PRA IC List
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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Biosimilar Delay
Modified
10
260
0
Form and Instruction
CMS-10844
Negotiation Program Drug Selection Information Collection Forms
Identification and Selection of Renegotiation-Eligible Drugs
New
25
3125
0
Form and Instruction
CMS-10844
Negotiation Program Drug Selection Information Collection Forms
Small Biotech Exception
Modified
30
292
0
Form and Instruction
CMS-10844
Negotiation Program Drug Selection Information Collection Forms
Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired After December 31, 2021)
Removed
0
0
0
Form and Instruction
CMS-10844
Small Biotech Exception and Biosimilar Delay Information Collection Request
Small Biotech Exception Without CGDP Agreement (Submitting Manufacture Acquired Not After December 31, 2021)
Removed
0
0
0
Form and Instruction
CMS-10844
Small Biotech Exception and Biosimilar Delay Information Collection Request
Small Biotech Exception with CGDP Agreement (Submitting Manufacture Acquired After December 31, 2021)
Removed
0
0
0
Form and Instruction
CMS-10844
Small Biotech Exception and Biosimilar Delay Information Collection Request
Total burden requested under this ICR:
65
3677
0
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