(IV) will use amounts received under the award in 
            accordance with the plan prepared under subclause (II), 
            including making expenditures to carry out the strategy 
            contained in the plan; and
                ``(V) with respect to the plan prepared under subclause 
            (II), will establish reasonable criteria to evaluate the 
            effective performance of entities that receive funds under 
            the award and include relevant benchmarks in the plan; or
            ``(B)(i) be a political subdivision of a State or a 
        consortium of 2 or more such subdivisions; and
            ``(ii) prepare and submit to the Secretary an application 
        at such time, and in such manner, and containing such 
        information as the Secretary may require.
        ``(2) Coordination with statewide plans.--An award under 
    subsection (a) to an eligible entity described in paragraph (1)(B) 
    may not be made unless the application of such entity is in 
    coordination with, and consistent with, applicable Statewide plans 
    described in subsection (d)(1).
    ``(c) Bioterrorism and Other Public Health Emergency Preparedness 
and Response Plan.--Not later than 60 days after receiving amounts 
under an award under subsection (a), an eligible entity described in 
subsection (b)(1)(A) shall prepare and submit to the Secretary a 
Bioterrorism and Other Public Health Emergency Preparedness and 
Response Plan. Recognizing the assessment of public health needs 
conducted under section 319B, such plan shall include a description of 
activities to be carried out by the entity to address the needs 
identified in such assessment (or an equivalent assessment).
    ``(d) Use of Funds.--An award under subsection (a) may be expended 
for activities that may include the following and similar activities:
        ``(1) To develop Statewide plans (including the development of 
    the Bioterrorism and Other Public Health Emergency Preparedness and 
    Response Plan required under subsection (c)), and community-wide 
    plans for responding to bioterrorism and other public health 
    emergencies that are coordinated with the capacities of applicable 
    national, State, and local health agencies and health care 
    providers, including poison control centers.
        ``(2) To address deficiencies identified in the assessment 
    conducted under section 319B.
        ``(3) To purchase or upgrade equipment (including stationary or 
    mobile communications equipment), supplies, pharmaceuticals or 
    other priority countermeasures to enhance preparedness for and 
    response to bioterrorism or other public health emergencies, 
    consistent with the plan described in subsection (c).
        ``(4) To conduct exercises to test the capability and 
    timeliness of public health emergency response activities.
        ``(5) To develop and implement the trauma care and burn center 
    care components of the State plans for the provision of emergency 
    medical services.
        ``(6) To improve training or workforce development to enhance 
    public health laboratories.
        ``(7) To train public health and health care personnel to 
    enhance the ability of such personnel--
            ``(A) to detect, provide accurate identification of, and 
        recognize the symptoms and epidemiological characteristics of 
        exposure to a biological agent that may cause a public health 
        emergency; and
            ``(B) to provide treatment to individuals who are exposed 
        to such an agent.
        ``(8) To develop, enhance, coordinate, or improve participation 
    in systems by which disease detection and information about 
    biological attacks and other public health emergencies can be 
    rapidly communicated among national, State, and local health 
    agencies, emergency response personnel, and health care providers 
    and facilities to detect and respond to a bioterrorist attack or 
    other public health emergency, including activities to improve 
    information technology and communications equipment available to 
    health care and public health officials for use in responding to a 
    biological threat or attack or other public health emergency.
        ``(9) To enhance communication to the public of information on 
    bioterrorism and other public health emergencies, including through 
    the use of 2-1-1 call centers.
        ``(10) To address the health security needs of children and 
    other vulnerable populations with respect to bioterrorism and other 
    public health emergencies.
        ``(11) To provide training and develop, enhance, coordinate, or 
    improve methods to enhance the safety of workers and workplaces in 
    the event of bioterrorism.
        ``(12) To prepare and plan for contamination prevention efforts 
    related to public health that may be implemented in the event of a 
    bioterrorist attack, including training and planning to protect the 
    health and safety of workers conducting the activities described in 
    this paragraph.
        ``(13) To prepare a plan for triage and transport management in 
    the event of bioterrorism or other public health emergencies.
        ``(14) To enhance the training of health care professionals to 
    recognize and treat the mental health consequences of bioterrorism 
    or other public health emergencies.
        ``(15) To enhance the training of health care professionals to 
    assist in providing appropriate health care for large numbers of 
    individuals exposed to a bioweapon.
        ``(16) To enhance training and planning to protect the health 
    and safety of personnel, including health care professionals, 
    involved in responding to a biological attack.
        ``(17) To improve surveillance, detection, and response 
    activities to prepare for emergency response activities including 
    biological threats or attacks, including training personnel in 
    these and other necessary functions and including early warning and 
    surveillance networks that use advanced information technology to 
    provide early detection of biological threats or attacks.
        ``(18) To develop, enhance, and coordinate or improve the 
    ability of existing telemedicine programs to provide health care 
    information and advice as part of the emergency public health 
    response to bioterrorism or other public health emergencies.
Nothing in this subsection may be construed as establishing new 
regulatory authority or as modifying any existing regulatory authority.
    ``(e) Priorities in Use of Grants.--
        ``(1) In general.--
            ``(A) Priorities.--Except as provided in subparagraph (B), 
        the Secretary shall, in carrying out the activities described 
        in this section, address the following hazards in the following 
        priority:
                ``(i) Bioterrorism or acute outbreaks of infectious 
            diseases.
                ``(ii) Other public health threats and emergencies.
            ``(B) Determination of the secretary.--In the case of the 
        hazard involved, the degree of priority that would apply to the 
        hazard based on the categories specified in clauses (i) and 
        (ii) of subparagraph (A) may be modified by the Secretary if 
        the following conditions are met:
                ``(i) The Secretary determines that the modification is 
            appropriate on the basis of the following factors:

                    ``(I) The extent to which eligible entities are 
                adequately prepared for responding to hazards within 
                the category specified in clause (i) of subparagraph 
                (A).
                    ``(II) There has been a significant change in the 
                assessment of risks to the public health posed by 
                hazards within the category specified in clause (ii) of 
                such subparagraph.

                ``(ii) Prior to modifying the priority, the Secretary 
            notifies the appropriate committees of the Congress of the 
            determination of the Secretary under clause (i) of this 
            subparagraph.
        ``(2) Areas of emphasis within categories.--The Secretary shall 
    determine areas of emphasis within the category of hazards 
    specified in clause (i) of paragraph (1)(A), and shall determine 
    areas of emphasis within the category of hazards specified in 
    clause (ii) of such paragraph, based on an assessment of the risk 
    and likely consequences of such hazards and on an evaluation of 
    Federal, State, and local needs, and may also take into account the 
    extent to which receiving an award under subsection (a) will 
    develop capacities that can be used for public health emergencies 
    of varying types.
    ``(f) Certain Activities.--In administering activities under 
section 319C(c)(4) or similar activities, the Secretary shall, where 
appropriate, give priority to activities that include State or local 
government financial commitments, that seek to incorporate multiple 
public health and safety services or diagnostic databases into an 
integrated public health entity, and that cover geographic areas 
lacking advanced diagnostic and laboratory capabilities.
    ``(g) Coordination with Local Medical Response System.--An eligible 
entity and local Metropolitan Medical Response Systems shall, to the 
extent practicable, ensure that activities carried out under an award 
under subsection (a) are coordinated with activities that are carried 
out by local Metropolitan Medical Response Systems.
    ``(h) Coordination of Federal Activities.--In making awards under 
subsection (a), the Secretary shall--
        ``(1) annually notify the Director of the Federal Emergency 
    Management Agency, the Director of the Office of Justice Programs, 
    and the Director of the National Domestic Preparedness Office, as 
    to the amount, activities covered under, and status of such awards; 
    and
        ``(2) coordinate such awards with other activities conducted or 
    supported by the Secretary to enhance preparedness for bioterrorism 
    and other public health emergencies.
    ``(i) Definition.--For purposes of this section, the term `eligible 
entity' means an entity that meets the conditions described in 
subparagraph (A) or (B) of subsection (b)(1).
    ``(j) Funding.--
        ``(1) Authorizations of appropriations.--
            ``(A) Fiscal year 2003.--
                ``(i) Authorizations.--For the purpose of carrying out 
            this section, there is authorized to be appropriated 
            $1,600,000,000 for fiscal year 2003, of which--

                    ``(I) $1,080,000,000 is authorized to be 
                appropriated for awards pursuant to paragraph (3) 
                (subject to the authority of the Secretary to make 
                awards pursuant to paragraphs (4) and (5)); and
                    ``(II) $520,000,000 is authorized to be 
                appropriated--

                        ``(aa) for awards under subsection (a) to 
                    States, notwitstanding the eligibility conditions 
                    under subsection (b), for the purpose of enhancing 
                    the preparedness of hospitals (including children's 
                    hospitals), clinics, health centers, and primary 
                    care facilities for bioterrorism and other public 
                    health emergencies; and
                        ``(bb) for Federal, State, and local planning 
                    and administrative activities related to such 
                    purpose.
                ``(ii) Contingent additional authorization.--If a 
            significant change in circumstances warrants an increase in 
            the amount authorized to be appropriated under clause (i) 
            for fiscal year 2003, there are authorized to be 
            appropriated such sums as may be necessary for such year 
            for carrying out this section, in addition to the amount 
            authorized in clause (i).
            ``(B) Other fiscal years.--For the purpose of carrying out 
        this section, there are authorized to be appropriated such sums 
        as may be necessary for each of the fiscal years 2004 through 
        2006.
        ``(2) Supplement not supplant.--Amounts appropriated under 
    paragraph (1) shall be used to supplement and not supplant other 
    State and local public funds provided for activities under this 
    section.
        ``(3) State bioterrorism and other public health emergency 
    preparedness and response block grant for fiscal year 2003.--
            ``(A) In general.--For fiscal year 2003, the Secretary 
        shall, in an amount determined in accordance with subparagraphs 
        (B) through (D), make an award under subsection (a) to each 
        State, notwithstanding the eligibility conditions described in 
        subsection (b), that submits to the Secretary an application 
        for the award that meets the criteria of the Secretary for the 
        receipt of such an award and that meets other implementation 
        conditions established by the Secretary for such awards. No 
        other awards may be made under subsection (a) for such fiscal 
        year, except as provided in paragraph (1)(A)(i)(II) and 
        paragraphs (4) and (5).
            ``(B) Base amount.--In determining the amount of an award 
        pursuant to subparagraph (A) for a State, the Secretary shall 
        first determine an amount the Secretary considers appropriate 
        for the State (referred to in this paragraph as the `base 
        amount'), except that such amount may not be greater than the 
        minimum amount determined under subparagraph (D).
            ``(C) Increase on basis of population.--After determining 
        the base amount for a State under subparagraph (B), the 
        Secretary shall increase the base amount by an amount equal to 
        the product of--
                ``(i) the amount appropriated under paragraph 
            (1)(A)(i)(I) for the fiscal year, less an amount equal to 
            the sum of all base amounts determined for the States under 
            subparagraph (B), and less the amount, if any, reserved by 
            the Secretary under paragraphs (4) and (5); and
                ``(ii) subject to paragraph (4)(C), the percentage 
            constituted by the ratio of an amount equal to the 
            population of the State over an amount equal to the total 
            population of the States (as indicated by the most recent 
            data collected by the Bureau of the Census).
            ``(D) Minimum amount.--Subject to the amount appropriated 
        under paragraph (1)(A)(i)(I), an award pursuant to subparagraph 
        (A) for a State shall be the greater of the base amount as 
        increased under subparagraph (C), or the minimum amount under 
        this subparagraph. The minimum amount under this subparagraph 
        is--
                ``(i) in the case of each of the several States, the 
            District of Columbia, and the Commonwealth of Puerto Rico, 
            an amount equal to the lesser of--

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

                ``(ii) in the case of each of American Samoa, Guam, the 
            Commonwealth of the Northern Mariana Islands, and the 
            Virgin Islands, an amount determined by the Secretary to be 
            appropriate, except that such amount may not exceed the 
            amount determined under clause (i).
        ``(4) Certain political subdivisions.--
            ``(A) In general.--For fiscal year 2003, the Secretary may, 
        before making awards pursuant to paragraph (3) for such year, 
        reserve from the amount appropriated under paragraph 
        (1)(A)(i)(I) for the year an amount determined necessary by the 
        Secretary to make awards under subsection (a) to political 
        subdivisions that have a substantial number of residents, have 
        a substantial local infrastructure for responding to public 
        health emergencies, and face a high degree of risk from 
        bioterrorist attacks or other public health emergencies. Not 
        more than three political subdivisions may receive awards 
        pursuant to this subparagraph.
            ``(B) Coordination with statewide plans.--An award pursuant 
        to subparagraph (A) may not be made unless the application of 
        the political subdivision involved is in coordination with, and 
        consistent with, applicable Statewide plans described in 
        subsection (c).
            ``(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)(C) for the 
        State, subtract from the population of the State an amount 
        equal to the population of such political subdivision.
            ``(D) Continuity of funding.--In determining whether to 
        make an award pursuant to subparagraph (A) to a political 
        subdivision, the Secretary may consider, as a factor indicating 
        that the award should be made, that the political subdivision 
        received public health funding from the Secretary for fiscal 
        year 2002.
        ``(5) Significant unmet needs; degree of risk.--
            ``(A) In general.--For fiscal year 2003, the Secretary may, 
        before making awards pursuant to paragraph (3) for such year, 
        reserve from the amount appropriated under paragraph 
        (1)(A)(i)(I) for the year an amount determined necessary by the 
        Secretary to make awards under subsection (a) to eligible 
        entities that--
                ``(i) have a significant need for funds to build 
            capacity to identify, detect, monitor, and respond to a 
            bioterrorist or other threat to the public health, which 
            need will not be met by awards pursuant to paragraph (3); 
            and
                ``(ii) face a particularly high degree of risk of such 
            a threat.
            ``(B) Recipients of grants.--Awards pursuant to 
        subparagraph (A) may be supplemental awards to States that 
        receive awards pursuant to paragraph (3), or may be awards to 
        eligible entities described in subsection (b)(1)(B) within such 
        States.
            ``(C) Finding with respect to district of columbia.--The 
        Secretary shall consider the District of Columbia to have a 
        significant unmet need for purposes of subparagraph (A), and to 
        face a particularly high degree of risk for such purposes, on 
        the basis of the concentration of entities of national 
        significance located within the District.
        ``(6) Funding of local entities.--For fiscal year 2003, the 
    Secretary shall in making awards under this section ensure that 
    appropriate portions of such awards are made available to political 
    subdivisions, local departments of public health, hospitals 
    (including children's hospitals), clinics, health centers, or 
    primary care facilities, or consortia of such entities.

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

    ``(a) Grants.--The Secretary shall make awards of grants or 
cooperative agreements to eligible entities to enable such entities to 
improve community and hospital preparedness for bioterrorism and other 
public health emergencies.
    ``(b) Eligibility.--To be eligible for an award under subsection 
(a), an entity shall--
        ``(1) be a partnership consisting of--
            ``(A) one or more hospitals (including children's 
        hospitals), clinics, health centers, or primary care 
        facilities; and
            ``(B)(i) one or more political subdivisions of States;
            ``(ii) one or more States; or
            ``(iii) one or more States and one or more political 
        subdivisions of States; and
        ``(2) prepare, in consultation with the Chief Executive Officer 
    of the State, District, or territory in which the hospital, clinic, 
    health center, or primary care facility described in paragraph 
    (1)(A) is located, and submit to the Secretary, an application at 
    such time, in such manner, and containing such information as the 
    Secretary may require.
    ``(c) Regional Coordination.--In making awards under subsection 
(a), the Secretary shall give preference to eligible entities that 
submit applications that, in the determination of the Secretary, will--
        ``(1) enhance coordination--
            ``(A) among the entities described in subsection (b)(1)(A); 
        and
            ``(B) between such entities and the entities described in 
        subsection (b)(1)(B); and
        ``(2) serve the needs of a defined geographic area.
    ``(d) Consistency of Planned Activities.--An entity described in 
subsection (b)(1) shall utilize amounts received under an award under 
subsection (a) in a manner that is coordinated and consistent, as 
determined by the Secretary, with an applicable State Bioterrorism and 
Other Public Health Emergency Preparedness and Response Plan.
    ``(e) Use of Funds.--An award under subsection (a) may be expended 
for activities that may include the following and similar activities--
        ``(1) planning and administration for such award;
        ``(2) preparing a plan for triage and transport management in 
    the event of bioterrorism or other public health emergencies;
        ``(3) enhancing the training of health care professionals to 
    improve the ability of such professionals to recognize the symptoms 
    of exposure to a potential bioweapon, to make appropriate 
    diagnosis, and to provide treatment to those individuals so 
    exposed;
        ``(4) enhancing the training of health care professionals to 
    recognize and treat the mental health consequences of bioterrorism 
    or other public health emergencies;
        ``(5) enhancing the training of health care professionals to 
    assist in providing appropriate health care for large numbers of 
    individuals exposed to a bioweapon;
        ``(6) enhancing training and planning to protect the health and 
    safety of personnel involved in responding to a biological attack;
        ``(7) developing and implementing the trauma care and burn 
    center care components of the State plans for the provision of 
    emergency medical services; or
        ``(8) conducting such activities as are described in section 
    319C-1(d) that are appropriate for hospitals (including children's 
    hospitals), clinics, health centers, or primary care facilities.
    ``(f) Limitation on Awards.--A political subdivision of a State 
shall not participate in more than one partnership described in 
subsection (b)(1).
    ``(g) Priorities in Use of Grants.--
        ``(1) In general.--
            ``(A) Priorities.--Except as provided in subparagraph (B), 
        the Secretary shall, in carrying out the activities described 
        in this section, address the following hazards in the following 
        priority:
                ``(i) Bioterrorism or acute outbreaks of infectious 
            diseases.
                ``(ii) Other public health threats and emergencies.
            ``(B) Determination of the secretary.--In the case of the 
        hazard involved, the degree of priority that would apply to the 
        hazard based on the categories specified in clauses (i) and 
        (ii) of subparagraph (A) may be modified by the Secretary if 
        the following conditions are met:
                ``(i) The Secretary determines that the modification is 
            appropriate on the basis of the following factors:

                    ``(I) The extent to which eligible entities are 
                adequately prepared for responding to hazards within 
                the category specified in clause (i) of subparagraph 
                (A).
                    ``(II) There has been a significant change in the 
                assessment of risks to the public health posed by 
                hazards within the category specified in clause (ii) of 
                such subparagraph.

                ``(ii) Prior to modifying the priority, the Secretary 
            notifies the appropriate committees of the Congress of the 
            determination of the Secretary under clause (i) of this 
            subparagraph.
        ``(2) Areas of emphasis within categories.--The Secretary shall 
    determine areas of emphasis within the category of hazards 
    specified in clause (i) of paragraph (1)(A), and shall determine 
    areas of emphasis within the category of hazards specified in 
    clause (ii) of such paragraph, based on an assessment of the risk 
    and likely consequences of such hazards and on an evaluation of 
    Federal, State, and local needs, and may also take into account the 
    extent to which receiving an award under subsection (a) will 
    develop capacities that can be used for public health emergencies 
    of varying types.
    ``(h) Coordination with Local Medical Response System.--An eligible 
entity and local Metropolitan Medical Response Systems shall, to the 
extent practicable, ensure that activities carried out under an award 
under subsection (a) are coordinated with activities that are carried 
out by local Metropolitan Medical Response Systems.
    ``(i) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of fiscal years 2004 through 2006.''.
    (b) Certain Grants.--Section 319C of the Public Health Service Act 
(42 U.S.C. 247d-3) is amended by striking subsection (f).

        Subtitle D--Emergency Authorities; Additional Provisions

SEC. 141. REPORTING DEADLINES.

    Section 319 of the Public Health Service Act (42 U.S.C. 247d) is 
amended by adding at the end the following:
    ``(d) Data Submittal and Reporting Deadlines.--In any case in which 
the Secretary determines that, wholly or partially as a result of a 
public health emergency that has been determined pursuant to subsection 
(a), individuals or public or private entities are unable to comply 
with deadlines for the submission to the Secretary of data or reports 
required under any law administered by the Secretary, the Secretary 
may, notwithstanding any other provision of law, grant such extensions 
of such deadlines as the circumstances reasonably require, and may 
waive, wholly or partially, any sanctions otherwise applicable to such 
failure to comply. Before or promptly after granting such an extension 
or waiver, the Secretary shall notify the Congress of such action and 
publish in the Federal Register a notice of the extension or waiver.''.

SEC. 142. STREAMLINING AND CLARIFYING COMMUNICABLE DISEASE QUARANTINE 
              PROVISIONS.

    (a) Elimination of Prerequisite for National Advisory Health 
Council Recommendation Before Issuing Quarantine Rules.--
        (1) Executive orders specifying diseases subject to individual 
    detentions.--Section 361(b) of the Public Health Act (42 U.S.C. 
    264(b)) is amended by striking ``Executive orders of the President 
    upon the recommendation of the National Advisory Health Council and 
    the Surgeon General'' and inserting ``Executive orders of the 
    President upon the recommendation of the Secretary, in consultation 
    with the Surgeon General,''.
        (2) Regulations providing for apprehension of individuals.--
    Section 361(d) of the Public Health Act (42 U.S.C. 264(d)) is 
    amended by striking ``On recommendation of the National Advisory 
    Health Council, regulations'' and inserting ``Regulations''.
        (3) Regulations providing for apprehension of individuals in 
    wartime.--Section 363 of the Public Health Act (42 U.S.C. 266) is 
    amended by striking ``the Surgeon General, on recommendation of the 
    National Advisory Health Council,'' and inserting ``the Secretary, 
    in consultation with the Surgeon General,''.
    (b) Apprehension Authority To Apply in Cases of Exposure to 
Disease.--
        (1) Regulations providing for apprehension of individuals.--
    Section 361(d) of the Public Health Act (42 U.S.C. 264(d)), as 
    amended by subsection (a)(2), is further amended--
            (A) by striking ``(1)'' and ``(2)'' and inserting ``(A)'' 
        and ``(B)'', respectively;
            (B) by striking ``(d)'' and inserting ``(d)(1)'';
            (C) in paragraph (1) (as designated by subparagraph (B) of 
        this paragraph), in the first sentence, by striking ``in a 
        communicable stage'' each place such term appears and inserting 
        ``in a qualifying stage''; and
            (D) by adding at the end the following paragraph:
    ``(2) For purposes of this subsection, the term `qualifying stage', 
with respect to a communicable disease, means that such disease--
        ``(A) is in a communicable stage; or
        ``(B) is in a precommunicable stage, if the disease would be 
    likely to cause a public health emergency if transmitted to other 
    individuals.''.
        (2) Regulations providing for apprehension of individuals in 
    wartime.--Section 363 of the Public Health Act (42 U.S.C. 266), as 
    amended by subsection (a)(3), is further amended by striking ``in a 
    communicable stage''.
    (c) State Authority.--Section 361 of the Public Health Act (42 
U.S.C. 264) is amended by adding at the end the following:
    ``(e) Nothing in this section or section 363, or the regulations 
promulgated under such sections, may be construed as superseding any 
provision under State law (including regulations and including 
provisions established by political subdivisions of States), except to 
the extent that such a provision conflicts with an exercise of Federal 
authority under this section or section 363.''.

