Reporting of Biological Product Deviations by Licensed Manufacturers - 600.14

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: 6151

Information Collection (IC) Details

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

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 FORM FDA-3486 12-5-13.pdf Yes Yes Fillable Printable

Health Consumer Health and Safety

 

91 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 702 0 0 305 0 397
Annual IC Time Burden (Hours) 1,404 0 0 610 0 794
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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