[Federal Register Volume 64, Number 192 (Tuesday, October 5, 1999)]
[Presidential Documents]
[Pages 54175-54178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26078]



[[Page 54173]]

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Part IV





The President





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Executive Order 13139--Improving Health Protection of Military 
Personnel Participating in Particular Military Operations
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                         Presidential Documents 
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  Federal Register / Vol. 64, No. 192 / Tuesday, October 5, 1999 / 
Presidential Documents  

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 Title 3--
 The President

[[Page 54175]]

                Executive Order 13139 of September 30, 1999

                
Improving Health Protection of Military Personnel 
                Participating in Particular Military Operations

                By the authority vested in me as President by the 
                Constitution and the laws of the United States of 
                America, including section 1107 of title 10, United 
                States Code, and in order to provide the best health 
                protection to military personnel participating in 
                particular military operations, it is hereby ordered as 
                follows:

                Section 1. Policy. Military personnel deployed in 
                particular military operations could potentially be 
                exposed to a range of chemical, biological, and 
                radiological weapons as well as diseases endemic to an 
                area of operations. It is the policy of the United 
                States Government to provide our military personnel 
                with safe and effective vaccines, antidotes, and 
                treatments that will negate or minimize the effects of 
                these health threats.

                Sec. 2. Administration of Investigational New Drugs to 
                Members of the Armed Forces.

                    (a) The Secretary of Defense (Secretary) shall 
                collect intelligence on potential health threats that 
                might be encountered in an area of operations. The 
                Secretary shall work together with the Secretary of 
                Health and Human Services to ensure appropriate 
                countermeasures are developed. When the Secretary 
                considers an investigational new drug or a drug 
                unapproved for its intended use (investigational drug) 
                to represent the most appropriate countermeasure, it 
                shall be studied through scientifically based research 
                and development protocols to determine whether it is 
                safe and effective for its intended use.
                    (b) It is the expectation that the United States 
                Government will administer products approved for their 
                intended use by the Food and Drug Administration (FDA). 
                However, in the event that the Secretary considers a 
                product to represent the most appropriate 
                countermeasure for diseases endemic to the area of 
                operations or to protect against possible chemical, 
                biological, or radiological weapons, but the product 
                has not yet been approved by the FDA for its intended 
                use, the product may, under certain circumstances and 
                strict controls, be administered to provide potential 
                protection for the health and well-being of deployed 
                military personnel in order to ensure the success of 
                the military operation. The provisions of 21 CFR Part 
                312 contain the FDA requirements for investigational 
                new drugs.

                Sec. 3. Informed Consent Requirements and Waiver 
                Provisions.

                    (a) Before administering an investigational drug to 
                members of the Armed Forces, the Department of Defense 
                (DoD) must obtain informed consent from each individual 
                unless the Secretary can justify to the President a 
                need for a waiver of informed consent in accordance 
                with 10 U.S.C. 1107(f). Waivers of informed consent 
                will be granted only when absolutely necessary.
                    (b) In accordance with 10 U.S.C. 1107(f), the 
                President may waive the informed consent requirement 
                for the administration of an investigational drug to a 
                member of the Armed Forces in connection with the 
                member's participation in a particular military 
                operation, upon a written determination by the 
                President that obtaining consent:
                    L(1) is not feasible;
                    L(2) is contrary to the best interests of the 
                member; or
                    L(3) is not in the interests of national security.

[[Page 54176]]

                    (c) In making a determination to waive the informed 
                consent requirement on a ground described in subsection 
                (b)(1) or (b)(2) of this section, the President is 
                required by law to apply the standards and criteria set 
                forth in the relevant FDA regulations, 21 CFR 50.23(d). 
                In determining a waiver based on subsection (b)(3) of 
                this section, the President will also consider the 
                standards and criteria of the relevant FDA regulations.
                    (d) The Secretary may request that the President 
                waive the informed consent requirement with respect to 
                the administration of an investigational drug. The 
                Secretary may not delegate the authority to make this 
                waiver request. At a minimum, the waiver request shall 
                contain:
                    L(1) A full description of the threat, including 
                the potential for exposure. If the threat is a 
                chemical, biological, or radiological weapon, the 
                waiver request shall contain an analysis of the 
                probability the weapon will be used, the method or 
                methods of delivery, and the likely magnitude of its 
                affect on an exposed individual.
                    L(2) Documentation that the Secretary has complied 
                with 21 CFR 50.23(d). This documentation shall include:

                  L(A) A statement that certifies and a written 
                    justification that documents that each of the 
                    criteria and standards set forth in 21 CFR 50.23(d) 
                    has been met; or

                  L(B) If the Secretary finds it highly impracticable 
                    to certify that the criteria and standards set 
                    forth in 21 CFR 50.23(d) have been fully met 
                    because doing so would significantly impair the 
                    Secretary's ability to carry out the particular 
                    military mission, a written justification that 
                    documents which criteria and standards have or have 
                    not been met, explains the reasons for failing to 
                    meet any of the criteria and standards, and 
                    provides additional justification why a waiver 
                    should be granted solely in the interests of 
                    national security.

