```

[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 1880 Introduced in Senate (IS)]

109th CONGRESS
  1st Session
                                S. 1880

   To amend the Public Health Service Act to enhance biodefense and 
       pandemic preparedness activities, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            October 17, 2005

   Mr. Kennedy (for himself, Mr. Dodd, Mr. Harkin, Ms. Mikulski, Mr. 
  Bingaman, Mrs. Clinton, Mr. Schumer, and Mr. Obama) introduced the 
 following bill; which was read twice and referred to the Committee on 
                 Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
   To amend the Public Health Service Act to enhance biodefense and 
       pandemic preparedness activities, and for other purposes.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``National 
Biodefense and Pandemic Preparedness Act of 2005''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
       TITLE I--RESTRUCTURING THE NATIONAL BIODEFENSE INITIATIVE

Sec. 101. National Biodefense Trust.
Sec. 102. Strategic Biodefense Initiative.
Sec. 103. Collaboration and coordination.
       TITLE II--ENSURING NATIONAL VACCINE MANUFACTURING CAPACITY

Sec. 201. Warm-based manufacturing for biological countermeasures.
Sec. 202. Emergency manufacturing.
Sec. 203. Construction of facilities.
                 TITLE III--IMPROVING PROJECT BIOSHIELD

Sec. 301. Improving project BioShield.
          TITLE IV--INCENTIVES FOR COUNTERMEASURE DEVELOPMENT

Sec. 401. Prize payments for countermeasures development.
Sec. 402. Providing for long-term sole-sourcing of countermeasures.
                 TITLE V--CROSSING THE VALLEY OF DEATH

Sec. 501. Early support for countermeasure development.
Sec. 502. Incentive payments.
         TITLE VI--ACCELERATING THE APPROVAL OF COUNTERMEASURES

Sec. 601. Accelerating the approval of countermeasures.
Sec. 602. Postmarketing studies for countermeasures.
           TITLE VII--BIODEFENSE INJURY COMPENSATION PROGRAM

Sec. 701. National Biodefense Injury Compensation Program.
      TITLE VIII--INDEMNIFICATION FOR PRODUCERS OF COUNTERMEASURES

Sec. 801. Indemnification for manufacturers and health care 
                            professionals who administer medical 
                            products needed for biodefense.
     TITLE IX--STRENGTHENING PUBLIC HEALTH READINESS FOR PANDEMICS

          Subtitle A--Improved Planning for Pandemic Influenza

Sec. 901. Federal Pandemic Influenza Preparedness Plan.
Sec. 902. Requirement to develop State pandemic influenza plans.
Sec. 903. Use of CDC and HRSA funds for public health preparedness.
                       Subtitle B--Vaccine Supply

Sec. 911. Buy-back program for flu vaccine.
         Subtitle C--Enhancing the National Strategic Stockpile

Sec. 921. Stockpiling of antivirals and other medications.
Sec. 922. Strategic plan for stockpile.
     Subtitle D--Prohibiting Price Gouging on Needed Flu Medicines

Sec. 931. Unfair or deceptive acts or practices in commerce related to 
                            treatments for pandemic influenza.
              Subtitle E--National Institute of Pathology

Sec. 941. National Institute of Pathology.
Sec. 942. Transfer of the Armed Forces Institute of Pathology.
   Subtitle F--Increased Influenza Vaccine and Outbreak Surveillance 
                               Activities

Sec. 951. Tracking network and demonstration grants.
Sec. 952. Educational efforts and grants.
                  Subtitle G--Miscellaneous Provisions

Sec. 961. HRSA curriculum development and training programs.
Sec. 962. Using health information technology to enahnce epidemic 
                            detection.
Sec. 963. Naturally occurring or deliberately introduced agents.
Sec. 964. Use of Federal facilities in emergencies.
Sec. 965. Advisory Committee on Vulnerable Populations.
Sec. 966. Emergency system for advance registration of health 
                            professions volunteers.
                     TITLE X--ENHANCING ANTIBIOTICS

Sec. 1001. Preserving the effectiveness of medically important 
                            antibiotics.
       TITLE XI--IMPROVING RESEARCH ON BIODEFENSE COUNTERMEASURES

Sec. 1101. Improving the ability of biodefense researchers to work with 
                            select agents.

       TITLE I--RESTRUCTURING THE NATIONAL BIODEFENSE INITIATIVE

SEC. 101. NATIONAL BIODEFENSE TRUST.

    (a) National BioVenture Trust.--
            (1) Purpose.--It is the purpose of this subsection to 
        establish a Federal Government corporation for the purpose of--
                    (A) administering the Federal BioShield program; 
                and
                    (B) identifying and supporting the development of 
                promising technologies that could lead to the 
                development of qualified countermeasures.
            (2) Establishment of trust.--There is established a body 
        corporate to be known as the ``National BioVenture Trust'' 
        (referred to in this section as the ``Trust'') which shall be 
        in the Department of Health and Human Services. The Trust shall 
        have succession until dissolved by Act of Congress. It shall 
        maintain its principal office in the District of Columbia and 
        shall be deemed, for purposes of venue in civil actions, to be 
        a resident thereof. Agencies or offices may be established by 
        the Trust in such other place or places as it may deem 
        necessary or appropriate in the conduct of its business.
            (3) Capitalization.--The Trust shall have common stock, 
        without par value, which shall be vested with all voting 
        rights, each share being entitled to one vote with rights of 
        cumulative voting at all elections of directors. The Trust may 
        eliminate such rights of cumulative voting by a resolution 
        adopted by its board of directors and approved by the holders 
        of a majority of the shares of common stock voting in person or 
        by proxy at the annual meeting, or other special meeting, at 
        which such resolution is considered. The corporation may have 
        preferred stock on such terms and conditions as the board of 
        directors shall prescribe. The free transferability of the 
        stock at all times to any person, firm, corporation, or other 
        entity shall not be restricted except that, as to the Trust, it 
        shall be transferable only on the books of the Trust. The Trust 
        may issue shares of common stock in return for appropriate 
        payments into capital or capital and surplus. Any proceeds 
        derived by the Trust under this paragraph shall be reinvested 
        for the develop of new technology. Notwithstanding any other 
        provision of law, the Secretary of Health and Human Service 
        shall ensure that not less than 51 percent of the stock 
        provided for under this paragraph s held by the Department of 
        Health and Human Services.
            (4) General management.--There is hereby established in the 
        Department of Health and Human Services the position of Chief 
        Executive Officer, National BioVenture Trust, who shall be 
        appointed by the President in consultation with the Secretary, 
        subject to the advice and consent of the Senate. All the powers 
        and duties of the Trust shall be vested in the Chief Executive 
        Officer. The Secretary shall select and effect the appointment 
        of qualified persons to fill the offices of vice president, and 
        such other offices as may be provided for in the bylaws of the 
        Trust. Persons appointed under the preceding sentence shall 
        perform such executive functions, powers, and duties as may be 
        prescribed by the bylaws or by the Secretary, and such persons 
        shall be executive officers of the Trust and shall discharge 
        all such executive functions, powers, and duties. The Chief 
        Executive Officer may participate in meeting provided for under 
        section 2(g) of the Clayton Act (15 U.S.C. 13) (as added by 
        section 103 of this Act). In carrying out the activities under 
        this subsection, the Chief Executive Officer, in consultation 
        with the National Advisory Committee on Vulnerable Populations 
        and Terrorism, and the Vulnerable Populations Working Group, 
        and based on the recommendations of the Secretary, shall give 
        priority to supporting and facilitating research and 
        development of countermeasures, and formulations of 
        countermeasures, that are likely to be safe and effective for 
        pediatric populations, pregnant women, and other vulnerable 
        populations.
            (5) Board of directors.--
                    (A) In general.--The Trust shall have a board of 
                directors, which shall consist of 18 individuals, 9 of 
                whom shall be appointed annually by the Secretary, and 
                the remainder of whom shall be elected annually by the 
                common stockholders. The board shall at all times have 
                as members appointed by the Secretary at least 3 
                individuals from the biotechnology or pharmacology 
                industry, at least 3 individuals with experience in 
                chemical, nuclear, or biological threats to the United 
                States (including naturally occurring biological 
                threats), and at least 3 individuals who are 
                representatives of healthcare consumers or workers.
                    (B) Terms and vacancies.--Each member of the board 
                of directors shall be appointed or elected for a term 
                ending on the date of the next annual meeting of the 
                stockholders, except that any such appointed member may 
                be removed from office by the Secretary for good cause. 
                Any elective seat on the board which becomes vacant 
                after the annual election of the directors shall be 
                filled by the board, but only for the unexpired portion 
                of the term. Any appointive seat which becomes vacant 
                shall be filled by appointment of the Secretary, but 
                only for the unexpired portion of the term.
                    (C) Powers.--Within the limitations of law and 
                regulation, the board shall determine the general 
                policies which shall govern the operations of the 
                Trust, and shall have power to adopt, amend, and repeal 
                bylaws governing the performance of the powers and 
                duties granted to or imposed upon it by law. The board 
                of directors shall select and effect the appointment of 
                qualified persons to fill the offices of president and 
                vice president, and such other offices as may be 
                provided for in the bylaws. The board shall make 
                recommendations to the Chief Executive Officer 
                concerning the policies for administering the Trust.
                    (D) Compensation.--Any member of the board who is a 
                full-time officer or employee of the Federal Government 
                shall not, as such member, receive compensation for his 
                or her services.
            (6) Grants.--
                    (A) In general.--The Trust shall award grants to 
                entities that have developed technologies that may (as 
                determined by the Trust) lead to the development of 
                qualified countermeasures. The Trust shall ensure that 
                grant funds are not provided under this section for 
                activities that will substantially occur outside of the 
                United States.
                    (B) Policies.--The Trust shall develop policies and 
                procedures for the awarding of grants under 
                subparagraph (A).
                    (C) Reasonable pricing.--To be eligible to receive 
                a grant under subparagraph (A), an entity shall enter 
                into an agreement with the Trust under which--
                            (i) products developed using grant funds 
                        will be made available at reasonable prices to 
                        the Trust, the Federal Government, and other 
                        consumers, except that in lieu of such an 
                        agreement, a grantee may provide the Trust with 
                        equity in return for the receipt of grant 
                        funds;
                            (ii) product developed using grant funds 
                        will be made available as provided for under 
                        clause (i) at not more than the market share 
                        price that exists on the commercial market; and
                            (iii) the Trust is provided with the 
                        authority to sell equity in products developed 
                        using grant funds and obtained by the Trust and 
                        to apply the proceeds from such sales for the 
                        awarding f grants under subparagraph (A).
            (7) Miscellaneous provisions.--
                    (A) In general.--The Trust shall have power to--
                            (i) adopt, alter, and use a corporate seal, 
                        which shall be judicially noticed;
                            (ii) to enter into and perform contracts, 
                        leases, cooperative agreements, or other 
                        transactions, on such terms as it may deem 
                        appropriate, with any agency or instrumentality 
                        of the United States, or with any State, 
                        Territory, or possession, or the Commonwealth 
                        of Puerto Rico, or with any political 
                        subdivision thereof, or with any person, firm, 
                        association, or corporation; to execute, in 
                        accordance with its bylaws, all instruments 
                        necessary or appropriate in the exercise of any 
                        of its powers;
                            (iii) in its corporate name, to sue and to 
                        be sued, and to complain and to defend, in any 
                        court of competent jurisdiction, State or 
                        Federal, but no attachment, injunction, or 
                        other similar process, final, shall be issued 
                        against the property of the Trust or against 
                        the Trust with respect to its property;
                            (iv) to conduct its business without regard 
                        to any qualification or similar statute in any 
                        State of the United States, including the 
                        District of Columbia, the Commonwealth of 
                        Puerto Rico, and the Territories and 
                        possessions of the United States;
                            (v) to lease, purchase, or acquire any 
                        property, real, personal, or mixed, or any 
                        interest therein, to hold, rent, maintain, 
                        modernize, use, and operate such property, and 
                        to sell, for cash or credit, lease, or 
                        otherwise dispose of the same, at such time and 
                        in such manner as and to the extent that it may 
                        deem necessary or appropriate;
                            (vi) to prescribe, repeal, and amend or 
                        modify, rules, regulations, or requirements 
                        governing the manner in which its general 
                        business may be conducted; and
                            (vii) to do all things as are necessary or 
                        incidental to the proper management of its 
                        affairs and the proper conduct of its business.
                    (B) Determination with respect to obligations and 
                expenditures.--Except as may be otherwise provided in 
                this section, with respect to chapter 91 of title 31, 
                or in other laws specifically applicable to Government 
                corporations, the Trust shall determine the necessity 
                for and the character and amount of its obligations and 
                expenditures and the manner in which they shall be 
                incurred, allowed, paid, and accounted for.
                    (C) Exemption from taxation.--The Trust, including 
                its franchise, capital, reserves, surplus, security 
                holdings, and income shall be exempt from all taxation 
                now or hereafter imposed by the United States, by any 
                territory, dependency, or possession thereof, or by any 
                State, county, municipality, or local taxing authority, 
                except that any real property of the Trust shall be 
                subject to State, territorial, county, municipal, or 
                local taxation to the same extent according to its 
                value as other real property is taxed.
                    (D) Appointment and compensation of personnel; use 
                of services of other agencies.--
                            (i) Appointment and compensation.--The 
                        Secretary shall have to power to select and 
                        appoint or employ such officers, attorneys, 
                        employees, and agents of the Trust, to vest 
                        them with such powers and duties, and to fix 
                        and to cause the Trust to pay such compensation 
                        to them for their services, as he may 
                        determine, subject to the civil service and 
                        classification laws.
                            (ii) Use of agencies.--With the consent of 
                        any Government corporation, or of any board, 
                        commission, independent establishment, or 
                        executive department of the Government, the 
                        Trust may avail itself on a reimbursable basis 
                        of the use of information, services, 
                        facilities, officers, and employees thereof, 
                        including any field service thereof, in 
                        carrying out the provisions of the section.
