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OMB Control No: 0910-0449	ICR Reference No: 202505-0910-005
Status: Received in OIRA	Previous ICR Reference No: 202203-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Postmarket Surveillance of Medical Devices
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: 12/23/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2026
Responses	131	86
Time Burden (Hours)	5,073	3,183
Cost Burden (Dollars)	0	0

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	131	86	45
Annual Time Burden (Hours)	5,073	3,183	1,890
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 increase of 1,890 total burden hours and a corresponding increase 45 total annual responses. This increase is based on internal FDA tracking data. The number of respondents varies annually, subject to the number of original plans, plan changes, and interim and final reports (which are dependent on enrollment progress for each study) received by FDA.

Annual Cost to Federal Government: $1,046,166

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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