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Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 502(x)) and Recommendation to Clarify its Purpose

IC 188840 under ICR 201903-0910-021 · OMB 0910-0641.

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

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Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 502(x)) and Recommendation to Clarify its Purpose CDER
 
No Unchanged
 
Voluntary
 
21 CFR 379aa  (To search for a specific CFR, visit the Code of Federal Regulations.)

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.pdf Yes No Paper Only

Health Health Care Services

 

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) 3,600 0 0 0 0 3,600
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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