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View ICR - OIRA Conclusion

OMB Control No: 0938-0921	ICR Reference No: 202604-0938-003
Status: Historical Active	Previous ICR Reference No: 202603-0938-006
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: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/17/2026
	Date Received in OIRA: 04/07/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2029	36 Months From Approved	02/28/2029
Responses	4,500	0	3,000
Time Burden (Hours)	49,500	0	38,500
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	4,500	3,000	1,500
Annual Time Burden (Hours)	49,500	38,500	11,000
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: 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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