[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3448 Engrossed Amendment Senate (EAS)]

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

                  In the Senate of the United States,

                      December 20 (legislative day, December 18), 2001.
    Resolved, That the bill from the House of Representatives (H.R. 
3448) entitled ``An Act to improve the ability of the United States to 
prevent, prepare for, and respond to bioterrorism and other public 
health emergencies.'', do pass with the following

                               AMENDMENT:

            Strike out all after the enacting clause and insert:

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Bioterrorism 
Preparedness 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 GOALS FOR BIOTERRORISM PREPAREDNESS

Sec. 101. Amendment to the Public Health Service Act.

        TITLE II--IMPROVING THE FEDERAL RESPONSE TO BIOTERRORISM

                   Subtitle A--Additional Authorities

Sec. 201. Additional authorities of the Secretary; Strategic National 
                            Pharmaceutical Stockpile.
Sec. 202. Improving the ability of the Centers for Disease Control and 
                            Prevention to respond effectively to 
                            bioterrorism.

           Subtitle B--Coordination of Efforts and Responses

Sec. 211. Assistant Secretary of Emergency Preparedness; National 
                            Disaster Medical System.
Sec. 212. Expanded authority of the Secretary of Health and Human 
                            Services to respond to public health 
                            emergencies.
Sec. 213. Public health preparedness and response to a bioterrorist 
                            attack.
Sec. 214. The official Federal Internet site on bioterrorism.
Sec. 215. Technical amendments.
Sec. 216. Regulation of biological agents and toxins.

           TITLE III--IMPROVING STATE AND LOCAL PREPAREDNESS

 Subtitle A--Emergency Measures To Improve State and Local Preparedness

Sec. 301. State bioterrorism preparedness and response block grant.

   Subtitle B--Improving Local Preparedness and Response Capabilities

Sec. 311. Designated bioterrorism response medical centers.
Sec. 312. Designated State public emergency announcement plan.
Sec. 313. Training for pediatric issues surrounding biological agents 
                            used in warfare and terrorism.
Sec. 314. General Accounting Office report.
Sec. 315. Additional research.
Sec. 316. Sense of the Senate.

     TITLE IV--DEVELOPING NEW COUNTERMEASURES AGAINST BIOTERRORISM

Sec. 401. Limited antitrust exemption.
Sec. 402. Developing new countermeasures against bioterrorism.
Sec. 403. Sequencing of priority pathogens.
Sec. 404. Accelerated countermeasure research and development.
Sec. 405. Accelerated approval of priority countermeasures.
Sec. 406. Use of animal trials in the approval of priority 
                            countermeasures.
Sec. 407. Miscellaneous provisions.

     TITLE V--PROTECTING THE SAFETY AND SECURITY OF THE FOOD SUPPLY

     Subtitle A--General Provisions To Expand and Upgrade Security

Sec. 511. Food safety and security strategy.
Sec. 512. Expansion of Animal and Plant Health Inspection Service 
                            activities.
Sec. 513. Expansion of Food Safety Inspection Service activities.
Sec. 514. Expansion of Food and Drug Administration activities.
Sec. 515. Biosecurity upgrades at the Department of Agriculture.
Sec. 516. Biosecurity upgrades at the Department of Health and Human 
                            Services.
Sec. 517. Agricultural biosecurity.
Sec. 518. Biosecurity of food manufacturing, processing, and 
                            distribution.

               Subtitle B--Protection of the Food Supply

Sec. 531. Administrative detention.
Sec. 532. Debarment for repeated or serious food import violations.
Sec. 533. Maintenance and inspection of records for foods.
Sec. 534. Registration of food manufacturing, processing, and handling 
                            facilities.
Sec. 535. Prior notice of imported food shipments.
Sec. 536. Authority to mark refused articles.
Sec. 537. Authority to commission other Federal officials to conduct 
                            inspections.
Sec. 538. Prohibition against port shopping.
Sec. 539. Grants to States for inspections.
Sec. 540. Rule of construction.

 Subtitle C--Research and Training To Enhance Food Safety and Security

Sec. 541. Surveillance and information grants and authorities.
Sec. 542. Agricultural bioterrorism research and development.

         TITLE I--NATIONAL GOALS FOR BIOTERRORISM PREPAREDNESS

SEC. 101. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

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

      ``TITLE XXVIII--STRENGTHENING THE NATION'S PREPAREDNESS FOR 
                              BIOTERRORISM

``SEC. 2801. CONGRESSIONAL FINDINGS ON BIOTERRORISM PREPAREDNESS.

    ``Congress finds that the United States should further develop and 
implement a coordinated strategy to prevent, and if necessary, to 
respond to biological threats or attacks upon the United States. Such 
strategy should include measures for--
            ``(1) enabling the Federal Government to provide health 
        care assistance to States and localities in the event of a 
        biological threat or attack;
            ``(2) improving public health, hospital, laboratory, 
        communications, and emergency response personnel preparedness 
        and responsiveness at the State and local levels;
            ``(3) rapidly developing and manufacturing needed 
        therapies, vaccines, and medical supplies; and
            ``(4) enhancing the protection of the nation's food supply 
        and protecting agriculture against biological threats or 
        attacks.''.

        TITLE II--IMPROVING THE FEDERAL RESPONSE TO BIOTERRORISM

                   Subtitle A--Additional Authorities

SEC. 201. ADDITIONAL AUTHORITIES OF THE SECRETARY; STRATEGIC NATIONAL 
              PHARMACEUTICAL STOCKPILE.

    Title XXVIII of the Public Health Service Act, as added by section 
101, is amended by adding at the end the following:

      ``Subtitle A--Improving the Federal Response to Bioterrorism

``SEC. 2811. AUTHORITY OF THE SECRETARY RELATED TO BIOTERRORISM 
              PREPAREDNESS.

    ``(a) Plan.--To meet the objectives of this title (and the 
amendments made by the Bioterrorism Preparedness Act of 2001), and to 
help the United States fully prepare for a biological threat or attack, 
the Secretary, consistent with the recommendations and activities of 
the working group established under section 319F(a), shall develop and 
implement a coordinated plan to meet such objectives that are within 
the jurisdiction of the Secretary. Such plan shall include the 
development of specific criteria that will enable measurements to be 
made of the progress made at the national, State, and local levels 
toward achieving the national goal of bioterrorism preparedness, 
including actions to strengthen the preparedness of rural communities 
for a biological threat or attack.
    ``(b) Biennial Reports.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this title, and biennially thereafter, the 
        Secretary shall prepare and submit to Congress a report 
        concerning the progress made and the steps taken by the 
        Secretary to further the purposes of this title (and the 
        amendments made by the Bioterrorism Preparedness Act of 2001). 
        Such report shall include an assessment of the activities 
        conducted under section 319F(c).
            ``(2) Additional authority.--In the biennial report 
        submitted under paragraph (1), the Secretary may make 
        recommendations concerning--
                    ``(A) additional legislative authority that the 
                Secretary determines is necessary to meet the 
                objectives of this title (and the amendments made by 
                the Bioterrorism Preparedness Act of 2001); and
                    ``(B) 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.
    ``(c) Other Reports.--Not later than 1 year after the date of 
enactment of this title, the Secretary shall prepare and submit to 
Congress a report concerning--
            ``(1) activities conducted under section 319F(b);
            ``(2) the characteristics that may render a rural community 
        uniquely vulnerable to a biological threat or 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) in any case in which the Secretary determines that 
        additional legislative authority is necessary to effectively 
        strengthen the preparedness of rural communities for responding 
        to a biological threat or attack, the recommendations of the 
        Secretary with respect to such legislative authority; and
            ``(4) the need for and benefits of a National Disaster 
        Response Medical Volunteer Service that would be a private-
        sector, community-based rapid response corps of medical 
        volunteers.

``SEC. 2812. STRATEGIC NATIONAL PHARMACEUTICAL STOCKPILE.

    ``(a) In General.--The Secretary, in coordination with the 
Secretary of Veterans Affairs, shall maintain a strategic stockpile of 
vaccines, therapies, and medical supplies that are adequate, as 
determined by the Secretary, to meet the health needs of the United 
States population, including children and other vulnerable populations, 
for use at the direction of the Secretary, in the event of a biological 
threat or attack or other public health emergency.
    ``(b) Rule of Construction.--Nothing in subsection (a) shall be 
construed to prohibit the Secretary from including in the stockpile 
described in such subsection such vaccines, therapies, or medical 
supplies as may be necessary to meet the needs of the United States in 
the event of a nuclear, radiological, or chemical attack or other 
public health emergency.
    ``(c) Definition.--In this section, the term `stockpile' means--
            ``(1) a physical accumulation of the material 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 such medical supplies as shall be 
        described in the contract at such time as shall be specified in 
        the contract.
    ``(d) Procedures.--The Secretary, in managing the stockpile under 
this section, shall--
            ``(1) ensure that adequate procedures are followed with 
        respect to the stockpile maintained under subsection (a) for 
        inventory management, accounting, and for the physical security 
        of such stockpile; and
            ``(2) in consultation with State and local officials, take 
        into consideration the timing and location of special events, 
        including designated national security events.
    ``(e) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $640,000,000 for fiscal year 
2002, and such sums as may be necessary for each of fiscal years 2003 
through 2006.''.

SEC. 202. IMPROVING THE ABILITY OF THE CENTERS FOR DISEASE CONTROL AND 
              PREVENTION TO RESPOND EFFECTIVELY TO BIOTERRORISM.

    (a) Revitalizing the CDC.--Section 319D of the Public Health 
Service Act (42 U.S.C. 247d-4) is amended--
            (1) in subsection (a), by inserting ``, and expanded, 
        enhanced, and improved capabilities of the Centers related to 
        biological threats or attacks,'' after ``modern facilities'';
            (2) in subsection (b)--
                    (A) by inserting ``, including preparing for or 
                responding to biological threats or attacks,'' after 
                ``public health activities''; and
                    (B) by inserting ``$60,000,000 for fiscal year 
                2002,''; and
            (3) by adding at the end the following:
    ``(c) Improving Public Health Laboratory Capacity.--
            ``(1) In general.--The Secretary shall provide for the 
        establishment of a coordinated network of public health 
        laboratories to assist with the detection of and response to a 
        biological threat or attack, that may, at the discretion of the 
        Secretary, include laboratories that serve as regional 
        reference laboratories.
            ``(2) Authority.--The Secretary may award grants, 
        contracts, or cooperative agreements to carry out paragraph 
        (1).
            ``(3) Coordination.--To the maximum extent practicable, the 
        Secretary shall ensure that activities conducted under 
        paragraph (1) are coordinated with existing laboratory 
        preparedness activities.
            ``(4) Local discretion.--Use of regional laboratories, if 
        established under paragraph (1), shall be at the discretion of 
        the public health agencies of the States.
            ``(5) Prohibited uses.--An eligible entity may not use 
        amounts received under this subsection to--
                    ``(A) purchase or improve land or purchase any 
                building or other facility; or
                    ``(B) construct, repair, or alter any building or 
                other facility.
            ``(6) Supplement not supplant.--Funds appropriated under 
        this subsection shall be used to supplement and not supplant 
        other Federal, State, and local public funds provided for 
        activities under this subsection.
            ``(7) Authorization of appropriations.--There is authorized 
        to be appropriated to carry out this subsection, $59,500,000 
        for fiscal year 2002, and such sums as may be necessary for 
        each of fiscal years 2003 through 2006.''.
    (b) Education and Training.--Section 319F(e) of the Public Health 
Service Act (42 U.S.C. 247d6(e)) is amended by adding at the end the 
following flush sentence:
``The education and training activities described in this subsection 
may be carried out through Public Health Preparedness Centers, Noble 
training facilities, the Emerging Infections Program, and the Epidemic 
Intelligence Service.''.

           Subtitle B--Coordination of Efforts and Responses

SEC. 211. ASSISTANT SECRETARY FOR EMERGENCY PREPAREDNESS; NATIONAL 
              DISASTER MEDICAL SYSTEM.

