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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3299 Reported in House (RH)]

<DOC>

                                                 Union Calendar No. 571
114th CONGRESS
  2d Session
                                H. R. 3299

                          [Report No. 114-735]

   To amend the Public Health Service Act to ensure preparedness for 
chemical, radiological, biological, and nuclear threats, and for other 
                               purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             July 29, 2015

   Mrs. Brooks of Indiana (for herself and Ms. Eshoo) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

                           September 9, 2016

 Additional sponsors: Mr. Flores, Mrs. Ellmers of North Carolina, Mrs. 
Blackburn, Mr. Mullin, Mr. Hunter, Mrs. Mimi Walters of California, Mr. 
 Bishop of Michigan, Mr. Long, Mr. Nunes, Mr. Turner, Mr. Burgess, Mr. 
   Knight, Mr. Carter of Georgia, Mr. Bilirakis, Mr. Garamendi, Mr. 
  Griffith, Mr. Swalwell of California, Mr. Collins of New York, Mr. 
   Lance, Mrs. Comstock, Mr. Guthrie, Mr. Hastings, Mr. Kinzinger of 
Illinois, Mr. Stewart, Mr. Vargas, Mr. Bucshon, Mr. Walden, Mr. Cramer, 
Mr. Hudson, Mr. Joyce, Mr. Johnson of Ohio, Mr. Quigley, Mr. Crenshaw, 
 Mr. Olson, Mr. David Scott of Georgia, Mr. Cardenas, Mr. Wittman, Mr. 
   Denham, Mr. Messer, Mr. Ruppersberger, Mr. Rush, Ms. Speier, Mr. 
 Shimkus, Mrs. McMorris Rodgers, Mr. Rodney Davis of Illinois, and Mr. 
                                Pascrell

                           September 9, 2016

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]
 [For text of introduced bill, see copy of bill as introduced on July 
                               29, 2015]

_______________________________________________________________________

                                 A BILL

 
   To amend the Public Health Service Act to ensure preparedness for 
chemical, radiological, biological, and nuclear threats, 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. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Strengthening 
Public Health Emergency Response Act of 2016''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. GAO report on State, local, and hospital preparedness programs.
Sec. 3. Strategic national stockpile.
Sec. 4. Project Bioshield procurement process.
Sec. 5. BARDA transaction authorities.
Sec. 6. Public health emergency medical countermeasures enterprise 
                            strategy and implementation plan.
Sec. 7. Priority review to encourage treatments for agents that present 
                            national security threats.

SEC. 2. GAO REPORT ON STATE, LOCAL, AND HOSPITAL PREPAREDNESS PROGRAMS.

    (a) In General.--Not later than 1 year after the date of enactment 
of this Act, the Comptroller General of the United States shall submit 
a report to the Congress on the programs for awarding cooperative 
agreements and grants under section 319C-1 of the Public Health Service 
Act (42 U.S.C. 247d-3a; improving State and local public health 
security) and section 319C-2 of such Act (42 U.S.C. 247d-3b; 
partnerships for State and regional hospital preparedness to improve 
surge capacity).
    (b) Contents.--The report under subsection (a) shall address each 
of the following:
            (1) The goals of the programs specified in subsection (a).
            (2) The extent to which such goals are being met, including 
        performance metrics that could help to assess whether such 
        programs are succeeding at the coalition and member level.
            (3) How such programs could be improved, including how such 
        programs could be modified to improve the medical preparedness 
        of hospitals, health care coalitions, and the continuity of 
        health care delivery.
            (4) How such programs complement other preparedness 
        programs of the Department of Health and Human Services.
            (5) How funds awarded through such programs should be 
        allocated and whether that allocation should be based on risk.
            (6) Progress made toward State and local preparedness 
        entities being self-sustaining.
            (7) Whether the level of funding for such programs is 
        sufficient.
            (8) How funding for such programs is being used to ensure 
        preparedness for at-risk populations including children, 
        pregnant women, senior citizens, and other individuals who may 
        have unique needs in the event of a public health emergency, 
        such as individuals with disabilities.
            (9)(A) How, and to what extent, entities are using the 
        funds awarded to such entities through section 319C-2 of the 
        Public Health Service Act (42 U.S.C. 247d-3b) to directly fund 
        regional health care coalitions and members of such coalitions.
            (B) The amount each such entity retains for its own 
        indirect and direct costs.
            (C) The purposes for which such retained funds are used and 
        whether these uses provide value for the program under such 
        section 319C-2, regional health care coalitions, and members of 
        such coalitions.
            (10) The extent to which the funds awarded through the 
        programs under sections 319C-1 and 319C-2 of the Public Health 
        Service Act (42 U.S.C. 247d-3a, 247d-3b) have been used for 
        overlapping purposes.

SEC. 3. STRATEGIC NATIONAL STOCKPILE.

