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OMB Control No: 0910-0338	ICR Reference No: 202606-0910-003
Status: Received in OIRA	Previous ICR Reference No: 202407-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Biologics License Applications; Procedures & Requirements
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 10/15/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2026
Responses	70,966	73,134
Time Burden (Hours)	860,177	831,044
Cost Burden (Dollars)	0	924

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	70,966	73,134	-2,168
Annual Time Burden (Hours)	860,177	831,044	29,133
Annual Cost Burden (Dollars)	0	924	-924

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:

Annual Cost to Federal Government: $20,830,410

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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