[107th Congress Public Law 188]
[From the U.S. Government Printing Office]


<DOC>
[DOCID: f:publ188.107]


[[Page 593]]

PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 
                                  2002

[[Page 116 STAT. 594]]

Public Law 107-188
107th Congress

                                 An Act


 
To improve the ability of the United States to prevent, prepare for, and 
            respond to bioterrorism and other public health 
          emergencies. <<NOTE: June 12, 2002 -  [H.R. 3448]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002.>> 

SECTION 1. SHORT TITLE; TABLE <<NOTE: 42 USC 201 note.>>  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.

[[Page 116 STAT. 595]]

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.

[[Page 116 STAT. 596]]

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 <<NOTE: 42 USC 300hh.>>  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,

[[Page 116 STAT. 597]]

        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 <<NOTE: Deadline.>> 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

[[Page 116 STAT. 598]]

        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 <<NOTE: 42 USC 247d-6 note.>> Reports.--
            (1) In general.--Not <<NOTE: Deadline.>> 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.

[[Page 116 STAT. 599]]

            (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 <<NOTE: Deadline. Reports.>> 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 <<NOTE: 42 USC 300hh-11.>> 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 <<NOTE: Establishment.>> established within the Department of 
        Health and Human Services the position of Assistant Secretary 
        for Public Health Emergency 
        Preparedness. <<NOTE: President.>> 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.

[[Page 116 STAT. 600]]

                    ``(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.

[[Page 116 STAT. 601]]

            ``(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

[[Page 116 STAT. 602]]

        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

[[Page 116 STAT. 603]]

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;

[[Page 116 STAT. 604]]

                    ``(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 <<NOTE: Deadline.>> 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.''.

[[Page 116 STAT. 605]]

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 <<NOTE: Establishment.>> 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 <<NOTE: Establishment.>> 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

[[Page 116 STAT. 606]]

                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 <<NOTE: 42 USC 247d-6 note.>> 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 <<NOTE: 42 USC 247d-6.>> 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

[[Page 116 STAT. 607]]

        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 <<NOTE: 42 USC 247d-7a.>> 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

[[Page 116 STAT. 608]]

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 <<NOTE: 42 USC 247d-7b.>> 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.''.

[[Page 116 STAT. 609]]

SEC. 108. WORKING GROUP.

    Section 319F of the Public Health Service Act, as amended by section 
104(a), <<NOTE: 42 USC 247d-6.>> 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;

[[Page 116 STAT. 610]]

                    ``(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

[[Page 116 STAT. 611]]

        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 <<NOTE: 42 USC 247d-7c.>> 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), <<NOTE: 42 USC 247d-1.>> by 
        striking ``10 years'' and inserting ``five years'';
            (2) in section 319B(a), in <<NOTE: 42 USC 247d-2.>> the 
        first sentence, by striking ``10 years'' and inserting ``five 
        years''; and
            (3) in section 391F(e)(2), as <<NOTE: 42 USC 247d-
        6.>> 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 <<NOTE: 42 USC 300hh-12.>> NATIONAL STOCKPILE.

    (a) Strategic National Stockpile.--

[[Page 116 STAT. 612]]

            (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 <<NOTE: Contracts.>> 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.--

[[Page 116 STAT. 613]]

            (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 <<NOTE: 21 USC 356-1.>> 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 <<NOTE: Deadline.>> 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.

[[Page 116 STAT. 614]]

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 <<NOTE: 42 USC 247d-7d.>> 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, <<NOTE: 42 USC 247d-6.>>  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.

[[Page 116 STAT. 615]]

            ``(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 <<NOTE: 42 USC 300hh-13.>> 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 <<NOTE: Deadline.>> 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 <<NOTE: 42 USC 300hh-12 note.>> 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:

[[Page 116 STAT. 616]]

                    (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 <<NOTE: Deadline.>> 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 <<NOTE: Deadline.>> 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 <<NOTE: Contracts.>> 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

[[Page 116 STAT. 617]]

                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 <<NOTE: Deadline.>> 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 <<NOTE: 42 USC 247d-3a.>> 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,

[[Page 116 STAT. 618]]

                      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 <<NOTE: Deadline.>> 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.

[[Page 116 STAT. 619]]

            ``(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

[[Page 116 STAT. 620]]

        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.

[[Page 116 STAT. 621]]

    ``(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.--

[[Page 116 STAT. 622]]

                    ``(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).

[[Page 116 STAT. 623]]

            ``(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.

[[Page 116 STAT. 624]]

            ``(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 <<NOTE: 42 USC 247d-3b.>> 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;

[[Page 116 STAT. 625]]

            ``(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.