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

    (a) Waiver Authority.--Title XI of the Social Security Act (42 
U.S.C. 1301 et seq.) is amended by inserting after section 1134 the 
following new section:


      ``authority to waive requirements during national emergencies

    ``Sec. 1135. (a) Purpose.--The purpose of this section is to enable 
the Secretary to ensure to the maximum extent feasible, in any 
emergency area and during an emergency period (as defined in subsection 
(g)(1))--
        ``(1) that sufficient health care items and services are 
    available to meet the needs of individuals in such area enrolled in 
    the programs under titles XVIII, XIX, and XXI; and
        ``(2) that health care providers (as defined in subsection 
    (g)(2)) that furnish such items and services in good faith, but 
    that are unable to comply with one or more requirements described 
    in subsection (b), may be reimbursed for such items and services 
    and exempted from sanctions for such noncompliance, absent any 
    determination of fraud or abuse.
    ``(b) Secretarial Authority.--To the extent necessary to accomplish 
the purpose specified in subsection (a), the Secretary is authorized, 
subject to the provisions of this section, to temporarily waive or 
modify the application of, with respect to health care items and 
services furnished by a health care provider (or classes of health care 
providers) in any emergency area (or portion of such an area) during 
any portion of an emergency period, the requirements of titles XVIII, 
XIX, or XXI, or any regulation thereunder (and the requirements of this 
title other than this section, and regulations thereunder, insofar as 
they relate to such titles), pertaining to--
        ``(1)(A) conditions of participation or other certification 
    requirements for an individual health care provider or types of 
    providers,
        ``(B) program participation and similar requirements for an 
    individual health care provider or types of providers, and
        ``(C) pre-approval requirements;
        ``(2) requirements that physicians and other health care 
    professionals be licensed in the State in which they provide such 
    services, if they have equivalent licensing in another State and 
    are not affirmatively excluded from practice in that State or in 
    any State a part of which is included in the emergency area;
        ``(3) sanctions under section 1867 (relating to examination and 
    treatment for emergency medical conditions and women in labor) for 
    a transfer of an individual who has not been stabilized in 
    violation of subsection (c) of such section if the transfer arises 
    out of the circumstances of the emergency;
        ``(4) sanctions under section 1877(g) (relating to limitations 
    on physician referral);
        ``(5) deadlines and timetables for performance of required 
    activities, except that such deadlines and timetables may only be 
    modified, not waived; and
        ``(6) limitations on payments under section 1851(i) for health 
    care items and services furnished to individuals enrolled in a 
    Medicare+Choice plan by health care professionals or facilities not 
    included under such plan.
Insofar as the Secretary exercises authority under paragraph (6) with 
respect to individuals enrolled in a Medicare+Choice plan, to the 
extent possible given the circumstances, the Secretary shall reconcile 
payments made on behalf of such enrollees to ensure that the enrollees 
do not pay more than would be required had they received services from 
providers within the network of the plan and may reconcile payments to 
the organization offering the plan to ensure that such organization 
pays for services for which payment is included in the capitation 
payment it receives under part C of title XVIII.
    ``(c) Authority for Retroactive Waiver.--A waiver or modification 
of requirements pursuant to this section may, at the Secretary's 
discretion, be made retroactive to the beginning of the emergency 
period or any subsequent date in such period specified by the 
Secretary.
    ``(d) Certification to Congress.--The Secretary shall provide a 
certification and advance written notice to the Congress at least two 
days before exercising the authority under this section with respect to 
an emergency area. Such a certification and notice shall include--
        ``(1) a description of--
            ``(A) the specific provisions that will be waived or 
        modified;
            ``(B) the health care providers to whom the waiver or 
        modification will apply;
            ``(C) the geographic area in which the waiver or 
        modification will apply; and
            ``(D) the period of time for which the waiver or 
        modification will be in effect; and
        ``(2) a certification that the waiver or modification is 
    necessary to carry out the purpose specified in subsection (a).
    ``(e) Duration of Waiver.--
        ``(1) In general.--A waiver or modification of requirements 
    pursuant to this section terminates upon--
            ``(A) the termination of the applicable declaration of 
        emergency or disaster described in subsection (g)(1)(A);
            ``(B) the termination of the applicable declaration of 
        public health emergency described in subsection (g)(1)(B); or
            ``(C) subject to paragraph (2), the termination of a period 
        of 60 days from the date the waiver or modification is first 
        published (or, if applicable, the date of extension of the 
        waiver or modification under paragraph (2)).
        ``(2) Extension of 60-day periods.--The Secretary may, by 
    notice, provide for an extension of a 60-day period described in 
    paragraph (1)(C) (or an additional period provided under this 
    paragraph) for additional period or periods (not to exceed, except 
    as subsequently provided under this paragraph, 60 days each), but 
    any such extension shall not affect or prevent the termination of a 
    waiver or modification under subparagraph (A) or (B) of paragraph 
    (1).
    ``(f) Report to Congress.--Within one year after the end of the 
emergency period in an emergency area in which the Secretary exercised 
the authority provided under this section, the Secretary shall report 
to the Congress regarding the approaches used to accomplish the 
purposes described in subsection (a), including an evaluation of such 
approaches and recommendations for improved approaches should the need 
for such emergency authority arise in the future.
    ``(g) Definitions.--For purposes of this section:
        ``(1) Emergency area; emergency period.--An `emergency area' is 
    a geographical area in which, and an `emergency period' is the 
    period during which, there exists--
            ``(A) an emergency or disaster declared by the President 
        pursuant to the National Emergencies Act or the Robert T. 
        Stafford Disaster Relief and Emergency Assistance Act; and
            ``(B) a public health emergency declared by the Secretary 
        pursuant to section 319 of the Public Health Service Act.
        ``(2) Health care provider.--The term `health care provider' 
    means any entity that furnishes health care items or services, and 
    includes a hospital or other provider of services, a physician or 
    other health care practitioner or professional, a health care 
    facility, or a supplier of health care items or services.''.
    (b) Effective Date.--The amendment made by subsection (a) shall be 
effective on and after September 11, 2001.

SEC. 144. PROVISION FOR EXPIRATION OF PUBLIC HEALTH EMERGENCIES.

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

                   Subtitle E--Additional Provisions

SEC. 151. DESIGNATED STATE PUBLIC EMERGENCY ANNOUNCEMENT PLAN.

    Section 613(b) of the Robert T. Stafford Disaster Relief and 
Emergency Assistance Act (42 U.S.C. 5196b(b)) is amended--
        (1) in paragraph (5), by striking ``and'' at the end;
        (2) in paragraph (6), by striking the period and inserting ``; 
    and''; and
        (3) by adding at the end the following:
        ``(7) include a plan for providing information to the public in 
    a coordinated manner.''.

SEC. 152. EXPANDED RESEARCH BY SECRETARY OF ENERGY.

    (a) Detection and Identification Research.--
        (1) In general.--In conjunction with the working group under 
    section 319F(a) of the Public Health Service Act, the Secretary of 
    Energy and the Administrator of the National Nuclear Security 
    Administration shall expand, enhance, and intensify research 
    relevant to the rapid detection and identification of pathogens 
    likely to be used in a bioterrorism attack or other agents that may 
    cause a public health emergency.
        (2) Authorized activities.--Activities carried out under 
    paragraph (1) may include--
            (A) the improvement of methods for detecting biological 
        agents or toxins of potential use in a biological attack and 
        the testing of such methods under variable conditions;
            (B) the improvement or pursuit of methods for testing, 
        verifying, and calibrating new detection and surveillance tools 
        and techniques; and
            (C) carrying out other research activities in relevant 
        areas.
        (3) Report.--Not later than 180 days after the date of the 
    enactment of this Act, the Administrator of the National Nuclear 
    Security Administration shall submit to the Committee on Energy and 
    Natural Resources and the Committee on Armed Services of the 
    Senate, and the Committee on Energy and Commerce and the Committee 
    on Armed Services of the House of Representatives, a report setting 
    forth the programs and projects that will be funded prior to the 
    obligation of funds appropriated under subsection (b).
    (b) Authorization.--For the purpose of carrying out this section, 
there are authorized to be appropriated such sums as may be necessary 
in each of fiscal years 2002 through 2006.

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

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

SEC. 154. ENHANCEMENT OF EMERGENCY PREPAREDNESS OF DEPARTMENT OF 
              VETERANS AFFAIRS.

    (a) Readiness of Department Medical Center.--(1) The Secretary of 
Veterans Affairs shall take appropriate actions to enhance the 
readiness of Department of Veterans Affairs medical centers to protect 
the patients and staff of such centers from chemical or biological 
attack or otherwise to respond to such an attack and so as to enable 
such centers to fulfil their obligations as part of the Federal 
response to public health emegencies.
    (2) Actions under paragraph (1) shall include--
        (A) the provision of decontamination equipment and personal 
    protection equipment at Department medical centers; and
        (B) the provision of training in the use of such equipment to 
    staff of such centers.
    (b) Security at Department Medical and Research Facilities.--(1) 
Not later than 180 days after the date of the enactment of this Act, 
the Secretary shall carry out an evaluation of the security needs at 
Department medical centers and research facilities. The evaluation 
shall address the following needs:
        (A) Needs for the protection of patients and medical staff 
    during emergencies, including a chemical or biological attack or 
    other terrorist attack.
        (B) Needs, if any, for screening personnel engaged in research 
    relating to biological pathogens or agents, including work 
    associated with such research.
        (C) Needs for securing laboratories or other facilities engaged 
    in research relating to biological pathogens or agents.
        (D) Any other needs the Secretary considers appropriate.
    (2) The Secretary shall take appropriate actions to enhance the 
security of Department medical centers and research facilities, 
including staff and patients at such centers and facilities. In taking 
such actions, the Secretary shall take into account the results of the 
evaluation required by paragraph (1).
    (c) Tracking of Pharmaceuticals and Medical Supplies and 
Equipment.--The Secretary shall develop and maintain a centralized 
system for tracking the current location and availability of 
pharmaceuticals, medical supplies, and medical equipment throughout the 
Department health care system in order to permit the ready 
identification and utilization of such pharmaceuticals, supplies, and 
equipment for a variety of purposes, including response to a chemical 
or biological attack or other terrorist attack.
    (d) Training.--The Secretary shall ensure that the Department 
medical centers, in consultation with the accredited medical school 
affiliates of such medical centers, develop and implement curricula to 
train resident physicians and health care personnel in medical matters 
relating to biological, chemical, or radiological attacks.
    (e) Participation in National Disaster Medical System.--(1) The 
Secretary shall, in consultation with the Secretary of Defense, the 
Secretary of Health and Human Services, and the Director of the Federal 
Emergency Management Agency, establish and maintain a training program 
to facilitate the participation of the staff of Department medical 
centers, and of the community partners of such centers, in the National 
Disaster Medical System.
    (2) The Secretary shall establish and maintain the training program 
under paragraph (1) in accordance with the recommendations of the 
working group under section 319F(a) of the Public Health Service Act.
    (f) Mental Health Counseling.--(1) With respect to activities 
conducted by personnel serving at Department medical centers, the 
Secretary shall, in consultation with the Secretary of Health and Human 
Services, the American Red Cross, and the working group under section 
319F(a) of the Public Health Service Act, develop and maintain various 
strategies for providing mental health counseling and assistance, 
including counseling and assistance for post-traumatic stress disorder, 
to local and community emergency response providers, veterans, active 
duty military personnel, and individuals seeking care at Department 
medical centers following a bioterrorist attack or other public health 
emergency.
    (2) The strategies under paragraph (1) shall include the following:
        (A) Training and certification of providers of mental health 
    counseling and assistance.
        (B) Mechanisms for coordinating the provision of mental health 
    counseling and assistance to emergency response providers referred 
    to in that paragraph.
    (g) Authorization of Appropriations.--There is hereby authorized to 
be appropriated for the Department of Veterans Affairs amounts as 
follows:
        (1) To carry out activities required by subsection (a)--
            (A) $100,000,000 for fiscal year 2002; and
            (B) such sums as may be necessary for each of fiscal years 
        2003 through 2006.
        (2) To carry out activities required by subsections (b) through 
    (f)--
            (A) $33,000,000 for fiscal year 2002; and
            (B) such sums as may be necessary for each of fiscal years 
        2003 through 2006.

SEC. 155. REAUTHORIZATION OF EXISTING PROGRAM.

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

SEC. 156. SENSE OF CONGRESS.

    It is the sense of the Congress that--
        (1) many excellent university-based programs are already 
    functioning and developing important biodefense products and 
    solutions throughout the United States;
        (2) accelerating the crucial work done at university centers 
    and laboratories will contribute significantly to the United States 
    capacity to defend against any biological threat or attack;
        (3) maximizing the effectiveness of, and extending the mission 
    of, established university programs would be one appropriate use of 
    the additional resources provided for in this Act and the 
    amendments made by this Act; and
        (4) the Secretary of Health and Human Services should, as 
    appropriate, recognize the importance of existing public and 
    private university-based research, training, public awareness, and 
    safety related biological defense programs when the Secretary makes 
    awards of grants and contracts in accordance with this Act and the 
    amendments made by this Act.

SEC. 157. GENERAL ACCOUNTING OFFICE REPORT.

    (a) In General.--The Comptroller General shall submit to the 
Committee on Health, Education, Labor, and Pensions and the Committee 
on Appropriations of the Senate, and to the Committee on Energy and 
Commerce and the Committee on Appropriations of the House of 
Representatives, a report that describes--
        (1) Federal activities primarily related to research on, 
    preparedness for, and the management of the public health and 
    medical consequences of a bioterrorist attack against the civilian 
    population;
        (2) the coordination of the activities described in paragraph 
    (1);
        (3) the effectiveness of such efforts in preparing national, 
    State, and local authorities to address the public health and 
    medical consequences of a potential bioterrorist attack against the 
    civilian population;
        (4) the activities and costs of the Civil Support Teams of the 
    National Guard in responding to biological threats or attacks 
    against the civilian population;
        (5) the activities of the working group under subsection (a) 
    and the efforts made by such group to carry out the activities 
    described in such subsection; and
        (6) the ability of private sector contractors to enhance 
    governmental responses to biological threats or attacks.

SEC. 158. CERTAIN AWARDS.

    Section 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)) 
is amended in the matter after and below paragraph (2) by striking 
``grants and'' and inserting ``grants, providing awards for expenses, 
and''.

SEC. 159. PUBLIC ACCESS DEFIBRILLATION PROGRAMS AND PUBLIC ACCESS 
              DEFIBRILLATION DEMONSTRATION PROJECTS.

    (a) Short Title.--This section may be cited as the ``Community 
Access to Emergency Defibrillation Act of 2002''.
    (b) Findings.--Congress makes the following findings:
        (1) Over 220,000 Americans die each year from cardiac arrest. 
    Every 2 minutes, an individual goes into cardiac arrest in the 
    United States.
        (2) The chance of successfully returning to a normal heart 
    rhythm diminishes by 10 percent each minute following sudden 
    cardiac arrest.
        (3) Eighty percent of cardiac arrests are caused by ventricular 
    fibrillation, for which defibrillation is the only effective 
    treatment.
        (4) Sixty percent of all cardiac arrests occur outside the 
    hospital. The average national survival rate for out-of-hospital 
    cardiac arrest is only 5 percent.
        (5) Communities that have established and implemented public 
    access defibrillation programs have achieved average survival rates 
    for out-of-hospital cardiac arrest as high as 50 percent.
        (6) According to the American Heart Association, wide use of 
    defibrillators could save as many as 50,000 lives nationally each 
    year.
        (7) Successful public access defibrillation programs ensure 
    that cardiac arrest victims have access to early 911 notification, 
    early cardiopulmonary resuscitation, early defibrillation, and 
    early advanced care.
    (c) Public Access Defibrillation Programs and Projects.--Part B of 
title III of the Public Health Service Act (42 U.S.C. 243 et seq.), as 
amended by Public Law 106-310, is amended by adding after section 311 
the following:

``SEC. 312. PUBLIC ACCESS DEFIBRILLATION PROGRAMS.

    ``(a) In General.--The Secretary shall award grants to States, 
political subdivisions of States, Indian tribes, and tribal 
organizations to develop and implement public access defibrillation 
programs--
        ``(1) by training and equipping local emergency medical 
    services personnel, including firefighters, police officers, 
    paramedics, emergency medical technicians, and other first 
    responders, to administer immediate care, including cardiopulmonary 
    resuscitation and automated external defibrillation, to cardiac 
    arrest victims;
        ``(2) by purchasing automated external defibrillators, placing 
    the defibrillators in public places where cardiac arrests are 
    likely to occur, and training personnel in such places to 
    administer cardiopulmonary resuscitation and automated external 
    defibrillation to cardiac arrest victims;
        ``(3) by setting procedures for proper maintenance and testing 
    of such devices, according to the guidelines of the manufacturers 
    of the devices;
        ``(4) by providing training to members of the public in 
    cardiopulmonary resuscitation and automated external 
    defibrillation;
        ``(5) by integrating the emergency medical services system with 
    the public access defibrillation programs so that emergency medical 
    services personnel, including dispatchers, are informed about the 
    location of automated external defibrillators in their community; 
    and
        ``(6) by encouraging private companies, including small 
    businesses, to purchase automated external defibrillators and 
    provide training for their employees to administer cardiopulmonary 
    resuscitation and external automated defibrillation to cardiac 
    arrest victims in their community.
    ``(b) Preference.--In awarding grants under subsection (a), the 
Secretary shall give a preference to a State, political subdivision of 
a State, Indian tribe, or tribal organization that--
        ``(1) has a particularly low local survival rate for cardiac 
    arrests, or a particularly low local response rate for cardiac 
    arrest victims; or
        ``(2) demonstrates in its application the greatest commitment 
    to establishing and maintaining a public access defibrillation 
    program.
    ``(c) Use of Funds.--A State, political subdivision of a State, 
Indian tribe, or tribal organization that receives a grant under 
subsection (a) may use funds received through such grant to--
        ``(1) purchase automated external defibrillators that have been 
    approved, or cleared for marketing, by the Food and Drug 
    Administration;
        ``(2) provide automated external defibrillation and basic life 
    support training in automated external defibrillator usage through 
    nationally recognized courses;
        ``(3) provide information to community members about the public 
    access defibrillation program to be funded with the grant;
        ``(4) provide information to the local emergency medical 
    services system regarding the placement of automated external 
    defibrillators in public places;
        ``(5) produce materials to encourage private companies, 
    including small businesses, to purchase automated external 
    defibrillators; and
        ``(6) further develop strategies to improve access to automated 
    external defibrillators in public places.
    ``(d) Application.--
        ``(1) In general.--To be eligible to receive a grant under 
    subsection (a), a State, political subdivision of a State, Indian 
    tribe, or tribal organization shall prepare and submit an 
    application to the Secretary at such time, in such manner, and 
    containing such information as the Secretary may reasonably 
    require.
        ``(2) Contents.--An application submitted under paragraph (1) 
    shall--
            ``(A) describe the comprehensive public access 
        defibrillation program to be funded with the grant and 
        demonstrate how such program would make automated external 
        defibrillation accessible and available to cardiac arrest 
        victims in the community;
            ``(B) contain procedures for implementing appropriate 
        nationally recognized training courses in performing 
        cardiopulmonary resuscitation and the use of automated external 
        defibrillators;
            ``(C) contain procedures for ensuring direct involvement of 
        a licensed medical professional and coordination with the local 
        emergency medical services system in the oversight of training 
        and notification of incidents of the use of the automated 
        external defibrillators;
            ``(D) contain procedures for proper maintenance and testing 
        of the automated external defibrillators, according to the 
        labeling of the manufacturer;
            ``(E) contain procedures for ensuring notification of local 
        emergency medical services system personnel, including 
        dispatchers, of the location and type of devices used in the 
        public access defibrillation program; and
            ``(F) provide for the collection of data regarding the 
        effectiveness of the public access defibrillation program to be 
        funded with the grant in affecting the out-of-hospital cardiac 
        arrest survival rate.
    ``(e) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $25,000,000 
for fiscal year 2003, and such sums as may be necessary for each of the 
fiscal years 2004 through 2006. Not more than 10 percent of amounts 
received under a grant awarded under this section may be used for 
administrative expenses.

``SEC. 313. PUBLIC ACCESS DEFIBRILLATION DEMONSTRATION PROJECTS.

    ``(a) In General.--The Secretary shall award grants to political 
subdivisions of States, Indian tribes, and tribal organizations to 
develop and implement innovative, comprehensive, community-based public 
access defibrillation demonstration projects that--
        ``(1) provide cardiopulmonary resuscitation and automated 
    external defibrillation to cardiac arrest victims in unique 
    settings;
        ``(2) provide training to community members in cardiopulmonary 
    resuscitation and automated external defibrillation; and
        ``(3) maximize community access to automated external 
    defibrillators.
    ``(b) Use of Funds.--A recipient of a grant under subsection (a) 
shall use the funds provided through the grant to--
        ``(1) purchase automated external defibrillators that have been 
    approved, or cleared for marketing, by the Food and Drug 
    Administration;
        ``(2) provide basic life training in automated external 
    defibrillator usage through nationally recognized courses;
        ``(3) provide information to community members about the public 
    access defibrillation demonstration project to be funded with the 
    grant;
        ``(4) provide information to the local emergency medical 
    services system regarding the placement of automated external 
    defibrillators in the unique settings; and
        ``(5) further develop strategies to improve access to automated 
    external defibrillators in public places.
    ``(c) Application.--
        ``(1) In general.--To be eligible to receive a grant under 
    subsection (a), a political subdivision of a State, Indian tribe, 
    or tribal organization shall prepare and submit an application to 
    the Secretary at such time, in such manner, and containing such 
    information as the Secretary may reasonably require.
        ``(2) Contents.--An application submitted under paragraph (1) 
    may--
            ``(A) describe the innovative, comprehensive, community-
        based public access defibrillation demonstration project to be 
        funded with the grant;
            ``(B) explain how such public access defibrillation 
        demonstration project represents innovation in providing public 
        access to automated external defibrillation; and
            ``(C) provide for the collection of data regarding the 
        effectiveness of the demonstration project to be funded with 
        the grant in--
                ``(i) providing emergency cardiopulmonary resuscitation 
            and automated external defibrillation to cardiac arrest 
            victims in the setting served by the demonstration project; 
            and
                ``(ii) affecting the cardiac arrest survival rate in 
            the setting served by the demonstration project.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $5,000,000 for each of fiscal 
years 2002 through 2006. Not more than 10 percent of amounts received 
under a grant awarded under this section may be used for administrative 
expenses.''.

 TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS
          Subtitle A--Department of Health and Human Services

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

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

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

    ``(a) Regulatory Control of Certain Biological Agents and Toxins.--
        ``(1) List of biological agents and toxins.--
            ``(A) In general.--The Secretary shall by regulation 
        establish and maintain a list of each biological agent and each 
        toxin that has the potential to pose a severe threat to public 
        health and safety.
            ``(B) Criteria.--In determining whether to include an agent 
        or toxin on the list under subparagraph (A), the Secretary 
        shall--
                ``(i) consider--

                    ``(I) the effect on human health of exposure to the 
                agent or toxin;
                    ``(II) the degree of contagiousness of the agent or 
                toxin and the methods by which the agent or toxin is 
                transferred to humans;
                    ``(III) the availability and effectiveness of 
                pharmacotherapies and immunizations to treat and 
                prevent any illness resulting from infection by the 
                agent or toxin; and
                    ``(IV) any other criteria, including the needs of 
                children and other vulnerable populations, that the 
                Secretary considers appropriate; and

                ``(ii) consult with appropriate Federal departments and 
            agencies and with scientific experts representing 
            appropriate professional groups, including groups with 
            pediatric expertise.
        ``(2) Biennial review.--The Secretary shall review and 
    republish the list under paragraph (1) biennially, or more often as 
    needed, and shall by regulation revise the list as necessary in 
    accordance with such paragraph.
    ``(b) Regulation of Transfers of Listed Agents and Toxins.--The 
Secretary shall by regulation provide for--
        ``(1) the establishment and enforcement of safety procedures 
    for the transfer of listed agents and toxins, including measures to 
    ensure--
            ``(A) proper training and appropriate skills to handle such 
        agents and toxins; and
            ``(B) proper laboratory facilities to contain and dispose 
        of such agents and toxins;
        ``(2) the establishment and enforcement of safeguard and 
    security measures to prevent access to such agents and toxins for 
    use in domestic or international terrorism or for any other 
    criminal purpose;
        ``(3) the establishment of procedures to protect the public 
    safety in the event of a transfer or potential transfer of such an 
    agent or toxin in violation of the safety procedures established 
    under paragraph (1) or the safeguard and security measures 
    established under paragraph (2); and
        ``(4) appropriate availability of biological agents and toxins 
    for research, education, and other legitimate purposes.
    ``(c) Possession and Use of Listed Agents and Toxins.--The 
Secretary shall by regulation provide for the establishment and 
enforcement of standards and procedures governing the possession and 
use of listed agents and toxins, including the provisions described in 
paragraphs (1) through (4) of subsection (b), in order to protect the 
public health and safety.
    ``(d) Registration; Identification; Database.--
        ``(1) Registration.--Regulations under subsections (b) and (c) 
    shall require registration with the Secretary of the possession, 
    use, and transfer of listed agents and toxins, and shall include 
    provisions to ensure that persons seeking to register under such 
    regulations have a lawful purpose to possess, use, or transfer such 
    agents and toxins, including provisions in accordance with 
    subsection (e)(6).
        ``(2) Identification; database.--Regulations under subsections 
    (b) and (c) shall require that registration include (if available 
    to the person registering) information regarding the 
    characterization of listed agents and toxins to facilitate their 
    identification, including their source. The Secretary shall 
    maintain a national database that includes the names and locations 
    of registered persons, the listed agents and toxins such persons 
    are possessing, using, or transferring, and information regarding 
    the characterization of such agents and toxins.
    ``(e) Safeguard and Security Requirements for Registered Persons.--
        ``(1) In general.--Regulations under subsections (b) and (c) 
    shall include appropriate safeguard and security requirements for 
    persons possessing, using, or transferring a listed agent or toxin 
    commensurate with the risk such agent or toxin poses to public 
    health and safety (including the risk of use in domestic or 
    international terrorism). The Secretary shall establish such 
    requirements in consultation with the Attorney General, and shall 
    ensure compliance with such requirements as part of the 
    registration system under such regulations.
        ``(2) Limiting access to listed agents and toxins.--
    Requirements under paragraph (1) shall include provisions to ensure 
    that registered persons--
            ``(A) provide access to listed agents and toxins to only 
        those individuals whom the registered person involved 
        determines have a legitimate need to handle or use such agents 
        and toxins;
            ``(B) submit the names and other identifying information 
        for such individuals to the Secretary and the Attorney General, 
        promptly after first determining that the individuals need 
        access under subparagraph (A), and periodically thereafter 
        while the individuals have such access, not less frequently 
        than once every five years;
            ``(C) deny access to such agents and toxins by individuals 
        whom the Attorney General has identified as restricted persons; 
        and
            ``(D) limit or deny access to such agents and toxins by 
        individuals whom the Attorney General has identified as within 
        any category under paragraph (3)(B)(ii), if limiting or denying 
        such access by the individuals involved is determined 
        appropriate by the Secretary, in consultation with the Attorney 
        General.
        ``(3) Submitted names; use of databases by attorney general.--
            ``(A) In general.--Upon the receipt of names and other 
        identifying information under paragraph (2)(B), the Attorney 
        General shall, for the sole purpose of identifying whether the 
        individuals involved are within any of the categories specified 
        in subparagraph (B), promptly use criminal, immigration, 
        national security, and other electronic databases that are 
        available to the Federal Government and are appropriate for 
        such purpose.
            ``(B) Certain individuals.--For purposes of subparagraph 
        (A), the categories specified in this subparagraph regarding an 
        individual are that--
                ``(i) the individual is a restricted person; or
                ``(ii) the individual is reasonably suspected by any 
            Federal law enforcement or intelligence agency of--

                    ``(I) committing a crime set forth in section 
                2332b(g)(5) of title 18, United States Code;
                    ``(II) knowing involvement with an organization 
                that engages in domestic or international terrorism (as 
                defined in section 2331 of such title 18) or with any 
                other organization that engages in intentional crimes 
                of violence; or
                    ``(III) being an agent of a foreign power (as 
                defined in section 1801 of title 50, United States 
                Code).

