# 42 C.F.R. § 11.62 (2026): What requirements apply to applicable clinical trials for which submission of clinical trial information has been determined by the Director to be necessary to protect the public health?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T42_P11_S11_62

## Section

- **Citation:** 42 C.F.R. § 11.62 (2026)
- **Heading:** What requirements apply to applicable clinical trials for which submission of clinical trial information has been determined by the Director to be necessary to protect the public health?
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 42 CFR: Public Health / Chapter I: PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 11: CLINICAL TRIALS REGISTRATION AND RESULTS INFORMATION SUBMISSION / Subpart D: Additional Submission of Clinical Trial Information / § 11.62: § 11.62   What requirements apply to applicable clinical trials for which submission of clinical trial information has been determined by the Director to be necessary to protect the public health?

## Text

(a) A responsible party who receives notification that the Director has determined that posting of clinical trial information for an applicable clinical trial described in paragraph (b) of this section is necessary to protect the public health must submit clinical trial information as specified in paragraph (c) of this section.
(b) An applicable clinical trial subject to this section must be either:
(1) An applicable clinical trial of an approved, licensed, or cleared drug product (including a biological product) or device product that has a primary completion date on or after September 27, 1997; or
(2) An applicable clinical trial that is subject to registration under § 11.22(a) and studies a drug product (including a biological product) or device product that is unapproved, unlicensed, or uncleared, regardless of whether approval, licensure, or clearance was, is, or will be sought, and that is not otherwise subject to results information submission in accordance with the regulation.
(c) Deadline for submission of clinical trial information:
(1)
General.
Except as provided in paragraphs (c)(2) and (c)(3) of this section, a responsible party for an applicable clinical trial that is subject to this section must submit the clinical trial registration information specified in § 11.28(a) and the clinical trial results information specified in § 11.48(a) not later than 30 calendar days after the submission date specified in the notification described in paragraph (a) of this section.
(2)
Exception.
If a responsible party submits a certification consistent with § 11.44(b) or (c) not later than 30 calendar days after the submission date specified in the notification described in paragraph (a) of this section, the responsible party must submit the clinical trial results information specified in § 11.48(a) not later than the deadline specified in § 11.44(b) or (c), as applicable.
(2)
Exception.
If a responsible party submits a certification consistent with § 11.44(b) or (c) not later than 30 calendar days after the submission date specified in the notification described in paragraph (a) of this section, the responsible party must submit the clinical trial results information specified in § 11.48(a) not later than the deadline specified in § 11.44(b) or (c), as applicable.
(3) If a responsible party submitted clinical trial registration information describing the applicable clinical trial specified in the notification described in paragraph (a) of this section prior to the date on which the notification is sent to the responsible party, the responsible party must update such clinical trial information to reflect changes, if any, in the applicable clinical trial not later than 30 calendar days after the submission date specified in the notification described in paragraph (a) of this section, irrespective of the deadline for updates specified in § 11.64.

## Nearby sections

- [42 C.F.R. § 11.60 (2026) § 11.60   What requirements apply to the voluntary submission of clinical trial information for clinical trials of FDA-regulated drug products (including biological products) and device products?](https://www.frixlaw.com/law-library/statutes/CFR_T42_P11_S11_60.md)
- [42 C.F.R. § 11.62 (2026) § 11.62   What requirements apply to applicable clinical trials for which submission of clinical trial information has been determined by the Director to be necessary to protect the public health?](https://www.frixlaw.com/law-library/statutes/CFR_T42_P11_S11_62.md)
- [42 C.F.R. § 11.64 (2026) § 11.64   When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected?](https://www.frixlaw.com/law-library/statutes/CFR_T42_P11_S11_64.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T42_P11_S11_62. Check the current official text before relying on it. Not legal advice.