Distributing and Dispensing a Medication Guide to Patients

Prescription Drug Product Labeling; Medication Guide Requirements

OMB: 0910-0393

IC ID: 205325

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Distributing and Dispensing a Medication Guide to Patients
No Modified
21 CFR 208.24(e)

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

Health Consumer Health and Safety


88,000 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 502,039,127 0 0 -4,198,873 0 506,238,000
Annual IC Time Burden (Hours) 25,102,000 0 0 -209,944 0 25,311,944
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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