            ``(C) Notification by attorney general regarding submitted 
        names.--After the receipt of a name and other identifying 
        information under paragraph (2)(B), the Attorney General shall 
        promptly notify the Secretary whether the individual is within 
        any of the categories specified in subparagraph (B).
        ``(4) Notifications by secretary.--The Secretary, after 
    receiving notice under paragraph (3) regarding an individual, shall 
    promptly notify the registered person involved of whether the 
    individual is granted or denied access under paragraph (2). If the 
    individual is denied such access, the Secretary shall promptly 
    notify the individual of the denial.
        ``(5) Expedited review.--Regulations under subsections (b) and 
    (c) shall provide for a procedure through which, upon request to 
    the Secretary by a registered person who submits names and other 
    identifying information under paragraph (2)(B) and who demonstrates 
    good cause, the Secretary may, as determined appropriate by the 
    Secretary--
            ``(A) request the Attorney General to expedite the process 
        of identification under paragraph (3)(A) and notification of 
        the Secretary under paragraph (3)(C); and
            ``(B) expedite the notification of the registered person by 
        the Secretary under paragraph (4).
        ``(6) Process regarding persons seeking to register.--
            ``(A) Individuals.--Regulations under subsections (b) and 
        (c) shall provide that an individual who seeks to register 
        under either of such subsections is subject to the same 
        processes described in paragraphs (2) through (4) as apply to 
        names and other identifying information submitted to the 
        Attorney General under paragraph (2)(B). Paragraph (5) does not 
        apply for purposes of this subparagraph.
            ``(B) Other persons.--Regulations under subsections (b) and 
        (c) shall provide that, in determining whether to deny or 
        revoke registration by a person other than an individual, the 
        Secretary shall submit the name of such person to the Attorney 
        General, who shall use criminal, immigration, national 
        security, and other electronic databases available to the 
        Federal Government, as appropriate for the purpose of promptly 
        notifying the Secretary whether the person, or, where relevant, 
        the individual who owns or controls such person, is a 
        restricted person or is reasonably suspected by any Federal law 
        enforcement or intelligence agency of being within any category 
        specified in paragraph (3)(B)(ii) (as applied to persons, 
        including individuals). Such regulations shall provide that a 
        person who seeks to register under either of such subsections 
        is subject to the same processes described in paragraphs (2) 
        and (4) as apply to names and other identifying information 
        submitted to the Attorney General under paragraph (2)(B). 
        Paragraph (5) does not apply for purposes of this subparagraph. 
        The Secretary may exempt Federal, State, or local governmental 
        agencies from the requirements of this subparagraph.
        ``(7) Review.--
            ``(A) Administrative review.--
                ``(i) In general.--Regulations under subsections (b) 
            and (c) shall provide for an opportunity for a review by 
            the Secretary--

                    ``(I) when requested by the individual involved, of 
                a determination under paragraph (2) to deny the 
                individual access to listed agents and toxins; and
                    ``(II) when requested by the person involved, of a 
                determination under paragraph (6) to deny or revoke 
                registration for such person.

                ``(ii) Ex parte review.--During a review under clause 
            (i), the Secretary may consider information relevant to the 
            review ex parte to the extent that disclosure of the 
            information could compromise national security or an 
            investigation by any law enforcement agency.
                ``(iii) Final agency action.--The decision of the 
            Secretary in a review under clause (i) constitutes final 
            agency action for purposes of section 702 of title 5, 
            United States Code.
            ``(B) Certain procedures.--
                ``(i) Submission of ex parte materials in judicial 
            proceedings.--When reviewing a decision of the Secretary 
            under subparagraph (A), and upon request made ex parte and 
            in writing by the United States, a court, upon a sufficient 
            showing, may review and consider ex parte documents 
            containing information the disclosure of which could 
            compromise national security or an investigation by any law 
            enforcement agency. If the court determines that portions 
            of the documents considered ex parte should be disclosed to 
            the person involved to allow a response, the court shall 
            authorize the United States to delete from such documents 
            specified items of information the disclosure of which 
            could compromise national security or an investigation by 
            any law enforcement agency, or to substitute a summary of 
            the information to which the person may respond. Any order 
            by the court authorizing the disclosure of information that 
            the United States believes could compromise national 
            security or an investigation by any law enforcement agency 
            shall be subject to the processes set forth in 
            subparagraphs (A) and (B)(i) of section 2339B(f)(5) of 
            title 18, United States Code (relating to interlocutory 
            appeal and expedited consideration).
                ``(ii) Disclosure of information.--In a review under 
            subparagraph (A), and in any judical proceeding conducted 
            pursuant to such review, neither the Secretary nor the 
            Attorney General may be required to disclose to the public 
            any information that under subsection (h) shall not be 
            disclosed under section 552 of title 5, United States Code.
        ``(8) Notifications regarding theft or loss of agents.--
    Requirements under paragraph (1) shall include the prompt 
    notification of the Secretary, and appropriate Federal, State, and 
    local law enforcement agencies, of the theft or loss of listed 
    agents and toxins.
        ``(9) Technical assistance for registered persons.--The 
    Secretary, in consultation with the Attorney General, may provide 
    technical assistance to registered persons to improve security of 
    the facilities of such persons.
    ``(f) Inspections.--The Secretary shall have the authority to 
inspect persons subject to regulations under subsection (b) or (c) to 
ensure their compliance with such regulations, including prohibitions 
on restricted persons and other provisions of subsection (e).
    ``(g) Exemptions.--
        ``(1) Clinical or diagnostic laboratories.--Regulations under 
    subsections (b) and (c) shall exempt clinical or diagnostic 
    laboratories and other persons who possess, use, or transfer listed 
    agents or toxins that are contained in specimens presented for 
    diagnosis, verification, or proficiency testing, provided that--
            ``(A) the identification of such agents or toxins is 
        reported to the Secretary, and when required under Federal, 
        State, or local law, to other appropriate authorities; and
            ``(B) such agents or toxins are transferred or destroyed in 
        a manner set forth by the Secretary by regulation.
        ``(2) Products.--
            ``(A) In general.--Regulations under subsections (b) and 
        (c) shall exempt products that are, bear, or contain listed 
        agents or toxins and are cleared, approved, licensed, or 
        registered under any of the Acts specified in subparagraph (B), 
        unless the Secretary by order determines that applying 
        additional regulation under subsection (b) or (c) to a specific 
        product is necessary to protect public health and safety.
            ``(B) Relevant laws.--For purposes of subparagraph (A), the 
        Acts specified in this subparagraph are the following:
                ``(i) The Federal Food, Drug, and Cosmetic Act.
                ``(ii) Section 351 of this Act.
                ``(iii) The Act commonly known as the Virus-Serum-Toxin 
            Act (the eighth paragraph under the heading `Bureau of 
            Animal Industry' in the Act of March 4, 1913; 21 U.S.C. 
            151-159).
                ``(iv) The Federal Insecticide, Fungicide, and 
            Rodenticide Act.
            ``(C) Investigational use.--
                ``(i) In general.--The Secretary may exempt an 
            investigational product that is, bears, or contains a 
            listed agent or toxin from the applicability of provisions 
            of regulations under subsection (b) or (c) when such 
            product is being used in an investigation authorized under 
            any Federal Act and the Secretary determines that applying 
            additional regulation under subsection (b) or (c) to such 
            product is not necessary to protect public health and 
            safety.
                ``(ii) Certain processes.--Regulations under 
            subsections (b) and (c) shall set forth the procedures for 
            applying for an exemption under clause (i). In the case of 
            investigational products authorized under any of the Acts 
            specified in subparagraph (B), the Secretary shall make a 
            determination regarding a request for an exemption not 
            later than 14 days after the first date on which both of 
            the following conditions have been met by the person 
            requesting the exemption:

                    ``(I) The person has submitted to the Secretary an 
                application for the exemption meeting the requirements 
                established by the Secretary.
                    ``(II) The person has notified the Secretary that 
                the investigation has been authorized under such an 
                Act.

        ``(3) Public health emergencies.--The Secretary may temporarily 
    exempt a person from the applicability of the requirements of this 
    section, in whole or in part, if the Secretary determines that such 
    exemption is necessary to provide for the timely participation of 
    the person in a response to a domestic or foreign public health 
    emergency (whether determined under section 319(a) or otherwise) 
    that involves a listed agent or toxin. With respect to the 
    emergency involved, such exemption for a person may not exceed 30 
    days, except that the Secretary, after review of whether such 
    exemption remains necessary, may provide one extension of an 
    additional 30 days.
        ``(4) Agricultural emergencies.--Upon request of the Secretary 
    of Agriculture, after the granting by such Secretary of an 
    exemption under section 212(g)(1)(D) of the Agricultural 
    Bioterrorism Protection Act of 2002 pursuant to a finding that 
    there is an agricultural emergency, the Secretary of Health and 
    Human Services may temporarily exempt a person from the 
    applicability of the requirements of this section, in whole or in 
    part, to provide for the timely participation of the person in a 
    response to the agricultural emergency. With respect to the 
    emergency involved, the exemption under this paragraph for a person 
    may not exceed 30 days, except that upon request of the Secretary 
    of Agriculture, the Secretary of Health and Human Services may, 
    after review of whether such exemption remains necessary, provide 
    one extension of an additional 30 days.
    ``(h) Disclosure of Information.--
        ``(1) Nondisclosure of certain information.--No Federal agency 
    specified in paragraph (2) shall disclose under section 552 of 
    title 5, United States Code, any of the following:
            ``(A) Any registration or transfer documentation submitted 
        under subsections (b) and (c) for the possession, use, or 
        transfer of a listed agent or toxin; or information derived 
        therefrom to the extent that it identifies the listed agent or 
        toxin possessed, used, or transferred by a specific registered 
        person or discloses the identity or location of a specific 
        registered person.
            ``(B) The national database developed pursuant to 
        subsection (d), or any other compilation of the registration or 
        transfer information submitted under subsections (b) and (c) to 
        the extent that such compilation discloses site-specific 
        registration or transfer information.
            ``(C) Any portion of a record that discloses the site-
        specific or transfer-specific safeguard and security measures 
        used by a registered person to prevent unauthorized access to 
        listed agents and toxins.
            ``(D) Any notification of a release of a listed agent or 
        toxin submitted under subsections (b) and (c), or any 
        notification of theft or loss submitted under such subsections.
            ``(E) Any portion of an evaluation or report of an 
        inspection of a specific registered person conducted under 
        subsection (f) that identifies the listed agent or toxin 
        possessed by a specific registered person or that discloses the 
        identity or location of a specific registered person if the 
        agency determines that public disclosure of the information 
        would endanger public health or safety.
        ``(2) Covered agencies.--For purposes of paragraph (1) only, 
    the Federal agencies specified in this paragraph are the following:
            ``(A) The Department of Health and Human Services, the 
        Department of Justice, the Department of Agriculture, and the 
        Department of Transportation.
            ``(B) Any Federal agency to which information specified in 
        paragraph (1) is transferred by any agency specified in 
        subparagraph (A) of this paragraph.
            ``(C) Any Federal agency that is a registered person, or 
        has a sub-agency component that is a registered person.
            ``(D) Any Federal agency that awards grants or enters into 
        contracts or cooperative agreements involving listed agents and 
        toxins to or with a registered person, and to which information 
        specified in paragraph (1) is transferred by any such 
        registered person.
        ``(3) Other exemptions.--This subsection may not be construed 
    as altering the application of any exemptions to public disclosure 
    under section 552 of title 5, United States Code, except as to 
    subsection 552(b)(3) of such title, to any of the information 
    specified in paragraph (1).
        ``(4) Rule of construction.--Except as specifically provided in 
    paragraph (1), this subsection may not be construed as altering the 
    authority of any Federal agency to withhold under section 552 of 
    title 5, United States Code, or the obligation of any Federal 
    agency to disclose under section 552 of title 5, United States 
    Code, any information, including information relating to--
            ``(A) listed agents and toxins, or individuals seeking 
        access to such agents and toxins;
            ``(B) registered persons, or persons seeking to register 
        their possession, use, or transfer of such agents and toxins;
            ``(C) general safeguard and security policies and 
        requirements under regulations under subsections (b) and (c); 
        or
            ``(D) summary or statistical information concerning 
        registrations, registrants, denials or revocations of 
        registrations, listed agents and toxins, inspection evaluations 
        and reports, or individuals seeking access to such agents and 
        toxins.
        ``(5) Disclosures to congress; other disclosures.--This 
    subsection may not be construed as providing any authority--
            ``(A) to withhold information from the Congress or any 
        committee or subcommittee thereof; or
            ``(B) to withhold information from any person under any 
        other Federal law or treaty.
    ``(i) Civil Money Penalty.--
        ``(1) In general.--In addition to any other penalties that may 
    apply under law, any person who violates any provision of 
    regulations under subsection (b) or (c) shall be subject to the 
    United States for a civil money penalty in an amount not exceeding 
    $250,000 in the case of an individual and $500,000 in the case of 
    any other person.
        ``(2) Applicability of certain provisions.--The provisions of 
    section 1128A of the Social Security Act (other than subsections 
    (a), (b), (h), and (i), the first sentence of subsection (c), and 
    paragraphs (1) and (2) of subsection (f)) shall apply to a civil 
    money penalty under paragraph (1) in the same manner as such 
    provisions apply to a penalty or proceeding under section 1128A(a) 
    of such Act. The Secretary may delegate authority under this 
    subsection in the same manner as provided in section 1128A(j)(2) of 
    the Social Security Act, and such authority shall include all 
    powers as contained in section 6 of the Inspector General Act of 
    1978 (5 U.S.C. App.).
    ``(j) Notification in Event of Release.--Regulations under 
subsections (b) and (c) shall require the prompt notification of the 
Secretary by a registered person whenever a release, meeting criteria 
established by the Secretary, of a listed agent or toxin has occurred 
outside of the biocontainment area of a facility of the registered 
person. Upon receipt of such notification and a finding by the 
Secretary that the release poses a threat to public health or safety, 
the Secretary shall take appropriate action to notify relevant State 
and local public health authorities, other relevant Federal 
authorities, and, if necessary, other appropriate persons (including 
the public). If the released listed agent or toxin is an overlap agent 
or toxin (as defined in subsection (l)), the Secretary shall promptly 
notify the Secretary of Agriculture upon notification by the registered 
person.
    ``(k) Reports.--The Secretary shall report to the Congress annually 
on the number and nature of notifications received under subsection 
(e)(8) (relating to theft or loss) and subsection (j) (relating to 
releases).
    ``(l) Definitions.--For purposes of this section:
        ``(1) The terms `biological agent' and `toxin' have the 
    meanings given such terms in section 178 of title 18, United States 
    Code.
        ``(2) The term `listed agents and toxins' means biological 
    agents and toxins listed pursuant to subsection (a)(1).
        ``(3) The term `listed agents or toxins' means biological 
    agents or toxins listed pursuant to subsection (a)(1).
        ``(4) The term `overlap agents and toxins' means biological 
    agents and toxins that--
            ``(A) are listed pursuant to subsection (a)(1); and
            ``(B) are listed pursuant to section 212(a)(1) of the 
        Agricultural Bioterrorism Protection Act of 2002.
        ``(5) The term `overlap agent or toxin' means a biological 
    agent or toxin that--
            ``(A) is listed pursuant to subsection (a)(1); and
            ``(B) is listed pursuant to section 212(a)(1) of the 
        Agricultural Bioterrorism Protection Act of 2002.
        ``(6) The term `person' includes Federal, State, and local 
    governmental entities.
        ``(7) The term `registered person' means a person registered 
    under regulations under subsection (b) or (c).
        ``(8) The term `restricted person' has the meaning given such 
    term in section 175b of title 18, United States Code.
    ``(m) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of the fiscal years 2002 through 2007.''.
    (b) Report to Congress.--Not later than one year after the date of 
the enactment of this Act, the Secretary of Health and Human Services, 
after consultation with other appropriate Federal agencies, shall 
submit to the Congress a report that--
        (1) describes the extent to which there has been compliance by 
    governmental and private entities with applicable regulations under 
    section 351A of the Public Health Service Act (as added by 
    subsection (a) of this section), including the extent of compliance 
    before the date of the enactment of this Act, and including the 
    extent of compliance with regulations promulgated after such date 
    of enactment;
        (2) describes the actions to date and future plans of the 
    Secretary for updating the list of biological agents and toxins 
    under such section 351A;
        (3) describes the actions to date and future plans of the 
    Secretary for determining compliance with regulations under such 
    section 351A and for taking appropriate enforcement actions;
        (4) evaluates the impact of such section 351A on research on 
    biological agents and toxins listed pursuant to such section; and
        (5) provides any recommendations of the Secretary for 
    administrative or legislative initiatives regarding such section 
    351A.

SEC. 202. IMPLEMENTATION BY DEPARTMENT OF HEALTH AND HUMAN SERVICES.

    (a) Date Certain for Notice of Possession.--Not later than 90 days 
after the date of the enactment of this Act, all persons (unless exempt 
under subsection (g) of section 351A of the Public Health Service Act, 
as added by section 201 of this Act) in possession of biological agents 
or toxins listed under such section 351A of the Public Health Service 
Act shall notify the Secretary of Health and Human Services of such 
possession. Not later than 30 days after such date of enactment, the 
Secretary shall provide written guidance on how such notice is to be 
provided to the Secretary.
    (b) Date Certain for Promulgation; Effective Date Regarding 
Criminal and Civil Penalties.--Not later than 180 days after the date 
of the enactment of this Act, the Secretary of Health and Human 
Services shall promulgate an interim final rule for carrying out 
section 351A of the Public Health Service Act, subject to subsection 
(c). Such interim final rule shall take effect 60 days after the date 
on which such rule is promulgated, including for purposes of--
        (1) section 175b(c) of title 18, United States Code (relating 
    to criminal penalties), as added by section 231(a)(5) of this Act; 
    and
        (2) section 351A(i) of the Public Health Service Act (relating 
    to civil penalties).
    (c) Transitional Provision Regarding Current Research and 
Education.--The interim final rule under subsection (b) shall include 
time frames for the applicability of the rule that minimize disruption 
of research or educational projects that involve biological agents and 
toxins listed pursuant to section 351A(a)(1) of the Public Health 
Service Act and that were underway as of the effective date of such 
rule.

SEC. 203. EFFECTIVE DATES.

    (a) In General.--Regulations promulgated by the Secretary of Health 
and Human Services under section 511 of the Antiterrorism and Effective 
Death Penalty Act of 1996 are deemed to have been promulgated under 
section 351A of the Public Health Service Act, as added by section 201 
of this Act. Such regulations, including the list under subsection 
(d)(1) of such section 511, that were in effect on the day before the 
date of the enactment of this Act remain in effect until modified by 
the Secretary in accordance with such section 351A and with section 202 
of this Act.
    (b) Effective Date Regarding Disclosure of Information.--Subsection 
(h) of section 351A of the Public Health Service Act, as added by 
section 201 of this Act, is deemed to have taken effect on the 
effective date of the Antiterrorism and Effective Death Penalty Act of 
1996.

SEC. 204. CONFORMING AMENDMENT.

    Subsections (d), (e), (f), and (g) of section 511 of the 
Antiterrorism and Effective Death Penalty Act of 1996 (42 U.S.C. 262 
note) are repealed.

                 Subtitle B--Department of Agriculture

SEC. 211. SHORT TITLE.

    This subtitle may be cited as the ``Agricultural Bioterrorism 
Protection Act of 2002''.

SEC. 212. REGULATION OF CERTAIN BIOLOGICAL AGENTS AND TOXINS.

