Sec. 7. Priority review to encourage treatments for endemic orphan fungal diseases
1,057 words·~5 min read·
/bill/115/hr/6562/ih/section-7A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Subchapter B of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360aa et seq.) is amended by adding at the end the following new section: In this section: The term endemic orphan fungal disease means a disease, such as coccidioidomycosis, that— is caused by a fungus; primarily occurs in certain limited geographic regions; and is a rare disease or condition (as that term is defined in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb(a)(2) )).
The term endemic orphan fungal disease drug application means an application that— is a human drug application for a drug intended for use— to prevent or treat harm from an endemic orphan fungal disease; or to cure an endemic orphan fungal disease; the Secretary determines eligible for priority review; is approved after the date of enactment of this section; and 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.
The term human drug application has the meaning given such term in section 735(1). The term priority review , with respect to a human drug application, 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.
The term priority review voucher means a voucher issued by the Secretary to the sponsor of an endemic orphan fungal disease drug 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 endemic orphan fungal disease drug application. The Secretary shall award a priority review voucher to the sponsor of an endemic orphan fungal disease drug application upon approval by the Secretary of such endemic orphan fungal disease drug application.
The sponsor of a endemic orphan fungal disease drug 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 endemic orphan fungal disease drug application. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.
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. 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. 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. 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. The Secretary shall establish, before the beginning of each fiscal year beginning after September 30, 2019, for that fiscal year, the amount of the priority review user fee. 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 Service Act for which the priority review voucher is used. 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. The Secretary may not grant a waiver, exemption, reduction, or refund of any fees due and payable under this section. Fees collected pursuant to this subsection for any fiscal year— shall be deposited and credited as offsetting collections to the account providing appropriations to the Food and Drug Administration; and shall not be collected for any fiscal year except to the extent provided in advance in appropriation Acts. 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: The Secretary issues a priority review voucher under this section. 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 issued under this section. 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. 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. The Secretary may not award any priority review vouchers under subsection
(b)after October 1, 2024. .
Connectionstraces to 2
Citation graph
cites case law
Sec. 7
Priority review to encourage treatments for endemic orphan fungal diseases
Cites 2Cited by 0 across 0 sources