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Executive Order 13139—Improving Health Protection of Military

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Executive Order 13139—Improving Health Protection of Military Administration of William J. Clinton, 1999 / Sept. 30 1875 (7) Department of Transportation; continue to serve after the expiration of their (8) Environmental Protection Agency; term until a successor is appointed. A mem- (9) Office of Management and Budget; ber appointed to fill an unexpired term will (10) National Security Council; be appointed for the remainder of such (11) Office of National Drug Control Pol- term.'' icy; Sec. 9. This order shall be effective Sep- (12) Council on Environmental Quality; tember 30, 1999. (13) Office of Cabinet Affairs; William J. Clinton (14) National Economic Council; (15) Domestic Policy Council; and The White House, (16) United States Coast Guard.'' September 30, 1999. Sec. 7. Executive Order 12367, as amend- ed, is further amended as follows: [Filed with the Office of the Federal Register, (a) in section 1, the text ``the director of 9:23 a.m., October 1, 1999] the International Communication Agency,'' NOTE: This Executive order was published in the is deleted; Federal Register on October 4. (b) in section 2, delete the first sentence and insert in lieu thereof ``The Committee shall advise, provide recommendations to, Executive Order 13139ÐImproving and assist the President, the National En- Health Protection of Military dowment of the Arts, the National Endow- Personnel Participating in Particular ment for the Humanities, and the Institute Military Operations of Museum and Library Services on matters September 30, 1999 relating to the arts and the humanities. The Committee shall initiate and assist in the de- By the authority vested in me as President velopment of (i) ways to promote public un- by the Constitution and the laws of the derstanding and appreciation of the arts and United States of America, including section the humanities; (ii) ways to promote private 1107 of title 10, United States Code, and in sector support for the arts and humanities; order to provide the best health protection (iii) ways to evaluate the effectiveness of Fed- to military personnel participating in par- eral support for the arts and humanities and ticular military operations, it is hereby or- their relationship with the private sector; (iv) dered as follows: the planning and coordination of appropriate Section 1. Policy. Military personnel de- participation (including productions and ployed in particular military operations could projects) in major national cultural events, in- potentially be exposed to a range of chemical, cluding the Millennium; (v) activities that in- biological, and radiological weapons as well corporate the arts and the humanities in gov- as diseases endemic to an area of operations. ernment objectives; and (vi) ways to promote It is the policy of the United States Govern- the recognition of excellence in the fields of ment to provide our military personnel with the arts and the humanities.''; and safe and effective vaccines, antidotes, and (c) in section 3(b), add the following sen- treatments that will negate or minimize the tence after the first sentence: ``Private funds effects of these health threats. accepted under the National Endowment for Sec. 2. Administration of Investigational the Arts' or the National Endowment for the New Drugs to Members of the Armed Forces. Humanities' gift authority may also be used (a) The Secretary of Defense (Secretary) to pay expenses of the Committee.'' shall collect intelligence on potential health Sec. 8. Executive Order 12345, as amend- threats that might be encountered in an area ed, is further amended by deleting the first of operations. The Secretary shall work to- sentence of section 2(b) and inserting in lieu gether with the Secretary of Health and thereof the following three sentences. ``The Human Services to ensure appropriate coun- council shall be composed of twenty mem- termeasures are developed. When the Sec- bers appointed by the President. Each mem- retary considers an investigational new drug ber shall serve a term of 2 years and may or a drug unapproved for its intended use 1876 Sept. 30 / Administration of William J. Clinton, 1999 (investigational drug) to represent the most in the relevant FDA regulations, 21 CFR appropriate countermeasure, it shall be stud- 50.23(d). In determining a waiver based on ied through scientifically based research and subsection (b)(3) of this section, the Presi- development protocols to determine whether dent will also consider the standards and cri- it is safe and effective for its intended use. teria of the relevant FDA regulations. (b) It is the expectation that the United (d) The Secretary may request that the States Government will administer products President waive the informed consent re- approved for their intended use by the Food quirement with respect to the administration and Drug Administration (FDA). However, of an investigational drug. The Secretary may in the event that the