§ 1107a. Emergency use products

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 2003

   National Defense Authorization Act for Fiscal Year 2004

   Pub. L. 108–136 div. A title XVI § 1603(b)(1) · 117 Stat. 1392

   Enacted · 10 U.S.C. § 1107a

   Added Pub. L. 108–136, div. A, title XVI, § 1603(b)(1), Nov. 24, 2003, 117 Stat. 1689

   Source evidence

   Code source credit
   Added Pub. L. 108–136, div. A, title XVI, § 1603(b)(1), Nov. 24, 2003, 117 Stat. 1689

   Enacted provision · exact public law section
   (1) Chapter 55 of title 10, United States Code, is amended by inserting after section 1107 the following new section: “§ 1107a. Emergency use products “(a) Waiver by the President.— In the case of the administration of a product authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act to members of the armed forces, the condition described in section 564(e)(1)(A)(ii)(III) of such Act and required under paragraph (1)(A) or (2)(A) of such section 564(e), designed to ensure that individuals are informed of an option to accept or refuse administration of a product, may be waived only by the President only if the President determines, in writing, that complying with such requirement is not feasible, is contrary to the best interests of the members affected, or is not in the interests of national security. “(b) Provision of Information.— If the President, under subsection (a), waives the condition described in section 564(e)(1)(A)(ii)(III) of the Federal Food, Drug, and Cosmetic Act, and if the Secretary of Defense, in consultation with the Secretary of Health and Human Services, makes a determination that it is not feasible based on time limitations for the information described in section 564(e)(1)(A)(ii)(I) or (II) of such Act and required under paragraph (1)(A) or (2)(A) of such section 564(e), to be provided to a member of the armed forces prior to the administration of the product, such information shall be provided to such member of the armed forces (or next-of-kin in the case of the death of a member) to whom the product was administered as soon as possible, but not later than 30 days, after such administration. The authority provided for in this subsection may not be delegated. Information concerning the administration of the product shall be recorded in the medical record of the member. “(c) Applicability of Other Provisions.— In the case of an authorization by the Secretary of Health and Human Services under section 564(a)(1) of the Federal Food, Drug, and Cosmetic Act based on a determination by the Secretary of Defense under section 564(b)(1)(B) of such Act, subsections (a) through (f) of section 1107 shall not apply to the use of a product that is the subject of such authorization, within the scope of such authorization and while such authorization is effective.” .

2. 2004

   Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005

   Pub. L. 108–375 § 726(b)(1) · 118 Stat. 1811

   1. Amended · 10 U.S.C. § 1107a(a)

      Pub. L. 108–375, § 726(b)(1), as amended by Pub. L. 109–364, § 1071(g)(7)

   2. Inserted · 10 U.S.C. § 1107a(a)

      Pub. L. 108–375, § 726(b)(1), as inserted “(A)” after “President.—”

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 108–375, § 726(b)(1), as amended by Pub. L. 109–364, § 1071(g)(7), inserted “(A)” after “President.—”.

   Enacted provision · exact public law section
   (1) by inserting “(A)” after “President.—(1)”;

3. 2004

   Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005

   Pub. L. 108–375 § 726(b)(2) · 118 Stat. 1811

   Struck · 10 U.S.C. § 1107a(a)(A)

   Pub. L. 108–375, § 726(b)(2), struck out “is not feasible, is contrary to the best interests of the members affected, or” after “such requirement”

   Source evidence

   Code amendment note
   Subsec. (a)(A). Pub. L. 108–375, § 726(b)(2), struck out “is not feasible, is contrary to the best interests of the members affected, or” after “such requirement”.

   Enacted provision · exact public law section
   (2) by striking “is not feasible,” and all that follows through “members affected, or”; and

4. 2004

   Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005

   Pub. L. 108–375 § 726(b)(3) · 118 Stat. 1811

   Added · 10 U.S.C. § 1107a(a)(B)

   Pub. L. 108–375, § 726(b)(3), added subpar. (B)

   Source evidence

   Code amendment note
   Subsec. (a)(B). Pub. L. 108–375, § 726(b)(3), added subpar. (B).

   Enacted provision · exact public law section
   (3) by adding at the end the following new subparagraph: “(B) The waiver authority provided in subparagraph (A) shall not be construed to apply to any case other than a case in which an individual is required to be informed of an option to accept or refuse administration of a particular product by reason of a determination by the Secretary of Health and Human Services that emergency use of such product is authorized under section 564 of the Federal Food, Drug, and Cosmetic Act.” .

5. 2006

   John Warner National Defense Authorization Act for Fiscal Year 2007

   Pub. L. 109–364 § 1071(g)(7) · 120 Stat. 2083

   Changed · 10 U.S.C. § 1107a(a)

   Pub. L. 109–364, § 1071(g)(7), made technical correction to directory language of Pub. L. 108–375, § 726(b)(1). See 2004 Amendment note below

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 109–364, § 1071(g)(7), made technical correction to directory language of Pub. L. 108–375, § 726(b)(1). See 2004 Amendment note below.

   Enacted provision · exact public law section
   (7) Section 726(b)(1) (118 Stat. 1992) is amended by striking “(1)” in the second quoted matter.