    Title XXVIII of the Public Health Service Act, as added by section 
101, and amended by section 201, is further amended by adding at the 
end the following:

``SEC. 2813. ASSISTANT SECRETARY FOR EMERGENCY PREPAREDNESS.

    ``(a) Appointment of Assistant Secretary for Emergency 
Preparedness.--The President, with the advice and consent of the 
Senate, shall appoint an individual to serve as the Assistant Secretary 
for Emergency Preparedness who shall head the Office for Emergency 
Preparedness. Such Assistant Secretary shall report to the Secretary.
    ``(b) Duties.--Subject to the authority of the Secretary, the 
Assistant Secretary for Emergency Preparedness shall--
            ``(1) serve as the principal adviser to the Secretary on 
        matters relating to emergency preparedness, including preparing 
        for and responding to biological threats or attacks and for 
        developing policy; and
            ``(2) coordinate all functions within the Department of 
        Health and Human Services relating to emergency preparedness, 
        including preparing for and responding to biological threats or 
        attacks.

``SEC. 2814. NATIONAL DISASTER MEDICAL SYSTEM.

    ``(a) National Disaster Medical System.--
            ``(1) In general.--There shall be operated a system to be 
        known as the National Disaster Medical System (in this section 
        referred to as the `National System') which shall be 
        coordinated by the Secretary, in collaboration with the 
        Secretary of Defense, the Secretary of Veterans Affairs, and 
        the Director of the Federal Emergency Management Agency.
            ``(2) Functions.--The National System shall provide 
        appropriate health services, health-related social services 
        and, if necessary, auxiliary services (including mortuary and 
        veterinary services) to respond to the needs of victims of a 
        public health emergency if the Secretary activates the System 
        with respect to the emergency. The National System shall carry 
        out such ongoing activities as may be necessary to prepare for 
        the provision of such services.
    ``(b) Temporary Disaster-Response Personnel.--
            ``(1) In general.--For the purpose of assisting the Office 
        of Emergency Preparedness and the National System in carrying 
        out duties under this section, the Secretary may in accordance 
        with section 316.401 of title 5, Code of Federal Regulations 
        (including revisions to such section), and notwithstanding the 
        eligibility requirements set forth in paragraphs (1) through 
        (8) of section 316.402(b) of such title (including revisions), 
        make temporary appointments of individuals to intermittent 
        positions to serve as personnel of such Office or System.
            ``(2) Travel and subsistence.--An individual appointed 
        under paragraph (1) shall, in accordance with subchapter I of 
        chapter 57 of title 5, United States Code, be eligible for 
        travel, subsistence, and other necessary expenses incurred in 
        carrying out the duties for which the individual was appointed, 
        including per diem in lieu of subsistence.
            ``(3) 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. Participation in training programs carried out by 
        the Office of Emergency Preparedness or Federal personnel of 
        the National System shall be considered within the scope of 
        such an appointment (regardless of whether the individual 
        receives compensation for such participation).
    ``(c) Temporary Disaster-Response Appointee.--For purposes of this 
section, the term `temporary disaster-response appointee' means an 
individual appointed by the Secretary under subsection (b).
    ``(d) Compensation for Work Injuries.--A temporary disaster-
response appointee, as designated by the Secretary, shall be deemed an 
employee, and an injury sustained by such an individual while actually 
serving or while participating in a uncompensated training exercise 
related to such service 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. In the event of an injury to such a 
temporary disaster-response appointee, the Secretary of Labor shall be 
responsible for making determinations as to whether the claimants are 
entitled to compensation or other benefits in accordance with chapter 
81 of title 5, United States Code.
    ``(e) Employment and Reemployment Rights.--
            ``(1) In general.--A temporary disaster-response appointee, 
        as designated by the Secretary, shall, when performing service 
        as a temporary disaster-response appointee or participating in 
        an uncompensated training exercise related to such service, be 
        deemed a person performing `service in the uniformed services' 
        for purposes of chapter 43 of title 38, United States Code, 
        pertaining to employment and reemployment rights of members in 
        the uniformed services. 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.
            ``(2) Notice of absence from position of employment.--
        Preclusion of giving notice of service by disaster response 
        necessity 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 disaster response necessity 
        shall be made pursuant to regulations prescribed by the 
        Secretary, in consultation with the Secretary of Defense, and 
        shall not be subject to judicial review.
    ``(f) Limitation.--A temporary disaster-response appointee shall 
not be deemed an employee of the Public Health Service or the Office of 
Emergency Preparedness for purposes other than those specifically set 
forth in this section.''.

SEC. 212. EXPANDED AUTHORITY OF THE SECRETARY OF HEALTH AND HUMAN 
              SERVICES TO RESPOND TO PUBLIC HEALTH EMERGENCIES.

    (a) Provision of Declaration to Congress.--Section 319(a) of the 
Public Health Service Act (42 U.S.C. 247d(a)) is amended by adding at 
the end the following: ``Not later than 48 hours after a declaration of 
a public health emergency under this section, the Secretary shall 
provide a written declaration to Congress indicating that an emergency 
under this section has been declared.''.
    (b) Waiver of Reporting Deadlines.--Section 319 of the Public 
Health Service Act (42 U.S.C. 247d) is amended by adding at the end the 
following:
    ``(d) Waiver of 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 any sanctions otherwise applicable to such failure to 
comply.''.
    (c) Emergency Declaration Period.--Section 319 of the Public Health 
Service Act (42 U.S.C. 247d), as amended by subsection (b), is further 
amended by adding at the end the following:
    ``(e) Emergency Declaration Period.--A determination by the 
Secretary under subsection (a) that a public health emergency exists 
shall remain in effect for not longer than the 180-day period beginning 
on the date of the determination. Such period may be extended by the 
Secretary if--
            ``(1) the Secretary determines that such an extension is 
        appropriate; and
            ``(2) the Secretary provides a written notification to 
        Congress within 48 hours of such extension.''.

SEC. 213. PUBLIC HEALTH PREPAREDNESS AND RESPONSE TO A BIOTERRORIST 
              ATTACK.

    Section 319F of the Public Health Service Act (42 U.S.C. 247d-6) is 
amended by striking subsections (a) and (b), and inserting the 
following:
    ``(a) Working Group on 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 Labor, and the Secretary of 
Agriculture, and with other similar Federal officials as determined 
appropriate, shall establish a joint interdepartmental working group on 
the prevention, preparedness, and response to a biological threat or 
attack on the civilian population. Such joint working group shall--
            ``(1) prioritize countermeasures required to treat, 
        prevent, or identify exposure to a biological agent or toxin 
        pursuant to section 351A;
            ``(2) coordinate and facilitate the awarding of grants, 
        contracts, or cooperative agreements for the development, 
        manufacture, distribution, and purchase of priority 
        countermeasures;
            ``(3) coordinate research on pathogens likely to be used in 
        a biological threat or attack on the civilian population;
            ``(4) develop shared standards for equipment to detect and 
        to protect against biological agents and toxins;
            ``(5) coordinate the development, maintenance, and 
        procedures for the release of materials from the Strategic 
        National Pharmaceutical Stockpile;
            ``(6) assess the priorities for and enhance the 
        preparedness of public health institutions, providers of 
        medical care, and other emergency service personnel (including 
        firefighters) to detect, diagnose, and respond (including 
        mental health response) to a biological threat or attack;
            ``(7) in the recognition that medical and public health 
        professionals are likely to provide much of the first response 
        to such an attack, develop, coordinate, enhance, and assure the 
        quality of joint planning and training programs that address 
        the public health and medical consequences of a biological 
        threat or attack on the civilian population between--
                    ``(A) local firefighters, ambulance personnel, 
                police and public security officers, or other emergency 
                response personnel; and
                    ``(B) hospitals, primary care facilities, and 
                public health agencies;
            ``(8) coordinate the development of strategies for Federal, 
        State, and local agencies to communicate information to the 
        public regarding biological threats or attacks;
            ``(9) develop methods to decontaminate facilities 
        contaminated as a result of a biological attack, including 
        appropriate protections for the safety of those conducting such 
        activities; and
            ``(10) ensure that the activities under this subsection 
        address the needs of children and other vulnerable populations.
The working group shall carry out paragraphs (1) and (2) in 
consultation with the pharmaceutical, biotechnology, and medical device 
industries, and other appropriate experts.
    ``(b) Advice to the Secretary.--The Secretary shall establish 
advisory committees to provide expert recommendations to the Secretary 
to assist the Secretary, including the following:
            ``(1) National task force on children and terrorism.--
                    ``(A) In general.--The National Task Force on 
                Children and Terrorism, which shall be composed of such 
                Federal officials as may be appropriate to address the 
                special needs of children, and child health experts on 
                infectious disease, environmental health, toxicology, 
                and other relevant professional disciplines.
                    ``(B) Duties.--The task force described in 
                subparagraph (A) shall provide recommendations to the 
                Secretary regarding--
                            ``(i) the preparedness of the 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 with respect to a 
                        biological threat or attack; and
                            ``(iii) changes, if necessary, to the 
                        Strategic National Pharmaceutical Stockpile, to 
                        meet the special needs of children.
            ``(2) Emergency public information and communications task 
        force.--
                    ``(A) In general.--The Emergency Public Information 
                and Communications (EPIC) Task Force, which shall be 
                composed of individuals with expertise in public 
                health, communications, behavioral psychology, and 
                other areas determined appropriate by the Secretary.
                    ``(B) Duties.--The task force described in 
                subparagraph (A) shall make recommendations and report 
                to the Secretary on appropriate ways to communicate 
                information regarding biological threats or attacks to 
                the public, including public service announcements or 
                other appropriate means to communicate in a manner that 
                maximizes information and minimizes panic, and includes 
                information relevant to children and other vulnerable 
                populations.
            ``(3) Sunset.--Each Task Force established under paragraphs 
        (1) and (2) shall terminate on the date that is 1 year after 
        the date of enactment of the Bioterrorism Preparedness Act of 
        2001.''.

SEC. 214. THE OFFICIAL FEDERAL INTERNET SITE ON BIOTERRORISM.

    It is the recommendation of Congress that there should be 
established an official Federal Internet site on bioterrorism, either 
directly or through provision of a grant to an entity that has 
expertise in bioterrorism and the development of websites, that should 
include information relevant to diverse populations (including messages 
directed at the general public and such relevant groups as medical 
personnel, public safety workers, and agricultural workers) and links 
to appropriate State and local government sites.

SEC. 215. TECHNICAL AMENDMENTS.

    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 (f), by inserting ``$420,000,000 for 
        fiscal year 2002,'' after ``2001,''.

SEC. 216. REGULATION OF 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 BIOLOGICAL AGENTS AND TOXINS.