    (a) Regulatory Control of Certain Biological Agents and Toxins.--
        (1) List of biological agents and toxins.--
            (A) In general.--The Secretary of Agriculture shall by 
        regulation establish and maintain a list of each biological 
        agent and each toxin that the Secretary determines has the 
        potential to pose a severe threat to animal or plant health, or 
        to animal or plant products.
            (B) Criteria.--In determining whether to include an agent 
        or toxin on the list under subparagraph (A), the Secretary 
        shall--
                (i) consider--

                    (I) the effect of exposure to the agent or toxin on 
                animal or plant health, and on the production and 
                marketability of animal or plant products;
                    (II) the pathogenicity of the agent or the toxicity 
                of the toxin and the methods by which the agent or 
                toxin is transferred to animals or plants;
                    (III) the availability and effectiveness of 
                pharmacotherapies and prophylaxis to treat and prevent 
                any illness caused by the agent or toxin; and
                    (IV) any other criteria that the Secretary 
                considers appropriate to protect animal or plant 
                health, or animal or plant products; and

                (ii) consult with appropriate Federal departments and 
            agencies and with scientific experts representing 
            appropriate professional groups.
        (2) Biennial review.--The Secretary shall review and republish 
    the list under paragraph (1) biennially, or more often as needed, 
    and shall by regulation revise the list as necessary in accordance 
    with such paragraph.
    (b) Regulation of Transfers of Listed Agents and Toxins.--The 
Secretary shall by regulation provide for--
        (1) the establishment and enforcement of safety procedures for 
    the transfer of listed agents and toxins, including measures to 
    ensure--
            (A) proper training and appropriate skills to handle such 
        agents and toxins; and
            (B) proper laboratory facilities to contain and dispose of 
        such agents and toxins;
        (2) the establishment and enforcement of safeguard and security 
    measures to prevent access to such agents and toxins for use in 
    domestic or international terrorism or for any other criminal 
    purpose;
        (3) the establishment of procedures to protect animal and plant 
    health, and animal and plant products, in the event of a transfer 
    or potential transfer of such an agent or toxin in violation of the 
    safety procedures established under paragraph (1) or the safeguard 
    and security measures established under paragraph (2); and
        (4) appropriate availability of biological agents and toxins 
    for research, education, and other legitimate purposes.
    (c) Possession and Use of Listed Agents and Toxins.--The Secretary 
shall by regulation provide for the establishment and enforcement of 
standards and procedures governing the possession and use of listed 
agents and toxins, including the provisions described in paragraphs (1) 
through (4) of subsection (b), in order to protect animal and plant 
health, and animal and plant products.
    (d) Registration; Identification; Database.--
        (1) Registration.--Regulations under subsections (b) and (c) 
    shall require registration with the Secretary of the possession, 
    use, and transfer of listed agents and toxins, and shall include 
    provisions to ensure that persons seeking to register under such 
    regulations have a lawful purpose to possess, use, or transfer such 
    agents and toxins, including provisions in accordance with 
    subsection (e)(6).
        (2) Identification; database.--Regulations under subsections 
    (b) and (c) shall require that registration include (if available 
    to the person registering) information regarding the 
    characterization of listed agents and toxins to facilitate their 
    identification, including their source. The Secretary shall 
    maintain a national database that includes the names and locations 
    of registered persons, the listed agents and toxins such persons 
    are possessing, using, or transferring, and information regarding 
    the characterization of such agents and toxins.
    (e) Safeguard and Security Requirements for Registered Persons.--
        (1) In general.--Regulations under subsections (b) and (c) 
    shall include appropriate safeguard and security requirements for 
    persons possessing, using, or transferring a listed agent or toxin 
    commensurate with the risk such agent or toxin poses to animal and 
    plant health, and animal and plant products (including the risk of 
    use in domestic or international terrorism). The Secretary shall 
    establish such requirements in consultation with the Attorney 
    General, and shall ensure compliance with such requirements as part 
    of the registration system under such regulations.
        (2) Limiting access to listed agents and toxins.--Requirements 
    under paragraph (1) shall include provisions to ensure that 
    registered persons--
            (A) provide access to listed agents and toxins to only 
        those individuals whom the registered person involved 
        determines have a legitimate need to handle or use such agents 
        and toxins;
            (B) submit the names and other identifying information for 
        such individuals to the Secretary and the Attorney General, 
        promptly after first determining that the individuals need 
        access under subparagraph (A), and periodically thereafter 
        while the individuals have such access, not less frequently 
        than once every five years; and
            (C)(i) in the case of listed agents and toxins that are not 
        overlap agents and toxins (as defined in subsection 
        (g)(1)(A)(ii)), limit or deny access to such agents and toxins 
        by individuals whom the Attorney General has identified as 
        within any category under paragraph (3)(B), if limiting or 
        denying such access by the individuals involved is determined 
        appropriate by the Secretary, in consultation with the Attorney 
        General; and
            (ii) in the case of listed agents and toxins that are 
        overlap agents--

                    (I) deny access to such agents and toxins by 
                individuals whom the Attorney General has identified as 
                within any category referred to in paragraph (3)(B)(i); 
                and
                    (II) limit or deny access to such agents and toxins 
                by individuals whom the Attorney General has identified 
                as within any category under paragraph (3)(B)(ii), if 
                limiting or denying such access by the individuals 
                involved is determined appropriate by the Secretary, in 
                consultation with the Attorney General.

        (3) Submitted names; use of databases by attorney general.--
            (A) In general.--Upon the receipt of names and other 
        identifying information under paragraph (2)(B), the Attorney 
        General shall, for the sole purpose of identifying whether the 
        individuals involved are within any of the categories specified 
        in subparagraph (B), promptly use criminal, immigration, 
        national security, and other electronic databases that are 
        available to the Federal Government and are appropriate for 
        such purpose.
            (B) Certain individuals.--For purposes of subparagraph (A), 
        the categories specified in this subparagraph regarding an 
        individual are that--
                (i) the individual is within any of the categories 
            described in section 175b(d)(1) of title 18, United States 
            Code (relating to restricted persons); or
                (ii) the individual is reasonably suspected by any 
            Federal law enforcement or intelligence agency of--

                    (I) committing a crime set forth in section 
                2332b(g)(5) of title 18, United States Code;
                    (II) knowing involvement with an organization that 
                engages in domestic or international terrorism (as 
                defined in section 2331 of such title 18) or with any 
                other organization that engages in intentional crimes 
                of violence; or
                    (III) being an agent of a foreign power (as defined 
                in section 1801 of title 50, United States Code).

            (C) Notification by attorney general regarding submitted 
        names.--After the receipt of a name and other identifying 
        information under paragraph (2)(B), the Attorney General shall 
        promptly notify the Secretary whether the individual is within 
        any of the categories specified in subparagraph (B).
        (4) Notifications by secretary.--The Secretary, after receiving 
    notice under paragraph (3) regarding an individual, shall promptly 
    notify the registered person involved of whether the individual is 
    granted or denied access under paragraph (2). If the individual is 
    denied such access, the Secretary shall promptly notify the 
    individual of the denial.
        (5) Expedited review.--Regulations under subsections (b) and 
    (c) shall provide for a procedure through which, upon request to 
    the Secretary by a registered person who submits names and other 
    identifying information under paragraph (2)(B) and who demonstrates 
    good cause, the Secretary may, as determined appropriate by the 
    Secretary--
            (A) request the Attorney General to expedite the process of 
        identification under paragraph (3)(A) and notification of the 
        Secretary under paragraph (3)(C); and
            (B) expedite the notification of the registered person by 
        the Secretary under paragraph (4).
        (6) Process regarding persons seeking to register.--
            (A) Individuals.--Regulations under subsections (b) and (c) 
        shall provide that an individual who seeks to register under 
        either of such subsections is subject to the same processes 
        described in paragraphs (2) through (4) as apply to names and 
        other identifying information submitted to the Attorney General 
        under paragraph (2)(B). Paragraph (5) does not apply for 
        purposes of this subparagraph.
            (B) Other persons.--Regulations under subsections (b) and 
        (c) shall provide that, in determining whether to deny or 
        revoke registration by a person other than an individual, the 
        Secretary shall submit the name of such person to the Attorney 
        General, who shall use criminal, immigration, national 
        security, and other electronic databases available to the 
        Federal Government, as appropriate for the purpose of promptly 
        notifying the Secretary whether the person, or, where relevant, 
        the individual who owns or controls such person, is within any 
        of the categories described in section 175b(d)(1) of title 18, 
        United States Code (relating to restricted persons), or is 
        reasonably suspected by any Federal law enforcement or 
        intelligence agency of being within any category specified in 
        paragraph (3)(B)(ii) (as applied to persons, including 
        individuals). Such regulations shall provide that a person who 
        seeks to register under either of such subsections is subject 
        to the same processes described in paragraphs (2) and (4) as 
        apply to names and other identifying information submitted to 
        the Attorney General under paragraph (2)(B). Paragraph (5) does 
        not apply for purposes of this subparagraph. The Secretary may 
        exempt Federal, State, or local governmental agencies from the 
        requirements of this subparagraph.
        (7) Review.--
            (A) Administrative review.--
                (i) In general.--Regulations under subsections (b) and 
            (c) shall provide for an opportunity for a review by the 
            Secretary--

                    (I) when requested by the individual involved, of a 
                determination under paragraph (2) to deny the 
                individual access to listed agents and toxins; and
                    (II) when requested by the person involved, of a 
                determination under under paragraph (6) to deny or 
                revoke registration for such person.

                (ii) Ex parte review.--During a review under clause 
            (i), the Secretary may consider information relevant to the 
            review ex parte to the extent that disclosure of the 
            information could compromise national security or an 
            investigation by any law enforcement agency.
                (iii) Final agency action.--The decision of the 
            Secretary in a review under clause (i) constitutes final 
            agency action for purposes of section 702 of title 5, 
            United States Code.
            (B) Certain procedures.--
                (i) Submission of ex parte materials in judicial 
            proceedings.--When reviewing a decision of the Secretary 
            under subparagraph (A), and upon request made ex parte and 
            in writing by the United States, a court, upon a sufficient 
            showing, may review and consider ex parte documents 
            containing information the disclosure of which could 
            compromise national security or an investigation by any law 
            enforcement agency. If the court determines that portions 
            of the documents considered ex parte should be disclosed to 
            the person involved to allow a response, the court shall 
            authorize the United States to delete from such documents 
            specified items of information the disclosure of which 
            could compromise national security or an investigation by 
            any law enforcement agency, or to substitute a summary of 
            the information to which the person may respond. Any order 
            by the court authorizing the disclosure of information that 
            the United States believes could compromise national 
            security or an investigation by any law enforcement agency 
            shall be subject to the processes set forth in 
            subparagraphs (A) and (B)(i) of section 2339B(f)(5) of 
            title 18, United States Code (relating to interlocutory 
            appeal and expedited consideration).
                (ii) Disclosure of information.--In a review under 
            subparagraph (A), and in any judical proceeding conducted 
            pursuant to such review, neither the Secretary nor the 
            Attorney General may be required to disclose to the public 
            any information that under subsection (h) shall not be 
            disclosed under section 552 of title 5, United States Code.
        (8) Notifications regarding theft or loss of agents.--
    Requirements under paragraph (1) shall include the prompt 
    notification of the Secretary, and appropriate Federal, State, and 
    local law enforcement agencies, of the theft or loss of listed 
    agents and toxins.
        (9) Technical assistance for registered persons.--The 
    Secretary, in consultation with the Attorney General, may provide 
    technical assistance to registered persons to improve security of 
    the facilities of such persons.
    (f) Inspections.--The Secretary shall have the authority to inspect 
persons subject to regulations under subsection (b) or (c) to ensure 
their compliance with such regulations, including prohibitions on 
restricted persons and other provisions of subsection (e).
    (g) Exemptions.--
        (1) Overlap agents and toxins.--
            (A) In general.--
                (i) Limitation.--In the case of overlap agents and 
            toxins, exemptions from the applicability of provisions of 
            regulations under subsection (b) or (c) may be granted only 
            to the extent provided in this paragraph.
                (ii) Definitions.--For purposes of this section:

                    (I) The term ``overlap agents and toxins'' means 
                biological agents and toxins that--

                        (aa) are listed pursuant to subsection (a)(1); 
                    and
                        (bb) are listed pursuant to section 315A(a)(1) 
                    of the Public Health Service Act.

                    (II) The term ``overlap agent or toxin'' means a 
                biological agent or toxin that--

                        (aa) is listed pursuant to subsection (a)(1); 
                    and
                        (bb) is listed pursuant to section 315A(a)(1) 
                    of the Public Health Service Act.
            (B) Clinical or diagnostic laboratories.--Regulations under 
        subsections (b) and (c) shall exempt clinical or diagnostic 
        laboratories and other persons who possess, use, or transfer 
        overlap agents or toxins that are contained in specimens 
        presented for diagnosis, verification, or proficiency testing, 
        provided that--
                (i) the identification of such agents or toxins is 
            reported to the Secretary, and when required under Federal, 
            State, or local law, to other appropriate authorities; and
                (ii) such agents or toxins are transferred or destroyed 
            in a manner set forth by the Secretary by regulation.
            (C) Products.--
                (i) In general.--Regulations under subsections (b) and 
            (c) shall exempt products that are, bear, or contain 
            overlap agents or toxins and are cleared, approved, 
            licensed, or registered under any of the Acts specified in 
            clause (ii), unless the Secretary by order determines that 
            applying additional regulation under subsection (b) or (c) 
            to a specific product is necessary to protect animal or 
            plant health, or animal or plant products.
                (ii) Relevant laws.--For purposes of clause (i), the 
            Acts specified in this clause are the following:

                    (I) The Federal Food, Drug, and Cosmetic Act.
                    (II) Section 351 of the Public Health Service Act.
                    (III) The Act commonly known as the Virus-Serum-
                Toxin Act (the eighth paragraph under the heading 
                ``Bureau of Animal Industry'' in the Act of March 4, 
                1913; 21 U.S.C. 151-159).
                    (IV) The Federal Insecticide, Fungicide, and 
                Rodenticide Act.

                (iii) Investigational use.--

                    (I) In general.--The Secretary may exempt an 
                investigational product that is, bears, or contains an 
                overlap agent or toxin from the applicability of 
                provisions of regulations under subsection (b) or (c) 
                when such product is being used in an investigation 
                authorized under any Federal Act and the Secretary 
                determines that applying additional regulation under 
                subsection (b) or (c) to such product is not necessary 
                to protect animal and plant health, and animal and 
                plant products.
                    (II) Certain processes.--Regulations under 
                subsections (b) and (c) shall set forth the procedures 
                for applying for an exemption under subclause (I). In 
                the case of investigational products authorized under 
                any of the Acts specified in clause (ii), the Secretary 
                shall make a determination regarding a request for an 
                exemption not later than 14 days after the first date 
                on which both of the following conditions have been met 
                by the person requesting the exemption:

                        (aa) The person has submitted to the Secretary 
                    an application for the exemption meeting the 
                    requirements established by the Secretary.
                        (bb) The person has notified the Secretary that 
                    the investigation has been authorized under such an 
                    Act.
            (D) Agricultural emergencies.--The Secretary may 
        temporarily exempt a person from the applicability of the 
        requirements of this section with respect to an overlap agent 
        or toxin, in whole or in part, if the Secretary determines that 
        such exemption is necessary to provide for the timely 
        participation of the person in a response to a domestic or 
        foreign agricultural emergency that involves such an agent or 
        toxin. With respect to the emergency involved, the exemption 
        under this subparagraph for a person may not exceed 30 days, 
        except that the Secretary, after review of whether such 
        exemption remains necessary, may provide one extension of an 
        additional 30 days.
            (E) Public health emergencies.--Upon request of the 
        Secretary of Health and Human Services, after the granting by 
        such Secretary of an exemption under 351A(g)(3) of the Public 
        Health Service Act pursuant to a finding that there is a public 
        health emergency, the Secretary of Agriculture may temporarily 
        exempt a person from the applicability of the requirements of 
        this section with respect to an overlap agent or toxin, in 
        whole or in part, to provide for the timely participation of 
        the person in a response to the public health emergency. With 
        respect to the emergency involved, such exemption for a person 
        may not exceed 30 days, except that upon request of the 
        Secretary of Health and Human Services, the Secretary of 
        Agriculture may, after review of whether such exemption remains 
        necessary, provide one extension of an additional 30 days.
        (2) General authority for exemptions not involving overlap 
    agents or toxins.--In the case of listed agents or toxins that are 
    not overlap agents or toxins, the Secretary may grant exemptions 
    from the applicability of provisions of regulations under 
    subsection (b) or (c) if the Secretary determines that such 
    exemptions are consistent with protecting animal and plant health, 
    and animal and plant products.
    (h) Disclosure of Information.--
        (1) Nondisclosure of certain information.--No Federal agency 
    specified in paragraph (2) shall disclose under section 552 of 
    title 5, United States Code, any of the following:
            (A) Any registration or transfer documentation submitted 
        under subsections (b) and (c), or permits issued prior to the 
        date of the enactment of this Act, for the possession, use or 
        transfer of a listed agent or toxin; or information derived 
        therefrom to the extent that it identifies the listed agent or 
        toxin possessed, used or transferred by a specific person or 
        discloses the identity or location of a specific person.
            (B) The national database developed pursuant to subsection 
        (d), or any other compilation of the registration or transfer 
        information submitted under subsections (b) and (c) to the 
        extent that such compilation discloses site-specific 
        registration or transfer information.
            (C) Any portion of a record that discloses the site-
        specific or transfer-specific safeguard and security measures 
        used by a registered person to prevent unauthorized access to 
        listed agents and toxins.
            (D) Any notification of a release of a listed agent or 
        toxin submitted under subsections (b) and (c), or any 
        notification of theft or loss submitted under such subsections.
            (E) Any portion of an evaluation or report of an inspection 
        of a specific registered person conducted under subsection (f) 
        that identifies the listed agent or toxin possessed by a 
        specific registered person or that discloses the identity or 
        location of a specific registered person if the agency 
        determines that public disclosure of the information would 
        endanger animal or plant health, or animal or plant products.
        (2) Covered agencies.--For purposes of paragraph (1) only, the 
    Federal agencies specified in this paragraph are the following:
            (A) The Department of Health and Human Services, the 
        Department of Justice, the Department of Agriculture, and the 
        Department of Transportation.
            (B) Any Federal agency to which information specified in 
        paragraph (1) is transferred by any agency specified in 
        subparagraph (A) of this paragraph.
            (C) Any Federal agency that is a registered person, or has 
        a sub-agency component that is a registered person.
            (D) Any Federal agency that awards grants or enters into 
        contracts or cooperative agreements involving listed agents and 
        toxins to or with a registered person, and to which information 
        specified in paragraph (1) is transferred by any such 
        registered person.
        (3) Other exemptions.--This subsection may not be construed as 
    altering the application of any exemptions to public disclosure 
    under section 552 of title 5, United States Code, except as to 
    subsection 552(b)(3) of such title, to any of the information 
    specified in paragraph (1).
        (4) Rule of construction.--Except as specifically provided in 
    paragraph (1), this subsection may not be construed as altering the 
    authority of any Federal agency to withhold under section 552 of 
    title 5, United States Code, or the obligation of any Federal 
    agency to disclose under section 552 of title 5, United States 
    Code, any information, including information relating to--
            (A) listed agents and toxins, or individuals seeking access 
        to such agents and toxins;
            (B) registered persons, or persons seeking to register 
        their possession, use, or transfer of such agents and toxins;
            (C) general safeguard and security policies and 
        requirements under regulations under subsections (b) and (c); 
        or
            (D) summary or statistical information concerning 
        registrations, registrants, denials or revocations of 
        registrations, listed agents and toxins, inspection evaluations 
        and reports, or individuals seeking access to such agents and 
        toxins.
        (5) Disclosures to congress; other disclosures.--This 
    subsection may not be construed as providing any authority--
            (A) to withhold information from the Congress or any 
        committee or subcommittee thereof; or
            (B) to withhold information from any person under any other 
        Federal law or treaty.
    (i) Civil Money Penalty.--
        (1) In general.--In addition to any other penalties that may 
    apply under law, any person who violates any provision of 
    regulations under subsection (b) or (c) shall be subject to the 
    United States for a civil money penalty in an amount not exceeding 
    $250,000 in the case of an individual and $500,000 in the case of 
    any other person.
        (2) Applicability of certain provisions.--The provisions of 
    sections 423 and 425(2) of the Plant Protection Act (7 U.S.C. 7733 
    and 7735(2)) shall apply to a civil money penalty or activity under 
    paragraph (1) in the same manner as such provisions apply to a 
    penalty or activity under the Plant Protection Act.
    (j) Notification in Event of Release.--Regulations under 
subsections (b) and (c) shall require the prompt notification of the 
Secretary by a registered person whenever a release, meeting criteria 
established by the Secretary, of a listed agent or toxin has occurred 
outside of the biocontainment area of a facility of the registered 
person. Upon receipt of such notification and a finding by the 
Secretary that the release poses a threat to animal or plant health, or 
animal or plant products, the Secretary shall take appropriate action 
to notify relevant Federal, State, and local authorities, and, if 
necessary, other appropriate persons (including the public). If the 
released listed agent or toxin is an overlap agent or toxin, the 
Secretary shall promptly notify the Secretary of Health and Human 
Services upon notification by the registered person.
    (k) Reports.--The Secretary shall report to the Congress annually 
on the number and nature of notifications received under subsection 
(e)(8) (relating to theft or loss) and subsection (j) (relating to 
releases).
    (l) Definitions.--For purposes of this section:
        (1) The terms ``biological agent'' and ``toxin'' have the 
    meanings given such terms in section 178 of title 18, United States 
    Code.
        (2) The term ``listed agents and toxins'' means biological 
    agents and toxins listed pursuant to subsection (a)(1).
        (3) The term ``listed agents or toxins'' means biological 
    agents or toxins listed pursuant to subsection (a)(1).
        (4) The terms ``overlap agents and toxins'' and ``overlap agent 
    or toxin'' have the meaning given such terms in subsection 
    (g)(1)(A)(ii).
        (5) The term ``person'' includes Federal, State, and local 
    governmental entities.
        (6) The term ``registered person'' means a person registered 
    under regulations under subsection (b) or (c).
        (7) The term ``Secretary'' means the Secretary of Agriculture.
    (m) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of the fiscal years 2002 through 2007, in 
addition to other funds that may be available.

SEC. 213. IMPLEMENTATION BY DEPARTMENT OF AGRICULTURE.

    (a) Date Certain for Promulgation of List.--Not later than 60 days 
after the date of the enactment of this Act, the Secretary of 
Agriculture (referred to in this section as the ``Secretary'') shall 
promulgate an interim final rule that establishes the initial list 
under section 212(a)(1). In promulgating such rule, the Secretary shall 
provide written guidance on the manner in which the notice required in 
subsection (b) is to be provided to the Secretary.
    (b) Date Certain for Notice of Possession.--Not later than 60 days 
after the date on which the Secretary promulgates the interim final 
rule under subsection (a), all persons (unless exempt under section 
212(g)) in possession of biological agents or toxins included on the 
list referred to in subsection (a) shall notify the Secretary of such 
possession.
    (c) Date Certain for Promulgation; Effective Date Regarding 
Criminal and Civil Penalties.--Not later than 180 days after the date 
of the enactment of this Act, the Secretary shall promulgate an interim 
final rule for carrying out section 212, other than for the list 
referred to in subsection (a) of this section (but such rule may 
incorporate by reference provisions promulgated pursuant to subsection 
(a)). Such interim final rule shall take effect 60 days after the date 
on which such rule is promulgated, including for purposes of--
        (1) section 175b(c) of title 18, United States Code (relating 
    to criminal penalties), as added by section 231(a)(5) of this Act; 
    and
        (2) section 212(i) of this Act (relating to civil penalties).
    (d) Transitional Provision Regarding Current Research and 
Education.--The interim final rule under subsection (c) shall include 
time frames for the applicability of the rule that minimize disruption 
of research or educational projects that involve biological agents and 
toxins listed pursuant to section 212(a)(1) and that were underway as 
of the effective date of such rule.

   Subtitle C--Interagency Coordination Regarding Overlap Agents and 
                                 Toxins

SEC. 221. INTERAGENCY COORDINATION.

