View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0776	ICR Reference No: 202011-0910-001
Status: Historical Active	Previous ICR Reference No: 201710-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Registration of Human Drug Compounding Outsourcing Facilities under section 503B of the FFDCA and Associated fees under section 744K
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/30/2020
	Date Received in OIRA: 11/27/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2023	36 Months From Approved	12/31/2020
Responses	116	0	109
Time Burden (Hours)	429	0	425
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	116	109	7
Annual Time Burden (Hours)	429	425	4
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 information collection reflects changes and adjustments. We have consolidated activity pertaining to the assessment of fees established under 0910-0777 into this collection established for registration of the outsourcing facilities that incur those fees. We have also adjusted the number of respondents to the collection consistent with submissions received since last review of the information collection.

Annual Cost to Federal Government: $208,103

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

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