Secretary considers a not delegate the authority to make this waiv- product to represent the most appropriate er request. At a minimum, the waiver request countermeasure for diseases endemic to the shall contain: area of operations or to protect against pos- (1) A full description of the threat, in- sible chemical, biological, or radiological cluding the potential for exposure. If weapons, but the product has not yet been the threat is a chemical, biological, or approved by the FDA for its intended use, radiological weapon, the waiver re- the product may, under certain cir- quest shall contain an analysis of the cumstances and strict controls, be adminis- probability the weapon will be used, tered to provide potential protection for the the method or methods of delivery, health and well-being of deployed military and the likely magnitude of its affect personnel in order to ensure the success of on an exposed individual. the military operation. The provisions of 21 (2) Documentation that the Secretary has CFR Part 312 contain the FDA require- complied with 21 CFR 50.23(d). This ments for investigational new drugs. documentation shall include: Sec. 3. Informed Consent Requirements (A) A statement that certifies and a writ- and Waiver Provisions. ten justification that documents that (a) Before administering an investigational each of the criteria and standards set drug to members of the Armed Forces, the forth in 21 CFR 50.23(d) has been Department of Defense (DoD) must obtain met; or informed consent from each individual un- (B) If the Secretary finds it highly imprac- less the Secretary can justify to the President ticable to certify that the criteria and a need for a waiver of informed consent in standards set forth in 21 CFR accordance with 10 U.S.C. 1107(f). Waivers 50.23(d) have been fully met because of informed consent will be granted only doing so would significantly impair when absolutely necessary. the Secretary's ability to carry out the (b) In accordance with 10 U.S.C. 1107(f), particular military mission, a written the President may waive the informed con- justification that documents which sent requirement for the administration of criteria and standards have or have an investigational drug to a member of the not been met, explains the reasons for Armed Forces in connection with the mem- failing to meet any of the criteria and ber's participation in a particular military op- standards, and provides additional eration, upon a written determination by the justification why a waiver should be President that obtaining consent: granted solely in the interests of na- (1) is not feasible; tional security. (2) is contrary to the best interests of the (3) Any additional information pertinent member; or to the Secretary's determination, in- (3) is not in the interests of national secu- cluding the minutes of the Institu- rity. tional Review Board's (IRB) delibera- (c) In making a determination to waive the tions and the IRB members' voting informed consent requirement on a ground record. described in subsection (b)(1) or (b)(2) of (e) The Secretary shall develop the waiver this section, the President is required by law request in consultation with the FDA. to apply the standards and criteria set forth Administration of William J. Clinton, 1999 / Sept. 30 1877 (f) The Secretary shall submit the waiver eral Register describing each waiver of in- request to the President and provide a copy formed consent determination and a sum- to the Commissioner of the FDA (Commis- mary of the most updated scientific informa- sioner). tion on the products used, as well as other (g) The Commissioner shall expeditiously information the President determines is ap- review the waiver request and certify to the propriate. Assistant to the President for National Secu- (d) The waiver will expire at the end of rity Affairs (APNSA) and the Assistant to the 1 year (or an alternative time period not to President for Science and Technology exceed 1 year, specified by the President at (APST) whether the standards and criteria the time of approval), or when the Secretary of the relevant FDA regulations have been informs the President that the particular adequately addressed and whether the inves- military operation creating the need for the tigational new drug protocol may proceed use of the investigational drug has ended, subject to a decision by the President on the whichever is earlier. The President may re- informed consent waiver request. FDA shall voke the waiver based on changed cir- base its decision on, and the certification cumstances or for any other reason. If the shall include an analysis describing, the ex- Secretary seeks to renew a waiver prior to tent and strength of the evidence on the safe- its expiration, the Secretary must submit to ty and effectiveness of the investigational the President an updated request, specifically new drug in relation to the medical risk that identifying any new information available rel- could be encountered during the military op- evant to the standards and criteria under 21 eration.
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