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Priority review Notice Amended Consultation

Proposed 30-Day Comment Request: Clinical Trials Reporting Program Database

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Published March 27th, 2026
Detected March 27th, 2026
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Summary

The National Institutes of Health (NIH) is seeking public comment on a proposed extension for the Clinical Trials Reporting Program (CTRP) Database. This notice provides an additional 30-day comment period for the data collection project, which aims to consolidate reporting for NCI-supported clinical research.

What changed

The National Institutes of Health (NIH), specifically the National Cancer Institute (NCI), has issued a notice requesting a 30-day public comment period for the Clinical Trials Reporting Program (CTRP) Database. This is a reinstatement with change request for an existing information collection (OMB control number 0925-0600), which was previously published for a 60-day comment period without receiving public input. The CTRP database serves as a central resource for NCI-supported clinical research, allowing for consolidated reporting and data aggregation by clinical research administrators.

Regulated entities, particularly those involved in NCI-supported clinical research, should review the proposed data collection and submit comments by April 27, 2026, to ensure their feedback is considered. The NIH is seeking OMB approval for a three-year period for this information collection. While no specific compliance deadline is mentioned for entities to act, the comment period deadline is critical for those wishing to influence the data collection process.

What to do next

  1. Submit comments on the proposed data collection by April 27, 2026.

Source document (simplified)

Notice

Proposed Collection: 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI)

A Notice by the National Institutes of Health on 03/27/2026

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  • Public Inspection Published Document: 2026-05937 (91 FR 14861) Document Headings ###### Department of Health and Human Services
National Institutes of Health

AGENCY:

National Institutes of Health, HHS.

ACTION:

Notice.

SUMMARY:

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Institutes of Health, National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

DATES:

Comments regarding this information collection are best assured of having their full effect if received by April 27, 2026.

ADDRESSES:

Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Melissa Park, PRA Liaison, Office of Management Policy and Compliance, National Cancer Institute, 9609 Medical Center Drive, Room 2E196, Bethesda, MD 20892 or call non-toll-free number (240) 276-5717 or email your request, including your address to: melissa.park@nih.gov. Formal requests for additional plans and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION:

This proposed information collection was previously published in the Federal Register on December 23, 2025 (Vol. 90, No. 244, FR 60112) and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

Proposed Collection Title: The Clinical Trials Reporting Program (CTRP) Database, 0925-0600, Expiration Date 02/28/2026-REINSTATEMENT WITH CHANGE, National Cancer Institute (NCI), National Institutes of Health (NIH).

Need and Use of Information Collection: The Clinical Trials Reporting Program (CTRP) is an electronic resource that serves as a single, definitive source of information about all NCI-supported clinical research. This resource allows the NCI to consolidate reporting, aggregate data, and reduce redundant submissions. Clinical research administrators submit information as designees of clinical investigators who conduct NCI-supported clinical research. The designees can electronically access the CTRP website to complete the initial trial registration. After registration, three amendments and four study subject accrual updates occur per trial annually.

OMB approval is requested for three years. There are no costs to respondents other than their time. The estimated annualized burden hours are 18,000.

| Form name | Type of respondents | Number of
respondents | Number of
responses per
respondent | Average
time per
response
(in hours) | Total annual burden hours |
| --- | --- | --- | --- | --- | --- |
| Initial Trial Registration | Individuals | 3,000 | 1 | 1 | 3,000 |
| Trial Registration Update | | 1,500 | 3 | 1 | 4,500 |
| Trial Registration Amendment | | 1,500 | 3 | 1 | 4,500 |
| Accrual Updates | | 3,000 | 4 | 30/60 | 6,000 |
| Totals | | 9,000 | 24,000 | | 18,000 |
Dated: March 24, 2026.

Melissa M. Park,

Project Clearance Liaison, National Cancer Institute, National Institutes of Health.

[FR Doc. 2026-05937 Filed 3-26-26; 8:45 am]

BILLING CODE 4140-01-P

Published Document: 2026-05937 (91 FR 14861)

Named provisions

Proposed Collection: 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI)

Classification

Agency
Health and Human Services Department
Published
March 27th, 2026
Comment period closes
April 27th, 2026 (30 days)
Instrument
Notice
Legal weight
Non-binding
Stage
Consultation
Change scope
Minor
Document ID
91 FR 14861
Supersedes
Federal Register on December 23, 2025 (Vol. 90, No. 244, FR 60112)

Who this affects

Applies to
Healthcare providers
Industry sector
6211 Healthcare Providers 3254 Pharmaceutical Manufacturing
Activity scope
Clinical Trial Reporting
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Data Management Research

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