Document ID: FDA-2019-N-2870-0001
Agency: fda
Document Type: Notice
Title: Electronic Submission; Data Standards; Support for Geopolitical
Entities, Names, and Codes
Posted Date: 2019-07-19T04:00Z

[Federal Register Volume 84, Number 139 (Friday, July 19, 2019)]
[Notices]
[Pages 34902-34903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15352]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2870]

Electronic Submission; Data Standards; Support for Geopolitical 
Entities, Names, and Codes

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the adoption of the current version of the Geopolitical Entities, 
Names, and Codes (GENC) Standard on December 17, 2020. The GENC 
Standard is the U.S. Government profile of International Organization 
for Standardization (ISO) 3166 ``Codes for the Representation of Names 
of Countries and Their Subdivisions.'' It specifies an authoritative 
set of country codes and names for use by the U.S. Government for 
information exchange, using ISO 3166 names and code elements wherever 
possible, with modifications only when necessary to comply with U.S. 
law and U.S. Government recognition policy. Adopting the GENC Standard 
will enable FDA to be in conformance with U.S. Government naming and 
recognition policies. You may submit comments at any time regarding the 
appropriateness or timing of FDA's adoption of the GENC Standard.

ADDRESSES: You may submit either electronic or written comments at any 
time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2019-N-2870 for ``Electronic Submission; Data Standards; Support 
for Geopolitical Entities, Names, and Codes.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations .gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Chenoa Conley, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 301-
796-0035, cderdatastandards@fda.hhs.gov, or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: On December 17, 2015, FDA began supporting 
GENC as the FDA standard for representing countries and their principal 
subdivisions. ISO is an organization that creates standards documents 
to provide requirements, specifications, and guidelines that can be 
followed by regulatory agencies and industry (https://nsgreg.nga.mil/genc/discovery). Before adopting GENC as its standard, FDA represented 
countries using ISO 3166-1 alpha-3 and represented countries' principal 
subdivisions using ISO 3166-2. Before adopting ISO 3166 as its 
standard, FDA represented countries using Federal Information 
Processing Standards (FIPS) 10-4 and represented principal subdivisions 
of the United States using FIPS 5-2 (https://nsgreg.nga.mil/doc/view?i=2564). FIPS are publicly announced standards developed by the 
U.S. Government for use in computer systems by nonmilitary Government 
Agencies and industry.
    Public Law 80-242 (1947) requires the U.S. Government to use 
geographic names that have been approved by the U.S. Board on 
Geographic Names (BGN). ISO 3166 contains a small set of country

[[Page 34903]]

and principal subdivision names that vary from those approved by the 
BGN. The geopolitical entities included in ISO 3166 are those that are 
recognized by the United Nations. Therefore, GENC is the U.S. 
Government implementation of ISO 3166 that conforms to BGN and U.S. 
Government recognition policy and will enable FDA to be in conformance 
with U.S. Government naming and recognition policies. The GENC Standard 
is specified by the combination of a stable information design document 
and information content consisting of dynamically managed entries in 
the GENC Registry. In accordance with OMB Circular A-119 (https://obamawhitehouse.archives .gov/omb/circulars_a119_a119fr), Federal 
Agencies are directed to use voluntary consensus standards in lieu of 
government-unique standards except when inconsistent with law or 
otherwise impractical. ISO 3166 is the base standard for the profile 
that is the GENC Standard. The GENC Standard asserts both restrictions 
to, and extensions of, the ISO 3166 base standard; it is a Class 2 
profile in accordance with the provisions of ISO 19106 (https://www.iso.org/standard/26011.html). Information regarding the development 
of the GENC Standard can be found at https://nsgreg.nga.mil/geopoliticalCode.jsp. Frequently asked questions regarding the content 
and use of the GENC Standard can be found at https://nsgreg.nga.mil/genc/faq.jsp? register=0.
    The information content of the GENC Standard is specified with 
respect to ISO 3166 (Parts 1 and 2). Entries of the GENC Standard are 
based on either direct reuse of ISO 3166 code elements or a type of 
variation from that standard (Exclusion, Exception, Extension, or 
Exigent) based on U.S. government requirements. In the case of 
Exceptions, the codes do not differ from ISO 3166. Exceptions are based 
on differences in naming (some politically significant, others simply 
stylistic) as approved by the BGN, or differences in how the 
territorial extent of an entity is understood. GENC Extensions 
introduce entities not included in ISO 3166. Entries from ISO 3166 that 
are excluded from the GENC Standard may be browsed in the GENC 
Registry.
    Infrequently, ISO 3166-1 code elements for a given country name are 
revised for reasons that are not related to a change in the country 
name itself. Consequently, a given country name may be assigned 
differing code element values over time. To enable information systems 
to easily recognize these occasions, a file specifying country code 
element correspondences is maintained in the NSG-unique Standards 
Register (https://nsgreg.nga.mil/doc/view?i=2563).
    For those occasions when it may be necessary to reference the names 
of countries that are not included in the content of the GENC Standard 
because of the disestablishment of those countries before the initial 
publication of the GENC, the Codes for Historical Country Names 
information guidance document specifies applicable codes and their 
corresponding names for use in ``country coding'' such data (this 
information can be found at https://nsgreg.nga.mil/doc/view?i=2565).
    While FDA currently supports the GENC standard, the FDA Data 
Standards Catalog will be updated to announce an implementation date of 
December 17, 2020, for GENC. After receiving comments, the Agency may 
consider further actions regarding the adoption of the GENC standard 
and/or its planned implementation date.

    Dated: July 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15352 Filed 7-18-19; 8:45 am]
 BILLING CODE 4164-01-P