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[House Report 107-481]
[From the U.S. Government Publishing Office]

107th Congress 
 2d Session             HOUSE OF REPRESENTATIVES         Report 107-481
_______________________________________________________________________
 
PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT 
                                OF 2002

                               __________

                           CONFERENCE REPORT

                              to accompany

                               H.R. 3448

                  May 21, 2002.--Ordered to be printed

107th Congress 
 2d Session             HOUSE OF REPRESENTATIVES         Report 107-481
======================================================================

 PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT 
                                OF 2002

                                _______
                                

                  May 21, 2002.--Ordered to be printed

                                _______
                                

 Mr. Tauzin, from the Committee of conference, submitted the following

                           CONFERENCE REPORT

                        [To accompany H.R. 3448]

    The committee of conference on the disagreeing votes of the 
two Houses on the amendment of the Senate to the bill (H.R. 
3448), to improve the ability of the United States to prevent, 
prepare for, and respond to bioterrorism and other public 
health emergencies, having met, after full and free conference, 
have agreed to recommend and do recommend to their respective 
Houses as follows:
    That the House recede from its disagreement to the 
amendment of the Senate and agree to the same with an amendment 
as follows:
    In lieu of the matter proposed to be inserted by the Senate 
amendment, insert the following:

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Public 
Health Security and Bioterrorism Preparedness and Response Act 
of 2002''.
    (b) Table of Contents.--The table of contents of the Act is 
as follows:

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

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

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

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

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

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

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

        Subtitle D--Emergency Authorities; Additional Provisions

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

                    Subtitle E--Additional Provisions

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

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

           Subtitle A--Department of Health and Human Services

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

                  Subtitle B--Department of Agriculture

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

Subtitle C--Interagency Coordination Regarding Overlap Agents and Toxins

Sec. 221. Interagency coordination.

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

Sec. 231. Criminal penalties.

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

                  Subtitle A--Protection of Food Supply

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

                  Subtitle B--Protection of Drug Supply

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

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

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

              TITLE IV--DRINKING WATER SECURITY AND SAFETY

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

                     TITLE V--ADDITIONAL PROVISIONS

                 Subtitle A--Prescription Drug User Fees

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

  Subtitle B--Funding Provisions Regarding Food and Drug Administration

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

                    Subtitle C--Additional Provisions

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

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

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

SEC. 101. NATIONAL PREPAREDNESS AND RESPONSE.

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

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

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

``SEC. 2801. NATIONAL PREPAREDNESS PLAN.

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

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

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

           ``Subtitle B--Emergency Preparedness and Response

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

SEC. 108. WORKING GROUP.

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

SEC. 109. ANTIMICROBIAL RESISTANCE.

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

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

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

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

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

SEC. 111. ADDITIONAL AMENDMENTS.

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

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

SEC. 121. STRATEGIC NATIONAL STOCKPILE.

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

SEC. 122. ACCELERATED APPROVAL OF PRIORITY COUNTERMEASURES.

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

SEC. 123. ISSUANCE OF RULE ON ANIMAL TRIALS.

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

SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND PRODUCTION.

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

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

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

SEC. 125. ACCELERATED COUNTERMEASURE RESEARCH AND DEVELOPMENT.

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

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

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

SEC. 127. POTASSIUM IODIDE.

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

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

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

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

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

    ``(a) In General.--To enhance the security of the United 
States with respect to bioterrorism and other public health 
emergencies, the Secretary shall make awards of grants or 
cooperative agreements to eligible entities to enable such 
entities to conduct the activities described in subsection (d).
    ``(b) Eligible Entities.--
            ``(1) In general.--To be eligible to receive an 
        award under subsection (a), an entity shall--
                    ``(A)(i) be a State; and
                    ``(ii) prepare and submit to the Secretary 
                an application at such time, and in such 
                manner, and containing such information as the 
                Secretary may require, including an assurance 
                that the State--
                            ``(I) has completed an evaluation 
                        under section 319B(a), or an evaluation 
                        that is substantially equivalent to an 
                        evaluation described in such section 
                        (as determined by the Secretary);
                            ``(II) has prepared, or will 
                        (within 60 days of receiving an award 
                        under this section) prepare, a 
                        Bioterrorism and Other Public Health 
                        Emergency Preparedness and Response 
                        Plan in accordance with subsection (c);
                            ``(III) has established a means by 
                        which to obtain public comment and 
                        input on the plan prepared under 
                        subclause (II), and on the 
                        implementation of such plan, that shall 
                        include an advisory committee or other 
                        similar mechanism for obtaining comment 
                        from the public at large as well as 
                        from other State and local 
                        stakeholders;
                            ``(IV) will use amounts received 
                        under the award in accordance with the 
                        plan prepared under subclause (II), 
                        including making expenditures to carry 
                        out the strategy contained in the plan; 
                        and
                            ``(V) with respect to the plan 
                        prepared under subclause (II), will 
                        establish reasonable criteria to 
                        evaluate the effective performance of 
                        entities that receive funds under the 
                        award and include relevant benchmarks 
                        in the plan; or
                    ``(B)(i) be a political subdivision of a 
                State or a consortium of 2 or more such 
                subdivisions; and
                    ``(ii) prepare and submit to the Secretary 
                an application at such time, and in such 
                manner, and containing such information as the 
                Secretary may require.
            ``(2) Coordination with statewide plans.--An award 
        under subsection (a) to an eligible entity described in 
        paragraph (1)(B) may not be made unless the application 
        of such entity is in coordination with, and consistent 
        with, applicable Statewide plans described in 
        subsection (d)(1).
    ``(c) Bioterrorism and Other Public Health Emergency 
Preparedness and Response Plan.--Not later than 60 days after 
receiving amounts under an award under subsection (a), an 
eligible entity described in subsection (b)(1)(A) shall prepare 
and submit to the Secretary a Bioterrorism and Other Public 
Health Emergency Preparedness and Response Plan. Recognizing 
the assessment of public health needs conducted under section 
319B, such plan shall include a description of activities to be 
carried out by the entity to address the needs identified in 
such assessment (or an equivalent assessment).
    ``(d) Use of Funds.--An award under subsection (a) may be 
expended for activities that may include the following and 
similar activities:
            ``(1) To develop Statewide plans (including the 
        development of the Bioterrorism and Other Public Health 
        Emergency Preparedness and Response Plan required under 
        subsection (c)), and community-wide plans for 
        responding to bioterrorism and other public health 
        emergencies that are coordinated with the capacities of 
        applicable national, State, and local health agencies 
        and health care providers, including poison control 
        centers.
            ``(2) To address deficiencies identified in the 
        assessment conducted under section 319B.
            ``(3) To purchase or upgrade equipment (including 
        stationary or mobile communications equipment), 
        supplies, pharmaceuticals or other priority 
        countermeasures to enhance preparedness for and 
        response to bioterrorism or other public health 
        emergencies, consistent with the plan described in 
        subsection (c).
            ``(4) To conduct exercises to test the capability 
        and timeliness of public health emergency response 
        activities.
            ``(5) To develop and implement the trauma care and 
        burn center care components of the State plans for the 
        provision of emergency medical services.
            ``(6) To improve training or workforce development 
        to enhance public health laboratories.
            ``(7) To train public health and health care 
        personnel to enhance the ability of such personnel--
                    ``(A) to detect, provide accurate 
                identification of, and recognize the symptoms 
                and epidemiological characteristics of exposure 
                to a biological agent that may cause a public 
                health emergency; and
                    ``(B) to provide treatment to individuals 
                who are exposed to such an agent.
            ``(8) To develop, enhance, coordinate, or improve 
        participation in systems by which disease detection and 
        information about biological attacks and other public 
        health emergencies can be rapidly communicated among 
        national, State, and local health agencies, emergency 
        response personnel, and health care providers and 
        facilities to detect and respond to a bioterrorist 
        attack or other public health emergency, including 
        activities to improve information technology and 
        communications equipment available to health care and 
        public health officials for use in responding to a 
        biological threat or attack or other public health 
        emergency.
            ``(9) To enhance communication to the public of 
        information on bioterrorism and other public health 
        emergencies, including through the use of 2-1-1 call 
        centers.
            ``(10) To address the health security needs of 
        children and other vulnerable populations with respect 
        to bioterrorism and other public health emergencies.
            ``(11) To provide training and develop, enhance, 
        coordinate, or improve methods to enhance the safety of 
        workers and workplaces in the event of bioterrorism.
            ``(12) To prepare and plan for contamination 
        prevention efforts related to public health that may be 
        implemented in the event of a bioterrorist attack, 
        including training and planning to protect the health 
        and safety of workers conducting the activities 
        described in this paragraph.
            ``(13) To prepare a plan for triage and transport 
        management in the event of bioterrorism or other public 
        health emergencies.
            ``(14) To enhance the training of health care 
        professionals to recognize and treat the mental health 
        consequences of bioterrorism or other public health 
        emergencies.
            ``(15) To enhance the training of health care 
        professionals to assist in providing appropriate health 
        care for large numbers of individuals exposed to a 
        bioweapon.
            ``(16) To enhance training and planning to protect 
        the health and safety of personnel, including health 
        care professionals, involved in responding to a 
        biological attack.
            ``(17) To improve surveillance, detection, and 
        response activities to prepare for emergency response 
        activities including biological threats or attacks, 
        including training personnel in these and other 
        necessary functions and including early warning and 
        surveillance networks that use advanced information 
        technology to provide early detection of biological 
        threats or attacks.
            ``(18) To develop, enhance, and coordinate or 
        improve the ability of existing telemedicine programs 
        to provide health care information and advice as part 
        of the emergency public health response to bioterrorism 
        or other public health emergencies.
Nothing in this subsection may be construed as establishing new 
regulatory authority or as modifying any existing regulatory 
authority.
    ``(e) Priorities in Use of Grants.--
            ``(1) In general.--
                    ``(A) Priorities.--Except as provided in 
                subparagraph (B), the Secretary shall, in 
                carrying out the activities described in this 
                section, address the following hazards in the 
                following priority:
                            ``(i) Bioterrorism or acute 
                        outbreaks of infectious diseases.
                            ``(ii) Other public health threats 
                        and emergencies.
                    ``(B) Determination of the secretary.--In 
                the case of the hazard involved, the degree of 
                priority that would apply to the hazard based 
                on the categories specified in clauses (i) and 
                (ii) of subparagraph (A) may be modified by the 
                Secretary if the following conditions are met:
                            ``(i) The Secretary determines that 
                        the modification is appropriate on the 
                        basis of the following factors:
                                    ``(I) The extent to which 
                                eligible entities are 
                                adequately prepared for 
                                responding to hazards within 
                                the category specified in 
                                clause (i) of subparagraph (A).
                                    ``(II) There has been a 
                                significant change in the 
                                assessment of risks to the 
                                public health posed by hazards 
                                within the category specified 
                                in clause (ii) of such 
                                subparagraph.
                            ``(ii) Prior to modifying the 
                        priority, the Secretary notifies the 
                        appropriate committees of the Congress 
                        of the determination of the Secretary 
                        under clause (i) of this subparagraph.
            ``(2) Areas of emphasis within categories.--The 
        Secretary shall determine areas of emphasis within the 
        category of hazards specified in clause (i) of 
        paragraph (1)(A), and shall determine areas of emphasis 
        within the category of hazards specified in clause (ii) 
        of such paragraph, based on an assessment of the risk 
        and likely consequences of such hazards and on an 
        evaluation of Federal, State, and local needs, and may 
        also take into account the extent to which receiving an 
        award under subsection (a) will develop capacities that 
        can be used for public health emergencies of varying 
        types.
    ``(f) Certain Activities.--In administering activities 
under section 319C(c)(4) or similar activities, the Secretary 
shall, where appropriate, give priority to activities that 
include State or local government financial commitments, that 
seek to incorporate multiple public health and safety services 
or diagnostic databases into an integrated public health 
entity, and that cover geographic areas lacking advanced 
diagnostic and laboratory capabilities.
    ``(g) Coordination With Local Medical Response System.--An 
eligible entity and local Metropolitan Medical Response Systems 
shall, to the extent practicable, ensure that activities 
carried out under an award under subsection (a) are coordinated 
with activities that are carried out by local Metropolitan 
Medical Response Systems.
    ``(h) Coordination of Federal Activities.--In making awards 
under subsection (a), the Secretary shall--
            ``(1) annually notify the Director of the Federal 
        Emergency Management Agency, the Director of the Office 
        of Justice Programs, and the Director of the National 
        Domestic Preparedness Office, as to the amount, 
        activities covered under, and status of such awards; 
        and
            ``(2) coordinate such awards with other activities 
        conducted or supported by the Secretary to enhance 
        preparedness for bioterrorism and other public health 
        emergencies.
    ``(i) Definition.--For purposes of this section, the term 
`eligible entity' means an entity that meets the conditions 
described in subparagraph (A) or (B) of subsection (b)(1).
    ``(j) Funding.--
            ``(1) Authorizations of appropriations.--
                    ``(A) Fiscal year 2003.--
                            ``(i) Authorizations.--For the 
                        purpose of carrying out this section, 
                        there is authorized to be appropriated 
                        $1,600,000,000 for fiscal year 2003, of 
                        which--
                                    ``(I) $1,080,000,000 is 
                                authorized to be appropriated 
                                for awards pursuant to 
                                paragraph (3) (subject to the 
                                authority of the Secretary to 
                                make awards pursuant to 
                                paragraphs (4) and (5)); and
                                    ``(II) $520,000,000 is 
                                authorized to be appropriated--
                                            ``(aa) for awards 
                                        under subsection (a) to 
                                        States, notwithstanding 
                                        the eligibility 
                                        conditions under 
                                        subsection (b), for the 
                                        purpose of enhancing 
                                        the preparedness of 
                                        hospitals (including 
                                        children's hospitals), 
                                        clinics, health 
                                        centers, and primary 
                                        care facilities for 
                                        bioterrorism and other 
                                        public health 
                                        emergencies; and
                                            ``(bb) for Federal, 
                                        State, and local 
                                        planning and 
                                        administrative 
                                        activities related to 
                                        such purpose.
                            ``(ii) Contingent additional 
                        authorization.--If a significant change 
                        in circumstances warrants an increase 
                        in the amount authorized to be 
                        appropriated under clause (i) for 
                        fiscal year 2003, there are authorized 
                        to be appropriated such sums as may be 
                        necessary for such year for carrying 
                        out this section, in addition to the 
                        amount authorized in clause (i).
                    ``(B) Other fiscal years.--For the purpose 
                of carrying out this section, there are 
                authorized to be appropriated such sums as may 
                be necessary for each of the fiscal years 2004 
                through 2006.
            ``(2) Supplement not supplant.--Amounts 
        appropriated under paragraph (1) shall be used to 
        supplement and not supplant other State and local 
        public funds provided for activities under this 
        section.
            ``(3) State bioterrorism and other public health 
        emergency preparedness and response block grant for 
        fiscal year 2003.--
                    ``(A) In general.--For fiscal year 2003, 
                the Secretary shall, in an amount determined in 
                accordance with subparagraphs (B) through (D), 
                make an award under subsection (a) to each 
                State, notwithstanding the eligibility 
                conditions described in subsection (b), that 
                submits to the Secretary an application for the 
                award that meets the criteria of the Secretary 
                for the receipt of such an award and that meets 
                other implementation conditions established by 
                the Secretary for such awards. No other awards 
                may be made under subsection (a) for such 
                fiscal year, except as provided in paragraph 
                (1)(A)(i)(II) and paragraphs (4) and (5).
                    ``(B) Base amount.--In determining the 
                amount of an award pursuant to subparagraph (A) 
                for a State, the Secretary shall first 
                determine an amount the Secretary considers 
                appropriate for the State (referred to in this 
                paragraph as the `base amount'), except that 
                such amount may not be greater than the minimum 
                amount determined under subparagraph (D).
                    ``(C) Increase on basis of population.--
                After determining the base amount for a State 
                under subparagraph (B), the Secretary shall 
                increase the base amount by an amount equal to 
                the product of--
                            ``(i) the amount appropriated under 
                        paragraph (1)(A)(i)(I) for the fiscal 
                        year, less an amount equal to the sum 
                        of all base amounts determined for the 
                        States under subparagraph (B), and less 
                        the amount, if any, reserved by the 
                        Secretary under paragraphs (4) and (5); 
                        and
                            ``(ii) subject to paragraph (4)(C), 
                        the percentage constituted by the ratio 
                        of an amount equal to the population of 
                        the State over an amount equal to the 
                        total population of the States (as 
                        indicated by the most recent data 
                        collected by the Bureau of the Census).
                    ``(D) Minimum amount.--Subject to the 
                amount appropriated under paragraph 
                (1)(A)(i)(I), an award pursuant to subparagraph 
                (A) for a State shall be the greater of the 
                base amount as increased under subparagraph 
                (C), or the minimum amount under this 
                subparagraph. The minimum amount under this 
                subparagraph is--
                            ``(i) in the case of each of the 
                        several States, the District of 
                        Columbia, and the Commonwealth of 
                        Puerto Rico, an amount equal to the 
                        lesser of--
                                    ``(I) $5,000,000; or
                                    ``(II) if the amount 
                                appropriated under paragraph 
                                (1)(A)(i)(I) is less than 
                                $667,000,000, an amount equal 
                                to 0.75 percent of the amount 
                                appropriated under such 
                                paragraph, less the amount, if 
                                any, reserved by the Secretary 
                                under paragraphs (4) and (5); 
                                or
                            ``(ii) in the case of each of 
                        American Samoa, Guam, the Commonwealth 
                        of the Northern Mariana Islands, and 
                        the Virgin Islands, an amount 
                        determined by the Secretary to be 
                        appropriate, except that such amount 
                        may not exceed the amount determined 
                        under clause (i).
            ``(4) Certain political subdivisions.--
                    ``(A) In general.--For fiscal year 2003, 
                the Secretary may, before making awards 
                pursuant to paragraph (3) for such year, 
                reserve from the amount appropriated under 
                paragraph (1)(A)(i)(I) for the year an amount 
                determined necessary by the Secretary to make 
                awards under subsection (a) to political 
                subdivisions that have a substantial number of 
                residents, have a substantial local 
                infrastructure for responding to public health 
                emergencies, and face a high degree of risk 
                from bioterrorist attacks or other public 
                health emergencies. Not more than three 
                political subdivisions may receive awards 
                pursuant to this subparagraph.
                    ``(B) Coordination with statewide plans.--
                An award pursuant to subparagraph (A) may not 
                be made unless the application of the political 
                subdivision involved is in coordination with, 
                and consistent with, applicable Statewide plans 
                described in subsection (c)(1).
                    ``(C) Relationship to formula grants.--In 
                the case of a State that will receive an award 
                pursuant to paragraph (3), and in which there 
                is located a political subdivision that will 
                receive an award pursuant to subparagraph (A), 
                the Secretary shall, in determining the amount 
                under paragraph (3)(B) for the State, subtract 
                from the population of the State an amount 
                equal to the population of such political 
                subdivision.
                    ``(D) Continuity of funding.--In 
                determining whether to make an award pursuant 
                to subparagraph (A) to a political subdivision, 
                the Secretary may consider, as a factor 
                indicating that the award should be made, that 
                the political subdivision received public 
                health funding from the Secretary for fiscal 
                year 2002.
            ``(5) Significant unmet needs; degree of risk.--
                    ``(A) In general.--For fiscal year 2003, 
                the Secretary may, before making awards 
                pursuant to paragraph (3) for such year, 
                reserve from the amount appropriated under 
                paragraph (1)(A)(i)(I) for the year an amount 
                determined necessary by the Secretary to make 
                awards under subsection (a) to eligible 
                entities that--
                            ``(i) have a significant need for 
                        funds to build capacity to identify, 
                        detect, monitor, and respond to a 
                        bioterrorist or other threat to the 
                        public health, which need will not be 
                        met by awards pursuant to paragraph 
                        (3); and
                            ``(ii) face a particularly high 
                        degree of risk of such a threat.
                    ``(B) Recipients of grants.--Awards 
                pursuant to subparagraph (A) may be 
                supplemental awards to States that receive 
                awards pursuant to paragraph (3), or may be 
                awards to eligible entities described in 
                subsection (b)(1)(B) within such States.
                    ``(C) Finding with respect to district of 
                columbia.--The Secretary shall consider the 
                District of Columbia to have a significant 
                unmet need for purposes of subparagraph (A), 
                and to face a particularly high degree of risk 
                for such purposes, on the basis of the 
                concentration of entities of national 
                significance located within the District.
            ``(6) Funding of local entities.--For fiscal year 
        2003, the Secretary shall in making awards under this 
        section ensure that appropriate portions of such awards 
        are made available to political subdivisions, local 
        departments of public health, hospitals (including 
        children's hospitals), clinics, health centers, or 
        primary care facilities, or consortia of such entities.

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

    ``(a) Grants.--The Secretary shall make awards of grants or 
cooperative agreements to eligible entities to enable such 
entities to improve community and hospital preparedness for 
bioterrorism and other public health emergencies.
    ``(b) Eligibility.--To be eligible for an award under 
subsection (a), an entity shall--
            ``(1) be a partnership consisting of--
                    ``(A) one or more hospitals (including 
                children's hospitals), clinics, health centers, 
                or primary care facilities; and
                    ``(B)(i) one or more political subdivisions 
                of States;
                    ``(ii) one or more States; or
                    ``(iii) one or more States and one or more 
                political subdivisions of States; and
            ``(2) prepare, in consultation with the Chief 
        Executive Officer of the State, District, or territory 
        in which the hospital, clinic, health center, or 
        primary care facility described in paragraph (1)(A) is 
        located, and submit to the Secretary, an application at 
        such time, in such manner, and containing such 
        information as the Secretary may require.
    ``(c) Regional Coordination.--In making awards under 
subsection (a), the Secretary shall give preference to eligible 
entities that submit applications that, in the determination of 
the Secretary, will--
            ``(1) enhance coordination--
                    ``(A) among the entities described in 
                subsection (b)(1)(A); and
                    ``(B) between such entities and the 
                entities described in subsection (b)(1)(B); and
            ``(2) serve the needs of a defined geographic area.
    ``(d) Consistency of Planned Activities.--An entity 
described in subsection (b)(1) shall utilize amounts received 
under an award under subsection (a) in a manner that is 
coordinated and consistent, as determined by the Secretary, 
with an applicable State Bioterrorism and Other Public Health 
Emergency Preparedness and Response Plan.
    ``(e) Use of Funds.--An award under subsection (a) may be 
expended for activities that may include the following and 
similar activities--
            ``(1) planning and administration for such award;
            ``(2) preparing a plan for triage and transport 
        management in the event of bioterrorism or other public 
        health emergencies;
            ``(3) enhancing the training of health care 
        professionals to improve the ability of such 
        professionals to recognize the symptoms of exposure to 
        a potential bioweapon, to make appropriate diagnosis, 
        and to provide treatment to those individuals so 
        exposed;
            ``(4) enhancing the training of health care 
        professionals to recognize and treat the mental health 
        consequences of bioterrorism or other public health 
        emergencies;
            ``(5) enhancing the training of health care 
        professionals to assist in providing appropriate health 
        care for large numbers of individuals exposed to a 
        bioweapon;
            ``(6) enhancing training and planning to protect 
        the health and safety of personnel involved in 
        responding to a biological attack;
            ``(7) developing and implementing the trauma care 
        and burn center care components of the State plans for 
        the provision of emergency medical services; or
            ``(8) conducting such activities as are described 
        in section 319C-1(d) that are appropriate for hospitals 
        (including children's hospitals), clinics, health 
        centers, or primary care facilities.
    ``(f) Limitation on Awards.--A political subdivision of a 
State shall not participate in more than one partnership 
described in subsection (b)(1).
    ``(g) Priorities in Use of Grants.--
            ``(1) In general.--
                    ``(A) Priorities.--Except as provided in 
                subparagraph (B), the Secretary shall, in 
                carrying out the activities described in this 
                section, address the following hazards in the 
                following priority:
                            ``(i) Bioterrorism or acute 
                        outbreaks of infectious diseases.
                            ``(ii) Other public health threats 
                        and emergencies.
                    ``(B) Determination of the secretary.--In 
                the case of the hazard involved, the degree of 
                priority that would apply to the hazard based 
                on the categories specified in clauses (i) and 
                (ii) of subparagraph (A) may be modified by the 
                Secretary if the following conditions are met:
                            ``(i) The Secretary determines that 
                        the modification is appropriate on the 
                        basis of the following factors:
                                    ``(I) The extent to which 
                                eligible entities are 
                                adequately prepared for 
                                responding to hazards within 
                                the category specified in 
                                clause (i) of subparagraph (A).
                                    ``(II) There has been a 
                                significant change in the 
                                assessment of risks to the 
                                public health posed by hazards 
                                within the category specified 
                                in clause (ii) of such 
                                subparagraph.
                            ``(ii) Prior to modifying the 
                        priority, the Secretary notifies the 
                        appropriate committees of the Congress 
                        of the determination of the Secretary 
                        under clause (i) of this subparagraph.
            ``(2) Areas of emphasis within categories.--The 
        Secretary shall determine areas of emphasis within the 
        category of hazards specified in clause (i) of 
        paragraph (1)(A), and shall determine areas of emphasis 
        within the category of hazards specified in clause (ii) 
        of such paragraph, based on an assessment of the risk 
        and likely consequences of such hazards and on an 
        evaluation of Federal, State, and local needs, and may 
        also take into account the extent to which receiving an 
        award under subsection (a) will develop capacities that 
        can be used for public health emergencies of varying 
        types.
    ``(h) Coordination With Local Medical Response System.--An 
eligible entity and local Metropolitan Medical Response Systems 
shall, to the extent practicable, ensure that activities 
carried out under an award under subsection (a) are coordinated 
with activities that are carried out by local Metropolitan 
Medical Response Systems.
    ``(i) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of fiscal 
years 2004 through 2006.''.
    (b) Certain Grants.--Section 319C of the Public Health 
Service Act (42 U.S.C. 247d-3) is amended by striking 
subsection (f).

