View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0925-0586	ICR Reference No: 202512-0925-004
Status: Active	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
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/01/2026
	Date Received in OIRA: 02/20/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2029	36 Months From Approved	04/30/2026
Responses	323,878	0	271,122
Time Burden (Hours)	1,411,181	0	1,219,801
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	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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