# 21 CFR § 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

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-10.31

## Section

- **Citation:** 21 CFR § 10.31
- **Heading:** Citizen petitions and petitions for stay of action related to abbreviated new drug applications, certain new drug applications, or certain biologics license applications
- **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

(a) Applicability. This section applies to a citizen petition or petition for stay of action that meets all of the following criteria:
(1) The petition requests that the Commissioner take any form of action that could, if taken, delay approval of an abbreviated new drug application submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act, a new drug application submitted through the pathway described by section 505(b)(2) of the Federal, Food, Drug and Cosmetic Act, or a biologics license application submitted under section 351(k) of the Public Health Service Act.
(2) The petition is submitted on or after September 27, 2007.
(3) The petition is submitted in writing and under § 10.30 (for citizen petitions) or § 10.35 (for petitions for stay of action).
(b) Date of submission. A petition subject to this section and submitted in accordance with § 10.20, § 10.30, § 10.31, or § 10.35 is regarded as submitted on the date on which the petition is received by the Dockets Management Staff.
(c) Certification. (1) FDA will not consider for review a petition that is subject to this section unless the petition is in writing and contains the following certification:
(2) The certification in paragraph (c)(1) of this section must contain one or more specific dates (month, day, and year) in the first blank space provided. If different categories of information become known at different times, the certification must contain each estimated relevant date. The information associated with a particular date must be identified.
(d) Verification. (1) FDA will not accept for review any supplemental information or comments on a petition that is subject to this section unless the supplemental information or comments are in writing and contain the following verification:
(2) The verification in paragraph (d)(1) of this section must contain one or more specific dates (month, day, and year) in the first blank space provided. If different categories of information become known at different times, the verification must contain each estimated relevant date. The information associated with a particular date must be identified.
[81 FR 78506, Nov. 8, 2016]

## 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)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-10.31. Check the current official text before relying on it. Not legal advice.