CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers

Investigational New Drug Regulations

OMB: 0910-0014

IC ID: 5669

Information Collection (IC) Details

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CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers
 
No Unchanged
 
Mandatory
 
21 CFR 312.1-312.10

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form 1571 Investigational New Drug Application FORM FDA 1571 3-4-2015.pdf Yes Yes Fillable Fileable Signable
Form and Instruction 1572 Statement of Investigator FORM FDA 1572 3-4-2015.pdf Yes Yes Fillable Fileable Signable

Health Public Health Monitoring

 

239 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 287 0 0 0 0 287
Annual IC Time Burden (Hours) 7,608 0 0 0 0 7,608
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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