View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0120	ICR Reference No: 202611-0910-002
Status: Active	Previous ICR Reference No: 202508-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Premarket Notification Submission 510(k), Subpart E
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: 11/06/2026
	Date Received in OIRA: 11/06/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2029	09/30/2029	09/30/2029
Responses	16,300	0	16,300
Time Burden (Hours)	469,688	0	469,688
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	16,300	16,300
Annual Time Burden (Hours)	469,688	469,688
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 increase of 146,309 hours and an increase of 3,630 responses. A significant driver of the overall burden increase is the growth in 510(k) submissions, which has risen from approximately 100 to 3,800 submissions annually. This submission corrects the burden inventory to reflect burden changes that were previously approved but were inadvertently not carried forward during the 2023 non-substantive change request that consolidated OMB Control No. 0910-0850 into this information collection. Specifically, this submission incorporates the burden previously approved under OMB Control No. 0910-0850. In addition, we have made nominal adjustments to individual provisions to reflect expected fluctuations in submission volumes.

Annual Cost to Federal Government: $90,930,272

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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