H.R. 3299 — what changed

removed This Act may be cited as the “Strengthening Public Health Emergency Response Act of 2015”.

removed Subsection (j) of section 319C–2 of the Public Health Service Act (42 U.S.C. 247d–3b) is amended by adding at the end the following:

removed “(5) Minimum funding level for awards—Of the amounts appropriated to carry out this section for a fiscal year, not less than 97 percent shall be awarded to eligible entities as described in subsection (a).”

added Section 319F–2(a)(2) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(2)) is amended—

added “(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.”

changed Section 319F–2(a)(2) 319F–2(c) of the Public Health Service Act (42 U.S.C. 247d–6b(a)(2)) 247d–6b(c)) is amended—

added “(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.”

removed “(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), 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.”

changed Section 319F–2(c) 319L(c)(5) of the Public Health Service Act (42 U.S.C. 247d–6b(c)) 247d–7e(c)(5)) is amended—amended by adding at the end the following:

added “(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.”

removed “(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.”

changed Section 319L(c)(5) 2811(d)(2) of the Public Health Service Act (42 U.S.C. 247d–7e(c)(5)) 300hh–10(d)(2)) is amended by adding at the end the following:amended—

added “(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”

removed “(H) Contracting authority—The Secretary shall delegate authority for negotiating and entering into any contracts, grants, or cooperative agreements under this section to the Director.”

added “565A. Priority review to encourage treatments for agents that present national security threats

added “(a) Definitions—In this section:

added “(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).

added “(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.

added “(3) Material threat medical countermeasure application—The term “material threat medical countermeasure application” means an application that—

added “(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;

added “(B) the Secretary deems eligible for priority review;

added “(C) is approved after the date of enactment of the Strengthening Public Health Emergency Response Act of 2016; and

added “(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.

added “(b) Priority review voucher

added “(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.

added “(2) Transferability

added “(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.

added “(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.

added “(3) Notification

added “(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.

added “(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.

added “(c) Priority review user fee

added “(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.

added “(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.

added “(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.

added “(4) Payment

added “(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.

added “(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.

added “(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.

added “(5) Offsetting collections—Fees collected pursuant to this subsection for any fiscal year—

added “(A) shall be deposited and credited as offsetting collections to the account providing appropriations to the Food and Drug Administration; and

added “(B) shall not be collected for any fiscal year except to the extent provided in advance in appropriation Acts.

added “(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:

added “(1) The Secretary issues a priority review voucher under this section.

added “(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.

added “(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.

added “(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.

added “(g) Medical countermeasure postapproval report

added “(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.

added “(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—

added “(A) the sponsor’s activities with Federal agencies related to the procurement, including stockpiling, of the approved medical countermeasure;

added “(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;

added “(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

added “(D) the sponsor’s plans, if any, to develop additional material threat medical countermeasures.

added “(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.

added “(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.”

removed Section 2811(d)(2) of the Public Health Service Act (42 U.S.C. 300hh–10(d)(2)) is amended—

removed “(K) report on the amount of time between the issuance of each request for proposal or task order from the Biomedical Advanced Research and Development Authority and the award of a contract pursuant to such request for proposal or task order; and”