                            (iii) Compensation.--The board of directors 
                        of the Trust shall have the power to select and 
                        appoint or employ such officers, attorneys, 
                        employees, and agents, to vest them with such 
                        powers and duties, and to fix and to cause the 
                        Trust to pay such compensation to them for 
                        their services, as the board of directors 
                        determines reasonable and comparable with 
                        compensation for employment in other similar 
                        businesses involving similar duties and 
                        responsibilities, except that a significant 
                        portion of potential compensation of all 
                        executive officers of the Trust shall be based 
                        on the performance of the Trust, and any such 
                        action shall be without regard to the Federal 
                        civil service and classification laws. 
                        Appointments, promotions, and separations so 
                        made shall be based on merit and efficiency, 
                        and no political tests or qualifications shall 
                        be permitted or given consideration.
                    (E) Prohibition against use of names; injunction; 
                damages.--No individual, association, partnership, or 
                corporation, except the Trust shall use the words 
                ``National BioVenture Trust'' as the name under which 
                the individual, association, partnership, or 
                corporation shall do business. Violations of the 
                foregoing sentence may be enjoined by any court of 
                general jurisdiction at the suit of the proper body 
                corporate. In any such suit, the plaintiff may recover 
                any actual damages flowing from such violation, and, in 
                addition, shall be entitled to punitive damages 
                (regardless of the existence or nonexistence of actual 
                damages) of not exceeding $100 for each day during 
                which such violation is committed or repeated.
                    (F) Vulnerable populations working group.--The 
                Trust shall establish and convene a Vulnerable 
                Populations Working Group composed of experts on 
                pediatric populations, pregnant women, and other 
                vulnerable populations to advise the Trust with respect 
                to--
                            (i) supporting and facilitating research 
                        and development of countermeasures, and 
                        formulations of countermeasures, that are safe 
                        and effective for such populations; and
                            (ii) other activities of the Trust that 
                        effect such populations.
    (b) Study.--Not later than 120 days after the date of enactment of 
this Act, the Government Accountability Office shall conduct a study, 
and submit to the appropriate committees of Congress, a report on the 
efficient organization of the administrative structure of the Federal 
Government for responding to public health emergencies. Such report 
shall contain the specific recommendations of the Government 
Accountability Office on--
            (1) whether the Assistant Secretary for Health of the 
        Department of Health and Human Services and the Surgeon General 
        positions should be held by same individual; and
            (2) the manner in which to improve coordination between the 
        Assistant Secretary for Health, the Surgeon General, the 
        National Institutes of Health, and the Centers for Disease 
        Control and Prevention with respect to biodefense preparedness.
    (c) Authorization of Appropriations.--There is authorized to be 
appropriate to carry out this section, $1,000,000,000 for fiscal year 
2006, and such sums as may be necessary for each subsequent fiscal 
year.
    (d) Conforming Amendments.--Section 319F-2(c) of the Public Health 
Service Act (42 U.S.C. 247d-6b(c)) is amended--
            (1) in paragraph (3), by striking ``Secretary, in 
        consultation with the Homeland Security Secretary,'' and 
        inserting ``National BioVenture Trust (referred to in this 
        section as the `Trust')'';
            (2) in paragraph (4)--
                    (A) in subparagraph (A)--
                            (i) by striking ``Homeland Security 
                        Secretary and the Secretary make'' and 
                        inserting ``Trust makes''; and
                            (ii) by striking ``such Secretaries may 
                        jointly submit to the President a proposal to'' 
                        and inserting ``the Trust may'';
                    (B) in subparagraph (B), by striking ``Homeland 
                Security Secretary and the Secretary'' and inserting 
                ``Trust''; and
                    (C) by striking subparagraph (C);
            (3) in paragraph (5)--
                    (A) in subparagraph (A)--
                            (i) by striking ``The Secretary'' and 
                        inserting ``The Trust''; and
                            (ii) by striking ``Secretary determines, in 
                        consultation with the Homeland Security 
                        Secretary,'' and inserting ``Trust 
                        determines''; and
                    (B) in subparagraph (B), by striking ``Secretary'' 
                and inserting ``Trust'';
            (4) in paragraph (6)--
                    (A) by striking subparagraphs (A) and (B);
                    (B) in subparagraph (C), by striking ``Secretary 
                and the Homeland Security Secretary'' and inserting 
                ``Trust''; and
                    (C) by redesignating subparagraphs (C) through (E), 
                as subparagraphs (A) through (C), respectively;
            (5) in paragraph (7)--
                    (A) in subparagraph (B), by striking ``the 
                Secretary'' each place that such appears and inserting 
                ``the Trust''; and
                    (B) in subparagraph (C)--
                            (i) by striking ``the Secretary'' each 
                        place that such appears and inserting ``the 
                        Trust'';
                            (ii) in clause (i), by striking ``The 
                        Secretary'' and inserting ``The Trust'';
                            (iii) in clause (ii)--
                                    (I) in subclause (I), by striking 
                                ``The Secretary's'' and inserting ``The 
                                Trust's''; and
                                    (II) by adding at the end the 
                                following:
                                    ``(VII) Delivery to secretary.--The 
                                contract shall provide that the 
                                products that are the subject of the 
                                contract shall be delivered to the 
                                Secretary (subject to the provisions of 
                                subclause (IV)) for inclusion in the 
                                National Strategic Stockpile.'';
                            (iv) in clause (iii), by striking ``the 
                        Secretary'' each place that such appears and 
                        inserting ``the Trust'';
                            (v) in clause (iv), by striking ``the 
                        Secretary'' each place that such appears and 
                        inserting ``the Trust'';
                            (vi) in clause (v)--
                                    (I) by striking ``the Secretary'' 
                                each place that such appears and 
                                inserting ``the Trust''; and
                                    (II) in subclause (II), by striking 
                                ``The Secretary's'' and inserting ``The 
                                Trust's'';
                            (vii) in clause (vi), by striking ``The 
                        Secretary'' and inserting ``The Trust''; and
                            (viii) in clause (vii), by striking ``The 
                        Secretary'' and inserting ``The Trust'';
            (6) by striking paragraph (8); and
            (7) by redesignating paragraphs (9) and (10) as paragraphs 
        (8) and (9), respectively.

SEC. 102. STRATEGIC BIODEFENSE INITIATIVE.

    (a) Call for the Development of Countermeasures.--Section 319F-
2(c)(4) of the Public Health Service Act (as added by Public Law 108-
276) is amended by adding at the end the following:
                    ``(D) Statement of Intent.--
                            ``(i) In general.--On any date that is 
                        subsequent to the date on which the Trust 
                        issues under subparagraph (B) a call for the 
                        development of a countermeasure, a person 
                        planning to develop the countermeasure that is 
                        the subject of such call may file with the 
                        Trust a statement of intent to develop such 
                        countermeasure.
                            ``(ii) Contents.--A statement of intent 
                        under clause (i) shall include a plan for the 
                        development of the countermeasure that is the 
                        subject of the call approved under subparagraph 
                        (C).
                            ``(iii) Advance payment.--The Trust may 
                        make an advance payment described in paragraph 
                        (7)(C)(ii)(I) only to a person that has 
                        submitted a statement of intent under this 
                        subparagraph.
                    ``(E) Evaluation of statement of intent.--
                            ``(i) No filing of qualified statement.--
                        If, by the date that is 120 days after the date 
                        on which the Trust issues a call for the 
                        development of a security countermeasure under 
                        subparagraph (B) (and subject to an extension 
                        of such period under clause (iii)), the Trust 
                        finds that no person has filed a statement of 
                        intent under subparagraph (D) that includes a 
                        plan for the development of such countermeasure 
                        that, in the determination of the Trust, is 
                        likely to lead to the development of such 
                        countermeasure in a manner that--
                                    ``(I) meets the specifications 
                                described under subparagraph (B) with 
                                respect to the countermeasure; and
                                    ``(II) satisfies the requirement of 
                                paragraph (5)(B)(ii);
                        then the Trust shall make the declaration of 
                        non-response described in subsection (d).
                            ``(ii) Extension of time period--.--The 
                        120-day period described in clause (i) shall be 
                        extended in the case of a grant awarded under 
                        subparagraph (F) for the duration of the grant 
                        period.''.
    (b) Establishment of Initiative.--Section 319F-2 of the Public 
Health Service Act (as added by Public Law 108-276) is amended--
            (1) by redesignating subsections (d) through (f), as 
        subsections (e) through (g), respectively; and
            (2) by inserting after subsection (c), the following:
    ``(d) Strategic Biodefense Initiative.--
            ``(1) Declaration of non-response.--If the Trust makes the 
        finding described in subsection (c)(4)(E)(i), the Trust shall 
        declare and communicate promptly to the Secretary that no 
        person has responded adequately to the call for the development 
        of a security countermeasure under subsection (c)(4). Such 
        declaration shall specify the security countermeasure with 
        respect to which the declaration applies.
            ``(2) Requirement for Feasibility Determination.--
                    ``(A) Determination of feasibility.--If the Trust 
                makes a declaration described in paragraph (1) with 
                respect to a security countermeasure, the Secretary 
                shall determine whether it is feasible to produce the 
                countermeasure at reasonable cost and within a 
                reasonable time through the procedures described in 
                paragraph (3).
                    ``(B) Further review required.--If the Secretary 
                makes a negative determination under subparagraph (A), 
                the Secretary shall determine whether it is feasible to 
                produce such countermeasure at reasonable cost and 
                within a reasonable period of time through the 
                procedures described in paragraph (4).
            ``(3) Production of countermeasures through contract.--
                    ``(A) In general.--This paragraph shall apply only 
                if the Secretary has made a positive determination 
                under paragraph (2)(A).
                    ``(B) Development of plan.--Not later than 120 days 
                after making a positive determination under paragraph 
                (2)(A), the Secretary shall develop a plan for the 
                production of the countermeasure involved through the 
                procedures described in subparagraph (C).
                    ``(C) Offers of contract.--Following the 
                development of the plan under subparagraph (B), the 
                Secretary shall issue an offer to enter into contracts 
                with any person for research, development, testing, 
                production, or any other activity that, in the 
                determination of the Secretary, is likely to expedite 
                the implementation of the plan under such subparagraph.
                    ``(D) Terms of offer.--The offer described in 
                subparagraph (C) shall describe the service or other 
                activity for which the Secretary desires to enter into 
                the contract and shall include a description of the 
                terms of the contract as specified in subparagraph (E).
                    ``(E) Terms of contract.--A contract entered into 
                pursuant to an offer under subparagraph (C) shall 
                provide that--
                            ``(i) the Secretary will retain the 
                        intellectual property rights to any product 
                        developed under the contract;
                            ``(ii) the Secretary will own the product 
                        developed under the contract;
                            ``(iii) the product developed under the 
                        contract will become a part of the national 
                        stockpile under subsection (a); and
                            ``(iv) the terms described in subsection 
                        (c)(7)(C)(ii) shall apply.
                    ``(F) Satisfactory bids not received.--If, within 
                120 days of the issuance of an offer described in 
                subparagraph (C), the Secretary has not received a bid 
                or bids from any person or persons to enter into a 
                contract or contracts for the services or other 
                activities described in such offer that, in the 
                determination of the Secretary, will result in the 
                production of the specified countermeasure at 
                reasonable cost and within a reasonable time, the 
                Secretary shall issue a statement indicating that 
                satisfactory bids have not been received and shall 
                conduct the feasibility determination described in 
                paragraph (2)(B).
            ``(4) Production of countermeasures by the secretary.--
                    ``(A) In general.--This paragraph shall apply only 
                if the Secretary has made a positive determination 
                under paragraph (2)(B) or if the Secretary has issued a 
                statement under paragraph (3)(F).
                    ``(B) Plan required.--Not later than 120 days after 
                making a positive determination under paragraph (2)(B) 
                or issuing a statement under paragraph (3)(F), the 
                Secretary shall develop a plan for producing the 
                countermeasure involved.
                    ``(C) Production of Countermeasures.--Following the 
                development of the plan under subparagraph (B), the 
                Secretary shall conduct activities, subject to the 
                availability of funds under paragraph (8), necessary to 
                implement the plan under subparagraph (B). Such 
                activities may include the production of 
                countermeasures at facilities owned or operated by the 
                Secretary or the expansion, enhancement or improvement 
                of such facilities.
            ``(5) Application of provisions.--The provisions of clauses 
        (iii) through (vii) of subsection (c)(7)(C) shall apply to the 
        procurement of countermeasures under contracts under this 
        subsection. The provisions of section 3l9F-1(f) shall apply to 
        actions of the Secretary under paragraphs (1) through (4).
            ``(6) Guidelines.--The Secretary, pursuant to existing 
        authority with respect to contracts with private sector 
        entities, shall establish guidelines concerning the process of 
        entering into contracts under this subsection, including the 
        submission and review of bids by entities.
            ``(7) Funding.--
                    ``(A) In general.--To carry out this subsection, 
                the Secretary may use not to exceed 10 percent of the 
                amounts in the special reserve fund under subsection 
                (c)(10) in each fiscal year.
                    ``(B) Authorization.--In addition to the amounts 
                described in subparagraph (A), there are authorized to 
                be appropriated such additional funds as may be 
                necessary for each of fiscal years 2005 through 2009 to 
                carry out this subsection.''.

SEC. 103. COLLABORATION AND COORDINATION.

    (a) In general.--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) Qualified countermeasures and qualified pandemic or 
        epidemic product development meetings.--
                    ``(A) Countermeasures and products development 
                meetings and consultations.--The Secretary of Health 
                and Human Services (referred to in this subsection as 
                the `Secretary') or the Chief Executive Officer of the 
                National BioVenture Trust (referred to in this 
                subsection as the `CEO'), in coordination with the 
                Attorney General and the Secretary of Homeland 
                Security, may conduct meetings and consultations with 
                parties involved in the development of qualified 
                countermeasures (as defined in section 319F-2 of the 
                Public Health Service Act) or qualified pandemic or 
                epidemic products (as defined in section 319F-3(c)(5) 
                of the Public Health Service Act) (referred to in this 
                section as ``countermeasures or products'') for the 
                purpose of the development, manufacture, distribution, 
                purchase, sale, or storage of countermeasures or 
                products consistent with the purposes of this title. 
