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OMB Control No: 0925-0586	ICR Reference No: 202512-0925-004
Status: Received in OIRA	Previous ICR Reference No: 202302-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Information Program on Clinical Trials: Maintaining a Registry and Results Databank (NLM)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 02/20/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2026
Responses	323,878	271,122
Time Burden (Hours)	1,411,181	1,219,801
Cost Burden (Dollars)	0	0

Abstract: This is a revision of a previously approved submission. The National Library of Medicine (NLM) operates the ClinicalTrials.gov website under the authority of the Director of the National Institutes of Health (NIH). ClinicalTrials.gov supports the collection of Clinical Trial Registration and Results Information necessary to implement statutory requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) and regulatory requirements at 42 Code of Federal Regulations (CFR) Part 11. Information collection at ClinicalTrials.gov also serves as a means of enhancing enrollment or complying with policies of federal agencies and other organizations. Information is collected via electronic submission to the ClinicalTrials.gov Protocol Registration and Results System (PRS). The information in the databank is publicly available. It is intended to provide current and reliable information on the broadest possible scale to members of the public, including patients, physicians, and researchers, about the existence, nature, enrollment status, location, eligibility criteria, sponsorship, progress, and outcomes of clinical trials.

Authorizing Statute(s): US Code: 42 USC 282(j) Name of Law: Expanded Clinical Trial Registry Databank
   US Code: 42 USC 282(i) Name of Law: None
   PL: Pub.L. 110 - 85 801 Name of Law: FDA Act of 2007
   PL: Pub.L. 105 - 115 113 Name of Law: FDAMA

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 54340	11/26/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 8012	02/19/2026
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	323,878	271,122	52,756
Annual Time Burden (Hours)	1,411,181	1,219,801	191,380
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This submission accounts for the information collection burden associated with the waiver request and appeal process under 42 CFR 11.54. This information is currently collected via e-mail and is anticipated to be implemented within the PRS in the future. During the past three years, no changes were made to information collection in the clinical trials registry under 42 CFR 11.28(a)(2), (b)(2), and (c); the PRS Account Application Form; and clinical trials results database under 42 CFR 11.48(a). Since information collection was determined to be consistent with Executive Order 14168 and 42 CFR Part 11, changes were not considered necessary.

Annual Cost to Federal Government: $17,090,270

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Mikia Currie 3014350941

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