Biologics; Licensing; General Biological Products Standards; and Additional Standards

General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension

OMB: 0910-0338

IC ID: 5935

Information Collection (IC) Details

View Information Collection (IC)

Biologics; Licensing; General Biological Products Standards; and Additional Standards
 
No Modified
 
Mandatory
 
21 CFR 601 21 CFR 610 21 CFR 640, 680  (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
Form and Instruction Form FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE FDA Form 2253.pdf Yes Yes Fillable Fileable
Form and Instruction Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE FORM FDA 2252 SUPPLEMENT.pdf Yes Yes Fillable Fileable
Form Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE FDA 2252.pdf Yes Yes Fillable Fileable
Form FDA 356h Application to Market a New or Abbreviated New Drug or Biologic For Human Use FORM FDA 356h Application Exp 2020.pdf Yes Yes Fillable Fileable
Other-Agency Guidance 0338 BLAs GFI for Cooperative MFR Arrangements NOV 2008.pdf https://www.fda.gov/media/70712/download Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

424 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 27,684 0 0 1 0 27,683
Annual IC Time Burden (Hours) 439,900 0 0 1 0 439,899
Annual IC Cost Burden (Dollars) 0 0 0 -23,314,647 0 23,314,647

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