                    L(3) Any additional information pertinent to the 
                Secretary's determination, including the minutes of the 
                Institutional Review Board's (IRB) deliberations and 
                the IRB members' voting record.
                    (e) The Secretary shall develop the waiver request 
                in consultation with the FDA.
                    (f) The Secretary shall submit the waiver request 
                to the President and provide a copy to the Commissioner 
                of the FDA (Commissioner).
                    (g) The Commissioner shall expeditiously review the 
                waiver request and certify to the Assistant to the 
                President for National Security Affairs (APNSA) and the 
                Assistant to the President for Science and Technology 
                (APST) whether the standards and criteria of the 
                relevant FDA regulations have been adequately addressed 
                and whether the investigational new drug protocol may 
                proceed subject to a decision by the President on the 
                informed consent waiver request. FDA shall base its 
                decision on, and the certification shall include an 
                analysis describing, the extent and strength of the 
                evidence on the safety and effectiveness of the 
                investigational new drug in relation to the medical 
                risk that could be encountered during the military 
                operation.
                    (h) The APNSA and APST will prepare a joint 
                advisory opinion as to whether the waiver of informed 
                consent should be granted and will forward it, along 
                with the waiver request and the FDA certification to 
                the President.
                    (i) The President will approve or deny the waiver 
                request and will provide written notification of the 
                decision to the Secretary and the Commissioner.

[[Page 54177]]

                Sec. 4. Required Action After Waiver is Issued. (a) 
                Following a Presidential waiver under 10 U.S.C. 
                1107(f), the DoD offices responsible for implementing 
                the waiver, DoD's Office of the Inspector General, and 
                the FDA, consistent with its regulatory role, will 
                conduct an ongoing review and monitoring to assess 
                adherence to the standards and criteria under 21 CFR 
                50.23(d) and this order. The responsible DoD offices 
                shall also adhere to any periodic reporting 
                requirements specified by the President at the time of 
                the waiver approval. The Secretary shall submit the 
                findings to the President and provide a copy to the 
                Commissioner.

                    (b) The Secretary shall, as soon as practicable, 
                make the congressional notifications required by 10 
                U.S.C. 1107(f)(2)(B).
                    (c) The Secretary shall, as soon as practicable and 
                consistent with classification requirements, issue a 
                public notice in the Federal Register describing each 
                waiver of informed consent determination and a summary 
                of the most updated scientific information on the 
                products used, as well as other information the 
                President determines is appropriate.
                    (d) The waiver will expire at the end of 1 year (or 
                an alternative time period not to exceed 1 year, 
                specified by the President at the time of approval), or 
                when the Secretary informs the President that the 
                particular military operation creating the need for the 
                use of the investigational drug has ended, whichever is 
                earlier. The President may revoke the waiver based on 
                changed circumstances or for any other reason. If the 
                Secretary seeks to renew a waiver prior to its 
                expiration, the Secretary must submit to the President 
                an updated request, specifically identifying any new 
                information available relevant to the standards and 
                criteria under 21 CFR 50.23(d). To request to renew a 
                waiver, the Secretary must satisfy the criteria for a 
                waiver as described in section 3 of this order.
                    (e) The Secretary shall notify the President and 
                the Commissioner if the threat countered by the 
                investigational drug changes significantly or if 
                significant new information on the investigational drug 
                is received.

                Sec. 5. Training for Military Personnel. (a) The DoD 
                shall provide ongoing training and health risk 
                communication on the requirements of using an 
                investigational drug in support of a military operation 
                to all military personnel, including those in 
                leadership positions, during chemical and biological 
                warfare defense training and other training, as 
                appropriate. This ongoing training and health risk 
                communication shall include general information about 
                10 U.S.C. 1107 and 21 CFR 50.23(d).

                    (b) If the President grants a waiver under 10 
                U.S.C. 1107(f), the DoD shall provide training to all 
                military personnel conducting the waiver protocol and 
                health risk communication to all military personnel 
                receiving the specific investigational drug to be 
                administered prior to its use.
                    (c) The Secretary shall submit the training and 
                health risk communication plans as part of the 
                investigational new drug protocol submission to the FDA 
                and the reviewing IRB. Training and health risk 
                communication shall include at a minimum:
                    L(1) The basis for any determination by the 
                President that informed consent is not or may not be 
                feasible;
                    L(2) The means for tracking use and adverse effects 
                of the investigational drug;
                    L(3) The benefits and risks of using the 
                investigational drug; and
                    L(4) A statement that the investigational drug is 
                not approved (or not approved for the intended use).
                    (d) The DoD shall keep operational commanders 
                informed of the overall requirements of successful 
                protocol execution and their role, with the support of 
                medical personnel, in ensuring successful execution of 
                the protocol.

                Sec. 6. Scope. (a) This order applies to the 
                consideration and Presidential approval of a waiver of 
                informed consent under 10 U.S.C. 1107 and does not 
                apply to other FDA regulations.

[[Page 54178]]

                    (b) This order is intended only to improve the 
                internal management of the Federal Government. Nothing 
                contained in this order shall create any right or 
                benefit, substantive or procedural, enforceable by any 
                party against the United States, its agencies or 
                instrumentalities, its officers or employees, or any 
                other person.

                    (Presidential Sig.)

                THE WHITE HOUSE,

                     September 30, 1999.

[FR Doc. 99-26078
Filed 10-4-99; 8:45 am]
Billing code 3195-01-P