        Subtitle D--Emergency Authorities; Additional Provisions

SEC. 141. REPORTING DEADLINES.

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

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

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

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

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

     ``authority to waive requirements during national emergencies

    ``Sec. 1135. (a) Purpose.--The purpose of this section is 
to enable the Secretary to ensure to the maximum extent 
feasible, in any emergency area and during an emergency period 
(as defined in subsection (g)(1))--
            ``(1) that sufficient health care items and 
        services are available to meet the needs of individuals 
        in such area enrolled in the programs under titles 
        XVIII, XIX, and XXI; and
            ``(2) that health care providers (as defined in 
        subsection (g)(2)) that furnish such items and services 
        in good faith, but that are unable to comply with one 
        or more requirements described in subsection (b), may 
        be reimbursed for such items and services and exempted 
        from sanctions for such noncompliance, absent any 
        determination of fraud or abuse.
    ``(b) Secretarial Authority.--To the extent necessary to 
accomplish the purpose specified in subsection (a), the 
Secretary is authorized, subject to the provisions of this 
section, to temporarily waive or modify the application of, 
with respect to health care items and services furnished by a 
health care provider (or classes of health care providers) in 
any emergency area (or portion of such an area) during any 
portion of an emergency period, the requirements of titles 
XVIII, XIX, or XXI, or any regulation thereunder (and the 
requirements of this title other than this section, and 
regulations thereunder, insofar as they relate to such titles), 
pertaining to--
            ``(1)(A) conditions of participation or other 
        certification requirements for an individual health 
        care provider or types of providers,
            ``(B) program participation and similar 
        requirements for an individual health care provider or 
        types of providers, and
            ``(C) pre-approval requirements;
            ``(2) requirements that physicians and other health 
        care professionals be licensed in the State in which 
        they provide such services, if they have equivalent 
        licensing in another State and are not affirmatively 
        excluded from practice in that State or in any State a 
        part of which is included in the emergency area;
            ``(3) sanctions under section 1867 (relating to 
        examination and treatment for emergency medical 
        conditions and women in labor) for a transfer of an 
        individual who has not been stabilized in violation of 
        subsection (c) of such section if the transfer arises 
        out of the circumstances of the emergency;
            ``(4) sanctions under section 1877(g) (relating to 
        limitations on physician referral);
            ``(5) deadlines and timetables for performance of 
        required activities, except that such deadlines and 
        timetables may only be modified, not waived; and
            ``(6) limitations on payments under section 1851(i) 
        for health care items and services furnished to 
        individuals enrolled in a Medicare+Choice plan by 
        health care professionals or facilities not included 
        under such plan.

Insofar as the Secretary exercises authority under paragraph 
(6) with respect to individuals enrolled in a Medicare+Choice 
plan, to the extent possible given the circumstances, the 
Secretary shall reconcile payments made on behalf of such 
enrollees to ensure that the enrollees do not pay more than 
would be required had they received services from providers 
within the network of the plan and may reconcile payments to 
the organization offering the plan to ensure that such 
organization pays for services for which payment is included in 
the capitation payment it receives under part C of title XVIII.
    ``(c) Authority for Retroactive Waiver.--A waiver or 
modification of requirements pursuant to this section may, at 
the Secretary's discretion, be made retroactive to the 
beginning of the emergency period or any subsequent date in 
such period specified by the Secretary.
    ``(d) Certification to Congress.--The Secretary shall 
provide a certification and advance written notice to the 
Congress at least two days before exercising the authority 
under this section with respect to an emergency area. Such a 
certification and notice shall include--
            ``(1) a description of--
                    ``(A) the specific provisions that will be 
                waived or modified;
                    ``(B) the health care providers to whom the 
                waiver or modification will apply;
                    ``(C) the geographic area in which the 
                waiver or modification will apply; and
                    ``(D) the period of time for which the 
                waiver or modification will be in effect; and
            ``(2) a certification that the waiver or 
        modification is necessary to carry out the purpose 
        specified in subsection (a).
    ``(e) Duration of Waiver.--
            ``(1) In general.--A waiver or modification of 
        requirements pursuant to this section terminates upon--
                    ``(A) the termination of the applicable 
                declaration of emergency or disaster described 
                in subsection (g)(1)(A);
                    ``(B) the termination of the applicable 
                declaration of public health emergency 
                described in subsection (g)(1)(B); or
                    ``(C) subject to paragraph (2), the 
                termination of a period of 60 days from the 
                date the waiver or modification is first 
                published (or, if applicable, the date of 
                extension of the waiver or modification under 
                paragraph (2)).
            ``(2) Extension of 60-day periods.--The Secretary 
        may, by notice, provide for an extension of a 60-day 
        period described in paragraph (1)(C) (or an additional 
        period provided under this paragraph) for additional 
        period or periods (not to exceed, except as 
        subsequently provided under this paragraph, 60 days 
        each), but any such extension shall not affect or 
        prevent the termination of a waiver or modification 
        under subparagraph (A) or (B) of paragraph (1).
    ``(f) Report to Congress.--Within one year after the end of 
the emergency period in an emergency area in which the 
Secretary exercised the authority provided under this section, 
the Secretary shall report to the Congress regarding the 
approaches used to accomplish the purposes described in 
subsection (a), including an evaluation of such approaches and 
recommendations for improved approaches should the need for 
such emergency authority arise in the future.
    ``(g) Definitions.--For purposes of this section:
            ``(1) Emergency area; emergency period.--An 
        `emergency area' is a geographical area in which, and 
        an `emergency period' is the period during which, there 
        exists--
                    ``(A) an emergency or disaster declared by 
                the President pursuant to the National 
                Emergencies Act or the Robert T. Stafford 
                Disaster Relief and Emergency Assistance Act; 
                and
                    ``(B) a public health emergency declared by 
                the Secretary pursuant to section 319 of the 
                Public Health Service Act.
            ``(2) Health care provider.--The term `health care 
        provider' means any entity that furnishes health care 
        items or services, and includes a hospital or other 
        provider of services, a physician or other health care 
        practitioner or professional, a health care facility, 
        or a supplier of health care items or services.''.
    (b) Effective Date.--The amendment made by subsection (a) 
shall be effective on and after September 11, 2001.

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

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

                   Subtitle E--Additional Provisions

SEC. 151. DESIGNATED STATE PUBLIC EMERGENCY ANNOUNCEMENT PLAN.

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

SEC. 152. EXPANDED RESEARCH BY SECRETARY OF ENERGY.

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

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

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

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

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

SEC. 155. REAUTHORIZATION OF EXISTING PROGRAM.

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

SEC. 156. SENSE OF CONGRESS.

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

SEC. 157. GENERAL ACCOUNTING OFFICE REPORT.

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

SEC. 158. CERTAIN AWARDS.

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

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

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

``SEC. 312. PUBLIC ACCESS DEFIBRILLATION PROGRAMS.

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

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

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

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

          Subtitle A--Department of Health and Human Services

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

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

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

    ``(a) Regulatory Control of Certain Biological Agents and 
Toxins.--
            ``(1) List of biological agents and toxins.--
                    ``(A) In general.--The Secretary shall by 
                regulation establish and maintain a list of 
                each biological agent and each toxin that has 
                the potential to pose a severe threat to public 
                health and safety.
                    ``(B) Criteria.--In determining whether to 
                include an agent or toxin on the list under 
                subparagraph (A), the Secretary shall--
                            ``(i) consider--
                                    ``(I) the effect on human 
                                health of exposure to the agent 
                                or toxin;
                                    ``(II) the degree of 
                                contagiousness of the agent or 
                                toxin and the methods by which 
                                the agent or toxin is 
                                transferred to humans;
                                    ``(III) the availability 
                                and effectiveness of 
                                pharmacotherapies and 
                                immunizations to treat and 
                                prevent any illness resulting 
                                from infection by the agent or 
                                toxin; and
                                    ``(IV) any other criteria, 
                                including the needs of children 
                                and other vulnerable 
                                populations, that the Secretary 
                                considers appropriate; and
                            ``(ii) consult with appropriate 
                        Federal departments and agencies and 
                        with scientific experts representing 
                        appropriate professional groups, 
                        including groups with pediatric 
                        expertise.
            ``(2) Biennial review.--The Secretary shall review 
        and republish the list under paragraph (1) biennially, 
        or more often as needed, and shall by regulation revise 
        the list as necessary in accordance with such 
        paragraph.
    ``(b) Regulation of Transfers of Listed Agents and 
Toxins.--The Secretary shall by regulation provide for--
            ``(1) the establishment and enforcement of safety 
        procedures for the transfer of listed agents and 
        toxins, including measures to ensure--
                    ``(A) proper training and appropriate 
                skills to handle such agents and toxins; and
                    ``(B) proper laboratory facilities to 
                contain and dispose of such agents and toxins;
            ``(2) the establishment and enforcement of 
        safeguard and security measures to prevent access to 
        such agents and toxins for use in domestic or 
        international terrorism or for any other criminal 
        purpose;
            ``(3) the establishment of procedures to protect 
        the public safety in the event of a transfer or 
        potential transfer of such an agent or toxin in 
        violation of the safety procedures established under 
        paragraph (1) or the safeguard and security measures 
        established under paragraph (2); and
            ``(4) appropriate availability of biological agents 
        and toxins for research, education, and other 
        legitimate purposes.
    ``(c) Possession and Use of Listed Agents and Toxins.--The 
Secretary shall by regulation provide for the establishment and 
enforcement of standards and procedures governing the 
possession and use of listed agents and toxins, including the 
provisions described in paragraphs (1) through (4) of 
subsection (b), in order to protect the public health and 
safety.
    ``(d) Registration; Identification; Database.--
            ``(1) Registration.--Regulations under subsections 
        (b) and (c) shall require registration with the 
        Secretary of the possession, use, and transfer of 
        listed agents and toxins, and shall include provisions 
        to ensure that persons seeking to register under such 
        regulations have a lawful purpose to possess, use, or 
        transfer such agents and toxins, including provisions 
        in accordance with subsection (e)(6).
            ``(2) Identification; database.--Regulations under 
        subsections (b) and (c) shall require that registration 
        include (if available to the person registering) 
        information regarding the characterization of listed 
        agents and toxins to facilitate their identification, 
        including their source. The Secretary shall maintain a 
        national database that includes the names and locations 
        of registered persons, the listed agents and toxins 
        such persons are possessing, using, or transferring, 
        and information regarding the characterization of such 
        agents and toxins.
    ``(e) Safeguard and Security Requirements for Registered 
Persons.--
            ``(1) In general.--Regulations under subsections 
        (b) and (c) shall include appropriate safeguard and 
        security requirements for persons possessing, using, or 
        transferring a listed agent or toxin commensurate with 
        the risk such agent or toxin poses to public health and 
        safety (including the risk of use in domestic or 
        international terrorism). The Secretary shall establish 
        such requirements in consultation with the Attorney 
        General, and shall ensure compliance with such 
        requirements as part of the registration system under 
        such regulations.
            ``(2) Limiting access to listed agents and 
        toxins.--Requirements under paragraph (1) shall include 
        provisions to ensure that registered persons--
                    ``(A) provide access to listed agents and 
                toxins to only those individuals whom the 
                registered person involved determines have a 
                legitimate need to handle or use such agents 
                and toxins;
                    ``(B) submit the names and other 
                identifying information for such individuals to 
                the Secretary and the Attorney General, 
                promptly after first determining that the 
                individuals need access under subparagraph (A), 
                and periodically thereafter while the 
                individuals have such access, not less 
                frequently than once every five years;
                    ``(C) deny access to such agents and toxins 
                by individuals whom the Attorney General has 
                identified as restricted persons; and
                    ``(D) limit or deny access to such agents 
                and toxins by individuals whom the Attorney 
                General has identified as within any category 
                under paragraph (3)(B)(ii), if limiting or 
                denying such access by the individuals involved 
                is determined appropriate by the Secretary, in 
                consultation with the Attorney General.
            ``(3) Submitted names; use of databases by attorney 
        general.--
                    ``(A) In general.--Upon the receipt of 
                names and other identifying information under 
                paragraph (2)(B), the Attorney General shall, 
                for the sole purpose of identifying whether the 
                individuals involved are within any of the 
                categories specified in subparagraph (B), 
                promptly use criminal, immigration, national 
                security, and other electronic databases that 
                are available to the Federal Government and are 
                appropriate for such purpose.
                    ``(B) Certain individuals.--For purposes of 
                subparagraph (A), the categories specified in 
                this subparagraph regarding an individual are 
                that--
                            ``(i) the individual is a 
                        restricted person; or
                            ``(ii) the individual is reasonably 
                        suspected by any Federal law 
                        enforcement or intelligence agency of--
                                    ``(I) committing a crime 
                                set forth in section 
                                2332b(g)(5) of title 18, United 
                                States Code;
                                    ``(II) knowing involvement 
                                with an organization that 
                                engages in domestic or 
                                international terrorism (as 
                                defined in section 2331 of such 
                                title 18) or with any other 
                                organization that engages in 
                                intentional crimes of violence; 
                                or
                                    ``(III) being an agent of a 
                                foreign power (as defined in 
                                section 1801 of title 50, 
                                United States Code).
                    ``(C) Notification by attorney general 
                regarding submitted names.--After the receipt 
                of a name and other identifying information 
                under paragraph (2)(B), the Attorney General 
                shall promptly notify the Secretary whether the 
                individual is within any of the categories 
                specified in subparagraph (B).
            ``(4) Notifications by secretary.--The Secretary, 
        after receiving notice under paragraph (3) regarding an 
        individual, shall promptly notify the registered person 
        involved of whether the individual is granted or denied 
        access under paragraph (2). If the individual is denied 
        such access, the Secretary shall promptly notify the 
        individual of the denial.
            ``(5) Expedited review.--Regulations under 
        subsections (b) and (c) shall provide for a procedure 
        through which, upon request to the Secretary by a 
        registered person who submits names and other 
        identifying information under paragraph (2)(B) and who 
        demonstrates good cause, the Secretary may, as 
        determined appropriate by the Secretary--
                    ``(A) request the Attorney General to 
                expedite the process of identification under 
                paragraph (3)(A) and notification of the 
                Secretary under paragraph (3)(C); and
                    ``(B) expedite the notification of the 
                registered person by the Secretary under 
                paragraph (4).
            ``(6) Process regarding persons seeking to 
        register.--
                    ``(A) Individuals.--Regulations under 
                subsections (b) and (c) shall provide that an 
                individual who seeks to register under either 
                of such subsections is subject to the same 
                processes described in paragraphs (2) through 
                (4) as apply to names and other identifying 
                information submitted to the Attorney General 
                under paragraph (2)(B). Paragraph (5) does not 
                apply for purposes of this subparagraph.
                    ``(B) Other persons.--Regulations under 
                subsections (b) and (c) shall provide that, in 
                determining whether to deny or revoke 
                registration by a person other than an 
                individual, the Secretary shall submit the name 
                of such person to the Attorney General, who 
                shall use criminal, immigration, national 
                security, and other electronic databases 
                available to the Federal Government, as 
                appropriate for the purpose of promptly 
                notifying the Secretary whether the person, or, 
                where relevant, the individual who owns or 
                controls such person, is a restricted person or 
                is reasonably suspected by any Federal law 
                enforcement or intelligence agency of being 
                within any category specified in paragraph 
                (3)(B)(ii) (as applied to persons, including 
                individuals). Such regulations shall provide 
                that a person who seeks to register under 
                either of such subsections is subject to the 
                same processes described in paragraphs (2) and 
                (4) as apply to names and other identifying 
                information submitted to the Attorney General 
                under paragraph (2)(B). Paragraph (5) does not 
                apply for purposes of this subparagraph. The 
                Secretary may exempt Federal, State, or local 
                governmental agencies from the requirements of 
                this subparagraph.
            ``(7) Review.--
                    ``(A) Administrative review.--
                            ``(i) In general.--Regulations 
                        under subsections (b) and (c) shall 
                        provide for an opportunity for a review 
                        by the Secretary--
                                    ``(I) when requested by the 
                                individual involved, of a 
                                determination under paragraph 
                                (2) to deny the individual 
                                access to listed agents and 
                                toxins; and
                                    ``(II) when requested by 
                                the person involved, of a 
                                determination under paragraph 
                                (6) to deny or revoke 
                                registration for such person.
                            ``(ii) Ex parte review.--During a 
                        review under clause (i), the Secretary 
                        may consider information relevant to 
                        the review ex parte to the extent that 
                        disclosure of the information could 
                        compromise nationalsecurity or an 
investigation by any law enforcement agency.
                            ``(iii) Final agency action.--The 
                        decision of the Secretary in a review 
                        under clause (i) constitutes final 
                        agency action for purposes of section 
                        702 of title 5, United States Code.
                    ``(B) Certain procedures.--
                            ``(i) Submission of ex parte 
                        materials in judicial proceedings.--
                        When reviewing a decision of the 
                        Secretary under subparagraph (A), and 
                        upon request made ex parte and in 
                        writing by the United States, a court, 
                        upon a sufficient showing, may review 
                        and consider ex parte documents 
                        containing information the disclosure 
                        of which could compromise national 
                        security or an investigation by any law 
                        enforcement agency. If the court 
                        determines that portions of the 
                        documents considered ex parte should be 
                        disclosed to the person involved to 
                        allow a response, the court shall 
                        authorize the United States to delete 
                        from such documents specified items of 
                        information the disclosure of which 
                        could compromise national security or 
                        an investigation by any law enforcement 
                        agency, or to substitute a summary of 
                        the information to which the person may 
                        respond. Any order by the court 
                        authorizing the disclosure of 
                        information that the United States 
                        believes could compromise national 
                        security or an investigation by any law 
                        enforcement agency shall be subject to 
                        the processes set forth in 
                        subparagraphs (A) and (B)(i) of section 
                        2339B(f)(5) of title 18, United States 
                        Code (relating to interlocutory appeal 
                        and expedited consideration).
                            ``(ii) Disclosure of information.--
                        In a review under subparagraph (A), and 
                        in any judical proceeding conducted 
                        pursuant to such review, neither the 
                        Secretary nor the Attorney General may 
                        be required to disclose to the public 
                        any information that under subsection 
                        (h) shall not be disclosed under 
                        section 552 of title 5, United States 
                        Code.
            ``(8) Notifications regarding theft or loss of 
        agents.--Requirements under paragraph (1) shall include 
        the prompt notification of the Secretary, and 
        appropriate Federal, State, and local law enforcement 
        agencies, of the theft or loss of listed agents and 
        toxins.
            ``(9) Technical assistance for registered 
        persons.--The Secretary, in consultation with the 
        Attorney General, may provide technical assistance to 
        registered persons to improve security of the 
        facilities of such persons.
    ``(f) Inspections.--The Secretary shall have the authority 
to inspect persons subject to regulations under subsection (b) 
or (c) to ensure their compliance with such regulations, 
including prohibitions on restricted persons and other 
provisions of subsection (e).
    ``(g) Exemptions.--
            ``(1) Clinical or diagnostic laboratories.--
        Regulations under subsections (b) and (c) shall exempt 
        clinical or diagnostic laboratories and other persons 
        who possess, use, or transfer listed agents or toxins 
        that are contained in specimens presented for 
        diagnosis, verification, or proficiency testing, 
        provided that--
                    ``(A) the identification of such agents or 
                toxins is reported to the Secretary, and when 
                required under Federal, State, or local law, to 
                other appropriate authorities; and
                    ``(B) such agents or toxins are transferred 
                or destroyed in a manner set forth by the 
                Secretary by regulation.
            ``(2) Products.--
                    ``(A) In general.--Regulations under 
                subsections (b) and (c) shall exempt products 
                that are, bear, or contain listed agents or 
                toxins and are cleared, approved, licensed, or 
                registered under any of the Acts specified in 
                subparagraph (B), unless the Secretary by order 
                determines that applying additional regulation 
                under subsection (b) or (c) to a specific 
                product is necessary to protect public health 
                and safety.
                    ``(B) Relevant laws.--For purposes of 
                subparagraph (A), the Acts specified in this 
                subparagraph are the following:
                            ``(i) The Federal Food, Drug, and 
                        Cosmetic Act.
                            ``(ii) Section 351 of this Act.
                            ``(iii) The Act commonly known as 
                        the Virus-Serum-Toxin Act (the eighth 
                        paragraph under the heading `Bureau of 
                        Animal Industry' in the Act of March 4, 
                        1913; 21 U.S.C. 151-159).
                            ``(iv) The Federal Insecticide, 
                        Fungicide, and Rodenticide Act.
                    ``(C) Investigational use.--
                            ``(i) In general.--The Secretary 
                        may exempt an investigational product 
                        that is, bears, or contains a listed 
                        agent or toxin from the applicability 
                        of provisions of regulations under 
                        subsection (b) or (c) when such product 
                        is being used in an investigation 
                        authorized under any Federal Act and 
                        the Secretary determines that applying 
                        additional regulation under subsection 
                        (b) or (c) to such product is not 
                        necessary to protect public health and 
                        safety.
                            ``(ii) Certain processes.--
                        Regulations under subsections (b) and 
                        (c) shall set forth the procedures for 
                        applying for an exemption under clause 
                        (i). In the case of investigational 
                        products authorized under any of the 
                        Acts specified in subparagraph (B), the 
                        Secretary shall make a determination 
                        regarding a request for an exemption 
                        not later than 14 days after the first 
                        date on which both of the following 
                        conditions have been met by the person 
                        requesting the exemption:
                                    ``(I) The person has 
                                submitted to the Secretary an 
                                application for the exemption 
                                meeting the requirements 
                                established by the Secretary.
                                    ``(II) The person has 
                                notified the Secretary that the 
                                investigation has been 
                                authorized under such an Act.
            ``(3) Public health emergencies.--The Secretary may 
        temporarily exempt a person from the applicability of 
        the requirements of this section, in whole or in part, 
        if the Secretary determines that such exemption is 
        necessary to provide for the timely participation of 
        the person in a response to a domestic or foreign 
        public health emergency (whether determined under 
        section 319(a) or otherwise) that involves a listed 
        agent or toxin. With respect to the emergency involved, 
        such exemption for a person may not exceed 30 days, 
        except that the Secretary, after review of whether such 
        exemption remains necessary, may provide one extension 
        of an additional 30 days.
            ``(4) Agricultural emergencies.--Upon request of 
        the Secretary of Agriculture, after the granting by 
        such Secretary of an exemption under section 
        212(g)(1)(D) of the Agricultural Bioterrorism 
        Protection Act of 2002 pursuant to a finding that there 
        is an agricultural emergency, the Secretary of Health 
        and Human Services may temporarily exempt a person from 
        the applicability of the requirements of this section, 
        in whole or in part, to provide for the timely 
        participation of the person in a response to the 
        agricultural emergency. With respect to the emergency 
        involved, the exemption under this paragraph for a 
        person may not exceed 30 days, except that upon request 
        of the Secretary of Agriculture, the Secretary of 
        Health and Human Services may, after review of whether 
        such exemption remains necessary, provide one extension 
        of an additional 30 days.
    ``(h) Disclosure of Information.--
            ``(1) Nondisclosure of certain information.--No 
        Federal agency specified in paragraph (2) shall 
        disclose under section 552 of title 5, United States 
        Code, any of the following:
                    ``(A) Any registration or transfer 
                documentation submitted under subsections (b) 
                and (c) for the possession, use, or transfer of 
                a listed agent or toxin; or information derived 
                therefrom to the extent that it identifies the 
                listed agent or toxin possessed, used, or 
                transferred by a specific registered person or 
                discloses the identity or location of a 
                specific registered person.
                    ``(B) The national database developed 
                pursuant to subsection (d), or any other 
                compilation of the registration or transfer 
                information submitted under subsections (b) and 
                (c) to the extent that such compilation 
                discloses site-specific registration or 
                transfer information.
                    ``(C) Any portion of a record that 
                discloses the site-specific or transfer-
                specific safeguard and security measures used 
                by a registered person to prevent unauthorized 
                access to listed agents and toxins.
                    ``(D) Any notification of a release of a 
                listed agent or toxin submitted under 
                subsections (b) and (c), or any notification of 
                theft or loss submitted under such subsections.
                    ``(E) Any portion of an evaluation or 
                report of an inspection of a specific 
                registered person conducted under subsection 
                (f) that identifies the listed agent or toxin 
                possessed by a specific registered person or 
                that discloses the identity or location of a 
                specific registered person if the agency 
                determines that public disclosure of the 
                information would endanger public health or 
                safety.
            ``(2) Covered agencies.--For purposes of paragraph 
        (1) only, the Federal agencies specified in this 
        paragraph are the following:
                    ``(A) The Department of Health and Human 
                Services, the Department of Justice, the 
                Department of Agriculture, and the Department 
                of Transportation.
                    ``(B) Any Federal agency to which 
                information specified in paragraph (1) is 
                transferred by any agency specified in 
                subparagraph (A) of this paragraph.
                    ``(C) Any Federal agency that is a 
                registered person, or has a sub-agency 
                component that is a registered person.
                    ``(D) Any Federal agency that awards grants 
                or enters into contracts or cooperative 
                agreements involving listed agents and toxins 
                to or with a registered person, and to which 
                information specified in paragraph (1) is 
                transferred by any such registered person.
            ``(3) Other exemptions.--This subsection may not be 
        construed as altering the application of any exemptions 
        to public disclosure under section 552 of title 5, 
        United States Code, except as to subsection 552(b)(3) 
        of such title, to any of the information specified in 
        paragraph (1).
            ``(4) Rule of construction.--Except as specifically 
        provided in paragraph (1), this subsection may not be 
        construed as altering the authority of any Federal 
        agency to withhold under section 552 of title 5, United 
        States Code, or the obligation of any Federal agency to 
        disclose under section 552 of title 5, United States 
        Code, any information, including information relating 
        to--
                    ``(A) listed agents and toxins, or 
                individuals seeking access to such agents and 
                toxins;
                    ``(B) registered persons, or persons 
                seeking to register their possession, use, or 
                transfer of such agents and toxins;
                    ``(C) general safeguard and security 
                policies and requirements under regulations 
                under subsections (b) and (c); or
                    ``(D) summary or statistical information 
                concerning registrations, registrants, denials 
                or revocations of registrations, listed agents 
                and toxins, inspection evaluations and reports, 
                or individuals seeking access to such agents 
                and toxins.
            ``(5) Disclosures to congress; other disclosures.--
        This subsection may not be construed as providing any 
        authority--
                    ``(A) to withhold information from the 
                Congress or any committee or subcommittee 
                thereof; or
                    ``(B) to withhold information from any 
                person under any other Federal law or treaty.
    ``(i) Civil Money Penalty.--
            ``(1) In general.--In addition to any other 
        penalties that may apply under law, any person who 
        violates any provision of regulations under subsection 
        (b) or (c) shall be subject to the United States for a 
        civil money penalty in an amount not exceeding $250,000 
        in the case of an individual and $500,000 in the case 
        of any other person.
            ``(2) Applicability of certain provisions.--The 
        provisions of section 1128A of the Social Security Act 
        (other than subsections (a), (b), (h), and (i), the 
        first sentence of subsection (c), and paragraphs (1) 
        and (2) of subsection (f)) shall apply to a civil money 
        penalty under paragraph (1) in the same manner as such 
        provisions apply to a penalty or proceeding under 
        section 1128A(a) of such Act. The Secretary may 
        delegate authority under this subsection in the same 
        manner as provided in section 1128A(j)(2) of the Social 
        Security Act, and such authority shall include all 
        powers as contained in section 6 of the Inspector 
        General Act of 1978 (5 U.S.C. App.).
    ``(j) Notification in Event of Release.--Regulations under 
subsections (b) and (c) shall require the prompt notification 
of the Secretary by a registered person whenever a release, 
meeting criteria established by the Secretary, of a listed 
agent or toxin has occurred outside of the biocontainment area 
of a facility of the registered person. Upon receipt of such 
notification and a finding by the Secretary that the release 
poses a threat to public health or safety, the Secretary shall 
take appropriate action to notify relevant State and local 
public health authorities, other relevant Federal authorities, 
and, if necessary, other appropriate persons (including the 
public). If the released listed agent or toxin is an overlap 
agent or toxin (as defined in subsection (l)), the Secretary 
shall promptly notify the Secretary of Agriculture upon 
notification by the registered person.
    ``(k) Reports.--The Secretary shall report to the Congress 
annually on the number and nature of notifications received 
under subsection (e)(8) (relating to theft or loss) and 
subsection (j) (relating to releases).
    ``(l) Definitions.--For purposes of this section:
            ``(1) The terms `biological agent' and `toxin' have 
        the meanings given such terms in section 178 of title 
        18, United States Code.
            ``(2) The term `listed agents and toxins' means 
        biological agents and toxins listed pursuant to 
        subsection (a)(1).
            ``(3) The term `listed agents or toxins' means 
        biological agents or toxins listed pursuant to 
        subsection (a)(1).
            ``(4) The term `overlap agents and toxins' means 
        biological agents and toxins that--
                    ``(A) are listed pursuant to subsection 
                (a)(1); and
                    ``(B) are listed pursuant to section 
                212(a)(1) of the Agricultural Bioterrorism 
                Protection Act of 2002.
            ``(5) The term `overlap agent or toxin' means a 
        biological agent or toxin that--
                    ``(A) is listed pursuant to subsection 
                (a)(1); and
                    ``(B) is listed pursuant to section 
                212(a)(1) of the Agricultural Bioterrorism 
                Protection Act of 2002.
            ``(6) The term `person' includes Federal, State, 
        and local governmental entities.
            ``(7) The term `registered person' means a person 
        registered under regulations under subsection (b) or 
        (c).
            ``(8) The term `restricted person' has the meaning 
        given such term in section 175b of title 18, United 
        States Code.
    ``(m) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2002 through 2007.''.
    (b) Report to Congress.--Not later than one year after the 
date of the enactment of this Act, the Secretary of Health and 
Human Services, after consultation with other appropriate 
Federal agencies, shall submit to the Congress a report that--
            (1) describes the extent to which there has been 
        compliance by governmental and private entities with 
        applicable regulations under section 351A of the Public 
        Health Service Act (as added by subsection (a) of this 
        section), including the extent of compliance before the 
        date of the enactment of this Act, and including the 
        extent of compliance with regulations promulgated after 
        such date of enactment;
            (2) describes the actions to date and future plans 
        of the Secretary for updating the list of biological 
        agents and toxins under such section 351A;
            (3) describes the actions to date and future plans 
        of the Secretary for determining compliance with 
        regulations under such section 351A and for taking 
        appropriate enforcement actions;
            (4) evaluates the impact of such section 351A on 
        research on biological agents and toxins listed 
        pursuant to such section; and
            (5) provides any recommendations of the Secretary 
        for administrative or legislative initiatives regarding 
        such section 351A.

