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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2055 Introduced in Senate (IS)]

<DOC>

114th CONGRESS
  1st Session
                                S. 2055

To amend the Public Health Service Act and the Federal Food, Drug, and 
         Cosmetic Act with respect to national health security.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           September 17, 2015

  Mr. Burr (for himself and Mr. Casey) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
To amend the Public Health Service Act and the Federal Food, Drug, and 
         Cosmetic Act with respect to national health security.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Countermeasure Innovation 
Act of 2015''.

SEC. 2. MEDICAL COUNTERMEASURE GUIDELINES.

    (a) Strategic National Stockpile and Security Countermeasure 
Procurements.--Section 319F-2 of the Public Health Service Act (42 
U.S.C. 247d-6b) is amended--
            (1) in subsection (a), by adding at the end the following:
            ``(3) Utilization guidelines.--The Secretary shall ensure 
        timely and accurate recommended utilization guidelines for 
        qualified countermeasures (as defined in section 319F-1), 
        qualified pandemic and epidemic products (as defined in section 
        319F-3), and security countermeasures (as defined in subsection 
        (c)), including for such products in the stockpile.''; and
            (2) in subsection (g)--
                    (A) by amending paragraph (4) to read as follows:
            ``(4) Report on security countermeasure procurement.--Not 
        later than March 1 of each year in which the Secretary 
        determines that the amount of funds available for procurement 
        of security countermeasures is less than $1,500,000,000, the 
        Secretary shall submit to the Committee on Appropriations and 
        the Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Appropriations and the Committee on 
        Energy and Commerce of the House of Representatives a report 
        detailing the amount of such funds available for procurement 
        and the impact such amount of funding will have--
                    ``(A) in meeting the security countermeasure needs 
                identified under this section; and
                    ``(B) on the annual Public Health Emergency Medical 
                Countermeasures Enterprise and Strategy Implementation 
                Plan (pursuant to section 2811(d)).''.

SEC. 3. CLARIFICATION ON BARDA CONTRACTING AUTHORITY.

    (a) In General.--Section 319F-2(g) of the Public Health Service Act 
(42 U.S.C. 247d-6b(g)) is amended by adding at the end the following:
            ``(5) Clarification on contracting authority.--The 
        Secretary, acting through the Director of the Biomedical 
        Advanced Research and Development Authority, shall carry out 
        the programs funded by the special reserve fund (for the 
        procurement of security countermeasures under subsection (c) 
        and for carrying out section 319L), including the execution of 
        procurement contracts, grants, and cooperative agreements 
        pursuant to this section and section 319L.''.
    (b) BARDA Contracting Authority.--Section 319L(c)(3) of the Public 
Health Service Act (42 U.S.C. 247d-7c) is amended by inserting ``, 
including the execution of procurement contracts, grants, and 
cooperative agreements pursuant to this section'' before the period.

SEC. 4. COUNTERMEASURES BUDGET PLAN.

    Section 2811(b)(7) of the Public Health Service Act (42 U.S.C. 
300hh-10(b)(7)) is amended--
            (1) by striking the first sentence and inserting ``Develop, 
        and update not later than March 1 of each year, a coordinated 
        5-year budget plan based on the medical countermeasure 
        priorities described in subsection (d), including with respect 
        to chemical, biological, radiological, and nuclear agent or 
        agents that may present a threat to the Nation, including such 
        agents that are novel or emerging infectious diseases, and the 
        corresponding efforts to develop qualified countermeasures (as 
        defined in section 319F-1), security countermeasures (as 
        defined in section 319F-2), and qualified pandemic or epidemic 
        products (as defined in section 319F-3) for each such 
        threat.'';
            (2) in subparagraph (C), by striking ``; and'' and 
        inserting a semicolon;
            (3) in subparagraph (D), by striking ``to the appropriate 
        committees of Congress upon request.'' and inserting ``, not 
        later than March 15 of each year, to the Committee on 
        Appropriations and the Committee on Health, Education, Labor, 
        and Pensions of the Senate and the Committee on Appropriations 
        and the Committee on Energy and Commerce of the House of 
        Representatives; and''; and
            (4) by adding at the end the following:
                    ``(E) not later than March 15 of each year, be made 
                publicly available.''.

SEC. 5. PRIORITIZING THE ANIMAL RULE GUIDANCE.

