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OMB Control No: 0910-0667	ICR Reference No: 202509-0910-003
Status: Received in OIRA	Previous ICR Reference No: 202202-0910-019
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Current Good Manufacturing Practices for Positron Emission Tomography (PET) Drugs
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: 12/30/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2026
Responses	197,698	184,847
Time Burden (Hours)	98,916	84,568
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	197,698	184,847	12,851
Annual Time Burden (Hours)	98,916	84,568	14,348
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: Our estimated burden for the information collection reflects an overall increase of 14,348 hours and 12,851 records annually. We attribute this adjustment to a corresponding increase in new facility registrations.

Annual Cost to Federal Government: $594,864

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: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

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