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<PRE>[DOCID: f:h3448rds.txt]
107th CONGRESS
  1st Session
                                H. R. 3448


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           December 18, 2001

                                Received

_______________________________________________________________________

                                 AN ACT


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

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

SECTION. 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Public Health 
Security and Bioterrorism Response Act of 2001''.
    (b) Table of Contents.--The table of contents of the Act is as 
follows:

Sec. 1. Short title; table of contents.
TITLE I--NATIONAL PREPAREDNESS FOR BIOTERRORISM AND OTHER PUBLIC HEALTH 
                              EMERGENCIES

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

Sec. 101. National preparedness and response.
Sec. 102. Assistant Secretary for Emergency Preparedness; National 
                            Disaster Medical System.
Sec. 103. Improving ability of Centers for Disease Control and 
                            Prevention with respect to bioterrorism and 
                            other public health emergencies; 
                            facilities.
Sec. 104. Advisory committees and communications.
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 verification of credentials of health 
                            professions volunteers.
Sec. 108. Enhancing preparedness activities for bioterrorism and other 
                            public health emergencies.
Sec. 109. Improving State and local core public health capacities.
Sec. 110. Antimicrobial resistance program.
Sec. 111. Study regarding communications abilities of public health 
                            agencies.
Sec. 112. Supplies and services in lieu of award funds.
Sec. 113. Additional amendments.
Sec. 114. Study regarding local emergency response methods.
Subtitle B--National Stockpile; Development of Priority Countermeasures

Sec. 121. National stockpile.
Sec. 122. Accelerated approval of priority countermeasures.
Sec. 123. Use of animal trials in approval of certain drugs and 
                            biologics; issuance of rule.
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--Emergency Authorities; Additional Provisions

Sec. 131. Expanded authority of Secretary of Health and Human Services 
                            to respond to public health emergencies.
Sec. 132. Streamlining and clarifying communicable disease quarantine 
                            provisions.
Sec. 133. Emergency waiver of Medicare, Medicaid, and SCHIP 
                            requirements.
Sec. 134. Provision for expiration of public health emergencies.
Sec. 135. Designated State public emergency announcement plan.
Sec. 136. Expanded research by Secretary of Energy.
Sec. 137. Agency for Toxic Substances and Disease Registry.
Sec. 138. Expanded research on worker health and safety.
Sec. 139. Technology opportunities program support.
              Subtitle D--Authorization of Appropriations

Sec. 151. Authorization of Appropriations.
 TITLE II--ENHANCING CONTROLS ON DANGEROUS BIOLOGICAL AGENTS AND TOXINS

Sec. 201. Regulation of certain biological agents and toxins.
      TITLE III-AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT

                 Subtitle A--Protection of Food Supply

Sec. 301. Protection against intentional adulteration of food.
Sec. 302. Administrative detention.
Sec. 303. Permissive debarment regarding food importation.
Sec. 304. Maintenance and inspection of records for foods.
Sec. 305. Registration.
Sec. 306. Prior notice of imported food shipments.
Sec. 307. Authority to mark articles refused admission into United 
                            States.
Sec. 308. Prohibition against port shopping for importation.
Sec. 309. Notices to States regarding imported food.
Sec. 310. Grants to States for inspections; response to notice 
                            regarding adulterated imported food.
                 Subtitle B--Protection of Drug Supply

Sec. 311. Annual registration of foreign manufacturers; shipping 
                            information; drug and device listing.
Sec. 312. Requirement of additional information regarding import 
                            components intended for use in export 
                            products.
              TITLE IV-DRINKING WATER SECURITY AND SAFETY

Sec. 401. Amendment of the Safe Drinking Water Act.

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.

    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) Consultation.--The Secretary shall carry out 
        paragraph (1) in consultation with the Secretary of Defense, 
        the Director of the Federal Emergency Management Agency, the 
        Secretary of Veterans Affairs, the Attorney General, the 
        Secretary of Agriculture, the Secretary of Energy, the 
        Secretary of Labor, and the Administrator of the Environmental 
        Protection Agency, and with other appropriate public and 
        private entities.
            ``(3) 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 through 
        local governments, such that there is a national plan for 
        preparedness for and responding effectively to such 
        emergencies.
            ``(4) 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) shall 
include provisions for achieving the following goals with respect to 
preparedness for and responding effectively to bioterrorism and
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 other 
public health emergencies:
            ``(1) Providing effective assistance to State and local 
        governments in the event of such an emergency.
            ``(2) Ensuring that State and local governments have 
        adequate and 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) Adequate laboratory readiness.
                    ``(C) Properly trained and equipped emergency 
                response, public health, and medical personnel.
                    ``(D) Health and safety protection of workers 
                involved in 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, and 
        medical devices) against biological agents that may be used in 
        such emergencies.
            ``(4) Ensuring coordination and minimizing duplication of 
        Federal, State, and local planning, preparedness, and response 
        activities, including among agencies during the investigation 
        of a suspicious disease outbreak.
            ``(5) Ensuring adequate readiness of hospitals and other 
        health care facilities to respond effectively to such 
        emergencies.
    ``(c) Evaluation of Using VA R&amp;D Capabilities.--The Secretary shall 
evaluate the feasibility of using the biomedical research and 
development capabilities of the Department of Veterans Affairs, in 
conjunction with that Department's affiliations with health-professions 
universities, as a means to assist the Secretary in achieving the goals 
specified in subsection (b).
    ``(d) Reports to Congress.--
            ``(1) Initial report to congress.--Not later than one year 
        after the date of the enactment of the Public Health Security 
        and Bioterrorism Response Act of 2001, the Secretary shall 
        submit to the Committee on Energy and Commerce of the House of 
        Representatives, and the Committee on Health, Education, Labor, 
        and Pensions of the Senate, a report concerning progress with 
        respect to the plan under subsection (a), including progress 
        toward achieving the goals specified in subsection (b).
            ``(2) Biennial reports.--Not later than 2 years after the 
        date on which the report under paragraph (1) is submitted, and 
        biennially thereafter, the Secretary shall submit to each of 
        the committees specified in such paragraph a report concerning 
        the progress made with respect to the plan under subsection 
        (a), including the goals under subsection (b).
            ``(3) Additional authority.--Reports submitted under 
        paragraph (2) by the Secretary 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 that a condition 
                described in section 319(a) occurs.
    ``(e) Other Reports.--Not later than one year after the date of the 
enactment of the Public Health Security and Bioterrorism Response Act 
of 2001, the Secretary shall submit to each of the committees specified 
in paragraph (1) a report concerning--
            ``(1) the recommendations and findings of the EPIC Advisory 
        Committee under section 319F(c)(3);
            ``(2) 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 conditions;
            ``(3) the characteristics that may render areas or 
        populations designated as medically underserved populations (as 
        defined in section 330) 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 
        conditions; and
            ``(4) 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).
    ``(f) 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 Response Act of 2001, were in effect with respect to 
preparing for and responding effectively to bioterrorism and other 
public health emergencies.''.

SEC. 102. ASSISTANT SECRETARY FOR 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 Emergency Preparedness.--
            ``(1) In general.--There is established within the 
        Department of Health and Human Services the position of 
        Assistant Secretary for Emergency Preparedness. The President, 
        by and with the advice and consent of the Senate, 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 Emergency Preparedness shall carry 
        out the following duties:
                    ``(A) Coordinate on behalf of the Secretary--
                            ``(i) all 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, including the 
                        activities of the joint interdepartmental 
                        working groups under subsections (a) and (b) of 
                        section 319F; and
                            ``(ii) all 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 or 
                public health emergencies.
                 
