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OMB Control No: 0910-0053	ICR Reference No: 202607-0910-008
Status: Received in OIRA	Previous ICR Reference No: 202212-0910-016
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Radioactive Drug Research Committees
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 07/28/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2026
Responses	933	1,030
Time Burden (Hours)	3,637	3,689
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	933	1,030	-97
Annual Time Burden (Hours)	3,637	3,689	-52
Annual Cost Burden (Dollars)	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: Our estimated burden for the information collection reflects an overall decrease of 52 hours and a corresponding decrease of 97 responses. This is attributed to the Agency receiving fewer submissions over the last few years due to decreased subject enrollment during the pandemic.

Annual Cost to Federal Government: $119,318

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. No

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: Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

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