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

<DOC>

                                                       Calendar No. 388
114th CONGRESS
  2d 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, Mr. Casey, Mr. Isakson, and Mr. Roberts) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

                             March 14, 2016

              Reported by Mr. Alexander, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Medical Countermeasure 
Innovation Act of 2015''.</DELETED>

<DELETED>SEC. 2. MEDICAL COUNTERMEASURE GUIDELINES.</DELETED>

<DELETED>    (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--</DELETED>
        <DELETED>    (1) in subsection (a), by adding at the end the 
        following:</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    (2) in subsection (g)--</DELETED>
                <DELETED>    (A) by amending paragraph (4) to read as 
                follows:</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) in meeting the security 
                countermeasure needs identified under this section; 
                and</DELETED>
                <DELETED>    ``(B) on the annual Public Health 
                Emergency Medical Countermeasures Enterprise and 
                Strategy Implementation Plan (pursuant to section 
                2811(d)).''.</DELETED>

<DELETED>SEC. 3. CLARIFICATION ON BARDA CONTRACTING 
              AUTHORITY.</DELETED>

<DELETED>    (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:</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (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.</DELETED>

<DELETED>SEC. 4. COUNTERMEASURES BUDGET PLAN.</DELETED>

<DELETED>    Section 2811(b)(7) of the Public Health Service Act (42 
U.S.C. 300hh-10(b)(7)) is amended--</DELETED>
        <DELETED>    (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.'';</DELETED>
        <DELETED>    (2) in subparagraph (C), by striking ``; and'' and 
        inserting a semicolon;</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (4) by adding at the end the following:</DELETED>
                <DELETED>    ``(E) not later than March 15 of each 
                year, be made publicly available.''.</DELETED>

<DELETED>SEC. 5. PRIORITIZING THE ANIMAL RULE GUIDANCE.</DELETED>

<DELETED>    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:</DELETED>
        <DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 6. STREAMLINING THE PROJECT BIOSHIELD PROCUREMENT 
              PROCESS.</DELETED>

<DELETED>    Section 319F-2(c) of the Public Health Service Act (42 
U.S.C. 247d-6b(c)) is amended--</DELETED>
        <DELETED>    (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'';</DELETED>
        <DELETED>    (2) in paragraph (6)--</DELETED>
                <DELETED>    (A) by striking subparagraphs (A), (B), 
                and (E);</DELETED>
                <DELETED>    (B) by redesignating subparagraphs (C) and 
                (D) as subparagraphs (A) and (B), 
                respectively;</DELETED>
                <DELETED>    (C) by amending subparagraph (A), as so 
                redesignated, to read as follows:</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    (D) in the heading, by striking 
                ``Recommendation for president's approval'' and 
                inserting ``Recommendations for procurement''; 
                and</DELETED>
        <DELETED>    (3) in paragraph (7)--</DELETED>
                <DELETED>    (A) by striking subparagraph 
                (A);</DELETED>
                <DELETED>    (B) by striking subparagraph (B) and 
                inserting the following:</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    (C) by redesignating subparagraph (C) as 
                subparagraph (B).</DELETED>

<DELETED>SEC. 7. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR AGENTS 
              THAT PRESENT NATIONAL SECURITY THREATS.</DELETED>

