[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	Type	Status	Availability
Form CMS-10110 Bona Fide Service Fee Certification Form	Form	Modified	Available
Form CMS-10110 Reasonable Assumptions Form	Form	Modified	Available
Form CMS-10110 Product Data Template	Form	Modified	Available
Form CMS-10110 Financial Data Template	Form	Modified	Available
CMS-10110 (0938-0921) Justification of Non-sub Change (2026 version 5).docx	Justification for No Material/Nonsubstantive Change	Uploaded 2026-06-25	Available
Crosswalk of Nonsubstantive Changes - Submitter User Guide.xlsx	Supplementary Document	Uploaded 2026-06-25	Available
DTS-ASP-Submitter-UserGuide-20260518_Redline.pdf	Supplementary Document	Uploaded 2026-06-25	Available
Crosswalk of Nonsubstantive Changes - Certifier User Guide.xlsx	Supplementary Document	Uploaded 2026-06-25	Available
DTS-ASP-Certifier-UserGuide-20260518_Redline.pdf	Supplementary Document	Uploaded 2026-06-25	Available
Crosswalk of Nonsubstantive Changes - Certification Form.xlsx	Supplementary Document	Uploaded 2026-06-25	Available
CMS-10110_BFSF Certification_Nonsubstantive Change_Redline_20260624.pdf	Supplementary Document	Uploaded 2026-06-25	Available
CMS_10110_Comment Response 30 day ICR.docx	Supplementary Document	Uploaded 2026-06-16	Available
CMS-10110_Supporting_Statement_A_(2026 version_26)_Clean.docx	Supporting Statement A	Uploaded 2026-06-25	Available
PRA Comment Response.pdf	Supplementary Document	Uploaded 2026-04-07	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
8767	Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)	Form	Modified	Bona Fide Service Fee Certification Form
8767	Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)	Form	Modified	Reasonable Assumptions Form
8767	Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)	Form	Modified	Product Data Template
8767	Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)	Form	Modified	Financial Data Template
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: 202606-0938-018
Status: Received in OIRA	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	Date Submitted to OIRA: 06/25/2026

	Requested	Previously Approved
Expiration Date	06/30/2029	06/30/2029
Responses	4,500	4,500
Time Burden (Hours)	49,500	49,500
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): PL: Pub.L. 117 - 169 11001 Name of Law: The Inflation Reduction Act
   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
  

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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 61154	12/30/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 17657	04/07/2026
Did the Agency receive public comments on this ICR? Yes

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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	4,500	4,500	0	0	0	0
Annual Time Burden (Hours)	49,500	49,500	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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.

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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: 06/25/2026

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