    (a) In General.--
        (1) Coordination.--The Secretary of Agriculture and the 
    Secretary of Health and Human Services shall in accordance with 
    this section coordinate activities regarding overlap agents and 
    toxins.
        (2) Overlap agents and toxins; other terms.--For purposes of 
    this section:
            (A) The term ``overlap agent or toxin'' means a biological 
        agent or toxin that--
                (i) is listed pursuant to section 315A(a)(1) of the 
            Public Health Service Act, as added by section 201 of this 
            Act; and
                (ii) is listed pursuant to section 212(a)(1) of this 
            Act.
            (B) The term ``section 351A program'' means the program 
        under section 351A of the Public Health Service Act.
            (C) The term ``section 212 program'' means the program 
        under section 212 of this Act.
    (b) Certain Matters.--In carrying out the section 351A program and 
the section 212 program, the Secretary of Health and Human Services and 
the Secretary of Agriculture shall, to the greatest extent practicable, 
coordinate activities to achieve the following purposes:
        (1) To minimize any conflicts between the regulations issued 
    under, and activities carried out under, such programs.
        (2) To minimize the administrative burden on persons subject to 
    regulation under both of such programs.
        (3) To ensure the appropriate availability of biological agents 
    and toxins for legitimate biomedical, agricultural or veterinary 
    research, education, or other such purposes.
        (4) To ensure that registration information for overlap agents 
    and toxins under the section 351A and section 212 programs is 
    contained in both the national database under the section 351A 
    program and the national database under the section 212 program.
    (c) Memorandum of Understanding.--
        (1) In general.--Promptly after the date of the enactment of 
    this Act, the Secretary of Agriculture and the Secretary of Health 
    and Human Services shall enter into a memorandum of understanding 
    regarding overlap agents and toxins that is in accordance with 
    paragraphs (2) through (4) and contains such additional provisions 
    as the Secretary of Agriculture and the Secretary of Health and 
    Human Services determine to be appropriate.
        (2) Single registration system regarding registered persons.--
    The memorandum of understanding under paragraph (1) shall provide 
    for the development and implementation of a single system of 
    registration for persons who possess, use, or transfer overlap 
    agents or toxins and are required to register under both the 
    section 351A program and the section 212 program. For purposes of 
    such system, the memorandum shall provide for the development and 
    implementation of the following:
            (A) A single registration form through which the person 
        submitting the form provides all information that is required 
        for registration under the section 351A program and all 
        information that is required for registration under the section 
        212 program.
            (B) A procedure through which a person may choose to submit 
        the single registration form to the agency administering the 
        section 351A program (in the manner provided under such 
        program), or to the agency administering the section 212 
        program (in the manner provided under such program).
            (C) A procedure through which a copy of a single 
        registration form received pursuant to subparagraph (B) by the 
        agency administering one of such programs is promptly provided 
        to the agency administering the other program.
            (D) A procedure through which the agency receiving the 
        single registration form under one of such programs obtains the 
        concurrence of the agency administering the other program that 
        the requirements for registration under the other program have 
        been met.
            (E) A procedure through which--
                (i) the agency receiving the single registration form 
            under one of such programs informs the agency administering 
            the other program whether the receiving agency has denied 
            the registration; and
                (ii) each of such agencies ensures that registrations 
            are entered into the national database of registered 
            persons that is maintained by each such agency.
        (3) Process of identification.--With respect to the process of 
    identification under the section 351A program and the section 212 
    program for names and other identifying information submitted to 
    the Attorney General (relating to certain categories of individuals 
    and entities), the memorandum of understanding under paragraph (1) 
    shall provide for the development and implementation of the 
    following:
            (A) A procedure through which a person who is required to 
        submit information pursuant to such process makes (in addition 
        to the submission to the Attorney General) a submission, at the 
        option of the person, to either the agency administering the 
        section 351A program or the agency administering the section 
        212 program, but not both, which submission satisfies the 
        requirement of submission for both of such programs.
            (B) A procedure for the sharing by both of such agencies of 
        information received from the Attorney General by one of such 
        agencies pursuant to the submission under subparagraph (A).
            (C) A procedure through which the agencies administering 
        such programs concur in determinations that access to overlap 
        agents and toxins will be granted.
        (4) Coordination of inspections and enforcement.--The 
    memorandum of understanding under paragraph (1) shall provide for 
    the development and implementation of procedures under which 
    Federal personnel under the section 351A program and the section 
    212 program may share responsibilities for inspections and 
    enforcement activities under such programs regarding overlap agents 
    and toxins. Activities carried out under such procedures by one of 
    such programs on behalf of the other may be carried out with or 
    without reimbursement by the agency that administers the other 
    program.
        (5) Date certain for implementation.--The memorandum of 
    understanding under paragraph (1) shall be implemented not later 
    than 180 days after the date of the enactment of this Act. Until 
    the single system of registration under paragraph (2) is 
    implemented, persons who possess, use, or transfer overlap agents 
    or toxins shall register under both the section 351A program and 
    the section 212 program.
    (d) Joint Regulations.--Not later than 18 months after the date on 
which the single system of registration under subsection (c)(2) is 
implemented, the Secretary of Health and Human Services and the 
Secretary of Agriculture shall jointly issue regulations for the 
possession, use, and transfer of overlap agents and toxins that meet 
the requirements of both the section 351A program and the section 212 
program.

Subtitle D--Criminal Penalties Regarding Certain Biological Agents and 
                                 Toxins

SEC. 231. CRIMINAL PENALTIES.

    (a) In General.--Section 175b of title 18, United States Code, as 
added by section 817 of Public Law 107-56, is amended--
        (1) by striking ``(a)'' and inserting ``(a)(1)'';
        (2) by transferring subsection (c) from the current placement 
    of the subsection and inserting the subsection before subsection 
    (b);
        (3) by striking ``(c)'' and inserting ``(2);
        (4) by redesignating subsection (b) as subsection (d); and
        (5) by inserting before subsection (d) (as so redesignated) the 
    following subsections:
    ``(b) Transfer to Unregistered Person.--
        ``(1) Select agents.--Whoever transfers a select agent to a 
    person who the transferor knows or has reasonable cause to believe 
    is not registered as required by regulations under subsection (b) 
    or (c) of section 351A of the Public Health Service Act shall be 
    fined under this title, or imprisoned for not more than 5 years, or 
    both.
        ``(2) Certain other biological agents and toxins.--Whoever 
    transfers a biological agent or toxin listed pursuant to section 
    212(a)(1) of the Agricultural Bioterrorism Protection Act of 2002 
    to a person who the transferor knows or has reasonable cause to 
    believe is not registered as required by regulations under 
    subsection (b) or (c) of section 212 of such Act shall be fined 
    under this title, or imprisoned for not more than 5 years, or both.
    ``(c) Unregistered for Possession.--
        ``(1) Select agents.--Whoever knowingly possesses a biological 
    agent or toxin where such agent or toxin is a select agent for 
    which such person has not obtained a registration required by 
    regulations under section 351A(c) of the Public Health Service Act 
    shall be fined under this title, or imprisoned for not more than 5 
    years, or both.
        ``(2) Certain other biological agents and toxins.--Whoever 
    knowingly possesses a biological agent or toxin where such agent or 
    toxin is a biological agent or toxin listed pursuant to section 
    212(a)(1) of the Agricultural Bioterrorism Protection Act of 2002 
    for which such person has not obtained a registration required by 
    regulations under section 212(c) of such Act shall be fined under 
    this title, or imprisoned for not more than 5 years, or both.''.
    (b) Conforming Amendments.--Chapter 10 of title 18, United States 
Code, is amended--
        (1) in section 175b (as added by section 817 of Public Law 107-
    56 and amended by subsection (a) of this section)--
            (A) in subsection (d)(1), by striking ``The term'' and all 
        that follows through ``does not include'' and inserting the 
        following: ``The term `select agent' means a biological agent 
        or toxin to which subsection (a) applies. Such term (including 
        for purposes of subsection (a)) does not include''; and
            (B) in the heading for the section, by striking 
        ``Possession by restricted persons'' and inserting ``Select 
        agents; certain other agents''; and
        (2) in the chapter analysis, in the item relating to section 
    175b, by striking ``Possession by restricted persons.'' and 
    inserting ``Select agents; certain other agents.''.
    (c) Technical Corrections.--Chapter 10 of title 18, United States 
Code, as amended by section 817 of Public Law 107-56 and subsections 
(a) and (b) of this section, is amended--
        (1) in section 175(c), by striking ``protective'' and all that 
    follows and inserting ``protective, bona fide research, or other 
    peaceful purposes.'';
        (2) in section 175b--
            (A) in subsection (a)(1), by striking ``described in 
        subsection (b)'' and all that follows and inserting the 
        following: ``shall ship or transport in or affecting interstate 
        or foreign commerce, or possess in or affecting interstate or 
        foreign commerce, any biological agent or toxin, or receive any 
        biological agent or toxin that has been shipped or transported 
        in interstate or foreign commerce, if the biological agent or 
        toxin is listed as a select agent in Appendix A of part 72 of 
        title 42, Code of Federal Regulations, pursuant to section 351A 
        of the Public Health Service Act, and is not exempted under 
        subsection (h) of section 72.6, or Appendix A of part 72, of 
        title 42, Code of Federal Regulations.''; and
            (B) in subsection (d)(3), by striking ``section 
        1010(a)(3)'' and inserting ``section 101(a)(3)'';
        (3) in section 176(a)(1)(A), by striking ``exists by reason 
    of'' and inserting ``pertains to''; and
        (4) in section 178--
            (A) in paragraph (1), by striking ``means any micro-
        organism'' and all that follows through ``product, capable of'' 
        and inserting the following: ``means any microorganism 
        (including, but not limited to, bacteria, viruses, fungi, 
        rickettsiae or protozoa), or infectious substance, or any 
        naturally occurring, bioengineered or synthesized component of 
        any such microorganism or infectious substance, capable of'';
            (B) in paragraph (2), by striking ``means the toxic'' and 
        all that follows through ``including--'' and inserting the 
        following: ``means the toxic material or product of plants, 
        animals, microorganisms (including, but not limited to, 
        bacteria, viruses, fungi, rickettsiae or protozoa), or 
        infectious substances, or a recombinant or synthesized 
        molecule, whatever their origin and method of production, and 
        includes--''; and
            (C) in paragraph (4), by striking ``recombinant molecule,'' 
        and all that follows through ``biotechnology,'' and inserting 
        ``recombinant or synthesized molecule,''.
    (d) Additional Technical Correction.--Section 2332a of title 18, 
United States Code, is amended--
        (1) in subsection (a), in the matter preceding paragraph (1), 
    by striking ``section 229F)'' and all that follows through 
    ``section 178)--'' and inserting ``section 229F)--''; and
        (2) in subsection (c)(2)(C), by striking ``a disease organism'' 
    and inserting ``a biological agent, toxin, or vector (as those 
    terms are defined in section 178 of this title)''.

   TITLE III--PROTECTING SAFETY AND SECURITY OF FOOD AND DRUG SUPPLY
                 Subtitle A--Protection of Food Supply

SEC. 301. FOOD SAFETY AND SECURITY STRATEGY.

    (a) In General.--The President's Council on Food Safety (as 
established by Executive Order No. 13100) shall, in consultation with 
the Secretary of Transportation, the Secretary of the Treasury, other 
relevant Federal agencies, the food industry, consumer and producer 
groups, scientific organizations, and the States, develop a crisis 
communications and education strategy with respect to bioterrorist 
threats to the food supply. Such strategy shall address threat 
assessments; technologies and procedures for securing food processing 
and manufacturing facilities and modes of transportation; response and 
notification procedures; and risk communications to the public.
    (b) Authorization of Appropriations.--For the purpose of 
implementing the strategy developed under subsection (a), there are 
authorized to be appropriated $750,000 for fiscal year 2002, and such 
sums as may be necessary for each subsequent fiscal year.

SEC. 302. PROTECTION AGAINST ADULTERATION OF FOOD.

    (a) Increasing Inspections for Detection of Adulteration of Food.--
Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) 
is amended by adding at the end the following subsection:
    ``(h)(1) The Secretary shall give high priority to increasing the 
number of inspections under this section for the purpose of enabling 
the Secretary to inspect food offered for import at ports of entry into 
the United States, with the greatest priority given to inspections to 
detect the intentional adulteration of food.''.
    (b) Improvements to Information Management Systems.--Section 801(h) 
of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) 
of this section, is amended by adding at the end the following 
paragraph:
    ``(2) The Secretary shall give high priority to making necessary 
improvements to the information management systems of the Food and Drug 
Administration that contain information related to foods imported or 
offered for import into the United States for purposes of improving the 
ability of the Secretary to allocate resources, detect the intentional 
adulteration of food, and facilitate the importation of food that is in 
compliance with this Act.''.
    (c) Linkages With Appropriate Public Entities.--Section 801(h) of 
the Federal Food, Drug, and Cosmetic Act, as amended by subsection (b) 
of this section, is amended by adding at the end the following 
paragraph:
    ``(3) The Secretary shall improve linkages with other regulatory 
agencies of the Federal Government that share responsibility for food 
safety, and shall with respect to such safety improve linkages with the 
States and Indian tribes (as defined in section 4(e) of the Indian 
Self-Determination and Education Assistance Act (25 U.S.C. 
450b(e))).''.
    (d) Testing for Rapid Detection of Adulteration of Food.--Section 
801 of the Federal Food, Drug, and Cosmetic Act, as amended by 
subsection (a) of this section, is amended by adding at the end the 
following:
    ``(i)(1) For use in inspections of food under this section, the 
Secretary shall provide for research on the development of tests and 
sampling methodologies--
        ``(A) whose purpose is to test food in order to rapidly detect 
    the adulteration of the food, with the greatest priority given to 
    detect the intentional adulteration of food; and
        ``(B) whose results offer significant improvements over the 
    available technology in terms of accuracy, timing, or costs.
    ``(2) In providing for research under paragraph (1), the Secretary 
shall give priority to conducting research on the development of tests 
that are suitable for inspections of food at ports of entry into the 
United States.
    ``(3) In providing for research under paragraph (1), the Secretary 
shall as appropriate coordinate with the Director of the Centers for 
Disease Control and Prevention, the Director of the National Institutes 
of Health, the Administrator of the Environmental Protection Agency, 
and the Secretary of Agriculture.
    ``(4) The Secretary shall annually submit to the Committee on 
Energy and Commerce of the House of Representatives, and the Committee 
on Health, Education, Labor, and Pensions of the Senate, a report 
describing the progress made in research under paragraph (1), including 
progress regarding paragraph (2).''.
    (e) Assessment of Threat of Intentional Adulteration of Food.--The 
Secretary of Health and Human Services, acting through the Commissioner 
of Food and Drugs, shall ensure that, not later than six months after 
the date of the enactment of this Act--
        (1) the assessment that (as of such date of enactment) is being 
    conducted on the threat of the intentional adulteration of food is 
    completed; and
        (2) a report describing the findings of the assessment is 
    submitted to the Committee on Energy and Commerce of the House of 
    Representatives and to the Committee on Health, Education, Labor, 
    and Pensions of the Senate.
    (f) Authorization of Appropriations.--For the purpose of carrying 
out this section and the amendments made by this section, there are 
authorized to be appropriated $100,000,000 for fiscal year 2002, and 
such sums as may be necessary for each of the fiscal years 2003 through 
2006, in addition to other authorizations of appropriations that are 
available for such purpose.

SEC. 303. ADMINISTRATIVE DETENTION.

    (a) Expanded Authority.--Section 304 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 334) is amended by adding at the end the 
following subsection:
    ``(h) Administrative Detention of Foods.--
        ``(1) Detention authority.--
            ``(A) In general.--An officer or qualified employee of the 
        Food and Drug Administration may order the detention, in 
        accordance with this subsection, of any article of food that is 
        found during an inspection, examination, or investigation under 
        this Act conducted by such officer or qualified employee, if 
        the officer or qualified employee has credible evidence or 
        information indicating that such article presents a threat of 
        serious adverse health consequences or death to humans or 
        animals.
            ``(B) Secretary's approval.--An article of food may be 
        ordered detained under subparagraph (A) only if the Secretary 
        or an official designated by the Secretary approves the order. 
        An official may not be so designated unless the official is the 
        director of the district under this Act in which the article 
        involved is located, or is an official senior to such director.
        ``(2) Period of detention.--An article of food may be detained 
    under paragraph (1) for a reasonable period, not to exceed 20 days, 
    unless a greater period, not to exceed 30 days, is necessary, to 
    enable the Secretary to institute an action under subsection (a) or 
    section 302. The Secretary shall by regulation provide for 
    procedures for instituting such action on an expedited basis with 
    respect to perishable foods.
        ``(3) Security of detained article.--An order under paragraph 
    (1) with respect to an article of food may require that such 
    article be labeled or marked as detained, and shall require that 
    the article be removed to a secure facility, as appropriate. An 
    article subject to such an order shall not be transferred by any 
    person from the place at which the article is ordered detained, or 
    from the place to which the article is so removed, as the case may 
    be, until released by the Secretary or until the expiration of the 
    detention period applicable under such order, whichever occurs 
    first. This subsection may not be construed as authorizing the 
    delivery of the article pursuant to the execution of a bond while 
    the article is subject to the order, and section 801(b) does not 
    authorize the delivery of the article pursuant to the execution of 
    a bond while the article is subject to the order.
        ``(4) Appeal of detention order.--
            ``(A) In general.--With respect to an article of food 
        ordered detained under paragraph (1), any person who would be 
        entitled to be a claimant for such article if the article were 
        seized under subsection (a) may appeal the order to the 
        Secretary. Within five days after such an appeal is filed, the 
        Secretary, after providing opportunity for an informal hearing, 
        shall confirm or terminate the order involved, and such 
        confirmation by the Secretary shall be considered a final 
        agency action for purposes of section 702 of title 5, United 
        States Code. If during such five-day period the Secretary fails 
        to provide such an opportunity, or to confirm or terminate such 
        order, the order is deemed to be terminated.
            ``(B) Effect of instituting court action.--The process 
        under subparagraph (A) for the appeal of an order under 
        paragraph (1) terminates if the Secretary institutes an action 
        under subsection (a) or section 302 regarding the article of 
        food involved.''.
    (b) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(bb) The transfer of an article of food in violation of an order 
under section 304(h), or the removal or alteration of any mark or label 
required by the order to identify the article as detained.''.
    (c) Temporary Holds at Ports of Entry.--Section 801 of the Federal 
Food, Drug, and Cosmetic Act, as amended by section 302(d)of this Act, 
is amended by adding at the end the following:
    ``(j)(1) If an officer or qualified employee of the Food and Drug 
Administration has credible evidence or information indicating that an 
article of food presents a threat of serious adverse health 
consequences or death to humans or animals, and such officer or 
qualified employee is unable to inspect, examine, or investigate such 
article upon the article being offered for import at a port of entry 
into the United States, the officer or qualified employee shall request 
the Secretary of Treasury to hold the food at the port of entry for a 
reasonable period of time, not to exceed 24 hours, for the purpose of 
enabling the Secretary to inspect, examine, or investigate the article 
as appropriate.
    ``(2) The Secretary shall request the Secretary of Treasury to 
remove an article held pursuant to paragraph (1) to a secure facility, 
as appropriate. During the period of time that such article is so held, 
the article shall not be transferred by any person from the port of 
entry into the United States for the article, or from the secure 
facility to which the article has been removed, as the case may be. 
Subsection (b) does not authorize the delivery of the article pursuant 
to the execution of a bond while the article is so held.
    ``(3) An officer or qualified employee of the Food and Drug 
Administration may make a request under paragraph (1) only if the 
Secretary or an official designated by the Secretary approves the 
request. An official may not be so designated unless the official is 
the director of the district under this Act in which the article 
involved is located, or is an official senior to such director.
    ``(4) With respect to an article of food for which a request under 
paragraph (1) is made, the Secretary, promptly after the request is 
made, shall notify the State in which the port of entry involved is 
located that the request has been made, and as applicable, that such 
article is being held under this subsection.''.

SEC. 304. DEBARMENT FOR REPEATED OR SERIOUS FOOD IMPORT VIOLATIONS.

    (a) Debarment Authority.--
        (1) Permissive debarment.--Section 306(b)(1) of the Federal 
    Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)(1)) is amended--
            (A) in subparagraph (A), by striking ``or'' after the comma 
        at the end;
            (B) in subparagraph (B), by striking the period at the end 
        and inserting ``, or''; and
            (C) by adding at the end the following subparagraph:
            ``(C) a person from importing an article of food or 
        offering such an article for import into the United States.''.
        (2) Amendment regarding debarment grounds.--Section 306(b)) of 
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) is 
    amended--
            (A) in paragraph (2), in the matter preceding subparagraph 
        (A), by inserting ``subparagraph (A) or (B) of'' before 
        ``paragraph (1)'';
            (B) by redesignating paragraph (3) as paragraph (4); and
            (C) by inserting after paragraph (2) the following 
        paragraph:
        ``(3) Persons subject to permissive debarment; food 
    importation.--A person is subject to debarment under paragraph 
    (1)(C) if--
            ``(A) the person has been convicted of a felony for conduct 
        relating to the importation into the United States of any food; 
        or
            ``(B) the person has engaged in a pattern of importing or 
        offering for import adulterated food that presents a threat of 
        serious adverse health consequences or death to humans or 
        animals.''.
    (b) Conforming Amendments.--Section 306 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 335a) is amended--
        (1) in subsection (a), in the heading for the subsection, by 
    striking ``Mandatory Debarment.--'' and inserting ``Mandatory 
    Debarment; Certain Drug Applications.--'';
        (2) in subsection (b)--
            (A) in the heading for the subsection, by striking 
        ``Permissive Debarment.--'' and inserting ``Permissive 
        Debarment; Certain Drug Applications; Food Imports.--''; and
            (B) in paragraph (2), in the heading for the paragraph, by 
        striking ``permissive debarment.--'' and inserting ``permissive 
        debarment; certain drug applications.--'';
        (3) in subsection (c)(2)(A)(iii), by striking ``subsection 
    (b)(2)'' and inserting ``paragraph (2) or (3) of subsection (b)'';
        (4) in subsection (d)(3)--
            (A) in subparagraph (A)(i), by striking ``or (b)(2)(A)'' 
        and inserting `` or paragraph (2)(A) or (3) of subsection 
        (b)'';
            (B) in subparagraph (A)(ii)(II), by inserting ``in 
        applicable cases,'' before ``sufficient audits'';
            (C) in subparagraph (B), in each of clauses (i) and (ii), 
        by inserting ``or subsection (b)(3)'' after ``subsection 
        (b)(2)(B)''; and
            (D) in subparagraph (B)(ii), by inserting before the period 
        the following: ``or the food importation process, as the case 
        may be''.
    (c) Effective Dates.--Section 306(l)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 335a(l)(2)) is amended--
        (1) in the first sentence--
            (A) by striking ``and'' after ``subsection (b)(2),''; and
            (B) by inserting ``, and subsection (b)(3)(A)'' after 
        ``subsection (b)(2)(B)''; and
        (2) in the second sentence, by inserting ``, subsection 
    (b)(3)(B),'' after ``subsection (b)(2)(B)''.
    (d) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act, as amended by section 303(b) of this Act, is amended by 
adding at the end the following:
    ``(cc) The importing or offering for import into the United States 
of an article of food by, with the assistance of, or at the direction 
of, a person debarred under section 306(b)(3).''.
    (e) Importation by Debarred Persons.--Section 801 of the Federal 
Food, Drug, and Cosmetic Act, as amended by section 303(c) of this Act, 
is amended by adding at the end the following subsection:
    ``(k)(1) If an article of food is being imported or offered for 
import into the United States, and the importer, owner, or consignee of 
the article is a person who has been debarred under section 306(b)(3), 
such article shall be held at the port of entry for the article, and 
may not be delivered to such person. Subsection (b) does not authorize 
the delivery of the article pursuant to the execution of a bond while 
the article is so held. The article shall be removed to a secure 
facility, as appropriate. During the period of time that such article 
is so held, the article shall not be transferred by any person from the 
port of entry into the United States for the article, or from the 
secure facility to which the article has been removed, as the case may 
be.
    ``(2) An article of food held under paragraph (1) may be delivered 
to a person who is not a debarred person under section 306(b)(3) if 
such person affirmatively establishes, at the expense of the person, 
that the article complies with the requirements of this Act, as 
determined by the Secretary.''.

SEC. 305. REGISTRATION OF FOOD FACILITIES.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the 
following:

``SEC. 415. REGISTRATION OF FOOD FACILITIES.

