View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0625	ICR Reference No: 202505-0910-006
Status: Active	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
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/08/2026
	Date Received in OIRA: 08/29/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2029	36 Months From Approved	04/30/2026
Responses	196,777	0	220,775
Time Burden (Hours)	95,292	0	113,832
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	196,777	220,775	-23,998
Annual Time Burden (Hours)	95,292	113,832	-18,540
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: ROCIS reflects a decrease in burden; however, the amount shown differs from the actual change because burden figures were erroneously entered in ROCIS during the prior renewal, and there were also calculation errors in the supporting statement. The current submission corrects these issues, and the resulting change reflects both the actual burden adjustment and the correction of those prior errors. Under the previous supporting statement, the estimated annual reporting burden was 63,297 hours and the recordkeeping burden was 39,649 hours, for a combined total of 102,946 hours. In the current period, reporting burden is estimated at 55,643 hours and recordkeeping remains 39,649 hours, for a new combined total of 95,292 hours. The estimated burden for the information collection reflects a decrease of 7,654 hours overall. FDA attributes this adjustment in the number of submissions 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

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