Manufacturers to Report Drug Pricing Information for Part B (§§ 414.802 and 414.902)

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

Documents and Forms

Document Name Document Type
cms10110.asp_data_collection_validation_macro_user_guide_032520.pdf Instruction
DTS-ASP-Certifier-UserGuide.pdf Instruction
DTS-ASP-Registration-UserGuide.pdf Instruction
DTS-ASP-Submitter-UserGuide.pdf Instruction
FinancialDataTemplate Instructions.pdf Instruction
ProductDataTemplate Instructions.pdf Instruction
ProductDataTemplate FDA Approval Type.pdf Instruction
ProductDataTemplate Generic Name.pdf Instruction
ProductDataTemplate Unit for Strength.pdf Instruction
ProductDataTemplate Unit of Volume Per Item.pdf Instruction
CMS-10110 Financial Data Template FinancialDataTemplate-FB.xlsx Form
CMS-10110 Product Data Template ProductDataTemplate.pdf Form

Information Collection (IC) Details

IC Title:	Manufacturers to Report Drug Pricing Information for Part B (§§ 414.802 and 414.902)	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:

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

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 435	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	1,740	-260	2,000
Annual IC Time Burden (Hours)	22,620	-3,380	26,000
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

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