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OMB Control No: 0910-0922	ICR Reference No: 202609-0910-008
Status: Received in OIRA	Previous ICR Reference No: 202307-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Devices--Voluntary Improvement Program
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: 10/02/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	604	0
Time Burden (Hours)	6,056	0
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Change Due to Adjustment in Estimate
Annual Number of Responses	604	604
Annual Time Burden (Hours)	6,056	6,056
Annual Cost Burden (Dollars)	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 decrease of 2,009 hours and a corresponding decrease of 200 responses. We attribute this adjustment based on our device registration and listing data and informal feedback from stakeholders. ROCIS reflects an increase in burden hours; however, this increase is not the result of any change to the information collection. Rather, it stems from the collection having been discontinued and FDA's current request for reinstatement of the previously approved collection.

Annual Cost to Federal Government: $76,388

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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