S. 2188 — Introduced in Senate

II 114th CONGRESS 1st Session S. 2188 IN THE SENATE OF THE UNITED STATES October 21, 2015 Mr. Gardner (for himself and Mr. Donnelly) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to the humanitarian device exemption. 1. Short title This Act may be cited as the Rare Disease Innovation Act. 2. Humanitarian device exemption application (a) In general Section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amended— (1) in paragraph (1) by striking fewer than 4,000 and inserting not more than 8,000; (2) in paragraph (2)(A) by striking fewer than 4,000 and inserting not more than 8,000; and (3) in paragraph (6)(A)(ii), by striking 4,000 and inserting 8,000. (b) Guidance document on probable benefit Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance document that defines the criteria for establishing probable benefit as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)(C)). (c) Reports to Congress Five years after the date of enactment of this Act and every 5 years thereafter, the Secretary of Health and Human Services shall submit to Congress a report on the effect of the amendments made by subsection (a).