312.32(c)(1)(ii) and (c)(1)(iii) - Investigational New Drug Safety Reports

Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans

OMB: 0910-0672

IC ID: 194532

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312.32(c)(1)(ii) and (c)(1)(iii) - Investigational New Drug Safety Reports
 
No Modified
 
Mandatory
 
21 CFR 312.32(c)(1)(ii)and(c)(1)(iii)

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

Health Consumer Health and Safety

 

100 0
   
Private Sector Businesses or other for-profits
 
   25 %

  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 600 0 0 0 0 600
Annual IC Time Burden (Hours) 7,200 0 0 0 0 7,200
Annual IC Cost Burden (Dollars) 250 0 0 0 0 250

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