Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services

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

OMB: 0910-0458

IC ID: 178970

Information Collection (IC) Details

View Information Collection (IC)

Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services
 
No Modified
 
Mandatory
 
21 CFR 606.171

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3486 Biological Product Deviation Report Form FDA 3486 control no 0910 0458.pdf https://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/biological-product-deviations Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

1,937 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 46,192 0 0 418 0 45,774
Annual IC Time Burden (Hours) 92,384 0 0 836 0 91,548
Annual IC Cost Burden (Dollars) 4,157,280 0 0 4,157,280 0 0

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