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

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

SEC. 203. EFFECTIVE DATES.

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

SEC. 204. CONFORMING AMENDMENT.

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

                 Subtitle B--Department of Agriculture

SEC. 211. SHORT TITLE.

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

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

    (a) Regulatory Control of Certain Biological Agents and 
Toxins.--
            (1) List of biological agents and toxins.--
                    (A) In general.--The Secretary of 
                Agriculture shall by regulation establish and 
                maintain a list of each biological agent and 
                each toxin that the Secretary determines has 
                the potential to pose a severe threat to animal 
                or plant health, or to animal or plant 
                products.
                    (B) Criteria.--In determining whether to 
                include an agent or toxin on the list under 
                subparagraph (A), the Secretary shall--
                            (i) consider--
                                    (I) the effect of exposure 
                                to the agent or toxin on animal 
                                or plant health, and on the 
                                production and marketability of 
                                animal or plant products;
                                    (II) the pathogenicity of 
                                the agent or the toxicity of 
                                the toxin and the methods by 
                                which the agent or toxin is 
                                transferred to animals or 
                                plants;
                                    (III) the availability and 
                                effectiveness of 
                                pharmacotherapies and 
                                prophylaxis to treat and 
                                prevent any illness caused by 
                                the agent or toxin; and
                                    (IV) any other criteria 
                                that the Secretary considers 
                                appropriate to protect animal 
                                or plant health, or animal or 
                                plant products; and
                            (ii) consult with appropriate 
                        Federal departments and agencies and 
                        with scientific experts representing 
                        appropriate professional groups.
            (2) Biennial review.--The Secretary shall review 
        and republish the list under paragraph (1) biennially, 
        or more often as needed, and shall by regulation revise 
        the list as necessary in accordance with such 
        paragraph.
    (b) Regulation of Transfers of Listed Agents and Toxins.--
The Secretary shall by regulation provide for--
            (1) the establishment and enforcement of safety 
        procedures for the transfer of listed agents and 
        toxins, including measures to ensure--
                    (A) proper training and appropriate skills 
                to handle such agents and toxins; and
                    (B) proper laboratory facilities to contain 
                and dispose of such agents and toxins;
            (2) the establishment and enforcement of safeguard 
        and security measures to prevent access to such agents 
        and toxins for use in domestic or international 
        terrorism or for any other criminal purpose;
            (3) the establishment of procedures to protect 
        animal and plant health, and animal and plant products, 
        in the event of a transfer or potential transfer of 
        such an agent or toxin in violation of the safety 
        procedures established under paragraph (1) or the 
        safeguard and security measures established under 
        paragraph (2); and
            (4) appropriate availability of biological agents 
        and toxins for research, education, and other 
        legitimate purposes.
    (c) Possession and Use of Listed Agents and Toxins.--The 
Secretary shall by regulation provide for the establishment and 
enforcement of standards and procedures governing the 
possession and use of listed agents and toxins, including the 
provisions described in paragraphs (1) through (4) of 
subsection (b), in order to protect animal and plant health, 
and animal and plant products.
    (d) Registration; Identification; Database.--
            (1) Registration.--Regulations under subsections 
        (b) and (c) shall require registration with the 
        Secretary of the possession, use, and transfer of 
        listed agents and toxins, and shall include provisions 
        to ensure that persons seeking to register under such 
        regulations have a lawful purpose to possess, use, or 
        transfer such agents and toxins, including provisions 
        in accordance with subsection (e)(6).
            (2) Identification; database.--Regulations under 
        subsections (b) and (c) shall require that registration 
        include (if available to the person registering) 
        information regarding the characterization of listed 
        agents and toxins to facilitate their identification, 
        including their source. The Secretary shall maintain a 
        national database that includes the names and locations 
        of registered persons, the listed agents and toxins 
        such persons are possessing, using, or transferring, 
        and information regarding the characterization of such 
        agents and toxins.
    (e) Safeguard and Security Requirements for Registered 
Persons.--
            (1) In general.--Regulations under subsections (b) 
        and (c) shall include appropriate safeguard and 
        security requirements for persons possessing, using, or 
        transferring a listed agent or toxin commensurate with 
        the risk such agent or toxin poses to animal and plant 
        health, and animal and plant products (including the 
        risk of use in domestic or international terrorism). 
        The Secretary shall establish such requirements in 
        consultation with the Attorney General, and shall 
        ensure compliance with such requirements as part of the 
        registration system under such regulations.
            (2) Limiting access to listed agents and toxins.--
        Requirements under paragraph (1) shall include 
        provisions to ensure that registered persons--
                    (A) provide access to listed agents and 
                toxins to only those individuals whom the 
                registered person involved determines have a 
                legitimate need to handle or use such agents 
                and toxins;
                    (B) submit the names and other identifying 
                information for such individuals to the 
                Secretary and the Attorney General, promptly 
                after first determining that the individuals 
                need access under subparagraph (A), and 
                periodically thereafter while the individuals 
                have such access, not less frequently than once 
                every five years; and
                    (C)(i) in the case of listed agents and 
                toxins that are not overlap agents and toxins 
                (as defined in subsection (g)(1)(A)(ii)), limit 
                or deny access to such agents and toxins by 
                individuals whom the Attorney General has 
                identified as within any category under 
                paragraph (3)(B), if limiting or denying such 
                access by the individuals involved is 
                determined appropriate by the Secretary, in 
                consultation with the Attorney General; and
                    (ii) in the case of listed agents and 
                toxins that are overlap agents--
                                    (I) deny access to such 
                                agents and toxins by 
                                individuals whom the Attorney 
                                General has identified as 
                                within any category referred to 
                                in paragraph (3)(B)(i); and
                                    (II) limit or deny access 
                                to such agents and toxins by 
                                individuals whom the Attorney 
                                General has identified as 
                                within any category under 
                                paragraph (3)(B)(ii), if 
                                limiting or denying such access 
                                by the individuals involved is 
                                determined appropriate by the 
                                Secretary, in consultation with 
                                the Attorney General.
            (3) Submitted names; use of databases by attorney 
        general.--
                    (A) In general.--Upon the receipt of names 
                and other identifying information under 
                paragraph (2)(B), the Attorney General shall, 
                for the sole purpose of identifying whether the 
                individuals involved are within any of the 
                categories specified in subparagraph (B), 
                promptly use criminal, immigration, national 
                security, and other electronic databases that 
                are available to the Federal Government and are 
                appropriate for such purpose.
                    (B) Certain individuals.--For purposes of 
                subparagraph (A), the categories specified in 
                this subparagraph regarding an individual are 
                that--
                            (i) the individual is within any of 
                        the categories described in section 
                        175b(d)(1) of title 18, United States 
                        Code (relating to restricted persons); 
                        or
                            (ii) the individual is reasonably 
                        suspected by any Federal law 
                        enforcement or intelligence agency of--
                                    (I) committing a crime set 
                                forth in section 2332b(g)(5) of 
                                title 18, United States Code;
                                    (II) knowing involvement 
                                with an organization that 
                                engages in domestic or 
                                international terrorism (as 
                                defined in section 2331 of such 
                                title 18) or with any other 
                                organization that engages in 
                                intentional crimes of violence; 
                                or
                                    (III) being an agent of a 
                                foreign power (as defined in 
                                section 1801 of title 50, 
                                United States Code).
                    (C) Notification by attorney general 
                regarding submitted names.--After the receipt 
                of a name and other identifying information 
                under paragraph (2)(B), the Attorney General 
                shall promptly notify the Secretary whether the 
                individual is within any of the categories 
                specified in subparagraph (B).
            (4) Notifications by secretary.--The Secretary, 
        after receiving notice under paragraph (3) regarding an 
        individual, shall promptly notify the registered person 
        involved of whether the individual is granted or denied 
        access under paragraph (2). If the individual is denied 
        such access, the Secretary shall promptly notify the 
        individual of the denial.
            (5) Expedited review.--Regulations under 
        subsections (b) and (c) shall provide for a procedure 
        through which, upon request to the Secretary by a 
        registered person who submits names and other 
        identifying information under paragraph (2)(B) and who 
        demonstrates good cause, the Secretary may, as 
        determined appropriate by the Secretary--
                    (A) request the Attorney General to 
                expedite the process of identification under 
                paragraph (3)(A) and notification of the 
                Secretary under paragraph (3)(C); and
                    (B) expedite the notification of the 
                registered person by the Secretary under 
                paragraph (4).
            (6) Process regarding persons seeking to 
        register.--
                    (A) Individuals.--Regulations under 
                subsections (b) and (c) shall provide that an 
                individual who seeks to register under either 
                of such subsections is subject to the same 
                processes described in paragraphs (2) through 
                (4) as apply to names and other identifying 
                information submitted to the Attorney General 
                under paragraph (2)(B). Paragraph (5) does not 
                apply for purposes of this subparagraph.
                    (B) Other persons.--Regulations under 
                subsections (b) and (c) shall provide that, in 
                determining whether to deny or revoke 
                registration by a person other than an 
                individual, the Secretary shall submit the name 
                of such person to the Attorney General, who 
                shall use criminal, immigration, national 
                security, and other electronic databases 
                available to the Federal Government, as 
                appropriate for the purpose of promptly 
                notifying the Secretary whether the person, or, 
                where relevant, the individual who owns or 
                controls such person, is within any of the 
                categories described in section 175b(d)(1) of 
                title 18, United States Code (relating to 
                restricted persons), or is reasonably suspected 
                by any Federal law enforcement or intelligence 
                agency of being within any category specified 
                in paragraph (3)(B)(ii) (as applied to persons, 
                including individuals). Such regulations shall 
                provide that a person who seeks to register 
                under either of such subsections is subject to 
                the same processes described in paragraphs (2) 
                and (4) as apply to names and other identifying 
                information submitted to the Attorney General 
                under paragraph (2)(B). Paragraph (5) does not 
                apply for purposes of this subparagraph. The 
                Secretary may exempt Federal, State, or local 
                governmental agencies from the requirements of 
                this subparagraph.
            (7) Review.--
                    (A) Administrative review.--
                            (i) In general.--Regulations under 
                        subsections (b) and (c) shall provide 
                        for an opportunity for a review by the 
                        Secretary--
                                    (I) when requested by the 
                                individual involved, of a 
                                determination under paragraph 
                                (2) to deny the individual 
                                access to listed agents and 
                                toxins; and
                                    (II) when requested by the 
                                person involved, of a 
                                determination under paragraph 
                                (6) to deny or revoke 
                                registration for such person.
                            (ii) Ex parte review.--During a 
                        review under clause (i), the Secretary 
                        may consider information relevant to 
                        the review ex parte to the extent that 
                        disclosure of the information could 
                        compromise national security or an 
                        investigation by any law enforcement 
                        agency.
                            (iii) Final agency action.--The 
                        decision of the Secretary in a review 
                        under clause (i) constitutes final 
                        agency action for purposes of section 
                        702 of title 5, United States Code.
                    (B) Certain procedures.--
                            (i) Submission of ex parte 
                        materials in judicial proceedings.--
                        When reviewing a decision of the 
                        Secretary under subparagraph (A), and 
                        upon request made ex parte and in 
                        writing by the United States, a court, 
                        upon a sufficient showing, may review 
                        and consider ex parte documents 
                        containing information the disclosure 
                        of which could compromise national 
                        security or an investigation by any law 
                        enforcement agency. If the court 
                        determines that portions of the 
                        documents considered ex parte should be 
                        disclosed to the person involved to 
                        allow a response, the court shall 
                        authorize the United States to delete 
                        from such documents specified items of 
                        information the disclosure of which 
                        could compromise national security or 
                        an investigation by any law enforcement 
                        agency, or to substitute a summary of 
                        the information to which the person may 
                        respond. Any order by the court 
                        authorizing the disclosure of 
                        information that the United States 
                        believes could compromise national 
                        security or an investigation by any law 
                        enforcement agency shall be subject to 
                        the processes set forth in 
                        subparagraphs (A) and (B)(i) of section 
                        2339B(f)(5) of title 18, United States 
                        Code (relating to interlocutory appeal 
                        and expedited consideration).
                            (ii) Disclosure of information.--In 
                        a review under subparagraph (A), and in 
                        any judical proceeding conducted 
                        pursuant to such review, neither the 
                        Secretary nor the Attorney General may 
                        be required to disclose to the public 
                        any information that under subsection 
                        (h) shall not be disclosed under 
                        section 552 of title 5, United States 
                        Code.
            (8) Notifications regarding theft or loss of 
        agents.--Requirements under paragraph (1) shall include 
        the prompt notification of the Secretary, and 
        appropriate Federal, State, and local law enforcement 
        agencies, of the theft or loss of listed agents and 
        toxins.
            (9) Technical assistance for registered persons.--
        The Secretary, in consultation with the Attorney 
        General, may provide technical assistance to registered 
        persons to improve security of the facilities of such 
        persons.
    (f) Inspections.--The Secretary shall have the authority to 
inspect persons subject to regulations under subsection (b) or 
(c) to ensure their compliance with such regulations, including 
prohibitions on restricted persons and other provisions of 
subsection (e).
    (g) Exemptions.--
            (1) Overlap agents and toxins.--
                    (A) In general.--
                            (i) Limitation.--In the case of 
                        overlap agents and toxins, exemptions 
                        from the applicability of provisions of 
                        regulations under subsection (b) or (c) 
                        may be granted only to the extent 
                        provided in this paragraph.
                            (ii) Definitions.--For purposes of 
                        this section:
                                    (I) The term ``overlap 
                                agents and toxins'' means 
                                biological agents and toxins 
                                that--
                                            (aa) are listed 
                                        pursuant to subsection 
                                        (a)(1); and
                                            (bb) are listed 
                                        pursuant to section 
                                        315A(a)(1) of the 
                                        Public Health Service 
                                        Act.
                                    (II) The term ``overlap 
                                agent or toxin'' means a 
                                biological agent or toxin 
                                that--
                                            (aa) is listed 
                                        pursuant to subsection 
                                        (a)(1); and
                                            (bb) is listed 
                                        pursuant to section 
                                        315A(a)(1) of the 
                                        Public Health Service 
                                        Act.
                    (B) Clinical or diagnostic laboratories.--
                Regulations under subsections (b) and (c) shall 
                exempt clinical or diagnostic laboratories and 
                other persons who possess, use, or transfer 
                overlap agents or toxins that are contained in 
                specimens presented for diagnosis, 
                verification, or proficiency testing, provided 
                that--
                            (i) the identification of such 
                        agents or toxins is reported to the 
                        Secretary, and when required under 
                        Federal, State, or local law, to other 
                        appropriate authorities; and
                            (ii) such agents or toxins are 
                        transferred or destroyed in a manner 
                        set forth by the Secretary by 
                        regulation.
                    (C) Products.--
                            (i) In general.--Regulations under 
                        subsections (b) and (c) shall exempt 
                        products that are, bear, or contain 
                        overlap agents or toxins and are 
                        cleared, approved, licensed, or 
                        registered under any of the Acts 
                        specified in clause (ii), unless the 
                        Secretary by order determines that 
                        applying additional regulation under 
                        subsection (b) or (c) to a specific 
                        product is necessary to protect animal 
                        or plant health, or animal or plant 
                        products.
                            (ii) Relevant laws.--For purposes 
                        of clause (i), the Acts specified in 
                        this clause are the following:
                                    (I) The Federal Food, Drug, 
                                and Cosmetic Act.
                                    (II) Section 351 of the 
                                Public Health Service Act.
                                    (III) The Act commonly 
                                known as the Virus-Serum-Toxin 
                                Act (the eighth paragraph under 
                                the heading `Bureau of Animal 
                                Industry' in the Act of March 
                                4, 1913; 21 U.S.C. 151-159).
                                    (IV) The Federal 
                                Insecticide, Fungicide, and 
                                Rodenticide Act.
                            (iii) Investigational use.--
                                    (I) In general.--The 
                                Secretary may exempt an 
                                investigational product that 
                                is, bears, or contains an 
                                overlap agent or toxin from the 
                                applicability of provisions of 
                                regulations under subsection 
                                (b) or (c) when such product is 
                                being used in an investigation 
                                authorized under any Federal 
                                Act and the Secretary 
                                determines that applying 
                                additional regulation under 
                                subsection (b) or (c) to such 
                                product is not necessary to 
                                protect animal and plant 
                                health, and animal and plant 
                                products.
                                    (II) Certain processes.--
                                Regulations under subsections 
                                (b) and (c) shall set forth the 
                                procedures for applying for an 
                                exemption under subclause (I). 
                                In the case of investigational 
                                products authorized under any 
                                of the Acts specified in clause 
                                (ii), the Secretary shall make 
                                a determination regarding a 
                                request for an exemption not 
                                later than 14 days after the 
                                first date on which both of the 
                                following conditions have been 
                                met by the person requesting 
                                the exemption:
                                            (aa) The person has 
                                        submitted to the 
                                        Secretary an 
                                        application for the 
                                        exemption meeting the 
                                        requirements 
                                        established by the 
                                        Secretary.
                                            (bb) The person has 
                                        notified the Secretary 
                                        that the investigation 
                                        has been authorized 
                                        under such an Act.
                    (D) Agricultural emergencies.-- The 
                Secretary may temporarily exempt a person from 
                the applicability of the requirements of this 
                section with respect to an overlap agent or 
                toxin, in whole or in part, if the Secretary 
                determines that such exemption is necessary to 
                provide for the timely participation of the 
                person in a response to a domestic or foreign 
                agricultural emergency that involves such an 
                agent or toxin. With respect to the emergency 
                involved, the exemption under this subparagraph 
                for a person may not exceed 30 days, except 
                that the Secretary, after review of whether 
                such exemption remains necessary, may provide 
                one extension of an additional 30 days.
                    (E) Public health emergencies.--Upon 
                request of the Secretary of Health and Human 
                Services, after the granting by such Secretary 
                of an exemption under 351A(g)(3) of the Public 
                Health Service Act pursuant to a finding that 
                there is a public health emergency, the 
                Secretary of Agriculture may temporarily exempt 
                a person from the applicability of the 
                requirements of this section with respect to an 
                overlap agent or toxin, in whole or in part, to 
                provide for the timely participation of the 
                person in a response to the public health 
                emergency. With respect to the emergency 
                involved, such exemption for a person may not 
                exceed 30 days, except that upon request of the 
                Secretary of Health and Human Services, the 
                Secretary of Agriculture may, after review of 
                whether such exemption remains necessary, 
                provide one extension of an additional 30 days.
            (2) General authority for exemptions not involving 
        overlap agents or toxins.--In the case of listed agents 
        or toxins that are not overlap agents or toxins, the 
        Secretary may grant exemptions from the applicability 
        of provisions of regulations under subsection (b) or 
        (c) if the Secretary determines that such exemptions 
        are consistent with protecting animal and plant health, 
        and animal and plant products.
    (h) Disclosure of Information.--
            (1) Nondisclosure of certain information.--No 
        Federal agency specified in paragraph (2) shall 
        disclose under section 552 of title 5, United States 
        Code, any of the following:
                    (A) Any registration or transfer 
                documentation submitted under subsections (b) 
                and (c), or permits issued prior to the date of 
                the enactment of this Act, for the possession, 
                use or transfer of a listed agent or toxin; or 
                information derived therefrom to the extent 
                that it identifies the listed agent or toxin 
                possessed, used or transferred by a specific 
                person or discloses the identity or location of 
                a specific person.
                    (B) The national database developed 
                pursuant to subsection (d), or any other 
                compilation of the registration or transfer 
                information submitted under subsections (b) and 
                (c) to the extent that such compilation 
                discloses site-specific registration or 
                transfer information.
                    (C) Any portion of a record that discloses 
                the site-specific or transfer-specific 
                safeguard and security measures used by a 
                registered person to prevent unauthorized 
                access to listed agents and toxins.
                    (D) Any notification of a release of a 
                listed agent or toxin submitted under 
                subsections (b) and (c), or any notification of 
                theft or loss submitted under such subsections.
                    (E) Any portion of an evaluation or report 
                of an inspection of a specific registered 
                person conducted under subsection (f) that 
                identifies the listed agent or toxin possessed 
                by a specific registered person or that 
                discloses the identity or location of a 
                specific registered person if the agency 
                determines that public disclosure of the 
                information would endanger animal or plant 
                health, or animal or plant products.
            (2) Covered agencies.--For purposes of paragraph 
        (1) only, the Federal agencies specified in this 
        paragraph are the following:
                    (A) The Department of Health and Human 
                Services, the Department of Justice, the 
                Department of Agriculture, and the Department 
                of Transportation.
                    (B) Any Federal agency to which information 
                specified in paragraph (1) is transferred by 
                any agency specified in subparagraph (A) of 
                this paragraph.
                    (C) Any Federal agency that is a registered 
                person, or has a sub-agency component that is a 
                registered person.
                    (D) Any Federal agency that awards grants 
                or enters into contracts or cooperative 
                agreements involving listed agents and toxins 
                to or with a registered person, and to which 
                information specified in paragraph (1) is 
                transferred by any such registered person.
            (3) Other exemptions.--This subsection may not be 
        construed as altering the application of any exemptions 
        to public disclosure under section 552 of title 5, 
        United States Code, except as to subsection 552(b)(3) 
        of such title, to any of the information specified in 
        paragraph (1).
            (4) Rule of construction.--Except as specifically 
        provided in paragraph (1), this subsection may not be 
        construed as altering the authority of any Federal 
        agency to withhold under section 552 of title 5, United 
        States Code, or the obligation of any Federal agency to 
        disclose under section 552 of title 5, United States 
        Code, any information, including information relating 
        to--
                    (A) listed agents and toxins, or 
                individuals seeking access to such agents and 
                toxins;
                    (B) registered persons, or persons seeking 
                to register their possession, use, or transfer 
                of such agents and toxins;
                    (C) general safeguard and security policies 
                and requirements under regulations under 
                subsections (b) and (c); or
                    (D) summary or statistical information 
                concerning registrations, registrants, denials 
                or revocations of registrations, listed agents 
                and toxins, inspection evaluations and reports, 
                or individuals seeking access to such agents 
                and toxins.
            (5) Disclosures to congress; other disclosures.--
        This subsection may not be construed as providing any 
        authority--
                    (A) to withhold information from the 
                Congress or any committee or subcommittee 
                thereof; or
                    (B) to withhold information from any person 
                under any other Federal law or treaty.
    (i) Civil Money Penalty.--
            (1) In general.--In addition to any other penalties 
        that may apply under law, any person who violates any 
        provision of regulations under subsection (b) or (c) 
        shall be subject to the United States for a civil money 
        penalty in an amount not exceeding $250,000 in the case 
        of an individual and $500,000 in the case of any other 
        person.
            (2) Applicability of certain provisions.--The 
        provisions of sections 423 and 425(2) of the Plant 
        Protection Act (7 U.S.C. 7733 and 7735(2) shall apply 
        to a civil money penalty or activity under paragraph 
        (1) in the same manner as such provisions apply to a 
        penalty or activity under the Plant Protection Act.
    (j) Notification in Event of Release.--Regulations under 
subsections (b) and (c) shall require the prompt notification 
of the Secretary by a registered person whenever a release, 
meeting criteria established by the Secretary, of a listed 
agent or toxin has occurred outside of the biocontainment area 
of a facility of the registered person. Upon receipt of such 
notification and a finding by the Secretary that the release 
poses a threat to animal or plant health, or animal or plant 
products, the Secretary shall take appropriate action to notify 
relevant Federal, State, and local authorities, and, if 
necessary, other appropriate persons (including the public). If 
the released listed agent or toxin is an overlap agent or 
toxin, the Secretary shall promptly notify the Secretary of 
Health and Human Services upon notification by the registered 
person.
    (k) Reports.--The Secretary shall report to the Congress 
annually on the number and nature of notifications received 
under subsection (e)(8) (relating to theft or loss) and 
subsection (j) (relating to releases).
    (l) Definitions.--For purposes of this section:
            (1) The terms ``biological agent'' and ``toxin'' 
        have the meanings given such terms in section 178 of 
        title 18, United States Code.
            (2) The term ``listed agents and toxins'' means 
        biological agents and toxins listed pursuant to 
        subsection (a)(1).
            (3) The term ``listed agents or toxins'' means 
        biological agents or toxins listed pursuant to 
        subsection (a)(1).
            (4) The terms ``overlap agents and toxins'' and 
        ``overlap agent or toxin'' have the meaning given such 
        terms in subsection (g)(1)(A)(ii).
            (5) The term ``person'' includes Federal, State, 
        and local governmental entities.
            (6) The term ``registered person'' means a person 
        registered under regulations under subsection (b) or 
        (c).
            (7) The term ```Secretary'' means the Secretary of 
        Agriculture.
    (m) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be 
appropriated such sums as may be necessary for each of the 
fiscal years 2002 through 2007, in addition to other funds that 
may be available.