    Section 565(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb-4(c)) is amended by adding at the end the following:
            ``(3) Written explanation.--The Secretary shall provide to 
        the Committee on Health, Education, Labor, and Pensions of the 
        Senate and the Committee on Energy and Commerce of the House of 
        Representatives a written explanation, not later than the last 
        day of each month after the date of enactment of the Medical 
        Countermeasure Innovation Act of 2015 in which the Secretary 
        fails to finalize such guidance, for why the Secretary has 
        failed to finalize the guidance as required by this 
        subsection.''.

SEC. 6. STREAMLINING THE PROJECT BIOSHIELD PROCUREMENT PROCESS.

    Section 319F-2(c) of the Public Health Service Act (42 U.S.C. 247d-
6b(c)) is amended--
            (1) in paragraph (4)(A)(ii), by striking ``make a 
        recommendation under paragraph (6) that the special reserve 
        fund as defined in subsection (h) be made available for the 
        procurement of such countermeasure'' and inserting ``make 
        available the special reserve fund as defined in subsection (h) 
        for procurement of such countermeasure, as applicable'';
            (2) in paragraph (6)--
                    (A) by striking subparagraphs (A), (B), and (E);
                    (B) by redesignating subparagraphs (C) and (D) as 
                subparagraphs (A) and (B), respectively;
                    (C) by amending subparagraph (A), as so 
                redesignated, to read as follows:
                    ``(A) Notice to appropriate congressional 
                committees.--The Secretary shall notify the Committee 
                on Appropriations and the Committee on Health, 
                Education, Labor, and Pensions of the Senate and the 
                Committee on Appropriations and the Committee on Energy 
                and Commerce of the House of Representatives of each 
                decision to make available the special reserve fund as 
                defined in subsection (h) for procurement of a security 
                countermeasure, including, where available, the number 
                of, the nature of, and other information concerning 
                potential suppliers of such countermeasure, and whether 
                other potential suppliers of the same or similar 
                countermeasures were considered and rejected for 
                procurement under this section and the reasons 
                therefore.''; and
                    (D) in the heading, by striking ``Recommendation 
                for president's approval'' and inserting 
                ``Recommendations for procurement''; and
            (3) in paragraph (7)--
                    (A) by striking subparagraph (A);
                    (B) by striking subparagraph (B) and inserting the 
                following:
                    ``(A) Payments from special reserve fund.--The 
                special reserve fund as defined in subsection (h) shall 
                be available for payments made by the Secretary to a 
                vendor for procurement of a security countermeasure in 
                accordance with the provisions of this paragraph.''; 
                and
                    (C) by redesignating subparagraph (C) as 
                subparagraph (B).

SEC. 7. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR AGENTS THAT PRESENT 
              NATIONAL SECURITY THREATS.

    Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb et seq.) is amended by inserting after section 
565 the following:

``SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR AGENTS THAT 
              PRESENT NATIONAL SECURITY THREATS.

