Form FDA 3486A Addendum

Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations; Form FDA 3486 and Addendum 3486A

OMB: 0910-0458

IC ID: 178972

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Form FDA 3486A Addendum
 
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 3486A Biological Product Deviation Report - Addendum EBPDR_AI_Screen_Shots 12-16-13.doc Yes Yes Fillable Printable

Health Consumer Health and Safety

 

87 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 2,289 0 0 -458 0 2,747
Annual IC Time Burden (Hours) 572 0 0 -115 0 687
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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