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e-CFR data is current as of September 17, 2020

Title 21Chapter ISubchapter FPart 601Subpart A → §601.7


Title 21: Food and Drugs
PART 601—LICENSING
Subpart A—General Provisions


§601.7   Procedure for hearings.

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to this part, for which the exemption from the Federal Food, Drug, and Cosmetic Act in §310.4 of this chapter has been revoked, shall be subject to the provisions of §314.200 of this chapter except to the extent that the notice of opportunity for hearing on the matter issued pursuant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

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