[[Page 116 STAT. 626]]

    ``(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 <<NOTE: Federal Register, publication.>> 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

[[Page 116 STAT. 627]]

        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 <<NOTE: 42 USC 1320b-5.>> 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

[[Page 116 STAT. 628]]

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--

[[Page 116 STAT. 629]]

                    ``(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 <<NOTE: 42 USC 1320b-5 
note.>> made by subsection (a) shall be effective on and after September 
11, 2001.

[[Page 116 STAT. 630]]

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 <<NOTE: 42 USC 247d note.>> 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 <<NOTE: 42 USC 7257d.>> 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.

[[Page 116 STAT. 631]]

            (3) Report.--Not <<NOTE: Deadline.>> 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 <<NOTE: 29 USC 669a.>> 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 <<NOTE: 38 USC note prec. 8101.>> 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 <<NOTE: Deadline.>> 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

[[Page 116 STAT. 632]]

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.

[[Page 116 STAT. 633]]

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 <<NOTE: 42 USC 300hh note.>> 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''.

[[Page 116 STAT. 634]]

SEC. 159. PUBLIC <<NOTE: Community Access to Emergency Defibrillation 
            Act of 2002.>> ACCESS DEFIBRILLATION PROGRAMS AND PUBLIC 
            ACCESS DEFIBRILLATION DEMONSTRATION PROJECTS.

    (a) Short Title.--This <<NOTE: 42 USC 201 note.>> section may be 
cited as the ``Community Access to Emergency Defibrillation Act of 
2002''.

    (b) Findings.--Congress <<NOTE: 42 USC 244 note.>> 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 <<NOTE: 42 USC 244.>> ACCESS DEFIBRILLATION PROGRAMS.

    ``(a) In General.--The <<NOTE: Grants.>> 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

[[Page 116 STAT. 635]]

        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

[[Page 116 STAT. 636]]

                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 <<NOTE: 42 USC 245.>> 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.

[[Page 116 STAT. 637]]

            ``(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 <<NOTE: 42 USC 262a.>> 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;

[[Page 116 STAT. 638]]

                                    ``(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

[[Page 116 STAT. 639]]

        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;

[[Page 116 STAT. 640]]

                                    ``(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

[[Page 116 STAT. 641]]

                (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

[[Page 116 STAT. 642]]

                      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

[[Page 116 STAT. 643]]

                      (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 <<NOTE: Deadline.>> 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)

[[Page 116 STAT. 644]]

                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.

[[Page 116 STAT. 645]]

            ``(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--

[[Page 116 STAT. 646]]

                    ``(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 <<NOTE: Deadline. 42 USC 262a 
note.>> 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 <<NOTE: Deadlines. 42 USC 262a note.>> 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 <<NOTE: Guidelines.>> 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 <<NOTE: Rules.>> 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--

[[Page 116 STAT. 647]]

            (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 <<NOTE: 42 USC 262a note.>> 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 <<NOTE: Agricultural Bioterrorism Protection Act 
of 2002.>> of Agriculture

SEC. 211. <<NOTE: 7 USC 8401 note.>> SHORT TITLE.

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

SEC. 212. REGULATION <<NOTE: 7 USC 8401.>> 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;

[[Page 116 STAT. 648]]

                                    (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 <<NOTE: Publication.>> 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 <<NOTE: Safety.>> 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

[[Page 116 STAT. 649]]

        identification, including their source. 
        The <<NOTE: Records.>> 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

[[Page 116 STAT. 650]]

                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

[[Page 116 STAT. 651]]

                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

[[Page 116 STAT. 652]]

                      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--

[[Page 116 STAT. 653]]

                          (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

[[Page 116 STAT. 654]]

                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

[[Page 116 STAT. 655]]

                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.--

[[Page 116 STAT. 656]]

            (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. <<NOTE: Deadlines.>> IMPLEMENTATION BY DEPARTMENT OF 
            AGRICULTURE.

    (a) <<NOTE: Rules. 7 USC 8401 note.>>  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

[[Page 116 STAT. 657]]

under section 212(a)(1). <<NOTE: Guidelines.>>  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.-- <<NOTE: Rules.>> 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. <<NOTE: 7 USC 8411.>>  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

[[Page 116 STAT. 658]]

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--

[[Page 116 STAT. 659]]

                          (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) <<NOTE: Deadline.>>  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) <<NOTE: Deadline.>>  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.

