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View ICR - OIRA Conclusion

OMB Control No: 0910-0883	ICR Reference No: 202505-0910-001
Status: Active	Previous ICR Reference No: 202302-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Obtaining Information to Understand and Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/03/2026
	Date Received in OIRA: 06/18/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2029	36 Months From Approved	03/31/2026
Responses	250	0	600
Time Burden (Hours)	146	0	600
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	250	600	-350
Annual Time Burden (Hours)	146	600	-454
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 454 hours and a corresponding decrease of 350 responses. We revised the survey to improve clarity and simplify the experience for participants. We made grammatical, stylistic, format, and other editorial changes to the content. In doing so, we reduced the number of questions from 31 to 20. We anticipate a reduction in burden hours to 30 minutes (.50 hour) per survey response from our previous estimate of 1 hour per response.

Annual Cost to Federal Government: $11,850

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

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