View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0052	ICR Reference No: 202106-0910-001
Status: Historical Active	Previous ICR Reference No: 201804-0910-015
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Blood Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
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: 07/13/2021
	Date Received in OIRA: 06/11/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2024	36 Months From Approved	07/31/2021
Responses	2,966	0	2,952
Time Burden (Hours)	1,496	0	1,496
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	2,966	2,952	14
Annual Time Burden (Hours)	1,496	1,496	0
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 agency adjustments. Based on our evaluation of Fiscal Year 2019 data from CBER’s Blood Establishment Registration and Product Listing system, we have adjusted the currently approved burden estimate to reflect an increase in annual product listing updates by 14 responses annually.

Annual Cost to Federal Government: $148,200

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

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