November 13, 2007 This directory contains documentation, data files, and other resources related to controlled terminology used by the U.S. Food and Drug Administration (FDA). NCI Enterprise Vocabulary Services (EVS) is working actively with FDA to develop and support controlled terminology in several areas, notably: SPL Structured Product Labeling ICSR Individual Case Safety Report CDRH Center for Devices and Radiological Health UNII Unique Ingredient Identifiers Contents - Files: FDA_NCIt_Subsets.txt (all FDA subsets in NCI Thesaurus: tabbed text) FDA_NCIt_Subsets.xls (all FDA subsets in NCI Thesaurus: Excel) FDA_NCIt_Subsets.zip (all FDA subsets in NCI Thesaurus: zipped Excel) NCITSubsets.doc (how to extract term sets from NCI Thesaurus) ReadMe.txt (this file) Contents - Directories: Archive (dated/earlier file versions) CDRH (CDRH subsets in NCI Thesaurus, new format) ICSR (ICSR subsets in NCI Thesaurus) ndfrt (VA NDF-RT SPL subsets) ProblemList (SPL Kaiser/VA problem list subset) ReportWriter (application to create subset reports) SPL (SPL subsets in NCI Thesaurus) UNII (UNII subset in NCI Thesaurus) Background: Additional documentation, data files, and related information are available on this Web page: http://www.cancer.gov/cancertopics/terminologyresources/FDA