US Codex

Notes

§360ee. Grants and contracts for development of drugs for rare diseases and conditions — Inbound Citations

21 U.S.C. § 360ee

Cited by 5 provisions in release 119-102.

Citations to 21 U.S.C. § 360ee as a whole

42 U.S.C. § 236(e)

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(e) The Board shall submit to the Committee on Labor and Human Resources of the Senate and the Committee on Energy and Commerce of the House of Representatives an annual report—

(1) identifying the drugs which have been designated under section 526 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bb] for a rare disease or condition,

(2) describing the activities of the Board, and

(3) containing the results of the evaluations carried out by the Board.

The Director of the National Institutes of Health shall submit to the Board for inclusion in the annual report a report on the rare disease and condition research activities of the Institutes of the National Institutes of Health; the Secretary of the Treasury shall submit to the Board for inclusion in the annual report a report on the use of the credit against tax provided by section 44H² of title 26; and the Secretary of Health and Human Services shall submit to the Board for inclusion in the annual report a report on the program of assistance under section 360ee of title 21 for the development of drugs for rare diseases and conditions. Each annual report shall be submitted by June 1 of each year for the preceding calendar year.

Citations to §360ee(b)

21 U.S.C. § 343(q)(5)(A)(iv)

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(iv) which is a medical food as defined in section 360ee(b) of this title, or
21 U.S.C. § 343(r)(5)(A)

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(A) This paragraph does not apply to infant formulas subject to section 350a(h) of this title and medical foods as defined in section 360ee(b) of this title.

Citations to §360ee(b)(2)

42 U.S.C. § 1382a(b)(26)

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(26) the first $2,000 received during a calendar year by such individual (or such spouse) as compensation for participation in a clinical trial involving research and testing of treatments for a rare disease or condition (as defined in section 360ee(b)(2) of title 21), but only if the clinical trial—

(A) has been reviewed and approved by an institutional review board that is established—

(i) to protect the rights and welfare of human subjects participating in scientific research; and

(ii) in accord with the requirements under part 46 of title 45, Code of Federal Regulations; and

(B) meets the standards for protection of human subjects as provided under part 46 of title 45, Code of Federal Regulations.

Citations to §360ee(b)(3)

21 U.S.C. § 321(ss)(2)

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(2) a medical food, as defined in section 360ee(b)(3) of this title.