Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 352(x)) and Recommendation to Clarify its Purpose

General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions

OMB: 0910-0340

IC ID: 250630

Documents and Forms
Document Name
Document Type
Other-Guidance
Other-Guidance
Information Collection (IC) Details

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Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 352(x)) and Recommendation to Clarify its Purpose CDER
 
No Removed
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance GUIDANCE (0910-0641) 2-29-2016 (1).pdf Yes No Printable Only

Health Health Care Services

 

300 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 0 0 0 -900 0 900
Annual IC Time Burden (Hours) 0 0 0 -3,600 0 3,600
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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