Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded

Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded

OMB: 0910-0688

IC ID: 197086

Documents and Forms
Document Name
Document Type
Other-Guidance
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Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
 
No Modified
 
Mandatory
 
21 CFR 330.14

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance GUIDANCE TEA 3-3-14.pdf No   Paper Only

Health Consumer Health and Safety

 

9 0
   
Individuals or Households
 
   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 9 0 0 7 0 2
Annual IC Time Burden (Hours) 7,756 0 0 3,056 0 4,700
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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