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: 178670

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Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
 
No Removed
 
Required to Obtain or Retain Benefits
 
21 CFR 314.94

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Other praeleclabel-0530 ss (2).doc Yes Yes Printable Only

Health Consumer Health and Safety

 

35 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 0 0 -82 0 82 0
Annual IC Time Burden (Hours) 0 0 -21 0 21 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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