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   ``(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) Coordinate the activities of the Department 
                with respect to research and development of priority 
                vaccines, other biological products, drugs, and devices 
                useful for detecting or responding to a bioterrorist 
                attack or other public health emergency.
                    ``(E) Coordinate the activities of the Department 
                with respect to public education, awareness, and 
                information relating to bioterrorism or other public 
                health emergencies, including the activities and 
                recommendations of the EPIC Advisory Committee under 
                section 319F(c)(3).
                    ``(F) Coordinate all other functions within the 
                Department of Health and Human Services relating to 
                emergency preparedness, including matters relating to 
                bioterrorism and other public health emergencies that 
                are addressed in the national plan under section 2801.
                    ``(G) 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 (in this section 
        referred to as the `National System'). The Secretary shall 
        designate the Assistant Secretary for Emergency Preparedness as 
        the head of the National System, subject to the authority of 
        the Secretary.
            ``(2) Federal and state collaborative system.--
                    ``(A) In general.--The National 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 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 
                        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 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 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 Response 
                Act of 2001, the Secretary shall conduct an exercise to 
                test the capability and timeliness of the National 
                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 System as the Secretary determines to be 
                appropriate.
    ``(c) Criteria.--
            ``(1) In general.--The Secretary shall establish criteria 
        for the operation of the National System.
            ``(2) Education and training of personnel.--In carrying out 
        paragraph (1), the Secretary shall establish criteria regarding 
        the education and training of individuals who provide emergency 
        services through the National System. In the case of permanent, 
        full-time positions in the Department of Health and Human 
        Services that involve significant supervisory roles within the 
        National System, the criteria shall require that individuals in 
        such positions have completed appropriate education or training 
        programs as determined by the Secretary.
            ``(3) 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 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 on a reimbursable 
                basis to respond to emergency situations for which the 
                National System has not been activated by the Secretary 
                pursuant to subsection (b)(3)(A).
                    ``(B) Provisions relating to circumstances in which 
                an individual or entity has agreements with both the 
                National 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 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 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 appo
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intment 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 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 System or when the individual 
                participates in a training program authorized by the 
                Assistant Secretary for 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 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) 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).
    ``(g) Authorization of Appropriations.--For the purpose of 
providing for the Assistant Secretary for Emergency Preparedness and 
the operations of the National 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 System.--It 
is the sense of the Congress that the Secretary of Health and Human 
Services should provide sufficient resources to individuals and 
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 such National System.

SEC. 103. IMPROVING ABILITY OF CENTERS FOR DISEASE CONTROL AND 
              PREVENTION WITH RESPECT TO BIOTERRORISM AND OTHER PUBLIC 
              HEALTH EMERGENCIES; FACILITIES.

    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) Findings.--Congress finds that the Centers for Disease 
Control and Prevention have an essential role in defending against and 
combatting public health threats of the 21st century and requires 
secure and modern facilities, and expanded and improved capabilities 
related to biological threats or attacks or other public health 
emergencies, sufficient to enable such Centers to conduct this 
important mission.
    ``(b) Improving the Capacities of the Centers for Disease Control 
and Prevention.--
            ``(1) In general.--The Secretary 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;
                    ``(C) improving capabilities for public health 
                surveillance and reporting activities;
                    ``(D) improving laboratory facilities related to 
                bioterrorism, including increasing the security of such 
                facilities; and
                    ``(E) such other activities as the Secretary 
                determines appropriate.
            ``(2) Improving public health laboratory capacity.--
                    ``(A) In general.--The Secretary, directly or 
                through awards of grants, contracts, or cooperative 
                agreements, shall provide for the establishment of a 
                coordinated network of public health laboratories, that 
                may, at the discretion of the Secretary, include 
                laboratories that serve as regional reference 
                laboratories.
                    ``(B) Priority.--In carrying out subparagraph (A), 
                the Secretary shall give priority to projects 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 or regional reference 
                laboratory, and that cover geographic areas lacking 
                advanced diagnostic and safety-level laboratory 
                capabilities.
            ``(3) National public health communications and 
     
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   surveillance network.--
                    ``(A) In general.--The Secretary, directly or 
                through awards of grants, contracts, or cooperative 
                agreements, shall provide for the establishment of 
                integrated public health communications and 
                surveillance networks between and among--
                            ``(i) Federal, State, and local public 
                        health officials;
                            ``(ii) public and private health-related 
                        laboratories, hospitals, and other health care 
                        facilities; and
                            ``(iii) any other entities determined 
                        appropriate by the Secretary.
                    ``(B) Requirements.--The Secretary shall ensure 
                that networks under subparagraph (A) allow for the 
                timely sharing and discussion, in a secure manner, of 
                essential information concerning a bioterrorist attack 
                or other public health emergency, or recommended 
                methods for responding to such an attack or emergency.
            ``(4) Continuity of effort.--To the maximum extent 
        practicable, the Secretary, in conducting activities under 
        paragraphs (1) through (3), shall administer such activities in 
        a manner that intensifies, expands, or enhances activities 
        being carried out on the date of enactment of this subsection.
    ``(c) Facilities.--
            ``(1) 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 related public health 
        activities.
            ``(2) Multiyear contracting authority.--For any project of 
        designing, constructing, equipping, or renovating any facility 
        under paragraph (1), 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.
    ``(d) Authorization of Appropriations.--
            ``(1) In general.--For the purposes of achieving the 
        mission of the Centers for Disease Control and Prevention 
        described in subsection (a), for carrying out subsection (b), 
        for better conducting the capacities described in section 319A, 
        and for supporting related 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) Facilities.--For the purpose of carrying out 
        subsection (c), 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.''.

SEC. 104. ADVISORY COMMITTEES AND COMMUNICATIONS.

    Section 319F of the Public Health Service Act (42 U.S.C. 247d-6) is 
amended--
            (1) by redesignating subsections (c) through (i) as 
        subsections (e) through (k), respectively; and
            (2) by inserting after subsection (b) the following 
        subsections:
    ``(c) Advice to the Federal Government.--
            ``(1) Required advisory committees.--In coordination with 
        the working groups under subsections (a) and (b), 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 
                        Response Act of 2001 to meet the special needs 
                        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 Response 
                Act of 2001.
            ``(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 and report on appropriate ways to 
                communicate public-health information regarding 
                biological attacks to the public.
                    ``(C) Composition.--The EPIC Advisory Committee 
                shall be composed of individuals representing a diverse 
                group of experts in public health, communications, 
                behavioral psychology, and other areas determined 
                appropriate by the Secretary.
                    ``(D) Dissemination.--The Secretary shall ensure 
                that the recommendations of the EPIC Advisory Committee 
                are widely disseminated to the media, State and local 
                governments, poison control centers, and others as the 
                Secretary determines appropriate.
                    ``(E) Termination.--The EPIC Advisory Committee 
                terminates one year after the date of the enactment of 
                the Public Health Security and Bioterrorism Response 
                Act of 2001.
    ``(d) Strategy for Communication of Information Regarding 
Biological Attack.--In coordination with the joint interdepartmental 
working group under subsection (b), the Secretary, acting through the 
Assistant Secretary for Emergency Preparedness, shall de
2000
velop a 
strategy for effectively communicating information regarding a 
biological attack, 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.''.

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(1) 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 (including proficiency testing) 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) provide for dissemination and teaching of the 
                materials described in subparagraphs (A) and (B) by all 
                appropriate means, including telemedicine, long-
                distance learning, or other such means; and
                    ``(D) to the extent practicable, establish and 
                maintain an electronic database of individuals 
                participating in training or education programs carried 
                out under this section, for the purpose of providing 
                continuing education materials and information to such 
                participants.
            ``(2) Grants.--In carrying out paragraph (1), the Secretary 
        may award grants to, or enter into cooperative agreements with, 
        professional organizations and societies, private accrediting 
        organizations, or other nonprofit institutions or entities 
        meeting criteria established by the Secretary, and may enter 
        into interagency cooperative agreements with other Federal 
        agencies.
            ``(3) 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 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 VERIFICATION OF CREDENTIALS 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 VERIFICATION 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 verifying the credentials, licenses, 
accreditations, and hospital privileges of individuals, who during 
public health emergencies volunteer to serve as health professionals 
(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 criteria 
regarding the verification system under subsection (a), including 
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) Advance Registration of Volunteers.--In order to facilitate 
the availability of health professionals during a public health 
emergency, the Secretary shall provide for the advance registration 
with the system of health professionals who are willing to serve as 
volunteers described in subsection (a), and may carry out activities to 
encourage health professionals to register with the system.
    ``(d) 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).
    ``(e) Coordination Among States.--The Secretary shall 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.
    ``(f) 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.
    ``(g) 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. ENHANCING PREPAREDNESS ACTIVITIES FOR BIOTERRORISM AND OTHER 
              PUBLIC HEALTH EMERGENCIES.

