This procedure is intended to assist manufacturers of vaccines and other biological products to electronically submit post marketing lot distribution data to FDA under 21 CFR 600.81.
Most manufacturers have submitted biological product lot distribution reports required under 21 CFR 600.81 in the form of printed paper reports, sometimes accompanied by electronic data files as American Standard Code for Information Interchange (ASCII) flat files, XML files or in other formats. FDA staff members then manually compiled the data into the Lot Distribution Database (LDD) system for use in post marketing safety surveillance.
On June 10, 2014, FDA issued a rule which, among other things, amended 21 CFR 600.81 to require applicants to submit Lot distribution reports to FDA in an electronic format that the Agency can process, review and archive. This reporting requirement is effective as of June 10, 2015. In addition, the Agency has issued a Draft Guidance for Industry on Electronic Submission of Lot Distribution Reports, which provides information on how to submit the reports (e.g., method of transmission, media, file formats, preparation and organization of files).
Electronic Submission of Lot Distribution Data
Manufacturers can now begin electronic submission of post marketing lot distribution data for all regulated vaccine and other biological products marketed with biologic license applications (BLAs). In accordance with current automation initiatives, the FDA is moving toward electronic submission of all regulatory data in computer-readable formats in compliance with Health Level Seven (HL7) Structured Product Labeling (SPL) requirements http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. The improved data file format provides a standardized and consistent presentation of lot distribution information that can be automatically transferred and validated against FDA’s Regulatory Management system, which tracks licensed FDA products and manufacturers.
Step by Step Submission Instructions:
Please follow these steps to begin submitting LDD Reports electronically:
Contact CBERSPL@FDA.HHS.GOV to advise FDA of your intent to begin submitting LDD Reports electronically. First time users should review FDA's Electronic Submission Gateway (ESG) User Guide that provides industry participants with information and guidance on how to use the FDA ESG.
Review FDA’s Draft Guidance for Industry: Electronic Submission of Lot Distribution Reports. SPL-compliant standards and data elements to be included in LDD submissions can be found in section 16.1 of the Structured Product Labeling Implementation Guide with Validation Procedures.
Submit a test file using FDA Test environment (provide link to the documentation you have for conducting pilot test). If the test file is compliant with technical requirements, then the LDD system will return an email test acknowledgment receipt with notification for data acceptance. If the test is not successful, review Step 2. For further information/assistance contact SPL@fda.hhs.gov.
For assistance with CBER LDD submissions, contact CBERSPL@FDA.HHS.GOV.