[IRA Collection] Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)

Forms and Documents

Document Name	Status
CMS-10110_Supporting_Statement_A_(2025 version_16).docx Supporting Statement A	2026-01-08

IC Document Collections

IC ID	Document Title	Status
8767	Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) Instruction	Modified

ICR Details

OMB Control No: 0938-0921	ICR Reference No: 202512-0938-022
Status: Received in OIRA	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	Date Submitted to OIRA: 01/08/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2027
Responses	3,000	2,000
Time Burden (Hours)	38,500	26,000
Cost Burden (Dollars)	0	0

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Abstract: Section 1847A of the Social Security Act requires that the Medicare Part B payment amounts for covered drugs and biologicals not paid on a cost or prospective payment basis be based upon manufacturers’ average sales price data submitted quarterly to the Centers for Medicare & Medicaid Services (CMS). The reporting requirements are specified in 42 CFR part 414, subpart J.

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Authorizing Statute(s): US Code: 42 USC 1395u(o)
   US Code: 42 USC 1395(a)(1)(S)
   US Code: 42 USC 1395w-3
   PL: Pub.L. 108 - 17 303 Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003
   Statute at Large: 18 Stat. 1847
   Statute at Large: 19 Stat. 1927
   US Code: 42 USC 1395w–3a
   PL: Pub.L. 117 - 169 11001 Name of Law: The Inflation Reduction Act
  

Citations for New Statutory Requirements: PL: Pub.L. 117 - 169 11101 Name of Law: The Inflation Reduction Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AV50	Final or interim final rulemaking	90 FR 49266	11/05/2025

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 32352	07/16/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 49266	11/05/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)	CMS-10110, CMS-10110, CMS-10110, CMS-10110	Financial Data Template ,   Product Data Template ,   Reasonable Assumptions Form ,   Bona Fide Service Fee Certification Form

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	3,000	2,000	0	1,000	0	0
Annual Time Burden (Hours)	38,500	26,000	0	12,500	0	0
Annual Cost Burden (Dollars)	0	0	0	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

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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

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 01/08/2026

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