    ``(a) Regulatory Control of Biological Agents and Toxins.--
            ``(1) List of biological agents and toxins.--
                    ``(A) In general.--The Secretary shall by 
                regulation establish and maintain a list of each 
                biological agent and each toxin that has the potential 
                to pose a severe threat to public health and safety.
                    ``(B) Criteria.--In determining whether to include 
                an agent or toxin on the list under subparagraph (A), 
                the Secretary shall--
                            ``(i) consider--
                                    ``(I) the effect on human health of 
                                exposure to the agent or toxin;
                                    ``(II) the degree of contagiousness 
                                of the agent or toxin and the methods 
                                by which the agent or toxin is 
                                transferred to humans;
                                    ``(III) the availability and 
                                effectiveness of pharmacotherapies and 
                                immunizations to treat and prevent any 
                                illness resulting from infection by the 
                                agent or toxin; and
                                    ``(IV) any other criteria, 
                                including the needs of children and 
                                other vulnerable populations, that the 
                                Secretary considers appropriate; and
                            ``(ii) consult with appropriate Federal 
                        departments and agencies, and scientific 
                        experts representing appropriate professional 
                        groups, including those with pediatric 
                        expertise.
            ``(2) Biennial review.--The Secretary shall review and 
        republish the list under paragraph (1) biennially, or more 
        often as needed, and shall, through rulemaking, revise the list 
        as necessary to incorporate additions or deletions to ensure 
        public health, safety, and security.
            ``(3) Exemptions.--The Secretary may exempt from the list 
        under paragraph (1)--
                    ``(A) attenuated or inactive biological agents or 
                toxins used in biomedical research or for legitimate 
                medical purposes; and
                    ``(B) products that are cleared or approved under 
                the Federal Food, Drug, and Cosmetic Act or under the 
                Virus-Serum-Toxin Act, as amended in 1985 by the Food 
                Safety and Security Act.'';
    ``(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.--Regulations under 
subsections (b) and (c) shall require registration for 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 biological agents and toxins with information 
regarding their characterizations.
    ``(e) Inspections.--The Secretary shall have the authority to 
inspect persons subject to the regulations under subsections (b) and 
(c) to ensure their compliance with such regulations, including 
prohibitions on restricted persons under subsection (g).
    ``(f) Exemptions.--
            ``(1) In general.--The Secretary shall establish 
        exemptions, including exemptions from the security provisions, 
        from the applicability of provisions of--
                    ``(A) the regulations issued under subsections (b) 
                and (c) when the Secretary determines that the 
                exemptions, including exemptions from the security 
                requirements for the use of attenuated or inactive 
                biological agents or toxins in biomedical research or 
                for legitimate medical purposes, are consistent with 
                protecting public health and safety; and
                    ``(B) the regulations issued under subsection (c).
            ``(2) Clinical laboratories.--The Secretary shall exempt 
        clinical laboratories and other persons that possess, use, or 
        transfer biological agents and toxins listed pursuant to 
        subsection (a)(1) from the applicability of provisions of 
        regulations issued under subsections (b) and (c) only when--
                    ``(A) such agents or toxins are presented for 
                diagnosis, verification, or proficiency testing;
                    ``(B) the identification of such agents and toxins 
                is, when required under Federal or State law, reported 
                to the Secretary or other public health authorities; 
                and
                    ``(C) such agents or toxins are transferred or 
                destroyed in a manner set forth by the Secretary in 
                regulation.
    ``(g) Security Requirements for Registered Persons.--
            ``(1) Security.--In carrying out paragraphs (2) and (3) of 
        subsection (b), the Secretary shall establish appropriate 
        security requirements for persons possessing, using, or 
        transferring biological agents and toxins listed pursuant to 
        subsection (a)(1), considering existing standards developed by 
        the Attorney General for the security of government facilities, 
        and shall ensure compliance with such requirements as a 
        condition of registration under regulations issued under 
        subsections (b) and (c).
            ``(2) Limiting access to listed agents and toxins.--
        Regulations issued under subsections (b) and (c) shall include 
        provisions--
                    ``(A) to restrict access to biological agents and 
                toxins listed pursuant to subsection (a)(1) only to 
                those individuals who need to handle or use such agents 
                or toxins; and
                    ``(B) to provide that registered persons promptly 
                submit the names and other identifying information for 
                such individuals to 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--
                            ``(i) are restricted persons, as defined in 
                        section 175b of title 18, United States Code; 
                        or
                            ``(ii) are named in a warrant issued to a 
                        Federal or State law enforcement agency for 
                        participation in any domestic or international 
                        act of terrorism.
            ``(3) Consultation and implementation.--Regulations under 
        subsections (b) and (c) shall be developed in consultation with 
        research-performing organizations, including universities, and 
        implemented with timeframes that take into account the need to 
        continue research and education using biological agents and 
        toxins listed pursuant to subsection (a)(1).
    ``(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), or any site-specific 
        information relating to the type, quantity, or characterization 
        of a biological agent or toxin listed pursuant to subsection 
        (a)(1) or the site-specific security mechanisms in place to 
        protect such agents and toxins, including the national database 
        required in subsection (d), 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.--Any person who violates a regulation 
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. 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) of such section) 
shall apply to civil money penalties under this subsection 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 section in the same manner as provided in section 
1128A(j)(2) of such Act and such authority shall include all powers 
described in section 6 of the Inspector General Act of 1978 (5 U.S.C. 
App. 2)
    ``(j) Definitions.--For purposes of this section, the terms 
`biological agent' and `toxin' have the same meaning as in section 178 
of title 18, United States Code.''.
            (2) Regulations.--
                    (A) Date certain for promulgation; effective date 
                regarding criminal and civil penalties.--Not later than 
                180 days after the date of the enactment of this title, 
                the Secretary of Health and Human Services shall 
                promulgate an interim final rule for carrying out 
                section 351A(c) of the Public Health Service Act, which 
                amends the Antiterrorism and Effective Death Penalty 
                Act of 1996. Such interim final rule will take effect 
                60 days after the date on which such rule is 
                promulgated, including for purposes of--
                            (i) section 175(b) of title 18, United 
                        States Code (relating to criminal penalties), 
                        as added by subsection (b)(1)(B) of this 
                        section; and
                            (ii) section 351A(i) of the Public Health 
                        Service Act (relating to civil penalties).
                    (B) Submission of registration applications.--A 
                person required to register for possession under the 
                interim final rule promulgated under subparagraph (A) 
                shall submit an application for such registration not 
                later than 60 days after the date on which such rule is 
                promulgated.
            (3) 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.
            (4) Effective date.--Paragraph (1) shall take effect as if 
        incorporated in the Antiterrorism and Effective Death Penalty 
        Act of 1996, and any regulations, including the list under 
        subsection (d)(1) of section 511 of that Act, issued under 
        section 511 of that Act shall remain in effect as if issued 
        under section 351A of the Public Health Service Act.
    (b) Select Agents.--
            (1) In general.--Section 175 of title 18, United States 
        Code, as amended by the Uniting and Strengthening America by 
        Providing Appropriate Tools Required to Intercept and Obstruct 
        Terrorism (USA PATRIOT ACT) Act of 2001 (Public Law 107-56), is 
        amended--
                    (A) by redesignating subsections (b) and (c) as 
                subsections (c) and (d), respectively; and
                    (B) by inserting after subsection (a) the 
                following:
    ``(b) Select Agents.--
            ``(1) 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 regulation issued 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) Transfer to unregistered person.--Whoever transfers a 
        select agent to a person who the transferor has reason to 
        believe has not obtained a registration required by regulations 
        issued under section 351A(b) or (c) of the Public Health 
        Service Act shall be fined under this title, or imprisoned for 
        not more than 5 years, or both.''.
            (2) Definitions.--Section 175 of title 18, United States 
        Code, as amended by paragraph (1), is further amended by 
        striking subsection (d) and inserting the following:
    ``(d) Definitions.--As used in this section:
            ``(1) The terms `biological agent' and `toxin' have the 
        meanings given such terms in section 178, except that, for 
        purposes of subsections (b) and (c), such terms do not 
        encompass any biological agent or toxin that is in its 
        naturally occurring environment, if the biological agent or 
        toxin has not been cultivated, cultured, collected, or 
        otherwise extracted from its natural source.
            ``(2) The term `for use as a weapon' includes the 
        development, production, transfer, acquisition, retention, or 
        possession of any biological agent, toxin, or delivery system, 
        other than for prophylactic, protective, or other peaceful 
        purposes.
            ``(3) The term `select agent' means a biological agent or 
        toxin, as defined in paragraph (1), that is on the list that is 
        in effect pursuant to section 511(d)(1) of the Antiterrorism 
        and Effective Death Penalty Act of 1996 (Public Law 104-132), 
        or as subsequently revised under section 351A(a) of the Public 
        Health Service Act.''.
            (3) Conforming amendment.--
                    (A) Section 175(a) of title 18, United States Code, 
                is amended in the second sentence by striking ``under 
                this section'' and inserting ``under this subsection''.
                    (B) Section 175(c) of title 18, United States Code, 
                (as redesignated by paragraph (1)), is amended by 
                striking the second sentence.
    (c) 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, 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 section 351A(a)(1) of the Public Health Service Act;
            (3) describes the actions to date and future plans of the 
        Secretary for determining compliance with regulations under 
        such section 351A of the Public Health Service Act and for 
        taking appropriate enforcement actions; and
            (4) provides any recommendations of the Secretary for 
        administrative or legislative initiatives regarding such 
        section 351A of the Public Health Service Act.

           TITLE III--IMPROVING STATE AND LOCAL PREPAREDNESS

 Subtitle A--Emergency Measures to Improve State and Local Preparedness

SEC. 301. STATE BIOTERRORISM PREPAREDNESS AND RESPONSE BLOCK GRANT.

