Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A

Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms 3486 and 3486A

OMB: 0910-0458

IC ID: 178971

Information Collection (IC) Details

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Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A
 
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 3486 Biological Product Deviation Report 0458 FDA-3486.doc No No Fillable Printable
Form and Instruction FDA 3486A BPDR SUPPLEMENTAL INFORMATION 0458 WEB FORM ADDENDUM TO FORM3486A.doc No No Fillable Printable

Health Consumer Health and Safety

 

6,210 0
   
Private Sector Businesses or other for-profits
 
   40 %

  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 9,311 0 0 0 0 9,311
Annual IC Time Burden (Hours) 18,622 0 0 0 0 18,622
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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