                The Secretary or CEO may convene such meeting or 
                consultation at the request of any person, the 
                Secretary of Homeland Security, the Attorney General, 
                the Chairperson of the Federal Trade Commission, an 
                industry representative or member, or upon initiation 
                by such Secretary. The Secretary or CEO shall give 
                notice of such meetings and consultations to 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 or 
                        CEO;
                            ``(ii) be open to parties involved in the 
                        development, manufacture, distribution, 
                        purchase, or sale of countermeasures or 
                        products, as determined by the Secretary or 
                        CEO;
                            ``(iii) be open to the Attorney General, 
                        the Secretary of Homeland Security, and the 
                        Chairperson;
                            ``(iv) be limited to discussions involving 
                        the development, manufacture, distribution, or 
                        sale of countermeasures or products, 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) Limitation.--The Secretary or CEO may not 
                require the disclosure of confidential commercial or 
                proprietary information.
                    ``(D) Minutes.--The Secretary or CEO shall maintain 
                minutes of meetings and consultations under this 
                subsection, which shall not be disclosed under section 
                552 of title 5, United States Code, unless such 
                Secretary or CEO, in consultation with the Attorney 
                General, determines that disclosure would pose no 
                threat to national security. Such determination shall 
                not be subject to judicial review.
                    ``(E) Exemption.--
                            ``(i) In general.--The antitrust laws shall 
                        not apply to meetings and consultations under 
                        this paragraph.
                            ``(ii) Limitation.--Clause (i) shall not 
                        apply to any agreement or conduct that results 
                        from a meeting or consultation and that does 
                        not receive an exemption pursuant to this 
                        subsection.
            ``(2) Written agreements.--The Secretary or the CEO 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 or CEO 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 or CEO 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 or 
                CEO and the parties involved.
                    ``(C) Determination.--The Attorney General, in 
                consultation with the Chairperson and the Secretary or 
                CEO--
                            ``(i) may not grant an exemption under this 
                        paragraph unless the Attorney General finds--
                                    ``(I) that the agreement involved 
                                is necessary to ensure the availability 
                                of countermeasures or products;
                                    ``(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 or 
                        the Chairperson.
            ``(5) Limitation on and renewal of exemptions.--An 
        exemption granted under paragraph (4) shall be limited to 
        covered activities, and shall be renewed (with modifications, 
        as appropriate) 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 not 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 this subsection, 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) Status of memorandums.--Minutes maintained by the 
        Secretary or CEO pursuant to paragraph (1)(D) shall not be 
        disclosed under section 552 of title 5, United States Code, if 
        the exemption is not renewed under paragraph (5), or if 
        meetings are no longer conducted, unless the Secretary or CEO, 
        in consultation with the Attorney General, determines that the 
        disclosure would pose no threat to national security. Such 
        determination shall not be subject to judicial review.
    ``(h) Definitions.--In this section:
            ``(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 countermeasures or products;
                            ``(ii) the development or testing of basic 
                        engineering techniques necessary to the 
                        development of countermeasures or products;
                            ``(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 countermeasures or products;
                            ``(iv) the production, distribution, or 
                        marketing of a product, process, or service 
                        that is a countermeasures or products;
                            ``(v) the testing in connection with the 
                        production of a product, process, or services 
                        necessary to the development of countermeasures 
                        or products;
                            ``(vi) the collection, exchange, and 
                        analysis of research or production information 
                        necessary to the development of countermeasures 
                        or products; 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 (g)(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 (g)(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.
            ``(4) 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 or 
        products.''.
    (b) Termination of Authority.--The authority provided for in the 
amendment made by subsection (a) shall terminate on the date that is 5 
years after the date of enactment of this Act.
    (c) Report.--Not later than 4 years after the date of enactment of 
this Act, the Government Accountability Office shall submit to the 
appropriate committees of Congress a report on the activities conducted 
under the authority provided under the amendment made by subsection 
(a).

       TITLE II--ENSURING NATIONAL VACCINE MANUFACTURING CAPACITY

SEC. 201. WARM-BASED MANUFACTURING FOR BIOLOGICAL COUNTERMEASURES.

    Section 319F-2(c)(7)(C)(ii) of the Public Health Service Act (42 
U.S.C. 247d-6b(c)(7)(C)(ii)), as amended by section 101(d), is further 
amended by adding at the end the following:
                                    ``(VIII) Warm-based 
                                manufacturing.--The contract shall, if 
                                the product is a biological product, 
                                provide for annual payments after the 
                                initial delivery of the product to meet 
                                the needs of the stockpile to pay the 
                                cost of maintaining domestic 
                                manufacturing capacity for, and 
                                providing additional units of, the 
                                product to the stockpile sufficient to 
                                allow the Secretary in an emergency or 
                                other time of need to promptly acquire 
                                additional units of the product for the 
                                stockpile.''.

SEC. 202. EMERGENCY MANUFACTURING.

    Section 319F-2(c)(7)(C)(ii) of the Public Health Service Act (42 
U.S.C. 247d-6b(c)(7)(C)(ii)), as amended by section 201, is further 
amended by adding at the end the following:
                                    ``(IX) Emergency manufacturing.--
                                The contract shall, if the product is 
                                not a biological product, provide for 
                                domestic manufacturing capacity, 
                                including through alternate domestic 
                                manufacturing arrangements such as 
                                through licensing to another 
                                manufacturer and preapproval of such 
                                manufacturer's product by the Food and 
                                Drug Administration, sufficient to 
                                allow the Trust in an emergency or 
                                other time of need to promptly acquire 
                                additional units of the product for the 
                                stockpile. Such contract shall ensure 
                                that the intellectual property 
                                resulting from such contract become the 
                                property of the Federal Government.''.

SEC. 203. CONSTRUCTION OF FACILITIES.

    Section 319F of the Public Health Service Act (42 U.S.C. 247d-6) is 
amended by adding at the end the following:
    ``(k) Loans for Construction.--
            ``(1) In general.--The Secretary shall establish a program 
        under which the Secretary may make loans to eligible entities 
        to enable such entities to provide for the construction of 
        countermeasure manufacturing facilities.
            ``(2) Eligibility.--To be eligible to receive a loan under 
        paragraph (1), an entity shall submit an application to the 
        Secretary at such time, in such manner, and containing such 
        information as the Secretary may require.
            ``(3) Forgiveness of loan amounts.--The Secretary may 
        forgive up to 25 percent of the amount of a loan if the entity 
        involved enters into an agreement with the Secretary to permit 
        the facilities constructed using loan amounts to be made 
        available to produce any countermeasure product specified by 
        the Secretary upon the declaration of a public health emergency 
        under section 319.
            ``(4) Labor standards.--All laborers and mechanics employed 
        by contractors or subcontractors on projects assisted by the 
        Secretary of Health and Human Services under this Act (or an 
        amendment made by this Act) shall be paid wages at rates not 
        less than those prevailing on similar construction in the 
        locality involved, as determined by the Secretary of Labor, in 
        accordance with sections 3141 through 3144, 3146, and 3147 of 
        title 40, United States Code. The Secretary of Health and Human 
        Services shall not award any contract, grant, cooperative 
        agreement, or other transaction under this Act (or amendments) 
        for such a project without first obtaining adequate assurance 
        that the labor standards provided for in this subsection will 
        be maintained upon the construction project. The Secretary of 
        Labor shall have, with respect to the labor standards specified 
        in this subsection, the authority and functions set forth in 
        Reorganization Plan Numbered 14 of 1950 (15 F.R. 3176; 64 Stat. 
        1267), and section 3145 of title 40, United States Code.
            ``(5) Authorization of appropriations.--There is authorized 
        to be appropriated, such sums as may be necessary to carry out 
        this section.''.

                 TITLE III--IMPROVING PROJECT BIOSHIELD

SEC. 301. IMPROVING PROJECT BIOSHIELD.

    (a) Statement of Congressional Intent.--Section 319F-2(c) of the 
Public Health Service Act (42 U.S.C. 247d-6b(c)) is amended--
            (1) by redesignating paragraphs (1) through (9) as 
        paragraphs (2) through (10), respectively; and
            (2) by inserting before paragraph (2), as so redesignated, 
        the following:
            ``(1) Statement of Congressional Intent.--
                    ``(A) In general.--The intent of Congress in 
                establishing Project BioShield (under the Project 
                BioShield Act of 2004 (Public law 108-276)) is--
                            ``(i) that the Project provide a guaranteed 
                        market for products for which the incentives of 
                        the commercial market are inadequate to induce 
                        their development and which meet important 
                        national needs in preparing for material 
                        threats to the health of the American public;
                            ``(ii) that the Project is not intended 
                        simply to procure products that are in advanced 
                        stages of development; and
                            ``(iii) that the Project should identify 
                        national needs in preparing for material 
                        threats to the health of the American public 
                        and accelerate the development of 
                        countermeasures to meet those needs.
                    ``(B) Requirement to follow intent.--Activities 
                conducted under this subsection shall be consistent 
                with the statement of intent described in subparagraph 
                (A).''.
    (b) Amendments.--Section 319F-2(c) of the Public Health Service Act 
(42 U.S.C. 247d-6b(c)), as amended by subsection (a), is further 
amended--
            (1) in paragraph (2)(B)--
                    (A) in clause (i)--
                            (i) in subclause (I), by striking 
                        ``(consistent with sections 302(2) and 304(a) 
                        of the Homeland Security Act of 2002)'';
                            (ii) in subclause (III)(bb), by striking 
                        ``within eight years'' and inserting ``within 8 
                        years or such additional time as the Trust 
                        determines to be reasonable''; and
                            (iii) by striking ``or'' at the end 
                        thereof;
                    (B) in clause (ii), by striking the period and 
                inserting ``; or''; and
                    (C) by adding at the end the following:
                            ``(iii) is a vaccine or microbicide used to 
                        treat or prevent AIDS, tuberculosis, Malaria, 
                        or a strain of influenza that may (in the 
                        determination of the Secretary) contribute to a 
                        pandemic.'';
            (2) in paragraph (3)--
                    (A) by redesignating subparagraphs (C) and (D) as 
                subparagraphs (D) and (E), respectively;
                    (B) by inserting after subparagraph (B), the 
                following:
                    ``(C) Requests for determinations.--The Secretary 
                may request the Homeland Security Secretary to make a 
                determination with respect to a specific chemical, 
                biological, radiological, or nuclear agent. The 
                Homeland Security Secretary shall respond to such 
                request within 90 days of such request.''; and
                    (C) in subparagraph (D) (as so redesignated), by 
                striking ``or (B)'' and inserting ``, (B), or (C)''; 
                and
            (3) in paragraph (6)(B)--
                    (A) in clause (ii), by striking ``within eight 
                years'' and inserting ``within 8 years or such 
                additional time as the Trust determines to be 
                reasonable''; and
                    (B) by striking clause (iii) and inserting the 
                following:
                            ``(iii) Whether the commercial market for 
                        the product is sufficient to ensure the 
                        continued development of the product. If the 
                        determination under this clause is that the 
                        commercial market for the product is 
                        sufficient, funds available under this 
                        subsection may not be provided for such 
                        product.''.

          TITLE IV--INCENTIVES FOR COUNTERMEASURE DEVELOPMENT

SEC. 401. PRIZE PAYMENTS FOR COUNTERMEASURES DEVELOPMENT.

    Section 319F-2(f) of the Public Health Service Act (42 U.S.C. 247d-
6b(f)) is amended by adding at the end the following:
            ``(3) Prize payment for countermeasure development and 
        production.--
                    ``(A) In general.--If the Secretary determines that 
                it is necessary to engage a biotechnology or 
                pharmaceutical company to ensure the development and 
                production of a countermeasure, and that procurement 
                under subsection (c)(7) will not engage such a company, 
                the Secretary may recommend that the President request 
                that Congress appropriate a prize payment, in a sum 
                that shall not exceed $1,000,000,000, to be made to 
                such company upon the delivery of the total number of 
                units of the countermeasure contracted for.
                    ``(B) Requirements.--If the Secretary makes a 
                recommendation under subparagraph (A), the President 
                shall promptly--
                            ``(i) request that Congress appropriate 
                        such a sum for a prize payment for such 
                        countermeasure; or
                            ``(ii) report to Congress concerning why 
                        such recommendation is inappropriate.
                    ``(C) Reasonable pricing.--To be eligible to 
                receive a payment under this paragraph, a manufacturer 
                shall provide assurances that the countermeasure with 
                respect to which the payment is to be made will be made 
                available--
                            ``(i) to the Federal Government at the 
                        lowest of --
                                    ``(I) the price paid for that 
                                product by the Department of Veterans 
                                Affairs;
                                    ``(II) the Federal ceiling price; 
                                or
                                    ``(III) the Federal supply schedule 
                                price; and
                            ``(ii) to the general public at a 
                        reasonable price determined by the Secretary 
                        through negotiations with the recipient, but in 
                        no case shall such price be higher than the 
                        average price paid for the countermeasure in 
                        the G-8 nations.
                    ``(D) License.--To be eligible to receive a payment 
                under this paragraph, a manufacturer shall provide 
                assurances that a license for the countermeasure with 
                respect to which the payment is to be made will be made 
                shall be granted to produce the product at low cost in 
                the developing world (as determined by the Secretary).
                    ``(E) Preference.--In making payments under this 
                paragraph, the Secretary shall give preference to any 
                vaccine or microbicide for AIDS, Tuberculosis, malaria, 
                or a strain of influenza that (in the determination of 
                the Secretary) contribute to a pandemic that is likely 
                to significantly reduce global mortality from these 
                diseases.
                    ``(F) Funding.--
                            ``(i) Authorization of appropriations.--For 
                        purposes of this paragraph, there are 
                        authorized to be appropriated $3,000,000,000 
                        for fiscal year 2006, and such sums as may be 
                        necessary in each fiscal year thereafter, to be 
                        used as a prize payment to be made to the 
                        vendor involved in the fiscal year in which the 
                        vendor delivers the total number of units 
                        contracted for. Amounts appropriated under this 
                        subparagraph shall remain available until 
                        expended.
                            ``(ii) Acceptance of donations.--
                        Notwithstanding any other provision of law, the 
                        Secretary may accept donations from foreign 
                        governments and other entities for the purpose 
                        of awarding prizes under this paragraph. The 
                        Secretary may use amounts received under this 
                        clause to increase the amount of prizes under 
                        this paragraph.''.

SEC. 402. PROVIDING FOR LONG-TERM SOLE-SOURCING OF COUNTERMEASURES.

