View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0938-1250	ICR Reference No: 202512-0938-020
Status: Active	Previous ICR Reference No: 202207-0938-010
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Medicare Coverage of Items and Services in FDA Investigational Device Exemption Clinical Studies--Revision of Medicare Coverage (CMS-10511)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/17/2026
	Date Received in OIRA: 12/30/2025
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2029	36 Months From Approved	07/31/2026
Responses	118	0	116
Time Burden (Hours)	236	0	232
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	118	116	2
Annual Time Burden (Hours)	236	232	4
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The number of responses increased from 116 to 118. The burden hours increased from 232 to 236.

Annual Cost to Federal Government: $367,160

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. No

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: Denise King 410 786-1013 Denise.King@cms.hhs.gov

Something went wrong when downloading this file. If you have any questions, please send an email to risc@gsa.gov.