<DELETED>    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:</DELETED>

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

<DELETED>    ``(a) Definitions.--In this section:</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Material threat medical countermeasure 
        application.--The term `material threat medical countermeasure 
        application' means an application that--</DELETED>
                <DELETED>    ``(A) is a human drug application as 
                defined in section 735(1)--</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(B) the Secretary deems eligible for 
                priority review;</DELETED>
                <DELETED>    ``(C) is approved after the date of 
                enactment of the Medical Countermeasure Innovation Act 
                of 2015; and</DELETED>
                <DELETED>    ``(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.</DELETED>
<DELETED>    ``(b) Priority Review Voucher.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Notification.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
<DELETED>    ``(c) Priority Review User Fee.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(4) Payment.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(5) Offsetting collections.--Fees collected 
        pursuant to this subsection for any fiscal year--</DELETED>
                <DELETED>    ``(A) shall be deposited and credited as 
                offsetting collections to the account providing 
                appropriations to the Food and Drug Administration; 
                and</DELETED>
                <DELETED>    ``(B) shall not be collected for any 
                fiscal year except to the extent provided in advance in 
                appropriation Acts.</DELETED>
<DELETED>    ``(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:</DELETED>
        <DELETED>    ``(1) The Secretary issues a priority review 
        voucher under this section.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Countermeasure Innovation 
Act of 2016''.

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)).''; and

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 in a manner that does not compromise 
                national security.''.

SEC. 5. MEDICAL COUNTERMEASURES INNOVATION.

