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OMB Control No: 0910-0308	ICR Reference No: 202403-0910-011
Status: Received in OIRA	Previous ICR Reference No: 202303-0910-016
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Biological Products; General records and postmarket adverse experience reporting
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: 04/26/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	06/30/2024
Responses	1,643,138	715,688
Time Burden (Hours)	12,703,247	5,914,444
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	1,643,138	715,688	927,450
Annual Time Burden (Hours)	12,703,247	5,914,444	6,788,803
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 adjustment. As communicated in Q-12 above, \on March 20, 2023, we requested, and OMB approved, the addition of burden attributable to provisions set forth in part 4, subpart B, previously included in OMB control number 0910–0834. Upon this submission, however, we noted an inadvertent recording overage (+20hrs) and have corrected it with this submission. We have also made adjustment to reporting and recordkeeping associated with biological product AERS based on recent submissions. Cumulatively these adjustments result in annual increase of 927,450 responses and 6,788,803 hours. We attribute to fluctuation to increased reporting during the COVID PHE and the inclusion of postmarketing safety reporting for combination biological products.

Annual Cost to Federal Government: $21,707,968

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