
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 10USC1107]

 
                         TITLE 10--ARMED FORCES
 
                    Subtitle A--General Military Law
 
                           PART II--PERSONNEL
 
                   CHAPTER 55--MEDICAL AND DENTAL CARE
 
Sec. 1107. Notice of use of an investigational new drug or a 
        drug unapproved for its applied use
        
    (a) Notice Required.--(1) Whenever the Secretary of Defense requests 
or requires a member of the armed forces to receive an investigational 
new drug or a drug unapproved for its applied use, the Secretary shall 
provide the member with notice containing the information specified in 
subsection (d).
    (2) The Secretary shall also ensure that health care providers who 
administer an investigational new drug or a drug unapproved for its 
applied use, or who are likely to treat members who receive such a drug, 
receive the information required to be provided under paragraphs (3) and 
(4) of subsection (d).
    (b) Time of Notice.--The notice required to be provided to a member 
under subsection (a)(1) shall be provided before the investigational new 
drug or drug unapproved for its applied use is first administered to the 
member.
    (c) Form of Notice.--The notice required under subsection (a)(1) 
shall be provided in writing.
    (d) Content of Notice.--The notice required under subsection (a)(1) 
shall include the following:
        (1) Clear notice that the drug being administered is an 
    investigational new drug or a drug unapproved for its applied use.
        (2) The reasons why the investigational new drug or drug 
    unapproved for its applied use is being administered.
        (3) Information regarding the possible side effects of the 
    investigational new drug or drug unapproved for its applied use, 
    including any known side effects possible as a result of the 
    interaction of such drug with other drugs or treatments being 
    administered to the members receiving such drug.
        (4) Such other information that, as a condition of authorizing 
    the use of the investigational new drug or drug unapproved for its 
    applied use, the Secretary of Health and Human Services may require 
    to be disclosed.

    (e) Records of Use.--The Secretary of Defense shall ensure that the 
medical records of members accurately document--
        (1) the receipt by members of any investigational new drug or 
    drug unapproved for its applied use; and
        (2) the notice required by subsection (a)(1).

    (f) Limitation and Waiver.--(1) In the case of the administration of 
an investigational new drug or a drug unapproved for its applied use to 
a member of the armed forces in connection with the member's 
participation in a particular military operation, the requirement that 
the member provide prior consent to receive the drug in accordance with 
the prior consent requirement imposed under section 505(i)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) may be waived 
only by the President. The President may grant such a waiver only if the 
President determines, in writing, that obtaining consent--
        (A) is not feasible;
        (B) is contrary to the best interests of the member; or
        (C) is not in the interests of national security.

    (2) In making a determination to waive the prior consent requirement 
on a ground described in subparagraph (A) or (B) of paragraph (1), the 
President shall apply the standards and criteria that are set forth in 
the relevant FDA regulations for a waiver of the prior consent 
requirement on that ground.
    (3) The Secretary of Defense may request the President to waive the 
prior consent requirement with respect to the administration of an 
investigational new drug or a drug unapproved for its applied use to a 
member of the armed forces in connection with the member's participation 
in a particular military operation. With respect to any such 
administration--
        (A) the Secretary may not delegate to any other official the 
    authority to request the President to waive the prior consent 
    requirement for the Department of Defense; and
        (B) if the President grants the requested waiver, the Secretary 
    shall submit to the chairman and ranking minority member of each 
    congressional defense committee a notification of the waiver, 
    together with the written determination of the President under 
    paragraph (1) and the Secretary's justification for the request or 
    requirement under subsection (a) for the member to receive the drug 
    covered by the waiver.

    (4) In this subsection:
        (A) The term ``relevant FDA regulations'' means the regulations 
    promulgated under section 505(i) of the Federal Food, Drug, and 
    Cosmetic Act (21 U.S.C. 355(i)).
        (B) The term ``prior consent requirement'' means the requirement 
    included in the relevant FDA regulations pursuant to section 
    505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
    355(i)(4)).
        (C) The term ``congressional defense committee'' means each of 
    the following:
            (i) The Committee on Armed Services and the Committee on 
        Appropriations of the Senate.
            (ii) The Committee on Armed Services and the Committee on 
        Appropriations of the House of Representatives.

