[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1291 Introduced in House (IH)]






109th CONGRESS
  1st Session
                                H. R. 1291

 To require the Secretaries of Health and Human Services, Defense, and 
  Homeland Security to carry out activities toward bringing to market 
   effective medical countermeasures to radiation from a nuclear or 
                          radiological attack.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 15, 2005

  Mr. Issa (for himself, Mrs. Davis of California, and Mr. Sessions) 
 introduced the following bill; which was referred to the Committee on 
    Energy and Commerce, and in addition to the Committees on Armed 
    Services and Homeland Security, for a period to be subsequently 
   determined by the Speaker, in each case for consideration of such 
 provisions as fall within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
 To require the Secretaries of Health and Human Services, Defense, and 
  Homeland Security to carry out activities toward bringing to market 
   effective medical countermeasures to radiation from a nuclear or 
                          radiological attack.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Radioprotectant Procurement Act of 
2005''.

SEC. 2. FINDINGS.

    Congress finds as follows:
            (1) The threat of a radiological or nuclear attack on the 
        American people is one of the greatest potential threats now 
        faced by the United States, considering the potential number of 
        deaths, injuries, illnesses and economic devastation such an 
        attack on American civilians or military personnel could have.
            (2) There are at least 30,000 known nuclear weapons 
        deployed around the world today and the proliferation of 
        nuclear weapons technology continues to pose an enormous threat 
        to the United States, its people, and its interests and allies 
        around the world.
            (3) Even a crude radiological weapon, using conventional 
        explosives combined with widely available radiological 
        materials, could cause death, radiation sickness, and 
        widespread panic and economic hardship if detonated in an urban 
        center of the United States, and such an attack would 
        dramatically strain our public health resources.
            (4) Numerous government and private studies, including the 
        findings of several leading medical journals, have concluded 
        that a nuclear weapon detonated in a large urban center would 
        cause widespread death, sickness, and physical and economic 
        damage. For example, in February 2002, the British Medical 
        Journal estimated that a 12.5 kiloton nuclear bomb 
        (approximately the size of the bomb used at Hiroshima), if 
        detonated in New York City, would cause 50,000 immediate 
        deaths, 200,000 short-term deaths from high-exposure radiation 
        injury, and 700,000 cases of radiation sickness.
            (5) There are 103 nuclear power plants in the United 
        States, each with the potential to expose area residents to 
        high levels of radiation in the event of a successful attack.
            (6) For potentially stockpiled radioprotectants to be most 
        effective, they must be administered soon after exposure to 
        radiation, so the procurement of a radioprotectant must be 
        large enough and located in enough regions of the country to 
        facilitate the rapid treatment of the hundreds of thousands and 
        potentially millions of Americans who would be exposed to 
        radiation, as well as the many ``worried well'' who will flood 
        emergency rooms should a nuclear or radiological attack or 
        large accident occur.
            (7) Considering the need to rapidly administer a 
        radioprotectant, Federal procurement of an effective 
        radioprotectant should be comparable to stockpiles of other 
        drugs designed to counter the effects of chemical or biological 
        agents.
            (8) Current treatment options for acute radiation exposure 
        are wholly inadequate, with potassium iodide being the only 
        widely stockpiled countermeasure currently available. This 
        treatment protects against the long-term risk of thyroid 
        cancer, and does nothing to counteract short-term radiation 
        sickness and possible death within the first 30 days of 
        exposure.
            (9) Effective medical countermeasures to both acute and 
        long-term exposure of radiation are presently in development at 
        the Armed Forces Radiobiology Research Institute (``AFRRI'') 
        and among pharmaceutical companies, including at least one 
        compound that has demonstrated efficacy in preventing radiation 
        sickness and death caused by the destruction of bone marrow 
        from acute radiation exposure.
            (10) While the Departments of Health and Human Services, 
        Homeland Security, and Defense are appropriately dedicating 
        substantial resources to the development and procurement of 
        countermeasures to biological threats, including smallpox and 
        anthrax vaccines, few resources to date have been dedicated to 
        bring to market and procure one or more effective, whole-body 
        radioprotectants.
            (11) In enacting the Homeland Security Act of 2002, it was 
        and is the intent of Congress that the development and 
        procurement of radiological and nuclear countermeasures be 
        given full and appropriate consideration and dedication of 
        resources.
            (12) The Department of Health and Human Services has issued 
        a request for information about radioprotectants to treat acute 
        radiation sickness (``ARS''). The Department should move 
        forward with all due haste to procure countermeasures against 
        ARS and other major health consequences of acute radiation 
        exposure.

