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

IC 8767 under ICR 202603-0938-006 · OMB 0938-0921.

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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 DTS-ASP-Certifier-UserGuide-20250829-CLEAN.pdf Yes Yes Printable Only
Instruction DTS-ASP-Registration-UserGuide-20250808.pdf Yes Yes Printable Only
Instruction DTS-ASP-Submitter-UserGuide-20250829-CLEAN.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
Form CMS-10110 Reasonable Assumptions Form Reasonable Assumptions Form.docx Yes Yes Fillable Fileable
Form CMS-10110 Bona Fide Service Fee Certification Form BFSF Certification Form_03.11.26_CLEAN.docx Yes Yes Fillable Fileable

Health Health Care Services

 

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

  Requested 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 4,500 0 1,500 0 0 3,000
Annual IC Time Burden (Hours) 71,500 0 33,000 0 0 38,500
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
Redline: Bona Fide Service Fee Certification Form BFSF Certification Form_03.11.26_TRACK CHANGES.docx 03/25/2026
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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