    Section 319F-2(c)(8)(C)(ii) of the Public Health Service Act (42 
U.S.C. 247d-6b(c)(7)(C)(ii)), as amended by section 202, is further 
amended by adding at the end the following:
                                    ``(X) Sole sourcing.--
                                            ``(aa) In general.--The 
                                        contract shall provide that the 
                                        vendor shall be the sole source 
                                        for the countermeasure for the 
                                        stockpile under subsection (a) 
                                        for a period of 20 years from 
                                        the first date of delivery of 
                                        the product to the Secretary 
                                        under the contract, except that 
                                        the contract shall provide that 
                                        the Secretary may purchase the 
                                        countermeasure from another 
                                        source to the extent to which 
                                        the vendor is unable or 
                                        unwilling to deliver the 
                                        product in the quantity or 
                                        timeframe required by the 
                                        Secretary or if the vendor 
                                        permits purchase from another 
                                        source.
                                            ``(bb) Rule of 
                                        construction.--Nothing in item 
                                        (aa) shall be construed to 
                                        prevent the Secretary from 
                                        purchasing a countermeasure 
                                        from a source other than the 
                                        source described in such 
                                        item.''.

                 TITLE V--CROSSING THE VALLEY OF DEATH

SEC. 501. EARLY SUPPORT FOR COUNTERMEASURE DEVELOPMENT.

    Section 319F-2(c)(4) of the Public Health Service Act (42 U.S.C. 
247d-6b(c)(4)), as amended by section 102, is further amended by adding 
at the end the following:
                    ``(F) Support for call for countermeasure.--The 
                Secretary may provide grants to one or more of the 
                persons to whom a call for a countermeasure is made 
                known under subparagraph (C) to support the cost of 
                screening, research, development, testing, and initial 
                manufacture of potential candidates for such 
                countermeasure.''.

SEC. 502. INCENTIVE PAYMENTS.

    Section 319F-2(c)(7)(C)(ii)(I) of the Public Health Service Act (42 
U.S.C. 247d-6b(c)(7)(C)(ii)(I)) is amended by adding at the end the 
following: ``In addition to the advance payments described in the 
preceding sentences, the contract may provide for not more than 3 
incentive payments to be made, each in an amount that does not exceed 5 
percent of the contract amount, for the achievement by the manufacturer 
of specific milestones. Any such incentive payments shall not be 
required to be repaid for failure to perform.''.

         TITLE VI--ACCELERATING THE APPROVAL OF COUNTERMEASURES

SEC. 601. ACCELERATING THE APPROVAL OF COUNTERMEASURES.

    The Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, shall facilitate the prompt 
development, review, and approval of security countermeasures that, 
pursuant to section 319F-2(c)(6) of the Public Health Service Act, the 
Secretary has identified for inclusion in the stockpile under section 
319F-2(a) of such Act, including, as appropriate, by--
            (1) working with such Directors or Administrators as may be 
        appropriate, to facilitate the identification and development 
        of animal models necessary to assess the effectiveness of such 
        countermeasures, if applicable;
            (2) meeting and otherwise interacting with the sponsor of 
        an application under the Federal Food, Drug, and Cosmetic Act 
        or under section 351 of the Public Health Service Act for 
        approval of such countermeasure to facilitate the development 
        and clinical testing of the product necessary for preparation 
        and review of such application;
            (3) considering such an application to be a priority, 
        subject to the performance goals established by the 
        Commissioner of Food and Drugs for priority drugs or devices; 
        or
            (3) reviewing such an application in reviewable unites, as 
        provided by the Commissioner of Food and Drugs in a pilot for 
        fast-track products under the performance goals established by 
        the Commissioner of Food and Drugs, or providing a modular 
        review, under section 515(c)(3) of the Federal Food, Drug, and 
        Cosmetic Act.

SEC. 602. POSTMARKETING STUDIES FOR COUNTERMEASURES.

    (a) New Drugs.--Section 505(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(k)) is amended by adding at the end the 
following:
            ``(3) Postmarketing studies for drugs approved using animal 
        data.--
                    ``(A) In general.--The sponsor of a drug approved 
                or licensed pursuant to the regulations under subpart I 
                of part 314 or under subpart H of part 601 of title 21, 
                Code of Federal Regulations (as in effect on the date 
                of enactment of the National Biodefense Act of 2005), 
                shall--
                            ``(i) when feasible and ethical, conduct 
                        postmarketing studies, according to the plan 
                        approved by the Secretary under subparagraph 
                        (D), to--
                                    ``(I) verify and describe the 
                                clinical benefit of the drug when used 
                                as indicated; and
                                    ``(II) assess the safety of the 
                                drug when used as indicated; and
                            ``(ii) immediately submit reports of all 
                        data from such studies to the Secretary 
                        (excluding names and any other information that 
                        identifies a patient or provider).
                    ``(B) Feasibility.--Postmarketing studies under 
                subparagraph (A) shall not be considered feasible until 
                an exigency requiring use of the drug arises.
                    ``(C) Due diligence.--When postmarketing studies 
                are feasible, the sponsor shall conduct such studies 
                with due diligence.
                    ``(D) Plan submission and approval.--A sponsor 
                shall include, as part of an application under 
                subsection (b) or section 351 of the Public Health 
                Service Act for which approval is sought under the 
                regulations described in subparagraph (A), a plan for 
                postmarketing study commitments in the event such 
                studies become ethical and feasible. The Secretary 
                shall approve such a plan with modifications deemed 
                necessary by the Secretary.
                    ``(E) Plan requirements.--Studies required under a 
                plan approved under subparagraph (D) shall include--
                            ``(i) short-term field studies, to be 
                        completed after the first, second, and fourth 
                        weeks of initial administration of the drug;
                            ``(ii) long-term tracking studies;
                            ``(iii) civilian and military populations; 
                        and
                            ``(iv) major population subgroups such as 
                        men, women (including pregnant and lactating 
                        women), children, the elderly, persons with 
                        multiple chronic conditions, and different 
                        racial and ethnic subgroups.
                    ``(F) Reports on studies.--The Secretary shall make 
                available--
                            ``(i) to the public, not later than 1 week 
                        after submission of data from a study required 
                        under subparagraph (A), a summary of the data 
                        from such study, including data for the major 
                        population subgroups identified in clauses 
                        (iii) and (iv) of subparagraph (E); and
                            ``(ii) to any physician or expert in public 
                        health, as soon as practicable but in no case 
                        later than 30 days after submission, the raw 
                        data from such a study.''.
    (b) Authorization for Medical Products for Use in Emergencies.--
Section 564(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-3(e)) is amended--
            (1) in paragraph (1)(A), by--
                    (A) redesignating clauses (iii) and (iv) as clauses 
                (iv) and (v), respectively; and
                    (B) inserting after clause (ii), the following:
                            ``(iii)(I) Appropriate postmarketing 
                        studies, conducted with due diligence, 
                        including short-term field studies (to be 
                        completed after the first, second, and fourth 
                        weeks of initial administration of the product) 
                        and long-term tracking studies, civilian and 
                        military populations (as appropriate to the 
                        declaration under subsection (b)), and major 
                        populations subgroups such as men, women 
                        (including pregnant and lactating women), 
                        children, the elderly, persons with multiple 
                        chronic conditions, and different racial and 
                        ethnic subgroups, to--
                                    ``(aa) verify and describe the 
                                clinical benefit of the product when 
                                used as indicated; and
                                    ``(bb) assess the safety of the 
                                product when used as indicated.
                            ``(II) Immediate submission of reports of 
                        all data from such studies to the Secretary 
                        (excluding names and any other information that 
                        identifies a patient or provider).'';
            (2) in paragraph (2)(A), by striking ``clauses (i) and (ii) 
        of paragraph (1)(A), and may establish conditions described in 
        clauses (iii) and (iv)'' and inserting ``clauses (i), (ii), and 
        (iii) of paragraph (1)(A), and may establish conditions 
        described in clauses (iv) and (v)''; and
            (3) by adding at the end the following:
            ``(5) Reports on studies.--The Secretary shall make 
        available--
                    ``(A) to the public, not later than 1 week after 
                submission of data from a study required under 
                paragraph (1)(A)(iii) or (2)(A), a summary of the data 
                from such study, including data for the major 
                population subgroups identified in paragraph 
                (1)(A)(iii); and
                    ``(B) to any physician or expert in public health, 
                as soon as practicable but in no case later than 30 
                days after submission, the raw data from such a 
                study.''.
    (c) Studies Required.--The Secretary of Health and Human Services 
shall conduct the postmarketing studies required by the amendments made 
by subsection (a) and (b) for any countermeasure that--
            (1) is the subject of a declaration under section 224(p)(2) 
        of the Public Health Service Act; and
            (2) is not subject to the amendments made by subsection (a) 
        or subsection (b).
    (d) Coordinated Surveillance.--The Secretary of Health and Human 
Services, the Secretary of Defense, and the Secretary of Veterans 
Affairs shall coordinate efforts to collect information on adverse 
events associated with the use of vaccines and other countermeasures 
through both active and passive surveillance, including through the 
Clinical Immunization Safety Assessment network, the Vaccine Healthcare 
Centers, and State and local health departments.

           TITLE VII--BIODEFENSE INJURY COMPENSATION PROGRAM

SEC. 701. NATIONAL BIODEFENSE INJURY COMPENSATION PROGRAM.

    (a) Establishment.--Section 224 of the Public Health Service Act 
(42 U.S.C. 233) is amended by adding at the end the following:
    ``(q) Biodefense Injury Compensation Program.--
            ``(1) Establishment.--There is established the Biodefense 
        Injury Compensation Program (referred to in this subsection as 
        the `Compensation Program') under which compensation may be 
        paid for death or any injury, illness, disability, or condition 
        that is likely (based on best available evidence) to have been 
        caused by the administration of a covered countermeasure to an 
        individual pursuant to a declaration under subsection (p)(2).
            ``(2) Administration and interpretation.--The statutory 
        provisions governing the Compensation Program shall be 
        administered and interpreted in consideration of the program 
        goals described in paragraph (4)(B)(iii).
            ``(3) Procedures and standards.--The Secretary shall by 
        regulation establish procedures and standards applicable to the 
        Compensation Program that follow the procedures and standards 
        applicable under the National Vaccine Injury Compensation 
        Program established under section 2110, except that the 
        regulations promulgated under this paragraph shall permit a 
        person claiming injury or death related to the administration 
        of any covered countermeasure to file either--
                    ``(A) a civil action for relief under subsection 
                (p); or
                    ``(B) a petition for compensation under this 
                subsection.
            ``(4) Injury table.--
                    ``(A) Inclusion.--For purposes of receiving 
                compensation under the Compensation Program with 
                respect to a countermeasure that is the subject of a 
                declaration under subsection (p)(2), the Vaccine Injury 
                Table under section 2114 shall be deemed to include 
                death and the injuries, disabilities, illnesses, and 
                conditions specified by the Secretary under 
                subparagraph (B)(ii).
                    ``(B) Injuries, disabilities, illnesses, and 
                conditions.--
                            ``(i) Institute of medicine.--Not later 
                        than 30 days after making a declaration 
                        described in subsection (p)(2), the Secretary 
                        shall enter into a contract with the Institute 
                        of Medicine, under which the Institute shall, 
                        within 180 days of the date on which the 
                        contract is entered into, and periodically 
                        thereafter as new information, including 
                        information derived from the monitoring of 
                        those who were administered the countermeasure, 
                        becomes available, provide its expert 
                        recommendations on the injuries, disabilities, 
                        illnesses, and conditions whose occurrence in 
                        one or more individuals are likely (based on 
                        best available evidence) to have been caused by 
                        the administration of a countermeasure that is 
                        the subject of the declaration.
                            ``(ii) Specification by secretary.--Not 
                        later than 30 days after the receipt of the 
                        expert recommendations described in clause (i), 
                        the Secretary shall, based on such 
                        recommendations, specify those injuries, 
                        disabilities, illnesses, and conditions deemed 
                        to be included in the Vaccine Injury Table 
                        under section 2114 for the purposes described 
                        in subparagraph (A).
                            ``(iii) Program goals.--The Institute of 
                        Medicine, under the contract under clause (i), 
                        shall make such recommendations, the Secretary 
                        shall specify, under clause (ii), such 
                        injuries, disabilities, illnesses, and 
                        conditions, and claims under the Compensation 
                        Program under this subsection shall be 
                        processed and decided taking into account the 
                        following goals of such program:
                                    ``(I) To encourage persons to 
                                develop, manufacture, and distribute 
                                countermeasures, and to administer 
                                covered countermeasures to individuals, 
                                by limiting such persons' liability for 
                                damages related to death and such 
                                injuries, disabilities, illnesses, and 
                                conditions.
                                    ``(II) To encourage individuals to 
                                consent to the administration of a 
                                covered countermeasure by providing 
                                adequate and just compensation for 
                                damages related to death and such 
                                injuries, disabilities, illnesses, or 
                                conditions.
                                    ``(III) To provide individuals 
                                seeking compensation for damages 
                                related to the administration of a 
                                countermeasure with a non-adversarial 
                                administrative process for obtaining 
                                adequate and just compensation.
                            ``(iv) Use of best available evidence.--The 
                        Institute of Medicine, under the contract under 
                        clause (i), shall make such recommendations, 
                        the Secretary shall specify, under clause (ii), 
                        such injuries, disabilities, illnesses, and 
                        conditions, and claims under the Compensation 
                        Program under this subsection shall be 
                        processed and decided using the best available 
                        evidence, including information from adverse 
                        event reporting or other monitoring of those 
                        individuals who were administered the 
                        countermeasure, whether evidence from clinical 
                        trials or other scientific studies in humans is 
                        available.
                            ``(v) Application of section 2116.--Section 
                        2116(b) shall apply to injuries, disabilities, 
                        illnesses, and conditions initially specified 
                        or revised by the Secretary under clause (ii), 
                        except that the exceptions contained in 
                        paragraphs (1) and (2) of such section shall 
                        not apply.
                    ``(C) Rule of construction.--Section 13632 (a)(3) 
                of Public Law 103-66 (107 Stat. 646) (making revisions 
                by Secretary to the Vaccine Injury Table effective on 
                the effective date of a corresponding tax) shall not be 
                construed to apply to any revision to the Vaccine 
                Injury Table made under regulations under this 
                paragraph.
