THIS SEARCH     THIS DOCUMENT     GO TO
Next Hit        Forward           New Bills Search
Prev Hit        Back              HomePage
Hit List        Best Sections     Help
                Contents Display

S.1880

National Biodefense and Pandemic Preparedness Act of 2005 (Introduced in Senate)

S 1880 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.