    Section 319F of the Public Health Service Act (42 U.S.C. 247d-6) is 
amended--
            (1) by amending subsection (a) to read as follows:
    ``(a) Working Group on Preparedness for Acts of Bioterrorism.--The 
Secretary, in coordination with the Secretary of Defense, the Director 
of the Federal Emergency Management Agency, the Attorney General, the 
Secretary of Veterans Affairs, the Secretary of Agriculture, t
2000
he 
Secretary of Energy, and the Administrator of the Environmental 
Protection Agency shall establish a joint interdepartmental working 
group on preparedness and readiness for the medical and public health 
effects of a bioterrorist attack on the civilian population. Such joint 
working group shall--
            ``(1) coordinate and prioritize research on, and the 
        development of countermeasures against, pathogens likely to be 
        used in a bioterrorist attack on the civilian population;
            ``(2) facilitate the development, production, and 
        regulatory review of priority countermeasures (as defined in 
        subsection (h)(2)(C)) for a bioterrorist attack on the civilian 
        population;
            ``(3) coordinate research and development into equipment to 
        detect pathogens likely to be used in a bioterrorist attack on 
        the civilian population and protect against infection from such 
        pathogens;
            ``(4) develop shared standards for equipment to detect and 
        to protect against infection from pathogens likely to be used 
        in a bioterrorist attack on the civilian population; and
            ``(5) coordinate the development, maintenance, and 
        procedures for the release and distribution of strategic 
        reserves of vaccines, drugs, and medical supplies which may be 
        needed rapidly after a bioterrorist attack upon the civilian 
        population, including consideration of vulnerable populations 
        (such as children, the elderly, and individuals with 
        disabilities).'';
            (2) in subsection (b)(1), by striking ``The Secretary'' and 
        all that follows through ``shall establish'' and inserting the 
        following: ``The Secretary, in collaboration with the Secretary 
        of Defense, the Director of the Federal Emergency Management 
        Agency, the Attorney General, the Secretary of Veterans 
        Affairs, the Secretary of Agriculture, the Secretary of Labor, 
        and the Administrator of the Environmental Protection Agency, 
        shall establish'';
            (3) in subsection (b)(2)--
                    (A) in subparagraph (A), by striking ``respond to a 
                bioterrorist attack; and'' and inserting the following: 
                ``respond 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) in subparagraph (B), by striking the period and 
                inserting ``; and''; and
                    (C) by adding at the end the following 
                subparagraph:
                    ``(C) subject to compliance with other provisions 
                of Federal law, clarify the responsibilities among 
                Federal officials for the investigation of suspicious 
                outbreaks of disease, and revise the interagency plan 
                known as the Federal response plan accordingly.'';
            (4) in subsection (b)(3), by striking ``Assistant Secretary 
        for Health'' and inserting ``Assistant Secretary for Emergency 
        Preparedness''; and
            (5) in subsection (e) (as redesignated by section 104(1) of 
        this Act)--
                    (A) in paragraph (1), by striking ``The Secretary'' 
                and all that follows and inserting the following: ``In 
                consultation with the working group established under 
                subsection (b), the Secretary shall, based on criteria 
                established by the Secretary, award grants to or enter 
                into cooperative agreements with eligible entities to 
                increase their capacity to detect, diagnose, and 
                respond to acts of bioterrorism upon the civilian 
                population.'';
                    (B) in paragraph (2)--
                            (i) by striking ``or'' after ``clinic,''; 
                        and
                            (ii) by inserting before the period the 
                        following: ``, professional organizations and 
                        societies, schools or programs that train 
                        medical laboratory personnel, private 
                        accrediting organizations, or other nonprofit 
                        institutions or entities meeting criteria 
                        established by the Secretary'';
                    (C) in paragraph (3)--
                            (i) in the matter preceding subparagraph 
                        (A), by striking ``the priorities'' and 
                        inserting ``any priorities''; and
                            (ii) by striking subparagraphs (A) through 
                        (D) and inserting the following:
                    ``(A) developing community-wide plans involving the 
                public and private health care infrastructure to 
                respond to bioterrorism or other public health 
                emergencies, which are coordinated with the capacities 
                of applicable national, State, and local health 
                agencies;
                    ``(B) training health care professionals and public 
                health personnel to enhance the ability of such 
                personnel to recognize the symptoms and epidemiological 
                characteristics of exposure to a potential bioweapon, 
                or other agents that may cause a public health 
                emergency;
                    ``(C) addressing rapid and accurate identification 
                of potential bioweapons, or other agents that may cause 
                a public health emergency;
                    ``(D) coordinating medical care for individuals 
                during public health emergencies, including 
                bioterrorism;
                    ``(E) conducting exercises to test the capability 
                and timeliness of public health emergency response 
                activities;
                    ``(F) facilitating and coordinating rapid 
                communication of data generated from a bioterrorist 
                attack or public health emergency among national, 
                State, and local health agencies, emergency response 
                personnel, and health care providers and facilities; 
                and
                    ``(G) purchasing or upgrading equipment, supplies, 
                pharmaceuticals or other countermeasures to enhance 
                preparedness for and response to bioterrorism or other 
                public health emergencies, consistent with a plan 
                described in subparagraph (A).''; and
                    (D) in paragraph (4)--
                            (i) in subparagraph (A), by striking 
                        ``and'' after the semicolon at the end;
                            (ii) in subparagraph (B), by striking the 
                        period at the end and inserting ``; and''; and
                            (iii) by adding at the end the following 
                        subparagraph:
                    ``(C) coordinate grants under this subsection with 
                grants under 319C.''.

SEC. 109. IMPROVING STATE AND LOCAL CORE PUBLIC HEALTH CAPACITIES.

    Section 319C of the Public Health Service Act (42 U.S.C. 247d-3) is 
amended--
            (1) in subsection (a), by striking ``competitive ''; and
            (2) in subsection (c)--
                    (A) in paragraph (3), by striking ``health care 
                providers; and'' and inserting ``health care providers, 
                including poison control centers;'';
                    (B) by redesignating paragraph (4) as paragraph 
                (7); and
                    (C) by inserting after paragraph (3) the following 
                paragraphs:
            ``(4) purchase or upgrade equipment, supplies, 
        pharmaceuticals or o
2000
ther countermeasures to enhance 
        preparedness for and response to bioterrorism or other public 
        health emergencies, consistent with a plan described in 
        paragraph (3);
            ``(5) conduct exercises to test the capability and 
        timeliness of public health emergency response activities;
            ``(6) within the meaning of part B of title XII, develop 
        and implement the trauma care component of the State plan for 
        the provision of emergency medical services; and'';

SEC. 110. ANTIMICROBIAL RESISTANCE PROGRAM.

    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 appropriate 
        DNA analysis, or other necessary 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. 111. 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 ensure that 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 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. 112. 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. 113. 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''; and
            (2) in section 319B(a), in the first sentence, by striking 
        ``10 years'' and inserting ``five years''.

SEC. 114. STUDY REGARDING LOCAL EMERGENCY RESPONSE METHODS.

    The Secretary of Health and Human Services shall conduct a study of 
best-practices methods for the provision of emergency response services 
through local governments (including through 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 Congress a report describing the findings of the study.