    (a) In General.--Section 319F of the Public Health Service Act (42 
U.S.C. 247d-6) is amended by striking subsection (c) and inserting the 
following:
    ``(c) State Bioterrorism Preparedness and Response Block Grants.--
            ``(1) In general.--The Secretary shall establish the State 
        Bioterrorism Preparedness and Response Block Grant Program 
        (referred to in this subsection as the `Program') under which 
        the Secretary shall award grants to or enter into cooperative 
        agreements with States, the District of Columbia, and 
        territories (referred to in this section as `eligible 
        entities') to enable such entities to prepare for and respond 
        to biological threats or attacks. The Secretary shall ensure 
        that activities conducted under this section are coordinated 
        with the activities conducted under this section and section 
        319C.
            ``(2) Eligibility.--To be eligible to receive amounts under 
        paragraph (1), a State, the District of Columbia, or a 
        territory shall prepare and submit to the Secretary an 
        application at such time, in such manner, and containing such 
        information as the Secretary may require, including an 
        assurance that the entity will--
                    ``(A) not later than 180 days after the date on 
                which a grant or contract is received under this 
                subsection, prepare and submit to the Secretary a 
                Bioterrorism Preparedness and Response Plan in 
                accordance with subsection (c);
                    ``(B) not later than 180 days after the date on 
                which a grant or contract is received under this 
                subsection, complete an assessment under section 
                319B(a), or an assessment that is substantially 
                equivalent as determined by the Secretary unless such 
                assessment has already been performed; and
                    ``(C) establish a means by which to obtain public 
                comment and input on the plan and plan implementation 
                that shall include an advisory committee or other 
                similar mechanism for obtaining input from the public 
                at large as well as other stakeholders;
                    ``(D) use amounts received under paragraph (1) in 
                accordance with the plan submitted under paragraph (3), 
                including making expenditures to carry out the strategy 
                contained in the plan;
                    ``(E) use amounts received under paragraph (1) to 
                supplement and not supplant funding at levels in 
                existence prior to September 11, 2001 for public health 
                capacities or bioterrorism preparedness; and
                    ``(F) with respect to the plan under paragraph (3), 
                establish reasonable criteria to evaluate the effective 
                performance of entities that receive funds under the 
                grant or agreement and shall include relevant 
                benchmarks in the plan.
            ``(3) Bioterrorism preparedness and response plan.--Not 
        later than 180 days after receiving amounts under this 
        subsection, and 1 year after such date, a State, the District 
        of Columbia, or a territory shall prepare and submit to the 
        Secretary a Bioterrorism Preparedness and Response Plan for 
        responding to biological threats or attacks. Recognizing the 
        assessment of public health capacity conducted under section 
        319B, such plan shall include--
                    ``(A) a description of the program that the 
                eligible entity will adopt to achieve the core 
                capacities developed under section 319A, including 
                measures that meet the needs of children and other 
                vulnerable populations;
                    ``(B) a description (including amounts expended by 
                the eligible entity for such purpose) of the programs, 
                projects, and activities that the eligible entity will 
                implement using amounts received in order to detect and 
                respond to biological threats or attacks, including the 
                manner in which the eligible entity will manage State 
                surveillance and response efforts and coordinate such 
                efforts with national efforts;
                    ``(C) a description of the training initiatives 
                that the eligible entity has carried out to improve its 
                ability to detect and respond to a biological threat or 
                attack, including training and planning to protect the 
                health and safety of those conducting such detection 
                and response activities;
                    ``(D) a description of the cleanup and 
                contamination prevention efforts that may be 
                implemented in the event of a biological threat or 
                attack;
                    ``(E) a description of efforts to ensure that 
                hospitals and health care providers have adequate 
                capacity and plans in place to provide health care 
                items and services (including mental health services 
                and services to meet the needs of children and other 
                vulnerable populations that may include the provision 
                of telehealth services) in the event of a biological 
                threat or attack; and
                    ``(F) other information the Secretary may by 
                regulation require.
            ``Nothing in subparagraph (E) shall be construed to require 
        or recommend that States establish or maintain stockpiles of 
        vaccines, therapies, or other medical supplies.
            ``(4) Use of funds.--
                    ``(A) In general.--In coordination with the 
                activities conducted under this section, an eligible 
                entity shall use amounts received under this section 
                to--
                            ``(i) conduct the assessment under section 
                        319B to achieve the capacities described in 
                        section 319A, if the assessment has not 
                        previously been conducted;
                            ``(ii) achieve the public health capacities 
                        developed under section 319A; and
                            ``(iii) carry out the plan under paragraph 
                        (3).
                    ``(B) Additional uses.--In addition to the 
                activities described in subparagraph (A), an eligible 
                entity may use amounts received under this subsection 
                to--
                            ``(i) improve surveillance, detection, and 
                        response activities to prepare for emergency 
                        response activities including biological 
                        threats or attacks, including training 
                        personnel in these and other necessary 
                        functions;
                            ``(ii) carry out activities to improve 
                        communications and coordination efforts within 
                        the eligible entity and between the eligible 
                        entity and the Federal Government, including 
                        activities to improve information technology 
                        and communications equipment available to 
                        health care and public health officials for use 
                        in responding to a biological threat or attack 
                        or other public health emergency and including 
                        early warning and surveillance networks that 
                        use advanced information technology to provide 
                        early detection of biological threats or 
                        attacks;
                            ``(iii) plan for triage and transport 
                        management in the event of a biological threat 
                        or attack;
                            ``(iv) meet the special needs of children 
                        and other vulnerable populations during and 
                        after a biological threat or attack, including 
                        the expansion of 2-1-1 call centers or other 
                        universal hotlines, or an alternative 
                        communication plan to assist victims and their 
                        families in receiving timely information;
                            ``(v) improve the ability of hospitals and 
                        other health care facilities to provide 
                        effective health care (including mental health 
                        care) during and after a biological threat or 
                        attack, including the development of model 
                        hospital preparedness plans by a hospital 
                        accreditation organization or similar 
                        organizations; and
                            ``(vi) enhance the safety of workplaces in 
                        the event of a biological threat or attack, 
                        except that nothing in this clause shall be 
                        construed to create a new, or deviate from an 
                        existing, authority to regulate, modify, or 
                        otherwise effect safety and health rules and 
                        standards.
                    ``(C) Prohibited uses.--An eligible entity may not 
                use amounts received under this subsection to--
                            ``(i) provide inpatient services;
                            ``(ii) make cash payments to intended 
                        recipients of health services;
                            ``(iii) purchase or improve land or 
                        purchase any building or other facility;
                            ``(iv) construct, repair, or alter any 
                        building or other facility; or
                            ``(v) satisfy any requirement for the 
                        expenditure of non-Federal funds as a condition 
                        for the receipt of Federal funds.
            ``(5) Amount of grant.--
                    ``(A) In general.--Except as provided in paragraph 
                (2), the amount awarded to a State, the District of 
                Columbia, or a territory under this subsection for a 
                fiscal year shall be an amount that bears the same 
                ratio to the amount appropriated under paragraph (9) 
                for such fiscal year (and remaining after amounts are 
                made available under subparagraphs (C) and (D)) as the 
                total population of the State, District, or territory 
                bears to the total population of the United States.
                    ``(B) Exceptions.--
                            ``(i) Minimum amount with respect to 
                        states.--Notwithstanding subparagraph (A) and 
                        subject to the extent of amounts made available 
                        under paragraph (9), a State may not receive an 
                        award under this subsection for a fiscal year 
                        in an amount that is less than--
                                    ``(I) $5,000,000 for any fiscal 
                                year in which the total amount 
                                appropriated under this subsection 
                                equals or exceeds $667,000,000; or
                                    ``(II) 0.75 percent of the total 
                                amount appropriated under this 
                                subsection for any fiscal year in which 
                                such total amount is less than 
                                $667,000,000.
                            ``(ii) Extraordinary needs.--
                                    ``(I) In general.--Notwithstanding 
                                subparagraph (A) and subject to the 
                                extent of amounts made available under 
                                paragraph (9), the Secretary may 
                                provide additional funds to a State, 
                                District, or territory under this 
                                subsection if the Secretary determines 
                                that such State, District, or territory 
                                has extraordinary needs with respect to 
                                bioterrorism preparedness.
                                    ``(II) Finding with respect to the 
                                district of columbia.--As a result of 
                                the concentration of entities of 
                                national significance located within 
                                the District of Columbia, Congress 
                                finds that the District of Columbia has 
                                extraordinary needs with respect to 
                                bioterrorism preparedness, and the 
                                Secretary shall recognize such finding 
                                for purposes of subclause (I).
                    ``(C) Rule with respect to unexpended funds.--To 
                the extent that all the funds appropriated under 
                paragraph (9) for a fiscal year and available in such 
                fiscal year are not otherwise paid to eligible entities 
                because--
                            ``(i) one or more eligible entities have 
                        not submitted an application or public health 
                        disaster plan in accordance with paragraphs (2) 
                        and (3) for the fiscal year;
                            ``(ii) one or more eligible entities have 
                        notified the Secretary that they do not intend 
                        to use the full amount awarded under this 
                        subsection; or
                            ``(iii) some eligible entity amounts are 
                        offset or repaid;
                such excess shall be provided to each of the remaining 
                eligible entities in proportion to the amount otherwise 
                provided to such entities under this paragraph for the 
                fiscal year without regard to this subparagraph.
                    ``(D) Availability of funds.--Any amount paid to an 
                eligible entity for a fiscal year under this subsection 
                and remaining unobligated at the end of such year shall 
                remain available for the next fiscal year to such 
                entity for the purposes for which it was made.
            ``(6) Indian tribes.--
                    ``(A) In general.--If the Secretary--
                            ``(i) receives a request from the governing 
                        body of an Indian tribe or tribal organization 
                        within any State that funds under this 
                        subsection be provided directly by the 
                        Secretary to such tribe or organization; and
                            ``(ii) determines that the members of such 
                        tribe or tribal organization would be better 
                        served by means of grants or agreements made 
                        directly by the Secretary under this 
                        subsection;
                the Secretary shall reserve from amounts which would 
                otherwise be provided to such State under this 
                subsection for the fiscal year the amount determined 
                under subparagraph (B).
                    ``(B) Amount.--The Secretary shall reserve for the 
                purpose of subparagraph (A) from amounts that would 
                otherwise be paid to such State under paragraph (1) an 
                amount equal to the amount which bears the same ratio 
                to the amount awarded to the State for the fiscal year 
                involved as the population of the Indian tribe or the 
                individuals represented by the tribal organization 
                bears to the total population of the State.
                    ``(C) Grant.--The amount reserved by the Secretary 
                on the basis of a determination under this paragraph 
                shall be granted to the Indian tribe or tribal 
                organization serving the individuals for whom such a 
                determination has been made.
                    ``(D) Plan.--In order for an Indian tribe or tribal 
                organization to be eligible for a grant for a fiscal 
                year under this paragraph, it shall submit to the 
                Secretary a plan for such fiscal year which meets such 
                criteria as the Secretary may prescribe.
                    ``(E) Definitions.--In this paragraph, the terms 
                `Indian tribe' and `tribal organization' have the same 
                meaning given such terms in section 4(b) and section 
                4(c) of the Indian Self-Determination and Education 
                Assistance Act.
            ``(7) Withholding.--
                    ``(A) Requirements.--
                            ``(i) In general.--The Secretary shall, 
                        after adequate notice and an opportunity for a 
                        hearing conducted within the affected eligible 
                        entity, withhold or recoup funds from any such 
                        entity that does not use amounts received under 
                        this subsection in accordance with the 
                        requirements of this subsection. The Secretary 
                        shall withhold or recoup such funds until the 
                        Secretary finds that the reason for the 
                        withholding or recoupment has been removed and 
                        there is reasonable assurance that it will not 
                        recur.
                            ``(ii) Investigation.--The Secretary may 
                        not institute proceedings to withhold or recoup 
                        funds under clause (i) unless the Secretary has 
                        conducted an investigation concerning whether 
                        the eligible entity has used grant or agreement 
                        amounts in accordance with the requirements of 
                        this subsection. Investigations required by 
                        this clause shall be conducted within the 
                        affected entity by qualified investigators.
                            ``(iii) Response to complaints.--The 
                        Secretary shall respond in an expeditious 
                        manner to complaints of a substantial or 
                        serious nature that an eligible entity has 
                        failed to use funds in accordance with the 
                        requirements of this subsection.
                            ``(iv) Minor failures.--The Secretary may 
                        not withhold or recoup funds under clause (i) 
                        from an eligible entity for a minor failure to 
                        comply with the requirements of this 
                        subsection.
                    ``(B) Availability of information for inspection.--
                Each eligible entity, and other entity which has 
                received funds under this section, shall make 
                appropriate books, documents, papers, and records 
                available to the Secretary or the Comptroller General 
                of the United States, or any of their duly authorized 
                representatives, for examination, copying, or 
                mechanical reproduction on or off the premises of the 
                appropriate entity upon a reasonable request therefore.
                    ``(C) Limitation on requests for information.--
                            ``(i) In general.--In conducting any 
                        investigation in an eligible entity, the 
                        Secretary or the Comptroller General of the 
                        United States may not make a request for any 
                        information not readily available to such 
                        eligible entity, or an entity which has 
                        received funds under this subsection, or make 
                        an unreasonable request for information to be 
                        compiled, collected, or transmitted in any form 
                        not readily available.
                            ``(ii) Judicial proceedings.--Clause (i) 
                        does not apply to the collection, compilation, 
                        or transmittal of data in the course of a 
                        judicial proceeding.
            ``(8) Definition.--In this subsection, the term `State' 
        means any of the several States.
            ``(9) Authorization of appropriations.--There is authorized 
        to be appropriated to carry out this subsection, $667,000,000 
        for fiscal year 2002, and such sums as may be necessary for 
        fiscal year 2003, and no funds are authorized to be 
        appropriated for subsequent fiscal years.''.
    (b) Reauthorization of Other Programs.--Section 319F(i) of the 
Public Health Service Act (42 U.S.C. 247d-6(i)) is amended to read as 
follows:
    ``(i) Authorization of Appropriations.--There are authorized to be 
appropriated--
            ``(1) to carry out subsection (d), $370,000,000 for fiscal 
        year 2002, and such sums as may be necessary for each 
        subsequent fiscal year through 2006; and
            ``(2) to carry out subsections (a), (b), and (e) through 
        (i), such sums as may be necessary for each of fiscal years 
        2002 through 2006.''.

   Subtitle B--Improving Local Preparedness and Response Capabilities

SEC. 311. DESIGNATED BIOTERRORISM RESPONSE MEDICAL CENTERS.