SEC. 213. IMPLEMENTATION BY DEPARTMENT OF AGRICULTURE.

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

   Subtitle C--Interagency Coordination Regarding Overlap Agents and 
                                 Toxins

SEC. 221. INTERAGENCY COORDINATION.

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

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

SEC. 231. CRIMINAL PENALTIES.

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

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

                 Subtitle A--Protection of Food Supply

SEC. 301. FOOD SAFETY AND SECURITY STRATEGY.

    (a) In General.--The President's Council on Food Safety (as 
established by Executive Order 13100) shall, in consultation 
with the Secretary of Transportation, the Secretary of the 
Treasury, other relevant Federal agencies, the food industry, 
consumer and producer groups, scientific organizations, and the 
States, develop a crisis communications and education strategy 
with respect to bioterrorist threats to the food supply. Such 
strategy shall address threat assessments; technologies and 
procedures for securing food processing and manufacturing 
facilities and modes of transportation; response and 
notification procedures; and risk communications to the public.
    (b) Authorization of Appropriations.--For the purpose of 
implementing the strategy developed under subsection (a), there 
are authorized to be appropriated $750,000 for fiscal year 
2002, and such sums as may be necessary for each subsequent 
fiscal year.

SEC. 302. PROTECTION AGAINST ADULTERATION OF FOOD.

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

SEC. 303. ADMINISTRATIVE DETENTION.

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

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

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

SEC. 305. REGISTRATION OF FOOD FACILITIES.

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

``SEC. 415. REGISTRATION OF FOOD FACILITIES.

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

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

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

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

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

SEC. 307. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.

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

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

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

SEC. 309. PROHIBITION AGAINST PORT SHOPPING.

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

SEC. 310. NOTICES TO STATES REGARDING IMPORTED FOOD.

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

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

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

SEC. 311. GRANTS TO STATES FOR INSPECTIONS.

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

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

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

SEC. 312. SURVEILLANCE AND INFORMATION GRANTS AND AUTHORITIES.

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

``SEC. 317R. FOOD SAFETY GRANTS.

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

SEC. 313. SURVEILLANCE OF ZOONOTIC DISEASES.

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

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

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

SEC. 315. RULE OF CONSTRUCTION.

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

                 Subtitle B--Protection of Drug Supply

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

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

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

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

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

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

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

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

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

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

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

SEC. 334. AGRICULTURAL BIOSECURITY.

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

SEC. 335. AGRICULTURAL BIOTERRORISM RESEARCH AND DEVELOPMENT.

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

SEC. 336. ANIMAL ENTERPRISE TERRORISM PENALTIES.

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

              TITLE IV--DRINKING WATER SECURITY AND SAFETY

SEC. 401. TERRORIST AND OTHER INTENTIONAL ACTS.

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

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

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

SEC. 402. OTHER SAFE DRINKING WATER ACT AMENDMENTS.

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

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

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

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

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

SEC. 403. MISCELLANEOUS AND TECHNICAL AMENDMENTS.

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

                     TITLE V--ADDITIONAL PROVISIONS

                Subtitle A--Prescription Drug User Fees

SEC. 501. SHORT TITLE.

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

SEC. 502. FINDINGS.

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

SEC. 503. DEFINITIONS.

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

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

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

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

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

SEC. 505. ACCOUNTABILITY AND REPORTS.

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

SEC. 506. REPORTS OF POSTMARKETING STUDIES.

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

SEC. 507. SAVINGS CLAUSE.

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

SEC. 508. EFFECTIVE DATE.

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

SEC. 509. SUNSET CLAUSE.

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

 Subtitle B--Funding Provisions Regarding Food and Drug Administration

SEC. 521. OFFICE OF DRUG SAFETY.

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

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

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

SEC. 523. OFFICE OF GENERIC DRUGS.

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

                   Subtitle C--Additional Provisions

SEC. 531. TRANSITION TO DIGITAL TELEVISION.

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

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

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

                From the Committee on Energy and Commerce, for 
                consideration of the House bill and the Senate 
                amendment, and modifications committed to 
                conference:
                                   Billy Tauzin,
                                   Michael Bilirakis,
                                   Paul E. Gillmor,
                                   Richard Burr,
                                   John Shimkus,
                                   John D. Dingell,
                                   Henry A. Waxman,
                                   Sherrod Brown,
                Provided that Mr. Pallone is appointed in lieu 
                of Mr. Brown of Ohio for consideration of title 
                IV of the House bill, and modifications 
                committed to conference:
                                   Frank Pallone, Jr.,
                From the Committee on Agriculture, for 
                consideration of title II of the House bill and 
                sec. 216 and title V of the Senate amendment, 
                and modifications committed to conference:
                                   Larry Combest,
                                   Frank D. Lucas,
                                   Saxby Chambliss,
                                   Charles Stenholm,
                                   Tim Holden,
                From the Committee on the Judiciary, for 
                consideration of title II of the House bill and 
                secs. 216 and 401 of the Senate amendment, and 
                modifications committed to conference:
                                   F. James Sensenbrenner, Jr.,
                                   Lamar Smith,
                                   John Conyers, Jr.,
                                 Managers on the Part of the House.

                                   Edward Kennedy,
                                   Chris Dodd,
                                   Tom Harkin,
                                   Barbara A. Mikulski,
                                   Jim Jeffords,
                                   Judd Gregg,
                                   Bill Frist,
                                   Mike Enzi,
                                   Tim Hutchinson,
                                Managers on the Part of the Senate.

       JOINT EXPLANATORY STATEMENT OF THE COMMITTEE OF CONFERENCE

    The managers on the part of the House and the Senate at the 
conference on the disagreeing votes of the two Houses on the 
amendment of the Senate to the bill (H.R. 3448), to improve the 
ability of the United States to prevent, prepare for, and 
respond to bioterrorism and other public health emergencies, 
submit the following joint statement to the House and the 
Senate in explanation of the effect of the action agreed upon 
by the managers and recommended in the accompanying conference 
report:
    The Senate amendment struck all of the House bill after the 
enacting clause and inserted a substitute text.
    The House recedes from its disagreement to the amendment of 
the Senate with an amendment that is a substitute for the House 
bill and the Senate amendment. The differences between the 
House bill, the Senate amendment, and the substitute agreed to 
in conference are noted below, except for clerical corrections, 
conforming changes made necessary by agreements reached by the 
conferees, and minor drafting and clerical changes.

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

      As approved by the conference Managers, Title I addresses 
core public health concerns associated with preparedness for 
and effective response to bioterrorism and other public health 
emergencies in a number of different ways. First Title I 
improves communications between and among all levels of 
government, public health officials, first responders, and 
health care providers and facilities during emergencies. The 
Managers have authorized substantial sums in FY 2002 and beyond 
in grants to States, local governments, and other public and 
private health care facilities and other entities to improve 
planning and preparedness activities, and educate and train 
health care personnel. Under Title I, the Department of Health 
and Human Services (HHS) will have a new focus, and improved 
coordination and accountability, through a new Assistant 
Secretary for Public Health Emergency Preparedness. The 
legislation also authorizes the National Disaster Medical 
System, new planning and reporting provisions, training 
exercises, and improved communications strategies and networks. 
The Managers also believe that the provisions of Title I will 
ensure that the nation has sufficient drugs, vaccines, and 
other supplies for our emergency health security. The Managers 
intend for activities under Title I to enhance the Nation's 
public health infrastructure at the national, state, and local 
levels. The Managers believe that an effective public health 
system is essential to responding effectively to bioterrorism 
and other public health emergencies.

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

Section 101. National Preparedness and Response
      House provision: The House provision requires the 
Secretary of HHS to continue the process of developing and 
implementing a coordinated strategy, including the preparation 
of a national plan for carrying out health-related activities 
to prepare for and respond effectively to bioterrorism and 
other public health emergencies. The plan would be in 
consultation with other Federal agencies and other appropriate 
public and private entities. The plan also would be coordinated 
with activities of State and local governments to meet 
preparedness goals set out under the Act. National preparedness 
goals include providing effective assistance to State and local 
governments to ensure that they and their health care 
facilities have adequate capacity and properly trained response 
personnel; a coordinated plan, effective communications 
networks, and laboratory readiness, training and surveillance; 
developing and maintaining medical countermeasures against 
biological agents; and effective coordination at all levels of 
government. There would be evaluations and reports of progress.
      Senate amendment: The Senate amendment contains similar 
provisions.
      Conference substitute: The Conference adopts the House 
provisions with certain modifications to clarify the provision 
does not expand regulatory or other authority, and to 
incorporate various advisory committee and study provisions. A 
study to emergency response services and their use during 
public health emergencies, formerly located in section 114 of 
the House bill, is now located in this section.
Section 102. Assistant Secretary for Public Health Emergency 
        Preparedness; National Disaster Medical System
      House provision: The House provision establishes the new 
position of Assistant Secretary for Emergency Preparedness to 
coordinate HHS activities under the new Act. The provision also 
would authorize the National Disaster Medical System, under the 
new Assistant Secretary to provide for further National 
capacity during public health emergencies.
      Senate amendment: The Senate amendment contains a similar 
provision in section 211 of the Senate amendment.
      Conference substitute: The Conference substitute uses the 
House language with modification. The Managers believe that 
there is a need to increase coordination of the Department of 
Health and Human Services' efforts in responding to 
bioterrorism and other public health emergencies, and thus has 
provided for the creation of an Assistant Secretary for Public 
Health Emergency Preparedness. The substitute also formally 
establishes the National Disaster Medical System (NDMS), 
recognizing the important role already played by the NDMS in 
the Federal government's response to all types of emergencies 
and disasters. The substitute also addresses a number of 
critical personnel issues within the NDMS, including liability 
protections, employment rights, and compensation for work 
injuries. In addition, the Secretary shall take into account 
the role and expertise of the Agency for Toxic Substances and 
Disease Registry.
Section 103. Improving Ability of Centers for Disease Control and 
        Prevention
      House provision: The House bill provides authorization 
and multi-year contracting authority for the renovation, 
development and security at facilities for the Centers for 
Disease Control and Prevention (CDC). The House bill also 
enhances training and nationwide laboratory capacity, and the 
establishment of integrated, national public health 
communications and surveillance networks.
      Senate amendment: The Senate amendment, in section 202, 
also contains provisions for upgrading CDC's activities and 
facilities.
      Conference substitute: The Conference substitute adopts 
the House provision with modifications. The substitute 
recognizes the critical role played by CDC in the nation's 
efforts to defend against bioterrorism and other public health 
emergencies. The Managers are concerned by extreme disrepair at 
many CDC laboratories and believe that repair and modernization 
funds are desperately needed. To that end, the substitute has 
provided multi-year contracting authority for CDC and has 
authorized an accelerated program of facilities funding. The 
substitute also recognizes the central role played by CDC in 
maintaining robust public health alert communications and 
surveillance networks, and has provided for grants, contracts, 
and cooperative agreements to further strengthen a national 
network that includes public health laboratories and other 
health care facilities. Provisions concerning priorities for 
public health lab enhancements have been moved to the general 
grants section, section 131, of the Conference substitute.
Section 104. Advisory Committees and Communications; Study Regarding 
        Communications Abilities of Public Health Agencies
      House provision: Section 104 of the House bill 
establishes an advisory committee on children and terrorism and 
also one on emergency public information and communications. 
The provision also requires a coordinated strategy on public 
health communications during a bioterrorism attack. Section 111 
also contains a provision for a study regarding the 
communications ability of public health agencies and to improve 
telecommunications infrastructure and connectivity during 
public health emergencies.
      Senate amendment: Section 213 of the Senate amendment 
contains similar provisions. Section 214 of the Senate 
amendment also contains a provision establishing the official 
Federal Internet Site on Bioterrorism.
      Conference substitute: The Conference substitute adopts, 
with minor modification, the provisions from the House and 
Senate establishing an advisory committee on children and 
terrorism; an advisory committee on emergency public 
information and communications; acoordinated strategy on public 
health communications during a bioterrorism attack; and the official 
Federal Internet Site on Bioterrorism.
Section 105. Education of Health Care Personnel; Training Regarding 
        Pediatric Issues
      House provision: The House bill requires the 
establishment of core curriculum materials for public health 
emergencies, for the purpose of education and training of 
health care personnel.
      Senate amendment: Section 105 of the Senate amendment 
contains a similar provision.
      Conference substitute: The Conference substitute adopts 
the House provision with minor modification. The Managers 
intend that the eligible entity phrase ``other appropriate 
educational entities'' includes medical schools that have 
established departments of medical education.
Section 106. Grants Regarding Shortages of Certain Health Professionals
      House provision: The House bill provides grants for 
training and education to certain categories of health care 
professionals for which there exist shortages impacting the 
ability to respond to bioterrorism and other public health 
emergencies.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference adopts the House 
provision without modification.
Section 107. Emergency System for Advance Registration of Health 
        Professions Volunteers
      House provision: The House bill establishes a national 
system to help verify the licenses, credentials and hospital 
privileges of health professionals who volunteer to respond 
during public health emergencies.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference adopts the House 
provision with modifications to make clear that use of the 
verification database is entirely voluntary, and that nothing 
in the section changes the roles of States in licensing or 
hospitals in establishing privileging requirements.
Section 108. Working Groups
      House provision: House section 108 makes modifications to 
the existing working groups in section 319 of the Public Health 
Service Act (PHSA).
      Senate amendment: The Senate amendment also makes 
modifications and additions to the working group provisions. 
The Senate amendment also consolidates the two existing working 
groups in sections 319F of the Public Health Service Act.
      Conference substitute: The Conference substitute adopts a 
single working group, but allows for subcommittees to represent 
the working group with respect to particular matters. The 
authority of the working group is limited through various 
savings clauses. The primary purposes of the working group are 
consultation, assisting in coordination, and making 
recommendations on a variety of topics related to preparedness 
for and response to bioterrorism and other public health 
emergencies. The Managers expect the working group to take into 
account the role and expertise of the Agency for Toxic 
Substances and Disease Registry. Additionally, the Managers 
encourage the working group to recognize the role of private 
ambulance services, especially when they may be the only 
ambulance services in the area.
Section 109. Antimicrobial Resistance
      House provision: The House bill authorizes further 
research and DNA analysis of priority pathogens that may be 
used by bioterrorists, and contains other provisions concerning 
antimicrobial resistance.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference substitute adopts 
the House provision on antimicrobial resistance. The provision 
concerning priority pathogens has been moved to section 125 of 
the Conference substitute.
Section 110. Supplies and Services in Lieu of Award Funds
      House provision: The House bill provides flexibility to 
allow the Secretary of HHS to supply actual supplies, 
equipment, or services instead of, or in conjunction with, 
grants.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference substitute adopts 
the House provision.
Section 111. Additional Amendments
      House provision: The House bill makes revisions to time 
frames to accelerate preparedness planning.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference substitute adopts 
the House provision.

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

Section 121. Strategic National Stockpile
      House provision: The House bill authorizes a national 
stockpile or stockpiles of drugs, vaccines, biologic products, 
medical devices and supplies to meet the health security needs 
of the United States. It requires enhanced procedures for 
coordination, maintenance, delivery, and distribution. House 
authorization language in section 151 of the House bill 
specifies specific sums for smallpox vaccines.
      Senate amendment: Section 201 of the Senate amendment 
also authorizes a national stockpile, and separately has a 
provision under section 402 for authorizing smallpox vaccines 
for the stockpile.
      Conference substitute: The Conference substitute adopts 
the House provision with modifications and inclusion of a 
specific provision on smallpox vaccines. The Managers believe 
that antiviral products may be appropriate for the strategic 
national stockpile and may include antiviral products reviewed 
by the Food and Drug Administration (FDA) or National 
Institutes of Health (NIH).
Section 122. Accelerated Approval of Priority Countermeasures
      House provision: The House bill clarifies certain fast-
track authority for drug priority countermeasures under the 
Federal Food, Drug, and Cosmetic Act.
      Senate amendment: Section 405 of the Senate amendment 
contains a similar provision.
      Conference substitute: The Conference substitute adopts 
the Senate provision with modification.
Section 123. Issuance of Rule on Animal Trials
      House provision: The House bill requires the FDA to issue 
a final rule within six months allowing reliance on animal 
trials for certain priority countermeasures for public health 
emergencies.
      Senate amendment: The Senate amendment contains a similar 
requirement with a 30-day time frame.
      Conference substitute: The Conference substitute adopts 
the House provision with modifications to provide the rule 
within 90 days of the date of enactment.
Section 124. Security for Countermeasure Development and Production
      House provision: The House bill authorizes the Secretary, 
in consultation with the Attorney General and Secretary of 
Defense, to provide technical or other assistance to enhance 
security at facilities that conduct development, production, 
distribution, or storage of priority countermeasures.
      Senate amendment: Section 402 of the Senate amendment 
contains a similar provision and also provides for best 
practices guidelines.
      Conference substitute: The Conference substitute adopts 
the House provisions without a requirement for best practices 
guidelines.
Section 125. Accelerated Countermeasure Research and Development
      House provision: The House bill directs the Secretary to 
conduct an accelerated countermeasure development program, and 
to award grants for biomedical research, development of 
vaccines, and diagnostic tests for priority countermeasures.
      Senate amendment: Section 404 of the Senate amendment 
contains similar provisions.
      Conference substitute: The Conference substitute adopts 
the Senate provisions with modifications. The House provision 
concerning priority pathogens is included. The Managers 
encourage the Secretary to consider novel methods for detecting 
and identifying viral and bacterial pathogens, and developing 
and manufacturing effective therapeutic responses, including 
both vaccines and antibiotics. The Managers also encourage the 
Secretary to consider the use of emerging biophysical and 
biomanufacturing technologies that hold the promise of 
producing rapid detection/response programs that can achieve 
accelerated responses to bioterrist attacks or threats. In 
addition, the Managers encourage the Secretary, in coordination 
with the Administrator of the Environmental Protection Agency, 
to develop protocols for and enhance facilities for testing 
technologies used to decontaminate facilities contaminated as a 
result of bioterrorism.
Section 126. Evaluation of New and Emerging Technologies Regarding 
        Bioterrist Attack and Other Public Health Emergencies
      House provision: The House bill requires the Secretary to 
evaluate new and emerging technologies to help detect, 
identify, diagnose, or conduct public health surveillance 
activities for public health emergencies, and prioritize 
development and deployment where warranted.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference substitute adopts 
the House provision with limiting modifications.
Section 127. Potassium Iodide
      House provision: The House bill requires the Secretary to 
make potassium iodide available to States and local governments 
that submit a plan for local stockpile and distribution for the 
population within 20 miles of a nuclear power plant.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference substitute adopts 
the House provision with modifications that include authority 
provided to the President; additional restrictions on the 
eligibility of local governments; and a different schedule for 
effective dates, and other modifications.

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

Section 131. Grants to Improve State, Local, and Hospital Preparedness 
        for and Response to Bioterrorism and Other Public Health 
        Emergencies
      House provision: The House bill modifies current 
authorities under section 319 of the PHSA and otherwise 
authorized grant funding to improve State, local, and hospital 
preparedness for and response tobioterrorism and other public 
health emergencies through the existing mechanisms of the PHSA. 
Authorization was provided from FY 2002-2006.
      Senate amendment: The Senate amendment contains a 
provision for State block grants for fiscal years 2002-2003 for 
bioterrorism activities only, and the authorization would not 
continue past FY 2003. It also provides an authorization for 
bioterrorism medical centers with authorization from FY 2002-
2006, limited to bioterrorism activities. Finally, the Senate 
amendment maintains and authorizes a portion of funding under 
section 319 for a broader list of purposes and eligible 
entities.
      Conference substitute: The Conference substitute reflects 
a compromise between House and Senate approaches. For FY 2003, 
there is a modified State block grant provision. Beyond FY 
2003, greater flexibility is provided to the Secretary to 
either continue the same approach or modify the approach 
without the restrictions of the FY 2003 formulas. The 
substitute also provides authorization for the purpose of 
enhancing the preparedness of hospitals (including children's 
hospitals), clinics, health centers, and primary care 
facilities, and for planning and administrative purposes 
relating to such authorizations. For FY 2004-2006, there is a 
new section 319 C-2.
      The Managers want to ensure that section 131 does not 
delay or disrupt the current grants and cooperative agreements 
that the Administration has been using in FY 2002, including 
those programs administered by CDC and the Health Resources and 
Services Administration (HRSA). It is the Managers' intent to 
allow the Administration to continue this approach. The 
Managers expect the Administration to evaluate the 
effectiveness of the program and make revisions where necessary 
to improve effectiveness and accountability.
      The Managers intend that a permissible use of funds under 
this section includes grants to one or more centers of 
excellence to develop appropriate innovative technology 
projects--for example, the development of a web-based 
computerized planning application that incorporates 
standardized language and utilizes wireless mobile technology. 
The Managers intend that training programs pursuant to this 
section could include the use of virtual reality training 
methods, human patient simulators, computer-assisted training 
modalities, and internet-based training and modeling 
capabilities. One or more centers of excellence could be 
established to develop, deploy, and evaluate virtual and 
augmented reality-based, internet-ready training capabilities.