            ``(5) Application.--The Compensation Program applies to any 
        death or injury, illness, disability, or condition that is 
        likely (based on best available evidence) to have been caused 
        by the administration of a covered countermeasure to an 
        individual pursuant to a declaration under subsection (p)(2).
            ``(6) Special masters.--
                    ``(A) Hiring.--In accordance with section 2112, the 
                judges of the United States Claims Court shall appoint 
                a sufficient number of special masters to address 
                claims for compensation under this subsection.
                    ``(B) Budget authority.--There are appropriated to 
                carry out this paragraph such sums as may be necessary 
                for fiscal year 2005 and each fiscal year thereafter. 
                This subparagraph constitutes budget authority in 
                advance of appropriations and represents the obligation 
                of the Federal Government.
            ``(7) Covered countermeasure.--For purposes of this 
        subsection, the term `covered countermeasure' has the meaning 
        given to such term in subsection (p)(7)(A).
            ``(8) Funding.--Compensation made under the Compensation 
        Program shall be made from the same source of funds as payments 
        made under subsection (p).''.
    (b) Effective Date.--This section shall take effect as of November 
25, 2002 (the date of enactment of the Homeland Security Act of 2002 
(Public Law 107-296; 116 Stat. 2135)).

      TITLE VIII--INDEMNIFICATION FOR PRODUCERS OF COUNTERMEASURES

SEC. 801. INDEMNIFICATION FOR MANUFACTURERS AND HEALTH CARE 
              PROFESSIONALS WHO ADMINISTER MEDICAL PRODUCTS NEEDED FOR 
              BIODEFENSE.

    Section 224(p) of the Public Health Service Act (42 U.S.C. 233(p)) 
is amended--
            (1) in the subsection heading by striking ``Smallpox'';
            (2) in paragraph (1), by striking ``against smallpox'';
            (3) in paragraph (2)--
                    (A) in the paragraph heading, by striking ``against 
                smallpox''; and
                    (B) in subparagraph (B), by striking clause (ii);
            (4) by striking paragraph (3) and inserting the following:
            ``(3) Exclusivity; offset.--
                    ``(A) Exclusivity.--With respect to an individual 
                to which this subsection applies, such individual may 
                bring a claim for relief under--
                            ``(i) this subsection;
                            ``(ii) subsection (q); or
                            ``(iii) part C.
                    ``(B) Election of alternatives.--An individual may 
                only pursue one remedy under subparagraph (A) at any 
                one time based on the same incident or series of 
                incidents. Nothing in the preceding sentence shall be 
                construed to prevent an individual from pursuing a 
                remedy under subparagraph (A) after such individual has 
                elected to decline to pursue another remedy.
                    ``(C) Statute of limitations.--For purposes of 
                determining how much time has lapsed when applying 
                statute of limitations requirements relating to 
                remedies under subparagraph (A), any limitation of time 
                for commencing an action, or filing an application, 
                petition, or claim for such remedies, shall be deemed 
                to have been suspended for the periods during which an 
                individual pursues a remedy under such subparagraph.
                    ``(D) Offset.--The value of all compensation and 
                benefits provided under part C of this title for an 
                incident or series of incidents shall be offset against 
                the amount of an award, compromise, or settlement of 
                money damages in a claim or suit under this subsection 
                based on the same incident or series of incidents.'';
            (5) in paragraph (6)--
                    (A) in subparagraph (A), by inserting ``or under 
                subsection (q)'' after ``under this subsection''; and
                    (B) by redesignating subparagraph (B) as 
                subparagraph (C);
                    (C) by inserting after subparagraph (A), the 
                following:
                    ``(B) Grossly negligent, reckless, or illegal 
                conduct and willful misconduct.--For purposes of 
                subparagraph (A), grossly negligent, reckless, or 
                illegal conduct or willful misconduct shall include the 
                administration by a qualified person of a covered 
                countermeasure to an individual who was not within a 
                category of individuals covered by a declaration under 
                subsection (p)(2) with respect to such countermeasure 
                where the qualified person fails to have had reasonable 
                grounds to believe such individual was within such a 
                category.''; and
                    (D) by adding at the end the following:
                    ``(D) Liability of the united states.--The United 
                States shall be liable under this subsection with 
                respect to a claim arising out of the manufacture, 
                distribution, or administration of a covered 
                countermeasure regardless of whether--
                            ``(i) the cause of action seeking 
                        compensation is alleged as negligence, strict 
                        liability, breach of warranty, failure to warn, 
                        or other action; or
                            ``(ii) the covered countermeasure is 
                        designated as a qualified anti-terrorism 
                        technology under the SAFETY Act (6 U.S.C. 441 
                        et seq.).
                    ``(E) Governing law.--Notwithstanding the 
                provisions of section 1346(b)(1) and chapter 171 of 
                title 28, United States Code, as they relate to 
                governing law, the liability of the United States as 
                provided in this subsection shall be in accordance with 
                the law of the place of injury.
                    ``(F) Military personnel and united states citizens 
                overseas.--
                            ``(i) Military personnel.--The liability of 
                        the United States as provided in this 
                        subsection shall extend to claims brought by 
                        United States military personnel.
                            ``(ii) Claims arising in a foreign 
                        country.--Notwithstanding the provisions of 
                        section 2680(k) of title 28, United States 
                        Code, the liability of the United States as 
                        provided for in the subsection shall extend to 
                        claims based on injuries arising in a foreign 
                        country where the injured party is a member of 
                        the United States military, is the spouse or 
                        child of a member of the United States 
                        military, or is a United States citizen.
                            ``(iii) Governing law.--With regard to all 
                        claims brought under clause (ii), and 
                        notwithstanding the provisions of section 
                        1346(b)(1) and chapter 171 of title 28, United 
                        States Code, and of subparagraph (C), as they 
                        relate to governing law, the liability of the 
                        United States as provided in this subsection 
                        shall be in accordance with the law of the 
                        claimant's domicile in the United States or 
                        most recent domicile with the United States.''; 
                        and
            (6) in paragraph (7)--
                    (A) by striking subparagraph (A) and inserting the 
                following:
                    ``(A) Covered countermeasure.--The term `covered 
                countermeasure', means--
                            ``(i) a substance that is--
                                    ``(I)(aa) used to prevent or treat 
                                smallpox (including the vaccinia or 
                                another vaccine); or
                                    ``(bb) vaccinia immune globulin 
                                used to control or treat the adverse 
                                effects of vaccinia inoculation; and
                                    ``(II) specified in a declaration 
                                under paragraph (2); or
                            ``(ii) a drug (as such term is defined in 
                        section 201(g)(1) of the Federal Food, Drug, 
                        and Cosmetic Act), biological product (as such 
                        term is defined in section 351(i) of this Act), 
                        or device (as such term is defined in section 
                        201(h) of the Federal Food, Drug, and Cosmetic 
                        Act) that--
                                    ``(I) the Secretary determines to 
                                be a priority (consistent with sections 
                                302(2) and 304(a) of the Homeland 
                                Security Act of 2002) to treat, 
                                identify, or prevent harm from any 
                                biological, chemical, radiological, or 
                                nuclear agent identified as a material 
                                threat under section 319F-
                                2(c)(2)(A)(ii), or to treat, identify, 
                                or prevent harm from a condition that 
                                may result in adverse health 
                                consequences or death and may be caused 
                                by administering a drug, biological 
                                product, or device against such an 
                                agent;
                                    ``(II) is--
                                            ``(aa) authorized for 
                                        emergency use under section 564 
                                        of the Federal Food, Drug, and 
                                        Cosmetic Act, so long as the 
                                        manufacturer of such drug, 
                                        biological product, or device 
                                        has--
                                                ``(AA) made all 
                                        reasonable efforts to obtain 
                                        applicable approval, clearance, 
                                        or licensure; and
                                                ``(BB) cooperated fully 
                                        with the requirements of the 
                                        Secretary under such section 
                                        564; or
                                            ``(bb) approved or licensed 
                                        solely pursuant to the 
                                        regulations under subpart I of 
                                        part 314 or under subpart H of 
                                        part 601 of title 21, Code of 
                                        Federal Regulations (as in 
                                        effect on the date of enactment 
                                        of the National Biodefense Act 
                                        of 2005); and
                                    ``(III) is specified in a 
                                declaration under paragraph (2).''; and
                    (B) in subparagraph (B)--
                            (i) by striking clause (ii), and inserting 
                        the following:
                            ``(ii) a health care entity, a State, or a 
                        political subdivision of a State under whose 
                        auspices such countermeasure was 
                        administered;'' and
                            (vi) in clause (viii), by inserting before 
                        the period ``if such individual performs a 
                        function for which a person described in clause 
                        (i), (ii), or (iv) is a covered person''.

     TITLE IX--STRENGTHENING PUBLIC HEALTH READINESS FOR PANDEMICS

          Subtitle A--Improved Planning for Pandemic Influenza

SEC. 901. FEDERAL PANDEMIC INFLUENZA PREPAREDNESS PLAN.

    Not later than 10 days after the date of enactment of this Act, the 
Secretary of Health and Human Services shall issue in final form a 
Pandemic Influenza Preparedness Plan to provide for a coordinated 
Federal, State, and local preparation and response to an influenza 
pandemic.

SEC. 902. REQUIREMENT TO DEVELOP STATE PANDEMIC INFLUENZA PLANS.

    (a) In General.--In fiscal years after the fiscal year in which the 
Secretary issues the Plan described in section 901, the Secretary shall 
withhold from a State that has not submitted to the Secretary an 
acceptable State pandemic influenza plan (as determined by the 
Secretary) the amounts described in subsection (b) for each fiscal year 
for which such a plan is not submitted. The Secretary shall develop 
criteria for what constitutes an acceptable State plan based on the 
Plan described in section 901.
    (b) Amounts Described.--The amounts described in this subsection 
with respect to a State described in subsection (a) are the following 
amounts that are payable to a State for a fiscal year under section 
319C, 319C-1, or 319C-2 of the Public Health Service Act or from the 
Public Health and Social Services Emergency Fund (or any successor to 
such Fund):
            (1) For the first fiscal year after the initial year in 
        which the Secretary of Health and Human Services issues the 
        Plan described in section 901, an amount equal to 10 percent of 
        the amount the State was eligible to receive for such fiscal 
        year.
            (2) For the second such fiscal year, an amount equal to 15 
        percent of the amount the State was eligible to receive for 
        such fiscal year.
            (3) For the third such fiscal year, an amount equal to 20 
        percent of the amount the State was eligible to receive for 
        such fiscal year.
            (4) For the fourth and each subsequent fiscal years, an 
        amount equal to 25 percent of the amount the State was eligible 
        to receive for such fiscal year.
    (c) Distribution.--The Secretary shall redistribute amounts 
withheld under this section to compliant States in proportion to the 
populations of such States.
    (d) Planning Grants.--The Secretary shall award planning grants to 
States to assist such States in preparing or enhancing the plans 
described in subsection (a).
    (e) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, such sums as may be necessary 
for each of fiscal years 2006 through 2010.

SEC. 903. USE OF CDC AND HRSA FUNDS FOR PUBLIC HEALTH PREPAREDNESS.

    (a) Applicability of Priority Statement to CDC Preparedness 
Programs.--
            (1) In general.--The statement of priorities described in 
        section 319C-1(e) of the Public Health Service Act shall apply 
        to awards made by the Centers for Disease Control and 
        Prevention--
                    (A) from amounts under the Public Health and Social 
                Services Emergency Fund (or any successor to such 
                Fund); and
                    (B) under the Public Health Preparedness and 
                Response for Bioterrorism program or any successor to 
                such program.
            (2) Limitation.--No State that receives as award under a 
        program described in paragraph (1) may deny funding or impose 
        any other sanction against an entity that uses funds received 
        under such program to enhance preparedness for naturally 
        occurring outbreaks of infectious disease.
            (2) Applicability of Priority Statement to HRSA 
        Preparedness Programs.--
            (1) In general.--The statement of priorities described in 
        section 319C-2(g) of the Public Health Service Act shall apply 
        to awards made by the Health Resources and Service 
        Administration--
                    (A) from amounts under the Public Health and Social 
                Services Emergency Fund (or any successor to such 
                Fund); and
                    (B) under the National Bioterrorism Hospital 
                Preparedness Program or any successor to such program.
            (2) Limitation.--No State that receives as award under a 
        program described in paragraph (1) may deny funding or impose 
        any other sanction against an entity that uses funds received 
        under such program to enhance preparedness for naturally 
        occurring outbreaks of infectious disease.

                       Subtitle B--Vaccine Supply

SEC. 911. BUY-BACK PROGRAM FOR FLU VACCINE.

    (a) Requests for More Doses.--
            (1) In general.--Not later than March 15 of each year, the 
        Secretary of Health and Human Services shall enter into 
        contracts with manufacturers to produce such additional doses 
        of the influenza vaccine as determined necessary by the 
        Secretary.
            (2) Content of contract.--A contract for additional doses 
        shall provide that the manufacturer will be compensated by the 
        Secretary at an equitable rate negotiated by the Secretary and 
        the manufacturer for any doses that--
                    (A) were not sold by the manufacturer through 
                routine market mechanisms at the end of the influenza 
                season for that year; and
                    (B) were requested by the Secretary to be produced 
                by such manufacturer.
            (3) When such vaccine purchases should take place.--The 
        Secretary of Health and Human Services may purchase from the 
        manufacturer the doses for which it has contracted at any time 
        after which it is determined by the Secretary, in consultation 
        with the manufacturer, that the doses will likely not be 
        absorbed by the private market.
    (b) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section such sums as may be necessary.

         Subtitle C--Enhancing the National Strategic Stockpile

SEC. 921. STOCKPILING OF ANTIVIRALS AND OTHER MEDICATIONS.

    (a) In General.--Section 319F-2(b) of the Public Health Service Act 
(42 U.S.C. 247d-6b(b)) is amended--
            (1) by striking the subsection heading and inserting the 
        following: ``Stockpiling National Priority Countermeasures''; 
        and
            (2) by adding at the end the following:
            ``(3) Medication for pandemic influenza.--
                    ``(A) In general.--The Secretary shall ensure that 
                the stockpile described in subsection (a) includes an 
                amount of antiviral medication sufficient to provide 
                for the emergency health security of the United States 
                (including the emergency health security of children 
                and other vulnerable populations) with respect to 
                strains of influenza that may (in the determination of 
                the Secretary) contribute to a pandemic.
