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View ICR - OIRA Conclusion

OMB Control No: 0938-0921	ICR Reference No: 202606-0938-018
Status: Active	Previous ICR Reference No: 202604-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-OM
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/26/2026
	Date Received in OIRA: 06/25/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2029	06/30/2029	06/30/2029
Responses	4,500	0	4,500
Time Burden (Hours)	49,500	0	49,500
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	4,500	4,500
Annual Time Burden (Hours)	49,500	49,500
Annual Cost Burden (Dollars)	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 proposed changes account for additional burden for a secretary/administrative assistant to follow up with fee recipients and monitor certification amendments. We also identified that we should account for new burden and include legal/compliance review. We also revised our Bona Fide Service Fee Certification form. Overall, this iteration proposes to add 1,500 responses and 11,000 hours.

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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