Small Biotech Exception and Biosimilar Delay Information Collection Request for Initial Price Applicability Year 2027 (CMS-10844) - IRA

OMB 0938-1443

Latest Forms, Documents, and Supporting Material

Document Name
Form CMS-10844 Biosimilar Delay for initial price applicability year 2027 Form and Instruction
Form CMS-10844 Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired After December 31, 2021) Form and Instruction
Form CMS-10844 Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired Not After December 31, 2021) Form and Instruction
Form CMS-10844 Small Biotech Exception with CGDP Agreement (Submitting Manufacture Acquired After December 31, 2021) Form and Instruction
Form CMS-10844 Small Biotech Exception with CGDP Agreement (Submitting Manufacture Not Acquired After December 31, 2021) Form and Instruction
CMS-10844_Supporting Statement_SBE Biosim Delay .docx Supporting Statement A
redline CMS-10844 IPAY 2027 SBE Biosim Delay 30-day ICR Forms.docx Supplementary Document
CMS 10844 IPAY 2027 60-day SBE Biosim Cmmt Response Summary Final.docx Supplementary Document
CMS-10844 30-day IPAY 2027 Crosswalk SBE Biosim.docx Supplementary Document
508_CMS-10844 60-day IPAY 2027 SBE and Biosimilar Delay ICR Crosswalk.pdf Supplementary Document
Biosimilar Delay for initial price applicability year 2027 Form and Instruction
Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired After December 31, 2021) Form and Instruction
Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired Not After December 31, 2021) Form and Instruction
Small Biotech Exception with CGDP Agreement (Submitting Manufacture Acquired After December 31, 2021) Form and Instruction
Small Biotech Exception with CGDP Agreement (Submitting Manufacture Not Acquired After December 31, 2021) Form and Instruction