21 Cfr Part 510 - Adverse Drug Reaction, Lack Of Effectiveness, Product Defect Report

21 CFR PART 510 - ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT

OMB: 0910-0012

IC ID: 109308

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21 CFR PART 510 - ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT
 
No Migrated
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form FDA 1932 & No No
Form 1932A No No


    

350 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 1,000 0 33 217 0 750
Annual IC Time Burden (Hours) 1,200 0 125 815 0 260
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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