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

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

OMB: 0938-0921

IC ID: 8767

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Information Collection (IC) Details

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Manufacturer Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs and Biological and Supporting Regulations (CMS-10110)
 
No Modified
 
Mandatory
 
42 CFR 414 Subpart J Section 800-806

Document Type Form No. Form Name Instrument File URL 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

Health Health Care Services

 

500 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 2,000 0 0 0 0 2,000
Annual IC Time Burden (Hours) 26,000 0 0 0 0 26,000
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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.

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