Proposed Inclusion of Terrain Factors in the Definition of Rural Area for Federal Office of Rural Health Policy Grants, 32451-32453 [2024-08931]
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Federal Register / Vol. 89, No. 82 / Friday, April 26, 2024 / Notices
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
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access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
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Hampshire Ave., Bldg. 22, Rm. 2169,
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7301, Silver Spring, MD 20993, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft guidance for industry, IRBs, and
clinical investigators entitled ‘‘Cancer
Clinical Trial Eligibility Criteria:
Laboratory Values.’’ The purposes of
eligibility criteria are to select the
intended patient population and reduce
potential risks to trial participants.
However, eligibility criteria are
sometimes more restrictive than
necessary, and expanding eligibility
criteria to be more inclusive is one trial
design consideration that may improve
the diversity of clinical trial
populations. This draft guidance is one
in a series of guidances that provide
recommendations regarding eligibility
criteria for clinical trials of
investigational drugs regulated by CDER
and CBER for the treatment of cancer.
Specifically, this draft guidance
includes recommendations to consider
appropriate use of laboratory values as
trial eligibility criteria and intends to
assist interested parties, including
sponsors and IRBs, who are responsible
for the development and oversight of
clinical trials.
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A clinical trial’s eligibility criteria (for
inclusion and exclusion) are essential
components of the trial, defining the
characteristics of the study population.
Because there is variability in
investigational drugs and trial
objectives, eligibility criteria should be
developed taking into consideration the
mechanism of action of the drug, the
targeted disease or patient population,
the anticipated safety of the
investigational drug, the availability of
adequate safety data, and the ability to
recruit trial participants from the patient
population to meet the objectives of the
clinical trial. The Agency recognizes
that some eligibility criteria may have
become commonly accepted over time
or used as a template across trials, but
such criteria should be carefully
considered and be appropriate for a
specific trial context. Unnecessarily
restrictive eligibility criteria may slow
patient accrual, limit patients’ access to
clinical trials, and lead to trial results
that do not fully represent treatment
effects in the patient population that
will ultimately use the drug.
Appropriately broadening cancer trial
eligibility criteria can improve the
generalizability of trial results and
provide a more detailed characterization
of the drug’s benefit-risk profile across
the patient population likely to use the
drug in clinical practice.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Cancer Clinical Trial Eligibility
Criteria: Laboratory Values.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). The collections of information in
21 CFR part 312 have been approved
under OMB control number 0910–0014;
the collections of information in 21 CFR
part 314 have been approved under
OMB control number 0910–0001; and
the collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338.
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III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: April 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–09039 Filed 4–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Proposed Inclusion of Terrain Factors
in the Definition of Rural Area for
Federal Office of Rural Health Policy
Grants
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
ACTION:
Request for public comment.
HRSA’s Federal Office of
Rural Health Policy (FORHP) utilizes
clear, consistent, and data-driven
methods of defining rural areas in the
United States for the purposes of
determining eligibility for its rural
health grant programs. FORHP monitors
ongoing national research and, as
appropriate, considers updates to its
definition. Because access to needed
health care is likely to be reduced when
roads are most difficult to traverse, with
this notice, FORHP proposes to modify
the definition of rural areas by
integrating the new Road Ruggedness
Scale (RRS) released in 2023 by the
Economic Research Service (ERS) of the
U.S. Department of Agriculture, which
characterizes topographic variability, or
ruggedness, of roads. This proposal does
not impact rural areas included in the
current FORHP definition. This notice
seeks public comment on FORHP’s
proposal. This notice also includes a
technical clarification explaining how
FORHP will use Census data to identify
outlying Metropolitan Statistical Area
counties that qualify as rural in future
updates given the U.S. Census Bureau’s
2020 Census terminology changes that
removed the categories of Urban
Clusters and Urbanized Areas.
SUMMARY:
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Federal Register / Vol. 89, No. 82 / Friday, April 26, 2024 / Notices
Submit comments no later than
May 28, 2024.