    Section 319F of the Public Health Service Act (42 U.S.C. 247d-6) is 
amended--
            (1) by redesignating subsections (d) through (h) and (i), 
        as subsections (e) through (i) and (l), respectively; and
            (2) by inserting after subsection (c), the following:
    ``(d) Designated Bioterrorism Response Medical Centers.--
            ``(1) Grants.--The Secretary shall award project grants to 
        eligible entities to enable such entities, in a manner 
        consistent with applicable provisions of the Bioterrorism 
        Preparedness and Response Plan, to improve local and 
        bioterrorism response medical center preparedness.
            ``(2) Eligibility.--To be eligible for a grant under 
        paragraph (1), an entity shall--
                    ``(A) be a consortium that consists of at least one 
                entity from each of the following categories--
                            ``(i) a hospital including children's 
                        hospitals, clinic, health center, or primary 
                        care facility;
                            ``(ii) a political subdivision of a State; 
                        and
                            ``(iii) a department of public health;
                    ``(B) prepare, in consultation with the Chief 
                Executive Officer of the State, District, or territory 
                in which the hospital, clinic, health center, or 
                primary care facility is located, and submits to the 
                Secretary, an application at such time, in such manner, 
                and containing such information as the Secretary may 
                require;
                    ``(C) within a reasonable period of time after 
                receiving a grant under paragraph (1), meet such 
                technical guidelines as may be applicable under 
                paragraph (4); and
                    ``(D) provide assurances satisfactory to the 
                Secretary that such entity shall, upon the request of 
                the Secretary or the Chief Executive Officer of the 
                State, District, or territory in which the entity is 
                located, during the emergency period, serve the needs 
                of the emergency area, including providing adequate 
                health care capacity, serving as a regional resource in 
                the diagnosis, treatment, or care for persons, 
                including children and other vulnerable populations, 
                exposed to a biological threat or attack, and accepting 
                the transfer of patients, where appropriate.
            ``(3) Use of funds.--An entity that receives a grant under 
        paragraph (1) shall use funds received under the grant for 
        activities that include--
                    ``(A) the training of health care professionals to 
                enhance the ability of such personnel to recognize the 
                symptoms of exposure to a potential biological threat 
                or attack and to provide treatment to those so exposed;
                    ``(B) the training of health care professionals to 
                recognize and treat the mental health consequences of a 
                biological threat or attack;
                    ``(C) increasing the capacity of such entity to 
                provide appropriate health care for large numbers of 
                individuals exposed to a biological threat or attack;
                    ``(D) the purchase of reserves of vaccines, 
                therapies, and other medical supplies to be used until 
                materials from the Strategic National Pharmaceutical 
                Stockpile arrive;
                    ``(E) training and planning to protect the health 
                and safety of personnel involved in responding to a 
                biological threat or attack; or
                    ``(F) other activities determined appropriate by 
                the Secretary.
            ``(4) Prohibited uses.--An eligible entity may not use 
        amounts received under this subsection to--
                    ``(A) purchase or improve land or purchase any 
                building or other facility; or
                    ``(B) construct, repair, or alter any building or 
                facility.
            ``(6) Technical assistance.--Not later than 180 days after 
        the date of enactment of the Bioterrorism Preparedness Act of 
        2001, the Secretary shall develop and publish technical 
        guidelines relating to equipment, training, treatment, 
        capacity, and personnel, relevant to the status as a 
        bioterrorism response medical center and the Secretary may 
        provide technical assistance to eligible entities, including 
        assistance to address the needs of children and other 
        vulnerable populations.''.

SEC. 312. 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. 313. TRAINING FOR PEDIATRIC ISSUES SURROUNDING BIOLOGICAL AGENTS 
              USED IN WARFARE AND TERRORISM.

    Section 319F(f) of the Public Health Service Act (42 U.S.C. 247d-
6(e)), as so redesignated by section 311, is amended--
            (1) in paragraph (1)--
                    (A) by inserting ``(including mental health care)'' 
                after ``and care''; and
                    (B) by striking ``and'' at the end;
            (2) in paragraph (2), by striking the period and inserting 
        ``; and''; and
            (3) by adding at the end the following:
            ``(3) develop educational programs for health care 
        professionals, recognizing the special needs of children and 
        other vulnerable populations.''.

SEC. 314. GENERAL ACCOUNTING OFFICE REPORT.

    Section 319F(h) of the Public Health Service Act (42 U.S.C. 247d-
6(g)), as so redesignated by section 311, is amended--
            (1) by striking ``Not later than 180 days after the date of 
        the enactment of this section, the'' and inserting ``The'';
            (2) in paragraph (3), by striking ``and'' at the end;
            (3) in paragraph (4), by striking the period and inserting 
        a semicolon; and
            (4) by adding at the end the following:
            ``(5) the activities and cost of the Civil Support Teams of 
        the National Guard in responding to biological threats or 
        attacks against the civilian population;
            ``(6) the activities of the working group described in 
        subsection (a) and the efforts made by such group to carry out 
        the activities described in such subsection;
            ``(7) the activities and cost of the 2-1-1 call centers and 
        other universal hotlines; and
            ``(8) the activities and cost of the development and 
        improvement of public health laboratory capacity.''.

SEC. 315. ADDITIONAL RESEARCH.

    Section 22 of the Occupational Safety and Health Act of 1970 (29 
U.S.C. 671) is amended by adding at the end the following:
    ``(h) Research Relating to Biological Threats or Attacks in the 
Workplace.--The Director shall enhance and expand research as deemed 
appropriate by the Director on the health and safety of workers who are 
at risk for biological threats or attacks in the workplace.''.

SEC. 316. SENSE OF THE SENATE.

    It is the sense of the Senate that--
            (1) many excellent university-based programs are already 
        functioning and developing important biodefense products and 
        solutions throughout the United States;
            (2) accelerating the crucial work done at university 
        centers and laboratories will contribute significantly to the 
        United States capacity to defend against any biological threat 
        or attack;
            (3) maximizing the effectiveness of, and extending the 
        mission of, established university programs would be one 
        appropriate use of the additional resources provided for in the 
        Bioterrorism Preparedness Act of 2001; and
            (4) Congress recognizes the importance of existing public 
        and private university-based research, training, public 
        awareness, and safety related biological defense programs in 
        the awarding of grants and contracts made in accordance with 
        this Act.

     TITLE IV--DEVELOPING NEW COUNTERMEASURES AGAINST BIOTERRORISM

SEC. 401. LIMITED ANTITRUST EXEMPTION.

    Section 2 of the Clayton Act (15 U.S.C. 13) is amended by adding at 
the end the following:
    ``(g) Limited Antitrust Exemption.--
            ``(1) Countermeasures development meetings.--
                    ``(A) Countermeasures development meetings and 
                consultations.--The Secretary may conduct meetings and 
                consultations with parties involved in the development 
                of priority countermeasures for the purpose of the 
                development, manufacture, distribution, purchase, or 
                sale of priority countermeasures consistent with the 
                purposes of this title. The Secretary shall give notice 
                of such meetings and consultations to the Attorney 
                General and the Chairperson of the Federal Trade 
                Commission (referred to in this subsection as the 
                `Chairperson').
                    ``(B) Meeting and consultation conditions.--A 
                meeting or consultation conducted under subparagraph 
                (A) shall--
                            ``(i) be chaired or, in the case of a 
                        consultation, facilitated by the Secretary;
                            ``(ii) be open to parties involved in the 
                        development, manufacture, distribution, 
                        purchase, or sale of priority countermeasures, 
                        as determined by the Secretary;
                            ``(iii) be open to the Attorney General and 
                        the Chairperson;
                            ``(iv) be limited to discussions involving 
                        the development, manufacture, distribution, or 
                        sale of priority countermeasures, consistent 
                        with the purposes of this title; and
                            ``(v) be conducted in such manner as to 
                        ensure that national security, confidential, 
                        and proprietary information is not disclosed 
                        outside the meeting or consultation.
                    ``(C) Minutes.--The Secretary shall maintain 
                minutes of meetings and consultations under this 
                subsection, which shall not be disclosed under section 
                552 of title 5, United States Code.
                    ``(D) Exemption.--The antitrust laws shall not 
                apply to meetings and consultations under this 
                paragraph, except that any agreement or conduct that 
                results from a meeting or consultation and that does 
                not receive an exemption pursuant to this subsection 
                shall be subject to the antitrust laws.
            ``(2) Written agreements.--The Secretary shall file a 
        written agreement regarding covered activities, made pursuant 
        to meetings or consultations conducted under paragraph (1) and 
        that is consistent with this paragraph, with the Attorney 
        General and the Chairperson for a determination of the 
        compliance of such agreement with antitrust laws. In addition 
        to the proposed agreement itself, any such filing shall 
        include--
                    ``(A) an explanation of the intended purpose of the 
                agreement;
                    ``(B) a specific statement of the substance of the 
                agreement;
                    ``(C) a description of the methods that will be 
                utilized to achieve the objectives of the agreement;
                    ``(D) an explanation of the necessity of a 
                cooperative effort among the particular participating 
                parties to achieve the objectives of the agreement; and
                    ``(E) any other relevant information determined 
                necessary by the Secretary in consultation with the 
                Attorney General and the Chairperson.
            ``(3) Determination.--The Attorney General, in consultation 
        with the Chairperson, shall determine whether an agreement 
        regarding covered activities referred to in paragraph (2) would 
        likely--
                    ``(A) be in compliance with the antitrust laws, and 
                so inform the Secretary and the participating parties; 
                or
                    ``(B) violate the antitrust laws, in which case, 
                the filing shall be deemed to be a request for an 
                exemption from the antitrust laws, limited to the 
                performance of the agreement consistent with the 
                purposes of this title.
            ``(4) Action on request for exemption.--
                    ``(A) In general.--The Attorney General, in 
                consultation with the Chairperson, shall grant, deny, 
                grant in part and deny in part, or propose 
                modifications to a request for exemption from the 
                antitrust laws under paragraph (3) within 15 days of 
                the receipt of such request.
                    ``(B) Extension.--The Attorney General may extend 
                the 15-day period referred to in subparagraph (A) for 
                an additional period of not to exceed 10 days. Such 
                additional period may be further extended only by the 
                United States district court, upon an application by 
                the Attorney General after notice to the Secretary and 
                the parties involved.
                    ``(C) Determination.--In granting an exemption 
                under this paragraph, the Attorney General, in 
                consultation with the Chairperson and the Secretary--
                            (i) must find--
                                    ``(I) that the agreement involved 
                                is necessary to ensure the availability 
                                of priority countermeasures;
                                    ``(II) that the exemption from the 
                                antitrust laws would promote the public 
                                interest; and
                                    ``(III) that there is no 
                                substantial competitive impact to areas 
                                not directly related to the purposes of 
                                the agreement; and
                            ``(ii) may consider any other factors 
                        determined relevant by the Attorney General and 
                        the Chairperson.
            ``(5) Limitation on and renewal of exemptions.--An 
        exemption granted under paragraph (4) shall be limited to 
        covered activities, and shall expire on the date that is 3 
        years after the date on which the exemption becomes effective 
        (and at 3 year intervals thereafter, if renewed) unless the 
        Attorney General in consultation with the Chairperson 
        determines that the exemption should be renewed (with 
        modifications, as appropriate) considering the factors 
        described in paragraph (4).
            ``(6) Limitation on parties.--The use of any information 
        acquired under an exempted agreement by the parties to such an 
        agreement for any purposes other than those specified in the 
        antitrust exemption granted by the Attorney General shall be 
        subject to the antitrust laws and any other applicable laws.
            ``(7) Guidelines.--The Attorney General and the Chairperson 
        may develop and issue guidelines to implement this subsection.
            ``(8) Report.--Not later than 1 year after the date of 
        enactment of the Bioterrorism Preparedness Act of 2001, and 
        annually thereafter, the Attorney General and the Chairperson 
        shall report to Congress on the use and continuing need for the 
        exemption from the antitrust laws provided by this subsection.
            ``(9) Sunset.--The authority of the Attorney General to 
        grant or renew a limited antitrust exemption under this 
        subsection shall expire at the end of the 6-year period that 
        begins on the date of enactment of the Bioterrorism 
        Preparedness Act of 2001.
    ``(h) Definitions.--In this section and title XXVIII of the Public 
Health Service Act:
            ``(1) Antitrust laws.--The term `antitrust laws'--
                    ``(A) has the meaning given such term in subsection 
                (a) of the first section of the Clayton Act (15 U.S.C. 
                12(a)), except that such term includes the Act of June 
                19, 1936 (15 U.S.C. 13 et seq.) commonly known as the 
                Robinson-Patman Act), and section 5 of the Federal 
                Trade Commission Act (15 U.S.C. 45) to the extent such 
                section 5 applies to unfair methods of competition; and
                    ``(B) includes any State law similar to the laws 
                referred to in subparagraph (A).
            ``(2) Covered activities.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), the term `covered activities' means 
                any group of activities or conduct, including 
                attempting to make, making, or performing a contract or 
                agreement or engaging in other conduct, for the purpose 
                of--
                            ``(i) theoretical analysis, 
                        experimentation, or the systematic study of 
                        phenomena or observable facts necessary to the 
                        development of priority countermeasures;
                            ``(ii) the development or testing of basic 
                        engineering techniques necessary to the 
                        development of priority countermeasures;
                            ``(iii) the extension of investigative 
                        findings or theory of a scientific or technical 
                        nature into practical application for 
                        experimental and demonstration purposes, 
                        including the experimental production and 
                        testing of models, prototypes, equipment, 
                        materials, and processes necessary to the 
                        development of priority countermeasures;
                            ``(iv) the production, distribution, or 
                        marketing of a product, process, or service 
                        that is a priority countermeasures;
                            ``(v) the testing in connection with the 
                        production of a product, process, or services 
                        necessary to the development of priority 
                        countermeasures;
                            ``(vi) the collection, exchange, and 
                        analysis of research or production information 
                        necessary to the development of priority 
                        countermeasures; or
                            ``(vii) any combination of the purposes 
                        described in clauses (i) through (vi);
                and such term may include the establishment and 
                operation of facilities for the conduct of covered 
                activities described in clauses (i) through (vi), the 
                conduct of such covered activities on a protracted and 
                proprietary basis, and the processing of applications 
                for patents and the granting of licenses for the 
                results of such covered activities.
                    ``(B) Exception.--The term `covered activities' 
                shall not include the following activities involving 2 
                or more persons:
                            ``(i) Exchanging information among 
                        competitors relating to costs, sales, 
                        profitability, prices, marketing, or 
                        distribution of any product, process, or 
                        service if such information is not reasonably 
                        necessary to carry out the purposes of covered 
                        activities.
                            ``(ii) Entering into any agreement or 
                        engaging in any other conduct--
                                    ``(I) to restrict or require the 
                                sale, licensing, or sharing of 
                                inventions, developments, products, 
                                processes, or services not developed 
                                through, produced by, or distributed or 
                                sold through such covered activities; 
                                or
                                    ``(II) to restrict or require 
                                participation by any person who is a 
                                party to such covered activities in 
                                other research and development 
                                activities, that is not reasonably 
                                necessary to prevent the 
                                misappropriation of proprietary 
                                information contributed by any person 
                                who is a party to such covered 
                                activities or of the results of such 
                                covered activities.
                            ``(iii) Entering into any agreement or 
                        engaging in any other conduct allocating a 
                        market with a competitor that is not expressly 
                        exempted from the antitrust laws by a 
                        determination under subsection (i)(4).
                            ``(iv) Exchanging information among 
                        competitors relating to production (other than 
                        production by such covered activities) of a 
                        product, process, or service if such 
                        information is not reasonably necessary to 
                        carry out the purpose of such covered 
                        activities.
                            ``(v) Entering into any agreement or 
                        engaging in any other conduct restricting, 
                        requiring, or otherwise involving the 
                        production of a product, process, or service 
                        that is not so expressly exempted from the 
                        antitrust laws by a determination under 
                        subsection (i)(4).
                            ``(vi) Except as otherwise provided in this 
                        subsection, entering into any agreement or 
                        engaging in any other conduct to restrict or 
                        require participation by any person who is a 
                        party to such activities, in any unilateral or 
                        joint activity that is not reasonably necessary 
                        to carry out the purpose of such covered 
                        activities.
            ``(3) Development.--The term `development' includes the 
        identification of suitable compounds or biological materials, 
        the conduct of preclinical and clinical studies, the 
        preparation of an application for marketing approval, and any 
        other actions related to preparation of a countermeasure.
            ``(4) Person.--The term `person' has the meaning given such 
        term in subsection (a) of the first section of the Clayton Act 
        (15 U.S.C. 12(a)).
            ``(5) Priority countermeasure.--The term `priority 
        countermeasure' means a countermeasure, including a drug, 
        medical device, biological product, or diagnostic test to 
        treat, identify, or prevent infection by a biological agent or 
        toxin on the list developed under section 351A(a)(1) and 
        prioritized under subsection (a)(1).''.

