eCFR Reference Browser

---

title: "21 CFR §601.7"

source: "https://www.ecfr.gov/current/title-21/section-601.7"

title_number: "21"

volume_number: "7"

chapter_number: "Unknown"

subchapter_code: "F"

subchapter_subject: "BIOLOGICS"

part_code: "601"

part_subject: "LICENSING"

subpart_code: "A"

subpart_subject: "General Provisions"

section_number: "601.7"

section_subject: "Procedure for hearings."

cfr_reference: "21 CFR 601.7"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 600 to 799"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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to this part, for which the exemption from the Federal Food, Drug, and Cosmetic Act in § 310.4 of this chapter has been revoked, shall be subject to the provisions of § 314.200 of this chapter except to the extent that the notice of opportunity for hearing on the matter issued pursuant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.

§601.7 - Procedure for hearings.