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Supplements and Other Changes to Approved New Animal Drug Applications - Final Rule

IC 178965 under ICR 200703-0910-002 · OMB 0910-0600.

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Document Type
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Supplements and Other Changes to Approved New Animal Drug Applications - Final Rule
 
No New
 
Mandatory
 
21 CFR 500.514.8

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

Health Consumer Health and Safety

 

40 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 1,228 0 1,228 0 0 0
Annual IC Time Burden (Hours) 63,561 0 63,561 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
Guidance for Industry: Chemistry Manufacturing and Control Changes for Approved NADA or ANADA Guidance FDAMA 116.doc
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