Subtitle B--National Stockpile; Development of Priority Countermeasures

SEC. 121. NATIONAL STOCKPILE.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary'') 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 adequate to meet 
the health security needs of the United States, including consideration 
of vulnerable populations (such as children, the elderly, and 
individuals with disabilities), in the event of a bioterrorist attack 
or other public health emergency.
    (b) Procedures.--The Secretary, in managing the stockpile under 
subsection (a), shall--
            (1) consult with the Director of the Federal Emergency 
        Management Agency, the Secretary of Defense, the Secretary of 
        Veterans Affairs, the Attorney General, the Secretary of 
        Energy, and the Administrator of the Environmental Protection 
        Agency;
            (2) ensure that adequate procedures are followed with 
        respect to such stockpile for inventory management and 
        accounting, and for the physical security of the stockpile;
            (3) in consultation with Federal, State, and local 
        officials, take into consideration the timing and location of 
        special events;
            (4) 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; and
            (5) devise plans for the effective and timely distribution 
        of the stockpile, in consultation with appropriate Federal, 
        State and local agencies, and the public and private health 
        care infrastructure.
    (c) 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).
    (d) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated 
$1,155,000,000 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). Such a designation may be made prior to the submission of--
            (1) a request for designation by the sponsor; 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 from declining such a 
        designation.
    (b) Review of 
2000
Priority Countermeasure Not Designated as Fast-Track 
Product.--A priority countermeasure shall be subject to the performance 
goals established by the Commissioner of Food and Drugs, unless it is 
designated as a fast-track product.
    (c) Definition.--For purposes of this section, the term ``priority 
countermeasure'' means a drug or biological product that is a 
countermeasure 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.

SEC. 123. USE OF ANIMAL TRIALS IN APPROVAL OF CERTAIN DRUGS AND 
              BIOLOGICS; ISSUANCE OF RULE.

    Not later than 180 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 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).

SEC. 124. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND PRODUCTION.

    Part B of title III of the Public Health Service Act, as amended by 
section 112 of this Act, is amended by inserting after section 319J the 
following section:

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

    ``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)(2)(C)).''.

SEC. 125. ACCELERATED COUNTERMEASURE RESEARCH AND DEVELOPMENT.

    Section 319F(h) of the Public Health Service Act, as redesignated 
by section 104(1) of this Act, is amended--
            (1) by redesignating paragraphs (1) through (4), as 
        subparagraphs (A) through (D), respectively;
            (2) by striking ``The Secretary'' and inserting the 
        following:
            ``(1) In general.--The Secretary'';
            (3) by moving each of subparagraphs (A) through (D) (as so 
        redesignated) two ems to the right; and
            (4) by adding at the end the following:
            ``(2) Accelerated countermeasure research and 
        development.--
                    ``(A) 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--
                            ``(i) the epidemiology and pathogenesis of 
                        such pathogens;
                            ``(ii) the development of new vaccines and 
                        therapeutics for use against such pathogens and 
                        other agents;
                            ``(iii) the development of diagnostic tests 
                        to detect such pathogens and other agents; and
                            ``(iv) other relevant areas of research;
                with consideration given to the needs of children and 
                other vulnerable populations.
                    ``(B) Role of department of veterans affairs.--In 
                carrying out subparagraph (A), 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 
                subparagraph, the Secretary may enter into cooperative 
                agreements with the Secretary of Veterans Affairs to 
                achieve such purposes.
                    ``(C) Priority countermeasures.--For purposes of 
                this paragraph, the term `priority countermeasure' 
                means a countermeasure, including a drug, medical or 
                other technological device, biological product, or 
                diagnostic test, 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.''.

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 evaluate new and emerging technologies that are 
designed to improve or enhance the ability of public health or safety 
officials to detect, identify, diagnose, or 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--
            (1) survey existing technology programs funded by the 
        Federal Government for potentially useful technologies;
            (2) promptly issue a request 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 joint interdepartmental 
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, 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 that 
provides a list of priority technologies whose development or 
deployment or both should be accelerated, and the estimated cost of 
doing so.

SEC. 127. POTASSIUM IODIDE.

    (a) In General.--Through the national stockpile under section 121, 
the Secretary of Health and Human Services (in this section referred to 
as the ``Secretary''), subject to subsection (b), 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, that are within 20 miles of a nuclear power 
plant, in quantities sufficient to provide adequate protection for the 
populations within such miles.
    (b) State and Local Plans.--Subsection (a) applies with respect to 
a State or local government if the government involved meets the 
following conditions:
            (1) Such government submits to the Secretary, and to the 
        Director of the Federal Emergency Management Agency, 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.
            (2) The plan is accompanied by certifications by such 
        government that--
                    (A) the government has not received sufficient 
                quantities of potassium iodide tablets from the Nuclear 
                Regulatory Commission; and
                    (B) in the case of a local government, such 
             
2000
   government has submitted the plan to the State 
                involved.
    (c)  Guidelines.--In consultation with the Director of the Federal 
Emergency Management Agency and with the Nuclear Regulatory Commission, 
the Secretary 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.
    (d) Information.--The Secretary shall carry out activities to 
inform State and local governments of the program under this section.
    (e) Report.--Not later than six months after the date of the 
enactment of this Act, the Secretary shall submit to the Congress a 
report--
            (1) on whether potassium iodide tablets have been made 
        available under subsection (a) and the extent to which State 
        and local governments have established stockpiles of such 
        tablets; and
    (2) the measures taken by the Secretary to implement this section.
    (f) Applicability.--Subsections (a) and (d) cease to apply as 
requirements if the Secretary determines that there is an alternative 
and more effective medical treatment to address adverse thyroid 
conditions that may result from the release of radionuclides from 
nuclear power plants.

        Subtitle C--Emergency Authorities; Additional Provisions

SEC. 131. EXPANDED AUTHORITY OF SECRETARY OF HEALTH AND HUMAN SERVICES 
              TO RESPOND TO PUBLIC HEALTH EMERGENCIES.

    (a) Transfers of Funds.--Section 319 of the Public Health Service 
Act (42 U.S.C. 247d) is amended by adding at the end the following:
    ``(d) Transfers of Funds Between Programs and Accounts.--
            ``(1) In general.--At any time during a public health 
        emergency declared by the Secretary under subsection (a), the 
        Secretary may, subject to paragraph (2), transfer funds, to the 
        extent authorized by law, between appropriations accounts 
        administered by the Secretary under this Act, without regard to 
        any waiting period imposed by any other provision of law, 
        including any provision of an appropriations Act, except as 
        provided in paragraphs (3) and (4).
            ``(2) Amount of transfers.--With respect to the public 
        health emergency involved:
                    ``(A) The Secretary may not make a transfer under 
                paragraph (1) in an amount exceeding a reasonable 
                estimate by the Secretary of the amount necessary to 
                respond to the emergency involved for a period of 60 
                days.
                    ``(B) Subsequent transfers under paragraph (1) may 
                be made by the Secretary, subject to compliance with 
                subparagraph (A).
            ``(3) Notification.--Not later than 48 hours prior to 
        making a transfer under paragraph (1), the Secretary shall 
        submit a notice of the intent to make such transfer to the 
        Committee on Appropriations of the House of Representatives, 
        the Committee on Energy and Commerce of the House of 
        Representatives, the Committee on Appropriations of the Senate, 
        and the Committee on Health, Education, Labor, and Pensions of 
        the Senate.
            ``(4) Scope.--Paragraph (1) shall apply, notwithstanding 
        any other provision of law including any provision of an 
        appropriations Act and any Act enacted after the date of 
        enactment of this subsection, unless such provision 
        specifically refers to and overrides this subsection.''.
     (b) Reporting Deadlines.--Section 319 of the Public Health Service 
Act (42 U.S.C. 247d), as amended by subsection (a), is further amended 
by adding at the end the following:
    ``(e) 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 declared 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. 132. 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 by inserting ``or exposed to'' after ``to be infected 
        with''.
            (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 
        inserting ``or exposed to'' after ``to be infected with''.
    (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. 133. 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:

``SEC. 1135. AUTHORITY TO WAIVE REQUIREMENTS DURING NATIONAL 
              EMERGENCIES.