    ``(a) Definitions.--In this section:
            ``(1) The term `priority review' with respect to a human 
        drug application as defined in section 735(1), means review and 
        action by the Secretary on such application not later than 6 
        months after receipt by the Secretary of such application, as 
        described in the Manual of Policies and Procedures in the Food 
        and Drug Administration and goals identified in the letters 
        described in section 101(b) of the Food and Drug Administration 
        Safety and Innovation Act.
            ``(2) Priority review voucher.--The term `priority review 
        voucher' means a voucher issued by the Secretary to the sponsor 
        of a material threat medical countermeasure application that 
        entitles the holder of such voucher to priority review of a 
        single human drug application submitted under section 505(b)(1) 
        or section 351 of the Public Health Service Act after the date 
        of approval of the material threat medical countermeasure 
        application.
            ``(3) Material threat medical countermeasure application.--
        The term `material threat medical countermeasure application' 
        means an application that--
                    ``(A) is a human drug application as defined in 
                section 735(1)--
                            ``(i) to prevent, or treat harm from a 
                        biological, chemical, radiological, or nuclear 
                        agent identified as a material threat under 
                        section 319F-2(c)(2)(A)(ii) of the Public 
                        Health Service Act, or
                            ``(ii) to mitigate, prevent, or treat harm 
                        from a condition that may result in adverse 
                        health consequences or death and may be caused 
                        by administering a drug, or biological product 
                        against such agent;
                    ``(B) the Secretary deems eligible for priority 
                review;
                    ``(C) is approved after the date of enactment of 
                the Medical Countermeasure Innovation Act of 2015; and
                    ``(D) is for a human drug, no active ingredient 
                (including any ester or salt of the active ingredient) 
                of which has been approved in any other application 
                under section 505(b)(1) or section 351 of the Public 
                Health Service Act.
    ``(b) Priority Review Voucher.--
            ``(1) In general.--The Secretary shall award a priority 
        review voucher to the sponsor of a material threat medical 
        countermeasure application upon approval by the Secretary of 
        such material threat medical countermeasure application.
            ``(2) Transferability.--The sponsor of a material threat 
        medical countermeasure application that receives a priority 
        review voucher under this section may transfer (including by 
        sale) the entitlement to such voucher to a sponsor of a human 
        drug for which an application under section 505(b)(1) or 
        section 351 of the Public Health Service Act will be submitted 
        after the date of the approval of the material threat medical 
        countermeasure application. There is no limit on the number of 
        times a priority review voucher may be transferred before such 
        voucher is used.
            ``(3) Notification.--
                    ``(A) In general.--The sponsor of a human drug 
                application shall notify the Secretary not later than 
                90 calendar days prior to submission of the human drug 
                application that is the subject of a priority review 
                voucher of an intent to submit the human drug 
                application, including the date on which the sponsor 
                intends to submit the application. Such notification 
                shall be a legally binding commitment to pay for the 
                user fee to be assessed in accordance with this 
                section.
                    ``(B) Transfer after notice.--The sponsor of a 
                human drug application that provides notification of 
                the intent of such sponsor to use the voucher for the 
                human drug application under subparagraph (A) may 
                transfer the voucher after such notification is 
                provided, if such sponsor has not yet submitted the 
                human drug application described in the notification.
    ``(c) Priority Review User Fee.--
            ``(1) In general.--The Secretary shall establish a user fee 
        program under which a sponsor of a human drug application that 
        is the subject of a priority review voucher shall pay to the 
        Secretary a fee determined under paragraph (2). Such fee shall 
        be in addition to any fee required to be submitted by the 
        sponsor under chapter VII.
            ``(2) Fee amount.--The amount of the priority review user 
        fee shall be determined each fiscal year by the Secretary and 
        based on the average cost incurred by the agency in the review 
        of a human drug application subject to priority review in the 
        previous fiscal year.
            ``(3) Annual fee setting.--The Secretary shall establish, 
        before the beginning of each fiscal year beginning after 
        September 30, 2015, for that fiscal year, the amount of the 
        priority review user fee.
            ``(4) Payment.--
                    ``(A) In general.--The priority review user fee 
                required by this subsection shall be due upon the 
                submission of a human drug application under section 
                505(b)(1) or section 351 of the Public Health Service 
                Act for which the priority review voucher is used.
                    ``(B) Complete application.--An application 
                described under subparagraph (A) for which the sponsor 
                requests the use of a priority review voucher shall be 
                considered incomplete if the fee required by this 
                subsection and all other applicable user fees are not 
                paid in accordance with the Secretary's procedures for 
                paying such fees.
                    ``(C) No waivers, exemptions, reductions, or 
                refunds.--The Secretary may not grant a waiver, 
                exemption, reduction, or refund of any fees due and 
                payable under this section.
            ``(5) Offsetting collections.--Fees collected pursuant to 
        this subsection for any fiscal year--
                    ``(A) shall be deposited and credited as offsetting 
                collections to the account providing appropriations to 
                the Food and Drug Administration; and
                    ``(B) shall not be collected for any fiscal year 
                except to the extent provided in advance in 
                appropriation Acts.
    ``(d) Notice of Issuance of Voucher and Approval of Products Under 
Voucher.--The Secretary shall publish a notice in the Federal Register 
and on the Internet Website of the Food and Drug Administration not 
later than 30 calendar days after the occurrence of each of the 
following:
            ``(1) The Secretary issues a priority review voucher under 
        this section.
            ``(2) The Secretary approves a drug pursuant to an 
        application submitted under section 505(b) of this Act or 
        section 351(a) of the Public Health Service Act for which the 
        sponsor of the application used a priority review voucher under 
        this section.
    ``(e) Eligibility for Other Programs.--Nothing in this section 
precludes a sponsor who seeks a priority review voucher under this 
section from participating in any other incentive program, including 
under this Act, except that no sponsor of a material threat medical 
countermeasure application may receive more than one priority review 
voucher with respect to such drug.
    ``(f) Relation to Other Provisions.--The provisions of this section 
shall supplement, not supplant, any other provisions of this Act or the 
Public Health Service Act that encourage the development of medical 
countermeasures.''.
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