    ``(a) Registration.--
        ``(1) In general.--The Secretary shall by regulation require 
    that any facility engaged in manufacturing, processing, packing, or 
    holding food for consumption in the United States be registered 
    with the Secretary. To be registered--
            ``(A) for a domestic facility, the owner, operator, or 
        agent in charge of the facility shall submit a registration to 
        the Secretary; and
            ``(B) for a foreign facility, the owner, operator, or agent 
        in charge of the facility shall submit a registration to the 
        Secretary and shall include with the registration the name of 
        the United States agent for the facility.
        ``(2) Registration.--An entity (referred to in this section as 
    the `registrant') shall submit a registration under paragraph (1) 
    to the Secretary containing information necessary to notify the 
    Secretary of the name and address of each facility at which, and 
    all trade names under which, the registrant conducts business and, 
    when determined necessary by the Secretary through guidance, the 
    general food category (as identified under section 170.3 of title 
    21, Code of Federal Regulations) of any food manufactured, 
    processed, packed, or held at such facility. The registrant shall 
    notify the Secretary in a timely manner of changes to such 
    information.
        ``(3) Procedure.--Upon receipt of a completed registration 
    described in paragraph (1), the Secretary shall notify the 
    registrant of the receipt of such registration and assign a 
    registration number to each registered facility.
        ``(4) List.--The Secretary shall compile and maintain an up-to-
    date list of facilities that are registered under this section. 
    Such list and any registration documents submitted pursuant to this 
    subsection shall not be subject to disclosure under section 552 of 
    title 5, United States Code. Information derived from such list or 
    registration documents shall not be subject to disclosure under 
    section 552 of title 5, United States Code, to the extent that it 
    discloses the identity or location of a specific registered person.
    ``(b) Facility.--For purposes of this section:
        ``(1) The term `facility' includes any factory, warehouse, or 
    establishment (including a factory, warehouse, or establishment of 
    an importer) that manufactures, processes, packs, or holds food. 
    Such term does not include farms; restaurants; other retail food 
    establishments; nonprofit food establishments in which food is 
    prepared for or served directly to the consumer; or fishing vessels 
    (except such vessels engaged in processing as defined in section 
    123.3(k) of title 21, Code of Federal Regulations).
        ``(2) The term `domestic facility' means a facility located in 
    any of the States or Territories.
        ``(3)(A) The term `foreign facility' means a facility that 
    manufacturers, processes, packs, or holds food, but only if food 
    from such facility is exported to the United States without further 
    processing or packaging outside the United States.
        ``(B) A food may not be considered to have undergone further 
    processing or packaging for purposes of subparagraph (A) solely on 
    the basis that labeling was added or that any similar activity of a 
    de minimis nature was carried out with respect to the food.
    ``(c) Rule of Construction.--Nothing in this section shall be 
construed to authorize the Secretary to require an application, review, 
or licensing process.''.
    (b) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331), as amended by section 304(d) of this Act, 
is amended by adding at the end the following:
    ``(dd) The failure to register in accordance with section 415.''.
    (c) Importation; Failure to Register.--Section 801 of the Federal 
Food, Drug, and Cosmetic Act, as amended by section 304(e) of this Act, 
is amended by adding at the end the following subsection:
    ``(l)(1) If an article of food is being imported or offered for 
import into the United States, and such article is from a foreign 
facility for which a registration has not been submitted to the 
Secretary under section 415, such article shall be held at the port of 
entry for the article, and may not be delivered to the importer, owner, 
or consignee of the article, until the foreign facility is so 
registered. Subsection (b) does not authorize the delivery of the 
article pursuant to the execution of a bond while the article is so 
held. The article shall be removed to a secure facility, as 
appropriate. During the period of time that such article is so held, 
the article shall not be transferred by any person from the port of 
entry into the United States for the article, or from the secure 
facility to which the article has been removed, as the case may be.''.
    (d) Electronic Filing.--For the purpose of reducing paperwork and 
reporting burdens, the Secretary of Health and Human Services may 
provide for, and encourage the use of, electronic methods of submitting 
to the Secretary registrations required pursuant to this section. In 
providing for the electronic submission of such registrations, the 
Secretary shall ensure adequate authentication protocols are used to 
enable identification of the registrant and validation of the data as 
appropriate.
    (e) Rulemaking; Effective Date.--Not later than 18 months after the 
date of the enactment of this Act, the Secretary of Health and Human 
Services shall promulgate proposed and final regulations for the 
requirement of registration under section 415 of the Federal Food, 
Drug, and Cosmetic Act (as added by subsection (a) of this section). 
Such requirement of registration takes effect--
        (1) upon the effective date of such final regulations; or
        (2) upon the expiration of such 18-month period if the final 
    regulations have not been made effective as of the expiration of 
    such period, subject to compliance with the final regulations when 
    the final regulations are made effective.

SEC. 306. MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act, as amended by section 305 of this Act, is amended by inserting 
before section 415 the following section:

``SEC. 414. MAINTENANCE AND INSPECTION OF RECORDS.

    ``(a) Records Inspection.--If the Secretary has a reasonable belief 
that an article of food is adulterated and presents a threat of serious 
adverse health consequences or death to humans or animals, each person 
(excluding farms and restaurants) who manufactures, processes, packs, 
distributes, receives, holds, or imports such article shall, at the 
request of an officer or employee duly designated by the Secretary, 
permit such officer or employee, upon presentation of appropriate 
credentials and a written notice to such person, at reasonable times 
and within reasonable limits and in a reasonable manner, to have access 
to and copy all records relating to such article that are needed to 
assist the Secretary in determining whether the food is adulterated and 
presents a threat of serious adverse health consequences or death to 
humans or animals. The requirement under the preceding sentence applies 
to all records relating to the manufacture, processing, packing, 
distribution, receipt, holding, or importation of such article 
maintained by or on behalf of such person in any format (including 
paper and electronic formats) and at any location.
    ``(b) Regulations Concerning Recordkeeping.--The Secretary, in 
consultation and coordination, as appropriate, with other Federal 
departments and agencies with responsibilities for regulating food 
safety, may by regulation establish requirements regarding the 
establishment and maintenance, for not longer than two years, of 
records by persons (excluding farms and restaurants) who manufacture, 
process, pack, transport, distribute, receive, hold, or import food, 
which records are needed by the Secretary for inspection to allow the 
Secretary to identify the immediate previous sources and the immediate 
subsequent recipients of food, including its packaging, in order to 
address credible threats of serious adverse health consequences or 
death to humans or animals. The Secretary shall take into account the 
size of a business in promulgating regulations under this section.
    ``(c) Protection of Sensitive Information.--The Secretary shall 
take appropriate measures to ensure that there are in effect effective 
procedures to prevent the unauthorized disclosure of any trade secret 
or confidential information that is obtained by the Secretary pursuant 
to this section.
    ``(d) Limitations.--This section shall not be construed--
        ``(1) to limit the authority of the Secretary to inspect 
    records or to require establishment and maintenance of records 
    under any other provision of this Act;
        ``(2) to authorize the Secretary to impose any requirements 
    with respect to a food to the extent that it is within the 
    exclusive jurisdiction of the Secretary of Agriculture pursuant to 
    the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the 
    Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg 
    Products Inspection Act (21 U.S.C. 1031 et seq.);
        ``(3) to have any legal effect on section 552 of title 5, 
    United States Code, or section 1905 of title 18, United States 
    Code; or
        ``(4) to extend to recipes for food, financial data, pricing 
    data, personnel data, research data, or sales data (other than 
    shipment data regarding sales).''.
    (b) Factory Inspection.--Section 704(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 374(a)) is amended--
        (1) in paragraph (1), by inserting after the first sentence the 
    following new sentence: ``In the case of any person (excluding 
    farms and restaurants) who manufactures, processes, packs, 
    transports, distributes, holds, or imports foods, the inspection 
    shall extend to all records and other information described in 
    section 414 when the Secretary has a reasonable belief that an 
    article of food is adulterated and presents a threat of serious 
    adverse health consequences or death to humans or animals, subject 
    to the limitations established in section 414(d).''; and
        (2) in paragraph (2), in the matter preceding subparagraph (A), 
    by striking ``second sentence'' and inserting ``third sentence''.
    (c) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended--
        (1) in paragraph (e)--
            (A) by striking ``by section 412, 504, or 703'' and 
        inserting ``by section 412, 414, 504, 703, or 704(a)''; and
            (B) by striking ``under section 412'' and inserting ``under 
        section 412, 414(b)''; and
        (2) in paragraph (j), by inserting ``414,'' after ``412,''.
    (d) Expedited Rulemaking.--Not later than 18 months after the date 
of the enactment of this Act, the Secretary shall promulgate proposed 
and final regulations establishing recordkeeping requirements under 
subsection 414(b) of the Federal Food, Drug, and Cosmetic Act (as added 
by subsection (a)).

SEC. 307. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.

    (a) In General.--Section 801 of the Federal Food, Drug, and 
Cosmetic Act, as amended by section 305(c) of this Act, is amended by 
adding at the end the following subsection:
    ``(m)(1) In the case of an article of food that is being imported 
or offered for import into the United States, the Secretary, after 
consultation with the Secretary of the Treasury, shall by regulation 
require, for the purpose of enabling such article to be inspected at 
ports of entry into the United States, the submission to the Secretary 
of a notice providing the identity of each of the following: The 
article; the manufacturer and shipper of the article; if known within 
the specified period of time that notice is required to be provided, 
the grower of the article; the country from which the article 
originates; the country from which the article is shipped; and the 
anticipated port of entry for the article. An article of food imported 
or offered for import without submission of such notice in accordance 
with the requirements under this paragraph shall be refused admission 
into the United States. Nothing in this section may be construed as a 
limitation on the port of entry for an article of food.
    ``(2)(A) Regulations under paragraph (1) shall require that a 
notice under such paragraph be provided by a specified period of time 
in advance of the time of the importation of the article of food 
involved or the offering of the food for import, which period shall be 
no less than the minimum amount of time necessary for the Secretary to 
receive, review, and appropriately respond to such notification, but 
may not exceed five days. In determining the specified period of time 
required under this subparagraph, the Secretary may consider, but is 
not limited to consideration of, the effect on commerce of such period 
of time, the locations of the various ports of entry into the United 
States, the various modes of transportation, the types of food imported 
into the United States, and any other such consideration. Nothing in 
the preceding sentence may be construed as a limitation on the 
obligation of the Secretary to receive, review, and appropriately 
respond to any notice under paragraph (1).
    ``(B)(i) If an article of food is being imported or offered for 
import into the United States and a notice under paragraph (1) is not 
provided in advance in accordance with the requirements under paragraph 
(1), such article shall be held at the port of entry for the article, 
and may not be delivered to the importer, owner, or consignee of the 
article, until such notice is submitted to the Secretary, and the 
Secretary examines the notice and determines that the notice is in 
accordance with the requirements under paragraph (1). Subsection (b) 
does not authorize the delivery of the article pursuant to the 
execution of a bond while the article is so held. The article shall be 
removed to a secure facility, as appropriate. During the period of time 
that such article is so held, the article shall not be transferred by 
any person from the port of entry into the United States for the 
article, or from the secure facility to which the article has been 
removed, as the case may be.
    ``(ii) In carrying out clause (i) with respect to an article of 
food, the Secretary shall determine whether there is in the possession 
of the Secretary any credible evidence or information indicating that 
such article presents a threat of serious adverse health consequences 
or death to humans or animals.
    ``(3)(A) This subsection may not be construed as limiting the 
authority of the Secretary to obtain information under any other 
provision of this Act.
    ``(B) This subsection may not be construed as authorizing the 
Secretary to impose any requirements with respect to a food to the 
extent that it is within the exclusive jurisdiction of the Secretary of 
Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 
et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), 
or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).''.
    (b) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act, as amended by section 305(b) of this Act, is amended by 
adding at the end the following:
    ``(ee) The importing or offering for import into the United States 
of an article of food in violation of the requirements under section 
801(m).''.
    (c) Rulemaking; Effective Date.--
        (1) In general.--Not later than 18 months after the date of the 
    enactment of this Act, the Secretary of Health and Human Services 
    shall promulgate proposed and final regulations for the requirement 
    of providing notice in accordance with section 801(m) of the 
    Federal Food, Drug, and Cosmetic Act (as added by subsection (a) of 
    this section). Such requirement of notification takes effect--
            (A) upon the effective date of such final regulations; or
            (B) upon the expiration of such 18-month period if the 
        final regulations have not been made effective as of the 
        expiration of such period, subject to compliance with the final 
        regulations when the final regulations are made effective.
        (2) Default; minimum period of advance notice.--If under 
    paragraph (1) the requirement for providing notice in accordance 
    with section 801(m) of the Federal Food, Drug, and Cosmetic Act 
    takes effect without final regulations having been made effective, 
    then for purposes of such requirement, the specified period of time 
    that the notice is required to be made in advance of the time of 
    the importation of the article of food involved or the offering of 
    the food for import shall be not fewer than eight hours and not 
    more than five days, which shall remain in effect until the final 
    regulations are made effective.

SEC. 308. AUTHORITY TO MARK ARTICLES REFUSED ADMISSION INTO UNITED 
              STATES.

    (a) In General.--Section 801 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(a)), as amended by section 307(a) of this 
Act, is amended by adding at the end the following:
    ``(n)(1) If a food has been refused admission under subsection (a), 
other than such a food that is required to be destroyed, the Secretary 
may require the owner or consignee of the food to affix to the 
container of the food a label that clearly and conspicuously bears the 
statement: `UNITED STATES: REFUSED ENTRY'.
    ``(2) All expenses in connection with affixing a label under 
paragraph (1) shall be paid by the owner or consignee of the food 
involved, and in default of such payment, shall constitute a lien 
against future importations made by such owner or consignee.
    ``(3) A requirement under paragraph (1) remains in effect until the 
Secretary determines that the food involved has been brought into 
compliance with this Act.''.
    (b) Misbranded Foods.--Section 403 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the 
following:
    ``(v) If--
        ``(1) it fails to bear a label required by the Secretary under 
    section 801(n)(1) (relating to food refused admission into the 
    United States);
        ``(2) the Secretary finds that the food presents a threat of 
    serious adverse health consequences or death to humans or animals; 
    and
        ``(3) upon or after notifying the owner or consignee involved 
    that the label is required under section 801, the Secretary informs 
    the owner or consignee that the food presents such a threat.''.
    (c) Rule of Construction.--With respect to articles of food that 
are imported or offered for import into the United States, nothing in 
this section shall be construed to limit the authority of the Secretary 
of Health and Human Services or the Secretary of the Treasury to 
require the marking of refused articles of food under any other 
provision of law.

SEC. 309. PROHIBITION AGAINST PORT SHOPPING.

    Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
342) is amended by adding at the end the following:
    ``(h) If it is an article of food imported or offered for import 
into the United States and the article of food has previously been 
refused admission under section 801(a), unless the person reoffering 
the article affirmatively establishes, at the expense of the owner or 
consignee of the article, that the article complies with the applicable 
requirements of this Act, as determined by the Secretary.''.

SEC. 310. NOTICES TO STATES REGARDING IMPORTED FOOD.

    Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
391 et seq.) is amended by adding at the end the following section:

``SEC. 908. NOTICES TO STATES REGARDING IMPORTED FOOD.

    ``(a) In General.--If the Secretary has credible evidence or 
information indicating that a shipment of imported food or portion 
thereof presents a threat of serious adverse health consequences or 
death to humans or animals, the Secretary shall provide notice 
regarding such threat to the States in which the food is held or will 
be held, and to the States in which the manufacturer, packer, or 
distributor of the food is located, to the extent that the Secretary 
has knowledge of which States are so involved. In providing notice to a 
State, the Secretary shall request the State to take such action as the 
State considers appropriate, if any, to protect the public health 
regarding the food involved.
    ``(b) Rule of Construction.--Subsection (a) may not be construed as 
limiting the authority of the Secretary with respect to food under any 
other provision of this Act.''.

SEC. 311. GRANTS TO STATES FOR INSPECTIONS.

    Chapter IX of the Federal Food, Drug, and Cosmetic Act, as amended 
by section 310 of this Act, is amended by adding at the end the 
following section:

``SEC. 909. GRANTS TO STATES FOR INSPECTIONS.

    ``(a) In General.--The Secretary is authorized to make grants to 
States, territories, and Indian tribes (as defined in section 4(e) of 
the Indian Self-Determination and Education Assistance Act (25 U.S.C. 
450b(e))) that undertake examinations, inspections, and investigations, 
and related activities under section 702. The funds provided under such 
grants shall only be available for the costs of conducting such 
examinations, inspections, investigations, and related activities.
    ``(b) Notices Regarding Adulterated Imported Food.--The Secretary 
may make grants to the States for the purpose of assisting the States 
with the costs of taking appropriate action to protect the public 
health in response to notification under section 908, including 
planning and otherwise preparing to take such action.
    ``(c) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $10,000,000 
for fiscal year 2002, and such sums as may be necessary for each of the 
fiscal years 2003 through 2006.''.

SEC. 312. SURVEILLANCE AND INFORMATION GRANTS AND AUTHORITIES.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by inserting after section 317P the following:

``SEC. 317R. FOOD SAFETY GRANTS.

    ``(a) In General.--The Secretary may award grants to States and 
Indian tribes (as defined in section 4(e) of the Indian Self-
Determination and Education Assistance Act (25 U.S.C. 450b(e))) to 
expand participation in networks to enhance Federal, State, and local 
food safety efforts, including meeting the costs of establishing and 
maintaining the food safety surveillance, technical, and laboratory 
capacity needed for such participation.
    ``(b) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $19,500,000 
for fiscal year 2002, and such sums as may be necessary for each of the 
fiscal years 2003 through 2006.''.

SEC. 313. SURVEILLANCE OF ZOONOTIC DISEASES.

    The Secretary of Health and Human Services, through the 
Commissioner of Food and Drugs and the Director of the Centers for 
Disease Control and Prevention, and the Secretary of Agriculture shall 
coordinate the surveillance of zoonotic diseases.

SEC. 314. AUTHORITY TO COMMISSION OTHER FEDERAL OFFICIALS TO CONDUCT 
              INSPECTIONS.

    Section 702(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 372(a)) is amended--
        (1) by striking ``(a)'' and inserting ``(a)(1)'';
        (2) by striking ``In the case of food packed'' and inserting 
    the following:
    ``(3) In the case of food packed'';
        (3) by striking ``For the purposes of this subsection'' and 
    inserting the following:
    ``(4) For the purposes of this subsection,''; and
        (4) by inserting after paragraph (1) (as designated by 
    paragraph (1) of this section) the following paragraph:
    ``(2)(A) In addition to the authority established in paragraph (1), 
the Secretary, pursuant to a memorandum of understanding between the 
Secretary and the head of another Federal department or agency, is 
authorized to conduct examinations and investigations for the purposes 
of this Act through the officers and employees of such other department 
or agency, subject to subparagraph (B). Such a memorandum shall include 
provisions to ensure adequate training of such officers and employees 
to conduct the examinations and investigations. The memorandum of 
understanding shall contain provisions regarding reimbursement. Such 
provisions may, at the sole discretion of the head of the other 
department or agency, require reimbursement, in whole or in part, from 
the Secretary for the examinations or investigations performed under 
this section by the officers or employees of the other department or 
agency.
    ``(B) A memorandum of understanding under subparagraph (A) between 
the Secretary and another Federal department or agency is effective 
only in the case of examinations or inspections at facilities or other 
locations that are jointly regulated by the Secretary and such 
department or agency.
    ``(C) For any fiscal year in which the Secretary and the head of 
another Federal department or agency carries out one or more 
examinations or inspections under a memorandum of understanding under 
subparagraph (A), the Secretary and the head of such department or 
agency shall with respect to their respective departments or agencies 
submit to the committees of jurisdiction (authorizing and 
appropriating) in the House of Representatives and the Senate a report 
that provides, for such year--
        ``(i) the number of officers or employees that carried out one 
    or more programs, projects, or activities under such memorandum;
        ``(ii) the number of additional articles that were inspected or 
    examined as a result of such memorandum; and
        ``(iii) the number of additional examinations or investigations 
    that were carried out pursuant to such memorandum.''.

SEC. 315. RULE OF CONSTRUCTION.

    Nothing in this title, or an amendment made by this title, shall be 
construed to alter the jurisdiction between the Secretaries of 
Agriculture and of Health and Human Services, under applicable statutes 
and regulations.

                 Subtitle B--Protection of Drug Supply

SEC. 321. ANNUAL REGISTRATION OF FOREIGN MANUFACTURERS; SHIPPING 
              INFORMATION; DRUG AND DEVICE LISTING.

    (a) Annual Registration; Listing.--Section 510 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360) is amended--
        (1) in subsection (i)(1)--
            (A) by striking ``Any establishment'' and inserting ``On or 
        before December 31 of each year, any establishment''; and
            (B) by striking ``shall register'' and all that follows and 
        inserting the following: ``shall, through electronic means in 
        accordance with the criteria of the Secretary, register with 
        the Secretary the name and place of business of the 
        establishment, the name of the United States agent for the 
        establishment, the name of each importer of such drug or device 
        in the United States that is known to the establishment, and 
        the name of each person who imports or offers for import such 
        drug or device to the United States for purposes of 
        importation.''; and
        (2) in subsection (j)(1), in the first sentence, by striking 
    ``or (d)'' and inserting ``(d), or (i)''.
    (b) Importation; Statement Regarding Registration of 
Manufacturer.--
        (1) In general.--Section 801 of the Federal Food, Drug, and 
    Cosmetic Act, as amended by section 308(a) of this Act, is amended 
    by adding at the end the following subsection:
    ``(o) If an article that is a drug or device is being imported or 
offered for import into the United States, and the importer, owner, or 
consignee of such article does not, at the time of offering the article 
for import, submit to the Secretary a statement that identifies the 
registration under section 510(i) of each establishment that with 
respect to such article is required under such section to register with 
the Secretary, the article may be refused admission. If the article is 
refused admission for failure to submit such a statement, the article 
shall be held at the port of entry for the article, and may not be 
delivered to the importer, owner, or consignee of the article, until 
such a statement is submitted to the Secretary. Subsection (b) does not 
authorize the delivery of the article pursuant to the execution of a 
bond while the article is so held. The article shall be removed to a 
secure facility, as appropriate. During the period of time that such 
article is so held, the article shall not be transferred by any person 
from the port of entry into the United States for the article, or from 
the secure facility to which the article has been removed, as the case 
may be.''.
        (2) Prohibited act.--Section 301 of the Federal Food, Drug, and 
    Cosmetic Act, as amended by section 307(b) of this Act, is amended 
    by adding at the end the following:
    ``(ff) The importing or offering for import into the United States 
of a drug or device with respect to which there is a failure to comply 
with a request of the Secretary to submit to the Secretary a statement 
under section 801(o).''.
    (c) Effective Date.--The amendments made by this section take 
effect upon the expiration of the 180-day period beginning on the date 
of the enactment of this Act.

SEC. 322. REQUIREMENT OF ADDITIONAL INFORMATION REGARDING IMPORT 
              COMPONENTS INTENDED FOR USE IN EXPORT PRODUCTS.

    (a) In General.--Section 801(d)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(d)(3)) is amended to read as follows:
    ``(3)(A) Subject to subparagraph (B), no component of a drug, no 
component part or accessory of a device, or other article of device 
requiring further processing, which is ready or suitable for use for 
health-related purposes, and no article of a food additive, color 
additive, or dietary supplement, including a product in bulk form, 
shall be excluded from importation into the United States under 
subsection (a) if each of the following conditions is met:
        ``(i) The importer of such article of a drug or device or 
    importer of such article of a food additive, color additive, or 
    dietary supplement submits to the Secretary, at the time of initial 
    importation, a statement in accordance with the following:
            ``(I) Such statement provides that such article is intended 
        to be further processed by the initial owner or consignee, or 
        incorporated by the initial owner or consignee, into a drug, 
        biological product, device, food, food additive, color 
        additive, or dietary supplement that will be exported by the 
        initial owner or consignee from the United States in accordance 
        with subsection (e) or section 802, or with section 351(h) of 
        the Public Health Service Act.
            ``(II) The statement identifies the manufacturer of such 
        article and each processor, packer, distributor, or other 
        entity that had possession of the article in the chain of 
        possession of the article from the manufacturer to such 
        importer of the article.
            ``(III) The statement is accompanied by such certificates 
        of analysis as are necessary to identify such article, unless 
        the article is a device or is an article described in paragraph 
        (4).
        ``(ii) At the time of initial importation and before the 
    delivery of such article to the importer or the initial owner or 
    consignee, such owner or consignee executes a good and sufficient 
    bond providing for the payment of such liquidated damages in the 
    event of default as may be required pursuant to regulations of the 
    Secretary of the Treasury.
        ``(iii) Such article is used and exported by the initial owner 
    or consignee in accordance with the intent described under clause 
    (i)(I), except for any portions of the article that are destroyed.
        ``(iv) The initial owner or consignee maintains records on the 
    use or destruction of such article or portions thereof, as the case 
    may be, and submits to the Secretary any such records requested by 
    the Secretary.
        ``(v) Upon request of the Secretary, the initial owner or 
    consignee submits a report that provides an accounting of the 
    exportation or destruction of such article or portions thereof, and 
    the manner in which such owner or consignee complied with the 
    requirements of this subparagraph.
    ``(B) Notwithstanding subparagraph (A), the Secretary may refuse 
admission to an article that otherwise would be imported into the 
United States under such subparagraph if the Secretary determines that 
there is credible evidence or information indicating that such article 
is not intended to be further processed by the initial owner or 
consignee, or incorporated by the initial owner or consignee, into a 
drug, biological product, device, food, food additive, color additive, 
or dietary supplement that will be exported by the initial owner or 
consignee from the United States in accordance with subsection (e) or 
section 802, or with section 351(h) of the Public Health Service Act.
    ``(C) This section may not be construed as affecting the 
responsibility of the Secretary to ensure that articles imported into 
the United States under authority of subparagraph (A) meet each of the 
conditions established in such subparagraph for importation.''.
    (b) Prohibited Act.--Section 301(w) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(w)) is amended to read as follows:
    ``(w) The making of a knowingly false statement in any statement, 
certificate of analysis, record, or report required or requested under 
section 801(d)(3); the failure to submit a certificate of analysis as 
required under such section; the failure to maintain records or to 
submit records or reports as required by such section; the release into 
interstate commerce of any article or portion thereof imported into the 
United States under such section or any finished product made from such 
article or portion, except for export in accordance with section 801(e) 
or 802, or with section 351(h) of the Public Health Service Act; or the 
failure to so export or to destroy such an article or portions thereof, 
or such a finished product.''.
    (c) Effective Date.--The amendments made by this section take 
effect upon the expiration of the 90-day period beginning on the date 
of the enactment of this Act.