    Section 319L(c)(4) of the Public Health Service Act (42 U.S.C. 
247d-7e(c)(4)) is amended by adding at the end the following:
                    ``(E) Medical countermeasures innovation partner.--
                            ``(i) In general.--To support the purposes 
                        described in paragraph (2), the Secretary, 
                        acting through the Director of BARDA, may enter 
                        into an agreement (including through the use of 
                        grants, contracts, cooperative agreements, or 
                        other transactions as described in paragraph 
                        (5)) with an independent, non-profit entity 
                        to--
                                    ``(I) foster and accelerate the 
                                development and innovation of medical 
                                countermeasures and technologies that 
                                may assist advanced research and 
                                development of qualified 
                                countermeasures and qualified pandemic 
                                or epidemic products, including through 
                                the use of strategic venture capital 
                                practices and methods;
                                    ``(II) promote the development of 
                                new and promising technologies that 
                                address urgent medical countermeasure 
                                needs, as identified by the Secretary;
                                    ``(III) address unmet public health 
                                needs that are directly related to 
                                medical countermeasure requirements, 
                                such as novel antimicrobials for 
                                multidrug resistant organisms and 
                                multiuse platform technologies for 
                                diagnostics, prophylaxis, vaccines, and 
                                therapeutics; and
                                    ``(IV) provide expert consultation 
                                and advice to foster viable medical 
                                countermeasure innovators, including 
                                helping qualified countermeasure 
                                innovators navigate unique industry 
                                challenges with respect to developing 
                                chemical, biological, radiological, and 
                                nuclear countermeasure products.
                            ``(ii) Eligibility.--
                                    ``(I) In general.--To be eligible 
                                to enter into an agreement under clause 
                                (i) an entity shall--
                                            ``(aa) be an independent, 
                                        non-profit entity;
                                            ``(bb) have a demonstrated 
                                        record of being able to create 
                                        linkages between innovators and 
                                        investors and leverage such 
                                        partnerships and resources for 
                                        the purpose of addressing 
                                        identified strategic needs of 
                                        the Federal Government;
                                            ``(cc) have experience in 
                                        promoting novel technology 
                                        innovation;
                                            ``(dd) be problem driven 
                                        and solution focused based on 
                                        the needs, requirements, and 
                                        problems identified by the 
                                        Secretary under clause (iv);
                                            ``(ee) demonstrate the 
                                        ability, or the potential 
                                        ability, to promote the 
                                        development of medical 
                                        countermeasure products;
                                            ``(ff) demonstrate 
                                        expertise, or the capacity to 
                                        develop or acquire expertise, 
                                        related to technical and 
                                        regulatory considerations with 
                                        respect to medical 
                                        countermeasures; and
                                            ``(gg) not be within the 
                                        Department of Health and Human 
                                        Services.
                                    ``(II) Partnering experience.--In 
                                selecting an entity with which to enter 
                                into an agreement under clause (i), the 
                                Secretary shall place a high value on 
                                the demonstrated experience of the 
                                entity in partnering with the Federal 
                                Government to meet identified strategic 
                                needs.
                            ``(iii) Not agency.--An entity that enters 
                        into an agreement under clause (i) shall not be 
                        deemed to be a Federal agency for any purpose, 
                        including for any purpose under title 5, United 
                        States Code.
                            ``(iv) Direction.--Pursuant to an agreement 
                        entered into under this subparagraph, the 
                        Secretary, acting through the Director of 
                        BARDA, shall provide direction to the entity 
                        that enters into an agreement under clause (i). 
                        As part of this agreement the Director of BARDA 
                        shall--
                                    ``(I) communicate the medical 
                                countermeasure needs, requirements, and 
                                problems to be addressed by the entity 
                                under the agreement;
                                    ``(II) develop a description of 
                                work to be performed by the entity 
                                under the agreement;
                                    ``(III) provide technical feedback 
                                and appropriate oversight over work 
                                carried out by the entity under the 
                                agreement, including subsequent 
                                development and partnerships consistent 
                                with the needs and requirements set 
                                forth in this subparagraph;
                                    ``(IV) ensure fair consideration of 
                                products developed under the agreement 
                                in order to maintain competition to the 
                                maximum practical extent, as applicable 
                                and appropriate under applicable 
                                provisions of this section; and
                                    ``(V) ensure, as a condition of the 
                                agreement--
                                            ``(aa) a comprehensive set 
                                        of policies that demonstrate a 
                                        commitment to transparency and 
                                        accountability;
                                            ``(bb) protection against 
                                        conflicts of interest through a 
                                        comprehensive set of policies 
                                        that address potential 
                                        conflicts of interest, ethics, 
                                        disclosure, and reporting 
                                        requirements;
                                            ``(cc) that the entity 
                                        provides monthly accounting on 
                                        the use of funds provided under 
                                        such agreement; and
                                            ``(dd) that the entity 
                                        provides on a quarterly basis, 
                                        reports regarding the progress 
                                        made toward meeting the 
                                        identified needs set forth in 
                                        the agreement.
                            ``(v) Supplement not supplant.--Activities 
                        carried out under this subparagraph shall 
                        supplement, and not supplant, other activities 
                        carried out under this section.
                            ``(vi) No establishment of entity.--To 
                        prevent unnecessary duplication and target 
                        resources effectively, nothing in this 
                        subparagraph shall be construed to authorize 
                        the Secretary to establish within the 
                        Department of Health and Human Services an 
                        entity for the purposes of carrying out this 
                        subparagraph.
                            ``(vii) Transparency and oversight.--Upon 
                        request, the Secretary shall provide to 
                        Congress the information provided to the 
                        Secretary under clause (iv)(V)(dd).
                            ``(viii) Independent evaluation.--Not later 
                        than 4 years after the date of enactment of 
                        this subparagraph, the Government 
                        Accountability Office shall conduct an 
                        independent evaluation, and submit to the 
                        Secretary and the appropriate committees of 
                        Congress a report, concerning the activities 
                        conducted under this subparagraph. Such report 
                        shall include recommendations with respect to 
                        any agreement or activities carried out 
                        pursuant to this subparagraph.
                            ``(ix) Sunset.--This subparagraph shall 
                        have no force or effect after September 30, 
                        2022.''.

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 ``and 
        subject to the availability of appropriations, 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(a) 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; and
                    ``(B) the Secretary deems eligible for priority 
                review;
                    ``(C) is approved after the date of enactment of 
                the Medical Countermeasure Innovation Act of 2016; 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(a) 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(a) 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(a) of the Public Health 
                Services 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
            ``(6) 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 issued under any section of this Act 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.''.

SEC. 8. GAO REPORT.