    Section 319F-2(a)(2) of the Public Health Service Act (42 U.S.C. 
247d-6b(a)(2)) is amended--
            (1) in subparagraph (G), by striking ``and'' at the end;
            (2) in subparagraph (H), by striking the period at the end 
        and inserting ``; and''; and
            (3) by adding at the end the following:
                    ``(I) ensure procedures are in place to coordinate 
                the ongoing stockpiling by the Biomedical Advanced 
                Research and Development Authority and Centers for 
                Disease Control and Prevention of qualified 
                countermeasures (as defined in section 319F-1) for 
                which funds have been made available under this part, 
                security countermeasures (as defined in this section), 
                and qualified pandemic or epidemic products (as defined 
                in section 319F-3) for which funds have been made 
                available under section 319L in order to avoid any gaps 
                in preparedness.''.

SEC. 4. 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'';
            (2) in paragraph (6)--
                    (A) by striking subparagraphs (A), (B), (C), and 
                (E); and
                    (B) by striking ``(6) Recommendations for 
                president's approval'' and all that follows through 
                ``(D) Subsequent specific countermeasures.--'' and 
                inserting ``(6) Subsequent specific countermeasures.--
                ''; and
            (3) in paragraph (7)--
                    (A) by striking subparagraph (A);
                    (B) by redesignating subparagraph (B) as 
                subparagraph (A) and amending such subparagraph (A), as 
                redesignated, to read as follows:
                    ``(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. 5. BARDA TRANSACTION AUTHORITIES.

    Section 319L(c)(5) of the Public Health Service Act (42 U.S.C. 
247d-7e(c)(5)) is amended by adding at the end the following:
                    ``(H) Contracting authority clarification.--The 
                Secretary shall delegate authority for negotiating and 
                entering into any contracts, grants, or cooperative 
                agreements under this section to the Director.''.

SEC. 6. PUBLIC HEALTH EMERGENCY MEDICAL COUNTERMEASURES ENTERPRISE 
              STRATEGY AND IMPLEMENTATION PLAN.

    Section 2811(d)(2) of the Public Health Service Act (42 U.S.C. 
300hh-10(d)(2)) is amended--
            (1) in subparagraph (A), by inserting after ``describe the 
        chemical, biological, radiological, and nuclear agent or agents 
        that may present a threat to the Nation'' the following: 
        ``(which shall include pandemic influenza)'';
            (2) by striking ``and'' at the end of subparagraph (J);
            (3) by redesignating subparagraph (K) as subparagraph (L); 
        and
            (4) by inserting after subparagraph (J) the following:
                    ``(K) report on the amount of time between the 
                issuance of each request for a proposal or task order 
                from the Biomedical Advanced Research and Development 
                Authority and the award of a contract pursuant to such 
                request for a proposal or task order; and''.

