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View ICR - OIRA Conclusion

OMB Control No: 0910-0827	ICR Reference No: 201911-0910-001
Status: Historical Active	Previous ICR Reference No: 201610-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 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: 11/26/2019
	Date Received in OIRA: 11/04/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2022	36 Months From Approved	12/31/2019
Responses	230	0	36,302
Time Burden (Hours)	230	0	36,302
Cost Burden (Dollars)	4,638,542	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	230	36,302	-36,072
Annual Time Burden (Hours)	230	36,302	-36,072
Annual Cost Burden (Dollars)	4,638,542	0	4,638,542

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: We have reduced our estimate by 36,150 hours and 36,072 responses. Upon evaluation we find that our original projections were higher than what we have realized in reports over the past three years.

Annual Cost to Federal Government: $142,500

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? Uncollected

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

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