21 C.F.R. § 601.7

Procedure for hearings.

Last amended: 2016Year: 2026Length: 150 wordsSubsections: 3Official source

Cite as 21 C.F.R. § 601.7 (2026)

(a) A notice of opportunity for hearing, notice of appearance and request for hearing, and grant or denial of hearing for a biological drug pursuant to this part, for which the exemption from the Federal Food, Drug, and Cosmetic Act in § 310.4 of this chapter has been revoked, shall be subject to the provisions of § 314.200 of this chapter except to the extent that the notice of opportunity for hearing on the matter issued pursuant to § 12.21(b) of this chapter specifically provides otherwise. (b) Hearings pursuant to §§ 601.4 through 601.6 shall be governed by part 12 of this chapter. (c) When a license has been suspended pursuant to § 601.6 and a hearing request has been granted, the hearing shall proceed on an expedited basis. [42 FR 4718, Jan. 25, 1977, as amended at 42 FR 15676, Mar. 22, 1977; 42 FR 19143, Apr. 12, 1977]
Cross-references to the CFR
12.21310.4314.200601.4601.6
21 C.F.R. § 601.7: Procedure for hearings. | Justis AI