        Subtitle D--Emergency Authorities; Additional Provisions

Section 141. Reporting Deadlines
      House provision: The House bill provides extensions for 
certain reporting deadlines during a public health emergency, 
and for transfer authority for funds during a public health 
emergency.
      Senate amendment: The Senate amendment contains an 
analogous provision on reporting deadlines and no new transfer 
authority.
      Conference substitute: The Conference substitute adopts 
the Senate provision on reporting deadlines with minor 
modifications.
Section 142. Streamlining and Clarifying Communicable Disease 
        Quarantine Provisions
      House provision: The House bill changes existing law to 
expand the authority of the Secretary, in consultation with the 
Surgeon General, and under certain conditions, to specify 
diseases that are subject to individual detention orders.
      Senate amendment: The senate amendment contains no 
analogous provision.
      Conference substitute: The Conference substitute adopts 
the House provision with modifications to the standards 
required before the Secretary may exercise this authority.
Section 143. Emergency Waiver of Medicare, Medicaid, and SCHIP 
        Requirements
      House provision: Section 143 allows the Secretary of 
Health and Human Services to waive certain requirements (and 
related regulations) inof titles XVIII, XIX, and XXI of the 
Social Security Act (as well as requirements and regulations under 
title XI of the Social Security Act, only as necessary to effectuate 
the waiver of the enumerated requirements of titles XVIII, XIX, and XXI 
to meet the purposes of this section) in the event of an emergency or 
disaster in order to: (1) facilitate the provision of health services 
in the emergency or disaster area, and (2) ensure that health care 
providers who furnish care in good faith to individuals enrolled in 
these programs during an emergency or disaster may be reimbursed 
without penalty. The Secretary can waive requirements pertaining to: 
conditions of participation for providers; provider licensing 
requirements; sanctions for physician self-referral; sanctions relating 
to transferring patients in an emergency; and deadlines for filing 
reports for periods of up to 90 days.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference substitute adopts 
the House provision with modifications. The Managers agree that 
the Secretary shall provide written notice to Congress, 
including a certification that a waiver is necessary. This 
notice shall be issued before the waiver authority is 
exercised. Additionally, the Secretary must report to Congress 
within a year evaluating the effectiveness of the approaches 
used during the operation of the waiver. The time frame for 
such waivers shall be 60 days.
Section 144. Provision for Expiration of Public Health Emergencies
      House provision: The House bill provides that public 
health emergencies expire by announcement of the Secretary, or 
after 90 days. The Secretary may renew emergency declarations 
at his or her discretion.
      Senate amendment: Section 212 of the Senate Amendment 
contains a similar provision, but with a 180-day expiration 
period.
      Conference substitute: The Conference substitute adopts 
the House provision with amendments, including clarifying the 
status of any existing declaration of public health 
emergencies.

                    Subtitle--Additional Provisions

Section 151. Designated State Public Emergency Announcement Plan
      House provision: Section 135 of the House bill amends the 
Stafford Act to provide for coordinated communications 
response.
      Senate amendment: Section 312 of the Senate amendment 
contains an identical provision.
      Conference substitute: The Conference substitute adopts 
the identical House and Senate provisions.
Section 152. Expanded Research by Secretary of Energy
      House provision: The House bill expands current research 
at the Department of Energy (DOE) and the National Nuclear 
Security Administration (NNSA) on rapid detection of pathogens 
likely to be used in bioterrorist attacks or other agents that 
may cause a public health emergency.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference substitute adopts 
the House provision.
Section 153. Expanded Research on Worker Health and Safety
      House provision: The House bill authorizes the National 
Institutes of Occupational Safety and Health (NIOSH) to expand 
research on health and safety of workers who are at risk for 
bioterrorist threats or attacks in the workplace.
      Senate amendment: The Senate amendment contains an 
analogous provision.
      Conference substitute: The Conference substitute adopts 
the Senate Amendment with minor modification.
Section 154. Enhancement of Emergency Preparedness of Department of 
        Veterans Affairs
      House provision: The House bill has no analogous 
provision.
      Senate amendment: The Senate amendment has no analogous 
provision.
      Conference substitute: The Conference substitute 
instructs the Secretary of Veterans Affairs to take appropriate 
actions to enhance the readiness of the Department's medical 
centers and research facilities for a chemical or biological 
attack, based on the results of an evaluation to be conducted 
by the Secretary on the security needs at these facilities.
Section 155. Reauthorization of Existing Program
      House provision: The House bill has no analogous 
provision.
      Senate amendment: The Senate amendment has no analogous 
provision.
      Conference substitute: The Conference substitute amends 
section 582(f) of the Public Health Service Act by 
reauthorizing a grant program through 2006 that provides awards 
to public and private entities, as well as Indian tribes and 
tribal organizations, that develop programs focusing on the 
behavioral and biological aspects of psychological trauma 
response and research that will help treat psychiatric 
disorders of children and youth resulting from witnessing or 
experiencing a traumatic event.
Section 156. Sense of Congress
      House provision: The House bill has no analogous 
provision.
      Senate amendment: The Senate amendment states that 
Congress recognizes that many university-based programs are 
already functioning and developing important biodefense 
products and solutions. Congress should recognize the 
importance of supporting work done at university centers and 
laboratories. In addition, Congress should recognize the 
importance of existing public and private university-based 
research, training, public awareness, and safety-related 
biological defense programs in the awarding of grants and 
contracts made in accordance with this Act.
      Conference substitute: The Conference substitute contains 
one modification to the Senate amendment, which clarifies that 
the Secretary of Health and Human Services may recognize the 
importance of existing public and private university-based 
efforts in grants and cooperative agreements.
Section 157. General Accounting Office Report
      House provision: The House bill has no analogous 
provision.
      Senate amendment: The Senate amendment requires a General 
Accounting Office (GAO) report to Congress on Federal 
bioterrorism-related activities.
      Conference substitute: The Conference substitute amends 
section 319F of the Public Health Service Act to require GAO to 
report on Federal bioterrorism-related activities, including 
research, preparedness, and response, to the following 
committees: Senate Health, Education, Labor, and Pensions; 
Senate Appropriations; House Energy and Commerce; and House 
Appropriations.
Section 158. Certain Awards
      House provision: The House bill has no analogous 
provision.
      Senate amendment: The Senate amendment has no analogous 
provision.
      Conference substitute: The Conference substitute amends 
section 319(a) of the Public Health Service Act by inserting 
after ``grants,'' ``providing awards for expenses, and.''
Section 159. Public Access Defibrillation Programs and Public Access 
        Defibrillation Demonstration Projects
      House provision: The House bill contains no analogous 
provision.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference substitute amends 
section 243 of title 42, United States Code, to enact the 
``Community Access to Emergency Defibrillation Act of 2002.'' 
The Conference substitute directs the Secretary to establish a 
new grant program for States, political subdivisions of States, 
Indian tribes, and tribal organizations to develop and 
implement public access defibrillation programs. These grants 
may be used to purchase automated external defibrillators 
(AEDs), to provide automated external defibrillation and basic 
life support training in AED usage, to provide information to 
community members about the public access defibrillation 
program, to provide information to the local emergency medical 
system regarding the placement of AEDs, and to produce 
materials to encourage private companies to purchase AEDs. For 
this new grant program, the Conference substitute authorizes 
the appropriation of $25 million in fiscal year 2002, and such 
sums as may be necessary for each of the fiscal years 2004 
through 2006. The Conference substitute also establishes a new 
grant program for political divisions of States, Indian tribes, 
and tribal organizations to develop and implement innovative, 
comprehensive, community-based public access defibrillation 
demonstration projects. These grants may be used to purchase 
AEDs, to provide basic life training in automated external 
defibrillator usage, to provide information to community 
members about the public access defibrillation demonstration 
project, and to provide information to the local emergency 
medical services system regarding the placement of AEDs. For 
these demonstration projects, the Conference substitute 
authorizes the appropriation of $5 million for fiscal years 
2003 through 2006. The Managers intend that the ``Good 
Samaritan'' protections regarding emergency use of AEDs 
outlined in section 238(q) of title 42, United States Code will 
apply to this section. It is the intent of the Managers that 
this new program coordinates its activities with the Rural AED 
program and avoid duplication of effort.

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

          Subtitle A--Department of Health and Human Services

Section 201. Regulation of Certain Biological Agents and Toxins
      House provision: The House bill requires all persons who 
possess, use or transfer ``select agents''--the 36 biological 
agents or toxins currently determined by the Secretary of the 
Department of Health and Human Services (HHS) to pose ``a 
severe threat to public health and safety''--to register with 
the Secretary and be subject to reasonable safety and security 
requirements and inspections. Current law requires registration 
only of those entities transferring such agents. The House bill 
also directs that the Secretary maintain a national database of 
all such agents, with sufficient information to facilitate 
their identification and traceability. The Secretary, in 
consultation with the Attorney General, must establish specific 
security requirements for registered facilities and a personnel 
screening protocol to ensure that access to such agents is not 
permitted by individuals who are ``restricted persons'' under 
the USA PATRIOT Act (18 U.S.C. 175b), are named in a warrant 
for violent criminal or terrorist activity, are under 
investigation for involvement in domestic or international 
terrorist or criminal organizations, or suspected of spying for 
the military or intelligence operations of a foreign nation. 
The Secretary is granted authority to assist public and 
nonprofit private entities in meeting such security 
requirements. The House bill also imposes civil penalties for 
those who violate the regulations, up to $500,000.
      The House bill grants the Secretary discretion to make 
exemptions to the registration requirements only where those 
exemptions are consistent with protecting the public health and 
safety--for example, with respect to inactivated or attenuated 
strains of select agents used in vaccines or other products for 
legitimate medical research or use--or when the agent is 
presented for diagnosis, verification or proficiency testing 
purposes at a clinical laboratory and is promptly destroyed or 
transferred to a registered facility after such identification. 
The House bill also exempts from mandatory disclosure under the 
Freedom of Information Act (FOIA) site-specific or identifying 
information submitted under these regulations concerning 
registered persons, select agents, and security mechanisms.
      Senate amendment: The Senate amendment is substantially 
similar to the House bill but differs in a few respects. First, 
in developing the list of select agents, the Secretary is 
directed to consider the needs of children and other vulnerable 
populations. Second, individuals who seek access to select 
agents are screened only to identify if they are ``restricted 
persons'' under the USA PATRIOT Act, or are named in a warrant 
for participation in a domestic or international act of 
terrorism. Third, the Secretary is permitted to exempt certain 
attenuated or inactive biological agents or toxins and certain 
approved medical products from the list of select agents.
      Conference substitute: The Conference substitute adopts 
provisions of both bills, with significant modifications. The 
primary goals of this subtitle are to ensure the prompt 
reporting to the Federal government of possession of select 
agents (including by those who were in possession prior to 
April 15, 1997, the effective date for reporting transfers of 
select agents), to increase the security over such agents 
(including access controls and screening of personnel), and to 
establish a comprehensive and detailed national database of the 
location and characterization of such agents and the identities 
of those in possession of them. To effectuate these goals, the 
substitute requires that, at a minimum, all possession of 
select agents (unless exempt under the provisions of this 
subtitle) must be registered with the Secretary. The Managers 
expect that most ``persons'' who register under this subtitle 
will be public and private entities, rather than individuals. 
But these provisions also will cover individuals possessing, 
using or transferring select agents who have not been granted 
authority to do so by registered persons. If an individual has 
not been granted such authority, then that individual would be 
a person required to register under this subtitle. If an 
individual has been granted such authority without proper 
authorization from the Secretary, as required by this subtitle, 
then the registered person is subject to any penalties provided 
for violation of such regulations. The Managers emphasize that 
the primary responsibility for registration and the screening 
of employees working with select agents is with the entity or 
employer, not the individual employee. The Secretary also is 
required to promulgate regulations establishing safety 
requirements for the possession, use, and transfer of select 
agents. These regulations must include procedures to protect 
the public safety in the event the safety requirements for 
possession, use or transfer are violated.
      The Managers recognize that some select agents may pose a 
greater threat to the public health and safety than others. 
Accordingly, the Conference substitute amends the security 
requirements of both bills by adding the phrase ``commensurate 
with the risk such agent or toxin poses to public health and 
safety (including the risk of use in domestic or international 
terrorism).'' The Secretary will have flexibility to impose 
different levels of security requirements on different select 
agents based on his or her evaluation of the level of threat to 
the public, as is currently done with respect to laboratory 
biosafety levels. Because an agent must pose a severe threat to 
human health to be placed on the select agent list, the 
Secretary may not decide that security requirements or 
registration of possession are unnecessary for a particular 
select agent.
      The substitute also modifies the existing statutory 
requirements for the transfer regulations by adding ``and 
security measures'' after ``safeguards'' in the term 
``safeguards to prevent access . . . for use in domestic or 
international terrorism or for any other criminal purposes'' to 
clarify that such regulations include the imposition of 
security requirements. The substitute also requires that 
registered persons promptly notify the Secretary whenever a 
select agent is lost, stolen, or released outside of a 
biocontainment area of a facility. Current HHS regulations do 
not mandate such notifications.
      The Conference substitute adds new provisions regarding 
the screening of entities and individuals seeking to register 
their possession, use or transfer of select agents. While both 
the House and Senate bills mandate screening of individuals 
seeking access to agents through a registered person, neither 
bill required screening of the registered persons themselves. 
The substitute provides for such screening in a similar manner 
to that performed for individuals working at the facilities of 
registered persons. Further with respect to screening, the 
substitute drops the provision in both bills relating to 
outstanding warrants, as duplicative of the fugitive provision 
in the restricted person categories of the USA PATRIOT Act, and 
adds a screening category that was in neither bill--those 
reasonably suspected of committing Federal crimes of terrorism. 
The substitute includes but makes revisions to the two 
additional screening categories contained in the House bill to 
ensure an objective basis for governmental suspicion of 
involvement with terrorist or criminal organizations, or with 
foreign powers. In the case of restricted persons, the 
substitute mandates that access to select agents be denied, 
because of the criminal prohibition on possession by such 
persons. In the case ofpersons falling within the other three 
specified categories, the substitute grants the Secretary and Attorney 
General discretion in determining how to proceed, given the law 
enforcement sensitivity of such situations. By making this distinction 
between the handling of restricted persons and other screening 
categories, the Managers do not intend that potential terrorists or 
foreign agents should be subject to a less strict screening standard 
than restricted persons. The substitute also clarifies that the 
screening performed by the Attorney General is for the sole purpose of 
identifying--through the use of official, electronic databases 
available to the Federal government--whether an individual or entity 
falls within any of the specified categories, and for notifying the HHS 
Secretary of such identification. It is the Managers' intent that the 
term ``electronic databases'' is not meant to preclude the use of other 
databases or files by the Attorney General to clarify or confirm 
information obtained during the electronic database search.
      To address concerns within the academic and research 
communities about the timeliness and accuracy of the background 
screening process, the Conference substitute amends both bills 
by requiring ``prompt'' action by the Attorney General and the 
Secretary with respect to screening of and notification to 
affected individuals, and by providing for an expedited review 
process where good cause has been demonstrated by the 
registered person. The substitute also provides for a review of 
denials by the Secretary based on the screening process, and 
subsequent judicial review--with provisions to ensure that 
classified or sensitive law enforcement information is not 
compromised during such reviews. Specifically, the substitute 
allows for ex parte review by the Secretary in administrative 
proceedings, and the court during judicial review, whenever a 
denial is challenged. In providing the right for ex parte 
review, the Managers intend to protect classified and law 
enforcement sensitive information, including through the use of 
in camera proceedings. Moreover, the Managers intend that a 
reviewing court should not order the disclosure of any 
information that the United States believes may compromise 
national security or an ongoing law enforcement investigation 
without affording the United States an opportunity for further 
review in accordance with this subtitle. It is the Managers' 
overall expectation that the screening process be conducted in 
a timely and fair manner, and that the Secretary and the 
Attorney General will work closely together to effectuate such 
intent.
      With respect to the national database of select agents 
that the Secretary must develop pursuant to this section, the 
Conference substitute slightly alters the language used in both 
bills with respect to the database's purpose. The object of the 
registration and database requirements is to provide 
information about all persons possessing, using or transferring 
select agents, and to collect sufficiently detailed 
characterization information on the registered select agents so 
that the database can differentiate between and within strains 
of a given agent or toxin. Such information should be in a 
format that public health and law enforcement officials can use 
to identify the origin or source of an agent or toxin that is 
used to cause harm to the public. Because of concerns over the 
potential for misconstruction, the term ``traceability''--which 
could imply a chain of custody or tracking requirement--was 
eliminated, and was replaced with the concept of ``source.''
      Significant modifications were made to both bills with 
respect to exemptions from the statutory and regulatory 
requirements governing select agents. The Conference substitute 
establishes several exemptions from the regulatory regime for 
select agents, most of which are consistent with the 
Secretary's current regulations and practices. First, the 
Conference substitute adopts, with modifications, the Senate 
amendment's language with respect to product exemptions. The 
substitute directs the Secretary to exempt from such 
regulations products that are, bear or contain a select agent 
and are licensed or approved under several specified Federal 
laws, unless the Secretary determines that additional 
regulation is necessary for a specific product to ensure 
protection of public health and safety. The Managers intend 
that the Secretary will exempt by regulation categories of 
products, consistent with current regulations, and will act to 
regulate a specific product, or a particular application of a 
specific product, only when existing regulation under other 
Federal laws is inadequate. For example, HHS currently exempts 
the FDA-approved medical product Botox, which is the select 
agent botulinum toxin, when it is used by licensed physicians 
in the treatment of patients. However, when it is used in 
purely research settings or as part of early-stage clinical 
trials, HHS has chosen not to exempt Botox from current 
regulations. The Managers do not intend to alter this 
flexibility.
      Second, the Conference substitute adds a provision 
granting the Secretary discretionary authority to exempt, on a 
case-by-case basis, investigational products when they are 
being used in investigational or clinical trials authorized 
under other Federal laws, such as the Federal Food, Drug, and 
Cosmetic Act. Given the time sensitivity of such trials, the 
substitute also includes a provision mandating a prompt 
determinationby the Secretary of such an exemption request--
within 14 days after the applicant has submitted a complete exemption 
request and has notified the Secretary that the investigation may 
proceed as authorized under Federal law.
      Third, with respect to clinical or diagnostic 
laboratories that may come into possession of select agents 
when conducting specimen diagnosis, verification or proficiency 
testing, the substitute adopts with minor changes the 
comparable provisions in the House and Senate bills. The 
Secretary shall exempt such laboratories from registration 
requirements, but only if they report the identification of 
select agents to the Secretary and either promptly transfer the 
agent to a registered person or destroy the agent on site, in 
accordance with regulations established by the Secretary. While 
HHS currently exempts such laboratories, existing regulations 
permit them to transfer, destroy, or store the agent on site 
for reference purposes. The Conference substitute expressly 
rejects that regulatory approach, as it is inconsistent with 
the fundamental premise of this title--that all those who 
maintain possession of a select agent must register and be 
subject to appropriate security and safety requirements. The 
Secretary may not exempt laboratories that possess select 
agents for reference purposes, or any other clinical or 
diagnostic laboratories that do not qualify for an exemption 
under the terms of this title. In addition, the Conference 
substitute creates two temporary exemption authorities to deal 
with public health emergencies and agricultural emergencies, 
whether domestic or foreign.
      With respect to funding, the Conference substitute 
authorizes such sums as may be necessary to carry out these new 
and expanded functions. The Managers note that, historically, 
HHS has had insufficient resources to properly run the existing 
select agent transfer program. While current regulations permit 
inspections, only 20 percent of all registered facilities have 
been inspected since the inception of the program in 1997, and 
virtually none of these inspections were conducted prior to 
registration. The Managers also note that HHS received a large 
increase in funding for this program in the Fiscal Year 2002 
supplemental appropriations bill. Given the broader, but 
uncertain scope of the new regulatory regime, it is unclear 
whether additional funds beyond current appropriations will be 
necessary for Fiscal Year 2003. Once all persons possessing 
select agents notify the Secretary of such possession 90 days 
after enactment of this title, the appropriations level may 
need to be re-evaluated.
Section 202. Implementation by Department of Health and Human Services
      House provision: The House bill requires notification to 
the Secretary by all persons possessing select agents within 60 
days of enactment, and an interim final rule establishing a 
regulatory structure to be issued within 120 days of enactment.
      Senate amendment: The Senate amendment requires the 
Secretary to issue an interim final rule within 180 days of 
enactment, and requires all persons possessing select agents to 
register within 60 days of issuance of the rule.
      Conference substitute: The Conference substitute adopts 
the House bill with modifications. The substitute requires 
notification to the Secretary by all persons possessing select 
agents within 90 days of enactment, based on guidance issued by 
the Secretary within 30 days of enactment, and the issuance of 
an interim final rule within 180 days of enactment. The 
substitute also provides that the interim final rule shall 
include time frames for applicability of the rule that minimize 
disruption of research or educational projects that involve 
select agents and that were underway as of the effective date 
of such rule. The Managers note that the interim final rule and 
effective date provisions will result in these new regulations 
going into effect at approximately the same time as the 
National Institutes of Health (NIH) begins to award Fiscal Year 
2003 grants for research, some of which will be in the select 
agent area. The Managers expect that the Secretary will 
encourage those seeking such grants to begin the registration 
and screening process under this title concurrently with the 
NIH grant process, and that the Secretary will ensure the 
timely registration and screening of such grantees, so as not 
to delay this important research.
Section 203. Effective Dates
      House provision and Senate amendment: Both the House bill 
and the Senate amendment provide that regulations promulgated 
by the Secretary under section 511 of the Antiterrorism and 
Effective Death Penalty Act of 1996 are deemed to have been 
promulgated under section 351A of the Public Health Service 
Act, as added by this Act. They bothalso provide that the FOIA 
exemptions apply retroactively to the effective date of the 
Antiterrorism and Effective Death Penalty Act of 1996.
      Conference substitute: The Conference substitute adopts 
the same provisions.
Section 204. Conforming Amendment
      House provision and Senate amendment: Both the House bill 
and the Senate amendment repeal those provisions of the 
Antiterrorism and Effective Death Penalty Act of 1996 that have 
been codified in section 351A of the Public Health Service Act 
by this Act.
      Conference substitute: The Conference substitute adopts 
the same provisions.

                 Subtitle B--Department of Agriculture

Section 211. Short Title
      House provision and Senate amendment: Neither the House 
bill nor the Senate amendment contain any analogous provision.
      Conference substitute: The Conference substitute includes 
a new subtitle, with its own short title--the Agricultural 
Bioterrorism Protection Act of 2002.
Section 212. Regulation of Certain Biological Agents and Toxins
      House provision and Senate amendment: Neither the House 
bill nor the Senate amendment contain any analogous provision.
      Conference substitute: The Conference substitute adopts 
provisions that would grant comparable regulatory authorities 
to the U.S. Department of Agriculture (USDA) as those granted 
to HHS under subtitle A of this title for the regulation of 
possession, use or transfer of listed biological agents and 
toxins that present a severe threat to plant or animal health, 
or animal or plant products. In an effort to minimize 
regulatory duplication and burden, the substitute seeks to 
ensure, to the greatest extent practicable, uniformity in the 
statutory authority that the two departments will administer. 
Exceptions exist in the criteria to be used by the Secretary of 
Agriculture in developing a list of agriculturally significant 
biological agents and toxins; considerations to be made in 
granting exemptions from regulation under the statute; 
procedures related to civil monetary penalties; and the time 
frames for promulgation of a biological agents and toxins list 
and the accompanying requirement that individuals who possess 
these agents notify the Secretary of such possession. In 
addition, with respect to the screening of persons registering 
or accessing listed agents, the substitute uses the same 
screening categories as are in subtitle A, but does not mandate 
any denials of access, given that possession of USDA-listed 
agents by restricted persons is not a Federal crime. Instead, 
the Secretary and Attorney General are granted discretion as to 
how to proceed in such situations.
      The Managers recognize that, under provisions of current 
law, biologics manufacturers have had to register, maintain 
associated paperwork, and be subject to inspections and 
requirements from both USDA and HHS. Likewise, the Managers are 
aware that the inadequacy of the penalty provisions of the 
Virus-Serum-Toxin Act--enacted in 1913 and under which USDA 
currently regulates these dangerous agents--as well as the lack 
of authority for the Secretary of Agriculture to regulate 
possession of biological agents and toxins that pose a severe 
threat to plant or animal health may expose the United States 
to potential acts of bioterrorism that could have a devastating 
impact on animal and plant health, or the domestic agricultural 
economy.
      The Managers intend that, in developing the list of 
agents and toxins to be regulated under this subtitle, the USDA 
Secretary shall consult with other appropriate Federal 
agencies. With regard to zoonotic agents, which pose a threat 
to both animals and humans, the Managers expect that the USDA 
Secretary will consult with the HHS Secretary in developing 
such a list. The Managers also intend that the USDA Secretary 
will develop the list of regulated agents and toxins based 
solely on the risk to animals or plants, or to animal or plant 
products, including consideration of the effect of exposure on 
the production and marketability of such products. The Managers 
do not intend that the USDA Secretary will include an agent or 
toxin on the USDA list because of the effect of that agent or 
toxin on human health, which is governed by the statutory 
provisions of section 351A of the Public Health Service Act, as 
amended by this title.
      The Managers expect that most ``persons'' who register 
under this subtitle will be public and private entities, rather 
than individuals. But these provisions also will cover 
individuals possessing, using or transferring listed agents who 
have not been granted authority to do so by registered persons. 
If an individual has not been granted such authority, then that 
individual would be a person required to register under this 
subtitle. If an individual has been granted such authority 
without proper authorization from the Secretary, as required by 
this subtitle, then the registered person is subject to any 
penalties provided for violation of such regulations. The 
Managers emphasize that the primary responsibility for 
registration and the screening of employees working with listed 
agents is with the entity or employer, not the individual 
employee.
      Procedures for the registration of persons, review of 
individuals, and inspection of facilities have been described 
in the statutory language in some detail. Of equal importance 
to the Managers are the regulations, to be established by the 
Secretary, which, to ensure compliance with this subtitle, 
shall include provisions for the revocation and suspension of 
registrations for failure to maintain safe and secure 
facilities.
Section 213. Implementation by the Department of Agriculture
      House provision and Senate amendment: Neither the House 
bill nor the Senate amendment contain any analagous provision.
      Conference substitute: The Conference substitute provides 
that, within 60 days of enactment, the Secretary of Agriculture 
shall promulgate an interim final rule that establishes an 
initial list of agents and toxins meeting the statutory 
criteria for enhanced regulation. Within 60 days of the 
publishing of the interim final rule, all persons (unless 
exempt) must notify the Secretary of such possession. Within 
180 days of enactment, the Secretary shall promulgate an 
interim final rule for carrying out the remainder of section 
212, which such rule shall include time frames that minimize 
disruption of ongoing research and education with listed agents 
and toxins.

