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OMB Control No: 0910-0139	ICR Reference No: 202603-0910-002
Status: Received in OIRA	Previous ICR Reference No: 202309-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including API), and AMT Designation
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 05/22/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2026
Responses	1,300,319	1,939,820
Time Burden (Hours)	890,455	1,286,787
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	1,300,319	1,939,820	20	-639,521
Annual Time Burden (Hours)	890,455	1,286,787	200	-396,532
Annual Cost Burden (Dollars)	0	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 a decrease in hours and responses, resulting from removal of burden attributable to information collection for medical gas requirements.

Annual Cost to Federal Government: $72,903,000

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: Kelly Covington 240 402-5661 kelly.covington@fda.hhs.gov

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