                    ``(B) Amount and type.--In determining the types 
                and amounts of the antivirals and other medications to 
                be placed in the stockpile under subparagraph (A), the 
                Secretary shall take into account the recommendations 
                of the World Health Organization and of professional 
                societies with expertise in infectious diseases.
                    ``(C) Authorization of appropriations.--
                            ``(i) In general.--There is authorized to 
                        be appropriated to carry out subparagraph (A), 
                        $3,080,000,000 for fiscal year 2006. Amounts 
                        appropriated under this paragraph shall remain 
                        available until expended.
                            ``(ii) Reallocation of unexpended 
                        amounts.--The Secretary shall reallocate 
                        amounts appropriated under clause (i) that are 
                        not utilized by the Secretary for the purchase 
                        of antivirals under such clause, for activities 
                        under sections 319C-1 and 319C-2 of the Public 
                        Health Service Act (42 U.S.C. 247d-3a and 247d-
                        3b). Such amounts shall be reallocated equally 
                        between such sections.''.
    (b) Technical Amendment.--Section 319F-2(a)(1) of the Public Health 
Service Act (42 U.S.C. 247d-6b(a)(1)) is amended by inserting 
``(including drugs, biologics, and devices to address acute 
exacerbation of chronic illness and mental health disorders)'' after 
``other supplies''.

SEC. 922. STRATEGIC PLAN FOR STOCKPILE.

    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services shall develop a 
comprehensive plan for the use of each medical intervention contained 
in the national stockpile under section 121 of the Public Health 
Security and Bioterrorism Preparedness and Response Act of 2002 (42 
U.S.C. 300hh-12).
    (b) Requirements of Plan.--The plan developed under subsection (a) 
shall--
            (1) cover all relevant Federal, State, and local agencies 
        as well as necessary members of the private sector;
            (2) with respect to all products in the stockpile, provide 
        for the coordination of activation, distribution, and 
        dissemination of such products to the population at large and 
        to specific high-risk groups such as health care professionals;
            (3) with respect to new medicines or vaccines that are 
        added to the stockpile, provide, within a reasonable period of 
        time, for the coordination of activation, distribution, and 
        dissemination of the product to the population at large and 
        specific high-risk groups such as health care professionals; 
        and
            (4) include procedures for triage or other methods to 
        prioritize the distribution of materials from the stockpile in 
        the event of multiple transit attacks or other public health 
        emergencies occurring simultaneously in different areas of the 
        nation.
    (c) Periodic Updating.--The plan developed under subsection (a) 
shall be periodically reviewed and updated to ensure the consideration 
of the needs of the changing nature of threats, the State of medical 
practice, and the capacities of the agencies and organizations 
involved.

     Subtitle D--Prohibiting Price Gouging on Needed Flu Medicines

SEC. 931. UNFAIR OR DECEPTIVE ACTS OR PRACTICES IN COMMERCE RELATED TO 
              TREATMENTS FOR PANDEMIC INFLUENZA.

    Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) 
is amended by adding at the end the following:
    ``(g) Unfair or Deceptive Acts or Practices in Commerce Related to 
Treatments for Pandemic Influenza.--
            ``(1) Sales to consumers at unconscionable price.--
                    ``(A) In general.--During any public health 
                emergency declared by the Secretary under section 319 
                related to pandemic influenza, it shall be unlawful for 
                any person to sell any drug (including an anti-viral 
                drug), device, or biologic for the prevention or 
                treatment of influenza in, or for use in, the area to 
                which that declaration applies at a price that--
                            ``(i) is unconscionably excessive (as 
                        determined by the Secretary); or
                            ``(ii) indicates the seller is taking 
                        unfair advantage of the circumstances to 
                        increase prices unreasonably.
                    ``(B) Factors to be considered.--In determining 
                whether a violation of paragraph (1) has occurred, a 
                court shall take into account, among other factors, 
                whether--
                            ``(i) the amount charged represents a gross 
                        disparity between the price of a drug, device, 
                        or biologic for the prevention or treatment of 
                        influenza and the price at which the drug, 
                        device, or biologic was offered for sale in the 
                        usual course of the seller's business 
                        immediately prior to the public health 
                        emergency; or
                            ``(ii) the amount charged grossly exceeds 
                        the price at which the same or similar drug, 
                        device, or biologic for the prevention or 
                        treatment of influenza was readily obtainable 
                        by other purchasers in the area in which the 
                        declaration applies.
                    ``(C) Mitigating factors.--In determining whether a 
                violation of subparagraph (A) has occurred, the court 
                shall also take into account, among other factors, the 
                price that would reasonably equate supply and demand in 
                a competitive and freely functioning market and whether 
                the price at which the drug, device, or biologic for 
                the prevention or treatment of influenza was sold 
                reasonably reflects additional costs, not within the 
                control of the seller, that were paid or incurred by 
                the seller.
            ``(2) False pricing information.--It shall be unlawful for 
        any person to report information related to the wholesale price 
        of any drug, device, or biologic for the prevention or 
        treatment of influenza to the Secretary if--
                    ``(A) that person knew, or reasonably should have 
                known, the information to be false or misleading;
                    ``(B) the information was required by law to be 
                reported; and
                    ``(C) the person intended the false or misleading 
                data to affect data compiled by the department or 
                agency involved for statistical or analytical purposes 
                with respect to the market for drugs, devices, or 
                biologics for the prevention or treatment of influenza.
            ``(3) Market manipulation.--It shall be unlawful for any 
        person, directly or indirectly, to use or employ, in connection 
        with the purchase or sale of drugs, devices, or biologics for 
        the prevention or treatment of influenza at wholesale, any 
        manipulative or deceptive device or contrivance, in 
        contravention of such rules and regulations as the Secretary 
        may prescribe as necessary or appropriate in the public 
        interest or for the protection of United States citizens.''.

              Subtitle E--National Institute of Pathology

SEC. 941. NATIONAL INSTITUTE OF PATHOLOGY.

    Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) 
is amended--
            (1) In section 401(b)(2), by adding at the end the 
        following:
            ``(H) The National Institute of Pathology.''; and
            (2) by adding at the end of part E (42 U.S.C. 287 et seq.) 
        the following:

              ``Subpart 7--National Institute of Pathology

``SEC. 485A. ESTABLISHMENT OF NATIONAL INSTITUTE OF PATHOLOGY.

    ``In order to provide pathology consultation for civilian and 
military health professionals (including Department of Veterans Affairs 
health professionals) there is established the National Institute of 
Pathology (in this subpart referred to as the `Institute'). The 
Institute shall be headed by a director, who shall be appointed by the 
Secretary. The Director of the Institute shall report directly to the 
Director of NIH.

``SEC. 485B. PURPOSES AND FUNCTIONS OF THE INSTITUTE.

    ``(a) Purposes of the Institute.--The general purposes of the 
Institute are to--
            ``(1) conduct and support research, education, training, 
        and other programs with respect to the science and clinical 
        practice of pathology;
            ``(2) maintain and improve a pathology tissue repository; 
        and
            ``(3) provide pathology consultation services.
    ``(b) Activities of the Director.--In order to carry out the 
purposes of the Institute described in subsection (a), the Director of 
the Institute--
            ``(1) shall--
                    ``(A) maintain and improve a comprehensive 
                repository of pathological specimens;
                    ``(B) provide consultations on request regarding 
                clinical cases;
                    ``(C) conduct educational programs and publish 
                educational materials on the science and clinical 
                practice of pathology;
                    ``(D) maintain and improve registries on such 
                clinical conditions as the Director of the Institute 
                determines appropriate; and
                    ``(E) conduct and support research on pathology; 
                and
            ``(2) may--
                    ``(A) collect reasonable and appropriate fees for 
                the activities described in paragraph (1)(B); and
                    ``(B) conduct such other activities as the Director 
                of the Institute determines appropriate to carry out 
                the purposes described in subsection (a).
    ``(c) Authority for Expert Opinions.--The Director of the Institute 
may enter into memoranda of understanding with officials at the 
Department of Veterans Affairs and the Department of Defense to provide 
expert second opinion pathology consultations and pathology education 
or training if the Secretary of either such Department determines that 
such provision would be in the best interest of either of their 
respective departments.

``SEC. 485C. BOARD OF REGENTS.

    ``(a) Membership.--
            ``(1) In general.--There is established a Board of Regents 
        of the Institute (in this subpart referred to as the `Board') 
        consisting of--
                    ``(A) the Surgeons General of--
                            ``(i) the Public Health Service;
                            ``(ii) the Army;
                            ``(iii) the Navy; and
                            ``(iv) the Air Force;
                    ``(B) the Chief Medical Director of the Department 
                of Medicine and Surgery of the Department of Veterans 
                Affairs;
                    ``(C) the Deputy Director of the National Library 
                of Medicine;
                    ``(D) the Assistant Secretary of Health of the 
                Department of Defense;
                    ``(E) the Dean of the Uniformed Services University 
                of the Health Sciences; and
                    ``(F) 11 members to be appointed by the Secretary 
                from among leaders in pathology research, education and 
                clinical practice.
            ``(2) Ex officio members.--The members of the Board 
        described in subparagraphs (A) through (E) of paragraph (1) 
        shall serve as ex officio members of the Board.
            ``(3) Chairperson.--The members of the Board appointed 
        under paragraph (1)(F) shall annually elect one of such members 
        to serve as the Chairperson of the Board until the next 
        election.
    ``(b) Duties of the Board.--It shall be the duty of the Board to 
advise, consult with, and make recommendations to the Director of NIH 
on important matters of policy in regard to the Institute, including 
such matters as the scope, content and organization of the research, 
education and consultative services provided by the Institute. The 
Board shall make recommendations to the Director of NIH regarding the 
rules under which specimens from the tissue repository will be used and 
under which it's publications, facilities and services will be made 
available to various kinds users
    ``(c) Terms of Office.--Each appointed member of the Board shall 
hold office for a term of 4 years, except that any member appointed to 
fill a vacancy occurring prior to the expiration of the term for which 
the predecessor of such member was appointed shall be appointed for the 
remainder of such term. None of the appointed members shall be eligible 
for reappointment within 1 year after the end of the preceding term of 
such member.
    ``(d) Compensation.--Appointed members of the Board who are not 
otherwise in the employ of the United States, while attending 
conferences of the Board or otherwise serving at the request of the 
Secretary in connection with the administration of the Board, shall be 
entitled to receive compensation, per diem in lieu of subsistence, and 
travel expenses in the same manner and under the same conditions as 
that prescribed under section 208(c).

``SEC. 485D. GIFTS TO THE INSTITUTE.

    ``Section 231 shall be applicable to the acceptance and 
administration of gifts made for the benefit of the Institute or for 
carrying out any of its functions.

``SEC. 485E. INSTITUTE FACILITIES.

    ``There are authorized to be appropriated amounts sufficient for 
the erection and equipment of suitable and adequate buildings and 
facilities for use of the Institute. The Administrator of General 
Services may acquire, by purchase, condemnation, donation, or 
otherwise, a suitable site or sites, selected by the Secretary in 
accordance with the direction of the Board, for such buildings and 
facilities and to erect thereon, furnish, and equip such buildings and 
facilities. The amounts authorized to be appropriated by this section 
include the cost of preparation of drawings and specifications, 
supervision of construction, and other administrative expenses incident 
to the work. The Administrator of General Services shall prepare the 
plans and specifications, make all necessary contracts, and supervise 
construction.''.

SEC. 942. TRANSFER OF THE ARMED FORCES INSTITUTE OF PATHOLOGY.

    (a) In General.--
            (1) In general.--Except as provided in paragraph (2), there 
        are transferred to the National Institute of Pathology 
        established under subpart 7 of part E of title IV of the Public 
        Health Service Act all functions, duties, personnel, assets, 
        liabilities, contracts, property, records, and unexpended 
        balances of appropriations of the Armed Forces Institute of 
        Pathology. The preceding sentence shall not affect any 
        proceedings, pending applications, suits, or other actions 
        pending on the date of enactment of this Act.
            (2) Exceptions.--The following components of the Armed 
        Forces Institute of Pathology shall not be transferred from the 
        Department of Defense pursuant to paragraph (1):
                    (A) The Armed Forces Medical Examiner.
                    (B) The Department of Defense DNA registry.
                    (C) Accident Investigation Program.
                    (D) The histopathology training program.
                    (E) The patient safety center.
                    (F) Department of Legal Medicine.
                    (G) Center for Clinical Laboratory Medicine.
                    (H) Drug Testing and Quality Assurance Program.
                    (I) Subject to the discretion of the Secretary of 
                Defense, medical research programs on the following:
                            (i) Body armor.
                            (ii) Environmental sarcoidosis.
                            (iii) Depleted uranium.
                            (iv) Military working dogs.
                            (v) Such other areas of research related to 
                        pathology as the Secretary of Defense shall 
                        choose to conduct.
    (b) References.--Any reference in any Federal law, Executive order, 
rule, regulation, or delegation of authority, or any document of or 
relating to the Armed Forces Institute of Pathology shall be deemed to 
be a reference to the National Institute of Pathology established under 
subpart 7 of part E of title IV of the Public Health Service Act.

   Subtitle F--Increased Influenza Vaccine and Outbreak Surveillance 
                               Activities

SEC. 951. TRACKING NETWORK AND DEMONSTRATION GRANTS.

    Title III of the Public Health Service Act is amended by inserting 
after section 319B (42 U.S.C. 247d-2) the following:

``SEC. 319B-1. TRACKING NETWORK AND DEMONSTRATION GRANTS.

    ``(a) Tracking System.--
            ``(1) Establishment.--Not later than 2 years after the date 
        of enactment of this section, the Director of the Centers for 
        Disease Control and Prevention, in conjunction with State and 
        local public health officials, shall establish an electronic 
        tracking system through which the Director and such officials 
        can determine the amount of influenza vaccine that is available 
        for distribution to patients, as well as the need for such 
        vaccine on a county-by-county basis, and the progress of 
        vaccine delivery and distribution efforts at the State and 
        local level.
