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OMB Control No: 0910-0458	ICR Reference No: 202606-0910-004
Status: Received in OIRA	Previous ICR Reference No: 202301-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 09/21/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	17,818	0
Time Burden (Hours)	34,191	0
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	17,818	2,642	15,176
Annual Time Burden (Hours)	34,191	4,612	29,579
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: Our estimated burden for the information collection reflects an overall increase of approximately 4,612 hours and a corresponding increase of 2,642 responses. We attribute this adjustment to an increase in the number of product deviations we received in FY 2024 from licensed manufacturers, unlicensed registered blood establishments and transfusion services under § 606.171.

Annual Cost to Federal Government: $285,460

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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