  Subtitle C--General Provisions Relating to Upgrade of Agricultural 
                                Security

SEC. 331. EXPANSION OF ANIMAL AND PLANT HEALTH INSPECTION SERVICE 
              ACTIVITIES.

    (a) In General.--The Secretary of Agriculture (referred to in this 
section as the ``Secretary'') may utilize existing authorities to give 
high priority to enhancing and expanding the capacity of the Animal and 
Plant Health Inspection Service to conduct activities to--
        (1) increase the inspection capacity of the Service at 
    international points of origin;
        (2) improve surveillance at ports of entry and customs;
        (3) enhance methods of protecting against the introduction of 
    plant and animal disease organisms by terrorists;
        (4) develop new and improve existing strategies and 
    technologies for dealing with intentional outbreaks of plant and 
    animal disease arising from acts of terrorism or from unintentional 
    introduction, including--
            (A) establishing cooperative agreements among Veterinary 
        Services of the Animal and Plant Health Inspection Service, 
        State animal health commissions and regulatory agencies for 
        livestock and poultry health, and private veterinary 
        practitioners to enhance the preparedness and ability of 
        Veterinary Services and the commissions and agencies to respond 
        to outbreaks of such animal diseases; and
            (B) strengthening planning and coordination with State and 
        local agencies, including--
                (i) State animal health commissions and regulatory 
            agencies for livestock and poultry health; and
                (ii) State agriculture departments; and
        (5) otherwise improve the capacity of the Service to protect 
    against the threat of bioterrorism.
    (b) Automated Recordkeeping System.--The Administrator of the 
Animal and Plant Health Inspection Service may implement a central 
automated recordkeeping system to provide for the reliable tracking of 
the status of animal and plant shipments, including those shipments on 
hold at ports of entry and customs. The Secretary shall ensure that 
such a system shall be fully accessible to or fully integrated with the 
Food Safety Inspection Service.
    (c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $30,000,000 for fiscal year 
2002, and such sums as may be necessary for each subsequent fiscal 
year.

SEC. 332. EXPANSION OF FOOD SAFETY INSPECTION SERVICE ACTIVITIES.

    (a) In General.--The Secretary of Agriculture may utilize existing 
authorities to give high priority to enhancing and expanding the 
capacity of the Food Safety Inspection Service to conduct activities 
to--
        (1) enhance the ability of the Service to inspect and ensure 
    the safety and wholesomeness of meat and poultry products;
        (2) improve the capacity of the Service to inspect 
    international meat and meat products, poultry and poultry products, 
    and egg products at points of origin and at ports of entry;
        (3) strengthen the ability of the Service to collaborate with 
    relevant agencies within the Department of Agriculture and with 
    other entities in the Federal Government, the States, and Indian 
    tribes (as defined in section 4(e) of the Indian Self-Determination 
    and Education Assistance Act (25 U.S.C. 450b(e))) through the 
    sharing of information and technology; and
        (4) otherwise expand the capacity of the Service to protect 
    against the threat of bioterrorism.
    (b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $15,000,000 for fiscal year 
2002, and such sums as may be necessary for each subsequent fiscal 
year.

SEC. 333. BIOSECURITY UPGRADES AT THE DEPARTMENT OF AGRICULTURE.

    There is authorized to be appropriated for fiscal year 2002, 
$180,000,000 for the purpose of enabling the Agricultural Research 
Service to conduct building upgrades to modernize existing facilities, 
of which (1) $100,000,000 shall be allocated for renovation, updating, 
and expansion of the Biosafety Level 3 laboratory and animal research 
facilities at the Plum Island Animal Disease Center (Greenport, New 
York), and of which (2) $80,000,000 shall be allocated for the 
Agricultural Research Service/Animal and Plant Health Inspection 
Service facility in Ames, Iowa. There are authorized to be appropriated 
such sums as may be necessary for fiscal years 2003 through 2006 for 
the purpose described in the preceding sentence, for the planning and 
design of an Agricultural Research Service biocontainment laboratory 
for poultry research in Athens, Georgia, and for the planning, 
updating, and renovation of the Arthropod-Borne Animal Disease 
Laboratory in Laramie, Wyoming.

SEC. 334. AGRICULTURAL BIOSECURITY.

    (a) Security at Colleges and Universities.--
        (1) Grants.--The Secretary of Agriculture (referred to in this 
    section as the ``Secretary'') may award grants to covered entities 
    to review security standards and practices at their facilities in 
    order to protect against bioterrorist attacks.
        (2) Covered entities.--Covered entities under this subsection 
    are colleges or universities that--
            (A) are colleges or universities as defined in section 1404 
        of the National Agricultural Research, Extension, and Teaching 
        Policy Act of 1977 (7 U.S.C. 3103); and
            (B) have programs in food and agricultural sciences, as 
        defined in such section.
        (3) Limitation.--Each individual covered entity may be awarded 
    one grant under paragraph (1), the amount of which shall not exceed 
    $50,000.
        (4) Contract authority.--Colleges and universities receiving 
    grants under paragraph (1) may use such grants to enter into 
    contracts with independent private organizations with established 
    and demonstrated security expertise to conduct the security reviews 
    specified in such paragraph.
    (b) Guidelines for Agricultural Biosecurity.--
        (1) In general.--The Secretary may award grants to associations 
    of food producers or consortia of such associations for the 
    development and implementation of educational programs to improve 
    biosecurity on farms in order to ensure the security of farm 
    facilities against potential bioterrorist attacks.
        (2) Limitation.--Each individual association eligible under 
    paragraph (1) may be awarded one grant under such paragraph, the 
    amount of which shall not exceed $100,000. Each consortium eligible 
    under paragraph (1) may be awarded one grant under such paragraph, 
    the amount of which shall not exceed $100,000 per association 
    participating in the consortium.
        (3) Contract authority.--Associations of food producers 
    receiving grants under paragraph (1) may use such grants to enter 
    into contracts with independent private organizations with 
    established and demonstrated expertise in biosecurity to assist in 
    the development and implementation of educational programs to 
    improve biosecurity specified in such paragraph.
    (c) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary 
for each fiscal year.

SEC. 335. AGRICULTURAL BIOTERRORISM RESEARCH AND DEVELOPMENT.

    (a) In General.--The Secretary of Agriculture (referred to in this 
section as the ``Secretary'') may utilize existing research authorities 
and research programs to protect the food supply of the United States 
by conducting and supporting research activities to--
        (1) enhance the capability of the Secretary to respond in a 
    timely manner to emerging or existing bioterrorist threats to the 
    food and agricultural system of the United States;
        (2) develop new and continue partnerships with institutions of 
    higher education and other institutions to help form stable, long-
    term programs to enhance the biosecurity and food safety of the 
    United States, including the coordination of the development, 
    implementation, and enhancement of diverse capabilities for 
    addressing threats to the nation's agricultural economy and food 
    supply, with special emphasis on planning, training, outreach, and 
    research activities related to vulnerability analyses, incident 
    response, detection, and prevention technologies;
        (3) strengthen coordination with the intelligence community to 
    better identify research needs and evaluate materials or 
    information acquired by the intelligence community relating to 
    potential threats to United States agriculture;
        (4) expand the involvement of the Secretary with international 
    organizations dealing with plant and animal disease control;
        (5) continue research to develop rapid detection field test 
    kits to detect biological threats to plants and animals and to 
    provide such test kits to State and local agencies preparing for or 
    responding to bioterrorism;
        (6) develop an agricultural bioterrorism early warning 
    surveillance system through enhancing the capacity of and 
    coordination between State veterinary diagnostic laboratories, 
    Federal and State agricultural research facilities, and public 
    health agencies; and
        (7) otherwise improve the capacity of the Secretary to protect 
    against the threat of bioterrorism.
    (b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $190,000,000 for fiscal year 
2002, and such sums as may be necessary for each subsequent fiscal 
year.

SEC. 336. ANIMAL ENTERPRISE TERRORISM PENALTIES.

    (a) In General.--Section 43(a) of title 18, United States Code, is 
amended to read as follows:
    ``(a) Offense.--Whoever--
        ``(1) travels in interstate or foreign commerce, or uses or 
    causes to be used the mail or any facility in interstate or foreign 
    commerce for the purpose of causing physical disruption to the 
    functioning of an animal enterprise; and
        ``(2) intentionally damages or causes the loss of any property 
    (including animals or records) used by the animal enterprise, or 
    conspires to do so,
shall be punished as provided for in subsection (b).''.
    (b) Penalties.--Section 43(b) of title 18, United States Code, is 
amended to read as follows:
    ``(b) Penalties.--
        ``(1) Economic damage.--Any person who, in the course of a 
    violation of subsection (a), causes economic damage not exceeding 
    $10,000 to an animal enterprise shall be fined under this title or 
    imprisoned not more than 6 months, or both.
        ``(2) Major economic damage.--Any person who, in the course of 
    a violation of subsection (a), causes economic damage exceeding 
    $10,000 to an animal enterprise shall be fined under this title or 
    imprisoned not more than 3 years, or both.
        ``(3) Serious bodily injury.--Any person who, in the course of 
    a violation of subsection (a), causes serious bodily injury to 
    another individual shall be fined under this title or imprisoned 
    not more than 20 years, or both.
        ``(4) Death.--Any person who, in the course of a violation of 
    subsection (a), causes the death of an individual shall be fined 
    under this title and imprisoned for life or for any term of 
    years.''.
    (c) Restitution.--Section 43(c) of title 18, United States Code, is 
amended--
        (1) in paragraph (1), by striking ``and'' at the end;
        (2) in paragraph (2), by striking the period at the end and 
    inserting ``; and''; and
        (3) by adding at the end the following:
        ``(3) for any other economic damage resulting from the 
    offense.''.

              TITLE IV--DRINKING WATER SECURITY AND SAFETY

SEC. 401. TERRORIST AND OTHER INTENTIONAL ACTS.

    The Safe Drinking Water Act (title XIV of the Public Health Service 
Act) is amended by inserting the following new section after section 
1432:

``SEC. 1433. TERRORIST AND OTHER INTENTIONAL ACTS.

    ``(a) Vulnerability Assessments.--(1) Each community water system 
serving a population of greater than 3,300 persons shall conduct an 
assessment of the vulnerability of its system to a terrorist attack or 
other intentional acts intended to substantially disrupt the ability of 
the system to provide a safe and reliable supply of drinking water. The 
vulnerability assessment shall include, but not be limited to, a review 
of pipes and constructed conveyances, physical barriers, water 
collection, pretreatment, treatment, storage and distribution 
facilities, electronic, computer or other automated systems which are 
utilized by the public water system, the use, storage, or handling of 
various chemicals, and the operation and maintenance of such system. 
The Administrator, not later than August 1, 2002, after consultation 
with appropriate departments and agencies of the Federal Government and 
with State and local governments, shall provide baseline information to 
community water systems required to conduct vulnerability assessments 
regarding which kinds of terrorist attacks or other intentional acts 
are the probable threats to--
        ``(A) substantially disrupt the ability of the system to 
    provide a safe and reliable supply of drinking water; or
        ``(B) otherwise present significant public health concerns.
    ``(2) Each community water system referred to in paragraph (1) 
shall certify to the Administrator that the system has conducted an 
assessment complying with paragraph (1) and shall submit to the 
Administrator a written copy of the assessment. Such certification and 
submission shall be made prior to:
        ``(A) March 31, 2003, in the case of systems serving a 
    population of 100,000 or more.
        ``(B) December 31, 2003, in the case of systems serving a 
    population of 50,000 or more but less than 100,000.
        ``(C) June 30, 2004, in the case of systems serving a 
    population greater than 3,300 but less than 50,000.
    ``(3) Except for information contained in a certification under 
this subsection identifying the system submitting the certification and 
the date of the certification, all information provided to the 
Administrator under this subsection and all information derived 
therefrom shall be exempt from disclosure under section 552 of title 5 
of the United States Code.
    ``(4) No community water system shall be required under State or 
local law to provide an assessment described in this section to any 
State, regional, or local governmental entity solely by reason of the 
requirement set forth in paragraph (2) that the system submit such 
assessment to the Administrator.
    ``(5) Not later than November 30, 2002, the Administrator, in 
consultation with appropriate Federal law enforcement and intelligence 
officials, shall develop such protocols as may be necessary to protect 
the copies of the assessments required to be submitted under this 
subsection (and the information contained therein) from unauthorized 
disclosure. Such protocols shall ensure that--
        ``(A) each copy of such assessment, and all information 
    contained in or derived from the assessment, is kept in a secure 
    location;
        ``(B) only individuals designated by the Administrator may have 
    access to the copies of the assessments; and
        ``(C) no copy of an assessment, or part of an assessment, or 
    information contained in or derived from an assessment shall be 
    available to anyone other than an individual designated by the 
    Administrator.
At the earliest possible time prior to November 30, 2002, the 
Administrator shall complete the development of such protocols for the 
purpose of having them in place prior to receiving any vulnerability 
assessments from community water systems under this subsection.
    ``(6)(A) Except as provided in subparagraph (B), any individual 
referred to in paragraph (5)(B) who acquires the assessment submitted 
under paragraph (2), or any reproduction of such assessment, or any 
information derived from such assessment, and who knowingly or 
recklessly reveals such assessment, reproduction, or information other 
than--
        ``(i) to an individual designated by the Administrator under 
    paragraph (5),
        ``(ii) for purposes of section 1445 or for actions under 
    section 1431, or
        ``(iii) for use in any administrative or judicial proceeding to 
    impose a penalty for failure to comply with this section,
shall upon conviction be imprisoned for not more than one year or fined 
in accordance with the provisions of chapter 227 of title 18, United 
States Code, applicable to class A misdemeanors, or both, and shall be 
removed from Federal office or employment.
    ``(B) Notwithstanding subparagraph (A), an individual referred to 
in paragraph (5)(B) who is an officer or employee of the United States 
may discuss the contents of a vulnerability assessment submitted under 
this section with a State or local official.
    ``(7) Nothing in this section authorizes any person to withhold any 
information from Congress or from any committee or subcommittee of 
Congress.
    ``(b) Emergency Response Plan.--Each community water system serving 
a population greater than 3,300 shall prepare or revise, where 
necessary, an emergency response plan that incorporates the results of 
vulnerability assessments that have been completed. Each such community 
water system shall certify to the Administrator, as soon as reasonably 
possible after the enactment of this section, but not later than 6 
months after the completion of the vulnerability assessment under 
subsection (a), that the system has completed such plan. The emergency 
response plan shall include, but not be limited to, plans, procedures, 
and identification of equipment that can be implemented or utilized in 
the event of a terrorist or other intentional attack on the public 
water system. The emergency response plan shall also include actions, 
procedures, and identification of equipment which can obviate or 
significantly lessen the impact of terrorist attacks or other 
intentional actions on the public health and the safety and supply of 
drinking water provided to communities and individuals. Community water 
systems shall, to the extent possible, coordinate with existing Local 
Emergency Planning Committees established under the Emergency Planning 
and Community Right-to-Know Act (42 U.S.C. 11001 et seq.) when 
preparing or revising an emergency response plan under this subsection.
    ``(c) Record Maintenance.--Each community water system shall 
maintain a copy of the emergency response plan completed pursuant to 
subsection (b) for 5 years after such plan has been certified to the 
Administrator under this section.
    ``(d) Guidance to Small Public Water Systems.--The Administrator 
shall provide guidance to community water systems serving a population 
of less than 3,300 persons on how to conduct vulnerability assessments, 
prepare emergency response plans, and address threats from terrorist 
attacks or other intentional actions designed to disrupt the provision 
of safe drinking water or significantly affect the public health or 
significantly affect the safety or supply of drinking water provided to 
communities and individuals.
    ``(e) Funding.--(1) There are authorized to be appropriated to 
carry out this section not more than $160,000,000 for the fiscal year 
2002 and such sums as may be necessary for the fiscal years 2003 
through 2005.
    ``(2) The Administrator, in coordination with State and local 
governments, may use funds made available under paragraph (1) to 
provide financial assistance to community water systems for purposes of 
compliance with the requirements of subsections (a) and (b) and to 
community water systems for expenses and contracts designed to address 
basic security enhancements of critical importance and significant 
threats to public health and the supply of drinking water as determined 
by a vulnerability assessment conducted under subsection (a). Such 
basic security enhancements may include, but shall not be limited to 
the following:
        ``(A) the purchase and installation of equipment for detection 
    of intruders;
        ``(B) the purchase and installation of fencing, gating, 
    lighting, or security cameras;
        ``(C) the tamper-proofing of manhole covers, fire hydrants, and 
    valve boxes;
        ``(D) the rekeying of doors and locks;
        ``(E) improvements to electronic, computer, or other automated 
    systems and remote security systems;
        ``(F) participation in training programs, and the purchase of 
    training manuals and guidance materials, relating to security 
    against terrorist attacks;
        ``(G) improvements in the use, storage, or handling of various 
    chemicals; and
        ``(H) security screening of employees or contractor support 
    services.
Funding under this subsection for basic security enhancements shall not 
include expenditures for personnel costs, or monitoring, operation, or 
maintenance of facilities, equipment, or systems.
    ``(3) The Administrator may use not more than $5,000,000 from the 
funds made available under paragraph (1) to make grants to community 
water systems to assist in responding to and alleviating any 
vulnerability to a terrorist attack or other intentional acts intended 
to substantially disrupt the ability of the system to provide a safe 
and reliable supply of drinking water (including sources of water for 
such systems) which the Administrator determines to present an 
immediate and urgent security need.
    ``(4) The Administrator may use not more than $5,000,000 from the 
funds made available under paragraph (1) to make grants to community 
water systems serving a population of less than 3,300 persons for 
activities and projects undertaken in accordance with the guidance 
provided to such systems under subsection (d).

SEC. 402. OTHER SAFE DRINKING WATER ACT AMENDMENTS.

    The Safe Drinking Water Act (title XIV of the Public Health Service 
Act) is amended by inserting the following new sections after section 
1433 (as added by section 401 of this Act):

``SEC. 1434. CONTAMINANT PREVENTION, DETECTION AND RESPONSE.

    ``(a) In General.--The Administrator, in consultation with the 
Centers for Disease Control and, after consultation with appropriate 
departments and agencies of the Federal Government and with State and 
local governments, shall review (or enter into contracts or cooperative 
agreements to provide for a review of) current and future methods to 
prevent, detect and respond to the intentional introduction of 
chemical, biological or radiological contaminants into community water 
systems and source water for community water systems, including each of 
the following:
        ``(1) Methods, means and equipment, including real time 
    monitoring systems, designed to monitor and detect various levels 
    of chemical, biological, and radiological contaminants or 
    indicators of contaminants and reduce the likelihood that such 
    contaminants can be successfully introduced into public water 
    systems and source water intended to be used for drinking water.
        ``(2) Methods and means to provide sufficient notice to 
    operators of public water systems, and individuals served by such 
    systems, of the introduction of chemical, biological or 
    radiological contaminants and the possible effect of such 
    introduction on public health and the safety and supply of drinking 
    water.
        ``(3) Methods and means for developing educational and 
    awareness programs for community water systems.
        ``(4) Procedures and equipment necessary to prevent the flow of 
    contaminated drinking water to individuals served by public water 
    systems.
        ``(5) Methods, means, and equipment which could negate or 
    mitigate deleterious effects on public health and the safety and 
    supply caused by the introduction of contaminants into water 
    intended to be used for drinking water, including an examination of 
    the effectiveness of various drinking water technologies in 
    removing, inactivating, or neutralizing biological, chemical, and 
    radiological contaminants.
        ``(6) Biomedical research into the short-term and long-term 
    impact on public health of various chemical, biological and 
    radiological contaminants that may be introduced into public water 
    systems through terrorist or other intentional acts.
    ``(b) Funding.--For the authorization of appropriations to carry 
out this section, see section 1435(e).

``SEC. 1435. SUPPLY DISRUPTION PREVENTION, DETECTION AND RESPONSE.

    ``(a) Disruption of Supply or Safety.--The Administrator, in 
coordination with the appropriate departments and agencies of the 
Federal Government, shall review (or enter into contracts or 
cooperative agreements to provide for a review of) methods and means by 
which terrorists or other individuals or groups could disrupt the 
supply of safe drinking water or take other actions against water 
collection, pretreatment, treatment, storage and distribution 
facilities which could render such water significantly less safe for 
human consumption, including each of the following:
        ``(1) Methods and means by which pipes and other constructed 
    conveyances utilized in public water systems could be destroyed or 
    otherwise prevented from providing adequate supplies of drinking 
    water meeting applicable public health standards.
        ``(2) Methods and means by which collection, pretreatment, 
    treatment, storage and distribution facilities utilized or used in 
    connection with public water systems and collection and 
    pretreatment storage facilities used in connection with public 
    water systems could be destroyed or otherwise prevented from 
    providing adequate supplies of drinking water meeting applicable 
    public health standards.
        ``(3) Methods and means by which pipes, constructed 
    conveyances, collection, pretreatment, treatment, storage and 
    distribution systems that are utilized in connection with public 
    water systems could be altered or affected so as to be subject to 
    cross-contamination of drinking water supplies.
        ``(4) Methods and means by which pipes, constructed 
    conveyances, collection, pretreatment, treatment, storage and 
    distribution systems that are utilized in connection with public 
    water systems could be reasonably protected from terrorist attacks 
    or other acts intended to disrupt the supply or affect the safety 
    of drinking water.
        ``(5) Methods and means by which information systems, including 
    process controls and supervisory control and data acquisition and 
    cyber systems at community water systems could be disrupted by 
    terrorists or other groups.
    ``(b) Alternative Sources.--The review under this section shall 
also include a review of the methods and means by which alternative 
supplies of drinking water could be provided in the event of the 
destruction, impairment or contamination of public water systems.
    ``(c) Requirements and Considerations.--In carrying out this 
section and section 1434--
        ``(1) the Administrator shall ensure that reviews carried out 
    under this section reflect the needs of community water systems of 
    various sizes and various geographic areas of the United States; 
    and
        ``(2) the Administrator may consider the vulnerability of, or 
    potential for forced interruption of service for, a region or 
    service area, including community water systems that provide 
    service to the National Capital area.
    ``(d) Information Sharing.--As soon as practicable after reviews 
carried out under this section or section 1434 have been evaluated, the 
Administrator shall disseminate, as appropriate as determined by the 
Administrator, to community water systems information on the results of 
the project through the Information Sharing and Analysis Center, or 
other appropriate means.
    ``(e) Funding.--There are authorized to be appropriated to carry 
out this section and section 1434 not more than $15,000,000 for the 
fiscal year 2002 and such sums as may be necessary for the fiscal years 
2003 through 2005.''.

SEC. 403. MISCELLANEOUS AND TECHNICAL AMENDMENTS.

    The Safe Drinking Water Act is amended as follows:
        (1) Section 1414(i)(1) is amended by inserting ``1433'' after 
    ``1417''.
        (2) Section 1431 is amended by inserting in the first sentence 
    after ``drinking water'' the following: ``, or that there is a 
    threatened or potential terrorist attack (or other intentional act 
    designed to disrupt the provision of safe drinking water or to 
    impact adversely the safety of drinking water supplied to 
    communities and individuals), which''.
        (3) Section 1432 is amended as follows:
            (A) By striking ``5 years'' in subsection (a) and inserting 
        ``20 years''.
            (B) By striking ``3 years'' in subsection (b) and inserting 
        ``10 years''.
            (C) By striking ``$50,000'' in subsection (c) and inserting 
        ``$1,000,000''.
            (D) By striking ``$20,000'' in subsection (c) and inserting 
        ``$100,000''.
        (4) Section 1442 is amended as follows:
            (A) By striking ``this subparagraph'' in subsection (b) and 
        inserting ``this subsection''.
            (B) By amending subsection (d) to read as follows:
    ``(d) There are authorized to be appropriated to carry out 
subsection (b) not more than $35,000,000 for the fiscal year 2002 and 
such sums as may be necessary for each fiscal year thereafter.''.

                     TITLE V--ADDITIONAL PROVISIONS
                Subtitle A--Prescription Drug User Fees

SEC. 501. SHORT TITLE.

