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OMB Control No: 0910-0284	ICR Reference No: 202512-0910-008
Status: Received in OIRA	Previous ICR Reference No: 202306-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Adverse Experience/Events with Approved New Animal Drugs
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 05/26/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2026
Responses	264,004	248,888
Time Burden (Hours)	1,936,481	1,914,412
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	264,004	248,888	15,116
Annual Time Burden (Hours)	1,936,481	1,914,412	22,069
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:

Annual Cost to Federal Government: $3,000,000

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: Kelly Covington 240 402-5661 kelly.covington@fda.hhs.gov

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