ADDRESSES: Comments should be
submitted to ruralpolicy@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
Greta Stuhlsatz, Statistician, Policy
Research Division, FORHP, HRSA, 5600
Fishers Lane, Rockville, Maryland
20857; (301) 443–0835; and
ruralpolicy@hrsa.gov.
SUPPLEMENTARY INFORMATION:
DATES:
Background
Section 711 of the Social Security Act
(42 U.S.C. 912) directs FORHP to advise
the Secretary of HHS on policies
affecting rural hospitals and health care
and coordinating activities within HHS
that relate to rural health care. Since the
1990s, FORHP has administered grants
that support activities related to
increasing access to health care in rural
areas. FORHP’s authorizing statute does
not, however, include a definition of
‘‘rural area.’’ To carry out this charge,
FORHP monitors ongoing national
research and analysis efforts related to
defining geographic areas and rurality.
As new methods and data become
available, FORHP may consider
revisions to the definition.
Historically, there have been two
principal definitions of ‘‘rural’’ that
were in use by the Federal Government:
The U.S. Census Bureau urban-rural
classification (https://www.census.gov/
programs-surveys/geography/guidance/
geo-areas/urban-rural.html) and the
Office of Management and Budget’s
definition of metropolitan, also called
metro, areas (https://www.census.gov/
programs-surveys/metro-micro.html).
Neither definition defined ‘‘rural’’
directly, but rather defined areas as
either ‘‘urban,’’ with all other territory
being ‘‘rural,’’ or as ‘‘metro,’’ with all
other territory being ‘‘non-metro.’’
Current FORHP Definition of Rural
Area
FORHP currently designates the
following areas as rural for purposes of
FORHP’s grant programs: 1
(1) All non-metro counties,
(2) All outlying metro counties
without an Urbanized Area,
(3) All metro census tracts with Rural
Urban Commuting Area (RUCA) codes
4–10, and
(4) Metro census tracts of at least 400
square miles in area with population
density of 35 or less per square mile
with RUCA codes 2–3.
FORHP’s current definition finds that
19.7 percent of the population, or
approximately 60.8 million people, live
in rural areas, and classifies 86 percent
of the land area of the United States as
rural (based on 2010 Census data; all
data will be updated when updated
RUCA codes are available using data
from the 2020 Census). Information on
whether individual addresses are within
a rural area can be identified in a search
tool at the HRSA Data Warehouse.2
HRSA updates the search tool as needed
to assist rural health grant applicants.
Adding Rugged Terrain Data to the
Definition of Rural Area
FORHP’s definition of rural area was
last updated in 2021.3 At that time,
some commenters suggested that
FORHP should further modify the
definition of rural area to account for
difficult and mountainous terrain
because travel on roads through such
terrain is more difficult and timeconsuming. FORHP did not have
national data that could consistently
identify areas of difficult terrain.
In 2023, the ERS published a report,
Characterizing Rugged Terrain in the
United States,4 which describes the
measurement of topographic variation
using the Terrain Ruggedness Index.
The ERS conducted a study to analyze
how population, population density,
and income vary by ruggedness and
rurality. The ERS produced two scales:
(1) The Area Ruggedness Scale (ARS)
measures the changes in elevation for all
terrain and classifies census tracts as: (1)
level, (2) nearly level, (3) slightly
rugged, (4) moderately rugged, (5)
highly rugged, and (6) extremely rugged.
This characterizes overall ruggedness in
the entire tract.
(2) The RRS measures the changes in
elevation beneath roads and classifies
census tracts as: (1) level, (2) nearly
level, (3) slightly rugged, (4) moderately
rugged, and (5) highly rugged. This
characterizes overall ruggedness along
roads in the tract.5
The RRS, or roads-only scale, helps to
study the impact of rugged terrain on
travel by vehicle. Based on the ERS
analysis of the RRS, population density
was highest, on average, for nearly level
census tracts (5,514 people per square
mile) and lowest for highly rugged
census tracts (3,390 people per square
mile).
