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 202405-0938-015 · 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⚠️ Notice: This information collection may be referencing outdated material.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
cms10110.asp_data_collection_validation_macro_user_guide_032520.pdf	Instruction
cms10110.asp_data_collection_validation_macro_user_guide_032520.pdf	Instruction
DTS-ASP-Certifier-UserGuide.pdf	Instruction
DTS-ASP-Certifier-UserGuide.pdf	Instruction
DTS-ASP-Registration-UserGuide.pdf	Instruction
DTS-ASP-Registration-UserGuide.pdf	Instruction
DTS-ASP-Submitter-UserGuide.pdf	Instruction
DTS-ASP-Submitter-UserGuide.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.pdf	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
Differences for FinancialDataTemplate.xlsx Financial Data Template Crosswalk	IC Document
Differences for FinancialDataTemplate.xlsx Financial Data Template Crosswalk	IC Document
Differences for ProductDataTemplate.xlsx Product Data Template Crosswalk	IC Document
Differences for ProductDataTemplate.xlsx Product Data Template 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.	Form Name	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction			cms10110.asp_data_collection_validation_macro_user_guide_032520.pdf	Yes	Yes	Printable Only
Instruction			DTS-ASP-Certifier-UserGuide.pdf	Yes	Yes	Printable Only
Instruction			DTS-ASP-Registration-UserGuide.pdf	Yes	Yes	Printable Only
Instruction			DTS-ASP-Submitter-UserGuide.pdf	Yes	Yes	Printable Only
Instruction			FinancialDataTemplate Instructions.pdf	Yes	Yes	Printable Only
Form	CMS-10110	Financial Data Template	FinancialDataTemplate-FB.xlsx	Yes	Yes	Fillable Printable
Instruction			ProductDataTemplate Instructions.pdf	Yes	Yes	Printable Only
Instruction			ProductDataTemplate FDA Approval Type.pdf	Yes	Yes	Printable Only
Instruction			ProductDataTemplate Generic Name.pdf	Yes	Yes	Printable Only
Instruction			ProductDataTemplate Unit for Strength.pdf	Yes	Yes	Printable Only
Instruction			ProductDataTemplate Unit of Volume Per Item.pdf	Yes	Yes	Printable Only
Form	CMS-10110	Product Data Template	ProductDataTemplate.pdf	Yes	Yes	Fillable Printable

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	Previously Approved
Annual Number of Responses for this IC	2,000	2,000
Annual IC Time Burden (Hours)	26,000	26,000
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
Financial Data Template Crosswalk	Differences for FinancialDataTemplate.xlsx	07/09/2024
Product Data Template Crosswalk	Differences for ProductDataTemplate.xlsx	05/14/2024

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