Regulation Text
(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to this part, for which the exemption from the Federal Food, Drug, and Cosmetic Act in § 310.4 of this chapter has been revoked, shall be subject to the provisions of § 314.200 of this chapter except to the extent that the notice of opportunity for hearing on the matter issued pursuant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.
Authority
15 U.S.C. 1451-1561;21 U.S.C. 321,351,352,353,355,356b,360,360c-360f,360h-360j,371,374,379e,381;42 U.S.C. 216,241,262,263,264; sec 122,Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note), sec 7002(e),Pub. L. 111-148, 124 Stat. 817, as amended by sec. 607, Division N,Pub. L. 116-94, 133 Stat. 3127.