Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statement

Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act

OMB: 0910-0734

IC ID: 204939

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Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statement CDER
 
No Modified
 
Voluntary
 
21 CFR 601.12 21 CFR 314.70

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

Health Consumer Health and Safety

 

36 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 36 0 0 -6 0 42
Annual IC Time Burden (Hours) 216 0 0 -36 0 252
Annual IC Cost Burden (Dollars) 16,200 0 0 16,200 0 0

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