TABLE 1—RRS CATEGORIES AND CENSUS TRACTS
Number of
census tracts
ddrumheller on DSK120RN23PROD with NOTICES1
RRS category
Percent of
census tracts
1—Level ...................................................................................................................................................................
2—Nearly level ........................................................................................................................................................
3—Slightly rugged ...................................................................................................................................................
4—Moderately rugged .............................................................................................................................................
5—Highly rugged .....................................................................................................................................................
47,740
16,297
5,518
1,956
1,254
65.6
22.4
7.6
2.7
1.7
Total ..................................................................................................................................................................
72,765
100.0
FORHP is proposing to expand its
definition of rural by incorporating the
RRS into the definition for purposes of
FORHP’s grant programs. All areas
included in the current definition
would remain included. The RRS
focuses on roads and the difficulty of
travelling in mountainous terrain, while
the ARS more generally classifies the
topography of the tract’s terrain. Access
to needed health care is likely to be
reduced when the roads are most
difficult to traverse. FORHP proposes
including census tracts of at least 20
square miles in area in metro counties
1 See the notice ‘‘Revised Geographic Eligibility
for Federal Office of Rural Health Policy Grants,’’
85 FR 59806 (Sept. 23, 2020), for a full description
of the methods and data sources used to develop
FORHP’s definition of rural areas. See the notice
‘‘Response to Comments on Revised Geographic
Eligibility for Federal Office of Rural Health Policy
Grants,’’ 86 FR 2418 (Jan. 12, 2021), for FORHP’s
current definition of rural areas. See Defining Rural
Population, https://www.hrsa.gov/rural-health/
about-us/what-is-rural.
2 HRSA Data Warehouse: https://data.hrsa.gov/
tools/rural-health.
3 ‘‘Response to Comments on Revised Geographic
Eligibility for Federal Office of Rural Health Policy
Grants.’’ 86 FR 2418 (Jan. 12, 2021).
4 Research Report No. ERR–322, August 2023.
Available at https://www.ers.usda.gov/publications/
pub-details/?pubid=107027.
5 ARS and RRS data are available at https://
www.ers.usda.gov/data-products/area-and-roadruggedness-scales/.
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Federal Register / Vol. 89, No. 82 / Friday, April 26, 2024 / Notices
with RRS 5 (highly rugged) and RUCA
code 2 or 3 in our definition of rural
area (tracts with RUCA codes 4–10
regardless of RRS are already included).
Some small area tracts within or on the
edge of cities can have rugged terrain
(e.g., State or local parks), but they are
very small size and adjacent to major
population centers.
FORHP estimates that including
census tracts that are at least 20 square
miles in area with RRS 5 and RUCA 2–
3 in the definition of rural area would
add 84 census tracts and approximately
an additional 304,834 people to the
60,758,275 people currently living in
FORHP-designated rural areas, an
increase of 0.5 percent in the total
number of people living in rural areas.
The number of eligible census tracts by
State is included in table 2.
Only tracts that meet all criteria—RRS
5 and RUCA 2–3 with an area over 20
square miles—would be newly eligible
under this proposed update. Tracts with
RRS 5 and RUCA code 1 could not be
classified as rural areas as tracts with
RUCA code 1 contain populations from
urban areas with over 50,000 residents.
Additionally, the RUCA code 1 tracts
located in metro counties are part of the
metropolitan area core and have
primary commuting flow within the
urban area.6 For example, San
Francisco, California has 31 census
tracts with RRS 5 and RUCA code 1, and
these small areas with rugged terrain
inside the metropolitan area core are not
rural in character.
TABLE 2—NUMBER OF CENSUS
TRACTS WITH RRS 5 AND RUCA
CODE 2 OR 3 AND AREA OVER 20
SQ. MILES, BY STATE
ddrumheller on DSK120RN23PROD with NOTICES1
State
New tracts
CA .........................................
OR ........................................
NC .........................................
WA ........................................
TN .........................................
CO ........................................
WV ........................................
MT .........................................
AK .........................................
MD ........................................
24
16
12
9
7
6
6
2
1
1
Total ...............................
