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View ICR - OIRA Conclusion

OMB Control No: 0910-0800	ICR Reference No: 202603-0910-014
Status: Active	Previous ICR Reference No: 202210-0910-015
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/21/2026
	Date Received in OIRA: 03/27/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2029	36 Months From Approved	05/31/2026
Responses	17,191	0	17,191
Time Burden (Hours)	8,960	0	8,944
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	17,191	17,191	0
Annual Time Burden (Hours)	8,960	8,944	16
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: While we have retained our currently approved burden estimates, we have corrected several inadvertent errors. We added more precision to the number of responses per respondent figures in rows 3 and 6; corrected the average burden per response in row 6 (from 0.2 to 0.025 hour (1.5 mins.)); and corrected the total hours calculation in rows 3, 6, and 7. Due to these corrections, we have adjusted our total burden estimate upward by 16 hours (from 8,944 to 8,960) annually.

Annual Cost to Federal Government: $1,513,211

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: Anne Taylor 240 402-5683 anne.taylor@fda.hhs.gov

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