XPORT transport format

This guidance document governs how electronic files should be sent to the FDA. Currently, the FDA requests that electronic documents be submitted as Portable Document Format (PDF) files. The PDF page should be a standard 8.5" x 11" page with 1" margins and 12-point font. Data sets are currently to be sent to the FDA as SAS XPORT transport format files. In the future it is likely that data sets will be required to be sent as XMF files, probably formatted in the CDISC ODM. 

The Electronic Common Technical Document (eCTD) is the vision for future electronic submissions to the FDA. This specification was developed by the International Conference on Harmonization (ICH) as an open-standards solution for electronic submissions to worldwide regulatory authorities. The FDA has adopted the eCTD as the future replacement for its other e-submission guidance, although for now the older guidance is still in effect. Note that the eCTD still depends largely on submitting text documents as PDF files and submitting data sets as SAS XPORT transport format files. 

Program 8.1 Creating SAS XPORT Transport Format Data Sets for the FDA... 

File format All files should be submitted in portable document format (PDF). The version of Acrobat Reader to be used for review should be confirmed with the agency. Electronic data sets should be provided in SAS System XPORT transport format (version 5 SAS transport file). 

SAS Transport File Format. We are able to archive data sets in SAS XPORT transport format, also called version 5 SAS transport format. This is an open, published file format developed by SAS Institute. For additional information, see the SAS Institute s Standards for Electronic Submissions and SAS XPORT transport format Web site. 

OPP scientists evaluated PDF submissions and supplemental files. For a pilot electronic data submission, OPP discussed the content of supplemental files with the registrant interested in providing an electronic data submission and worked on the data fields of interest for several toxicology studies. OPP evaluated SAS-XPORT (SAS Transport) files as a neutral file format for data tables. Two programs were evaluated by OPP DBMA Copy and Stat Transfer, which will transfer the data from the SAS-XPORT format into a format usable by the reviewer. 

Both of these export methods create a SAS XPORT format transport file called dm.xpt. Although any file extension could be used, xpt is the FDA-expected file extension for the transport file. Also note that the libref dm is strange in that it contains an actual filename and not just a directory path. This makes creating a series of SAS XPORT files a bit more challenging. You could create a series of XPORT files with a SAS macro such as the following. 

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