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View ICR - OIRA Conclusion

OMB Control No: 0938-0921	ICR Reference No: 202512-0938-022
Status: Active	Previous ICR Reference No: 202405-0938-015
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-FFS
Title: [IRA Collection] Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/11/2026
	Date Received in OIRA: 01/08/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2029	36 Months From Approved	07/31/2027
Responses	3,000	0	2,000
Time Burden (Hours)	38,500	0	26,000
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	3,000	2,000	1,000
Annual Time Burden (Hours)	38,500	26,000	12,500
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 revisions in this iteration are associated with our November 5, 2025 (90 FR 49266) CY 2026 Physician Fee Schedule (PFS) final rule (CMS-1832-F, OMB 0938-AV50). Other changes are based on internal review (plus 1 hr for the certifier to log into the system, review the data, and certify the data and maximize burden by including all possible voluntary reporters). This iteration revises the following user guides: • Medicare Part B Average Sales Price (ASP) Module Submitter User Guide • Medicare Part B Average Sales Price (ASP) Module Certifier User Guide • Medicare Part B Average Sales Price (ASP) Module Registration User Guide This iteration also adds the following user forms: • Reasonable Assumptions Form • Bona Fide Service Fee Certification Form

Annual Cost to Federal Government: $2,239,300

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: Mitch Bryman 410 786-5258 Mitch.Bryman@cms.hhs.gov

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