II 114th CONGRESS 1st Session S. 2055 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.

1. Short title This Act may be cited as the Medical Countermeasure Innovation Act of 2015 . 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)). . 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. 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. . 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. . 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). 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: 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. .