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OMB Control No: 0925-0600	ICR Reference No: 202601-0925-001
Status: Received in OIRA	Previous ICR Reference No: 202209-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No: 19222
Title: The Clinical Trials Reporting Program (CTRP) Database (NCI)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 04/01/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	24,000	0
Time Burden (Hours)	18,000	0
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Change Due to Agency Discretion	Change Due to Potential Violation of the PRA
Annual Number of Responses	24,000	-3,000	27,000
Annual Time Burden (Hours)	18,000	0	18,000
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: Yes

Burden Reduction Due to: Changing Forms

Short Statement: This is a Reinstatement With Change with several notable changes listed in A.15 of the Supporting Statement A.

Annual Cost to Federal Government: $6,412,305

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. Yes

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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