Lot Distribution Data (LDD) Electronic Submission
|Quick Links and Instructions||Background and Project Status|
Please follow these steps to begin submitting LDD reports electronically:
A. Cover Letter should be filled out and saved with a designated naming convention, such as prefix LDD, company name, and reporting period.
B. Electronic file(s) with Lot Distribution Data per technical requirements.
For data submitted in XML format:
- Validation should be done against LDD XML Schema (any appropriate program can be used).
For Electronic Submission via FDA ESG:
- Setup an FDA ESG test Account.- Submit the LDD prepared package (Step 4) through the test gateway during the gateway hours of operation. See the status page for the current status of the gateway.
- When sending an LDD package (folder), select "CBER" from the Center drop-down list and "LDD" for the Submission Type.
- The gateway will return an acknowledgment of receipt of the transmission when the submitted package is successfully received and decrypted. The LDD system will return an ICH M2 compliant acknowledgment test message when the LDD Report has been processed and loaded into the FDA database.
- If the test is successful, then you can Setup an FDA ESG production Account.
- Submit the production package using your FDA ESG production account.
- The gateway will return an acknowledgment of receipt of the transmission when the submitted package is successfully received and decrypted. The LDD system will return an ICH M2 compliant acknowledgment production message when the LDD report has been processed and loaded into the FDA database.
For Electronic Submission using Physical Media:
Mail the submission package to the address below.
This procedure is intended to assist manufacturers of vaccines and other biological products to electronically submit post marketing lot distribution data to CBER's Lot Distribution Database (LDD). In the past, these data primarily came to CBER under 21 CFR 600.81 as paper reports. Conversion to uniform electronic submissions will improve accuracy, efficiency, and timeliness.
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 or in other formats. CBER staff members then manually compiled the data into the LDD system for use in post marketing safety surveillance. In accordance with current automation initiatives, the FDA is moving toward electronic submission of all regulatory data in computer-readable formats. Although establishing electronic reporting will initially require additional effort by both FDA and regulated industry, the resultant process will increase efficiency and the accuracy and timeliness of data. The improved data file format provides a standardized and consistent presentation of lot distribution information that can be automatically transferred and validated against CBER's Regulatory Management system, which tracks licensed CBER products and manufacturers.
We anticipate expansion to electronic data submission of post marketing lot distribution data for all vaccine and other biological products marketed for human use with biologic license applications (BLAs) regulated by CBER. (Electronic Lot Distribution Data submission is only for biological products regulated by CBER. It does not apply to therapeutic biologics transferred to the Center for Drug Evaluation and Research (CDER) on June 30, 2003. The FDA CBER website http://www.fda.gov/cber/ lists these products.)
Because FDA authority is limited to the United States, the scope of LDD submissions should similarly focus on product lots intended for "domestic" distribution, i.e., distribution within the U.S. or to U.S. military bases abroad. Lots intended for distribution to other countries should not be included. However, we retain a field to distinguish between domestic and foreign distribution for consistency with previous file formats and in case special circumstances might warrant tracking of non-domestic lots.