312.315(c) and 312.305 (b) Submissions related to expanded access and treatment of an individual patient.

Investigational New Drug Regulations

OMB: 0910-0014

IC ID: 197925

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312.315(c) and 312.305 (b) Submissions related to expanded access and treatment of an individual patient.
 
No New
 
Mandatory
 
21 CFR 312.315(c) and 312.305 (b)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Public Health Monitoring

 

68 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 68 0 0 68 0 0
Annual IC Time Burden (Hours) 8,160 0 0 8,160 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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