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OMB Control No: 0910-0120	ICR Reference No: 202508-0910-002
Status: Received in OIRA	Previous ICR Reference No: 202308-0910-018
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Premarket Notification Submission 510(k), Subpart E
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: 07/30/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2026
Responses	16,300	12,670
Time Burden (Hours)	469,688	323,379
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	16,300	12,670	3,630
Annual Time Burden (Hours)	469,688	323,379	146,309
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 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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