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View ICR - OIRA Conclusion

OMB Control No: 0910-0052	ICR Reference No: 202312-0910-001
Status: Active	Previous ICR Reference No: 202106-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
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: 09/18/2024
	Date Received in OIRA: 06/28/2024
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2027	36 Months From Approved	09/30/2024
Responses	2,722	0	2,966
Time Burden (Hours)	1,460	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	2,722	2,966	-244
Annual Time Burden (Hours)	1,460	1,496	-36
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. We have adjusted the currently approved burden estimate we attribute to establishment registration and product listing to reflect a decrease in product listing updates and an increase in the number of initial registrations. Our estimated burden for the information collection reflects an overall decrease of 36 hours.

Annual Cost to Federal Government: $126,949

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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