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OMB Control No: 0910-0264	ICR Reference No: 202503-0910-004
Status: Received in OIRA	Previous ICR Reference No: 202208-0910-016
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Export of Medical Devices ; Foreign Letters of Approval
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: 09/11/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	36	36
Time Burden (Hours)	72	72
Cost Burden (Dollars)	10,080	9,000

Annual Cost to Federal Government: $348,721

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