    (g) Definitions.--In this section:
        (1) The term ``investigational new drug'' means a drug covered 
    by section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 
    U.S.C. 355(i)).
        (2) The term ``drug unapproved for its applied use'' means a 
    drug administered for a use not described in the approved labeling 
    of the drug under section 505 of the Federal Food, Drug, and 
    Cosmetic Act (21 U.S.C. 355).

(Added Pub. L. 105-85, div. A, title VII, Sec. 766(a), Nov. 18, 1997, 
111 Stat. 1827; amended Pub. L. 105-261, div. A, title VII, 
Sec. 731(a)(1), (b), Oct. 17, 1998, 112 Stat. 2070, 2071; Pub. L. 106-
65, div. A, title X, Sec. 1067(1), Oct. 5, 1999, 113 Stat. 774.)


                               Amendments

    1999--Subsec. (f)(4)(C)(ii). Pub. L. 106-65 substituted ``Committee 
on Armed Services'' for ``Committee on National Security''.
    1998--Subsec. (b). Pub. L. 105-261, Sec. 731(b)(1), struck out ``, 
if practicable, but in no case later than 30 days after the drug is 
first administered to the member'' after ``administered to the member''.
    Subsec. (c). Pub. L. 105-261, Sec. 731(b)(2), struck out ``unless 
the Secretary of Defense determines that the use of written notice is 
impractical because of the number of members receiving the 
investigational new drug or drug unapproved for its applied use, time 
constraints, or similar reasons. If the Secretary provides notice under 
subsection (a)(1) in a form other than in writing, the Secretary shall 
submit to Congress a report describing the notification method used and 
the reasons for the use of the alternative method'' after ``provided in 
writing''.
    Subsecs. (f), (g). Pub. L. 105-261, Sec. 731(a)(1), added subsec. 
(f) and redesignated former subsec. (f) as (g).


                    Effective Date of 1998 Amendment

    Pub. L. 105-261, div. A, title VII, Sec. 731(a)(2), Oct. 17, 1998, 
112 Stat. 2071, provided that: ``Subsection (f) of section 1107 of title 
10, United States Code (as added by paragraph (1)), shall apply to the 
administration of an investigational new drug or a drug unapproved for 
its applied use to a member of the Armed Forces in connection with the 
member's participation in a particular military operation on or after 
the date of the enactment of this Act [Oct. 17, 1998].''


Waivers of Requirement for Prior Consent Granted Before October 17, 1998

    Pub. L. 105-261, div. A, title VII, Sec. 731(a)(3), Oct. 17, 1998, 
112 Stat. 2071, provided that: ``A waiver of the requirement for prior 
consent imposed under the regulations required under paragraph (4) of 
section 505(i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 
355(i)(4)] (or under any antecedent provision of law or regulations) 
that has been granted under that section (or antecedent provision of law 
or regulations) before the date of the enactment of this Act [Oct. 17, 
1998] for the administration of a drug to a member of the Armed Forces 
in connection with the member's participation in a particular military 
operation may be applied in that case after that date only if--
        ``(A) the Secretary of Defense personally determines that the 
    waiver is justifiable on each ground on which the waiver was 
    granted;
        ``(B) the President concurs in that determination in writing; 
    and
        ``(C) the Secretary submits to the chairman and ranking minority 
    member of each congressional committee referred to in section 
    1107(f)(4)(C) of title 10, United States Code (as added by paragraph 
    (1))--
            ``(i) a notification of the waiver;
            ``(ii) the President's written concurrence; and
            ``(iii) the Secretary's justification for the request or for 
        the requirement under subsection 1107(a) of such title for the 
        member to receive the drug covered by the waiver.''

 Ex. Ord. No. 13139. Improving Health Protection of Military Personnel 
             Participating in Particular Military Operations

    Ex. Ord. No. 13139, Sept. 30, 1999, 64 F.R. 54175, provided:
    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:
        (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 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.
    (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.
