The FDA is defining standards for various types of electronic submissions to the agency. A transport format developed by SAS Institute has been adopted as an FDA standard for accepting and archiving data sets.
The following links provide information on using the SAS XPORT transport format to submit data sets to the FDA. Specifications for the XPORT format are provided in TS-140 so that it is not necessary to use SAS software to translate data sets to/from this format.
Federal Government