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View ICR - OIRA Conclusion

OMB Control No: 0910-0756	ICR Reference No: 202505-0910-013
Status: Active	Previous ICR Reference No: 202212-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/21/2026
	Date Received in OIRA: 02/27/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2029	36 Months From Approved	05/31/2026
Responses	8,265	0	3,730
Time Burden (Hours)	864,418	0	406,438
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	8,265	3,730	4,535
Annual Time Burden (Hours)	864,418	406,438	457,980
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: Based on our experience with the Q-Submission and Early Payor Feedback Request Programs and Medical Device Development Tools, our estimated burden for the information collection reflects an overall increase of 457,980 hours and 4,535 responses annually. We attribute this adjustment to an increase in the number of respondents according to FDA data.

Annual Cost to Federal Government: $32,604,480

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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