Format and Content Requirements for Over--the-Counter Drug Product Labeling; new OTC drug products

Format and Content Requirements for Over-the-Counter Drug Product Labeling

OMB: 0910-0340

IC ID: 5943

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Format and Content Requirements for Over--the-Counter Drug Product Labeling; new OTC drug products
 
No Modified
 
Mandatory
 
21 CFR 201.66 21 CFR 201.66(c) and (d)

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

Health Consumer Health and Safety

 

300 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 900 0 0 0 0 900
Annual IC Time Burden (Hours) 10,800 0 0 0 0 10,800
Annual IC Cost Burden (Dollars) 0 0 -2,100,000 0 0 2,100,000

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