[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.--

[[Page 131 STAT. 2024]]

            (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

[[Page 131 STAT. 2025]]

        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.

                                  <all>