SEC. 402. DEVELOPING NEW COUNTERMEASURES AGAINST BIOTERRORISM.

    Title XXVIII of the Public Health Service Act, as added by section 
101 and amended by section 201, is further amended by adding at the end 
the following:

   ``Subtitle B--Developing New Countermeasures Against Bioterrorism

``SEC. 2841. SMALLPOX VACCINE AND OTHER VACCINE DEVELOPMENT.

    ``(a) In General.--The Secretary shall award contracts, enter into 
cooperative agreements, or carry out such other activities as may 
reasonably be required in order to ensure that the stockpile described 
in section 2812 shall include the number of doses of vaccine against 
smallpox and other such vaccines determined by the Secretary to be 
sufficient to meet the needs of the population of the United States.
    ``(b) Rule of Construction.--Nothing in this section shall be 
construed to limit the private distribution, purchase, or sale of 
vaccines from sources other than the stockpile described in subsection 
(a).
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $509,000,000 for fiscal year 
2002, and such sums as may be necessary for each of fiscal years 2003 
through 2006.

``SEC. 2842. CONTRACT AUTHORITY FOR PRIORITY COUNTERMEASURES.

    ``(a) In General.--The Secretary shall, to the extent the Secretary 
determines necessary to achieve the purposes of this title, enter into 
long-term contracts and comparable grants or cooperative agreements, 
for the purpose of--
            ``(1) ensuring the development of priority countermeasures 
        that are necessary to prepare for a bioterrorist attack or 
        other significant disease emergency;
            ``(2) securing the manufacture, distribution, and adequate 
        supply of such countermeasures, including through the 
        development of novel production methods for such 
        countermeasures;
            ``(3) maintaining the Strategic National Pharmaceutical 
        Stockpile under section 2812; and
            ``(4) carrying out such other activities determined 
        appropriate by the Secretary to achieve the purposes of this 
        title.
    ``(b) Terms of Contracts.--Notwithstanding any other provision of 
law, the Secretary may enter into a contract or cooperative agreement 
under subsection (a) prior to the development, approval, or clearance 
of the countermeasure that is the subject of the contract. The contract 
or cooperative agreement may provide for its termination for the 
convenience of the Federal Government if the contractor does not 
develop the countermeasure involved. Such a contract or cooperative 
agreement may--
            ``(1) involve one or more aspects of the development, 
        manufacture, purchase, or distribution of one or more uses of 
        one or more countermeasures; and
            ``(2) set forth guaranteed minimum quantities of products 
        and negotiated unit prices.

``SEC. 2843. SECURITY FOR COUNTERMEASURE DEVELOPMENT AND PRODUCTION.

    ``(a) In General.--The Secretary, in consultation with the Attorney 
General and the Secretary of Defense, may provide technical or other 
assistance, to provide security to persons or facilities that conduct 
development, production, distribution, or storage of priority 
countermeasures.
    ``(b) Best Practices.--The Secretary shall develop guidelines and 
best practices to enable entities eligible to receive assistance under 
this section to secure their facilities against potential terrorist 
attack.''.

SEC. 403. SEQUENCING OF PRIORITY PATHOGENS.

    Section 319F(g) of the Public Health Service Act (42 U.S.C. 247d-
6(f)), as so redesignated by section 311, is amended--
            (1) in paragraph (3), by striking ``and'' at the end;
            (2) by redesignating paragraph (4) as paragraph (5); and
            (3) by inserting after paragraph (3), the following:
            ``(4) the sequencing of the genomes of priority pathogens 
        as determined appropriate by the Director of the National 
        Institutes of Health, in consultation with the working group 
        established in subsection (a); and''.

SEC. 404. ACCELERATED COUNTERMEASURE RESEARCH AND DEVELOPMENT.

    Section 319F(g) of the Public Health Service Act (42 U.S.C. 247d-
6(f)), as so redesignated by section 311 and amended by section 403, is 
further amended--
            (1) by redesignating paragraphs (1) through (5), as 
        subparagraphs (A) through (E), respectively and indenting 
        appropriately;
            (2) by striking ``The Secretary'' and inserting the 
        following:
            ``(1) In general.--The Secretary''; and
            (3) by adding at the end the following:
            ``(2) Accelerated countermeasure research and 
        development.--
                    ``(A) In general.--The Secretary 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 
                        biological agents or toxins of potential use in 
                        a bioterrorist attack;
                            ``(ii) the development of new vaccines and 
                        therapeutics for use against biological agents 
                        or toxins of potential use in a bioterrorist 
                        attack;
                            ``(iii) the development of diagnostic tests 
                        to detect biological agents or toxins of 
                        potential use in a bioterrorist attack; and
                            ``(iv) other relevant areas of research;
                with consideration given to the needs of children and 
                other vulnerable populations.
                    ``(B) Priority.--The Secretary shall give priority 
                under this paragraph to the funding of research and 
                other studies related to priority countermeasures.''.

SEC. 405. ACCELERATED APPROVAL OF PRIORITY COUNTERMEASURES.

    (a) In General.--The Secretary of Health and Human Services may 
designate a priority countermeasure as a fast-track product pursuant to 
section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) 
or as a device granted priority review pursuant to section 515(d)(5) of 
such Act (21 U.S.C. 366e(d)(5)). Such a designation may be made prior 
to the submission of--
            (1) a request for designation by the sponsor or applicant; 
        or
            (2) an application for the investigation of the drug under 
        section 505(i) of such Act or section 351(a)(3) of the Public 
        Health Service Act.
Nothing in this subsection shall be construed to prohibit a sponsor or 
applicant from declining such a designation.
    (b) Use of Animal Trials.--A drug for which approval is sought 
under section 505(d) of the Federal Food, Drug, and Cosmetic Act or 
section 351 of the Public Health Service Act on the basis of evidence 
of effectiveness that is derived from animal studies under section 406 
may be designated as a fast track product for purposes of this section.
    (c) Priority Review.--
            (1) In general.--A priority countermeasure that is a drug 
        or biological product shall be subject to the performance goals 
        established by the Commissioner of Food and Drugs for priority 
        drugs or biological products.
            (2) Definition.--In this subsection the term ``priority 
        drugs or biological products'' means a drug or biological 
        product that is the subject of a drug application referred to 
        in section 101(4) of the Food and Drug Administration 
        Modernization Act of 1997.

SEC. 406. USE OF ANIMAL TRIALS IN THE APPROVAL OF PRIORITY 
              COUNTERMEASURES.

    Not later than 30 days after the date of enactment of this Act, the 
Secretary of Health and Human Services shall issue a final rule for the 
proposal 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'' as published in the Federal Register on 
October 5, 1999 (64 Fed. Reg.).

SEC. 407. MISCELLANEOUS PROVISIONS.

    Title XXVIII of the Public Health Service Act, as added by section 
101 and amended by section 403, is further amended by adding at the end 
the following:

                 ``Subtitle C--Miscellaneous Provisions

``SEC. 2851. SUPPLEMENT NOT SUPPLANT.

    ``A State or local government, or other entity to which a grant, 
contract, or cooperative agreement is awarded under this title, may not 
use amounts received under the grant, contract, or cooperative 
agreement to supplant expenditures by the entity for activities 
provided for under this title, but shall use such amounts only to 
supplement such expenditures at a level at least equal to the level of 
such expenditures for fiscal year 2001 (excluding those additional, 
extraordinary expenditures that may have been made after September 10, 
2001).''.

     TITLE V--PROTECTING THE SAFETY AND SECURITY OF THE FOOD SUPPLY

     Subtitle A--General Provisions to Expand and Upgrade Security

SEC. 511. FOOD SAFETY AND SECURITY STRATEGY.

