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View ICR - OIRA Conclusion

OMB Control No: 0910-0332	ICR Reference No: 202505-0910-007
Status: Active	Previous ICR Reference No: 202303-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Medical Devices; Humanitarian Use Devices
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/12/2026
	Date Received in OIRA: 12/19/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2029	36 Months From Approved
Responses	323	0	0
Time Burden (Hours)	22,584	0	0
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	323	-63	386
Annual Time Burden (Hours)	22,584	-321	22,905
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 decrease of 321 hours and a corresponding decrease of 63 responses. The total hour burden for this information collection is estimated to be 22,584 hours.

Annual Cost to Federal Government: $9,781,342

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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