10 USC 2370 - Sec. 2370a. Medical countermeasures against biowarfare threats: allocation of funding between near-term and other threats

10 USC - U.S. Code - Title 10: Armed Forces (January 2004)


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  (a) Allocation Between Near-Term and Other Threats. - Of the funds appropriated or otherwise made available for any fiscal year for the medical component of the Biological Defense Research Program (BDRP) of the Department of Defense - (1) not more than 80 percent may be obligated and expended for product development, or for research, development, test, or evaluation, of medical countermeasures against near-term validated biowarfare threat agents; and (2) not more than 20 percent may be obligated or expended for product development, or for research, development, test, or evaluation, of medical countermeasures against mid-term or far-term validated biowarfare threat agents. (b) Definitions. - In this section: (1) The term "validated biowarfare threat agent" means a biological agent that - (A) is named in the biological warfare threat list published by the Defense Intelligence Agency; and (B) is identified as a biowarfare threat by the Deputy Chief of Staff of the Army for Intelligence in accordance with Army regulations applicable to intelligence support for the medical component of the Biological Defense Research Program. (2) The term "near-term validated biowarfare threat agent" means a validated biowarfare threat agent that has been, or is being, developed or produced for weaponization within 5 years, as assessed and determined by the Defense Intelligence Agency. (3) The term "mid-term validated biowarfare threat agent" means a validated biowarfare threat agent that is an emerging biowarfare threat, is the object of research by a foreign threat country, and will be ready for weaponization in more than 5 years and less than 10 years, as assessed and determined by the Defense Intelligence Agency. (4) The term "far-term validated biowarfare threat agent" means a validated biowarfare threat agent that is a future biowarfare threat, is the object of research by a foreign threat country, and could be ready for weaponization in more than 10 years and less than 20 years, as assessed and determined by the Defense Intelligence Agency. (5) The term "weaponization" means incorporation into usable ordnance or other militarily useful means of delivery.