    (a) In General.--The President's Council on Food Safety (as 
established by Executive Order 13100), the Secretary of Commerce, and 
the Secretary of Transportation, shall, in consultation with the food 
industry and consumer and producer groups, and the States, develop a 
crisis communications and education strategy with respect to 
bioterrorist threats to the food supply. Such strategy shall address 
threat assessments, response and notification procedures, and risks 
communications to the public.
    (b) Authorization of Appropriations.--There is authorized to be 
appropriated, $500,000 for fiscal year 2002, and such sums as may be 
necessary in each subsequent fiscal year to implement the strategy 
developed under subsection (a) in cooperation with the Secretary of 
Agriculture, the Secretary of Health and Human Services, and the 
Administrator of the Environmental Protection Agency.

SEC. 512. EXPANSION OF ANIMAL AND PLANT HEALTH INSPECTION SERVICE 
              ACTIVITIES.

    (a) In General.--The Secretary of Agriculture (referred to in this 
section as the ``Secretary'') shall enhance and expand the capacity of 
the Animal and Plant Health Inspection Service through the conduct of 
activities to--
            (1) increase the inspection capacity of the Service at 
        international points of origin;
            (2) improve surveillance at ports of entry and customs;
            (3) enhance methods of protecting against the introduction 
        of plant and animal disease organisms by terrorists;
            (4) adopt new strategies and technologies for dealing with 
        intentional outbreaks of plant and animal disease arising from 
        acts of terrorism or from unintentional introduction, 
        including--
                    (A) establishing cooperative agreements among 
                Veterinary Services of the Animal and Plant Health 
                Inspection Service, State animal health commissions and 
                regulatory agencies for livestock and poultry health, 
                and private veterinary practitioners to enhance the 
                preparedness and ability of Veterinary Services and the 
                commissions and agencies to respond to outbreaks of 
                such animal diseases; and
                    (B) strengthening planning and coordination with 
                State and local agencies, including--
                            (i) State animal health commissions and 
                        regulatory agencies for livestock and poultry 
                        health; and
                            (ii) State agriculture departments; and
            (5) otherwise expand the capacity of the Service to protect 
        against the threat of bioterrorism.
    (b) High-Tech Agriculture Early Warning and Emergency Response 
System.--
            (1) In general.--To provide the agricultural system of the 
        United States with a new, enhanced level of protection and 
        biosecurity that does not exist on the date of enactment of 
        this Act, the Secretary of Agriculture, in coordination with 
        the Secretary of Health and Human Services, shall implement a 
        fully secure surveillance and response system that utilizes, or 
        is capable of utilizing, field test devices capable of 
        detecting biological threats to animals and plants and that 
        electronically integrates the devices and the tests on a real-
        time basis into a comprehensive surveillance, incident 
        management, and emergency response system.
            (2) Expansion of system.--The Secretary shall expand the 
        system implemented under paragraph (1) as soon as practicable 
        to include other Federal agencies and the States where 
        appropriate and necessary to enhance the protection of the food 
        and agriculture system of the United States. To facilitate the 
        expansion of the system, the Secretary shall award grants to 
        States.
    (c) Automated Recordkeeping System.--The Administrator of the 
Animal and Plant Health Inspection Service shall implement a central 
automated recordkeeping system to provide for the reliable tracking of 
the status of animal and plant shipments, including those shipments on 
hold at ports of entry and customs. The Secretary shall ensure that 
such a system shall be fully accessible to or fully integrated with the 
Food Safety Inspection Service.
    (d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $30,000,000 for fiscal year 
2002, and such sums as may be necessary for each subsequent fiscal 
year.

SEC. 513. EXPANSION OF FOOD SAFETY INSPECTION SERVICE ACTIVITIES.

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

SEC. 514. EXPANSION OF FOOD AND DRUG ADMINISTRATION ACTIVITIES.

    (a) In General.--The Secretary of Health and Human Services shall 
expand the capacity of the Food and Drug Administration to--
            (1) increase inspections to ensure the safety of the food 
        supply consistent with the amendments made by subtitle B; and
            (2) improve linkages between the Agency and other 
        regulatory agencies of the Federal Government, the States, and 
        Indian tribes with shared responsibilities.
    (b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $59,000,000 for fiscal year 
2002, and such sums as may be necessary for each subsequent fiscal 
year.

SEC. 515. BIOSECURITY UPGRADES AT THE DEPARTMENT OF AGRICULTURE.

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

SEC. 516. BIOSECURITY UPGRADES AT THE DEPARTMENT OF HEALTH AND HUMAN 
              SERVICES.

    The Secretary of Health and Human Services shall take such actions 
as may be necessary to secure existing facilities of the Department of 
Health and Human Services where potential animal and plant pathogens 
are housed or researched.

SEC. 517. AGRICULTURAL BIOSECURITY.

    (a) Land Grant Assessments.--
            (1) In general.--The Secretary of Agriculture (referred to 
        in this section as the ``Secretary'') shall establish minimum 
        security standards and award grants to land grant universities 
        to conduct security needs assessments and to plan for 
        improvement of--
                    (A) the security of all facilities where hazardous 
                biological agents and toxins are stored or used for 
                agricultural research purposes; and
                    (B) communication networks that transmit 
                information about hazardous biological agents and 
                toxins.
            (2) Availability of standards.--Not later than 45 days 
        after the establishment of security standards under paragraph 
        (1), the Secretary shall make such standards available to land 
        grant universities.
            (3) Grants.--Not later than 45 days after the date of 
        enactment of this Act, the Secretary shall award grants, not to 
        exceed $50,000 each, to land grant universities to enable such 
        universities to conduct a security needs assessment and plan 
        activities to improve security. Such an assessment shall be 
        completed not later than 45 days after the date on which such 
        grant funds are received.
    (b) National Hazardous Agent Inventory.--The Secretary shall carry 
out activities necessary to develop a national inventory of hazardous 
biological agents and toxins contained in agricultural research 
facilities. Such activities shall include developing and distributing a 
model inventory procedure, developing secure means of transmitting 
inventory information, and conducting annual inventory activities. The 
inventory shall be developed in coordination with, or as a component 
of, similar systems in existence on the date of enactment of this Act.
    (c) Screening Protocol.--The Secretary shall establish a national 
protocol for the screening of individuals who require access to 
agricultural research facilities in a manner that provides for the 
protection of personal privacy.
    (d) Industry-On-Farm Education.--
            (1) In general.--The Secretary shall develop and implement 
        a program to provide education relating to farms, livestock 
        confinement operations, and livestock auction biosecurity to 
        prevent the intentional or accidental introduction of a foreign 
        animal disease and to attempt to discover the introduction of 
        such a disease before it can spread into an outbreak. 
        Biosecurity for livestock includes animal quarantine 
        procedures, blood testing of new arrivals, farm locations, 
        control of human movement onto farms and holding facilities, 
        control of vermin, and movement of vehicles onto farms.
            (2) Quarantine and testing.--The Secretary shall develop 
        and disseminate through educational programs animal quarantine 
        and testing guidelines to enable farmers and producers to 
        better monitor new arrivals. Any educational seminars and 
        training carried out by the Secretary under this paragraph 
        shall emphasize the economic benefits of biosecurity and the 
        profound negative impact of an outbreak.
            (3) Crop guidelines.--The Secretary may develop guidelines 
        and educational materials relating to biosecurity issues to be 
        distributed to local crop producers and facilities that handle, 
        process, or transport crops.
    (e) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $20,000,000 for fiscal year 
2002, and such sums as may be necessary for each subsequent fiscal 
year, of which not less than $5,000,000 shall be made available in 
fiscal year 2002 for activities under subsection (a).

SEC. 518. BIOSECURITY OF FOOD MANUFACTURING, PROCESSING, AND 
              DISTRIBUTION.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary''), in consultation 
with the Attorney General, may award grants, contracts, or cooperative 
agreements to enable food manufacturers, food processors, food 
distributors, and other entities regulated by the Secretary to ensure 
the safety of food through the development and implementation of 
educational programs to ensure the security of their facilities and 
modes of transportation against potential bioterrorist attack.
    (b) Best Practices.--The Secretary may develop best practices to 
enable entities eligible for funding under this section to secure their 
facilities and modes of transportation against potential bioterrorist 
attacks.
    (c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $500,000 in fiscal year 2002, 
and such sums as may be necessary for each fiscal year thereafter.

               Subtitle B--Protection of the Food Supply

SEC. 531. 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:
    ``(h) Administrative Detention of Foods.--
            ``(1) Authority.--Any 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 the article is in violation of this 
        Act and presents a threat of serious adverse health 
        consequences or death to humans or animals.
            ``(2) Period of detention; approval by secretary or 
        secretary's designee.--
                    ``(A) Duration.--An article of food may be detained 
                under this subsection for a reasonable period, not to 
                exceed 20 days, unless a greater period of time, not to 
                exceed 30 days, is necessary to enable the Secretary to 
                institute an action under subsection (a) or section 
                302.
                    ``(B) Secretary's approval.--Before an article of 
                food may be ordered detained under this subsection, the 
                Secretary or an officer or qualified employee 
                designated by the Secretary must approve such order, 
                after determining that the article presents a threat of 
                serious adverse health consequences or death to humans 
                or animals.
            ``(3) Security of detained article.--A detention order 
        under this subsection with respect to an article of food may 
        require that the article be labeled or marked as detained, and 
        may require that the article be removed to a secure facility. 
        An article subject to a detention order under this subsection 
        shall not be moved by any person from the place at which it is 
        ordered detained until released by the Secretary, or the 
        expiration of the detention period applicable to such order, 
        whichever occurs first.
            ``(4) Appeal of detention order.--Any person who would be 
        entitled to claim a detained article if it were seized under 
        subsection (a) may appeal to the Secretary the detention order 
        under this subsection. Within 15 days after such an appeal is 
        filed, the Secretary, after affording opportunity for an 
        informal hearing, shall by order confirm the detention order or 
        revoke it.
            ``(5) Perishable foods.--The Secretary shall provide in 
        regulation or in guidance for procedures for instituting and 
        appealing on an expedited basis administrative detention of 
        perishable foods.''.
    (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 new subsection:
            ``(bb) The movement 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 in order to identify 
        the article as detained.''.

SEC. 532. DEBARMENT FOR REPEATED OR SERIOUS FOOD IMPORT VIOLATIONS.

    (a) Debarment Authority.--
            (1) Permissive debarment.--Section 306(b)(1) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)(1)) is 
        amended--
                    (A) by striking the period at the end of 
                subparagraph (B) and inserting ``; or''; and
                    (B) by adding at the end the following:
                    ``(C) a person from importing a food or offering a 
                food for import into the United States if--
                            ``(i) the person has been convicted of a 
                        felony for conduct relating to the importation 
                        into the United States of any food; or
                            ``(ii) the person has engaged in a pattern 
                        of importing or offering for import adulterated 
                        food that presents a threat of serious adverse 
                        health consequences or death to humans or 
                        animals.''.
            (2) Conforming amendment.--Section 306(b)(2) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)(2)) is 
        amended--
                    (A) in the paragraph heading, by inserting 
                ``relating to drug applications'' after ``Debarment''; 
                and
                    (B) in the matter preceding subparagraph (A), by 
                striking ``paragraph (1)'' and inserting 
                ``subparagraphs (A) and (B) of paragraph (1)''.
            (3) Debarment period.--Section 306(c)(2)(A)(iii) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        335a(c)(2)(A)(iii)) is amended by striking ``subsection 
        (b)(2)'' and inserting ``subsection (b)(1)(C) or (b)(2)''.
            (4) Termination of debarment.--Section 306(d)(3) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(d)(3)) is 
        amended--
                    (A) in subparagraph (A)(i), by striking ``or 
                (b)(2)(A)'' and inserting ``, or (b)(2)(A), or 
                (b)(1)(C)'';
                    (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 (b)(1)(C)'' after 
                ``(b)(2)(B)''.
            (5) Effective dates.--Section 306(l)(2) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 335a(l)(2)) is 
        amended--
                    (A) in the first sentence, by inserting ``and 
                subsection (b)(1)(C)'' after ``subsection (b)(2)(B)''; 
                and
                    (B) in the second sentence, by striking ``and 
                subsections (f) and (g) of this section'' and inserting 
                ``subsections (f) and (g), and subsection (b)(1)(C)''.
    (b) Conforming Amendment.--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 by, with the assistance of, or at the direction 
of, a person debarred under section 306(b)(1)(C).''.

