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OMB Control No: 0910-0738	ICR Reference No: 202508-0910-001
Status: Received in OIRA	Previous ICR Reference No: 202208-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Center for Devices and Radiological Health Appeals Processes
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: 12/04/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	75	0
Time Burden (Hours)	600	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	75	40	35
Annual Time Burden (Hours)	600	320	280
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 320 hours and a corresponding increase of 40 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years.

Annual Cost to Federal Government: $181,136

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