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Guidance for Industry on Safety Labeling Changes; Implementation of Section 505(o)(4) of the FD&C Act-- Rebuttal Statement
 
No New
 
Voluntary
 
21 CFR 314.70

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance FINAL GUIDANCE SAFETY LAB CHGS FINAL 1-31-13.doc Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

6 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 6 0 6 0 0 0
Annual IC Time Burden (Hours) 36 0 36 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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