New Animal Drugs for Investigational Use

New Animal Drugs for Investigational Use

OMB: 0910-0117

IC ID: 5728

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Information Collection (IC) Details

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New Animal Drugs for Investigational Use
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR 511.1 (a)(3) 21 CFR 511.1(b)(3) 21 CFR 511.1(b)(4) 21 CFR 511.1(b)(5)(ii)&(iii) 21 CFR 511.1(b)(6) 21 CFR 511.1(b)(7)(ii) 21 CFR 511.1(b)(8)(i) 21 CFR 511.1(b)(8)(ii) 21 CFR 511.1(b)(9)

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

 

134 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 4 0 0 -4,523 0 4,527
Annual IC Time Burden (Hours) 23,805 0 0 -10,817 0 34,622
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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