# Submission for OMB Review; 30-Day Comment Request; The Clinical Trials Reporting Program (CTRP) Database (NCI)
**AGENCY:**
National Institutes of Health, HHS.
**ACTION:**
Notice.
**SUMMARY:**
In compliance with 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.
**DATES:**
Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
**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: Gisele Sarosy, MD, Coordinating Center for Clinical Trials (CCCT), National Cancer Institute, 9609 Medical Center Drive, 6W134, Rockville, MD 20852 or call non-toll-free number 240-276-6172 or Email your request, including your address to: *[email protected].*
**SUPPLEMENTARY INFORMATION:**
This proposed information collection was previously published in the *Federal Register* on June 29, 2022, page 38765 (Vol. 87, No. 124) and allowed 60 days for public comment. One public comment was 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:* The Clinical Trials Reporting Program (CTRP) Database (NCI), 0925-0600, Expiration Date 10/31/2022—EXTENSION, 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, four 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 | Number of | Average time per response | Total annual |
| --- | --- | --- | --- | --- | --- |
| Initial Registration | Clinical Trials | 3,000 | 1 | 1 | 3,000 |
| Amendment | | 1,500 | 4 | 1 | 6,000 |
| Update | | 1,500 | 4 | 1 | 6,000 |
| Accrual Updates | | 3,000 | 4 | 15/60 | 3,000 |
| Totals | | 9,000 | 27,000 | | 18,000 |
Dated: September 13, 2022.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National Institutes of Health.