   Subtitle C--Interagency Coordination Regarding Overlap Agents and 
                                 Toxins

Section 221. Interagency Coordination
    House provision: The House bill requires that the HHS 
Secretary ensure that select agent regulations are coordinated 
with the existing regulations of USDA governing certain of the 
select agents that are used in the development of vaccines or 
other products for the treatment of domestic animals. The 
purpose of such coordination is to minimize conflict and 
duplication of administrative burdens of registered persons.
    Senate amendment: The Senate amendment contains no 
analogous provision.
    Conference substitute: The Conference substitute, in adding 
new USDA regulatory authority comparable to that given HHS in 
subtitle A of this title, also adopts provisions that would 
facilitate coordination and cooperation between USDA and HHS 
with respect to the regulation of those ``overlap'' agents or 
toxins that are regulated by both such agencies.
    In the case of zoonotic agents that appear on both the USDA 
and HHS lists of dangerous biological agents and toxins 
developed under this title, the Managers intend that the two 
Secretaries shall work cooperatively to develop a streamlined, 
joint registration whereby the registrant shall be permitted to 
submit a single registration document to either USDA or HHS. 
Upon receipt of the registration document, the receiving agency 
shall review the application and transfer it to the other 
agency in order that the second agency may conduct an 
independent review. Upon completion of the individual reviews 
by both agencies, and if both agencies concur that the 
registration should not be denied, the receiving agency shall 
notify the prospective registrant of this determination. In the 
absence of concurrence, the receiving agency shall notify the 
prospective registrant of the denial of the application.
    The Managers intend that this system of joint registration 
should be implemented through the development of a 
comprehensive Memorandum of Understanding between the two 
agencies no later than six months after the date of enactment 
of this act, which will coincide with the issuance by each 
Secretary of an interim final rule requiring the registration 
of listed agents and toxins. Until such time as the Memorandum 
of Understanding is implemented, the separate regulatory 
systems of USDA and HHS shall remain in effect.
      It is the Managers' intent that the two Secretaries will 
coordinate closely with respect to exemptions from these new 
regulatory regimes for overlap agents, so as to create a 
uniform and consistent approach. The Managers also intend that, 
under the Memorandum of Understanding, a regulated party will 
interact with one agency with respect to all matters--including 
registration, screening, and inspections--so as to avoid 
confusion and forum shopping. The Managers also expect that the 
two Departments will coordinate and consult with respect to 
overlap agent registration, screening, and exemptions in a 
timely manner, particularly in situations of public health or 
agricultural emergencies.
      Within 18 months of the implementation of a Memorandum of 
Understanding between USDA and HHS, the Managers intend that a 
formal, joint regulatory system shall be implemented by the two 
Departments for agents and toxins that appear on both the USDA 
and HHS lists. Once implemented, the Managers intend that these 
joint regulations shall supercede the Memorandum of 
Understanding with respect to matters covered by such 
regulations.

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

Section 231. Criminal Penalties
      House provision: The House bill authorizes amendments to 
current law to require all persons who possess, use or transfer 
biological agents or toxins that have been listed as select 
agents by the HHS Secretary to register with the Secretary. To 
enforce these new regulatory provisions, subsection (a) of 
section 231 of the House bill provides that any person who 
knowingly transfers a select agent to any person without first 
verifying such registration with the Secretary could be fined 
or imprisoned up to five years, or both. The subsection also 
provides that any person who knowingly possesses a biological 
agent or toxin, where such agent or toxin is a select agent for 
which such person has not obtained a registration required by 
the Secretary, could be fined or imprisoned for up to five 
years, or both.
      The House bill makes technical changes to 18 U.S.C. 175b 
to renumber current subsection (a) as (a)(1), and to 
redesignate subsection (c) as (a)(2). This change will result 
in the description of the possible penalties being placed 
immediately following the description of the unlawful conduct. 
The House bill also redesignates subsection (b) as subsection 
(d). The two new criminal provisions added under this bill are 
designated subsections (b) and (c) of section 175b. The House 
bill also makes conforming amendments to clarify the definition 
of the term ``select agent.'' The House bill also changes the 
title of section 175b from ``Possession by restricted persons'' 
to ``Select Agents.''
      Senate amendment: The Senate amendment includes the same 
criminal provision relating to those who possess select agents 
without being registered, but differs with respect to the 
criminal penalty for unauthorized transfers. The Senate 
amendment criminalizes transfers to unregistered persons when 
the transferor has reason to believe that the recipient is not 
registered. The Senate amendment also differs by including the 
unlawful conduct in 18 U.S.C. 175, rather than 175b. The Senate 
amendment makes conforming changes to 18 U.S.C. 175 to make the 
sections technically correct and to eliminate a definition that 
is already provided in another section. The Senate amendment 
provides that current 18 U.S.C. 175(b) and (c) are redesignated 
as (c) and (d). New subsection (b) creates the criminal 
penalties referenced above. New subsection (d), which contains 
the definitions, amends current law to provide new definitions 
for the following terms: ``biological agent,'' ``for use as a 
weapon,'' and ``select agent.''
      Conference substitute: The Conference substitute adopts 
the House language with regard to technical changes to 18 
U.S.C. 175b, but adopts the Senate language with respect to new 
criminal penalties with modifications. The Conference 
substitute adopts the common language dealing with unlawful 
possession. However, the Conference substitute amends the 
Senate language regarding transfers to provide that any person 
who transfers a select agent to any person one knows or has 
reasonable cause to believe has not registered with the HHS 
Secretary could be fined or imprisoned up to five years, or 
both.
      The Conference substitute also amends both bills by 
adding language that requires all persons who possess, use or 
transfer biological agents that have been listed as agents that 
pose a threat to agriculture by the Secretary of Agriculture to 
register with such Secretary. The Conference substitute 
provides that knowing possession of a biological agent or 
toxin, where such agent or toxin is listed by the Secretary of 
Agriculture under this Act and for which a required 
registration has notbeen obtained, is punishable by a fine or 
up to five years imprisonment, or both. Similarly, transfer of a 
biological agent or toxin listed by the Secretary of Agriculture to a 
person one knows or has reasonable cause to believe has not registered 
with the Secretary is punishable by a fine or up to five years 
imprisonment, or both.
      The Conference substitute also makes additional 
conforming and technical amendments to title 18, including 
providing a comma in 18 U.S.C. 175(c); specifically describing 
what activities restricted persons are prohibited from engaging 
in under this section; referring to the correct code section 
for the definition of ``alien''; replacing legislative language 
in 176(a)(1)(A); modifying the definitions in 18 U.S.C. 178 for 
``biological agent'', ``toxin'', and ``vector'' to make each 
more accurate; and modifying 18 U.S.C. 2332a regarding use of 
weapons of mass destruction to make it clear it refers to use 
of biological agents or toxins.
      The Managers expect that most ``persons'' who register 
under this title will be public and private entities, rather 
than individuals. When an entity fails to register as required, 
the new criminal possession statutes will apply to that entity. 
These provisions also will cover individuals possessing select 
or listed agents who are unregistered and who have not been 
granted access to such agents by registered persons. If an 
individual has not been granted access by a registered person, 
then that individual would be a person required to register 
under this title for purposes of these criminal possession 
provisions. If an individual is granted access to a select or 
listed agent by a registered person without proper 
authorization from the Secretary, as required by this title, 
then the registered person is subject to any penalties provided 
for violation of such regulations. The Managers emphasize that 
the primary responsibility for registration and the screening 
of employees working with select or listed agents is with the 
entity or employer, not the individual employee. This same 
analysis applies to the criminal transfer provisions set forth 
in this section.

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

                 Subtitle A--Protection of Food Supply

      For purposes of this Title, the term ``Secretary'' refers 
to the Secretary of Health and Human Services, unless otherwise 
indicated.
Section 301. Food Safety and Security Strategy
      House provision: The House bill contains no analogous 
provision.
      Senate amendment: The Senate amendment expands the 
responsibilities of the President's Council on Food and Safety 
(established by Executive Order 13100) by directing the 
Council, with the Secretary of Commerce and the Secretary of 
Treasury to develop a crisis communications and education 
strategy with respect to bioterrorist threats to the food 
supply. The Senate amendment authorizes to be appropriated 
$500,000 to develop such a strategy.
      Conference substitute: The Conference substitute adopts 
the Senate amendment with modification. The Conference 
substitute expands the scope of consultation between the 
President's Council on Food Safety and other entities to 
include any other relevant Federal agencies, including law 
enforcement and intelligence related agencies, and scientific 
organizations. The Conference substitute also expands the scope 
of the food safety and security strategy to address 
technologies, threat assessments, risk communication, and 
procedures for securing food processing and manufacturing 
facilities and modes of transportation. The Conference 
substitute increases the amount of funds that are authorized to 
be appropriated for fiscal year 2002 to $750,000 to develop 
such a strategy.
Section 302. Protection Against Adulteration of Food
      House provision: The House bill authorizes to be 
appropriated $100,000,000 for fiscal year 2002, and such sums 
as may be necessary for each year from fiscal year 2003 thorugh 
fiscal year 2006, for the Secretary to carry out increased 
activities to ensure the safety of the food supply. 
Specifically, the House bill amends section 801 of the Federal 
Food Drug and Cosmetic Act (FFDCA) directing the Secretary to 
give high priority to increasing the number of food safety 
inspections at ports of entry, with highest priority on 
inspections to detect intentional adulteration of food.The 
House bill also directs the Secretary to give a high priority to 
improving the information management systems that support food safety 
inspection programs for the purpose of improving the ability of the 
Secretary to detect intentional adulteration of food and to facilitate 
the importation of food that is in compliance with the Act. Further, 
the House bill directs the Secretary to give high priority to 
researching and developing improved tests and sampling methods for the 
purpose of rapidly detecting adulterated foods, with highest priority 
on detection of intentional adulteration. Finally, the House bill 
directs the Secretary to complete an assessment of potential threats to 
the food supply posed by efforts to intentionally adulterate food, and 
to report the findings on such assessment to Congress within six 
months.
      Senate amendment: The Senate amendment authorizes to be 
appropriated $59,000,000 for fiscal year 2002 and such sums as 
may be necessary for each year thereafter to expand the 
capacity of the Food and Drug Administration (FDA) to increase 
inspections to ensure the safety of the food supply and to 
improve linkages between the FDA and other Federal regulatory 
agencies, the States, and Indian tribes.
      Conference substitute: The Conference substitute adopts 
the House bill with modification. The Conference substitute 
directs the Secretary to improve linkages with other Federal 
regulatory agencies that share responsibility for food safety, 
and directs the Secretary to improve linkages with the States 
and Indian tribes with respect to food safety. The Managers 
intend that the Secretary in making improvements to the 
information management systems that support food safety 
inspection programs, including the OASIS system, may include 
improvements that assist food importers and filers in providing 
accurate and timely information on entries filed on food import 
shipments. The Managers also intend that in conducting research 
to develop improved tests and sampling methods for the purpose 
of rapidly detecting adulterated foods, the Secretary may 
involve institutions of higher education, including such 
institutions that receive Federal funding to operate 
consortiums within the food industries, for the purpose of 
conducting research and development in food safety and food 
security. Finally, it is the understanding of the Managers that 
FDA already has underway (under agreement with Battelle 
Laboratories) an assessment of potential threats to the food 
supply posed by efforts to intentionally adulterate food. For 
purposes of this section, the requirement to conduct an 
assessment of potential threats to the food supply posed by 
efforts to intentionally adulterate food refers to such threat 
assessment that is already underway or very recently completed.
Section 303. Administrative Detention
      House provision: The House bill amends section 304 of the 
FFDCA by authorizing the Secretary to administratively detain 
an article of food that is found during an inspection, 
examination or investigation under this Act if the Secretary 
has credible evidence or information indicating that the 
article presents a threat of serious adverse health 
consequences or death to humans or animals. Such food may be 
detained for a reasonable period of up to 20 days, and where 
needed up to 30 days, for the purpose of enabling the Secretary 
to institute a seizure action under section 304(a) or 
injunctive relief under section 302, as warranted. The House 
bill authorizes the Secretary to move detained food from the 
place at which it has been detained to a secured facility, as 
appropriate, for the period of detention or until released by 
the Secretary. The House bill also authorizes a claimant of an 
article of food that has been detained under this section to 
appeal the detention of the article. In addition, where the 
Secretary already has credible evidence or information 
indicating that an imported article of food presents a threat 
of serious adverse health consequences or death to humans or 
animals, this section also requires the Secretary to request 
the Secretary of Treasury to temporarily hold imported food at 
a port of entry for up to 24 hours to enable the Secretary to 
inspect, examine or investigate the food. For an article of 
food temporarily held under this section, the Secretary is also 
required to notify the State in which the port of entry is 
located about such request or that such food is being 
temporarily held.
      Senate amendment: The Senate amendment provides authority 
to administratively detain food that is similar to the House 
bill. The Senate amendment allows the Secretary to detain food 
that violates the FFDCA and that presents a threat of serious 
adverse health consequences or death, and requires that the 
Secretary provide an opportunity for a hearing (and to confirm 
or to revoke) a detention order within 15 days of the filing of 
an appeal by a claimant. Unlike the House bill, the Senate 
amendment does not include additional authority to temporarily 
hold food, nor does itrequire the Secretary to notify a State 
regarding the port of entry within such State at which food is being 
temporarily held.
      Conference substitute: The Conference substitute adopts 
the House bill with modification. The Conference substitute 
clarifies that food that is detained under this section may not 
be delivered pursuant to an execution of a bond in accordance 
with section 801 of the FFDCA (if the detained food is 
imported) or otherwise (if the detained food is domestically 
produced), while the food is subject to the detention order, 
unless released by the Secretary. The Conference substitute 
requires the Secretary in response to an appeal filed by a 
claimant challenging the detention of an article of food to 
conduct an informal hearing and confirm or terminate a 
detention order within five days after an appeal is filed, at 
which time the Secretary's determination is subject to judicial 
review in accordance with section 702 of title 5, United States 
Code. The Conference substitute amends section 304 of the FFDCA 
by authorizing the Secretary to detain an article of food for 
the purpose of enabling the Secretary to institute a seizure 
action under section 304(a) or to seek injunctive relief under 
section 302 of the Act. This section provides a claimant of the 
food the right to appeal a detention order, but that right of 
appeal terminates if the Secretary institutes either a seizure 
action under section 304(a) or injunctive relief under section 
302 of the Act. The Managers do not intend to terminate the 
claimant's right to appeal a detention order under paragraph 
4(B) of such subsection, unless the basis for the seizure 
action instituted under section 304(a) or the injunctive relief 
sought under section 302 is related to the original basis for 
detention under this section.
      The Conference substitute provides that an article of 
food subject to detention shall be held in a secure facility, 
as appropriate. Under this title, in instances where the 
Secretary moves food that has been refused admission to a 
secure facility, the Secretary should ensure that such food 
will be held under appropriate conditions of cleanliness, 
temperature, humidity and other such considerations that are 
necessary so as not to erode the safety and wholesomeness of 
the detained article.
      The Managers recognize that perishable foods may be 
detained under this section. As a result, the Secretary is 
required to promulgate a rule to establish expedited procedures 
for instituting an action under section 304(a) or section 302 
of the FFDCA for perishable foods, such as fresh produce, fresh 
fish and fresh seafood products. The Secretary should promptly 
complete such rule making.
      The Conference substitute requires the Secretary to 
temporarily hold food for not longer than 24 hours, where the 
Secretary has credible evidence or information indicating that 
such article of food presents a threat of serious adverse 
health consequences or death to humans or animals. The period 
of temporary hold is intended to allow the Secretary time to 
dispatch an inspector to the port of entry in order to conduct 
the needed inspection, examination or investigation.
Section 304. Debarment for Repeated or Serious Food Import Violations
      House provision: The House bill provides authority to the 
Secretary to debar from importing articles of food, any person 
that is convicted of a felony relating to food importation or 
any person that repeatedly imports food and who knew, or should 
have known, that such food was adulterated. The House bill 
treats the importation or offer for importation of an article 
of food by a debarred person as a prohibited act under section 
301 of the FFDCA.
      Senate amendment: The Senate amendment includes 
permissive debarment authority for food importers that is 
similar to the permissive debarment authority of the House 
bill, but replaces the standard in the House bill, allowing 
debarment for repeatedly importing unsafe food, with a 
different standard allowing debarment of food importers for 
engaging in a pattern of importing unsafe food. Unlike the 
House bill, the Senate amendment treats food that is imported 
by a debarred person as adulterated.
      Conference substitute: The Conference substitute adopts 
the Senate amendment with modification. Unlike the Senate 
amendment, the Conference substitute does not treat food that 
is imported by a debarred person as adulterated solely on the 
basis of its importation by a debarred person. Rather the 
Conference substitute treats the importation or offering for 
importation into the United States of an article of food by, 
and with the assistance of, or at the direction of, a debarred 
person as a prohibited act under section 301 of the FFDCA. In 
addition, the Conference substitute requires food imported by a 
debarred person to berefused admission and held in a secure 
facility, as appropriate, unless a person, other than a debarred 
person, affirmatively establishes that such food complies with the 
requirements of the FFDCA. The Conference substitute also clarifies 
that imported food that is refused admission may not be delivered 
pursuant to the execution of a bond under subsection (b) of section 801 
of the FFDCA. For purposes of this section, the person other than the 
debarred person who may established that food, which has been refused 
admission under this section, is in compliance with this Act is 
intended to be an innocent purchaser of food, not a person that is 
engaged in the improper importation of food with a debarred person. In 
addition, the classification as a prohibited act (under section 301 of 
the FFDCA) of the importation or offer for importation of food ``with 
the assistance of'' a debarred person is not intended to include an 
innocent purchaser who did not have knowledge, actual or constructive, 
of the importer's debarred status. Finally, the Conference substitute 
clarifies that the Secretary has the authority to terminate the 
debarment of corporations or persons under this subsection.
Section 305. Registration of Food Facilities
      House provision: The House bill requires facilities 
(excluding farms) that manufacture, process, pack or hold food 
for consumption in the United States to file with the 
Secretary, and keep up to date, a registration that contains 
the identity and address of the facility and, when the 
Secretary determines appropriate the general category of food 
manufactured, processed, packed or held at the facility. The 
House bill also authorizes the Secretary to exempt certain 
retail establishments only if the Secretary determines that the 
registration of such facilities is not needed for effective 
enforcement. Enforcement of this section is delayed one hundred 
and eighty days from the date of enactment, and this section 
requires the Secretary to notify and issue guidance within 
sixty days identifying facilities that are required to register 
under this section.
      Senate amendment: The Senate amendment includes a 
requirement for certain food facilities to register with the 
Secretary that is similar to the registration requirement for 
food facilities that is contained in the House bill. The Senate 
amendment exempts types of farms or retail establishments but, 
unlike the House bill, farms can be exempted only if the 
Secretary determines that the registration of such facilities 
is not needed for effective enforcement of the FFDCA. The 
Senate amendment also lacks the requirements of the House bill 
relating to notice to those who must register and relating to 
electronic registration.
      Conference substitute: The Conference substitute adopts 
the Senate amendment with modification. The Conference 
substitute requires the Secretary to establish registration 
requirements for specified food facilities by regulation not 
later than eighteen months after the date of enactment of this 
Act. If such regulations are not effective prior to the 
conclusion of such eighteen-month period, the requirements of 
this section are self-executing and enter into effect at such 
time and remain in effect unless superseded by such final 
regulations. The Managers strongly encourage the Secretary to 
complete this rule making in a timely manner in order to enable 
the efficient operation of these registration requirements.
      The Conference substitute treats the failure of a 
specified facility to register under this section as a 
prohibited act under section 301 of the FFDCA. The Conference 
substitute requires the Secretary to refuse admission to food 
imported from foreign facilities that have failed to register 
in accordance with this section until such facility is 
registered, and requires the Secretary to remove such food to a 
secure facility, as appropriate. The Conference substitute 
clarifies that imported food that is refused admission under 
this section shall not be delivered pursuant to the execution 
of a bond under subsection (b) of section 801 of the FFDCA.
      The Conference substitute exempts from the requirements 
of registration farms, restaurants, other retail food 
establishments, non-profit food establishments in which food is 
prepared for, or served directly to, the consumer, and fishing 
vessels not engaged in processing, as defined in section 
123.3(k) of title 21, Code of Federal Regulations. The Managers 
intend that, for purposes of this section, the term ``retail 
food establishments'' includes establishments that store, 
prepare, package, serve or otherwise provide articles of food 
directly to the retail consumer for human consumption, such as 
grocery stores, convenience stores, cafeterias, lunch rooms, 
food stands, saloons, taverns, bars, lounges, catering or 
vending facilities, or other similar establishments that 
provide food directly to a retail consumer. The term does not 
include a warehouse that does not provide articles of food 
directly to a retail consumer as its primary function. The 
Managers intend that, for purposes of this section,the term 
``non-profit food establishments'' includes not-for-profit 
establishments in which food is prepared for, or served directly to the 
consumer, such as food banks, soup kitchens, homebound food delivery 
services, or other similar charitable organizations that provide food 
or meals for human consumption. In addition, the Managers intend that, 
for purposes of this section, ``facility'' does not include trucks or 
other motor carriers, by reason of their receipt, carriage, holding, or 
delivery of food in the usual course of business as carriers. In 
addition, nothing in this section shall be construed to alter or amend 
the treatment of carriers under section 703 of the FFDCA.
      Finally, the Conference substitute calls for one-time 
registration of covered facilities, rather than annual 
registration of such facilities. Once a facility is registered 
it should amend its original registration in a timely manner to 
reflect any changes. The Conference substitute encourages 
electronic registration to help reduce paperwork and reporting 
burden, but registration is also permitted using a paper form.
Section 306. Maintenance and Inspection of Records for Foods
      House provision: The House bill provides the Secretary 
with authority to inspect and copy all records relating to an 
article of food if the Secretary has credible evidence or 
information indicating that an article of food presents a 
threat of serious health consequences or death to humans or 
animals. The House bill contains certain limitations on the 
Secretary's authority, including limitations to ensure the 
protection of trade secrets and confidential information. The 
House bill provides the Secretary with the discretion to issue 
a regulation requiring maintenance of additional records that 
are needed to identify the source and chain of distribution of 
food, in order to address credible threats of serious adverse 
health consequences or death to humans or animals. The House 
bill excludes restaurants and farms, and the Secretary is 
provided the authority to take into account the size of the 
business when imposing any record keeping requirements.
      Senate amendment: The Senate amendment includes records 
access authority that is similar to the records access 
authority granted to the Secretary in the House bill. The 
Senate amendment authorizes the Secretary to inspect and copy 
records relating to the violation when he has a reason to 
believe that an article of food is adulterated or misbranded 
and presents a threat of serious adverse health consequences or 
death. The Senate amendment also includes record keeping 
authority that is similar to the record keeping authority in 
the House bill. The Senate amendment requires the Secretary to 
issue a regulation to require the maintenance and retention of 
records to trace the chain and distribution of food within 18 
months of enactment of the Act. In addition, the Senate 
amendment allows the Secretary to require maintenance and 
retention of records necessary to determine if a food may be 
adulterated or misbranded to the extent that it presents a 
threat of serious adverse health consequences or death. The 
Senate amendment limits the Secretary's authority to require 
the retention of either type of records for not longer than two 
years. The Senate amendment also criminalizes the release of 
trade secret information obtained by inspection of records 
under this section.
      Conference substitute: The Conference substitute adopts 
the House bill with modification. The Conference substitute 
replaces the standard for records acccess in the House bill 
with a different standard that grants the Secretary records 
access if the Secretary has a reasonable belief that an article 
of food is adulterated and presents a threat of serious adverse 
health consequences or death to humans or animals. The 
Conference substitute limits access to those records relating 
to such article of food that are needed to assist the Secretary 
in determining whether food is adulterated and presents a 
threat of serious adverse health consequences or death to 
humans or animals.
      The Conference substitute amends the scope of record 
keeping authority contained in the House bill by clarifying 
that the authority under this section applies to both the 
establishment and maintenance of records that meet the standard 
under this section and by limiting the record retention 
requirement to a period of not longer than 2 years. The 
Conference substitute also adopts the requirement of the Senate 
amendment to criminalize the disclosure of trade secrets 
obtained under this section.
      The Conference substitute authorizes the issuance of 
regulations to require establishment and maintenance of chain 
of distribution records. This authority should not be used to 
require a business to maintain records regarding transactions 
or activities to which it was not a party. The Managers intend 
that those records that document the person from whom food was 
directly received, and to whom food was directlydelivered, are 
adequate to enable identification of the source and distribution of 
food. As a result, for purposes of this section, the terms ``immediate 
previous sources'' and ``immediate subsequent recipients'' refer to the 
person from whom the food was received and the person to whom the food 
was delivered, respectively.
      The Managers did not adopt a Senate proposal to authorize 
the Secretary to require the maintenance and retention of other 
records for inspection relating to food safety, because the 
Secretary has authority under section 701(a) of the FFDCA to 
issue regulations for the ``efficient enforcement of this Act'' 
and this authority, in combination with other provisions (such 
as section 402), gives the Secretary the authority to require 
appropriate record keeping in food safety regulations.
Section 307. Prior Notice of Imported Food Shipments
      House provision: The House bill directs the Secretary by 
regulation to require importers of articles of food to provide 
up to seventy-two hours, but not less than twenty-four hours, 
prior notice that food will be imported or offered for import 
into the United States. The House bill requires that the notice 
contain the following information: a description of food to be 
imported; the identity of the manufacturer and shipper; and, if 
known within the specified period of time that notice is 
required to be provided, the identity of the grower; the 
country of origin of the article; the country from which the 
food is being shipped; and the anticipated port of entry into 
the United States. In the event notice is not provided in 
advance of importation in accordance with the Secretary's 
regulation, the food shall be held at the port of entry until 
notice is properly provided and the Secretary determines 
whether there is credible evidence or information in his 
possession indicating that the article presents a threat of 
serious adverse health consequences or death to humans or 
animals.
      Senate amendment: The Senate amendment, like the House 
bill, includes a requirement that food importers provide prior 
notice to the Secretary of incoming food imports. The Senate 
amendment differs from the requirement in the House bill, 
because the prior notice requirement in the Senate amendment is 
self-effectuating upon enactment of the Act and requires at 
least four hours minimum prior notice and no limitation on the 
maximum notice allowable. The Senate amendment requires that 
the notification contain the identity of the food, the food's 
country of origin, the quantity imported, and other information 
that the Secretary may require by regulation. Finally, if an 
importer fails to provide the required prior notice, under the 
Senate amendment the Secretary is provided with discretion to 
refuse admission into the United States of the food.
      Conference substitute: The Conference substitute adopts 
the House amendment with modification. The Conference 
substitute requires the Secretary to establish by regulation 
the period of time for prior notice, that must be no less than 
the minimum amount of time necessary for the Secretary to 
receive, review, and appropriately respond to the notice, but 
that may not exceed five days. In determining the specified 
period of time for prior notice, by regulation, the Conference 
substitute identified several factors the Secretary may take 
into account, including the effect on commerce, the locations 
of various ports of entry, the various modes of transportation, 
the types of food imported into the United States, and other 
such considerations. Nothing in the preceding sentence may be 
construed as a limitation on the obligation of the Secretary to 
receive, review, and appropriately respond to any notice under 
this section.
      The Conference substitute treats the failure to provide 
adequate prior notice under this section as a prohibited act 
under section 301 of the FFDCA. The Conference substitute 
requires the Secretary to refuse admission to food imported 
without properly providing prior notice in accordance with this 
section until such prior notice is properly provided. In 
addition, the Conference substitute requires the Secretary to 
remove such food to a secure facility, as appropriate and 
clarifies that imported food that is refused admission under 
this section shall not be delivered pursuant to the execution 
of a bond under subsection (b) of section 801 of the FFDCA.
      The Conference substitute directs the Secretary to 
establish prior notice requirements for imported foods by 
regulation not later than eighteen months after the date of 
enactment of this Act. If such regulations are not effective 
prior to the conclusion of such eighteen-month period, the 
requirements of this section are self-executing and enter into 
effect at such time and remain in effect unless superseded by 
such final regulations. In addition, at the conclusion of the 
eighteen-month period, if such final regulations are not 
effective, the Conference substitute establishes a default 
period of time for prior notice of not less than 8 hours and 
not more than 5 days that remains in effect unless superseded 
by such final regulations. The Managers strongly encouragethe 
Secretary to complete this rule making in a timely manner in order to 
enable the efficient operation of these requirements.
      The Managers intend that the requirements of this section 
should not be construed to apply to packaging materials if, at 
the time of importation, such materials will not be used for, 
or in contact with, food as defined under section 201 of the 
FFDCA. Nothing in this section shall be construed to alter or 
amend the regulatory treatment of food packaging materials or 
food contact substances under the FFDCA. Also, the Conference 
substitute requires the importer of an article of food to 
provide information about the grower of the article of food, 
but this provision only requires the importer to provide the 
identity of the grower of the article of food if known during 
the period of time in which prior notice is required to be 
provided. Finally, the Secretary shall consult and coordinate 
with the Secretary of Treasury in developing the prior notice 
regulation. This section of the Conference substitute contains 
prior notice requirements for imported food and is not intended 
as a limitation on the port of entry for an article of food.
Section 308. Authority to Mark Articles Refused Admission into United 
        States
      House provision: The House bill requires that food that 
has been refused admission to the United States, but has not 
been ordered destroyed, may have a label affixed to its 
container at the expense of the owner or consignee indicating 
that it has been refused admission.
      Senate amendment: The Senate amendment, similar to the 
House bill, includes authority regarding the marking of food 
that has been refused admission into the United States. Unlike 
the House bill, the Senate amendment provides the Secretary 
with a broader authority than the House bill to mark foods as 
refused admission, including foods that have not been 
determined to present a threat of serious adverse health 
consequences or death to humans or animals. The Senate contains 
an enforcement provision under which food that has been refused 
admission but that has not been properly marked as refused 
admission is treated as misbranded if it is determined that it 
presents a threat of serious adverse health consequences or 
death to humans or animals.
      Conference substitute: The Conference substitute adopts 
the House bill with modification. The Conference substitute 
provides the Secretary with discretionary authority to require 
that items that have been refused admission to the United 
States under section 801 of the FFDCA shall be so marked. The 
Conference substitute clarifies that the marking of such items 
may be applied to the container of the food. The Conference 
substitute also requires the Secretary to notify the owner or 
consignee of an article of food that has been refused admission 
and that has been required to be so marked under this section, 
if at some time subsequent to requirement to mark the food, the 
Secretary determines that the food is misbranded and presents a 
threat of serious adverse health consequences or death to 
humans or animals.
      Nothing in this section shall be construed to alter or 
amend the authority of the Secretary to authorize the admission 
of an article of food that has been relabeled, reconditioned or 
otherwise brought into compliance with the Act in accordance 
with subsection (b) of section 801 of the Act.
Section 309. Prohibition Against Port Shopping
      House provision: The House bill requires any person 
attempting to re-offer for admission an article of food at a 
port of entry into the United States, after it has been 
previously refused admission at another port of entry into the 
United States, to affirmatively establish that the food is not 
adulterated.
      Senate amendment: The Senate amendment contains a 
prohibition against port shopping that is comparable to the 
prohibition contained in the House bill. The Senate amendment 
prohibits a person from port shopping with respect to food that 
has been refused admission, by requiring that the person show 
that food that has been refused admission previously, has been 
brought into compliance with the applicable requirements of the 
FFDCA.
      Conference substitute: The Conference substitute adopts 
the Senate amendment without modification.
Section 310. Notice to States Regarding Imported Food
      House provision: The House bill requires that where the 
Secretary has credible evidence or information indicating that 
an article of food presents a threat of serious adverse health 
consequences or death to humans or animals, the Secretary shall 
provide notice regarding the threat posed by such food to those 
States in which the food is held or will be held and shall 
request that such States take appropriate remedial action.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference substitute adopts 
the House bill with modification. The Conference substitute 
clarifies the scope of the rule of construction included in 
subsection (b) of this section.
Section 311. Grants to States for Inspections
      House provision: The House bill authorizes the Secretary 
to make grants for increased food safety inspections, 
examinations, investigations and related activities and to 
assist States in taking appropriate actions to respond to any 
Federal notice received pursuant to section 309 (governing 
notice to States) of the House bill. The House bill authorizes 
to be appropriated such sums as may be necessary for fiscal 
year 2002 through fiscal year 2006 to establish and carry out 
the grants under the section.
      Senate amendment: The Senate amendment authorizes the 
Secretary to make grants to States, territories, and Federally 
recognized tribes to cover the cost of food safety 
examinations, inspections, investigations, and related 
activities under section 702 of the FFDCA, and it authorizes to 
be appropriated $10 million in fiscal year 2002 and such sums 
as may be necessary for each year thereafter for such purpose.
      Conference substitute: The Conference substitute adopts 
the House bill with modification. The Conference substitute 
extends the grants made available under this section to Indian 
tribes to the extent they undertake inspections, investigations 
or examinations under section 702 of the FFDCA. The Conference 
substitute authorizes to be appropriated $10 million in fiscal 
year 2002 and such sums as may be necessary for each fiscal 
year 2003-2006 for such purpose.
Section 312. Surveillance and Information Grants and Authorities
      House provision: The House bill contains no analogous 
provision.
      Senate amendment: The Senate amendment authorizes the 
Secretary to award grants to States to increase participation 
in Pulsenet, the Foodborne Diseases Active Surveillance 
Network, and other such networks, and authorizes to be 
appropriated $19.5 million in fiscal year 2002, and such sums 
as may be necessary each year for such purpose from fiscal year 
2003 through fiscal year 2006.
      Conference substitute: The Conference substitute adopts 
the Senate amendment with modification. The Managers intend 
that funds awarded under this section shall be used by States 
and Indian tribes to assist in meeting the costs of 
establishing and maintaining the food safety surveillance, 
technical and laboratory capacity needed to participate in 
programs, including Pulsenet, Foodborne Diseases Active 
Surveillance Network, and other networks to enhance Federal, 
State, and local food safety efforts.
Section 313. Surveillance of Zoonotic Disease
      House provision: The House bill contains no analogous 
provision.
      Senate amendment: The Senate amendment requires the 
Secretary of Health and Human Services and the Secretary of 
Agriculture to develop and implement a plan for the 
surveillance of zoonotic and human disease.
      Conference substitute: The Conference substitute adopts 
the Senate amendment with modification. The Conference 
substitute directsthe Secretary, through the Commissioner of 
FDA and the Director of the Centers for Disease Control and Prevention 
(CDC), and the Secretary of Agriculture to coordinate the surveillance 
of zoonotic diseases.
Section 314. Authority to Commission Other Federal Officials to Conduct 
        Inspections
      House provision: The House bill does contain no analogous 
provision.
      Senate amendment: The Senate amendment includes authority 
that is not included in the House bill that allows the 
Secretary to commission officers and qualified employees of 
other Federal Departments or Federal agencies to conduct 
examinations and inspections for the Secretary under section 
702 of the FFDCA.
      Conference substitute: The Conference substitute adopts 
the Senate amendment with modification. The Conference 
substitute clarifies that the authority of the Secretary to 
commission other Federal officials to conduct inspections, 
examinations and investigations under section 702 of the FFDCA 
shall be carried out pursuant to a memorandum of understanding 
between the Secretary and the head of the Department or agency 
of such other Federal employees.
Section 315. Rule of Construction
      House provision: The House bill does contain no analogous 
provision.
      Senate amendment: The Senate amendment includes a rule of 
construction that applies to the amendments made in Title V of 
the Senate amendment that provides that such amendments do not 
provide the FDA with additional authority over meat, poultry, 
and egg products, nor do such amendments limit the authority of 
the Department of Agriculture over such products.
      Conference substitute: The Conference substitute adopts 
the Senate amendment with modification. The Conference 
substitute clarifies that nothing in this Title, or an 
amendment made by this Title, shall be construed to alter the 
jurisdiction between the Secretary and the Secretary of 
Agriculture, under applicable statutes and regulations.

