Vaccines, Blood & Biologics
Lot Distribution Database (LDD)
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. For a list of these products, see: Transfer of Therapeutic Products to the Center for Drug Evaluation and Research.)
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.
Office of Biostatistics and Epidemiology
Center for Biologics Evaluation and Research, FDA
1401 Rockville Pike, 200S/HFM-220Rockville, MD 20852-1448