---
kind: "section"
citation: "21 C.F.R. § 12.38"
title: "21"
number: "12.38"
heading: "Effective date of an order."
url: "https://uscodex.org/cfr/21/12.38"
---

# §12.38. Effective date of an order.

- (a) If a person who is subject to a notice of opportunity for hearing under [§ 12.21(b)](/cfr/21/12.21.md?p=b) does not request a hearing, the Commissioner will—
  - (1) Publish a final order denying or withdrawing approval of an NDA, NADA, device premarket approval application, or biologics license, in whole or in part, or revoking a device product development protocol or notice of completion, or declaring that such a protocol has not been completed, and stating the effective date of the order; and
  - (2) If the order involves withdrawal of approval of an NADA, forthwith revoke, in whole or in part, the applicable regulation, under [section 512(i)](/cfr/21/512.md?p=i) of the act.
- (b) If a person who is subject to a notice of opportunity for hearing under [§ 12.21(b)](/cfr/21/12.21.md?p=b) requests a hearing and others do not, the Commissioner may issue a final order covering all the drug or device products at once or may issue more than one final order covering different drug or device products at different times.

## Notes

### Authority

Authority: 21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 42 U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-558, 701-721; 28 U.S.C. 2112.

### Source

Source: 44 FR 22339, Apr. 13, 1979, unless otherwise noted.