                 Subtitle B--Protection of Drug Supply

Section 321. Annual Registration of Foreign Manufacturers; Shipping 
        Information; Drug and Device Listing
      House provision: The House bill mandates annual 
registration of foreign manufacturers engaged in the import of 
drug and device products into United States. The House bill 
also requires that the annual registration include information 
on each importer or carrier transporting the foreign 
manufacturer's drug or device products. The House bill also 
directs that the registration and listing numbers be included 
in the declaration for the products when offered for import.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference substitute adopts 
the House bill with modification. The conference substitute 
requires registration through electronic means. The Conference 
substitute deletes carrier in the annual registration and 
replaces with ``person who imports or offers for import.'' The 
Conference substitute makes non-registration a prohibited act 
rather than deeming it misbranded. Non-registration is a 
failure to comply with the Secretary's request to submit 
registration information. The Conference substitute provides 
for a non-registered drug or device to be removed to a secure 
facility until non-registration is cured. For purposes of this 
section, the Managers intend ``person who imports or offers for 
import'' to capture import brokers and other persons who file 
import-related paperwork with the U.S. Customs Service or the 
FDA.
Section 322. Requirement of Additional Information Regarding Import 
        Components Intended for Use in Export Products
      House provision: The House bill mandates a chain of 
possession identification and a customs bond for those firms 
that seek to importcomponents of drugs, devices, food 
additives, color additives, or dietary supplements for further 
processing and export. The House bill requires certificates of analysis 
for components containing any chemical substance or biological 
substance intended for export.
      Senate provision: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference substitute adopts 
the House bill with modification. The Conference substitute 
deletes reference to carriers in chain of possession 
identification. The Conference substitute exempts devices and 
products covered by section 801(d)(4) of the FFDCA from the 
certificate of analysis requirement. The Conference substitute 
clarifies that the provisions permitting import-for-export do 
not apply to articles for which the Secretary of Health and 
Human Services determines that there is credible evidence or 
information indicating the article is not intended to be 
imported for export.
      The Managers understand this section does not change any 
definitions of regulated articles or the scope of regulation of 
those articles as set forth in the FFDCA and its implementing 
regulations.
      The Managers intend that this section shall not be 
construed to restrict or facilitate the entry of articles 
imported for research and development or quality assurance 
purposes under subsection 801(d)(3) of the FFDCA beyond the 
existing authority.
      For the purposes of articles subject to subsection 
801(d)(4) of the FFDCA, the Managers understand that the 
collection agency would be considered the first manufacturer 
under subsection 801(d)(3)(A)(i)(II) of the FFDCA, relating to 
the chain-of-possession.
      The Managers agree that certificates of analysis are not 
required if the only chemical or biological component of the 
article imported under subsection 801(d)(3) of the FFDCA is de 
minimis, incidental and poses no danger to human or animal 
health. Further, the Managers expect that the Secretary will 
understand that ``certificate of analysis'' is a widely 
understood and utilized document to assure the identity of the 
substance and its components in the chemical and drug 
industries. However, the Secretary in consultation with other 
affected industries may accept documents that convey equivalent 
assurance as to the identity of the article and its components 
or substances. For example, the Secretary may determine that 
for an article of food additive or color additive, a document 
indicating specification of purity serves as the functional 
equivalent of a certificate of analysis and meets the 
requirement of a certificate analysis for purposes of this 
section. This section exempts devices and blood and blood 
products covered under subsection 801(d)(4) of the FFDCA from 
the certificate of analysis requirement.
      The Managers do not intend the Secretary of the Treasury 
to engage in a new rulemaking to specify the requirement for 
the bonding of goods imported under subsection 801(d)(3) of 
FFDCA. Existing requirements for the bonding of goods imported 
for further processing and export should be applied.
      The Managers agree that articles imported for export 
under this section 322 which otherwise meet the requirements of 
this section should be permitted entry unless the Secretary 
determines there is credible evidence or information that an 
article offered for import is not intended to be imported for 
export. In this regard, the Managers believe that refusal of 
entry should not involve shipments between known shippers and 
known recipients unless the Secretary has received credible 
evidence or information that suggests such shipments may not be 
legitimate. The Managers intend to permit the Secretary to 
refuse admission of articles if the Secretary determines there 
is credible evidence or information that the articles may be 
used as instruments of terror. Such evidence might include 
highly toxic or otherwise exceptionally dangerous products 
going to recipients unknown to the Secretary or to recipients 
believed to lack the capacity to further process such dangerous 
articles, for example, nitroglycerin imported under this 
section for delivery to a business other than a pharmaceutical 
manufacturer. Such standard may also include, for example, 
presentation for entry of articles not consistent with the 
accompanying documentation.

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

Section 331. Expansion of Animal and Plant Health Inspection Service 
        Activities
      House provision: The House bill contains no analogous 
provision.
      Senate amendment: The Senate amendment requires the 
Secretary of Agriculture to enhance and expand the capacity of 
theAnimal and Plant Health Inspection Service (APHIS) to 
protect against the threat of bioterrorism, including through increased 
inspection capacity internationally, improved surveillance at ports of 
entry, and enhanced protections against terrorist use of plant and 
animal disease organisms. The Senate amendment also requires the 
Secretary of Agriculture to implement and then expand a high-tech 
agriculture early warning and emergency response system, as well as an 
automated record keeping system to track animal and plant shipments. 
The Senate amendment authorizes the appropriation of $30 million in 
fiscal year 2002 and such sums in each year thereafter, as may be 
necessary for such purposes.
      Conference substitute: The Conference substitute adopts 
the Senate amendment with modification. The Conference 
substitute clarifies that this section provides additional 
authorization of appropriations to the Secretary of Agriculture 
to utilize existing authorities to give high priority to 
enhancing and expanding the capacity of APHIS to conduct the 
specified activities and to otherwise improve the capacity of 
APHIS to protect against the threat of bioterrorism. The 
Conference substitute authorizes to be appropriated $30 million 
for fiscal year 2002, and such sums as may be necessary for 
each subsequent fiscal year.
Section 332. Expansion of Food Safety Inspection Service Activities
      House provision: The House bill contains no analogous 
provision.
      Senate amendment: The Senate amendment requires the 
Secretary of Agriculture to enhance and expand the capacity of 
the Food Safety Inspection Service (FSIS) to protect against 
the threat of bioterrorism, including through enhanced ability 
to inspect meat and poultry products and increased inspections 
of meat and meat products, poultry and poultry products, and 
egg products at ports of entry. The Senate amendment authorizes 
the appropriation of $15 million in fiscal year 2002 and such 
sums in each year thereafter, as may be necessary for such 
purposes.
      Conference substitute: The Conference substitute adopts 
the Senate amendment with modification. The Conference 
substitute authorizes to be appropriated $15 million in fiscal 
year 2002 and such sums in each year thereafter, as may be 
necessary for the the purpose of providing additional 
authorization to the Secretary of Agriculture to utilize 
existing authorities to give high priority to enhancing and 
expanding the capacity of FSIS to conduct the specified 
activities and to otherwise improve the capacity of FSIS to 
protect against the threat of bioterrorism.
Section 333. Biosecurity Upgrades at the Department of Agriculture
      House provision: The House bill contains no analogous 
provision.
      Senate amendment: The Senate amendment authorizes to be 
appropriated $180 million in fiscal year 2002 to update, 
renovate, and expand the Department of Agriculture laboratory 
and research facilities at Plum Island Animal Disease Center 
and the Agricultural Research Service and Animal and Plant 
Health Inspection Service facility in Ames, Iowa, and also 
authorizes such sums as may be necessary in each year from 
fiscal year 2003 through fiscal year 2006, for those 
facilities, and for similar improvements at two other 
Department of Agriculture facilities, one in Athens, Georgia, 
and the other in Laramie, Wyoming.
      Conference substitute: The Conference substitute adopts 
the Senate amendment without modification. In addition to the 
biosecurity upgrades at the Department of Agriculture 
authorized in this section, the Managers intend that the 
Secretary of Health and Human Services shall also continue to 
take such actions as may be necessary to secure existing 
facilities of the Department of Health and Human Services where 
potential animal and plant pathogens are housed and researched.
Section 334. Agricultural Biosecurity
      House provision: The House bill contains no analogous 
provision.
      Senate amendment: The Senate amendment requires the 
Secretary of Agriculture to establish minimum security 
standards andaward grants of up to $50,000 to land grant 
universities to assess security needs and plan upgrades of both 
security of facilities where hazardous biological agents or toxins are 
stored or used, and communication networks about such agents or toxins, 
as well as to develop a national inventory of such agents and toxins. 
The Senate amendment also requires the Secretary of Agriculture to 
provide for screening of personnel who require access at agricultural 
research facilities, and to develop and implement educational programs 
directed at biosecurity at agricultural facilities, including farms, 
livestock confinement operations, and crop producers, handlers, 
processors, and transporters, as well as educational programs related 
to animal quarantine and testing. The Senate amendment authorizes to be 
appropriated $20 million in fiscal year 2002 and such sums in each year 
thereafter, as may be necessary for such purposes.
      Conference substitute: The Conference substitute adopts 
the Senate amendment with modification. The Conference 
substitute authorizes to be appropriated such sums as may be 
necessary for the Secretary of Agriculture to award grants of 
up to $50,000 each, to colleges and universities that have food 
and agricultural science programs to review security standards 
and practices at their facilities in order to protect against 
bioterrorist threats. The Conference substitute also authorizes 
the Secretary of Agriculture to award grants, of up to $100,000 
per association, to associations of food producers or consortia 
of such associations for the development and implementation of 
educational programs to improve bio-security on farms against 
bioterrorist attacks.
Section 335. Agricultural Bioterrorism Research and Development
      House provision: The House bill contains no analogous 
provision.
      Senate amendment: The Senate amendment requires the 
Secretary of Agriculture, to the maximum extent practicable, to 
expand research and development programs of the Agricultural 
Research Service and the Cooperative State Research Education 
and Extension Service to protect the nation's food supply from 
bioterrorism, including by enhancing their capability to 
respond to the needs of other food and agricultural regulatory 
agencies, continuing existing partnerships with institutions of 
higher education with programs related to agricultural 
biosecurity, and by strengthening linkages with the 
intelligence community. The Senate amendment authorizes the 
appropriation of $190 million in fiscal year 2002 and such sums 
in each year thereafter, as may be necessary for such purposes.
      Conference substitute: The Conference substitute adopts 
the Senate amendment with modification. The Conference 
substitute authorizes to be appropriated $190 million in fiscal 
year 2002 and such sums in each year thereafter, as may be 
necessary for the Secretary of Agriculture to utilize existing 
research authorities and programs to protect the food supply of 
the United States by conducting various research activities, 
including developing new and continuing partnerships with 
institutions of higher education and other institutions to 
establish and enhance bio-security and food safety programs, 
with special emphasis on vulnerability analyses, incident 
response, detection and prevention technologies. The Conference 
substitute also authorizes the Secretary of Agriculture to 
continue research to develop improved rapid detection field 
test kits to detect biological threats to plants and animals 
for use in responding to bioterrorism, and to develop an 
agriculture bioterrorism early warning surveillance system by 
enhancing the capacity of and coordination between State 
veterinary diagnostic laboratories, Federal and State 
agricultural research facilities, and public health agencies.
Section 336. Animal Enterprise Terrorism Penalties
      House provision: The House bill contains no analogous 
provision.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference substitute amends 
section 43(a) of title 18, United States Code, establishing a 
Federal criminal offense against a person traveling in 
interstate or foreign commerce for intentionally damaging or 
causing the loss of any property used by the animal enterprise, 
or conspiring to do such activities. The Conference substitute 
establishes penalties for such criminal offense and authorizes 
restitution for economic damage resulting from the loss.

