[Title 3 CFR 13139]
[Code of Federal Regulations (annual edition) - January 1, 2000 Edition]
[Title 3 - Presidential Documents]
[Executive Order 13139 - Executive Order 13139 of September 30, 1999]
[From the U.S. Government Printing Office]
3Presidential Documents12000-01-012000-01-01falseExecutive Order 13139 of September 30, 199913139Executive Order 13139Presidential Documents
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:
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(1) is not feasible;
(2) is contrary to the best interests of the member; or
(3) is not in the interests of national security.
(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:
(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.
(2) Documentation that the Secretary has complied with 21 CFR
50.23(d). This documentation shall include:
(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
(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.
(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
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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.
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.
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(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:
(1) The basis for any determination by the President that informed
consent is not or may not be feasible;
(2) The means for tracking use and adverse effects of the
investigational drug;
(3) The benefits and risks of using the investigational drug; and
(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.
(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.
WILLIAM J. CLINTON
THE WHITE HOUSE,
September 30, 1999.