Pub.L. 107-189 To reauthorize the Export-Import Bank of the United States. <> ...

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[[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) 

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