    ``(a) Purpose.--
            ``(1) In general.--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--
                    ``(A) 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
                    ``(B) that health care providers (as defined in 
                subsection (g)) that furnish such items and services in 
                good faith, but that are unable to comply
2000
 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.
            ``(2) Emergency area; emergency period.--For purposes of 
        this section, 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.
    ``(b) Secretarial Authority.--To the extent necessary to accomplish 
the purposes 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 in any emergency area (or portion of such an area) 
during an emergency period, the requirements of titles XVIII, XIX, or 
XXI, or any regulation thereunder (and the requirements of this title, 
and regulations thereunder, insofar as they relate to such titles), 
pertaining to--
            ``(1) conditions of participation or other certification 
        requirements for an individual health care provider or types of 
        providers; program participation and similar requirements for 
        an individual health care provider or types of providers; and 
        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;
            ``(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); and
            ``(5) deadlines and timetables for performance of required 
        activities, except that such deadlines and timetables may only 
        be modified, not waived.
    ``(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) Notification of Congress.--The Secretary shall provide 
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 notice shall include a description of the 
specific provisions that will be waived or modified, the health care 
providers to whom the waiver or modification will apply, the geographic 
area in which the waiver or modification will apply, and the period of 
time for which the waiver or modification will be in effect.
    ``(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 
                (a)(2)(B);
                    ``(B) the termination of the applicable declaration 
                of public health emergency described in subsection 
                (a)(2)(B); or
                    ``(C) subject to paragraph (2), the termination of 
                a period of 90 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 90-day periods.--The Secretary may, by 
        notice, provide for an extension of a 90-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, 
        90 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 the 
success of such approaches and recommendations for improved approaches 
should the need for such emergency authority arise in the future.
    ``(g) Health Care Provider Defined.--For purposes of this section, 
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 amendments made by subsection (a) shall be 
effective on and after September 11, 2001.

SEC. 134. PROVISION FOR EXPIRATION OF PUBLIC HEALTH EMERGENCIES.

    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.''.

SEC. 135. 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. 136. EXPANDED RESEARCH BY SECRETARY OF ENERGY.

    (a) In General.--In coordination with the joint interdepartmental 
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.
    (b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section such sums as may be necessary 
for each of the fiscal years 2002 through 2006.

SEC. 137. AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY.

    (a) In General.--In planning for and responding to bioterrorism and 
other public health emergencies, including assisting State health 
departments, the Secretary of Health and Human Services (in this 
section referred to as the ``Secretary'') shall take into account the 
role and expertise of the Agency for Toxic Substances and Disease 
Registry (in this section referred to as ``ATSDR'').
    (b) Authorization of Appropriations.--For the pur
2000
pose of providing 
resources (including increased personnel, as appropriate) for ATSDR to 
use authorities under section 104(i) of the Comprehensive Environmental 
Response, Compensation, and Liability Act of 1980 to assist the 
Secretary in planning for or responding to bioterrorism or other public 
health emergencies, there are authorized to be appropriated to the 
Secretary such sums as may be necessary for each of the fiscal years 
2002 through 2006, in addition to any other authorizations of 
appropriations that are available for such purpose.

SEC. 138. EXPANDED RESEARCH ON WORKER HEALTH AND SAFETY.

    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.

SEC. 139. TECHNOLOGY OPPORTUNITIES PROGRAM SUPPORT.

     For fiscal years 2003 and 2004, all of the information 
infrastructure grants provided by the National Telecommunications and 
Information Administration (under the program also known as the 
Technology Opportunities Program) shall be used to provide grants to 
health providers to facilitate participation in the national public 
health communications and surveillance networks authorized under 
section 319D(b)(3) of the Public Health Service Act.

              Subtitle D--Authorization of Appropriations

SEC. 151. AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--For the purpose of carrying out activities of the 
Department of Health and Human Services in accordance with the 
provisions referred to in subsection (b), including making awards of 
grants, cooperative agreements, or contracts and providing other 
assistance to States and other public or private entities, there are 
authorized to be appropriated $2,720,000,000 for fiscal year 2002, and 
such sums as may be necessary for each of the fiscal years 2003 through 
2006.
    (b) Relevant Provisions.--For purposes of this section, the 
provisions referred to in this subsection are--
            (1) the provisions of this title;
            (2) sections 319A through 319K of the Public Health Service 
        Act;
            (3) title XXVIII of such Act; and
            (4) section 301 of such Act, to the extent that such 
        section is used as the authority of the Secretary of Health and 
        Human Services to carry out activities to supplement the 
        activities carried out under the provisions referred to in 
        paragraphs (1) through (3);
except that this section does not have any applicability with respect 
to the use of section 301 of such Act as authority for activities of 
the National Institutes of Health.
    (c) Fiscal Year 2002.--
            (1) In general.--The aggregate amount of authorizations of 
        appropriations under this title and under the Public Health 
        Service Act for fiscal year 2002 for the purpose described in 
        subsection (a) does not exceed the amount specified for fiscal 
        year 2002 in such subsection, notwithstanding other 
        authorizations of appropriations.
            (2) Allocations of authorizations.--Of the amount that is 
        authorized to be appropriated under subsection (a) for fiscal 
        year 2002, the following authorizations of appropriations for 
        such fiscal year for the purpose described in such subsection 
        apply:
                    (A) For making awards of grants, cooperative 
                agreements, or contracts and providing other assistance 
                to States and other public or private entities, 
                $1,000,000,000 is authorized, of which--
                            (i) $455,000,000 is authorized for grants 
                        under section 319C of the Public Health Service 
                        Act;
                            (ii) $455,000,000 is authorized for grants 
                        or cooperative agreements under section 319F of 
                        such Act; and
                            (iii) $40,000,000 is authorized for grants 
                        or cooperative agreements under section 319H of 
                        the Public Health Service Act, as added by 
                        section 106 of this Act (relating to shortages 
                        of certain health professionals).
                    (B) For the national stockpile under section 121 of 
                this Act, other than activities of the National 
                Institutes of Health regarding smallpox vaccine, 
                $1,155,000,000 is authorized, of which $509,000,0000 is 
                authorized for the acquisition of smallpox vaccine.
                    (C) For the Centers for Disease Control and 
                Prevention, other than purposes to which the 
                authorization established in subparagraph (A) applies, 
                $450,000,000, of which $300,000,000 is authorized for 
                facilities of such Centers for purposes described in 
                section 399D(c) of the Public Health Service Act.
                    (D) For activities on antimicrobial resistance 
                under section 319E of such Act, $25,000,000 is 
                authorized.

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

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.--
            (1) Public health service act.--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 immunizations to 
                                prevent and treatments for any illness 
                                resulting from infection by the agent 
                                or toxin; and
                                    ``(IV) any other criteria that the 
                                Secretary considers appropriate; and
                            ``(ii) consult with scientific experts 
                        representing appropriate professional groups.
            ``(2) Biennial publication.--The Secretary shall publish 
        the list under paragraph (1) biennially, or at such more 
        frequent intervals as the Secretary determines to be 
        appropriate. Before publishing the list, the Secretary shall 
        review the list, and shall make such revisions as are 
        appropriate to protect the public health and safety. In 
        reviewing and revising the list, the Secretary shall consider 
        the needs of vulnerable populations, including children, and 
        shall consult with appropriate Federal agencies and State and 