Research And Development Of Defense Biomedical Countermeasures

Pub. L. 108-136, div. A, title XVI, Sec. 1601, Nov. 24, 2003, 117 Stat. 1680, provided that: "(a) In General. - The Secretary of Defense (in this section referred to as the 'Secretary') shall carry out a program to accelerate the research, development and procurement of biomedical countermeasures, including but not limited to therapeutics and vaccines, for the protection of the Armed Forces from attack by one or more biological, chemical, radiological, or nuclear agents. "(b) Interagency Cooperation. - (1) In carrying out the program under subsection (a), the Secretary may enter into interagency agreements and other collaborative undertakings with other Federal agencies. "(2) The Secretary, through regular, structured, and close consultation with the Secretary of Health and Human Services and the Secretary of Homeland Security, shall ensure that the activities of the Department of Defense in carrying out the program are coordinated with, complement, and do not unnecessarily duplicate activities of the Department of Health and Human Services or the Department of Homeland Security. "(c) Expedited Procurement Authority. - (1) For any procurement of property or services for use (as determined by the Secretary) in performing, administering, or supporting biomedical countermeasures research and development, the Secretary may, when appropriate, use streamlined acquisition procedures and other expedited procurement procedures authorized in - "(A) section 32A of the Office of Federal Procurement Policy Act, as added by section 1443 of this Act [41 U.S.C. 428a]; and "(B) section 2371 of title 10, United States Code, and section 845 of the National Defense Authorization Act for Fiscal Year 1994 (Public Law 103-160; 10 U.S.C. 2371 note). "(2) Notwithstanding paragraph (1) and the provisions of law referred to in such paragraph, each of the following provisions shall apply to the procurements described in this subsection to the same extent that such provisions would apply to such procurements in the absence of paragraph (1): "(A) Chapter 37 of title 40, United States Code (relating to contract work hours and safety standards). "(B) Subsections (a) and (b) of section 7 of the Anti-Kickback Act of 1986 (41 U.S.C. 57(a) and (b)). "(C) Section 2313 of title 10, United States Code (relating to the examination of contractor records). "(3) The Secretary shall institute appropriate internal controls for use of the authority under paragraph (1), including requirements for documenting the justification for each use of such authority. "(d) Department of Defense Facilities Authority. - (1) If the Secretary determines that it is necessary to acquire, lease, construct, or improve laboratories, research facilities, and other real property of the Department of Defense in order to carry out the program under this section, the Secretary may do so using the procedures set forth in paragraphs (2), (3), (4), and (5). "(2) The Secretary shall use existing construction authorities provided by subchapter I of chapter 169 of title 10, United States Code, to the maximum extent possible. "(3)(A) If the Secretary determines that use of authorities in paragraph (2) would prevent the Department from meeting a specific facility requirement for the program, the Secretary shall submit to the congressional defense committees [Committees on Armed Services and Appropriations of Senate and House of Representatives] advance notification, which shall include the following: "(i) Certification by the Secretary that use of existing construction authorities would prevent the Department from meeting the specific facility requirement. "(ii) A detailed explanation of the reasons why existing authorities cannot be used. "(iii) A justification of the facility requirement. "(iv) Construction project data and estimated cost. "(v) Identification of the source or sources of the funds proposed to be expended. "(B) The facility project may be carried out only after the end of the 21-day period beginning on the date the notification is received by the congressional defense committees. "(4) If the Secretary determines: (A) that the facility is vital to national security or to the protection of health, safety, or the quality of the environment; and (B) the requirement for the facility is so urgent that the advance notification in paragraph (3) and the subsequent 21-day deferral of the facility project would threaten the life, health, or safety of personnel, or would otherwise jeopardize national security, the Secretary may obligate funds for the facility and notify the congressional defense committees within seven days after the date on which appropriated funds are obligated with the information required in paragraph (3). "(5) The Secretary shall submit to the congressional defense committees a quarterly report detailing any use of the authority provided by paragraph (4), including costs incurred or to be incurred by the United States as a result of the use of the authority. "(6) Nothing in this section shall be construed to authorize the Secretary to acquire, construct, lease, or improve a facility having general utility beyond the specific purposes of the program. "(7) In this subsection, the term 'facility' has the meaning given the term in section 2801(c) of title 10, United States Code. "(e) Authority for Personal Services Contracts. - (1) Subject to paragraph (2), the authority provided by section 1091 of title 10, United States Code, for personal services contracts to carry out health care responsibilities in medical treatment facilities of the Department of Defense shall also be available, subject to the same terms and conditions, for personal services contracts to carry out research and development activities under this section.

The number of individuals whose personal services are obtained under this subsection may not exceed 30 at any time. "(2) The authority provided by such section 1091 may not be used for a personal services contract unless the contracting officer for the contract ensures that - "(A) the services to be procured are urgent or unique; and "(B) it would not be practicable for the Department of Defense to obtain such services by other measures. "(f) Streamlined Personnel Authority. - (1) The Secretary may appoint highly qualified experts, including scientific and technical personnel, to carry out research and development under this section in accordance with the authorities provided in section 342 of the National Defense Authorization Act for Fiscal Year 1995 (Public Law 103-337; 108 Stat. 2721), section 1101 of the Strom Thurmond National Defense Authorization Act for Fiscal Year 1999 (Public Law 105-261 [5 U.S.C. 3104 note]), and section 1101 of this Act [enacting chapter 99 of Title 5, Government Organization and Employees, and provisions set out as a note under section 9901 of Title 5]. "(2) The Secretary may use the authority under paragraph (1) only upon a determination by the Secretary that use of such authority is necessary to accelerate the research and development under the program. "(3) The Secretary shall institute appropriate internal controls for each use of the authority under paragraph (1)." ACCELERATION OF RESEARCH, DEVELOPMENT, AND PRODUCTION OF MEDICAL COUNTERMEASURES FOR DEFENSE AGAINST BIOLOGICAL WARFARE AGENTS Pub. L. 107-107, div. A, title X, Sec. 1044(a), Dec. 28, 2001, 115 Stat. 1219, provided that: "(1) The Secretary of Defense shall carry out a program to aggressively accelerate the research, development, testing, and licensure of new medical countermeasures for defense against the biological warfare agents that are the highest threat. "(2) The program shall include the following activities: "(A) As the program's first priority, investment in multiple new technologies for medical countermeasures for defense against the biological warfare agents that are the highest threat, including for the prevention and treatment of anthrax. "(B) Leveraging of ideas and technologies from the biological technology industry."

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