# 21 CFR § 10.25: Initiation of administrative proceedings

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-10.25

## Section

- **Citation:** 21 CFR § 10.25
- **Heading:** Initiation of administrative proceedings
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER A—GENERAL > PART 10—ADMINISTRATIVE PRACTICES AND PROCEDURES > Subpart B—General Administrative Procedures

## Text

An administrative proceeding may be initiated in the following three ways:
(a) An interested person may petition the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action. A petition must be either:
(1) In the form specified in other applicable FDA regulations, e.g., the form for a color additive petition in § 71.1, for a food additive petition in § 171.1 or § 571.1, for a new drug application in § 314.50, for a request to establish or amend an import tolerance in § 510.205, for a new animal drug application in § 514.1, or
(2) in the form for a citizen petition in § 10.30.
(b) The Commissioner may initiate a proceeding to issue, amend, or revoke a regulation or order or take or refrain from taking any other form of administrative action. FDA has primary jurisdiction to make the initial determination on issues within its statutory mandate, and will request a court to dismiss, or to hold in abeyance its determination of or refer to the agency for administrative determination, any issue which has not previously been determined by the agency or which, if it has previously been determined, the agency concluded should be reconsidered and subject to a new administrative determination. The Commissioner may utilize any of the procedures established in this part in reviewing and making a determination on any matter initiated under this paragraph.
(c) The Commissioner will institute a proceeding to determine whether to issue, amend, or revoke a regulation or order, or take or refrain from taking any other form of administrative action whenever any court, on its own initiative, holds in abeyance or refers any matter to the agency for an administrative determination and the Commissioner concludes that an administrative determination is feasible within agency priorities and resources.
[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989; 86 FR 52409, Sept. 21, 2021]

## Nearby sections

- [21 CFR § 10.1 § 10.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.1.md)
- [21 CFR § 10.3 § 10.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.3.md)
- [21 CFR § 10.10 § 10.10 Summaries of administrative practices and procedures.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.10.md)
- [21 CFR § 10.19 § 10.19 Waiver, suspension, or modification of procedural requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.19.md)
- [21 CFR § 10.20 § 10.20 Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.20.md)
- [21 CFR § 10.25 § 10.25 Initiation of administrative proceedings.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.25.md)
- [21 CFR § 10.30 § 10.30 Citizen petition.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.30.md)
- [21 CFR § 10.31 § 10.31 Citizen petitions and petitions for stay of action related to abbreviated new drug applications, certain new drug applications, or certain biologics license applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.31.md)
- [21 CFR § 10.33 § 10.33 Administrative reconsideration of action.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.33.md)
- [21 CFR § 10.35 § 10.35 Administrative stay of action.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.35.md)
- [21 CFR § 10.40 § 10.40 Promulgation of regulations for the efficient enforcement of the law.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.40.md)
- [21 CFR § 10.45 § 10.45 Court review of final administrative action; exhaustion of administrative remedies.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.45.md)
- [21 CFR § 10.50 § 10.50 Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.50.md)
- [21 CFR § 10.55 § 10.55 Separation of functions; ex parte communications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-10.55.md)

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-10.25. Check the current official text before relying on it. Not legal advice.