---
kind: "section"
citation: "21 C.F.R. § 601.7"
title: "21"
number: "601.7"
heading: "Procedure for hearings."
url: "https://uscodex.org/cfr/21/601.7"
---

# §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which the exemption from the Federal Food, Drug, and Cosmetic Act in [§ 310.4](/cfr/21/310.4.md) of this chapter has been revoked, shall be subject to the provisions of [§ 314.200](/cfr/21/314.200.md) of this chapter except to the extent that the notice of opportunity for hearing on the matter issued pursuant to [§ 12.21(b)](/cfr/21/12.21.md?p=b) of this chapter specifically provides otherwise.
- (b) Hearings pursuant to [§§ 601.4 through 601.6](/cfr/21/601.4..601.6.md) shall be governed by [part 12](/cfr/21/part12.md) of this chapter.
- (c) When a license has been suspended pursuant to [§ 601.6](/cfr/21/601.6.md) and a hearing request has been granted, the hearing shall proceed on an expedited basis.

## Notes

### Amendments

[42 FR 4718, Jan. 25, 1977, as amended at 42 FR 15676, Mar. 22, 1977; 42 FR 19143, Apr. 12, 1977]

### Authority

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.

### Source

Source: 38 FR 32052, Nov. 20, 1973, unless otherwise noted.

### Amendments

[42 FR 4718, Jan. 25, 1977, as amended at 42 FR 15676, Mar. 22, 1977; 42 FR 19143, Apr. 12, 1977]