---
kind: "section"
citation: "21 C.F.R. § 12.22"
title: "21"
number: "12.22"
heading: "Filing objections and requests for a hearing on a regulation or order."
url: "https://uscodex.org/cfr/21/12.22"
---

# §12.22. Filing objections and requests for a hearing on a regulation or order.

- (a) Objections and requests for a hearing under [§ 12.20(d)](/cfr/21/12.20.md?p=d) must be submitted to the Dockets Management Staff and will be accepted for filing if they meet the following conditions:
  - (1) They are submitted within the time specified in [§ 12.20(e)](/cfr/21/12.20.md?p=e).
  - (2) **Each objection is separately numbered.**
  - (3) Each objection specifies with particularity the provision of the regulation or proposed order objected to.
  - (4) **Each objection on which a hearing is requested specifically so states.** Failure to request a hearing on an objection constitutes a waiver of the right to a hearing on that objection.
  - (5) Each objection for which a hearing is requested includes a detailed description and analysis of the factual information to be presented in support of the objection. Failure to include a description and analysis for an objection constitutes a waiver of the right to a hearing on that objection. The description and analysis may be used only for the purpose of determining whether a hearing has been justified under [§ 12.24](/cfr/21/12.24.md), and do not limit the evidence that may be presented if a hearing is granted.
    - (i) A copy of any report, article, survey, or other written document relied upon must be submitted, except if the document is—

      (a) An FDA document that is routinely publicly available; or

      (b) A recognized medical or scientific textbook that is readily available to the agency.

    - (ii) A summary of the nondocumentary testimony to be presented by any witnesses relied upon must be submitted.
- (b) Requests for hearing submitted under [§ 12.21](/cfr/21/12.21.md) will be submitted to the Dockets Management Staff and will be accepted for filing if they meet the following conditions:
  - (1) They are submitted on or before the 30th day after the date of publication of the notice of opportunity for hearing.
  - (2) They comply with §§ [314.200](/cfr/21/314.200.md), [514.200](/cfr/21/514.200.md), or [601.7(a)](/cfr/21/601.7.md?p=a).
- (c) If an objection or request for a public hearing fails to meet the requirements of this section and the deficiency becomes known to the Dockets Management Staff, the Dockets Management Staff shall return it with a copy of the applicable regulations, indicating those provisions not complied with. A deficient objection or request for a hearing may be supplemented and subsequently filed if submitted within the 30-day time period specified in [§ 12.20(e)](/cfr/21/12.20.md?p=e) or [§ 12.21(b)](/cfr/21/12.21.md?p=b).
- (d) If another person objects to a regulation issued in response to a petition submitted under [§ 12.20(a)(2)](/cfr/21/12.20.md?p=a-2), the petitioner may submit a written reply to the Dockets Management Staff.

## Notes

### Amendments

[44 FR 22339, Apr. 13, 1979, as amended at 54 FR 9035, Mar. 3, 1989; 64 FR 69190, Dec. 10, 1999]

### 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 54 FR 9035, Mar. 3, 1989; 64 FR 69190, Dec. 10, 1999]