84
Note: Data in this table are based on 2010
census tract geographies. For a complete list
of impacted census tracts see: https://
www.hrsa.gov/rural-health/about-us/what-isrural/data-files.
FORHP’s proposal to modify our
definition of rural area for purposes of
6 See the description of Rural-Urban Commuting
Area Codes at https://www.ers.usda.gov/dataproducts/rural-urban-commuting-area-codes.
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FORHP’s grant programs reflects efforts
to be responsive to stakeholder feedback
and target programs towards the
intended communities. Other rural
definitions for other purposes may be
set by statute or regulation or be
designed to meet different program
goals.
Notification of FORHP’s Technical
Clarification in Response to the U.S.
Census Bureau’s 2020 Census
Terminology Changes Removing Urban
Clusters and Urbanized Areas
Prior to the 2020 Census, the U.S.
Census Bureau designated two
categories of urban areas—Urban
Clusters (with a population of 2,500 to
49,999) and Urbanized Areas (with a
population of 50,000 or more). With the
elimination of these sub-categories to
differentiate urban areas with large and
small populations, the U.S. Census
Bureau now only designates urban areas
(population of 5,000 and up or housing
units of 2,000 or more) and does not
sub-categorize urban areas by size.
FORHP’s rural definition excludes
outlying metro counties with an
Urbanized Area. To retain the
distinction between urban areas with
population over and under 50,000 in
FORHP’s definition of rural area,
FORHP will identify and categorize
urban areas based on population size.
With this technical clarification, the
definition, ‘‘all outlying metro counties
with no urban population from an urban
area of 50,000 or more people,’’ will
replace ‘‘all outlying metro counties
without an urbanized area.’’
FORHP will use the urban area
population counts published by the U.S.
Census Bureau in the list of qualifying
urban areas for the 2020 Census (https://
www.census.gov/programs-surveys/
geography/guidance/geo-areas/urbanrural.html) to sub-categorize urban areas
as less than 50,000 people (e.g., a
population of 49,999 or fewer) and as
50,000 or more people in the next
update to rural area data files.
Consistent with our current definition,
FORHP will consider outlying metro
counties without population from urban
areas with 50,000 or more people as
rural areas, and the entire county would
be considered a rural area for our grant
programs.
There are 327 outlying metro counties
in the Office of Management and
Budget’s Bulletin No. 23–01, released
July 21, 2023, that have no population
part of an urban area with 50,000 or
more people. Outlying metro counties
with any population from urban areas
with 50,000 or more people would not
be considered rural areas, however
census tracts within those counties
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32453
would be considered rural areas if they
meet the RUCA criteria or the RUCA
and RRS criteria, as applicable.
Proposed FORHP Definition of Rural
Area Incorporating the RRS and the
Technical Clarification in Response to
Census Terminology Changes
FORHP proposes to designate the
following areas as rural for purposes of
FORHP’s grant programs:
(1) Non-metro counties,
(2) Outlying metro counties with no
urban population from an urban area of
50,000 or more people,
(3) Census tracts in metro counties
with RUCA codes 4–10,
(4) Census tracts in metro counties of
at least 400 square miles in area with
population density of 35 or less per
square mile with RUCA codes 2–3, and
(5) Census tracts in metro counties
with RRS 5 and RUCA codes 2–3 that
are at least 20 square miles in area.
Request for Public Comment
FORHP is proposing to modify the
current definition of rural area for
purposes of FORHP’s grant programs.
FORHP seeks comments from the public
on the proposed use of the RRS to
identify rural areas as described above.
This request for comments is issued
solely for information and planning
purposes; it does not constitute a
Request for Proposal, applications,
proposal abstracts, or quotations. This
request does not commit the
Government to contract for any supplies
or services or make a grant or
cooperative agreement award or take
any other official action. Further, HRSA
is not seeking proposals through this
request for comments and will not
accept unsolicited proposals.
Carole Johnson,
Administrator.
