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[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.
```