[115th Congress Public Law 92]
[From the U.S. Government Publishing Office]
[[Page 131 STAT. 2023]]
Public Law 115-92
115th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act to authorize
additional emergency uses for medical products to reduce deaths and
severity of injuries caused by agents of war, and for other
purposes. <<NOTE: Dec. 12, 2017 - [H.R. 4374]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. ADDITIONAL EMERGENCY USES FOR MEDICAL PRODUCTS TO
REDUCE DEATHS AND SEVERITY OF
INJURIES CAUSED BY AGENTS OF WAR.
(a) FDA Authorization for Medical Products for Use in Emergencies.--
Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-3) is amended--
(1) <<NOTE: Determinations.>> in subsection (b)--
(A) in paragraph (1), by amending subparagraph (B)
to read as follows:
``(B) a determination by the Secretary of Defense
that there is a military emergency, or a significant
potential for a military emergency, involving a
heightened risk to United States military forces,
including personnel operating under the authority of
title 10 or title 50, United States Code, of attack
with--
``(i) a biological, chemical, radiological, or
nuclear agent or agents; or
``(ii) an agent or agents that may cause, or
are otherwise associated with, an imminently life-
threatening and specific risk to United States
military forces;''; and
(B) by adding at the end the following:
``(6) <<NOTE: Time period.>> Military emergencies.--In the
case of a determination described in paragraph (1)(B), the
Secretary shall determine, within 45 calendar days of such
determination, whether to make a declaration under paragraph
(1), and, if appropriate, shall promptly make such a
declaration.''; and
(2) in subsection (c)--
(A) in paragraph (3), by striking ``; and'' and
inserting ``;'';
(B) by redesignating paragraph (4) as paragraph (5);
and
(C) by inserting after paragraph (3) the following:
``(4) in the case of a determination described in subsection
(b)(1)(B)(ii), that the request for emergency use is made by the
Secretary of Defense; and''.
(b) <<NOTE: 21 USC 360bbb-3c.>> Emergency Uses for Medical
Products.--
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(1) In general.--The Secretary of Defense may request that
the Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, take actions to expedite the
development of a medical product, review of investigational new
drug applications under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)), review of
investigational device exemptions under section 520(g) of such
Act (21 U.S.C. 360j(g)), and review of applications for approval
and clearance of medical products under sections 505, 510(k),
and 515 of such Act (21 U.S.C. 355, 360(k), 360(e)) and section
351 of the Public Health Service Act (42 U.S.C. 262), including
applications for licensing of vaccines or blood as biological
products under such section 351, or applications for review of
regenerative medicine advanced therapy products under section
506(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356(g)), if there is a military emergency, or significant
potential for a military emergency, involving a specific and
imminently life-threatening risk to United States military
forces of attack with an agent or agents, and the medical
product that is the subject of such application, submission, or
notification would be reasonably likely to diagnose, prevent,
treat, or mitigate such life-threatening risk.
(2) <<NOTE: Review. Notification.>> Actions.--Upon a
request by the Secretary of Defense under paragraph (1), the
Secretary of Health and Human Services, acting through the
Commissioner of Food and Drugs, shall take action to expedite
the development and review of an applicable application or
notification with respect to a medical product described in
paragraph (1), which may include, as appropriate--
(A) holding meetings with the sponsor and the review
team throughout the development of the medical product;
(B) providing timely advice to, and interactive
communication with, the sponsor regarding the
development of the medical product to ensure that the
development program to gather the nonclinical and
clinical data necessary for approval or clearance is as
efficient as practicable;
(C) involving senior managers and experienced review
staff, as appropriate, in a collaborative, cross-
disciplinary review;
(D) assigning a cross-disciplinary project lead for
the review team to facilitate an efficient review of the
development program and to serve as a scientific liaison
between the review team and the sponsor;
(E) taking steps to ensure that the design of the
clinical trials is as efficient as practicable, when
scientifically appropriate, such as by minimizing the
number of patients exposed to a potentially less
efficacious treatment;
(F) applying any applicable Food and Drug
Administration program intended to expedite the
development and review of a medical product; and
(G) in appropriate circumstances, permitting
expanded access to the medical product during the
investigational phase, in accordance with applicable
requirements of the Food and Drug Administration.
(3) <<NOTE: Time periods. Determination.>> Enhanced
collaboration and communication.--In order to facilitate
enhanced collaboration and communication
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with respect to the most current priorities of the Department of
Defense--
(A) <<NOTE: Review.>> the Food and Drug
Administration shall meet with the Department of Defense
and any other appropriate development partners, such as
the Biomedical Advanced Research and Development
Authority, on a semi-annual basis for the purposes of
conducting a full review of the relevant products in the
Department of Defense portfolio; and
(B) the Director of the Center for Biologics
Evaluation and Research shall meet quarterly with the
Department of Defense to discuss the development status
of regenerative medicine advanced therapy, blood, and
vaccine medical products and projects that are the
highest priorities to the Department of Defense (which
may include freeze dried plasma products and platelet
alternatives),
unless the Secretary of Defense determines that any such
meetings are not necessary.
(4) <<NOTE: Definition.>> Medical product.--In this
subsection, the term ``medical product'' means a drug (as
defined in section 201 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321)), a device (as defined in such section 201),
or a biological product (as defined in section 351 of the Public
Health Service Act (42 U.S.C. 262)).
(c) <<NOTE: Effective date. 10 USC 1107a note.>> 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.
Approved December 12, 2017.
LEGISLATIVE HISTORY--H.R. 4374:
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CONGRESSIONAL RECORD, Vol. 163 (2017):
Nov. 15, considered and passed House.
Nov. 16, considered and passed Senate.
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