2000
        local public health officials.
    ``(b) Regulation of Transfers of Listed Biological Agents and 
Toxins.--The Secretary shall by regulation provide for--
            ``(1) the establishment and enforcement of safety 
        procedures for the transfer of biological agents and toxins 
        listed pursuant to subsection (a)(1), 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) safeguards 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 a 
        biological agent or toxin in violation of the safety procedures 
        established under paragraph (1) or the safeguards 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 Biological Agents and Toxins.--
The Secretary shall by regulation provide for the establishment and 
enforcement of standards and procedures governing the possession and 
use of biological agents and toxins listed pursuant to subsection 
(a)(1) in order to protect the public health and safety, including the 
measures, safeguards, procedures, and availability of such agents and 
toxins described in paragraphs (1) through (4) of subsection (b), 
respectively.
    ``(d) Registration and Traceability Mechanisms; Database.--
Regulations under subsections (b) and (c) shall require registration of 
the possession, use, and transfer of biological agents and toxins 
listed pursuant to subsection (a)(1), and such registration shall 
include (if available to the registered person) information regarding 
the characterization of such biological agents and toxins to facilitate 
their identification and traceability. The Secretary shall maintain a 
national database of the location of such agents and toxins, with 
information regarding their characterizations.
    ``(e) Inspections.--The Secretary may conduct inspections to ensure 
that persons subject to regulations under subsection (b) or (c) are in 
compliance with such regulations, including provisions regarding 
security and restrictions on access under subsection (g).
    ``(f) Exemptions.--The Secretary may establish exemptions from the 
applicability of provisions of regulations under subsection (b) or (c) 
if the Secretary determines that such exemptions are consistent with 
protecting the public health and safety. In the case of a clinical 
laboratory that is in possession of a biological agent or toxin listed 
pursuant to subsection (a)(1), such an exemption may be provided only 
if such agent or toxin has been presented for diagnosis, verification, 
or proficiency testing, and upon identification or verification of the 
agent or toxin, such laboratory--
            ``(1) promptly notifies the Secretary or other public 
        health authorities when required under Federal or State law; 
        and
            ``(2) transfers or destroys the agent or toxin in 
        accordance with such regulations.
    ``(g) Security Requirements for Registered Persons.--
            ``(1) In general.--In carrying out the provisions of 
        subsections (b) and (c) that relate to safeguards, the 
        Secretary, in consultation with the Attorney General, shall by 
        regulation establish appropriate security requirements for 
        persons possessing, using, or transferring biological agents or 
        toxins listed pursuant to subsection (a)(1), and ensure 
        compliance with such requirements as a condition of 
        registration under subsection (b) or (c).
            ``(2) Limiting access to listed agents and toxins.--
                    ``(A) In general.--Regulations issued under 
                subsections (b) and (c) shall include provisions--
                            ``(i) to restrict access to biological 
                        agents and toxins listed pursuant to subsection 
                        (a)(1) to only those individuals who have a 
                        legitimate need for access, as determined 
                        according to the purposes for which the 
                        registration under such regulations is 
                        provided; and
                            ``(ii) to ensure that individuals granted 
                        such access are not--
                                    ``(I) restricted persons, as 
                                defined in section 175b of title 18, 
                                United States Code;
                                    ``(II) named in a warrant issued to 
                                a Federal or State law enforcement 
                                agency for participation in any 
                                domestic or international act of 
                                terrorism or other act of violence;
                                    ``(III) under investigation for 
                                involvement with a domestic or 
                                international terrorist or criminal 
                                organization by any Federal law 
                                enforcement or intelligence agency; or
                                    ``(IV) suspected by any Federal law 
                                enforcement or intelligence agency of 
                                seeking to obtain covertly information 
                                relating to biological agents or toxins 
                                on behalf of the intelligence or 
                                military operations of a foreign 
                                nation.
                    ``(B) Screening protocol.--To carry out 
                subparagraph (A), the Secretary shall require that 
                registered persons promptly submit the names and other 
                identifying information for individuals described in 
                subparagraph (A)(i) to the Secretary and the Attorney 
                General, with which information the Attorney General 
                shall promptly use criminal, immigration, and national 
                security databases available to the Federal Government 
                to identify whether such individuals satisfy the 
                conditions for access under subparagraph (A)(ii). The 
                Secretary, in consultation with the Attorney General 
                and other Federal agencies, shall periodically review 
                and as appropriate revise the protocol for screening 
                individuals for purposes of subparagraph (A), and may 
                require by regulation additional screening measures if 
                determined necessary to achieve the purposes of this 
                section.
            ``(3) Assistance for certain entities.--The Secretary, in 
        consultation with the Attorney General, may make awards of 
        grants, contracts, or cooperative agreements to public and 
        nonprofit private entities (other than Federal agencies), and 
        may provide technical assistance to such entities, to improve 
        security of the facilities of registered persons.
    ``(h) Disclosure of Information.--
            ``(1) In general.--Any information in the possession of any 
        Federal agency that identifies a person, or the geographic 
        location of a person, who is registered pursuant to regulations 
        under this section (including regulations promulgated before 
        the effective date of this subsection), and any site-specific 
        information relating to the type, quantity, or identity of a 
        biological agent or toxin 
2000
listed pursuant to subsection (a)(1) 
        or the site-specific security mechanisms in place to protect 
        such agents and toxins, shall not be disclosed under section 
        552(a) of title 5, United States Code.
            ``(2) Disclosures for public health and safety; congress.--
        Nothing in this section may be construed as preventing the head 
        of any Federal agency--
                    ``(A) from making disclosures of information 
                described in paragraph (1) for purposes of protecting 
                the public health and safety; or
                    ``(B) from making disclosures of such information 
                to any committee or subcommittee of the Congress with 
                appropriate jurisdiction, upon request.
    ``(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.
    ``(j) Coordination With Regulations Under Virus-Serum-Toxin Act.--
            ``(1) In general.--In establishing and enforcing 
        regulations under subsections (b) and (c), the Secretary shall 
        consult with the Secretary of Agriculture to ensure that such 
        activities are coordinated, to the greatest extent practicable, 
        with regulations governing certain biological agents and toxins 
        listed pursuant to subsection (a)(1) issued by the Secretary of 
        Agriculture under 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) (in this subsection referred to as the `VST Act'). The 
        purpose of such coordination shall be--
                    ``(A) to minimize any conflicts between the 
                regulations issued by, or the activities of, the 
                Secretary of Health and Human Services and the 
                Secretary of Agriculture with respect to such agents 
                and toxins;
                    ``(B) to minimize the administrative burden on 
                persons subject to regulations under both this section 
                and the VST Act;
                    ``(C) to ensure the appropriate availability of 
                such agents and toxins for legitimate agricultural or 
                veterinary research, education, or other such purposes; 
                and
                    ``(D) to ensure the establishment of a national 
                database of such agents or toxins pursuant to 
                subsection (d).
            ``(2) Persons regulated by department of agriculture.--With 
        respect to persons possessing or using biological agents or 
        toxins listed pursuant to subsection (a)(1) who, as of the date 
        of enactment of the Public Health Security and Bioterrorism 
        Response Act of 2001, possess an unexpired, unrevoked, and 
        unsuspended permit or license from the Department of 
        Agriculture for such possession or use, such persons may, for 
        purposes of registration under subsection (b) or (c), submit to 
        the Secretary of Health and Human Services the same information 
        previously provided to the Secretary of Agriculture to obtain 
        such permit or license, provided that the information so 
        submitted is accurate as of the time of submittal to the 
        Secretary of Health and Human Services, and provided further 
        that such Secretary may, after review of such submission, 
        request such additional information as the Secretary determines 
        to be necessary to achieve the purposes of this section.
            ``(3) Savings provision.--Nothing in this section shall be 
        construed as limiting any authority of the Secretary of 
        Agriculture under the VST Act or any regulations issued 
        thereunder.
    ``(k) 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 `registered person' means a person 
        registered under regulations under subsection (b) or (c).
    ``(l) 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.''.
            (2) Relation to other laws.--
                    (A) Rule of construction.--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 paragraph (1) of this subsection. 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 (including any 
                revisions required under subsection (a)(2) of such 
                section 351A).
                    (B) 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.
            (3) Date certain for promulgation of certain regulations; 
        effective date regarding criminal and civil penalties.--With 
        respect to section 351A of the Public Health Service Act (as 
        added by paragraph (1) of this subsection):
                    (A) Not later than 30 days after the date of the 
                enactment of this Act, the Secretary of Health and 
                Human Services shall promulgate an interim final rule 
                requiring all persons in possession of biological 
                agents or toxins listed pursuant to subsection (a)(1) 
                of such section (unless exempt under subsection (e) of 
                such section) to provide notice to the Secretary of 
                such possession, and to include in the notice such 
                additional information as the Secretary may require for 
                compliance with subsection (d) of such section or any 
                other provision of such section, by not later than 30 
                days after the date on which such rule is promulgated. 
                Such interim final rule takes effect on the date on 
                which the rule is promulgated, except as follows:
                          (i) For purposes of section 175b(c) of title 
                        18, United States Code (relating to criminal 
                        penalties), as added by subsection (a)(1)(E) of 
                        this section, the rule takes effect 60 days 
                        after the date on w
2000
hich the rule is 
                        promulgated.
                            (ii) For purposes of subsection (i) of such 
                        section 351A (relating to civil penalties), the 
                        rule takes effect 60 days after the date on 
                        which the rule is promulgated.
                    (B) Not later than 120 days after the date of 
                enactment of this Act, such Secretary shall promulgate 
                an interim final rule for carrying out subsections (b) 
                and (c) of such section 351A. Such interim final rule 
                takes effect 60 days after the date on which the rule 
                is promulgated.
            (4) Effective date regarding disclosure of information.--
        Subsection (h) of section 351A of the Public Health Service 
        Act, as added by paragraph (1) of this subsection, is deemed to 
        have taken effect on the effective date of the Antiterrorism 
        and Effective Death Penalty Act of 1996.
    (b) Criminal Penalties Regarding Select Agents.--
            (1) In general.--Section 175b of title 18, United States 
        Code, as added by section 817 of Public Law 107-56, is 
        amended--
                    (A) by striking ``(a)'' and inserting ``(a)(1)'';
                    (B) by transferring subsection (c) from the current 
                placement of the subsection and inserting the 
                subsection before subsection (b);
                    (C) by striking ``(c)'' and inserting ``(2);
                    (D) by redesignating subsection (b) as subsection 
                (d); and
                    (E) by inserting before subsection (d) (as so 
                redesignated) the following subsections:
    ``(b) Transfer to Unregistered Person.--Whoever knowingly transfers 
a select agent to a person without first verifying with the Secretary 
of Health and Human Services that the person has obtained a 
registration 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.
    ``(c) Unregistered for Possession.--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) Conforming amendments.--Chapter 10 of title 18, United 
        States Code, is amended--
                    (A) in section 175b (as added by section 817 of 
                Public Law 107-56 and amended by paragraph (1) of this 
                subsection)--
                            (i) 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
                            (ii) in the heading for the section, by 
                        striking ``Possession by restricted persons'' 
                        and inserting ``Select agents''; and
                    (B) in the chapter analysis, in the item relating 
                to section 175b, by striking ``Possession by restricted 
                persons.'' and inserting ``Select agents.''.
            (3) Technical corrections.--Chapter 10 of title 18, United 
        States Code, as amended by section 817 of Public Law 107-56 and 
        paragraphs (1) and (2) of this subsection, is amended--
                    (A) in section 175--
                            (i) in subsection (a), in the second 
                        sentence, by striking ``this section'' and 
                        inserting ``this subsection''; and
                            (ii) in subsection (c), by striking 
                        ``protective'' and all that follows and 
                        inserting ``protective, bona fide research, or 
                        other peaceful purposes.'';
                    (B) in section 175b--
                            (i) 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
                            (ii) in subsection (d)(3), by striking 
                        ``section 1010(a)(3)'' and inserting ``section 
                        101(a)(3)'';
                    (C) in section 176(a)(1)(A), by striking ``exists 
                by reason of'' and inserting ``pertains to''; and
                    (D) in section 178--
                            (i) 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'';
                            (ii) 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
                            (iii) in paragraph (4), by striking 
                        ``recombinant molecule,'' and all that follows 
                        through ``biotechnology,'' and inserting 
                        ``recombinant or synthesized molecule,''.
            (4) Additional technical correction.--Section 2332a of 
        title 18, United States Code, is amended--
                    (A) 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
                    (B) 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)''.
    (c) Security Upgrades at the
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 Department of Health and Human 
Services.--For the purpose of enabling the Secretary of Health and 
Human Services to secure existing facilities of the Department of 
Health and Human Services where biological agents or toxins listed 
under section 351A(a)(1) of the Public Health Service Act are housed or 
researched, or where vaccines are housed or researched, there are 
authorized to be appropriated such sums as may be necessary for fiscal 
year 2002 and each subsequent fiscal year.
    (d) Report to Congress.--Not later than 1 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; and
            (4) provides any recommendations of the Secretary for 
        administrative or legislative initiatives regarding such 
        section 351A.

