Information Collection

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

IC 8767 under ICR 202512-0938-022 · OMB 0938-0921.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0938-0921 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form CMS-10110 Financial Data Template Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)	Form
Form CMS-10110 Product Data Template Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)	Form
Form CMS-10110 Reasonable Assumptions Form Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)	Form
Form CMS-10110 Bona Fide Service Fee Certification Form Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)	Form
DTS-ASP-Certifier-UserGuide-20250829-CLEAN.pdf	Instruction
DTS-ASP-Certifier-UserGuide-20250829-CLEAN.pdf	Instruction
DTS-ASP-Certifier-UserGuide.pdf	Instruction
DTS-ASP-Certifier-UserGuide.pdf	Instruction
DTS-ASP-Registration-UserGuide-20250808.pdf	Instruction
DTS-ASP-Registration-UserGuide-20250808.pdf	Instruction
DTS-ASP-Submitter-UserGuide-20250829-CLEAN.pdf	Instruction
DTS-ASP-Submitter-UserGuide-20250829-CLEAN.pdf	Instruction
FinancialDataTemplate Instructions.pdf	Instruction
FinancialDataTemplate Instructions.pdf	Instruction
ProductDataTemplate Instructions.pdf	Instruction
ProductDataTemplate Instructions.pdf	Instruction
ProductDataTemplate FDA Approval Type.pdf	Instruction
ProductDataTemplate FDA Approval Type.pdf	Instruction
ProductDataTemplate Generic Name.pdf	Instruction
ProductDataTemplate Generic Name.pdf	Instruction
ProductDataTemplate Unit for Strength.pdf	Instruction
ProductDataTemplate Unit for Strength.pdf	Instruction
ProductDataTemplate Unit of Volume Per Item.pdf	Instruction
ProductDataTemplate Unit of Volume Per Item.pdf	Instruction
CMS-10110 Financial Data Template FinancialDataTemplate-FB.xlsx	Form
CMS-10110 Financial Data Template FinancialDataTemplate-FB.xlsx	Form
CMS-10110 Product Data Template ProductDataTemplate.pdf	Form
CMS-10110 Product Data Template ProductDataTemplate.pdf	Form
CMS-10110 Reasonable Assumptions Form Reasonable Assumptions Form.docx	Form
CMS-10110 Reasonable Assumptions Form Reasonable Assumptions Form.docx	Form
CMS-10110 Bona Fide Service Fee Certification Form BFSF Certification Form_11.20.25.docx	Form
CMS-10110 Bona Fide Service Fee Certification Form BFSF Certification Form_11.20.25.docx	Form
DTS-ASP-Certifier-UserGuide-20250829-UPDATES (1).docx Certifier User Guide ( Redline)	IC Document
DTS-ASP-Certifier-UserGuide-20250829-UPDATES (1).docx Certifier User Guide ( Redline)	IC Document
DTS-ASP-Registration-UserGuide-20250829-TrackChanges.docx Registration User Guide (Redline)	IC Document
DTS-ASP-Registration-UserGuide-20250829-TrackChanges.docx Registration User Guide (Redline)	IC Document
DTS-ASP-Submitter-UserGuide-20250829-UPDATES (1).docx Submitter User Guide (Redline)	IC Document
DTS-ASP-Submitter-UserGuide-20250829-UPDATES (1).docx Submitter User Guide (Redline)	IC Document
Certifier User Guide (Crosswalk).xlsx Certifier User Guide (Crosswalk)	IC Document
Certifier User Guide (Crosswalk).xlsx Certifier User Guide (Crosswalk)	IC Document
Registration User Guide (Crosswalk).xlsx Registration User Guide (Crosswalk)	IC Document
Registration User Guide (Crosswalk).xlsx Registration User Guide (Crosswalk)	IC Document

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

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

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 42 CFR 414 Subpart J Section 800-806

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction		Yes	Yes	Printable Only
Instruction		Yes	Yes	Printable Only
Instruction		Yes	Yes	Printable Only
Instruction		Yes	Yes	Printable Only
Instruction		Yes	Yes	Printable Only
Form	CMS-10110	Yes	Yes	Fillable Printable
Instruction		Yes	Yes	Printable Only
Instruction		Yes	Yes	Printable Only
Instruction		Yes	Yes	Printable Only
Instruction		Yes	Yes	Printable Only
Instruction		Yes	Yes	Printable Only
Form	CMS-10110	Yes	Yes	Fillable Printable
Form	CMS-10110	Yes	Yes	Fillable Fileable
Form	CMS-10110	Yes	Yes	Fillable Fileable

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 500

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	3,000	1,000	2,000
Annual IC Time Burden (Hours)	38,500	12,500	26,000
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
Certifier User Guide ( Redline)		01/07/2026
Registration User Guide (Redline)		01/07/2026
Submitter User Guide (Redline)		01/07/2026
Certifier User Guide (Crosswalk)		01/07/2026
Registration User Guide (Crosswalk)		01/07/2026

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

Something went wrong when downloading this file. If you have any questions, please send an email to [email protected].