Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format

Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format

OMB: 0910-0530

IC ID: 6248

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Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR 314.50

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

Health Consumer Health and Safety

 

75 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 5,000 0 0 4,889 111 0
Annual IC Time Burden (Hours) 6,250 0 0 6,222 28 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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