    This subtitle may be cited as the ``Prescription Drug User Fee 
Amendments of 2002''.

SEC. 502. FINDINGS.

    The Congress finds that--
        (1) prompt approval of safe and effective new drugs and other 
    therapies is critical to the improvement of the public health so 
    that patients may enjoy the benefits provided by these therapies to 
    treat and prevent illness and disease;
        (2) the public health will be served by making additional funds 
    available for the purpose of augmenting the resources of the Food 
    and Drug Administration that are devoted to the process for the 
    review of human drug applications and the assurance of drug safety;
        (3) the provisions added by the Prescription Drug User Fee Act 
    of 1992, as amended by the Food and Drug Administration 
    Modernization Act of 1997, have been successful in substantially 
    reducing review times for human drug applications and should be--
            (A) reauthorized for an additional 5 years, with certain 
        technical improvements; and
            (B) carried out by the Food and Drug Administration with 
        new commitments to implement more ambitious and comprehensive 
        improvements in regulatory processes of the Food and Drug 
        Administration, including--
                (i) strengthening and improving the review and 
            monitoring of drug safety;
                (ii) considering greater interaction between the agency 
            and sponsors during the review of drugs and biologics 
            intended to treat serious diseases and life-threatening 
            diseases; and
                (iii) developing principles for improving first-cycle 
            reviews; and
        (4) the fees authorized by amendments made in this subtitle 
    will be dedicated towards expediting the drug development process 
    and the process for the review of human drug applications as set 
    forth in the goals identified for purposes of part 2 of subchapter 
    C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in 
    the letters from the Secretary of Health and Human Services to the 
    chairman of the Committee on Energy and Commerce of the House of 
    Representatives and the chairman of the Committee on Health, 
    Education, Labor and Pensions of the Senate, as set forth in the 
    Congressional Record.

SEC. 503. DEFINITIONS.

    Section 735 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379g) is amended--
        (1) in paragraph (1), in the matter after and below 
    subparagraph (C), by striking ``licensure, as described in 
    subparagraph (D)'' and inserting ``licensure, as described in 
    subparagraph (C)'';
        (2) in paragraph (3)--
            (A) in subparagraph (A), by striking ``and'' at the end;
            (B) in subparagraph (B), by striking the period and 
        inserting ``, and'';
            (C) by inserting after subparagraph (B) the following 
        subparagraph:
            ``(C) which is on the list of products described in section 
        505(j)(7)(A) or is on a list created and maintained by the 
        Secretary of products approved under human drug applications 
        under section 351 of the Public Health Service Act.''; and
            (D) in the matter after and below subparagraph (C) (as 
        added by subparagraph (C) of this paragraph), by striking 
        ``Service Act,'' and all that follows through ``biological 
        product'' and inserting the following: ``Service Act. Such term 
        does not include a biological product'';
        (3) in paragraph (6), by adding at the end the following 
    subparagraph:
            ``(F) In the case of drugs approved after October 1, 2002, 
        under human drug applications or supplements: collecting, 
        developing, and reviewing safety information on the drugs, 
        including adverse event reports, during a period of time after 
        approval of such applications or supplements, not to exceed 
        three years.''; and
        (4) in paragraph (8)--
            (A) by striking the matter after and below subparagraph 
        (B);
            (B) by striking subparagraph (B);
            (C) by striking ``is the lower of'' and all that follows 
        through ``Consumer Price Index'' and inserting ``is the 
        Consumer Price Index''; and
            (D) by striking ``1997, or'' and inserting ``1997.''.

SEC. 504. AUTHORITY TO ASSESS AND USE DRUG FEES.

    (a) Types of Fees.--Section 736(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(a)) is amended--
        (1) in the matter preceding paragraph (1), by striking ``fiscal 
    year 1998'' and inserting ``fiscal year 2003'';
        (2) in paragraph (1)(A)--
            (A) in each of clauses (i) and (ii), by striking ``in 
        subsection (b)'' and inserting ``under subsection (c)(4)''; and
            (B) in clause (ii), by adding at the end the following 
        sentence: ``Such fee shall be half of the amount of the fee 
        established under clause (i).'';
        (3) in paragraph (2)(A), in the matter after and below clause 
    (ii)--
            (A) by striking ``in subsection (b)'' and inserting ``under 
        subsection (c)(4)''; and
            (B) by striking ``payable on or before January 31'' and 
        inserting ``payable on or before October 1''; and
        (4) in paragraph (3)--
            (A) by amending subparagraph (A) to read as follows:
            ``(A) In general.--Except as provided in subparagraph (B), 
        each person who is named as the applicant in a human drug 
        application, and who, after September 1, 1992, had pending 
        before the Secretary a human drug application or supplement, 
        shall pay for each such prescription drug product the annual 
        fee established under subsection (c)(4). Such fee shall be 
        payable on or before October 1 of each year. Such fee shall be 
        paid only once for each product for a fiscal year in which the 
        fee is payable.''; and
            (B) in subparagraph (B), by striking ``The listing'' and 
        all that follows through ``filed under section 505(b)(2)'' and 
        inserting the following: ``A prescription drug product shall 
        not be assessed a fee under subparagraph (A) if such product is 
        identified on the list compiled under section 505(j)(7)(A) with 
        a potency described in terms of per 100 mL, or if such product 
        is the same product as another product approved under an 
        application filed under section 505(b)''.
    (b) Fee Amounts.--Section 736(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(b)) is amended to read as follows:
    ``(b) Fee Revenue Amounts.--Except as provided in subsections (c), 
(d), (f), and (g), fees under subsection (a) shall be established to 
generate the following revenue amounts:
---------------------------------------------------------------------------
  

----------------------------------------------------------------------------------------------------------------
                                             Fiscal Year   Fiscal Year   Fiscal Year   Fiscal Year   Fiscal Year
           ``Type of Fee Revenue                2003          2004          2005          2006          2007
----------------------------------------------------------------------------------------------------------------
Application/Supplement....................   $74,300,000   $77,000,000   $84,000,000   $86,434,000   $86,434,000
Establishment.............................   $74,300,000   $77,000,000   $84,000,000   $86,433,000   $86,433,000
Product...................................   $74,300,000   $77,000,000   $84,000,000   $86,433,000   $86,433,000
Total Fee Revenue.........................  $222,900,000  $231,000,000  $252,000,000  $259,300,000  $259,300,000
----------------------------------------------------------------------------------------------------------------


If, after the date of the enactment of the Prescription Drug User Fee 
Amendments of 2002, legislation is enacted requiring the Secretary to 
fund additional costs of the retirement of Federal personnel, fee 
revenue amounts shall be increased in each year by the amount necessary 
to fully fund the portion of such additional costs that are 
attributable to the process for the review of human drug 
applications.''.
    (c) Adjustments.--Section 736(c) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379h(c)) is amended--
        (1) in paragraph (1)--
            (A) in the matter preceding subparagraph (A), by striking 
        ``fees and total fee revenues'' and inserting ``revenues'';
            (B) in subparagraph (A)--
                (i) by striking ``during the preceding fiscal year''; 
            and
                (ii) by striking ``, or'' and inserting the following: 
            ``for the 12 month period ending June 30 preceding the 
            fiscal year for which fees are being established, or'';
            (C) in subparagraph (B), by striking ``for such fiscal 
        year'' and inserting ``for the previous fiscal year''; and
            (D) in the matter after and below subparagraph (B), by 
        striking ``fiscal year 1997''; and inserting ``fiscal year 
        2003'';
        (2) by redesignating paragraphs (2) and (3) as paragraphs (4) 
    and (5), respectively;
        (3) by inserting after paragraph (1) the following paragraphs:
        ``(2) Workload adjustment.--Beginning with fiscal year 2004, 
    after the fee revenues established in subsection (b) are adjusted 
    for a fiscal year for inflation in accordance with paragraph (1), 
    the fee revenues shall be adjusted further for such fiscal year to 
    reflect changes in the workload of the Secretary for the process 
    for the review of human drug applications. With respect to such 
    adjustment:
            ``(A) The adjustment shall be determined by the Secretary 
        based on a weighted average of the change in the total number 
        of human drug applications, commercial investigational new drug 
        applications, efficacy supplements, and manufacturing 
        supplements submitted to the Secretary. The Secretary shall 
        publish in the Federal Register the fee revenues and fees 
        resulting from the adjustment and the supporting methodologies.
            ``(B) Under no circumstances shall the adjustment result in 
        fee revenues for a fiscal year that are less than the fee 
        revenues for the fiscal year established in subsection (b), as 
        adjusted for inflation under paragraph (1).
        ``(3) Final year adjustment.--For fiscal year 2007, the 
    Secretary may, in addition to adjustments under paragraphs (1) and 
    (2), further increase the fee revenues and fees established in 
    subsection (b) if such an adjustment is necessary to provide for 
    not more than three months of operating reserves of carryover user 
    fees for the process for the review of human drug applications for 
    the first three months of fiscal year 2008. If such an adjustment 
    is necessary, the rationale for the amount of the increase shall be 
    contained in the annual notice establishing fee revenues and fees 
    for fiscal year 2007. If the Secretary has carryover balances for 
    such process in excess of three months of such operating reserves, 
    the adjustment under this paragraph shall not be made.''; and
        (4) in paragraph (4) (as redesignated by paragraph (2) of this 
    subsection), by amending such paragraph to read as follows:
        ``(4) Annual fee setting.--The Secretary shall, 60 days before 
    the start of each fiscal year that begins after September 30, 2002, 
    establish, for the next fiscal year, application, product, and 
    establishment fees under subsection (a), based on the revenue 
    amounts established under subsection (b) and the adjustments 
    provided under this subsection.''.
    (d) Fee Waiver or Reduction.--Section 736(d)) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--
        (1) in paragraph (1)--
            (A) in subparagraph (C), by inserting ``or'' after the 
        comma at the end;
            (B) by striking subparagraph (D); and
            (C) by redesignating subparagraph (E) as subparagraph (D); 
        and
        (2) in paragraph (3), in each of subparagraphs (A) and (B), by 
    striking ``paragraph (1)(E)'' each place such term appears and 
    inserting ``paragraph (1)(D)''.
    (e) Assessment of Fees.--Section 736(f) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 379h(f)) is amended--
        (1) in the heading for the subsection, by striking ``Assessment 
    of Fees.--'' and inserting ``Limitations.--''; and
        (2) in paragraph (1), by striking the heading for the paragraph 
    and all that follows through ``fiscal year beginning'' and 
    inserting the following: ``In general.--Fees under subsection (a) 
    shall be refunded for a fiscal year beginning''.
    (f) Crediting and Availability of Fees.--
        (1) In general.--Section 736(g)(1) of the Federal Food, Drug, 
    and Cosmetic Act (21 U.S.C. 379h(g)(1)) is amended by striking 
    ``Fees collected for a fiscal year'' and all that follows through 
    ``fiscal year limitation.'' and inserting the following: ``Fees 
    authorized under subsection (a) shall be collected and available 
    for obligation only to the extent and in the amount provided in 
    advance in appropriations Acts. Such fees are authorized to remain 
    available until expended.''.
        (2) Collections and appropriation acts.--Section 736(g)(2) of 
    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(2)) is 
    amended--
            (A) by redesignating subparagraphs (A) and (B) as clauses 
        (i) and (ii), respectively;
            (B) by striking ``(2) Collections'' and all that follows 
        through ``the amount specified'' in clause (i) (as so 
        redesignated) and inserting the following:
        ``(2) Collections and appropriation acts.--
            ``(A) In general.--The fees authorized by this section--
                ``(i) shall be retained in each fiscal year in an 
            amount not to exceed the amount specified'';
            (C) by moving clause (ii) (as so redesignated) two ems to 
        the right; and
            (D) by adding at the end the following subparagraph:
            ``(B) Compliance.--The Secretary shall be considered to 
        have met the requirements of subparagraph (A)(ii) in any fiscal 
        year if the costs funded by appropriations and allocated for 
        the process for the review of human drug applications--
                ``(i) are not more than 3 percent below the level 
            specified in subparagraph (A)(ii); or
                ``(ii)(I) are more than 3 percent below the level 
            specified in subparagraph (A)(ii), and fees assessed for 
            the fiscal year following the subsequent fiscal year are 
            decreased by the amount in excess of 3 percent by which 
            such costs fell below the level specified in such 
            subparagraph; and
                ``(II) such costs are not more than 5 percent below the 
            level specified in such subparagraph.''.
        (3) Authorization of appropriations.--Section 736(g)(3) of the 
    Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)(3)) is 
    amended by striking subparagraphs (A) through (E) and inserting the 
    following:
            ``(A) $222,900,000 for fiscal year 2003;
            ``(B) $231,000,000 for fiscal year 2004;
            ``(C) $252,000,000 for fiscal year 2005;
            ``(D) $259,300,000 for fiscal year 2006; and
            ``(E) $259,300,000 for fiscal year 2007;''.

SEC. 505. ACCOUNTABILITY AND REPORTS.

    (a) Public Accountability.--
        (1) Consultation.--In developing recommendations to the 
    Congress for the goals and plans for meeting the goals for the 
    process for the review of human drug applications for the fiscal 
    years after fiscal year 2007, and for the reauthorization of 
    sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act, 
    the Secretary of Health and Human Services (referred to in this 
    section as the ``Secretary'') shall consult with the Committee on 
    Energy and Commerce of the House of Representatives, the Committee 
    on Health, Education, Labor, and Pensions of the Senate, 
    appropriate scientific and academic experts, health care 
    professionals, representatives of patient and consumer advocacy 
    groups, and the regulated industry.
        (2) Recommendations.--The Secretary shall publish in the 
    Federal Register recommendations under paragraph (1), after 
    negotiations with the regulated industry; shall present such 
    recommendations to the congressional committees specified in such 
    paragraph; shall hold a meeting at which the public may present its 
    views on such recommendations; and shall provide for a period of 30 
    days for the public to provide written comments on such 
    recommendations.
    (b) Performance Report.--Beginning with fiscal year 2003, not later 
than 60 days after the end of each fiscal year during which fees are 
collected under part 2 of subchapter C of chapter VII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of 
Health and Human Services shall prepare and submit to the President, 
the Committee on Energy and Commerce of the House of Representatives, 
and the Committee on Health, Education, Labor, and Pensions of the 
Senate a report concerning the progress of the Food and Drug 
Administration in achieving the goals identified in the letters 
described in section 502(4) during such fiscal year and the future 
plans of the Food and Drug Administration for meeting the goals.
    (c) Fiscal Report.--Beginning with fiscal year 2003, not later than 
120 days after the end of each fiscal year during which fees are 
collected under the part described in subsection (b), the Secretary of 
Health and Human Services shall prepare and submit to the Committee on 
Energy and Commerce of the House of Representatives, and the Committee 
on Health, Education, Labor, and Pensions of the Senate, a report on 
the implementation of the authority for such fees during such fiscal 
year and the use, by the Food and Drug Administration, of the fees 
collected during such fiscal year for which the report is made.

SEC. 506. REPORTS OF POSTMARKETING STUDIES.

    Section 506B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
356b) is amended by adding at the end the following subsections:
    ``(d) Disclosure.--If a sponsor fails to complete an agreed upon 
study required by this section by its original or otherwise negotiated 
deadline, the Secretary shall publish a statement on the Internet site 
of the Food and Drug Administration stating that the study was not 
completed and, if the reasons for such failure to complete the study 
were not satisfactory to the Secretary, a statement that such reasons 
were not satisfactory to the Secretary.
    ``(e) Notification.--With respect to studies of the type required 
under section 506(b)(2)(A) or under section 314.510 or 601.41 of title 
21, Code of Federal Regulations, as each of such sections was in effect 
on the day before the effective date of this subsection, the Secretary 
may require that a sponsor who, for reasons not satisfactory to the 
Secretary, fails to complete by its deadline a study under any of such 
sections of such type for a drug or biological product (including such 
a study conducted after such effective date) notify practitioners who 
prescribe such drug or biological product of the failure to complete 
such study and the questions of clinical benefit, and, where 
appropriate, questions of safety, that remain unanswered as a result of 
the failure to complete such study. Nothing in this subsection shall be 
construed as altering the requirements of the types of studies required 
under section 506(b)(2)(A) or under section 314.510 or 601.41 of title 
21, Code of Federal Regulations, as so in effect, or as prohibiting the 
Secretary from modifying such sections of title 21 of such Code to 
provide for studies in addition to those of such type.''.

SEC. 507. SAVINGS CLAUSE.

    Notwithstanding section 107 of the Food and Drug Administration 
Modernization Act of 1997, and notwithstanding the amendments made by 
this subtitle, part 2 of subchapter C of chapter VII of the Federal 
Food, Drug, and Cosmetic Act, as in effect on the day before the date 
of the enactment of this Act, continues to be in effect with respect to 
human drug applications and supplements (as defined in such part as of 
such day) that, on or after October 1, 1997, but before October 1, 
2002, were accepted by the Food and Drug Administration for filing and 
with respect to assessing and collecting any fee required by such Act 
for a fiscal year prior to fiscal year 2003.

SEC. 508. EFFECTIVE DATE.

    The amendments made by this subtitle shall take effect October 1, 
2002.

SEC. 509. SUNSET CLAUSE.

    The amendments made by sections 503 and 504 cease to be effective 
October 1, 2007, and section 505 ceases to be effective 120 days after 
such date.

 Subtitle B--Funding Provisions Regarding Food and Drug Administration

SEC. 521. OFFICE OF DRUG SAFETY.

    Of the amounts appropriated for the Food and Drug Administration 
for a fiscal year, the Secretary of Health and Human Services shall 
reserve for the Office of Drug Safety (within such Administration), the 
following amounts:
        (1) For fiscal year 2003, an amount equal to the sum of 
    $5,000,000 and the amount made available under appropriations Acts 
    for such Office for fiscal year 2002.
        (2) For fiscal year 2004, an amount equal to the sum of 
    $10,000,000 and the amount made available under appropriations Acts 
    for such Office for fiscal year 2002.
        (3) For each subsequent fiscal year, an amount equal to the sum 
    of the amount made available under appropriations Acts for such 
    Office for fiscal year 2004 and an amount sufficient to offset the 
    effects of inflation occurring after the beginning of fiscal year 
    2004.

SEC. 522. DIVISION OF DRUG MARKETING, ADVERTISING, AND COMMUNICATIONS.

    For the Division of Drug Marketing, Advertising, and Communications 
(within the Office of Medical Policy, Food and Drug Administration), 
there are authorized to be appropriated the following amounts, stated 
as increases above the amount made available under appropriations Acts 
for such Division for fiscal year 2002:
        (1) For fiscal year 2003, an increase of $2,500,000.
        (2) For fiscal year 2004, an increase of $4,000,000.
        (3) For fiscal year 2005, an increase of $5,500,000.
        (4) For fiscal year 2006, an increase of $7,500,000.
        (5) For fiscal year 2007, an increase of $7,500,000.

SEC. 523. OFFICE OF GENERIC DRUGS.

    For the Office of Generic Drugs (within the Food and Drug 
Administration), there are authorized to be appropriated the following 
amounts, stated as increases above the amount made available under 
appropriations Acts for such Office for fiscal year 2002:
        (1) For fiscal year 2003, an increase of $3,000,000.
        (2) For fiscal year 2004, an increase of $6,000,000.
        (3) For fiscal year 2005, an increase of $9,000,000.
        (4) For fiscal year 2006, an increase of $12,000,000.
        (5) For fiscal year 2007, an increase of $15,000,000.

                   Subtitle C--Additional Provisions

SEC. 531. TRANSITION TO DIGITAL TELEVISION.

    (a) Pair Assignment Required.--In order to further promote the 
orderly transition to digital television, and to promote the equitable 
allocation and use of digital channels by television broadcast 
permittees and licensees, the Federal Communications Commission, at the 
request of an eligible licensee or permittee, shall, within 90 days 
after the date of enactment of this Act, allot, if necessary, and 
assign a paired digital television channel to that licensee or 
permittee, provided that--
        (1) such channel can be allotted and assigned without further 
    modification of the tables of allotments as set forth in sections 
    73.606 and 73.622 of the Commission's regulations (47 CFR 73.606, 
    73.622); and
        (2) such allotment and assignment is otherwise consistent with 
    the Commission's rules (47 CFR part 73).
    (b) Eligible Transition Licensee or Permittee.--For purposes of 
subsection (a), the term ``eligible licensee or permittee'' means only 
a full power television broadcast licensee or permittee (or its 
successor in interest) that--
        (1) had an application pending for an analog television station 
    construction permit as of October 24, 1991, which application was 
    granted after April 3, 1997; and
        (2) as of the date of enactment of this Act, is the permittee 
    or licensee of that station.
    (c) Requirements on Licensee or Permittee.--
        (1) Construction deadline.--Any licensee or permittee receiving 
    a paired digital channel pursuant to this section--
            (A) shall be required to construct the digital television 
        broadcast facility within 18 months of the date on which the 
        Federal Communications Commission issues a construction permit 
        therefore, and
            (B) shall be prohibited from obtaining or receiving an 
        extension of time from the Commission beyond the construction 
        deadline established by paragraph (1).
        (2) Prohibition of analog operation using digital pair.--Any 
    licensee or permittee receiving a paired digital channel pursuant 
    to this section shall be prohibited from giving up its current 
    paired analog assignment and becoming a single-channel broadcaster 
    and operating in analog on such paired digital channel.
    (d) Relief Restricted.--Any paired digital allotment and assignment 
made under this section shall not be available to any other applicant 
unless such applicant is an eligible licensee or permittee within the 
meaning of subsection (b).

SEC. 532. 3-YEAR DELAY IN LOCK IN PROCEDURES FOR MEDICARE+CHOICE PLANS; 
              CHANGE IN CERTAIN MEDICARE+CHOICE DEADLINES AND ANNUAL, 
              COORDINATED ELECTION PERIOD FOR 2003, 2004, AND 2005.

    (a) Lock-In Delay.--Section 1851(e) of the Social Security Act (42 
U.S.C. 1395w-21(e)) is amended--
        (1) in paragraph (2)(A), by striking ``through 2001'' and 
    ``during 1998, 1999, 2000, and 2001'' and inserting ``through 
    2004'' and ``during the period beginning January 1, 1998, and 
    ending on December 31, 2004'', respectively;
        (2) in the heading to paragraph (2)(B), by striking ``during 
    2002'' and inserting ``during 2005'';
        (3) in paragraphs (2)(B)(i) and (2)(C)(i), by striking ``2002'' 
    and inserting ``2005'' each place it appears;
        (4) in paragraph (2)(D), by striking ``2001'' and inserting 
    ``2004''; and
        (5) in paragraph (4), by striking ``2002'' and inserting 
    ``2005'' each place it appears.
    (b) Change in Reporting Deadline.--
        (1) In general.--Section 1854(a)(1) of such Act (42 U.S.C. 
    1395w-24(a)(1)) is amended by striking ``Not later than July 1 of 
    each year'' and inserting ``Not later than the second Monday in 
    September of 2002, 2003, and 2004 (or July 1 of each other year)''.
        (2) Effective date.--The amendment made by paragraph (1) shall 
    apply to information submitted for years beginning with 2003.
    (c) Delay in Annual, Coordinated Election Period.--
        (1) In general.--Section 1851(e) of such Act (42 U.S.C. 1395w-
    21(e)) is amended--
            (A) in paragraph (3)(B), by striking ``means'' and all that 
        follows and inserting the following: ``means, with respect to a 
        year before 2003 and after 2005, the month of November before 
        such year and with respect to 2003, 2004, and 2005, the period 
        beginning on November 15 and ending on December 31 of the year 
        before such year.''; and
            (B) in paragraph (6)(A), by striking ``each subsequent year 
        (as provided in paragraph (3))'' and inserting ``during the 
        annual, coordinated election period under paragraph (3) for 
        each subsequent year''.
        (2) Effective date.--The amendment made by paragraph (1) shall 
    apply to the annual, coordinated election period for years 
    beginning with 2003.
    (d) Change to Annual Announcement of Payment Rates.--
        (1) In general.--Section 1853(b)(1) of such Act (42 U.S.C. 
    1395w-23(b)(1)) is amended by striking ``not later than March 1 
    before the calendar year concerned'' and inserting ``for years 
    before 2004 and after 2005 not later than March 1 before the 
    calendar year concerned and for 2004 and 2005 not later than the 
    second Monday in May before the respective calendar year''.
        (2) Effective date.--The amendment made by paragraph (1) shall 
    first apply to announcements for years after 2003.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.