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View ICR - OIRA Conclusion

OMB Control No: 0910-0116	ICR Reference No: 202308-0910-020
Status: Active	Previous ICR Reference No: 202307-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Current Good Manufacturing Practices for Blood and Related Regulations for and Blood Components; and Requirements for Donor Testing, Donor Notification, and "Lookback"
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: 10/04/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/30/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2026	36 Months From Approved	08/31/2026
Responses	4,455,597	0	4,455,497
Time Burden (Hours)	583,874	0	583,474
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	4,455,597	4,455,497	100
Annual Time Burden (Hours)	583,874	583,474	400
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Short Statement: We have revised the information collection to add the draft guidance for industry entitled “Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements” as discussed at Question-1 and we have made nominal adjustments in burden as enumerated in Question-12a. The result is an increase of 100 responses and 400 hours annually to the information collection.

Annual Cost to Federal Government: $2,836,116

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