SEC. 533. 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:

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

    ``(a) In General.--If the Secretary has reason to believe that an 
article of food is adulterated or misbranded under this Act and 
presents a threat of serious adverse health consequences or death to 
humans or animals, each person (excluding restaurants and farms) that 
manufactures, processes, packs, distributes, receives, holds, or 
imports such food 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 to copy all records relating 
to such food that may assist the Secretary to determine the cause and 
scope of the violation. This requirement applies to all records 
relating to such manufacture, processing, packing, distribution, 
receipt, holding, or importation of such food 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 shall 
promulgate regulations regarding the maintenance and retention of 
records for inspection for not longer than 2 years by persons 
(excluding restaurants and farms) that manufacture, process, pack, 
transport, distribute, receive, hold, or import food, as may be needed 
to allow the Secretary--
            ``(1) to promptly trace the source and chain of 
        distribution of food and its packaging to address threats of 
        serious adverse health consequences or death to humans or 
        animals; or
            ``(2) to determine whether food manufactured, processed, 
        packed, or held by the person may be adulterated or misbranded 
        to the extent that it presents a threat of serious adverse 
        health consequences or death to humans or animals under this 
        Act.
The Secretary may impose reduced requirements under such regulations 
for small businesses with 50 or fewer employees.
    ``(c) Limitations.--Nothing in this section shall be construed--
            ``(1) to limit the authority of the Secretary to inspect 
        records or to require maintenance of records under any other 
        provision of or regulations issued under 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 extend to recipes for food, financial data, sales 
        data other than shipment data, pricing data, personnel data, or 
        research data; or
            ``(4) to alter, amend, or affect in any way the disclosure 
        or nondisclosure under section 552 of title 5, United States 
        Code, of information copied or collected under this section, or 
        its treatment under section 1905 of title 18, United States 
        Code.''.
    (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 adding after the first sentence 
        the following: ``In the case of any person (excluding 
        restaurants and farms) that manufactures, processes, packs, 
        transports, distributes, receives, holds, or imports foods, the 
        inspection shall extend to all records and other information 
        described in section 414(a), or required to be maintained 
        pursuant to section 414(b).''; and
            (2) in paragraph (2), in the matter preceding subparagraph 
        (A), by striking ``second sentence'' and inserting ``third 
        sentence''.
    (c) Prohibited Act.--Section 301 of the Federal Food, Drug and 
Cosmetic Act (21 U.S.C. 331) is amended--
            (1) in subsection (e)--
                    (A) by striking ``by section 412, 504, or 703'' and 
                inserting ``by section 412, 414, 504, 703, or 704(a)''; 
                and
                    (B) by striking ``under section 412'' and inserting 
                ``under section 412, 414(b)''; and
            (2) in section (j), by inserting ``414,'' after ``412,''.
    (d) Expedited Rulemaking.--Not later than 18 months after the date 
of enactment of this Act, the Secretary shall promulgate proposed and 
final regulations establishing recordkeeping requirements under 
subsection 414(b)(1) of the Federal Food, Drug, and Cosmetic Act.

SEC. 534. REGISTRATION OF FOOD MANUFACTURING, PROCESSING, AND HANDLING 
              FACILITIES.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.), as amended by section 533, is further 
amended by adding at the end the following:

``SEC. 415. REGISTRATION OF FOOD MANUFACTURING, PROCESSING, AND 
              HANDLING FACILITIES.

    ``(a) Registration.--
            ``(1) In general.--Any facility engaged in manufacturing, 
        processing, or handling 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 name and address of each 
        facility at which, and all trade names under which, the 
        registrant conducts business and, when determined necessary by 
        the Secretary through guidance, the general food category (as 
        identified under section 170.3 of title 21, Code of Federal 
        Regulations) of any food manufactured, processed, or handled 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 Authority.--The Secretary may by regulation exempt 
types of retail establishments or farms from the requirements of 
subsection (a) if the Secretary determines that the registration of 
such facilities is not needed for effective enforcement of chapter IV 
and any regulations issued under such chapter.
    ``(c) Facility.--In this section, the term `facility' includes any 
factory, warehouse, or establishment (including a factory, warehouse, 
or establishment of an importer), that manufactures, handles, or 
processes food. Such term does not include restaurants.
    ``(d) Rule of Construction.--Nothing in this section shall be 
construed to authorize the Secretary to require an application, review, 
or licensing process.''.
    (b) Misbranded Foods.--Section 403 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the 
following:
    ``(t) If it is a food from a facility for which registration has 
not been submitted to the Secretary under section 415(a).''.
    (c) Effective Date.--The amendment made by subsection (b) shall 
take effect 180 days after the date of enactment of this Act.

SEC. 535. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.

    (a) Prior Notice of Imported Food Shipments.--Section 801 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by 
adding at the end the following:
    ``(j) Prior Notice of Imported Food Shipments.--
            ``(1) In general.--At least 4 hours before a food is 
        imported or offered for importation into the United States, the 
        producer, manufacturer, or shipper of the food shall provide 
        documentation to the Secretary of the Treasury and the 
        Secretary of Health and Human Services that--
                    ``(A) identifies--
                            ``(i) the food;
                            ``(ii) the countries of origin of the food; 
                        and
                            ``(iii) the quantity to be imported; and
                    ``(B) includes such other information as the 
                Secretary of Health and Human Services may require by 
                regulation.
            ``(2) Refusal of admission.--If documentation is not 
        provided as required by paragraph (1) at least 4 hours before 
        the food is imported or offered for importation, the food may 
        be refused admission.
            ``(3) Limitation.--Nothing in this subsection shall be 
        construed 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.).''.
    (b) Prohibition of Knowingly Making False Statements.--Section 301 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331), as amended 
by section 531(b), is further amended by inserting after subsection 
(bb) the following:
    ``(cc) Knowingly making a false statement in documentation required 
under section 801(j).''.

SEC. 536. AUTHORITY TO MARK REFUSED ARTICLES.

    (a) Misbranded Foods.--Section 403 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343), as amended by section 534(b), is further 
amended by adding at the end the following:
    ``(u) If--
            ``(1) it has been refused admission under section 801(a);
            ``(2) it has not been required to be destroyed under 
        section 801(a);
            ``(3) the packaging of it does not bear a label or labeling 
        described in section 801(a); and
            ``(4) it presents a threat of serious adverse health 
        consequences or death to humans or animals.''.
    (b) Requirement.--Section 801(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381(a)) is amended by adding at the end the 
following: ``The Secretary of Health and Human Services may require the 
owner or consignee of a food that has been refused admission under this 
section, and has not been required to be destroyed, to affix to the 
packaging of the food a label or labeling that--
            ``(1) clearly and conspicuously bears the statement: 
        `United States: Refused Entry';
            ``(2) is affixed to the packaging until the food is brought 
        into compliance with this Act; and
            ``(3) has been provided at the expense of the owner or 
        consignee of the food.''.
    (c) Rule of Construction.--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 under any other provision of law.

SEC. 537. AUTHORITY TO COMMISSION OTHER FEDERAL OFFICIALS TO CONDUCT 
              INSPECTIONS.

    Section 702(a) of the Federal Food, Drug and Cosmetic Act (21 
U.S.C. 372(a)) is amended in the first sentence--
            (1) by inserting ``qualified'' before ``employees''; and
            (2) by inserting ``or of other Federal Departments or 
        agencies, notwithstanding any other provision of law 
        restricting the use of a Department's or agency's officers, 
        employees, or funds,'' after ``officers and qualified employees 
        of the Department''.

SEC. 538. PROHIBITION AGAINST PORT SHOPPING.

    Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
342), as amended by section 532(b), is further amended by adding at the 
end the following:
    ``(i) If it is an article of food imported or offered for import 
into the United States and the article of food has previously been 
refused admission under section 801(a), unless the person reoffering 
the article affirmatively establishes, at the expense of the owner or 
consignee of the article, that the article complies with the applicable 
requirements of this Act, as determined by the Secretary.''.

SEC. 539. GRANTS TO STATES FOR INSPECTIONS.

    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:

``SEC. 910. GRANTS TO STATES FOR INSPECTIONS.

    ``(a) In General.--The Secretary is authorized to make grants to 
States, territories, and Federally recognized Indian tribes that 
undertake examinations, inspections, and investigations, and related 
activities under section 702. The funds provided under such grants 
shall only be available for the costs of conducting such examinations, 
inspections, investigations, and related activities.
    ``(b) Authorization of Appropriations.--There are authorized to be 
appropriated $10,000,000 for fiscal year 2002, and such sums as may be 
necessary to carry out this section for each subsequent fiscal year.''.

SEC. 540. RULE OF CONSTRUCTION.

    Nothing in this title, or an amendment made by this title, shall be 
construed to--
            (1) provide the Food and Drug Administration with 
        additional authority related to the regulation of meat, 
        poultry, and egg products; or
            (2) limit the authority of the Secretary of Agriculture 
        with respect to such products.

 Subtitle C--Research and Training to Enhance Food Safety and Security

SEC. 541. SURVEILLANCE AND INFORMATION GRANTS AND AUTHORITIES.

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

``SEC. 317Q. FOOD SAFETY GRANTS.

    ``(a) In General.--The Secretary may award food safety grants to 
States to expand the number of States participating in Pulsenet, the 
Foodborne Diseases Active Surveillance Network, and other networks to 
enhance Federal, State, and local food safety efforts.
    ``(b) Use of Funds.--Funds awarded under this section shall be used 
by States to assist such States in meeting the costs of establishing 
and maintaining the food safety surveillance, technical and laboratory 
capacity needed to participate in Pulsenet, Foodborne Diseases Active 
Surveillance Network, and other networks to enhance Federal, State, and 
local food safety efforts.
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $19,500,000 for fiscal year 
2002, and such sums as may be necessary for each of fiscal years 2003 
through 2006.

``SEC. 317R. SURVEILLANCE OF ANIMAL AND HUMAN HEALTH.

    ``The Secretary, through the Commissioner of the Food and Drug 
Administration and the Director of the Centers for Disease Control and 
Prevention, and the Secretary of Agriculture shall develop and 
implement a plan for coordinating the surveillance for zoonotic disease 
and human disease.''.

SEC. 542. AGRICULTURAL BIOTERRORISM RESEARCH AND DEVELOPMENT.

    (a) In General.--The Secretary of Agriculture, to the maximum 
extent practicable, shall utilize existing authorities to expand 
Agricultural Research Service, and Cooperative State Research Education 
and Extension Service, programs to protect the food supply of the 
United States by conducting activities to--
            (1) enhance the capability of the Service to respond 
        immediately to the needs of Federal regulatory agencies 
        involved in protecting the food and agricultural system;
            (2) continue existing partnerships with institutions of 
        higher education (including partnerships with 3 institutions of 
        higher education that are national centers for countermeasures 
        against agricultural bioterrorism and 7 additional institutions 
        with existing programs related to bioterrorism) to help form 
        stable, long-term programs of research, development, and 
        evaluation of options to enhance the biosecurity of United 
        States agriculture;
            (3) strengthen linkages with the intelligence community to 
        better identify research needs and evaluate acquired materials;
            (4) expand Service involvement with international 
        organizations dealing with plant and animal disease control; 
        and
            (5) otherwise expand the capacity of the Service to protect 
        against the threat of bioterrorism.
    (b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, $190,000,000 for fiscal year 
2002, and such sums as may be necessary for each subsequent fiscal 
year.

            Attest:

                                                             Secretary.
107th CONGRESS

  1st Session

                               H. R. 3448

_______________________________________________________________________

                               AMENDMENT