[FR Doc. 2024–08931 Filed 4–25–24; 8:45 am]
BILLING CODE 4165–15–P
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Office of the Secretary
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]]>Agencies
[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Notices]
[Pages 32451-32453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08931]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Proposed Inclusion of Terrain Factors in the Definition of Rural
Area for Federal Office of Rural Health Policy Grants
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: HRSA's Federal Office of Rural Health Policy (FORHP) utilizes
clear, consistent, and data-driven methods of defining rural areas in
the United States for the purposes of determining eligibility for its
rural health grant programs. FORHP monitors ongoing national research
and, as appropriate, considers updates to its definition. Because
access to needed health care is likely to be reduced when roads are
most difficult to traverse, with this notice, FORHP proposes to modify
the definition of rural areas by integrating the new Road Ruggedness
Scale (RRS) released in 2023 by the Economic Research Service (ERS) of
the U.S. Department of Agriculture, which characterizes topographic
variability, or ruggedness, of roads. This proposal does not impact
rural areas included in the current FORHP definition. This notice seeks
public comment on FORHP's proposal. This notice also includes a
technical clarification explaining how FORHP will use Census data to
identify outlying Metropolitan Statistical Area counties that qualify
as rural in future updates given the U.S. Census Bureau's 2020 Census
terminology changes that removed the categories of Urban Clusters and
Urbanized Areas.
[[Page 32452]]
DATES: Submit comments no later than May 28, 2024.
ADDRESSES: Comments should be submitted to [email protected].
FOR FURTHER INFORMATION CONTACT: Greta Stuhlsatz, Statistician, Policy
Research Division, FORHP, HRSA, 5600 Fishers Lane, Rockville, Maryland
20857; (301) 443-0835; and [email protected].
SUPPLEMENTARY INFORMATION:
Background
Section 711 of the Social Security Act (42 U.S.C. 912) directs
FORHP to advise the Secretary of HHS on policies affecting rural
hospitals and health care and coordinating activities within HHS that
relate to rural health care. Since the 1990s, FORHP has administered
grants that support activities related to increasing access to health
care in rural areas. FORHP's authorizing statute does not, however,
include a definition of ``rural area.'' To carry out this charge, FORHP
monitors ongoing national research and analysis efforts related to
defining geographic areas and rurality. As new methods and data become
available, FORHP may consider revisions to the definition.
Historically, there have been two principal definitions of
``rural'' that were in use by the Federal Government: The U.S. Census
Bureau urban-rural classification (https://www.census.gov/programs-surveys/geography/guidance/geo-areas/urban-rural.html) and the Office
of Management and Budget's definition of metropolitan, also called
metro, areas (https://www.census.gov/programs-surveys/metro-micro.html). Neither definition defined ``rural'' directly, but rather
defined areas as either ``urban,'' with all other territory being
``rural,'' or as ``metro,'' with all other territory being ``non-
metro.''
Current FORHP Definition of Rural Area
FORHP currently designates the following areas as rural for
purposes of FORHP's grant programs: \1\
---------------------------------------------------------------------------
\1\ See the notice ``Revised Geographic Eligibility for Federal
Office of Rural Health Policy Grants,'' 85 FR 59806 (Sept. 23,
2020), for a full description of the methods and data sources used
to develop FORHP's definition of rural areas. See the notice
``Response to Comments on Revised Geographic Eligibility for Federal
Office of Rural Health Policy Grants,'' 86 FR 2418 (Jan. 12, 2021),
for FORHP's current definition of rural areas. See Defining Rural
Population, https://www.hrsa.gov/rural-health/about-us/what-is-rural.
---------------------------------------------------------------------------
(1) All non-metro counties,
(2) All outlying metro counties without an Urbanized Area,
(3) All metro census tracts with Rural Urban Commuting Area (RUCA)
codes 4-10, and
(4) Metro census tracts of at least 400 square miles in area with
population density of 35 or less per square mile with RUCA codes 2-3.
FORHP's current definition finds that 19.7 percent of the
population, or approximately 60.8 million people, live in rural areas,
and classifies 86 percent of the land area of the United States as
rural (based on 2010 Census data; all data will be updated when updated
RUCA codes are available using data from the 2020 Census). Information
on whether individual addresses are within a rural area can be
identified in a search tool at the HRSA Data Warehouse.\2\ HRSA updates
the search tool as needed to assist rural health grant applicants.