            ``(2) Estimates.--The tracking system established under 
        paragraph (1) shall collect estimates of the size of high 
        priority populations (as defined by the Advisory Committee on 
        Immunization Practices and the Centers for Disease Control and 
        Prevention) (referred to in this section as `high priority 
        populations') in each county in the United States, so as to 
        better determine where influenza vaccine resources may need to 
        be directed in the case of an emergency.
            ``(3) Provision of information.--To be eligible to 
        participate in the program under section 911 the vaccine 
        manufacturer shall provide information to the tracking system 
        as the Director of the Centers for Disease Control and 
        Prevention determines appropriate in accordance with subtitle 3 
        of title XXI.
            ``(4) Database.--In consultation with manufacturers, 
        distributors, wholesalers, and State and local health 
        departments, the Secretary shall develop guidelines for the 
        development and use of a database in order to maintain 
        confidentiality and ensure that none of the information 
        provided under paragraph (3) and contained in the database can 
        be used to provide a proprietary advantage within the vaccine 
        market while allowing State and local health officials such 
        information to maximize the delivery and availability of 
        vaccines to high priority populations.
    ``(b) Expansion of Current Systems and Activities.--
            ``(1) Surveillance system.--Not later than 4 years after 
        the date of enactment of this section, the Director of the 
        Centers for Disease Control and Prevention shall upgrade the 
        influenza surveillance system of the Centers for Disease 
        Control and Prevention to report influenza data from State and 
        local health departments into the tracking system established 
        under subsection (a)(1).
            ``(2) Educational materials.--The tracking system shall 
        contain information to assist users in accessing influenza 
        education, outreach, and communications tools.
            ``(3) Emergency provider database.--The Director of the 
        Centers for Disease Control and Prevention shall coordinate 
        access to, in conjunction with State and local health 
        departments and State licensing boards for health 
        professionals, a database registry of medical personnel who can 
        provide services in the event of a health emergency, including 
        pandemic influenza or an influenza vaccine shortage. Such 
        information shall be made available through the tracking 
        network.
    ``(c) Demonstration Grants.--
            ``(1) In general.--The Director of the Centers for Disease 
        Control and Prevention shall award demonstration grants to 
        State and local health departments to enable such departments 
        to enter into contract with hospitals, community health 
        centers, long-term care facilities, physicians' offices, and 
        health care facilities operated or funded by such departments 
        to assist such entities in upgrading their information 
        technology, and workforce in a manner that will allow such 
        entities to improve their ability to report and track influenza 
        vaccine dissemination.
            ``(2) Priority.--In awarding grants under paragraph (1), 
        priority shall be given to entities that serve high priority 
        populations in medically underserved areas.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated--
            ``(1) to carry out subsection (a), $100,000,000 for each of 
        fiscal years 2007 through 2011, of which $500,000 for each 
        fiscal year shall be made available to implement subsection 
        (b)(3); and
            ``(2) to carry out subsection (c), $100,000,000 for each of 
        fiscal years 2007 through 2011.''.

SEC. 952. EDUCATIONAL EFFORTS AND GRANTS.

    Title III of the Public Health Service Act is amended by inserting 
after section 319B-1 (as added by section 951) the following:

``SEC. 319B-2. IMMUNIZATION EDUCATIONAL EFFORTS AND GRANTS.

    ``(a) In General.--The Director of the Centers for Disease Control 
and Prevention, in conjunction with State and local health departments, 
shall revise and expand the influenza-related educational materials to 
the Centers for Disease Control and Prevention, and facilitate the use 
of such materials by health care providers and patients. The Director 
is authorized to coordinate such educational efforts with nonprofit 
provider and patient advocacy groups.
    ``(b) Influenza Vaccine Education and Outreach.--
            ``(1) In general.--In order to achieve an optimal balance 
        in the influenza vaccine market, and to ensure that the 
        recommendations of the Advisory Committee on Immunization 
        Practices to the Centers for Disease Control and Prevention for 
        vaccine administration are carried out to the maximum extent 
        possible, the Director of the Centers for Disease Control and 
        Prevention, in conjunction with State and local health 
        departments, shall carry out influenza immunization education 
        and outreach activities that target physicians and other health 
        care providers, health insurance providers, health care 
        institutions and patients, particularly those in high priority 
        populations (as defined by the Advisory Committee on 
        Immunization Practices and the Centers for Disease Control and 
        Prevention) (referred to in this section as `high priority 
        populations').
            ``(2) Types of activities.--The education and outreach 
        activities under paragraph (1) shall include--
                    ``(A) activities to encourage voluntary 
                participation in influenza vaccination programs, with 
                the goal of increasing overall influenza vaccination 
                rates in the United States, achieving full influenza 
                vaccination of all high priority populations, and full 
                use of each season's influenza vaccine supply;
                    ``(B) the provision of information on influenza 
                prevention;
                    ``(C) activities to increase the number of 
                healthcare providers who receive influenza vaccines 
                each year; and
                    ``(D) other influenza educational efforts 
                determined appropriate by the Director.
    ``(c) Grants.--The Director of the Centers for Disease Control and 
Prevention may award grants to State and local health departments to 
carry out activities to encourage individuals, particularly those from 
high priority populations, to seek out influenza vaccinations.
    ``(d) Collaboration.--State and local health departments that 
receive grants under subsection (b) are encouraged to collaborate on 
projects with physicians and other health care providers, health 
insurance providers, health care institutions, and groups representing 
high priority populations.
    ``(e) Authorization of Appropriations.--In addition to any amounts 
otherwise available through the Secretary for influenza outreach and 
education, there is authorized to be appropriated to carry out this 
section, $10,000,000 for each of fiscal years 2007 through 2011.''.

                  Subtitle G--Miscellaneous Provisions

SEC. 961. HRSA CURRICULUM DEVELOPMENT AND TRAINING PROGRAMS.

    In carrying out activities under section 319F(g) of the Public 
Health Service Act and any related activities on the development of 
training program for health professionals in the recognition of the 
signs and symptoms of exposure to a potential bioweapon and other 
agents that may create a public health emergency (including the 
Bioterrorism Training and Curriculum Development program of the Health 
Resources and Services Administration), the Secretary of Health and 
Human Services shall, to the maximum extent practicable, provide awards 
to a single entity or a small number of entities that have the capacity 
to provide consistent training nationwide. In carrying out the 
requirement of the preceding sentence, the Secretary may not, except if 
there is no practicable alternative, provide awards to any single 
entity that is less than 20 percent of the total awards made for any 
fiscal year.

SEC. 962. USING HEALTH INFORMATION TECHNOLOGY TO ENAHNCE EPIDEMIC 
              DETECTION.

    Section 319F of the Public Health Service Act (42 U.S.C. 247d-6) is 
amended by adding at the end the following:
    ``(k) Using Health Information Technology To Enhance Epidemic 
Detection.--
            ``(1) In general.--The Secretary may award demonstration 
        grants to eligible entities to enable such entities to 
        establish or enhance information technology systems for the 
        rapid detection of infectious disease outbreaks.
            ``(2) Eligibility.--To be eligible to receive a grant under 
        paragraph (1), an entity shall--
                    ``(A) be a State or local government or nonprofit 
                entity; and
                    ``(B) submit to the Secretary an application at 
                such time, in such manner, and containing such 
                information as the Secretary may require, including and 
                assurance that the entity will submit to the Secretary 
                a report on the effective of the systems funded under 
                the grant.
            ``(3) Evaluation of systems.--Not later than 1 year after 
        the date of enactment of this subsection, and annually 
        thereafter, the Director of the Centers for Disease Control and 
        Prevention shall conduct an evaluation of the systems 
        implemented under grants under this subsection to determined 
        which systems are most effective. The Director shall issue 
        recommendations on best practices for such systems.
            ``(4) Independent evaluation.--Not later than 4 years after 
        the date of enactment of this subsection, the Government 
        Accountability Office shall conduct an independent evaluation, 
        and submit to the Secretary and the appropriate committees of 
        Congress a report, concerning the activities conducted under 
        this subsection.
            ``(5) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this subsection, 
        $50,000,000 for each of fiscal years 2006 through 2010.''.

SEC. 963. NATURALLY OCCURRING OR DELIBERATELY INTRODUCED AGENTS.

    Section 319C-1(d)(7)(A) of the Public Health Service Act (42 U.S.C. 
247d-3a(d)(7)(A)) is amended by inserting ``(where such biological 
agent may be naturally occurring or deliberately introduced)'' after 
``agent''.

SEC. 964. USE OF FEDERAL FACILITIES IN EMERGENCIES.

    (a) Identification.--Not later than 90 days after the date of 
enactment of this Act, the Secretary of Health and Human Services shall 
identify Federal facilities that are capable of being used to provide 
health care as surge capacity hospitals during a public health 
emergency under section 319 of the Public Health Service Act.
    (b) Memorandum of Understanding.--The Secretary of Health and Human 
Services may enter into a memorandum of understanding with the heads of 
appropriate Federal agencies and other workforce groups to utilize the 
facilities identified under subsection (a) during a public health 
emergency under section 319 of the Public Health Service Act.

SEC. 965. ADVISORY COMMITTEE ON VULNERABLE POPULATIONS.

    (a) In general.--Section 319F(b)(2) of the Public Health Service 
Act (42 U.S.C. 247d-6(b)(2)) is amended to read as follows:
            ``(2) National advisory committee on vulnerable populations 
        and terrorism.--
                    ``(A) In general.--For purposes of paragraph (1), 
                the Secretary shall establish an advisory committee to 
                be known as the National Advisory Committee on 
                Vulnerable Populations and Terrorism (referred to in 
                this paragraph as the `Advisory Committee').
                    ``(B) Duties.--The Advisory Committee shall--
                            ``(i) provide recommendations regarding--
                                    ``(I) the preparedness of the 
                                health care (including mental health 
                                care) system to respond to bioterrorism 
                                as it relates to children, pregnant 
                                women, and other vulnerable 
                                populations;
                                    ``(II) needed changes to the health 
                                care and emergency medical service 
                                systems and emergency medical services 
                                protocols to meet the special needs of 
                                children, pregnant women, and other 
                                vulnerable populations; and
                                    ``(III) changes, if necessary, to 
                                the national stockpile under section 
                                121 of the Public Health Security and 
                                Bioterrorism Preparedness and Response 
                                Act of 2002 to meet the emergency 
                                health security of children, pregnant 
                                women, and other vulnerable 
                                populations; and
                            ``(ii) advise the National BioVenture Trust 
                        with respect to granting priority to supporting 
                        and facilitating research and development of 
                        countermeasures, and formulations of 
                        countermeasures, that are likely to be safe and 
                        effective for children, pregnant women, and 
                        other vulnerable populations.
                    ``(C) Composition.--The Advisory Committee shall be 
                composed of such Federal officials as may be 
                appropriate to address the special needs of the diverse 
                population groups of children, pregnant women, and 
                other populations and health experts on infectious 
                disease, environmental health, toxicology, and other 
                relevant professional disciplines.''.
    (b) Annual Review of Strategic National Stockpile.--
            (1) In general.--The Secretary, in consultation with the 
        National Advisory Committee on Vulnerable Populations and 
        Terrorism and other experts as determined appropriate by the 
        Secretary, shall annually conduct a review of--
                    (A) the capacity of the Strategic National 
                Stockpile under section 319F-2 of the Public Health 
                Service Act (42 U.S.C. 247d-6b) to address the 
                emergency health needs of pediatric populations, 
                pregnant women, and other vulnerable populations; and
                    (B) any formulary additions or modifications with 
                respect to the contents of such Stockpile to ensure 
                that the needs of such populations are met.
            (2) Recommendations.--Based on the review under paragraph 
        (1), the Secretary shall--
                    (A) determine and prioritize recommendations of 
                formulary additions to the Strategic National Stockpile 
                with respect to pediatric populations, pregnant women, 
                and other vulnerable populations; and
                    (B) submit such recommendations to Congress.

SEC. 966. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF HEALTH 
              PROFESSIONS VOLUNTEERS.

    Section 319I(a) of the Public Health Service Act (42 U.S.C. 247d-
7b(a)) is amended by striking ``maintain a system'' and inserting 
``maintain a single system''.

                     TITLE X--ENHANCING ANTIBIOTICS

SEC. 1001. PRESERVING THE EFFECTIVENESS OF MEDICALLY IMPORTANT 
              ANTIBIOTICS.

    (a) Proof of Safety of Critical Antimicrobial Animal Drugs.--
            (1) Definitions.--Section 201 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 321) is amended by adding at the 
        end the following:
    ``(nn) Critical Antimicrobial Animal Drug.--The term `critical 
antimicrobial animal drug' means a drug that--
            ``(1) is intended for use in food-producing animals; and
            ``(2) is composed wholly or partly of--
                    ``(A) any kind of penicillin, tetracycline, 
                bacitracin, macrolide, lincomycin, streptogramin, 
                aminoglycoside, sulfonamide; or
                    ``(B) any other drug or derivative of a drug that 
                is used in humans or intended for use in humans to 
                treat or prevent disease or infection caused by 
                microorganisms.
    ``(oo) Nontherapeutic use.--The term `nontherapeutic use', with 
respect to a critical antimicrobial animal drug, means any use of the 
drug as a feed or water additive for an animal in the absence of any 
clinical sign of disease in the animal for growth promotion, feed 
efficiency, weight gain, routine disease prevention, or other routine 
purpose.''.
            (2) Nontherapeutic use.--Section 512(d)(1) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)) is 
        amended--
                    (A) in the first sentence--
                            (i) in subparagraph (H), by striking ``or'' 
                        at the end;
                            (ii) by redesignating subparagraph (I) as 
                        subparagraph (J); and
                            (iii) by inserting after subparagraph (H) 
                        the following:
                    ``(I) with respect to a critical antimicrobial 
                animal drug or a drug of the same chemical class as a 
                critical antimicrobial animal drug, the applicant has 
                failed to demonstrate that there is a reasonable 
                certainty of no harm to human health due to the 
                development of antimicrobial resistance that is 
                attributable, in whole or in part, to the 
                nontherapeutic use of the drug; or''; and
                    (B) in the second sentence, by striking ``(A) 
                through (I)'' and inserting ``(A) through (J)''.