      TITLE III-AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT

                 Subtitle A--Protection of Food Supply

SEC. 301. PROTECTION AGAINST INTENTIONAL ADULTERATION OF FOOD.

    (a) Increasing Inspections for Detection of Intentional 
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 
paragraphs:
    ``(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.
    ``(3) 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, periodic reports 
describing the activities of the Secretary under paragraphs (1) and 
(2).''.
    (c) Testing for Rapid Detection of Intentional 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).''.
    (d) 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.
    (e) 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. 302. 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.--A
2000
n order under 
        paragraph (1) with respect to an article of food may require 
        that such article be labeled or marked as detained, and may 
        require that the article be removed to a secure facility. 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.
            ``(4) Appeal of detention order.--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 72 hours 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 72-hour period the 
        Secretary fails to provide such an opportunity, or to confirm 
        or terminate such order, the order is deemed to be 
        terminated.''.
    (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 301(c) 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.
    ``(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. 303. PERMISSIVE DEBARMENT REGARDING FOOD IMPORTATION.

    (a) In General.--Section 306(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 335a(b)) is amended--
            (1) in paragraph (1)--
                    (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) in paragraph (2), in the matter preceding subparagraph 
        (A), by inserting ``subparagraph (A) or (B) of'' before 
        ``paragraph (1)'';
            (3) by redesignating paragraph (3) as paragraph (4); and
            (4) 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 article of food; or
                    ``(B)(i) the person has repeatedly imported or 
                offered for import adulterated articles of food; and
                    ``(ii) the person knew, or should have known, that 
                such articles were adulterated.''.
    (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''; and
                    (C) in subparagraph (B), in each of clauses (i) and 
                (ii), by inserting ``or subsection (b)(3)'' after 
                ``subsection (b)(2)(B).
    (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)'' after 
                ``subsection (b)(2)(B)''; and
            (2) in the second sentence, by inserting ``, subsection 
        (b)(3),'' after ``subsection (b)(2)(B)''.
    (d) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act, as amended by section 302(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)(1)(C).''.

SEC. 304. MAINTENANCE AND INSPECTION OF RECORDS FOR FOODS.

    (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 section:

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

    ``(a) Records Inspection.--If the Secretary ha
2000
s credible evidence 
or information indicating that an article of food 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 investigating such credible evidence or 
information. 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 
maintenance of records by persons (excluding farms and restaurants) who 
manufacture, process, pack, transport, distribute, receive, hold, or 
import food, as may be necessary to trace the source and chain of 
distribution of food and 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 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 credible 
        evidence or information indicating that an article of food 
        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(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(e)) is amended--
            (1) by striking ``by section 412, 504, or 703'' and 
        inserting ``by section 412, 414, 504, 703, or 704(a); and
            (2) by striking ``under section 412'' and inserting ``under 
        section 412, 414(b)''.

SEC. 305. REGISTRATION.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.), as amended by section 304 of this Act, is 
amended by adding at the end the following:

``SEC. 415. REGISTRATION.

    ``(a) Registration.--
            ``(1) In general.--Any facility (excluding farms) engaged 
        in manufacturing, processing, packing, or holding food for 
        consumption in the United States shall 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 identity 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, or successor 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 other information required to be 
        submitted under this subsection shall not be subject to the 
        disclosure requirements of section 552 of title 5, United 
        States Code.
    ``(b) Exemption.--The Secretary shall by regulation exempt types of 
retail establishments from the requirements of subsection (a) only if 
the Secretary determines that the registration of such facilities is 
not needed for effective enforcement of this chapter and any 
regulations issued under this chapter.
    ``(c) Facility.--For purposes of this section, 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 restaurants 
or other establishments in which food is served solely for immediate 
human consumption.
    ``(d) 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.--
            (1) In general.--Section 301 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 331), as amended by section 303(d) of 
        this Act, is amended by adding at the end the following:
    ``(dd) The failure to register in accordance with section 415.''.
            (2) Misbranded food.--Section 403 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at 
        the end the following:
    ``(t) If it is manufactured, processed,
2000
 packed, or held in a 
facility that is not registered in accordance with section 415.''.
    (c) Effective Date.--The amendment made by subsection (b) shall 
take effect 180 days after the date of the enactment of this Act.
    (d) Notice.--Not later than 60 days after the date of the enactment 
of this Act, the Secretary of Health and Human Services, after 
consultation with appropriate State and local officials, shall take 
sufficient measures to notify entities that manufacture, process, pack, 
or hold food for consumption in the United States of the requirement 
pursuant to this section that facilities be registered with the 
Secretary. The Secretary shall develop guidance, as needed, to identify 
facilities required to register under this section.
    (e) 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.
    (f) Savings Clause.--This section may not be construed as 
authorizing the Secretary of Health and Human Services 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).

