511.1(b)(4) NCIE for clinical investigations

New Animal Drugs for Investigational Use

OMB: 0910-0117

IC ID: 5728

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511.1(b)(4) NCIE for clinical investigations
 
No Modified
 
Mandatory
 
21 CFR 511.1(b)(4)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction 3458 Notice of Claimed Investigational Exemption FDA Form 3458.pdf Yes Yes Fillable Printable

Health Consumer Health and Safety

 

206 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 1,238 0 0 1,234 4 0
Annual IC Time Burden (Hours) 1,238 0 0 -22,567 23,805 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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