View Information Collection (IC)
View Information Collection (IC)

View Information Collection (IC)

Applications, including labeling and requests for samples
 
No Modified
 
Required to Obtain or Retain Benefits
 
21 CFR Subchapter F: Biologics 21 CFR 601 - Licensing 21 CFR 600; 610-680 (Product Stds.) 21 CFR 10.115; 601.29 - Guidance  (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 Yes Yes Fillable Fileable
Form and Instruction Form FDA 2252 Yes Yes Fillable Fileable
Form Form FDA 2252 Yes Yes Fillable Fileable
Other-Agency Guidance https://www.fda.gov/media/70712/download Yes Yes Fillable Fileable
Form FDA 3988 Yes Yes Fillable Fileable
Instruction Yes Yes Fillable Fileable
Form FDA 3989 Yes Yes Fillable Fileable
Instruction Yes Yes Fillable Fileable
Form FDA 3674 Yes Yes Fillable Fileable
Instruction Yes Yes Fillable Fileable
Other-Agency Guidance https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cooperative-manufacturing-arrangements-licensed-biologics Yes Yes Fillable Fileable
Other-Agency Guidance https://www.fda.gov/regulatory-information/search-fda-guidance-documents/voluntary-consensus-standards-recognition-program-regenerative-medicine-therapies Yes Yes Fillable Fileable
Form and Instruction 356h https://www.fda.gov/about-fda/reports-manuals-forms/forms Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

371 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Requested 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 65,814 0 0 -1,303 0 67,117
Annual IC Time Burden (Hours) 812,607 0 0 -410 0 813,017
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
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