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

    (a) In General.--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) Priority review.--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 of 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 
        (Public Law 112-144).
            ``(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) 
        of this Act 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) 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;
                    ``(B) the Secretary deems eligible for priority 
                review;
                    ``(C) is approved after the date of enactment of 
                the Strengthening Public Health Emergency Response 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 pursuant to any other 
                application under section 505(b)(1) of this Act 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 application.
            ``(2) Transferability.--
                    ``(A) In general.--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) of this Act 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.
                    ``(B) Notification of transfer.--Each person to 
                whom a voucher is transferred shall notify the 
                Secretary of such change in ownership of the voucher 
                not later than 30 days after the date of such transfer.
            ``(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, 2016, 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 
                notification by a sponsor of the intent of such sponsor 
                to use the voucher, as specified in subsection 
                (b)(3)(A). All other user fees associated with the 
                human drug application shall be due as required by the 
                Secretary or under applicable law.
                    ``(B) Complete application.--An application 
                described in 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 public 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 the drug 
that is the subject of such application.
    ``(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.
    ``(g) Medical Countermeasure Postapproval Report.--
            ``(1) In general.--Not later than 5 years after the date of 
        approval of a material threat medical countermeasure 
        application, the sponsor of such application shall submit a 
        report to the Secretary on such medical countermeasure.
            ``(2) Contents.--A report under paragraph (1) shall 
        include, with respect to each of the first 2 years after 
        approval of such material threat medical countermeasure 
        application, a description of--
                    ``(A) the sponsor's activities with Federal 
                agencies related to the procurement, including 
                stockpiling, of the approved medical countermeasure;
                    ``(B) the sponsor's progress in fulfilling 
                contracts entered into with Federal agencies, including 
                the Biomedical Advanced Research and Development 
                Authority, the Centers for Disease Control and 
                Prevention, and the Department of Defense, related to 
                such procurement;
                    ``(C) the extent to which the Federal Government 
                has fulfilled its stated medical countermeasure 
                requirements for the threat intended to be treated by 
                the approved medical countermeasure; and
                    ``(D) the sponsor's plans, if any, to develop 
                additional material threat medical countermeasures.
            ``(3) Availability to congressional committees.--The 
        Secretary shall make each report submitted under this 
        subsection available to the Committee on Energy and Commerce of 
        the House of Representatives and the Committee on Health, 
        Education, Labor, and Pensions of the Senate upon request by 
        either such Committee not later than 30 days after receipt of 
        such request.
            ``(4) Rule of construction.--Nothing in this subsection 
        shall be construed to permit the disclosure of confidential 
        commercial or trade secret information or the disclosure of 
        information that could compromise national security.''.
    (b) GAO Report.--
            (1) 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 subsection (a), in providing 
        incentives for the development of material threat medical 
        countermeasure applications under such section 565A. In 
        conducting such study, the Comptroller General shall examine 
        the following:
                    (A) The impact of such priority review on the 
                development of material threat medical countermeasures 
                and the impact of such investment, as applicable, on 
                the development of such countermeasures.
                    (B) How the drugs for which such priority review 
                vouchers were awarded--
                            (i) addressed identified medical 
                        countermeasure needs; and
                            (ii) impacted United States preparedness 
                        against chemical, biological, radiological, and 
                        nuclear threats, including both identified 
                        threats and naturally occurring threats.
                    (C) How many material threat medical 
                countermeasures were licensed or approved, or otherwise 
                significantly advanced in clinical development, in the 
                15 years following the enactment of such section 565A 
                compared to the 15 years prior to the enactment of such 
                section, including a comparative analysis of Federal 
                advanced development and procurement dollars available 
                in the 15 years following such enactment compared to 
                the prior 15 years.
                    (D) How material threat medical countermeasures 
                developed after the date of enactment of this Act 
                impact--
                            (i) the supply of products in the strategic 
                        national stockpile under section 319F-2 of the 
                        Public Health Service Act (42 U.S.C. 247d-6b); 
                        and
                            (ii) national preparedness.
                    (E) How the Federal Government supported sponsors 
                of material threat medical countermeasures during the 
                research, development, application review, and 
                production of such drugs, including the use of 
                government research, provision of resources through 
                contracts or grants, and use of federally funded 
                research facilities.
                    (F) An analysis of the drugs for which such 
                priority review vouchers were used, which shall 
                include--
                            (i) 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(b)(1)) or section 351(a) of the Public 
                        Health Service Act (42 U.S.C. 262(a));
                            (ii) whether unmet medical needs were 
                        addressed through the approval of such drugs, 
                        including, for each such drug--
                                    (I) if there was a currently 
                                marketed therapy approved to prevent or 
                                treat the same indication in the same 
                                patient population at the time the 
                                application was submitted to the Food 
                                and Drug Administration; and
                                    (II) if the drug provided a 
                                significant benefit or improvement in 
                                safety and effectiveness compared to 
                                such currently marketed product;
                            (iii) the price of the priority review 
                        voucher if transferred or sold prior to 
                        redemption; and
                            (iv) the length of time between the date on 
                        which a priority review voucher was awarded and 
                        the date on which it was used.
                    (G) With respect to the priority review voucher 
                program under such section 565A--
                            (i) 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 15 
                        years following the date of enactment of such 
                        section;
                            (ii) 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 if 
                        implementation of such section 565A prohibited 
                        the Food and Drug Administration from meeting 
                        drug application review goals;
                            (iii) recommendations on whether 
                        appropriate Federal funding for advanced 
                        development and research would necessitate the 
                        priority review voucher program for medical 
                        countermeasures;
                            (iv) the degree to which this incentive 
                        program impacts other priority review voucher 
                        programs; and
                            (v) the degree to which guaranteed Federal 
                        funding for advanced development and research 
                        is a greater incentive for new investment in 
                        research and the development of medical 
                        countermeasures than the uncertain values of 
                        vouchers.
            (2) Consultations.--In conducting the study under 
        subsection (a), the Comptroller General of the United States 
        shall consult with--
                    (A) drug manufacturers involved in the research and 
                development of medical countermeasures to address 
                biological, chemical, radiological, and nuclear 
                threats;
                    (B) stakeholders involved in investing in the 
                research and development of such medical 
                countermeasures, including venture capitalists;
                    (C) the Federal Government agencies responsible for 
                advancing, reviewing, and procuring such medical 
                countermeasures, including--
                            (i) 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
                            (ii) the Department of Defense;
                    (D) biodefense stakeholders, as applicable; and
                    (E) drug manufacturers involved in the research and 
                development of therapies that address--
                            (i) tropical diseases (as defined in 
                        section 524(a) of the Federal Food, Drug, and 
                        Cosmetic Act (21 U.S.C. 360n(a))); or
                            (ii) rare pediatric diseases (as defined in 
                        section 529(a) of such Act (21 U.S.C. 
                        360ff(a))).
            (3) Initial assessment.--Not later than 10 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 subsection (a).
            (4) Report.--Not later than 16 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 paragraph 
        (1).
            (5) Protection of national security.--The Comptroller 
        General of the United States shall conduct the study under 
        paragraph (1) and issue the assessment and report under 
        paragraphs (3) and (4) in a manner that does not compromise 
        national security.
                                                 Union Calendar No. 571

114th CONGRESS

  2d Session

                               H. R. 3299

                          [Report No. 114-735]

_______________________________________________________________________

                                 A BILL

   To amend the Public Health Service Act to ensure preparedness for 
chemical, radiological, biological, and nuclear threats, and for other 
                               purposes.

_______________________________________________________________________

                           September 9, 2016

  Reported with an amendment, committed to the Committee of the Whole 
       House on the State of the Union, and ordered to be printed
```