---
kind: "section"
citation: "21 C.F.R. § 12.45"
title: "21"
number: "12.45"
heading: "Notice of participation."
url: "https://uscodex.org/cfr/21/12.45"
---

# §12.45. Notice of participation.

- (a) Within 30 days after publication of the notice of hearing under [§ 12.35](/cfr/21/12.35.md), a person desiring to participate in a hearing is to file with the Dockets Management Staff under [§ 10.20](/cfr/21/10.20.md) a notice of participation in the following form:
- (b) An amendment to a notice of participation should be filed with the Dockets Management Staff and served on all participants.
- (c) No person may participate in a hearing who has not filed a written notice of participation or whose participation has been stricken under [paragraph (e)](#e) of this section.
- (d) The presiding officer may permit the late filing of a notice of participation upon a showing of good cause.
- (e) The presiding officer may strike the participation of a person for nonparticipation in the hearing or failure to comply with any requirement of this subpart, e.g., disclosure of information as required by [§ 12.85](/cfr/21/12.85.md) or the prehearing order issued under [§ 12.92](/cfr/21/12.92.md). Any person whose participation is stricken may petition the Commissioner for interlocutory review.

## Notes

### Amendments

[44 FR 22339, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981; 59 FR 14364, Mar. 28, 1994; 68 FR 24879, May 9, 2003]

### 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.

### Amendments

[44 FR 22339, Apr. 13, 1979, as amended at 46 FR 8456, Jan. 27, 1981; 59 FR 14364, Mar. 28, 1994; 68 FR 24879, May 9, 2003]