# 21 CFR § 16.26: Denial of hearing and summary decision

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-16.26

## Section

- **Citation:** 21 CFR § 16.26
- **Heading:** Denial of hearing and summary decision
- **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 16—REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION > Subpart B—Initiation of Proceedings

## Text

(a) A request for a hearing may be denied, in whole or in part, if the Commissioner or the FDA official to whom authority is delegated to make the final decision on the matter determines that no genuine and substantial issue of fact has been raised by the material submitted. If the Commissioner or his or her delegate determines that a hearing is not justified, written notice of the determination will be given to the parties explaining the reason for denial.
(b) After a hearing commences, the presiding officer may issue a summary decision on any issue in the hearing if the presiding officer determines from the material submitted in connection with the hearing, or from matters officially noticed, that there is no genuine and substantial issue of fact respecting that issue. For the purpose of this paragraph, a hearing commences upon the receipt by FDA of a request for hearing submitted under § 16.22(b).
(c) The Commissioner or his or her delegate may review any summary decision of the presiding officer issued under paragraph (b) of this section at the request of a party or on the Commissioner's or his or her delegate's own initiative.
[53 FR 4615, Feb. 17, 1988, as amended at 69 FR 17290, Apr. 2, 2004]

## Nearby sections

- [21 CFR § 16.1 § 16.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.1.md)
- [21 CFR § 16.5 § 16.5 Inapplicability and limited applicability.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.5.md)
- [21 CFR § 16.22 § 16.22 Initiation of regulatory hearing.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.22.md)
- [21 CFR § 16.24 § 16.24 Regulatory hearing required by the act or a regulation.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.24.md)
- [21 CFR § 16.26 § 16.26 Denial of hearing and summary decision.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.26.md)
- [21 CFR § 16.40 § 16.40 Commissioner.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.40.md)
- [21 CFR § 16.42 § 16.42 Presiding officer.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.42.md)
- [21 CFR § 16.44 § 16.44 Communication to presiding officer and Commissioner.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.44.md)
- [21 CFR § 16.60 § 16.60 Hearing procedure.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.60.md)
- [21 CFR § 16.62 § 16.62 Right to counsel.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.62.md)
- [21 CFR § 16.80 § 16.80 Administrative record of a regulatory hearing.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.80.md)
- [21 CFR § 16.85 § 16.85 Examination of administrative record.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.85.md)
- [21 CFR § 16.95 § 16.95 Administrative decision and record for decision.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.95.md)
- [21 CFR § 16.119 § 16.119 Reconsideration and stay of action.](https://www.frixlaw.com/law-library/statutes/ecfr-21-16.119.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-16.26. Check the current official text before relying on it. Not legal advice.