Guidance for Industry on Safety Labeling Changes; Implementation of Section 505(o)(4) of the FD&C Act-- Rebuttal Statement

Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act

OMB: 0910-0734

IC ID: 204939

Documents and Forms
Document Name
Document Type
Other-Guidance
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Guidance for Industry on Safety Labeling Changes; Implementation of Section 505(o)(4) of the FD&C Act-- Rebuttal Statement CDER
 
No Modified
 
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 0734 1-11-2016.pdf Yes Yes Paper Only

Health Consumer Health and Safety

 

42 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 42 0 0 36 0 6
Annual IC Time Burden (Hours) 252 0 0 216 0 36
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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