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(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 13139—Improving 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. CFR 50.23(d). To request to renew a waiver, (h) The APNSA and APST will prepare the Secretary must satisfy the criteria for a a joint advisory opinion as to whether the waiver as described in section 3 of this order. waiver of informed consent should be grant- ed and will forward it, along with the waiver (e) The Secretary shall notify the President request and the FDA certification to the and the Commissioner if the threat coun- President. tered by the investigational drug changes sig- (i) The President will approve or deny the nificantly or if significant new information on waiver request and will provide written noti- the investigational drug is received. fication of the decision to the Secretary and Sec. 5. Training for Military Personnel. (a) the Commissioner. The DoD shall provide ongoing training and Sec. 4. Required Action After Waiver is health risk communication on the require- Issued. (a) Following a Presidential waiver ments of using an investigational drug in sup- under 10 U.S.C. 1107(f), the DoD offices re- port of a military operation to all military per- sponsible for implementing the waiver, sonnel, including those in leadership posi- DoD’s Office of the Inspector General, and tions, during chemical and biological warfare the FDA, consistent with its regulatory role, defense training and other training, as appro- will conduct an ongoing review and moni- priate. This ongoing training and health risk toring to assess adherence to the standards communication shall include general infor- and criteria under 21 CFR 50.23(d) and this mation about 10 U.S.C. 1107 and 21 CFR order. The responsible DoD offices shall also 50.23(d). adhere to any periodic reporting require- (b) If the President grants a waiver under ments specified by the President at the time 10 U.S.C. 1107(f), the DoD shall provide of the waiver approval. The Secretary shall training to all military personnel conducting submit the findings to the President and pro- the waiver protocol and health risk commu- vide a copy to the Commissioner. nication to all military personnel receiving (b) The Secretary shall, as soon as prac- the specific investigational drug to be admin- ticable, make the congressional notifications istered prior to its use. required by 10 U.S.C. 1107(f)(2)(B). (c) The Secretary shall submit the training (c) The Secretary shall, as soon as prac- and health risk communication plans as part ticable and consistent with classification re- of the investigational new drug protocol sub- quirements, issue a public notice in the Fed- mission to the FDA and the reviewing IRB. 1878 Sept. 30 / Administration of William J. Clinton, 1999

Training and health risk communication shall under section 902 of the India-Pakistan Re- include at a minimum: lief Act of 1998 (as enacted in Public Law (1) The basis for any determination by 105–277), to the extent provided in that sec- the President that informed consent tion, I hereby waive until October 21, 1999, is not or may not be feasible; the sanctions and prohibitions contained in (2) The means for tracking use and ad- sections 101 and 102 of the Arms Export verse effects of the investigational Control Act, section 620E(e) of the Foreign drug; Assistance Act of 1961, and section 2(b)(4) (3) The benefits and risks of using the of the Export-Import Bank Act of 1945, inso- investigational drug; and far as such sanctions and prohibitions would (4) A statement that the investigational otherwise apply to any credit, credit guar- drug is not approved (or not approved antee, or financial assistance provided by the for the intended use). Department of Agriculture to support the (d) The DoD shall keep operational com- purchase of food or other agricultural com- manders informed of the overall require- modity. ments of successful protocol execution and The Secretary of State is hereby author- their role, with the support of medical per- ized and directed to report this determina- sonnel, in ensuring successful execution of tion to the Congress and to arrange for its the protocol. publication in the Federal Register. Sec. 6. Scope. (a) This order applies to William J. Clinton the consideration and Presidential approval of a waiver of informed consent under 10 NOTE: This memorandum was released by the Of- U.S.C. 1107 and does not apply to other fice of the Press Secretary on October 1. FDA regulations. (b) This order is intended only to improve Memorandum on Fiscal Year 2000 the internal management of the Federal Refugee Admissions Government. Nothing contained in this order shall create any right or benefit, substantive September 30, 1999 or procedural, enforceable by any party Presidential Determination No. 99–45 against the United States, its agencies or in- strumentalities, its officers or employees, or Memorandum for the Secretary of State any other person. Subject: Presidential Determination on FY William J. Clinton 2000 Refugee Admissions Numbers and The White House, Authorizations of In-Country Refugee Status September 30, 1999. Pursuant to Sections 207 and 101(a)(42), Respectively, of the Immigration and [Filed with the Office of the Federal Register, Nationality Act, and Determination Pursuant 8:45 a.m., October 4, 1999] to Section 2(b)(2) of the Migration and NOTE: This Executive order will be published in Refugee Assistance Act, as Amended the Federal Register on October 5. In accordance with section 207 of the Im- migration and Nationality Act (the ‘‘Act’’) (8 Memorandum on Pakistan and India U.S.C. 1157), as amended, and after appro- September 30, 1999 priate consultation with the Congress, I here- by make the following determinations and Presidential Determination No. 99–44 authorize the following actions: The admission of up to 90,000 refugees Memorandum for the Secretary of State, the to the United States during FY 2000 is justi- Secretary of Agriculture fied by humanitarian concerns or is otherwise in the national interest; provided, however, Subject: Pakistan and India that this number shall be understood as in- Pursuant to the authority vested in me as cluding persons admitted to the United President of the United States, including States during FY 2000 with Federal refugee