Biowaiver request: powder oral dosage form, using same API/solubility approach

Abbreviated New Animal Drug Applications

OMB: 0910-0669

IC ID: 237370

Documents and Forms
Document Name
Document Type
Other-guidance
Information Collection (IC) Details

View Information Collection (IC)

Biowaiver request: powder oral dosage form, using same API/solubility approach CVM
 
No New
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-guidance bioequivalence guidance.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

5 0
   
Private Sector Businesses or other for-profits
 
   100 %

  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 5 0 5 0 0 0
Annual IC Time Burden (Hours) 50 0 50 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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