SEC. 306. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.

    (a) In General.--Section 801 of the Federal Food, Drug, and 
Cosmetic Act, as amended by section 302(c) of this Act, is amended by 
adding at the end the following subsection:
    ``(k)(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, and 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 regulations 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, 
not fewer than 24 hours, in advance of the time of the importation of 
the article of food involved or the offering of the food for import, 
except that the advance period so required may not exceed 72 hours.
    ``(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 subparagraph (A), 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 
regulations under paragraph (1). The preceding sentence may not be 
construed as authorizing such delivery pursuant to the execution of a 
bond, pending such a determination by the Secretary.
    ``(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)(1) 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 regulations under section 
801(k).''.

SEC. 307. 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 306(a) of this 
Act, is amended by adding at the end the following:
    ``(l)(1) If a food has been refused admission under subsection (a), 
other than such a food that is required to be destroyed, and the 
Secretary determines that the food presents a threat of serious adverse 
health consequences or death to humans or animals, 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), as amended by section 305(b)(2) of this 
Act, is amended by adding at the end the following:
    ``(u) If it fails to bear a label required by the Secretary under 
section 801(l)(1) (relating to food refused admission into the United 
States).''.
    (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. 308. PROHIBITION AGAINST PORT SHOPPING FOR IMPORTATION.

    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 such article 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 is not adulterated, as 
determined by the Secretary.''.

SEC. 309. 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 new 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 th
2000
reat 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 the 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 adulterated 
food under any other provision of this Act.''.

SEC. 310. GRANTS TO STATES FOR INSPECTIONS; RESPONSE TO NOTICE 
              REGARDING ADULTERATED IMPORTED FOOD.

    Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
391 et seq.), as amended by section 309 of this Act, is amended by 
adding at the end the following new section:

``SEC. 909. GRANTS TO STATES REGARDING FOOD INSPECTIONS.

    ``(a) In General.--The Secretary may make grants to States and 
Territories for the purpose of conducting with respect to food 
examinations, inspections, investigations, and related activities under 
section 702 through individuals who, under subsection (a) of such 
section, are duly commissioned by the Secretary as officers of the 
Department.
    ``(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 notices 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 such sums as 
may be necessary for each of the fiscal years 2002 through 2006.''.

                 Subtitle B--Protection of Drug Supply

SEC. 311. ANNUAL REGISTRATION OF FOREIGN MANUFACTURERS; SHIPPING 
              INFORMATION; DRUG AND DEVICE LISTING.

    (a) Annual Registration; Listing.--
            (1) In general.--Section 510 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 360) is amended--
                    (A) in subsection (i)(1)--
                            (i) by striking ``Any establishment'' and 
                        inserting ``On or before December 31 of each 
                        year, any establishment'';
                            (ii) by striking ``establishment and the 
                        name'' and inserting ``establishment, the 
                        name''; and
                            (iii) by inserting before the period the 
                        following: ``, 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 carrier used by the establishment in 
                        transporting such drug or device to the United 
                        States for purposes of importation''; and
                    (B) in subsection (j)(1), in the first sentence, by 
                striking ``or (d)'' and inserting ``(d), or (i)''.
            (2) Misbranding.--Section 502(o) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 352(o)) is amended by striking ``in 
        any State''.
    (b) Importation; Statement Regarding Registration of 
Manufacturer.--
            (1) In general.--Section 801 of the Federal Food, Drug, and 
        Cosmetic Act, as amended by section 307(a) of this Act, is 
        amended by adding at the end the following subsection:
    ``(m) A drug or device that is imported or offered for import into 
the United States may be refused admission if the importer of the drug 
or device does not, at the time of offering the drug or device for 
import, submit to the Secretary a statement that identifies the 
registration under section 510(i) of each establishment that with 
respect to such drug or device is required under such section to 
register with the Secretary.''.
            (2) Prohibited act.--Section 301 of the Federal Food, Drug, 
        and Cosmetic Act, as amended by section 306(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 an order of the Secretary to submit to the Secretary a statement 
under section 801(m).''.
    (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. 312. REQUIREMENT OF ADDITIONAL INFORMATION REGARDING IMPORT 
              COMPONENTS INTENDED FOR USE IN EXPORT PRODUCTS.

    (a) In General.--Section 801(d)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(d)(3)) is amended to read as follows:
    ``(3)(A) Subject to subparagraph (B), no component of a drug, no 
component part or accessory of a device, or other article of device 
requiring further processing, which is ready or suitable for use for 
health-related purposes, and no article of a food additive, color 
additive, or dietary supplement, including a product in bulk form, 
shall be excluded from importation into the United States under 
subsection (a) if each of the following conditions is met:
            ``(i) The importer of such article of a drug or device or 
        importer of such article of a food additive, color additive, or 
        dietary supplement submits to the Secretary, at the time of 
        initial importation, a statement in accordance with the 
        following:
                    ``(I) Such statement provides that such article is 
                intended to be further processed by the initial owner 
                or consignee, or incorporated by the initial owner or 
                consignee, into a drug, biological product, device, 
                food, food additive, color additive, or dietary 
                supplement that will be exported by the initial owner 
                or consignee from the United States in accordance with 
                subsection (e) or section 802, or with section 351(h) 
                of the Public Health Service Act.
                    ``(II) The statement identifies the manufacturer of 
                such article and each processor, packer, distributor, 
                carrier, 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.
            ``(ii) If such article is known to be, or to contain or 
        bear, any chemical substance or biological substance, the 
        statement under clause (i) is accompanied by such certificates 
        of analysis as are necessary to identify each such substance.
            ``(iii) 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.
            ``(iv) 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.
            ``(v) 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.
            ``(vi) 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
2000
 
        the requirements of this subparagraph.
    ``(B) Subparagraph (A) does not apply to the import or offering for 
import into the United States of an article if the Secretary determines 
that there is credible evidence or information indicating that such 
article presents a threat of serious adverse health consequences or 
death to humans or animals.
    ``(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.

              TITLE IV-DRINKING WATER SECURITY AND SAFETY

SEC. 401. AMENDMENT OF THE SAFE DRINKING WATER ACT.

    The Safe Drinking Water Act (title XIV of the Public Health Service 
Act) is amended as follows:
            (1) By inserting the following new sections 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 March 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) prior to:
            ``(A) December 31, 2002, in the case of systems serving a 
        population of 100,000 or more.
            ``(B) June 30, 2003, in the case of systems serving a 
        population of 50,000 or more but less than 100,000.
            ``(C) December 31, 2003, in the case of systems serving a 
        population greater than 3,300 but less than 50,000.
    ``(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) 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 or drinking water provided to 
communities and individuals.
    ``(d) Funding.--There are authorized to be appropriated to carry 
out this section not more than $120,000,000 for the fiscal year 2002 
and such sums as may be necessary for fiscal year 2003 and fiscal year 
2004. The Administrator, in coordination with State and local 
governments, may 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 under subsection (a).

``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 designed to monitor and 
        detect chemical, biological, and radiological contaminants and 
        reduce the likelihood that such contaminants can be 
        successfully introduced into water supplies 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) Procedures and equipment necessary to prevent the 
        flow of contaminated drinking water to individuals served by 
        public water systems.
            ``(4) Methods, means, and equipment which could negate or 
        mitigate deleterious effects on public health and the 
13bb
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.
            ``(5) 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 of other intentional acts.
    ``(b) Funding.--For the authorization of appropriations to carry 
out this section, see section 1435(c).

``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.
    ``(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) 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 fiscal year 2003 
and fiscal year 2004.''.
            (2) Section 1414(i)(1) is amended by inserting ``1433'' 
        after ``1417''.
            (3) 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''.
            (4) 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''.
            (5) 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.''.

            Passed the House of Representatives December 12, 2001.

            Attest:

                                                 JEFF TRANDAHL,

                                                                 Clerk.

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