Sec. 6. Grants for development of drugs, biological products, medical devices, and biomaterials for use in regenerative medicine

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The Secretary may make grants to eligible entities for the purpose of funding projects that have as their aim— the research and development of drugs, biological products, medical devices, and biomaterials for use in regenerative medicine; and the making of an investigational new drug application with respect to such drugs or biological products, or the making of an investigational device exemption application with respect to such devices, by not later than the end of the 4-year period beginning on the date on which such grant is made.

A grant under this section may be made on such terms and conditions as the Secretary determines appropriate. In awarding grants under this section, the Secretary shall take into consideration the priorities established by the Regenerative Medicine Coordinating Council under section 4(e). In this section: The term biological product has the meaning given the term in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)). The terms drug and medical device have the meanings given to the terms drug and device , respectively, in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ).

The term eligible entity means a collaborative partnership including— a qualified nonprofit entity or an institution of higher education; and a for-profit entity. The term institution of higher education has the meaning given that term in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001). The term investigational new drug application means an investigational new drug application that is made to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 505(i)).

The term investigational device exemption application means an application for an investigational device exemption that is made to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j(g) ). The term qualified nonprofit entity means an entity that— is described in section 501(c)(3) of the Internal Revenue Code of 1986 ( 26 U.S.C. 501(c)(3) ); and is exempt from tax under section 501(a) of the Internal Revenue Code of 1986 ( 26 U.S.C. 501(a) ).

The term Secretary means the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health.

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