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Information Collection

Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired After December 31, 2021)

IC 271325 under ICR 202509-0938-014 · OMB 0938-1443.

Documents and Forms
Document Name
Document Type
Form and Instruction
Form and Instruction
Form and Instruction
Form and Instruction
Information Collection (IC) Details

View Information Collection (IC)

Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired After December 31, 2021)
 
No Removed
 
Required to Obtain or Retain Benefits
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction CMS-10844 Small Biotech Exception and Biosimilar Delay Information Collection Request CMS-10844 IPAY 2027 SBE Biosim Delay 30-day ICR Forms.docx Yes Yes Fillable Fileable

Health Health Care Services

 

1 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 0 0 -1 0 0 1
Annual IC Time Burden (Hours) 0 0 -18 0 0 18
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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