[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4374 Enrolled Bill (ENR)]
H.R.4374
One Hundred Fifteenth Congress
of the
United States of America
AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the third day of January, two thousand and seventeen
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.
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) 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) 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) Emergency Uses for Medical Products.--
(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) 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) Enhanced collaboration and communication.--In order to
facilitate enhanced collaboration and communication with respect to
the most current priorities of the Department of Defense--
(A) 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) 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) 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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.