Electronic Submission; Data Standards; Support for Geopolitical Entities, Names, and Codes, 34902-34903 [2019-15352]
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34902
Federal Register / Vol. 84, No. 139 / Friday, July 19, 2019 / Notices
Roughead, ‘‘Quality of Pharmaceutical
Advertisements in Medical Journals: A
Systematic Review,’’ PLoS Medicine,
4:e6350, https://doi.org/10.1371/
journal.pone.0006350, 2009.
Dated: July 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–15350 Filed 7–18–19; 8:45 am]
BILLING CODE 4164–01–P
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.
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:
jbell on DSK3GLQ082PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
18:36 Jul 18, 2019
Jkt 247001
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
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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/201523389.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
E:\FR\FM\19JYN1.SGM
19JYN1
jbell on DSK3GLQ082PROD with NOTICES
Federal Register / Vol. 84, No. 139 / Friday, July 19, 2019 / Notices
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
VerDate Sep<11>2014
18:36 Jul 18, 2019
Jkt 247001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Ryan White
HIV/AIDS Program (RWHAP) Parts A
and B Unobligated Balances and
Rebate Addendum Tables, OMB No.
0906–xxxx–New
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than September 17,
2019.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
SUMMARY:
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
34903
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Ryan White HIV/AIDS Program Parts A
and B Unobligated Balances and Rebate
Addendum Tables, OMB No. 0906–
xxxx–New.
Abstract: HRSA’s Ryan White HIV/
AIDS Program (RWHAP) funds and
coordinates with cities, states and
territories, and local clinics/communitybased organizations to deliver efficient
and effective HIV care, treatment, and
support to low-income people
diagnosed with HIV. Nearly two-thirds
of RWHAP clients live at or below 100
percent of the federal poverty level and
approximately three-quarters of RWHAP
clients are racial and ethnic minorities.
Since 1990, RWHAP has developed a
comprehensive system of HIV service
providers who deliver high quality
direct health care and support services
to over half a million people diagnosed
with HIV (more than 50 percent of all
people diagnosed with HIV in the
United States).
Grant recipients funded under Parts
A, B, C, and D of RWHAP (codified
under Title XXVI of the Public Health
Service Act) are required to report
financial data to HRSA at the beginning
(Allocations Report) and at the end of
each grant budget period (Expenditures
Report) using the HRSA Electronic
Handbooks (EHBs).1 HRSA RWHAP’s
Parts A and B collect unobligated
balances (UOB) of federal funds and
rebate addendum information by
subprogram from their grant recipients.
Parts A and B use the UOB and rebate
addendum financial information to
determine formula funding as directed
by RWHAP statute. These data were
collected when grant recipients
submitted their annual Federal
Financial Report (FFR SF–425) in hard
copy only, and submitted to the
individual HHS Operating Divisions
(OPDIVs). HRSA combined the FFR SF–
425 with the UOB and rebate addendum
1 The Allocations Report and the Expenditures
Report were approved by OMB under the 0915–
0318 control number.
E:\FR\FM\19JYN1.SGM
19JYN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, [email protected], 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