View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0191	ICR Reference No: 202309-0910-006
Status: Active	Previous ICR Reference No: 202305-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: OC
Title: Administrative Practices and Procedures; Formal Hearings
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/18/2023
	Date Received in OIRA: 09/06/2023
Terms of Clearance: Approved with the understanding that FDA will now discontinue the collection of information currently approved under OMB control number 0910-0566.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2026	08/31/2026	08/31/2026
Responses	4,219	0	4,215
Time Burden (Hours)	6,400	0	6,360
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	4,219	4,215	4
Annual Time Burden (Hours)	6,400	6,360	40
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: For efficiency of agency operations, we are requesting to consolidate the related information collection activity and account for burden we attribute to the recommendations for dispute resolution affecting animal drugs or other products that are regulated by Center for Veterinary Medicine (CVM).

Annual Cost to Federal Government: $469,972

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. Yes

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: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

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