Content and Format of a Medication Guide

Prescription Drug Product Labeling; Medication Guide Requirements

OMB: 0910-0393

IC ID: 6050

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Content and Format of a Medication Guide
No Modified
21 CFR 208; 208.20 21 CFR 314.50  (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

Health Consumer Health and Safety


41 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 41 0 0 -20 0 61
Annual IC Time Burden (Hours) 13,120 0 0 -6,400 0 19,520
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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