§387s. User fees — Inbound Citations

Code of Federal Regulations Citations

Cited by 1 regulation in the Code of Federal Regulations.

• 21 C.F.R. § 1150.1 — Scope.

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  This part establishes requirements related to tobacco product user fees under section 919 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387s). The total amount of user fees may not exceed the amount specified for that fiscal year in section 919(b) of the Federal Food, Drug, and Cosmetic Act. All domestic manufacturers and importers of tobacco products are required to pay to FDA their percentage share of the total assessment for a fiscal year.

Citations to 21 U.S.C. § 387s as a whole

• 21 U.S.C. § 387b(4)

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  (4) the manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 387s of this title by the date specified in section 387s of this title or by the 30th day after final agency action on a resolution of any dispute as to the amount of such fee;

• 21 U.S.C. § 387v(a)

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  (a) For fiscal year 2022 and each subsequent fiscal year for which fees are collected under section 387s of this title, the Secretary of Health and Human Services shall, not later than 180 days after the end of the fiscal year, prepare and submit to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate, an annual report that contains the information required under subsection (b).

• 21 U.S.C. § 387v(b)(9)

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  (9) The number of full-time equivalent employees funded pursuant to fees collected under section 387s of this title, including identification of the centers and offices within the Food and Drug Administration in which such positions are located.