Sec. 1602. PROCUREMENT OF DEFENSE BIOMEDICAL COUNTERMEASURES
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## SEC. 1602 PROCUREMENT OF DEFENSE BIOMEDICAL COUNTERMEASURES **[**[10 U.S.C. 2302 note](/us/usc/t10/s2302)**]** ###
(a)Determination of Material Threats ####
(1)The Secretary of Defense (in this section referred to as the “Secretary”) shall on an ongoing basis— #####
(A)assess current and emerging threats of use of biological, chemical, radiological, and nuclear agents; and #####
(B)identify, on the basis of such assessment, those agents that present a material risk of use against the Armed Forces. ####
(2)The Secretary shall on an ongoing basis— #####
(A)assess the potential consequences to the health of members of the Armed Forces of use against the Armed Forces of the agents identified under paragraph (1)(B); and #####
(B)identify, on the basis of such assessment, those agents for which countermeasures are necessary to protect the health of members of the Armed Forces. ###
(b)Assessment of Availability and Appropriateness of Countermeasures The Secretary shall on an ongoing basis assess the availability and appropriateness of specific countermeasures to address specific threats identified under subsection (a). ###
(c)Secretary's Determination of Countermeasures Appropriate for Procurement ####
(1)The Secretary, in accordance with paragraph (2), shall on an ongoing basis identify specific countermeasures that the Secretary determines to be appropriate for procurement for the Department of Defense stockpile of biomedical countermeasures. ####
(2)The Secretary may not identify a specific countermeasure under paragraph
(1)unless the Secretary determines that— #####
(A)the countermeasure is a qualified countermeasure; and #####
(B)it is reasonable to expect that producing and delivering, within 5 years, the quantity of that countermeasure required to meet the needs of the Department (as determined by the Secretary) is feasible. ###
(d)Interagency Cooperation ####
(1)Activities of the Secretary under this section shall be carried out in regular, structured, and close consultation and coordination with the Secretaries of Homeland Security and Health and Human Services, including the activities described in subsections (a), (b), and
(c)and those activities with respect to interagency agreements described in paragraph (2). ####
(2)The Secretary may enter into an interagency agreement with the Secretaries of Homeland Security and Health and Human Services to provide for acquisition by the Secretary of Defense for use by the Armed Forces of biomedical countermeasures procured for the Strategic National Stockpile by the Secretary of Health and Human Services. The Secretary may transfer such funds to the Secretary of Health and Human Services as are necessary to carry out such agreements (including administrative costs of the Secretary of Health and Human Services), and the Secretary of Health and Human Services may expend any such transferred funds to procure such countermeasures for use by the Armed Forces, or to replenish the stockpile. The Secretaries are authorized to establish such terms and conditions for such agreements as the Secretaries determine to be in the public interest. The transfer authority provided under this paragraph is in addition to any other transfer authority available to the Secretary. ###
(e)Definitions In this section: ####
(1)The term “**qualified countermeasure**” means a biomedical countermeasure— #####
(A)that is approved under section 505(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or that is approved under section 515 or cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e and 360) for use as such a countermeasure to a biological, chemical, radiological, or nuclear agent identified as a material threat under subsection (a); or #####
(B)with respect to which the Secretary of Health and Human Services makes a determination that sufficient and satisfactory clinical experience or research data (including data, if available, from preclinical and clinical trials) exists to support a reasonable conclusion that the product will qualify for such approval or licensing for use as such a countermeasure. ####
(2)The term “**biomedical countermeasure**” means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))), or biological product (as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i))) that is— #####
(A)used to treat, identify, or prevent harm from any biological, chemical, radiological, or nuclear agent that may cause a military health emergency affecting the Armed Forces; or #####
(B)used 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 or biological product that is used as described in subparagraph (A). ####
(3)The term “**Strategic National Stockpile**” means the stockpile established under section 121(a) of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (42 U.S.C. 300hh–12(a)). ###
(f)Funding Of the amount authorized to be appropriated for the Department of Defense and available within the transfer authority established under section 1001 of this Act for fiscal year 2004 and for each fiscal year thereafter, such sums are authorized as may be necessary for the costs incurred by the Secretary in the procurement of countermeasures under this section. # TITLE XXVIII GENERAL PROVISIONS * * * * * * * ## Subtitle A Military Construction Program and Military Family Housing Changes * * * * * * *
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- 42 USC 300hh–12(a)
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Sec. 1602
PROCUREMENT OF DEFENSE BIOMEDICAL COUNTERMEASURES
Cite42 USC 300hh–12(a)
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