CDER DATA STANDARDS MANUAL

FDA Data Element Number. GEO-00101

CDER Data Element Number. C-GEO-00101

Data Element Name. Countries, Dependencies, and Areas of Special Sovereignty.

Version Number. 002

Description.This standard provides names and abbreviations for representing countries, dependencies, and areas of special sovereignty.

Source. ISO 3166-1 alpha-3

Relationship.

FDA Specifications. ISO 3166-1 alpha-3 (three character country codes) is the FDA standard for representing country codes, effective 01-JAN-2007. It is the FDA's position that ISO 3166-1 alpha-3 be used so that FDA data standards are fully compatible with HL7 and CDISC data standards.

However, FDA realizes that the exclusive use of ISO 3166-1 alpha-3 is not always possible, especially where the FDA interfaces with data systems from outside organizations that use ISO 3166-1 alpha-2 (e.g., U.S. Immigrations and Customs Enforcement at the Department of Homeland Security). In those instances, ISO 3166-1 alpha-2 (two character country codes) may be used. When the use of ISO 3166-1 alpha-2 is necessary, those FDA organizational components that use ISO 3166-1 alpha-2 must maintain ready access to an ISO 3166 mapping table in order to permit users to readily navigate between ISO 3166-1 alpha-3 and ISO 3166-1 alpha-2.

All FDA systems in operation at the time of adoption of the ISO 3166-1 alpha-3 must incorporate the standard during the next major system modification or within the next five (5) years (i.e., 31-DEC-2011), whichever occurs first, as specified in FDA Staff Manual Guide 3260.1, with the noted provision above for the use of ISO 3166-1 alpha-2.

FIPS 10-3, as stated in FIPS Publication 104, is no longer used as either the Agency country code standard or as the CDER country code standard, as of January 1, 2007.

CDER Specifications. No further specifications.

FDA Approved Date. October 9, 1986.

CDER Approved Date. November 5, 1991.

FDA Revised Date. December 7, 2006.

CDER Revised Date. February 11, 1992; April 14, 1992; October 11, 1994; November 14, 1997; December 7, 2006.

Data Values. The following is a snapshot of the mapping between ISO 3166-1 alpha-3 and ISO 3166-1 alpha-2 on January 17, 2007.  For a current mapping, please consult the NCI Enterprise Vocabulary Service (NCI EVS) at http://nciterms.nci.nih.gov/NCIBrowser/Dictionary.do.

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