[[Page 116 STAT. 660]]

 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

[[Page 116 STAT. 661]]

                    (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

[[Page 116 STAT. 662]]

            (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. <<NOTE: 21 USC 341 note.>>  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

[[Page 116 STAT. 663]]

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) <<NOTE: Reports.>>  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) <<NOTE: Deadline.>>  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) <<NOTE: Reports.>>  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

[[Page 116 STAT. 664]]

                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. <<NOTE: Regulation.>>  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:

[[Page 116 STAT. 665]]

    ``(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, <<NOTE: 21 USC 381.>>  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)'';

[[Page 116 STAT. 666]]

                    (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 <<NOTE: 21 USC 335a.>>  (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).''.

[[Page 116 STAT. 667]]

    (e) Importation by Debarred Persons.--Section 801 of the Federal 
Food, Drug, and Cosmetic Act, as amended by section 303(c) of this 
Act, <<NOTE: 21 USC 381.>>  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. <<NOTE: 21 USC 350d.>>  REGISTRATION OF FOOD FACILITIES.

    ``(a) Registration.--
            ``(1) <<NOTE: Regulations.>>  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. <<NOTE: Notification.>>  The registrant shall notify 
        the Secretary in a timely manner of changes to such information.
            ``(3) <<NOTE: Notification.>>  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) <<NOTE: Records.>>  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

[[Page 116 STAT. 668]]

        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, <<NOTE: 21 USC 381.>>  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) <<NOTE: 21 USC 350d note.>>  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

[[Page 116 STAT. 669]]

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) <<NOTE: Deadline.>>  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. <<NOTE: 21 USC 350c.>>  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. <<NOTE: Applicability.>>  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.

[[Page 116 STAT. 670]]

    ``(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) <<NOTE: Deadline. 21 USC 350c note.>>  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) <<NOTE: Regulations.>>  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

[[Page 116 STAT. 671]]

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.).''.

[[Page 116 STAT. 672]]

    (b) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act, as amended by section 305(b) of this Act, <<NOTE: 21 USC 
331.>>  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) <<NOTE: 21 USC 351 note.>>  Rulemaking; Effective Date.--
            (1) <<NOTE: Deadline.>>  In general.--Not later than 18 
        months after the date of the enactment of this Act, the 
        Secretary of Health and Human Services shall promulgate proposed 
        and final regulations for the requirement of providing notice in 
        accordance with section 801(m) of the Federal Food, Drug, and 
        Cosmetic Act (as added by subsection (a) of this section). Such 
        requirement of notification takes effect--
                    (A) upon the effective date of such final 
                regulations; or
                    (B) upon the expiration of such 18-month period if 
                the final regulations have not been made effective as of 
                the expiration of such period, subject to compliance 
                with the final regulations when the final regulations 
                are made effective.
            (2) Default; minimum period of advance notice.--If under 
        paragraph (1) the requirement for providing notice in accordance 
        with section 801(m) of the Federal Food, Drug, and Cosmetic Act 
        takes effect without final regulations having been made 
        effective, then for purposes of such requirement, the specified 
        period of time that the notice is required to be made in advance 
        of the time of the importation of the article of food involved 
        or the offering of the food for import shall be not fewer than 
        eight hours and not more than five days, which shall remain in 
        effect until the final regulations are made effective.

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

    (a) In General.--Section 801 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 381(a)), as amended by section 307(a) of this Act, is 
amended by adding at the end the following:
    ``(n)(1) If a food has been refused admission under subsection (a), 
other than such a food that is required to be destroyed, the Secretary 
may require the owner or consignee of the food to affix to the container 
of the food a label that clearly and conspicuously bears the statement: 
`UNITED STATES: REFUSED ENTRY'.
    ``(2) All expenses in connection with affixing a label under 
paragraph (1) shall be paid by the owner or consignee of the food 
involved, and in default of such payment, shall constitute a lien 
against future importations made by such owner or consignee.
    ``(3) A requirement under paragraph (1) remains in effect until the 
Secretary determines that the food involved has been brought into 
compliance with this Act.''.
    (b) Misbranded Foods.--Section 403 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the 
following:
    ``(v) If--
            ``(1) it fails to bear a label required by the Secretary 
        under section 801(n)(1) (relating to food refused admission into 
        the United States);

[[Page 116 STAT. 673]]

            ``(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) <<NOTE: 21 USC 381 note.>>  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. <<NOTE: 21 USC 398.>>  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. <<NOTE: 21 USC 399.>>  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

[[Page 116 STAT. 674]]

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. <<NOTE: 42 USC 247b-20.>>  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. <<NOTE: 7 USC 8319.>>  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

[[Page 116 STAT. 675]]

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) <<NOTE: Reports.>>  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. <<NOTE: 21 USC 331 note.>>  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)''.