            (3) Phased elimination of nontherapeutic use in animals of 
        critical antimicrobial animal drugs important for human 
        health.--Section 512 of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 360b) is amended by adding at the end the 
        following:
    ``(q) Phased Elimination of Nontherapeutic Use in Animals of 
Critical Antimicrobial Animal Drugs Important for Human Health.--
            ``(1) Applicability.--This subsection applies to the 
        nontherapeutic use in a food-producing animal of--
                    ``(A)(i) a drug that is a critical antimicrobial 
                animal drug; or
                    ``(ii) a drug that is of the same chemical class as 
                a critical antimicrobial animal drug; and
                    ``(B) a drug--
                            ``(i) for which, as of the day before the 
                        date of enactment of this subsection, there was 
                        in effect an approval of an application filed 
                        under subsection (b) or (j) of section 505; or
                            ``(ii) that was otherwise marketed for use.
            ``(2) Withdrawal.--The Secretary shall withdraw the 
        approval of a nontherapeutic use in food-producing animals 
        described in paragraph (1) on the date that is 2 years after 
        the date of enactment of this subsection unless--
                    ``(A) before the date that is 2 years after that 
                date of enactment, the Secretary makes a written 
                determination that the holder of the approved 
                application has demonstrated that there is a reasonable 
                certainty of no harm to human health due to the 
                development of antimicrobial resistance that is 
                attributable in whole or in part to the nontherapeutic 
                use of the drug; or
                    ``(B) before the date specified in subparagraph 
                (A), the Secretary makes a final written determination 
                under this subsection, with respect to a risk analysis 
                of the drug conducted by the Secretary and other 
                relevant information, that there is a reasonable 
                certainty of no harm to human health due to the 
                development of antimicrobial resistance that is 
                attributable in whole or in part to the nontherapeutic 
                use of the drug.
            ``(3) Exemptions.--Except as provided in paragraph (5), if 
        the Secretary grants an exemption under section 505(i) for a 
        drug that is a critical antimicrobial animal drug, the 
        Secretary shall rescind each approval of a nontherapeutic use 
        in a food-producing animal of the critical antimicrobial animal 
        drug, or of a drug in the same chemical class as the critical 
        antimicrobial animal drug, as of the date that is 2 years after 
        the date on which the Secretary grants the exemption.
            ``(4) Approvals.--If an application for a drug that is 
        critical antimicrobial animal drug is submitted to the 
        Secretary under section 505(b), the Secretary shall rescind 
        each approval of a nontherapeutic use in a food-producing 
        animal of the critical antimicrobial animal drug, or of a drug 
        in the same chemical class as the critical antimicrobial animal 
        drug, as of the date that is 2 years after the date on which 
        the application is submitted to the Secretary.
            ``(5) Exception.--Paragraph (3) or (4), as the case may be, 
        shall not apply if, before the date on which approval would be 
        rescinded under that subparagraph, the Secretary determines 
        that the holder of the approved application has demonstrated 
        that there is a reasonable certainty of no harm to human health 
        due to the development of antimicrobial resistance that is 
        attributable, in whole or in part, to the nontherapeutic use in 
        the food-producing animal of the critical antimicrobial animal 
        drug.''.
    (b) Assistance to Defray Expenses of Livestock or Poultry Producers 
in Phasing Out Nontherapeutic Use of Critical Antimicrobial Animal 
Drugs.--
            (1) Definitions.--In this subsection, the terms ``critical 
        antimicrobial animal drug'' and ``nontherapeutic use'' have the 
        meanings given the terms in section 201 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 321).
            (2) Payments.--The Secretary of Agriculture may make 
        payments to producers of livestock or poultry that the 
        Secretary determines are substantially reducing, or have 
        substantially reduced, the nontherapeutic use of critical 
        antimicrobial animal drugs in livestock or poultry in order to 
        defray the costs of such reduction.
            (3) Priority for family farmers and small farms.--In 
        awarding payments under paragraph (2), the Secretary of 
        Agriculture shall give priority to family-owned and family-
        operated farms or ranches and to small farms or ranches, as 
        determined by the Secretary.
            (4) Authorization of appropriations.--There are authorized 
        to be appropriated such sums as are necessary to carry out this 
        subsection for fiscal year 2005 and for each subsequent fiscal 
        year.
    (c) Research and Demonstration Programs.--Subtitle D of title VII 
of the Farm Security and Rural Investment Act of 2002 (116 Stat. 455) 
is amended by adding at the end the following:

``SEC. 7413. PHASING OUT OF NONTHERAPEUTIC USE OF CRITICAL 
              ANTIMICROBIAL ANIMAL DRUGS.

    ``(a) Definitions.--In this section, the terms `critical 
antimicrobial animal drug' and `nontherapeutic use' have the meanings 
given the terms in section 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321).
    ``(b) Grants.--The Secretary, in consultation with the Secretary of 
Health and Human Services, shall award grants to colleges and 
universities to establish research and demonstration programs for--
            ``(1) phasing out the nontherapeutic use of critical 
        antimicrobial animal drugs in livestock or poultry; and
            ``(2) informing livestock and poultry producers of methods 
        for accomplishing the objective described in paragraph (1).
    ``(c) Education.--The Secretary shall use the results of the 
research and demonstration programs and the experience of agricultural 
producers that have reduced or eliminated the nontherapeutic use of 
critical antimicrobial animal drugs to educate other agricultural 
producers, through the Cooperative Research, Education, and Extension 
Service, concerning how to successfully phase out such use in livestock 
or poultry.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as are necessary to carry out this section for 
fiscal years 2004 through 2007.''.
    (d) Collection of Data on Critical Antimicrobial Animal Drugs.--
            (1) In general.--Chapter V of the Federal Food, Drug, and 
        Cosmetic Act is amended by inserting after section 512 (21 
        U.S.C. 360b) the following:

``SEC. 512A. COLLECTION OF DATA ON CRITICAL ANTIMICROBIAL ANIMAL DRUGS.

    ``(a) In General.--Not later than July 1 of each year, a 
manufacturer of a critical antimicrobial animal drug or an animal feed 
for food-producing animals bearing or containing a critical 
antimicrobial animal drug shall submit to the Secretary a report, in 
such form as the Secretary shall require, containing information on the 
sales during the previous calendar year of the critical antimicrobial 
animal drug or animal feed.
    ``(b) Information To Be Included.--A report under subsection (a) 
shall--
            ``(1) state separately the quantity of the critical 
        antimicrobial animal drug, including in animal feed bearing or 
        containing the critical antimicrobial animal drug, sold for 
        each kind of food-producing animal;
            ``(2) describe the claimed purpose of use for each kind of 
        food-producing animal as being for growth promotion, weight 
        gain, feed efficiency, disease prevention, disease control, 
        disease treatment, or another purpose; and
            ``(3) describe the dosage form of the drug.
    ``(c) Publication.--
            ``(1) In general.--The Secretary shall--
                    ``(A) make the information submitted under 
                subsection (a) available to the public; and
                    ``(B) publish the information at least annually.
            ``(2) Protection of confidentiality.--The Secretary shall 
        aggregate information, if necessary, to avoid disclosure under 
        paragraph (1) of confidential business information.''.
            (2) Prohibited acts.--Section 301(e) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331(e)) is amended by 
        striking ``515(f)'' and inserting ``512A, 515(f),''.
            (3) Effective Date.--The amendments made by this subsection 
        take effect on January 1, 2005.
    (e) Limitation on Antibiotic Uses.--If a countermeasure that is 
developed using assistance provided under the Project BioShield Program 
(under the Project BioShield Act of 2004, and the amendments made by 
such Act) is an antibiotic (as defined for purposes of the Federal 
Food, Drug, and Cosmetic Act)--
            (1) such countermeasure may not be used for nontherapeutic 
        uses (as defined in section 201(oo) of the Federal Food, Drug, 
        and Cosmetic Act (as added by subsection (a)) in animals; and
            (2) the Secretary of Health and Human Services shall 
        transfer from the BioShield fund an amount equal to 10 percent 
        of the funds provided to the programs authorized under section 
        319E of the Public Health Service Act (42 U.S.C. 247d-5) for 
        purposes of funding the countermeasure.

       TITLE XI--IMPROVING RESEARCH ON BIODEFENSE COUNTERMEASURES

SEC. 1101. IMPROVING THE ABILITY OF BIODEFENSE RESEARCHERS TO WORK WITH 
              SELECT AGENTS.

    Section 351A of the Public Health Service Act (42 U.S.C. 262a) is 
amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)(B)(ii), by inserting ``, and 
                with the Advisory Committee established under 
                subsection (m) in the manner described in paragraph (3) 
                of such subsection'' before the period; and
                    (B) by striking paragraph (2), and inserting the 
                following:
            ``(2) Biennial review.--
                    ``(A) In general.--The Secretary shall, on a 
                biennial or more frequent basis as determined 
                appropriate, review and republish the list established 
                under paragraph (1), and by regulation revise such list 
                as necessary in accordance with such paragraph.
                    ``(B) Consultation.--In carrying out the activities 
                described in subparagraph (A), the Secretary shall 
                consult with the Advisory Committee established under 
                subsection (m) in the manner described in paragraph (3) 
                of such subsection.'';
            (2) in subsection (e)(3), by adding at the end the 
        following:
                    ``(D) Presumption of allowed access.--
                            ``(i) In general.--If an individual 
                        described in subclause (I) or (II) of clause 
                        (iii) transfers employment or professional 
                        affiliation from one registered person 
                        (referred to in this subparagraph as the 
                        `sender') to another registered person 
                        (referred to in this subparagraph as the 
                        `recipient'), and the recipient determines that 
                        such individual is an individual described in 
                        paragraph (2)(A), the recipient shall take the 
                        actions described in paragraph (2) with respect 
                        to such individual.
                            ``(ii) Treatment during attorney general 
                        review.--During the period in which the 
                        Attorney General is conducting a review 
                        pursuant to this paragraph with respect to an 
                        individual described in clause (i), such 
                        individual shall be presumed not to be an 
                        individual described in clauses (i) or (ii) of 
                        subparagraph (B).
                            ``(iii) Individual described.--An 
                        individual described in this clause is--
                                    ``(I) an individual the name of 
                                whom the sender has submitted to the 
                                Secretary and the Attorney General 
                                under paragraph (2)(B) and whom the 
                                Attorney General has determined is not 
                                described in clause (i) or (ii) of 
                                subparagraph (B); or
                                    ``(II) an individual who is a 
                                registered person under paragraph 
                                (6)(A).
                            ``(iv) Not later than 180 days after the 
                        date of enactment of this subparagraph, the 
                        Secretary shall promulgate regulations to 
                        implement this subparagraph.'';
            (3) by redesignating subsection (m) as subsection (p); and
            (4) by inserting after subsection (l), the following:
    ``(m) Select Agent Scientific Advisory Committee.--
            ``(1) Establishment.--The Secretary shall establish a 
        Select Agent Advisory Committee (referred to in this section as 
        the `Advisory Committee') to consult with, and provide expert 
        advice to, the Secretary and the Secretary of Agriculture in 
        the manner described in paragraph (3).
            ``(2) Membership.--
                    ``(A) In general.--The Advisory Committee shall be 
                composed of individuals, to be appointed by the 
                Secretary, having expertise in scientific research with 
                select agents or other microbial or viral pathogens.
                    ``(B) Terms.--An individual appointed under 
                subparagraph (A) shall serve for a 2-year term. The 
                terms of the initial members appointed under such 
                subparagraph shall be staggered as determined by the 
                Secretary,
            ``(3) Consultation and response.--
                    ``(A) In general.--Except during a public health 
                emergency, the Secretary shall, not later than 90 days 
                prior to promulgating a regulation under this section, 
                transmit a draft of such regulation to the Advisory 
                Committee.
                    ``(B) Comments and recommendations.--The Advisory 
                Committee may submit to the Secretary comments and 
                recommendations regarding a draft regulation submitted 
                by the Secretary under subparagraph (A).
                    ``(C) With respect to any recommendations submitted 
                by the Advisory Committee under subparagraph (B) 
                relating to a draft regulation during the 60-day period 
                beginning on the date on which such draft regulation 
                was transmitted to the Advisory Committee, the 
                Secretary shall, prior to promulgating such 
                regulation--
                            ``(i) modify the draft regulation to 
                        incorporate the recommendations of the Advisory 
                        Committee; or
                            ``(ii) publish an explanation of why the 
                        recommendation has not been adopted.
    ``(n) Report by Comptroller General.--Not later than 1 year after 
the date of enactment of this subsection, the Comptroller shall submit 
to the appropriate committees of Congress a report that--
            ``(1) describes the length of time required to complete the 
        security checks and other procedures required for an 
        institution to become a registered person;
            ``(2) makes recommendations on ways to reduce the length of 
        time described in paragraph (1) without compromising security;
            ``(3) describes the ongoing costs for a registered person 
        to comply with the requirements of regulations promulgated 
        under this section;
            ``(4) makes recommendations on ways to reduce the costs 
        described in paragraph (3) without compromising security; and
            ``(5) describes the degree to which registered persons that 
        are nonprofit institutions are able to recoup the costs 
        described in paragraph (3) from Federal agencies that provide 
        financial support for research conducted at such institutions; 
        and
            ``(6) describes the source or sources of funding used by 
        registered persons that are nonprofit institutions to comply 
        with the requirements of regulations promulgated under this 
        section.
    ``(o) Clarification of Certain Terms.--
            ``(1) Findings.--Congress finds that--
                    ``(A) certainty and predictability are essential 
                for registered persons to be able to comply properly 
                with the requirements of the regulations promulgated 
                under this section;
                    ``(B) the terms `access' and `incident' are of 
                central importance in the requirements of such 
                regulations; and
                    ``(C) it is essential for there to be a clear 
                definition in such regulations of such terms.
            ``(2) Requirement to publish.--
                    ``(A) In general.--Not later than 180 days after 
                the date of enactment of this subsection, the Secretary 
                shall by regulation promulgate a definition of the 
                terms `access' and `incident' as such terms are used in 
                regulations promulgated pursuant to this section.
                    ``(B) Consultation.--In carrying out subparagraph 
                (A), the Secretary shall consult with the Advisory 
                Committee established under subsection (m) in the 
                manner paragraph (3) of such subsection.''.
                                 <all>
```