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OMB Control No: 0910-0625	ICR Reference No: 202505-0910-006
Status: Received in OIRA	Previous ICR Reference No: 202206-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Electronic Submission of Medical Device Registration and Listing
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: 08/29/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	186,249	220,775
Time Burden (Hours)	96,195	113,832
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	186,249	220,775	-34,526
Annual Time Burden (Hours)	96,195	113,832	-17,637
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 decrease of 17,637 hours and a corresponding decrease of 34,526 responses/records. We attribute this adjustment to a decrease in the number of submissions we received over the last approval period.

Annual Cost to Federal Government: $724,544

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