Reporting of Biological Product Deviations by Licensed Manufacturer

Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing

OMB: 0910-0458

IC ID: 6151

Documents and Forms
Document Name
Document Type
Other-IT Landing Page Screenshot
Other-IT Landing Page Screenshot
Form and Instruction
Form and Instruction
Information Collection (IC) Details

View Information Collection (IC)

Reporting of Biological Product Deviations by Licensed Manufacturer
 
No Modified
 
Mandatory
 
21 CFR 600.14

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-IT Landing Page Screenshot FURLS Screenshot.docx Yes Yes Fillable Fileable
Form and Instruction FDA 3486 Biological Product Deviation Report FDA 3486 3-12-20 Secured.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

103 0
   
Private Sector Businesses or other for-profits
 
   95 %

  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 707 0 0 136 0 571
Annual IC Time Burden (Hours) 1,414 0 0 272 0 1,142
Annual IC Cost Burden (Dollars) 0 0 0 -51,390 0 51,390

Title Document Date Uploaded
No associated records found
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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