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View ICR - OIRA Conclusion

OMB Control No: 0910-0858	ICR Reference No: 202405-0910-002
Status: Active	Previous ICR Reference No: 202107-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Human Drug Compounding, Repackaging, and Related Activities Regarding 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 with change	Conclusion Date: 04/30/2025
	Date Received in OIRA: 09/24/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2028	36 Months From Approved	04/30/2025
Responses	2,217	0	2,123
Time Burden (Hours)	1,082	0	968
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	2,217	2,123	94
Annual Time Burden (Hours)	1,082	968	114
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: The burden estimate is adjusted to reflect a resulting increase of 114 hours and 94 responses annually.

Annual Cost to Federal Government: $27,500

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: Rachel Showalter 202 693-2146 Showalter.Rachel@dol.gov

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