[[Page 116 STAT. 676]]

    (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) <<NOTE: 21 USC 331 note.>>  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,

[[Page 116 STAT. 677]]

                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) <<NOTE: Records.>>  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) <<NOTE: Reports.>>  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

[[Page 116 STAT. 678]]

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) <<NOTE: 21 USC 331 note.>>  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. <<NOTE: 7 USC 8320.>>  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.

[[Page 116 STAT. 679]]

SEC. 332. <<NOTE: 21 USC 679c.>>  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. <<NOTE: Appropriation authorization. State listing.>>  
            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. <<NOTE: 7 USC 3353.>>  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.

[[Page 116 STAT. 680]]

            (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. <<NOTE: 7 USC 3354.>>  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;

[[Page 116 STAT. 681]]

            (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.''.

[[Page 116 STAT. 682]]

              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. <<NOTE: 42 USC 300i-2.>>  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. <<NOTE: Deadline.>>  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) <<NOTE: Certification. Deadlines.>>  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) <<NOTE: Deadlines. Protocols.>>  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

[[Page 116 STAT. 683]]

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. <<NOTE: Certification. Deadline.>>  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

[[Page 116 STAT. 684]]

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

[[Page 116 STAT. 685]]

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. <<NOTE: 42 USC 300i-3.>>  CONTAMINANT PREVENTION, DETECTION 
            AND RESPONSE.

    ``(a) <<NOTE: Contracts.>>  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).

[[Page 116 STAT. 686]]

``SEC. 1435. <<NOTE: 42 USC 300i-4.>>  SUPPLY DISRUPTION PREVENTION, 
            DETECTION AND RESPONSE.

    ``(a) <<NOTE: Contracts.>>  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

[[Page 116 STAT. 687]]

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) <<NOTE: 42 USC 300g-3.>>  is amended 
        by inserting ``1433'' after ``1417''.
            (2) Section 1431 <<NOTE: 42 USC 300i.>>  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 <<NOTE: 42 USC 300i-1.>>  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 <<NOTE: 42 USC 300j-1.>>  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) <<NOTE: Appropriation authorization.>>  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 <<NOTE: Prescription Drug User Fee Amendments of 2002.>>  A--
Prescription Drug User Fees

SEC. 501. <<NOTE: 21 USC 301 note.>>  SHORT TITLE.

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

SEC. 502. <<NOTE: 21 USC 379g note.>>  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

[[Page 116 STAT. 688]]

        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

[[Page 116 STAT. 689]]

                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:
      

[[Page 116 STAT. 690]]



----------------------------------------------------------------------------------------------------------------
                                             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) <<NOTE: Effective date.>>  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. <<NOTE: Federal Register, publication.>>  
                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).

[[Page 116 STAT. 691]]

            ``(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) <<NOTE: Effective date.>>  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;

[[Page 116 STAT. 692]]

                    (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. <<NOTE: Effective dates. Deadlines. 21 USC 379g note.>>  
            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) <<NOTE: Federal Register, publication.>>  
        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

[[Page 116 STAT. 693]]

        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.''.

[[Page 116 STAT. 694]]

SEC. 507. <<NOTE: 21 USC 379g note.>>  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. <<NOTE: 21 USC 356b note.>>  EFFECTIVE DATE.

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

SEC. 509. <<NOTE: 21 USC 379g note.>>  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. <<NOTE: Appropriation authorization.>>  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.

[[Page 116 STAT. 695]]

SEC. 523. <<NOTE: Appropriation authorization.>>  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. <<NOTE: 47 USC 336 note.>>  TRANSITION TO DIGITAL TELEVISION.

    (a) <<NOTE: Deadline.>>  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

[[Page 116 STAT. 696]]

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) <<NOTE: Applicability. 42 USC 1395w-24 note.>>  
        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) <<NOTE: Applicability. 42 USC 1395w-21 note.>>  
        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''.

[[Page 116 STAT. 697]]

            (2) <<NOTE: Applicability. 42 USC 1395w-23 note.>>  
        Effective date.--The amendment made by paragraph (1) shall first 
        apply to announcements for years after 2003.

    Approved June 12, 2002.

LEGISLATIVE HISTORY--H.R. 3448:
---------------------------------------------------------------------------

HOUSE REPORTS: No. 107-481 (Comm. of Conference).
CONGRESSIONAL RECORD:
                                                        Vol. 147 (2001):
                                    Dec. 11, 12, considered and passed 
                                        House.
                                    Dec. 20, considered and passed 
                                        Senate, amended.
                                                        Vol. 148 (2002):
                                    May 22, House agreed to conference 
                                        report.
                                    May 23, Senate agreed to conference 
                                        report.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 38 (2002):
            June 12, Presidential remarks.

                                  <all>