21 C.F.R. § 15.1

Scope

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The procedures in this part apply when:

(a) The Commissioner concludes, as a matter of discretion, that it is in the public interest to permit persons to present information and views at a public hearing on any matter pending before the Food and Drug Administation.

(b) The act or regulation specifically provides for a public hearing before the Commissioner on a matter, e.g., § 330.10(a)(8) relating to over-the-counter drugs and sections 520 (b) and (f)(1)(B), and 521 of the act relating to proposals to allow persons to order custom devices, to proposed device good manufacturing practice regulations, and to proposed exemptions from preemption of State and local device requirements under § 808.25(e).

(c) A person who has right to an opportunity for a formal evidentiary public hearing under part 12 waives that opportunity and instead requests under § 12.32 a public hearing before the Commissioner, and the Commissioner, as a matter of discretion, accepts the request.

Notes of Decisions

Cited in 3 cases, 1975–1977 · leading case: Jones v. Rath Packing Co., 430 U.S. 519 (1977).

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Jones v. Rath Packing Co., 430 U.S. 519 (1977). · cites it 2× “21 CFR § 15.1 (1976). [36] App. 32-35. Weight fluctuations of 3% to 4% resulting from changes in moisture content are not uncommon during good distribution practice within the continental United States.”

Gen. Mills, Inc. v. Jones, 530 F.2d 1317 (9th Cir. 1975). “§ 341 in regulations set forth at 21 CFR 15.1. Jones conceded at argument before the district court that the compliance of the packages of flour with the federal weight labeling standards discussed infra when they left the millers’ plants was not a material issue of fact.”

Gen. Mills, Inc., a Corp., Plaintiffs-Counterdefendants-Appellants v. Joseph W. Jones, as Dir. of the Cnty. of Riverside Dep't of Weightsand Measures, Defendant-Counterclaimant-Appellee. Gen. Mills, Inc., a Corp., Plaintiffs-Counterdefendants-Appellees v. Joseph W. Jones, as Dir. of the Cnty. of Riverside Dep't of Weightsand Measures, Defendant-Counterclaimant-Appellant, 530 F.2d 1317 (9th Cir. 1976). “341 in regulations set forth at 21 CFR 15.1. Jones conceded at argument before the district court that the compliance of the packages of flour with the federal weight labeling standards discussed infra when they left the millers' plants was not a material issue of fact.”

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