OMB control number

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

OMB 0938-0921 · HHS/CMS.

OMB 0938-0921

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.

The latest form for [IRA Collection] Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) expires 2029-06-30 and is listed under ICR 202606-0938-018.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form CMS-10110 Bona Fide Service Fee Certification FormForm
Form CMS-10110 Bona Fide Service Fee Certification FormForm
Form CMS-10110 Reasonable Assumptions FormForm
Form CMS-10110 Reasonable Assumptions FormForm
Form CMS-10110 Product Data TemplateForm
Form CMS-10110 Product Data TemplateForm
Form CMS-10110 Financial Data TemplateForm
Form CMS-10110 Financial Data TemplateForm
CMS-10110 (0938-0921) Justification of Non-sub Change (2026 version 5).docxJustification for No Material/Nonsubstantive Change
CMS-10110 (0938-0921) Justification of Non-sub Change (2026 version 5).docxJustification for No Material/Nonsubstantive Change
Crosswalk of Nonsubstantive Changes - Submitter User Guide.xlsxSupplementary Document
Crosswalk of Nonsubstantive Changes - Submitter User Guide.xlsxSupplementary Document
DTS-ASP-Submitter-UserGuide-20260518_Redline.pdfSupplementary Document
DTS-ASP-Submitter-UserGuide-20260518_Redline.pdfSupplementary Document
Crosswalk of Nonsubstantive Changes - Certifier User Guide.xlsxSupplementary Document
Crosswalk of Nonsubstantive Changes - Certifier User Guide.xlsxSupplementary Document
DTS-ASP-Certifier-UserGuide-20260518_Redline.pdfSupplementary Document
DTS-ASP-Certifier-UserGuide-20260518_Redline.pdfSupplementary Document
Crosswalk of Nonsubstantive Changes - Certification Form.xlsxSupplementary Document
Crosswalk of Nonsubstantive Changes - Certification Form.xlsxSupplementary Document
CMS-10110_BFSF Certification_Nonsubstantive Change_Redline_20260624.pdfSupplementary Document
CMS-10110_BFSF Certification_Nonsubstantive Change_Redline_20260624.pdfSupplementary Document
CMS_10110_Comment Response 30 day ICR.docxSupplementary Document
CMS_10110_Comment Response 30 day ICR.docxSupplementary Document
CMS-10110_Supporting_Statement_A_(2026 version_26)_Clean.docxSupporting Statement A
CMS-10110_Supporting_Statement_A_(2026 version_26)_Clean.docxSupporting Statement A
PRA Comment Response.pdfSupplementary Document
PRA Comment Response.pdfSupplementary Document
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) Form
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) Form
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) Form
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) Form
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) Form
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) Form
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) Form
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) Form
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110) Instruction

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202606-0938-018 No material or nonsubstantive change to a currently approved collection 2026-06-25 Approved without change
202604-0938-003 Revision of a currently approved collection 2026-04-07
202603-0938-006 No material or nonsubstantive change to a currently approved collection 2026-03-25 Withdrawn and continue
202512-0938-022 Revision of a currently approved collection 2026-01-08 Approved with change
202508-0938-003 Revision of a currently approved collection 2025-11-13
202405-0938-015 Revision of a currently approved collection 2024-05-17 Approved without change
202304-0938-010 Revision of a currently approved collection 2023-04-18 Approved without change
202007-0938-011 Revision of a currently approved collection 2020-08-11
201710-0938-002 Revision of a currently approved collection 2017-10-05 Approved with change
201603-0938-002 Reinstatement without change of a previously approved collection 2016-03-10 Approved with change
201112-0938-002 Revision of a currently approved collection 2011-12-08 Approved without change
200904-0938-009 Revision of a currently approved collection 2009-04-14 Approved without change
200603-0938-007 Revision of a currently approved collection 2006-03-09 Approved without change
200407-0938-005 Extension without change of a currently approved collection 2004-07-23 Approved without change
200403-0938-006 New collection (Request for a new OMB Control Number) 2004-03-19 Approved with change