SEC. 3. AMENDMENT TO THE HOMELAND SECURITY ACT OF 2002.

    Section 304 of the Homeland Security Act of 2002 (6 U.S.C. 184; 
Public Law 107-296) is amended by adding at the end the following 
subsection:
    ``(d) Development and Procurement of Radiation Medical 
Countermeasures.--For the purpose of rapidly developing, bringing to 
market, and procuring whole-body radioprotectants, the Secretaries of 
Health and Human Services, Homeland Security, and Defense shall utilize 
and expend such funds as may be necessary, including funds appropriated 
by Congress, and not otherwise prohibited from being used for such 
purpose, under the appropriations headings `Public Health Programs', 
`Strategic National Stockpile', `Nuclear and Radiological 
Countermeasures', `Biodefense Countermeasures', `Research, Development, 
Acquisition and Operations', `Biological Countermeasures', and `Chem-
Bio Defense Initiative', as well as relevant departmental and subagency 
operations budgets, subject to the appropriations Act involved.''.

SEC. 4. REPORT REGARDING EFFECTIVE RADIOPROTECTANTS; DEVELOPMENT AND 
              PROCUREMENT.

    (a) Report.--Not later than 30 days after the date of the enactment 
of this Act, the Secretary of Homeland Security (referred to in this 
section as the ``Secretary'') shall, in consultation with the Secretary 
of Health and Human Services and the Secretary of Defense, submit to 
the Congress a report providing a determination by the Secretary of--
            (1) the scope and nature of the threat of a nuclear or 
        radiological attack against the United States; and
            (2) the current and potential future availability of 
        effective radioprotectant medical countermeasures against--
                    (A) acute radiation sickness;
                    (B) DNA mutagenasis; and
                    (C) other major health consequences of acute 
                radiation exposure.
    (b) Development and Procurement.--
            (1) In general.--If in carrying out subsection (a) the 
        Secretary determines that one or more effective 
        radioprotectants are currently available, or may become 
        available within a reasonable amount of time, then not later 
        than 60 days after the submission of the report under such 
        subsection, the Secretary shall enter into one or more 
        agreements with one or more private companies for the 
        development and procurement of one or more effective, safe, 
        stable, and low-cost radioprotectants, subject to the 
        availability of funds under an appropriations Act.
            (2) Adequate protection.--An agreement under paragraph (1) 
        shall provide for the procurement and stockpiling of enough 
        dose regimens of the radioprotectants involved to provide for 
        adequate protection of the people of the United States, 
        including adequate response to a multi-location attack 
        scenario, if in carrying out subsection (a) the Secretary 
        determines that such a scenario is plausible.
            (3) Certain authorities.--
                    (A) Development.--With respect to an agreement 
                under paragraph (1) that provides funds for the 
                development of a radioprotectant, the Secretary may use 
                the same authorities as are described in subsections 
                (b) through (e) of section 319F-1 of the Public Health 
                Service Act.
                    (B) Procurement.--With respect to an agreement 
                under paragraph (1) that provides funds for the 
                procurement of a radioprotectant, the Secretary may use 
                the same authorities as are described in section 319F-
                2(c)(7) of the Public Health Service Act.
                    (C) Conditions.--An agreement under paragraph (1) 
                may contain such reasonable conditions in addition to 
                the conditions required in paragraph (2) as the 
                Secretary determines to be appropriate, including--
                            (i) the condition that some or all 
                        procurement payments be contingent upon 
                        approval of the radioprotectants by the Food 
                        and Drug Administration; and
                            (ii) the condition that the company or 
                        companies that produce such radioprotectants 
                        may be required to assume the development costs 
                        of improvements to the radioprotectants, but 
                        such costs may be considered in determining the 
                        payment for such improvements.
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