    (a) Study.--The Comptroller General of the United States shall 
conduct a study on the effectiveness of priority review vouchers under 
section 565A of the Federal Food, Drug, and Cosmetic Act (as added by 
section 7) in providing incentives for the development of material 
threat medical countermeasures applications under such section 565A. In 
conducting such study, the Comptroller General shall examine the 
following:
            (1) The impact of the priority review voucher in attracting 
        investment into the development of material threat medical 
        countermeasures and the impact of such investment, as 
        applicable, on the development of such countermeasures.
            (2) How the drugs for which priority review vouchers were 
        awarded under such section 565A--
                    (A) addressed identified medical countermeasure 
                needs; and
                    (B) impacted United States preparedness against 
                chemical, biological, radiological, and nuclear 
                threats, including both identified threats and 
                naturally-occurring threats.
            (3) How many material threat medical countermeasures were 
        licensed or approved, or otherwise significantly advanced in 
        clinical development, in the 10 years following the enactment 
        of such section 565A compared to the 10 years prior to the 
        enactment of such section.
            (4) An analysis of the drugs for which such priority review 
        vouchers were used, which shall include--
                    (A) the indications for which such drugs were 
                approved under section 505(b)(1) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 355) or section 
                351(a) of the Public Health Service Act (42 U.S.C. 
                262);
                    (B) whether unmet medical needs were addressed 
                through the approval of such drugs, including, for each 
                such drug--
                            (i) if an alternative therapy was 
                        previously available to treat the indication; 
                        and
                            (ii) if the drug provided a benefit or 
                        advantage over another available therapy;
                    (C) the value of the priority review voucher if 
                transferred; and
                    (D) the length of time between the date on which a 
                priority review voucher was awarded and the date on 
                which it was used.
            (5) With respect to the priority review voucher program 
        under such section 565A--
                    (A) how many priority review vouchers were awarded 
                under such section 565A and how many of such awarded 
                vouchers were redeemed for priority review of a drug 
                application in the 10 years following the date of 
                enactment of such section;
                    (B) the resources associated with the Food and Drug 
                Administration implementation of such section 565A and 
                review of applications for which a voucher awarded 
                under such section 565A is redeemed for priority 
                review; and
                    (C) recommendations, if any, with respect to how 
                such section 565A could be improved to better achieve 
                the objective of incentivizing the timely development 
                of medical countermeasures to address identified 
                chemical, biological, radiological, and nuclear 
                threats, including for medical countermeasures that 
                might otherwise not be developed, potentially eligible 
                for an emergency use authorization, licensed, or 
                approved.
    (b) Consultations.--In conducting the study under subsection (a), 
the Comptroller General of the United States shall consult with--
            (1) drug manufacturers involved in the research and 
        development of medical countermeasures to address biological, 
        chemical, radiological, and nuclear threats;
            (2) stakeholders involved in investing in the research and 
        development of medical countermeasures, including venture 
        capitalists;
            (3) the Federal Government agencies responsible for 
        advancing, reviewing, and procuring medical countermeasures, 
        including--
                    (A) the Department of Health and Human Services, 
                including the Office of the Assistant Secretary for 
                Preparedness and Response, the Biomedical Advanced 
                Research and Development Authority, and the Food and 
                Drug Administration; and
                    (B) the Department of Defense; and
            (4) biodefense stakeholders, as applicable.
    (c) Initial Assessment.--Not later than 7 years after the date of 
enactment of this Act, the Comptroller General of the United States 
shall submit to the Committee on Health, Education, Labor, and Pensions 
of the Senate and the Committee on Energy and Commerce of the House of 
Representatives an initial assessment of the effectiveness of the 
priority review voucher program set forth in section 565A of the 
Federal Food, Drug, and Cosmetic Act (as added by section 7).
    (d) Report.--Not later than 12 years after the date of enactment of 
this Act, the Comptroller General of the United States shall submit 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 report containing the results of the study conducted 
under subsection (a).
    (e) Protection of National Security.--The Comptroller General of 
the United States shall conduct the study and issue the assessment and 
report under this section in a manner that does not compromise national 
security.
                                                       Calendar No. 388

114th CONGRESS

  2d Session

                                S. 2055

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                             March 14, 2016

                       Reported with an amendment
```