6. 2006

   John Warner National Defense Authorization Act for Fiscal Year 2007

   Pub. L. 109–364 § 1071(a)(5) · 120 Stat. 2083

   1. Redesignated · 10 U.S.C. § 1107a(a)

      Pub. L. 109–364, § 1071(a)(5), redesignated subpars. (A) and (B) as pars. (1) and (2), respectively, and, in par. (2)

   2. Substituted · 10 U.S.C. § 1107a(a)

      Pub. L. 109–364, § 1071(a)(5), substituted “paragraph (1)” for “subparagraph (A)”

   Target inherited from the preceding amendment note.

   Source evidence

   Code amendment note
   Pub. L. 109–364, § 1071(a)(5), redesignated subpars. (A) and (B) as pars. (1) and (2), respectively, and, in par. (2), substituted “paragraph (1)” for “subparagraph (A)”.

   Enacted provision · exact public law section
   (5) Section 1107a(a) is amended— (A) by redesignating subparagraphs (A) and (B) as paragraphs (1) and (2), respectively; and (B) in paragraph (2), as so redesignated, by striking “subparagraph (A)” and inserting “paragraph (1)”.

7. 2017

   Pub. L. 115–92 § 1(c) · 131 Stat. 2023

   Struck · 10 U.S.C. § 1107a(d)

   Pub. L. 115–92 struck out subsec. (d) which related to additional authority to reduce deaths and severity of injuries caused by agents of war

   Source evidence

   Code amendment note
   Subsec. (d). Pub. L. 115–92 struck out subsec. (d) which related to additional authority to reduce deaths and severity of injuries caused by agents of war.

   Enacted provision · exact public law section
   (c) Repeal.— Effective as of the enactment of the National Defense Authorization Act for Fiscal Year 2018, subsection (d) of section 1107a of title 10, United States Code, as added by section 716 of the National Defense Authorization Act for Fiscal Year 2018, is repealed.

   Effective date note
   Pub. L. 115–92, § 1(c), Dec. 12, 2017, 131 Stat. 2025, provided that the amendment made by section 1(c) is effective as of the enactment of the National Defense Authorization Act for Fiscal Year 2018 [Pub. L. 115–91].

8. 2017

   National Defense Authorization Act for Fiscal Year 2018

   Pub. L. 115–91 div. A title VII § 716 · 131 Stat. 1283

   Added · 10 U.S.C. § 1107a(d)

   Pub. L. 115–91 added subsec. (d)

   Target inherited from the preceding amendment note.

   Source evidence

   Code amendment note
   Pub. L. 115–91 added subsec. (d).

   Enacted provision · exact public law section
   SEC. 716. ADDITIONAL EMERGENCY USES FOR MEDICAL PRODUCTS TO REDUCE DEATHS AND SEVERITY OF INJURIES CAUSED BY AGENTS OF WAR.   Section 1107a of title 10, United States Code, is amended by adding at the end the following new subsection: “(d) Additional Authority to Reduce Deaths and Severity of Injuries Caused by Agents of War.— (1) In a case in which an emergency use of an unapproved product or an emergency unapproved use of an approved product cannot be authorized under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) because the emergency does not involve an actual or threatened attack with a biological, chemical, radiological, or nuclear agent or agents, the Secretary of Defense may authorize an emergency use outside the United States of the product to reduce the number of deaths or the severity of harm to members of the armed forces (or individuals associated with deployed members of the armed forces) caused by a risk or agent of war. “(2) Except as otherwise provided in this subsection, an authorization by the Secretary under paragraph (1) shall have the same effect with respect to the armed forces as an emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3). “(3) The Secretary may issue an authorization under paragraph (1) with respect to the emergency use of an unapproved product or the emergency unapproved use of an approved product only if— “(A) the committee established under paragraph (5) has recommended that the Secretary issue the authorization; and “(B) the Assistant Secretary of Defense for Health Affairs makes a written determination, after consultation with the Commissioner of Food and Drugs, that, based on the totality of scientific evidence available to the Assistant Secretary, criteria comparable to those specified in section 564(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3(c)) have been met. “(4) With respect to the emergency use of an unapproved product or the emergency unapproved use of an approved product under this subsection, the Secretary of Defense shall establish such scope, conditions, and terms under this subsection as the Secretary considers appropriate, including scope, conditions, and terms comparable to those specified in section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3). “(5) (A) There is established in the Department of Defense a Department of Defense Emergency Use Authorization Committee (in this paragraph referred to as the ‘Committee’) to advise the Assistant Secretary of Defense for Health Affairs on proposed authorizations under this subsection. “(B) Members of the Committee shall be appointed by the Secretary of Defense and shall consist of prominent health care professionals who are not employees of the Department of Defense (other than for purposes of serving as a member of the Committee). “(C) The Committee may be established as a subcommittee of another Federal advisory committee. “(6) In this subsection: “(A) The term ‘biological product’ has the meaning given that term in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)). “(B) The terms ‘device’ and ‘drug’ have the meanings given those terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321). “(C) The term ‘product’ means a drug, device, or biological product. “(D) The terms ‘unapproved product’ and ‘unapproved use of an approved product’ have the meanings given those terms in section 564(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3(a)(4)).” .

   Effective date note
   Pub. L. 115–92, § 1(c), Dec. 12, 2017, 131 Stat. 2025, provided that the amendment made by section 1(c) is effective as of the enactment of the National Defense Authorization Act for Fiscal Year 2018 [Pub. L. 115–91].

10 of 10 references resolved to an enrolled provision