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Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type a Medicated Articles

IC 6298 under ICR 201504-0910-006 · OMB 0910-0575.

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Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type a Medicated Articles
 
No Modified
 
Voluntary
 
21 CFR 514.1(b)(8) 21 CFR 514.1(b)(7)

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

Health Consumer Health and Safety

 

18 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 18 0 0 -18 0 36
Annual IC Time Burden (Hours) 265 0 0 -265 0 530
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
Waivers of In Vivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Guidance 0910-0575.pdf 01/12/2009
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