              TITLE IV--DRINKING WATER SECURITY AND SAFETY

      The conference agreement builds upon title IV of the 
House bill to ensure that drinking water systems across the 
country assess their vulnerability to terrorist attack and 
develop emergency plans to prepare for and respond to such 
attacks. Americans deserve to know that the water they drink 
everyday is safe. The legislation will lay the groundwork for 
developing the necessary information, and emergency planning 
and response efforts that are needed to address potential 
terrorist attacks at drinking water systems.
Section 401. Terrorist and Other Intentional Acts
      House provision: The House bill requires community water 
systems serving over 3,300 persons to conduct vulnerability 
assessments. These requirements are phased-in, depending on the 
size of the community water system. Community water systems 
serving over 100,000 persons must complete a vulnerability 
assessment by December 31, 2002; community water systems 
serving over 50,000 persons must complete a vulnerability 
assessment by June 30, 2003; community water systems serving 
over 3,300 persons must complete a vulnerability assessment by 
December 31, 2003. Each community water system must certify to 
the Administrator of the Environmental Protection Agency (EPA) 
that they have conducted a vulnerability assessment. The 
Administrator of EPA is also required to provide baseline 
information by June 1, 2002 regarding which kinds of terrorist 
attacks or other intentional acts are probable threats.
      The House bill also requires community water systems to 
prepare or revise emergency response plans that incorporate the 
results of the vulnerability assessments. Community water 
systems must certify to the Administrator of the Environmental 
Protection Agency within 6 months of the completion of a 
vulnerability assessment that they have completed an emergency 
response plan. To the extent possible, community water systems 
are to coordinate with Local Emergency Planning Committees when 
preparing or revising an emergency response plan. The House 
bill additionally requires EPA to provide guidance to community 
water systems serving under 3,300 persons on how to conduct 
vulnerability assessments and prepare emergency response plans.
      In order to carry out the provisions of the section, the 
House bill authorized $120 million in Fiscal Year 2002 and such 
sums as necessary in Fiscal Years 2003 and 2004. The funds are 
made available for purposes of complying with vulnerability 
assessment and emergency response plan requirements and to 
address basic security enhancements of critical importance and 
significant threats to public health as determined by a 
vulnerability assessment.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference substitute adopts 
the House provision with modifications. The Conference 
substitute extends dates for certifying that systems have 
completed a vulnerability assessment by three months for 
systems serving over 100,000 persons and by six months for all 
other systems. The substitute also extends the time for EPA 
baseline information to August 1, 2002 to reflect the passage 
of time between House action and conference agreement.
      The Conference substitute also adds the requirement that 
community water systems provide a copy of their vulnerability 
assessment to the Administrator of the EPA. Under the 
conference substitute, however, information that is provided by 
a community water system to EPA and information that is derived 
thereof is exempt from disclosure under the Freedom of 
Information Act except for information that identifies the 
community water system and the date on which a community water 
system certifies to EPA that it has completed a vulnerability 
assessment. In addition, no community water system shall be 
required under State or local law to provide an assessment to 
any State, regional or local governmental authority solely by 
reason of the requirements to submit such assessment to the 
Administrator of EPA.
      The Administrator of the EPA is also required, by 
November 30, 2002 to develop protocols to protect the 
assessments from unauthorized disclosure. These protocols shall 
ensure that all assessments and information are kept in a 
secure location, only individuals designated by the 
Administrator have access and that assessment in whole or in 
part or information contained or derived from such assessments 
shall not be available to anyone other than individuals 
designated by the Administrator.
      The Conference substitute also provides that any 
individual designated by the Administrator who acquires 
assessments or information derived from assessments and who 
knowingly or recklessly reveals such information other than to 
an individual designated by the Administrator shall be subject 
to up to 1 year imprisonment, or a fine in accordance with 16 
U.S.C. 227 and shall be removed from Federal office or 
employment unless the information is revealed for purposes of 
section 1445 of the Act, or actions taken under section 1431 of 
the Act, or for use in any administrative or judicial 
proceeding to impose a penalty for failure to comply with 
section 1433 of the bill. The substitute further provides that 
an individual designated by the Administrator who is an 
employee or officer of the United States may discuss the 
content of a vulnerability assessment submitted under this 
section with a State or local official. The Conference 
substitute provides that nothing authorizes any person to 
withhold any information from Congress.
      The Conference substitute adds the requirement that each 
community water system maintain a copy of the emergency 
response plan it has completed for 5 years after it certifies 
to the Administrator of the EPA that it has completed such 
plan. The Conference agreement also increases authorized 
funding for Fiscal Year 2002 to $160 million and adds 
additional specification of basic security enhancements. The 
Conference Agreement also extends authorizations in this 
section through Fiscal Year 2005. Finally, the Conference 
agreement provides that not more than $5,000,000 of the funds 
made available under the section may be used by the 
Administrator of EPA for immediate and urgent security needs 
and for grants for community water systems under 3,300 in 
accordance with the guidance provided by EPA under the section.
Section 402. Other Safe Drinking Water Act Amendments
      House provision: The House bill provides for a review of 
current and future methods to prevent, detect and respond to 
the intentional introduction of chemical, biological and 
radiological contaminants into community water systems and 
source water for community water systems. This review is to 
encompass methods and means to detect contaminants, to provide 
sufficient notice of contamination, to prevent the flow of 
contaminated drinking water, to negate or mitigate deleterious 
effects on public health and to conduct biomedical research.
      The House bill also provides for a review of methods and 
means by which terrorists or other individuals or groups could 
disrupt the supply of safe drinking water or render a public 
water system significantly less safe for human consumption. The 
House bill required a review of the methods and means by which 
pipes, constructed conveyances, collection, pretreatment, 
storage or distribution facilities could be destroyed or 
otherwise prevented from providing adequate supplies of 
drinking water and methods and means by which they could be 
protected. The House bill also required a review of methods and 
means by which such items could be subjected to cross-
contamination and a review of methods and means by which 
alternative supplies of water could be provided in the event of 
destruction, impairment or contamination of public water 
systems. The House bill authorized $15,000,000 in Fiscal Year 
2002 to carry out sections 1434 and 1435 and such sums as may 
be necessary for Fiscal Years 2003 and 2004.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The Conference substitute adopts 
the House provision with modifications. The Conference 
substitute includes further specification in section 1434 as to 
the detection of various levels of contaminants and indicators 
of contaminants using methods, means and equipment that include 
real time monitoring systems. The Conference substitute 
additionally requires methods and means for developing 
education and awareness programs for community water systems.
      The conference substitute also adds additional 
specification to the reviews undertaken under section 1435 to 
include methods and means by which information systems, 
including process controls, supervisory control and data 
acquisition and syber systems could be disrupted by terrorists 
or other groups. The Conference substitute also includes 
additional requirements and considerations that are applicable 
in the implementation of sections 1434 and 1435. These 
requirements and considerations include the assurance that 
reviews reflect the needs of various community water system 
sizes and geographical locations, the vulnerability of regions 
or service areas, including the National Capital area, and that 
the Administrator of EPA disseminate certain information 
through the Information Sharing and Analysis Center. The 
Conference substitute also provides such sums as may be 
necessary in Fiscal Year2005.
Section 403. Miscellaneous and Technical Amendments
      House provision: The House bill provides that section 
1433 be included as a cross-reference in section 1414(i)(1) on 
the Safe Drinking Water Act (SDWA), that section 1431 of the 
SDWA be amended, that existing penalties for tampering with 
drinking water systems under section 1432 be increased and that 
section 1442 of the SDWA be amended to provide authorization 
for $35 million in Fiscal Year 2002 and such sums as may be 
necessary in fiscal years thereafter.
      Senate amendment: The Senate amendment contains no 
analogous provision.
      Conference substitute: The conference substitute adopts 
the House provisions. The conferees encourage the committees of 
jurisdiction in the House and Senate to develop comparable 
legislation covering publicly owned treatment works in this 
legislative session. The conferees encourage EPA to work 
closely with organizations representing small and rural water 
systems to implement the provisions of this Title.

                     TITLE V--ADDITIONAL PROVISIONS

      The Managers agree to the following provisions.

                Subtitle A--Prescription Drug User Fees

Section 501. Short Title
      Designates the name of this title as the ``Prescription 
Drug User Fee Amendments of 2002.''
Section 502. Findings
      Declares the findings of Congress related to the 
reauthorization of prescription drug user fees.
Section 503. Definitions
      The following terms in section 735 of the Federal Food, 
Drug, and Cosmetic Act (FFD&C Act) (21 U.S.C. 379g) are 
modified by this section: human drug application, prescription 
drug product, process for the review of human drug 
applications, and adjustment factor. These modifications are 
necessary to give effect to the changes instituted by the 
reauthorization of the Prescription Drug User Fee Act (PDUFA).
      The term ``human drug application'' is modified to make a 
technical correction.
      The term ``prescription drug product'' is modified to 
allow the Secretary to use the Prescription Drug Product List 
(the active portion) in the ``Approved Drug Products with 
Therapeutic Equivalence Evaluations,'' (the Orange Book) as the 
basis for identifying which products should be considered to be 
prescription drug products for fee assessment purposes. The 
Managers expect that these proposed changes will lead to a more 
efficient, less burdensome, billing procedure. Under current 
law, any prescription drug product eligible for drug listing is 
subject to product fees. Determining eligibility for listing is 
administratively complex and sometimes resource intensive. In 
addition, listing is often controlled by a re-packer or 
distributor rather than by the sponsor, but the sponsor must 
nonetheless pay the product fee. The Managers expect that the 
use of the Orange Book, which is found on FDA's Internet site, 
as the basis to identify products for user fee assessment 
purposes will not be construed to affect the legal status of 
the book or the products in the book. The purpose of using this 
method is merely a tool for the Secretary to provide a public, 
efficient billing process. It also provides sponsors an easier 
way to remove products from the list that is the basis for 
billing.
      Also, the addition of the reference to the list of 
products approved under human drug applications under section 
351 of the Public Health Service Act created and maintained by 
the Secretary refers to the current FDA method of identifying 
biological products considered to be prescription drug products 
for fee assessment determinations. The Managers do not intend 
this to be a change in practice; rather it documents FDA's 
current practice. The list is to be provided on FDA's Internet 
site.
      A further change to the term ``prescription drug 
product'' deletes the clause ``does not include a large volume 
parenteral drug product approved before September 1, 1992.'' As 
a result, any large volume parenteral (LVP) product is treated 
as a prescription drug product and issubject to a fee. However, 
when coupled with a corresponding change proposed to section 
736(a)(3)(B), all LVP's would be exempt from product fees in this 
reauthorization, including products approved after September 1, 1992. 
The Managers intend this change to decrease FDA's administrative burden 
in determining which products should be billed.
      The term ``process for the review of human drug 
applications'' is modified to allow the use of funds, for a 
period of up to three years after approval, to cover risk 
management activities for products approved after October 1, 
2002. This change is highly important to the Managers, as 
improving drug and biological product safety is a goal shared 
by all.
      The term ``adjustment factor'' is modified to eliminate 
obsolete provisions.
Section 504. Authority to Assess and Use Drug Fees
      Subsection (a) of this section allows fees authorized by 
the Act to be assessed beginning on October 1, 2002. With 
respect to prescription drug establishment fees and 
prescription drug product fees, the subsection advances the 
date by which fees are payable to October 1 of each year.
      Under the second Prescription Drug User Fee Act (PDUFA), 
prescription drug establishment and product fees, which 
represent two-thirds of PDUFA fees were due January 31, four 
months into the fiscal year. This necessitated carrying forward 
funds from a previous year to sustain operations for the first 
four months of each new fiscal year. By advancing the date for 
annual fees to be paid to FDA, the necessity of carrying 
forward these large cash surpluses from year to year is 
eliminated. Also, by making this change effective for FY 2003, 
FDA will have access to revenue as early in FY 2003 as invoices 
can be issued and fees collected rather than having to wait 
until January 31 to collect funds. This is especially important 
for FDA operations in FY 2003 because the agency does not 
expect to have any appreciable carryover funds at the end of FY 
2002.
      Making the fee due and payable on October 1 necessitates 
other changes to the FFD&C Act that are executed in subsection 
(e) and (f) of this section.
      This section sets forth a table containing the 
application, establishment, and product fee revenues, and total 
fee revenue, for fiscal years 2003 through 2007. The subsection 
further authorizes an increase in fee revenue amounts to fully 
fund the portion of additional costs attributable to the cost 
of the retirement of Federal personnel. This provision would go 
into effect, if, after the enactment of the Prescription Drug 
User Fee Amendments of 2002, legislation is enacted requiring 
the Secretary to fund additional costs of the retirement of 
Federal personnel.
      This section also authorizes inflation adjustments, 
workload adjustments, and a final year adjustment. Under 
present law, annual inflation adjustments were based on the 
higher of the federal pay raise applicable for employees in the 
fiscal year for which the fees were set or the CPI for the 
previous year. In order to collect fees on October 1, FDA will 
have to set fees and issue invoices in August of each year well 
before the pay-raise determination for the next fiscal year is 
made. For this reason the inflation adjustment factors have 
been changed to the Federal pay raise for employees in the 
Washington, D.C., area for the previous fiscal year or the 
change in the CPI for the 12 month period ending June 30, 
whichever is higher. Both of these figures will be available in 
August when fees must be set. As has been the case in the past, 
these inflationary changes will continue to be cumulative and 
compounded.
      Under the workload adjustment, annual revenue adjustments 
are made that reflect changes in review workload, after 
inflation adjustments. the workload adjustment is to be 
determined by the Secretary based on a weighted average of the 
changes in the total number of (1) human drug applications, (2) 
commercial investigational new drug applications, (3) efficacy 
supplements, and (4) manufacturing supplements. The subsection 
provides that the Secretary shall publish in the Federal 
Register the fees resulting from this adjustment and the 
supporting methodologies. Each of the 4 components used to 
develop the workload adjustment is a defined category of 
applications that FDA currently counts. Each component will be 
given a weighting factor that corresponds to its percent of FDA 
review workload.
      The workload adjustment envisioned for each component has 
as its base the average number of applications of each 
particular type that FDA received over the five-year period of 
current law. It requires that a rolling average of submissions 
also be calculated each year for the latest five-year period 
that ends on June 30 before the end of each fiscal year 
beginning on or after October 1, 2002. The percent change in 
the latest five-year average, compared to the base year is then 
multiplied by the weighting factor for that component. Then all 
four components of the workload adjuster are added together and 
the total percent that results is the workload adjuster that 
will be used to further adjust the inflation-adjustedstatutory 
revenue levels each year after FY 2003. Use of five year rolling 
averages in this process dampens the impact of revenue fluctuations--
both up and down.
      Under this section, the revenue adjuster will never 
result in lower revenues than the inflation-adjusted statutory 
revenue levels. Nonetheless, in years when fee-paying 
applications fall below projections, FDA will automatically 
experience a shortfall in revenues due to the shortfall in fee-
paying applications. Further downward adjustment of the 
revenues would over-compensate for such a decline in workload 
and is not authorized under the subsection. This is a lesson 
learned from experience during 1998 through 2002. If such a 
model had been in place for the past five years, revenues 
during PDUFA II would have been much more predictable year to 
year rather than exhibiting the volatility FDA experienced.
      Also under this section, FDA is allowed to make a one-
time increase in fees in FY 2007, if necessary, to assure that 
the agency will have no less than three months of operating 
reserves on hand at the end of FY 2007, when this legislation 
will expire. This final year adjustment will allow the agency 
sufficient fees to operate for up to 3 months in FY 2008 if 
there is any delay in the reauthorization of PDUFA at the end 
of FY 2007. Further, delaying this payment from industry until 
FY 2007 minimizes the need for FDA to carry large balances over 
from year to year, reducing industry outlays until they are 
necessary to support operations.
      Finally, this section provides that application, product, 
and establishment fees are to be established 60 days before the 
start of the fiscal year based on the revenue amounts 
previously established in this section.
      Under subsection (d), the waiver or fee reduction for 
supplements filed under section 505(b)(1) of the FFD&C Act is 
eliminated.
      In this section the word ``assessed'' in section 736(f) 
of the FFD&C Act has been changed to ``retained.'' This change 
is part of a series of changes made to permit FDA to issue 
invoices and collect fees before an appropriation is actually 
made for the fiscal year. The change maintains the original 
intent of this and related provisions, however, by providing 
that the conditions originally specified in these sections must 
be fulfilled once all appropriations for the fiscal year, 
including any supplemental appropriations, are enacted. If the 
conditions are not fulfilled, FDA may not retain the fees it 
collects. Further, under this section, the word ``collected'' 
in section 736(g)(2)(A) of the FFD&C Act is changed to 
``retained.'' Once again, this change is part of a series of 
changes made to permit FDA to issue invoices and collect fees 
before an appropriation is actually made for the fiscal year. 
The change maintains the original intent of this and related 
provisions by asserting that the conditions originally 
specified in these sections must be fulfilled once all 
appropriations for the fiscal year, including any supplemental 
appropriations, are enacted.
      This section also responds to the problems associated 
with FDA's inability under the FFD&C Act to collect and spend 
fees in any year that FDA fails to spend from appropriations as 
much as it spent in FY 1997, adjusted for inflation. Failing to 
meet this obligation by as little as one dollar causes FDA to 
lose the authority to collect application, product and 
establishment fees for a given fiscal year. The consequence of 
failing to meet this ``trigger'' would be catastrophic. Since 
the trigger is based on the amount FDA spends, the agency can 
never identify exactly how much it has actually spent until 
after the end of the fiscal year. As a result, FDA consistently 
overspends by a substantial amount to be certain that FDA 
expenditures do not fall below the trigger amount and thereby 
cause the agency to lose the authority to collect fees.
      Modifications to section 736(g)(2)(B) are proposed to 
provide FDA a margin of error in its effort to meet this 
requirement of the law. This section is being modified so that 
if FDA's spending is within five percent of the amount required 
by this section of the Act, the requirement of this section is 
considered to be satisfied. If FDA under-spends by three 
percent or less, there are no consequences. If FDA under-spends 
by more than three percent but not more than five percent, FDA 
will be required to reduce collections in the fiscal year 
following the subsequent fiscal year by the amount in excess of 
three percent by which FDA under-spent from appropriations. The 
intent is to relieve FDA of the need to overspend from 
appropriations each year, as it has done consistently since 
1993 to assure that this trigger is met. Spending from 
appropriations on the drug review process each year is still 
expected to be at or very close to the amount specified by this 
trigger, and may never be more than five percent below the 
trigger amount.
      This section also authorizes appropriations for fiscal 
years 2003 through 2007 in amounts consistent with the total 
fee revenue amounts set forth in subsection (b).
Section 505. Accountability and Annual Reports
      This section for the first time requires the agency to 
meet with interested public and private stakeholders when 
considering the reauthorization of this program before its 
expiration. The Managers believe that the agency will be in the 
best position to recognize what best serves the public health 
by meeting with representatives of consumer and patient 
advocacy groups, industry, the Congress, health care 
professionals, and academic experts prior to the next 
reauthorization of PDUFA. Further, the Managers believe that it 
is very important for the agency to make any recommendations to 
the Congress public, so this section requires that the FDA both 
publish the recommendations, as well as hold a public hearing 
at which time the agency can receive public feedback.
      This section also requires an annual Performance Report 
and a Financial Report.
Section 506. Reports of Postmarketing Studies
      Under this section, the Managers intend that in instances 
wherein a study subject to the reporting requirements of 
Section 130 is not completed by the original or otherwise 
negotiated deadline agreed upon by the sponsor and if the 
reasons for such failure to complete the study were not 
satisfactory to the Secretary, the Secretary shall so note on 
the agency website. The Managers intend that the Secretary 
would not find the delay or termination of a study 
unsatisfactory if the Secretary determined that the delay or 
termination occurred through no fault of the sponsor (such as 
ethical concerns, or the study is no longer needed).
      This section also empowers the Secretary to require a 
sponsor of a study required under section 505(b)(2)(A) or 
sections 314.510 or 601.41 of Title 21, Code of Federal 
Regulations, to notify health care practitioners who prescribe 
such drugs or biological products of the sponsor's failure to 
complete the study, and the questions of clinical benefit and, 
where appropriate, questions of safety, that remain unanswered 
as a result of such failure. The Managers intend that this 
authority not be utilized in cases where, through no fault of 
the sponsor (such as ethical concerns, or the study is no 
longer needed), the study has been delayed or terminated.
Section 507. Savings Clause
      This section authorizes user fees to be assessed and 
collected after October 1, 2002 for human drug applications and 
supplements accepted for filing prior to October 1, 2002. For 
example, in the event that application fees are owed but have 
not been collected prior to the expiration date for PDUFA II 
established by section 107 of the Food and Drug Administration 
Modernization Act (FDAMA), the section will allow these fees to 
be collected after October 1, 2002. The section further 
authorizes assessment and collection of product and 
establishment fees after October 1, 2002 that are owed but have 
not been collected.
Section 508. Effective Date
      Section 508 provides that the Prescription Drug User Fee 
Amendments of 2002 shall take effect October 1, 2002.
Section 509. Sunset Clause
      Section 509 provides that the amendments made by sections 
503 (relating to definitions) and 504 (relating to the 
authority to assess and use drug fees) shall cease to be 
effective on October 1, 2007.
      The section further provides that the amendments made by 
section 505 (relating to annual reports) shall cease to be 
effective 120 days after October 1, 2007. The additional 120 
days will allow the prescription drug user fee reports for 
fiscal year 2007 to be prepared and submitted.

Subtitle B--Additional Authorizations of Appropriations Regarding Food 
                        and Drug Administration

Section 521. Office of Drug Safety
      This section will help the FDA fulfill its vitally 
important role of ensuring drug safety. The Managers are highly 
supportive of the postmarket surveillance activities conducted 
by the Office of Drug Safety (ODS), and to that end other 
provisions in this legislation ensure for the first time that 
user fee monies will be available for postmarket purposes.This 
section complements those efforts by ensuring that not only will new 
user fee monies be available for this very important purpose, but so 
will new appropriated monies.
Section 522. Division of Drug Marketing, Advertising, and 
        Communications
      This section provides an increased authorization for the 
Division of Drug Marketing, Advertising, and Communications 
(DDMAC) within the Office of Medical Policy, Center for Drug 
Evaluation and Research at the FDA. DDMAC plays a vital role in 
ensuring that promotional drug material is not false or 
misleading, and they do so on a limited budget. The authorized 
amounts will better ensure that DDMAC can perform its mission.
Section 523. Office of Generic Drugs
      This section provides an increased authorization for the 
Office of Generic Drugs (OGD) within the Center for Drug 
Evaluation and Research at the FDA. OGD is vitally important to 
ensuring that Americans have access to safe, effective generic 
drugs. This Office needs increased funding, however, due to the 
fact that it presently takes OGD nearly 18 months to review the 
typical ANDA. This section will lead to increased funding, so 
that these review times can be decreased without compromising 
health and safety.

                   Subtitle C--Additional Provisions

Section 531. Transition to Digital Television
      In an effort to further promote the orderly transition to 
digital television, and to promote the equitable allocation and 
use of digital channels by television broadcast permittees and 
licensees, the Managers direct the Federal Communications 
Commission, at the request of an eligible licensee or 
permittee, to, within 90 days after the date of enactment of 
this Act, allot, if necessary, and assign a requested and 
identified paired digital television channel to that licensee 
or permittee. In order to avoid any undue burden to the 
Commission, which is required to allot and assign the paired 
digital television channel within a short timeframe, the 
Managers expect all eligible applicants to file their 
applications as soon as practicable after the date of 
enactment. The FCC shall only do this if such channel can be 
allotted and assigned without further modification of the 
tables of allotments as set forth in sections 73.606 and 73.622 
of the Commission's regulations (47 CFR 73.606, 73.622) and 
such allotment and assignment is consistent with the 
Commission's technical rules (47 CFR part 73). The only 
licensees or permittees eligible for this digital allotment are 
those that are full power television broadcast licensee or 
permittees (or their successors in interest) that had an 
application pending for an analog television station 
construction permit as of October 24, 1991, which application 
was granted after April 3, 1997; and as of the date of 
enactment of this Act, is the permittee or licensee of that 
station. This provision enables such licensees or permittees an 
opportunity to realize their expectations created by prior FCC 
action to foster a digital audience during the transition 
period to digital television without having to terminate 
abruptly analog service now enjoyed by their viewers. Without 
this change, those broadcast licensees or permittees would be 
denied the flexibility to operate an analog and a digital 
facility simultaneously in the near term, especially in a major 
market. This is contrary to the Congressional goals of 
increasing competition and accelerating the digital television 
transition. The Managers are ensuring that eligible licensees 
or permittees will meet the intended objectives by doing two 
important things. First, the Managers impose an unequivocally 
hard 18-month deadline for the construction of the digital 
facility from the time of the FCC's issuance of the 
construction permit for the new digital channel. In this 
regard, eligible licensees are absolutely prohibited from 
obtaining or receiving an extension of time from the Commission 
pursuant to 47 C.F.R. 73.624(d)(3). Second, the Managers 
safeguard against eligible licensees from using the newly 
granted ``in-core'' digital channel allotment and assignment to 
provide analog service.
Section 532. 3-Year Delay in Lock-in Procedures for Medicare+Choice 
        Plans; Change in Medicare+Choice Reporting Deadlines and 
        Annual, Coordinated Election Period for 2003, 2004, and 2005
      This section changes the deadline for Medicare+Choice 
plans to submit information to the Secretary on Medicare 
benefits, premiums, cost sharing, supplemental benefits, and 
actuarial values of such coveragefrom July 1 to the second 
Monday in September for the years 2002, 2003, and 2004. It would also 
delay the annual election period for Medicare enrollees to select a M+C 
plan to the period of time beginning on November 15 and ending on 
December 31 in 2002, 2003, and 2004. This section also delays the 
phase-in of the limitation on Medicare beneficiaries changing health 
plans more than once a year (the ``lock-in''). This requirement, 
enacted in the Balanced Budget Act of 1997, was scheduled to phase in 
incrementally beginning in 2002. The substitute would postpone the 
lock-in requirements until 2005.

                From the Committee on Energy and Commerce, for 
                consideration of the House bill and the Senate 
                amendment, and modifications committed to 
                conference:
                                   Billy Tauzin,
                                   Michael Bilirakis,
                                   Paul E. Gillmor,
                                   Richard Burr,
                                   John Shimkus,
                                   John D. Dingell,
                                   Henry A. Waxman,
                                   Sherrod Brown,
                Provided that Mr. Pallone is appointed in lieu 
                of Mr. Brown of Ohio for consideration of title 
                IV of the House bill, and modifications 
                committed to conference:
                                   Frank Pallone, Jr.,
                From the Committee on Agriculture, for 
                consideration of title II of the House bill and 
                sec. 216 and title V of the Senate amendment, 
                and modifications committed to conference:
                                   Larry Combest,
                                   Frank D. Lucas,
                                   Saxby Chambliss,
                                   Charles Stenholm,
                                   Tim Holden,
                From the Committee on the Judiciary, for 
                consideration of title II of the House bill and 
                secs. 216 and 401 of the Senate amendment, and 
                modifications committed to conference:
                                   F. James Sensenbrenner, Jr.,
                                   Lamar Smith,
                                   John Conyers, Jr.,
                                 Managers on the Part of the House.

                                   Edward Kennedy,
                                   Chris Dodd,
                                   Tom Harkin,
                                   Barbara A. Mikulski,
                                   Jim Jeffords,
                                   Judd Gregg,
                                   Bill Frist,
                                   Mike Enzi,
                                   Tim Hutchinson,
                                Managers on the Part of the Senate.

                                
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