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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Lot Distribution Data (LDD) Electronic Submission

 

The instructions entitled:
 
  • "Lot Distribution Data (LDD) Electronic Submission"
  • "Electronic Submissions of Biological Product Lot Distribution Data  'ELECTRONIC SUBMISSION INSTRUCTIONS FOR LOT DISTRIBUTION DATA (eLDD)'"
  • "ELECTRONIC SUBMISSION INSTRUCTIONS FOR BIOLOGICAL LOT DISTRIBUTION DATA (eLDD) in ASCII file format"
  • "Cover Letter for Lot Distribution Data (LDD) Report"
  • "ELECTRONIC SUBMISSION INSTRUCTIONS FOR BIOLOGICAL LOT DISTRIBUTION DATA (eLDD) in XML file format"
 
were withdrawn on September 14, 2010.  Following publication of the guidance document entitled, “Guidance for Industry: Electronic Submission of Lot Distribution Reports for Biological Products,” implementation issues arose, and the guidance was subsequently withdrawn on September 2, 2010. FDA is working now to resolve these issues.
 
FDA is no longer recruiting new participants for this project. If you are already submitting lot distribution reports (LDRs) to CBER electronically, you may continue to do so through the existing electronic procedures. However, we recommend that firms await revisions to CBER’s approach for submitting electronic LDRs before developing new processes and procedures.
 
If you have questions about electronic reporting of lot distribution data, please contact the Office of Communication, Outreach and Development toll-free at 1-800-835-4709 (toll 301-827-1800) or by email at Industry.Biologics@fda.gov.