[IRA] 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_(CMS-1832-P_version_5)_clean.docx Supporting Statement A	2025-09-12

IC Document Collections

IC ID	Document Title	Status
8767	Manufacturers to Report Drug Pricing Information for Part B (§§ 414.802 and 414.902) Instruction	Modified
277540	Average Sales Price: Price Concessions and Bona Fide Service Fees (§§ 414.802 and 414.804)	New

ICR Details

OMB Control No: 0938-0921	ICR Reference No: 202508-0938-003
Status: Received in OIRA	Previous ICR Reference No: 202405-0938-015
Agency/Subagency: HHS/CMS	Agency Tracking No: CM-FFS
Title: [IRA] 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: 11/13/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	07/31/2027
Responses	2,610	2,000
Time Burden (Hours)	33,495	26,000
Cost Burden (Dollars)	0	0

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Abstract: In accordance with Section 1847A of the Social Security Act (the Act), Medicare Part B covered drugs and biologicals not paid on a cost or prospective payment basis are paid based on the manufacturers’ average sales price (ASP) data submitted to the Centers for Medicare & Medicaid Services (CMS). The reporting requirements are specified in 42 CFR Part 414 Subpart J. In the Calendar Year (CY) 2005 IFC, we published information about the ASP reporting requirements for Medicare Part B drugs and biologicals (66 FR 17935) and specified that manufacturers must report the ASP data using our Addendum A template. CMS migrated the submission of ASP data and signatures to an internet-based automated system in July 2020. The data that is being collected has not changed. As part of an ASP modernization effort, the data collection system has been modified and enhanced to improve the design and flow through the use of Human-Centered Design best practices. These modifications include changes to the design and function of the data collection system, the addition of new data fields, and revisions to the product and financial data templates. The field “Marketing Start Date” is being added so that the user can input the marketing date for the drug. The marketing date of the drug is used to determine how the payment will be calculated and to assign the benchmark quarter used to calculate inflation adjusted coinsurance and rebates per IRA 11101.

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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	Proposed rulemaking	90 FR 32352	07/16/2025

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

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Average Sales Price: Price Concessions and Bona Fide Service Fees (§§ 414.802 and 414.804)
Manufacturers to Report Drug Pricing Information for Part B (§§ 414.802 and 414.902)	CMS-10110, CMS-10110	Financial Data Template ,   Product Data Template

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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	2,610	2,000	0	610	0	0
Annual Time Burden (Hours)	33,495	26,000	0	7,495	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Our CY 2026 PFS NPRM (CMS-1832-P, OMB 0938-AV50) published in the Federal Register on July 16, 2025 (90 FR 32352). Overall, the rule would increase our active burden estimates by 610 responses and 7,495 hours.

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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: 11/13/2025

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