---------------------------------------------------------------------------
\2\ HRSA Data Warehouse: https://data.hrsa.gov/tools/rural-health.
---------------------------------------------------------------------------
Adding Rugged Terrain Data to the Definition of Rural Area
FORHP's definition of rural area was last updated in 2021.\3\ At
that time, some commenters suggested that FORHP should further modify
the definition of rural area to account for difficult and mountainous
terrain because travel on roads through such terrain is more difficult
and time-consuming. FORHP did not have national data that could
consistently identify areas of difficult terrain.
---------------------------------------------------------------------------
\3\ ``Response to Comments on Revised Geographic Eligibility for
Federal Office of Rural Health Policy Grants.'' 86 FR 2418 (Jan. 12,
2021).
---------------------------------------------------------------------------
In 2023, the ERS published a report, Characterizing Rugged Terrain
in the United States,\4\ which describes the measurement of topographic
variation using the Terrain Ruggedness Index. The ERS conducted a study
to analyze how population, population density, and income vary by
ruggedness and rurality. The ERS produced two scales:
---------------------------------------------------------------------------
\4\ Research Report No. ERR-322, August 2023. Available at
https://www.ers.usda.gov/publications/pub-details/?pubid=107027.
---------------------------------------------------------------------------
(1) The Area Ruggedness Scale (ARS) measures the changes in
elevation for all terrain and classifies census tracts as: (1) level,
(2) nearly level, (3) slightly rugged, (4) moderately rugged, (5)
highly rugged, and (6) extremely rugged. This characterizes overall
ruggedness in the entire tract.
(2) The RRS measures the changes in elevation beneath roads and
classifies census tracts as: (1) level, (2) nearly level, (3) slightly
rugged, (4) moderately rugged, and (5) highly rugged. This
characterizes overall ruggedness along roads in the tract.\5\
---------------------------------------------------------------------------
\5\ ARS and RRS data are available at https://www.ers.usda.gov/data-products/area-and-road-ruggedness-scales/.
---------------------------------------------------------------------------
The RRS, or roads-only scale, helps to study the impact of rugged
terrain on travel by vehicle. Based on the ERS analysis of the RRS,
population density was highest, on average, for nearly level census
tracts (5,514 people per square mile) and lowest for highly rugged
census tracts (3,390 people per square mile).
Table 1--RRS Categories and Census Tracts
------------------------------------------------------------------------
Number of Percent of
RRS category census tracts census tracts
------------------------------------------------------------------------
1--Level................................ 47,740 65.6
2--Nearly level......................... 16,297 22.4
3--Slightly rugged...................... 5,518 7.6
4--Moderately rugged.................... 1,956 2.7
5--Highly rugged........................ 1,254 1.7
-------------------------------
Total............................... 72,765 100.0
------------------------------------------------------------------------
FORHP is proposing to expand its definition of rural by
incorporating the RRS into the definition for purposes of FORHP's grant
programs. All areas included in the current definition would remain
included. The RRS focuses on roads and the difficulty of travelling in
mountainous terrain, while the ARS more generally classifies the
topography of the tract's terrain. Access to needed health care is
likely to be reduced when the roads are most difficult to traverse.
FORHP proposes including census tracts of at least 20 square miles in
area in metro counties
[[Page 32453]]
with RRS 5 (highly rugged) and RUCA code 2 or 3 in our definition of
rural area (tracts with RUCA codes 4-10 regardless of RRS are already
included). Some small area tracts within or on the edge of cities can
have rugged terrain (e.g., State or local parks), but they are very
small size and adjacent to major population centers.
FORHP estimates that including census tracts that are at least 20
square miles in area with RRS 5 and RUCA 2-3 in the definition of rural
area would add 84 census tracts and approximately an additional 304,834
people to the 60,758,275 people currently living in FORHP-designated
rural areas, an increase of 0.5 percent in the total number of people
living in rural areas. The number of eligible census tracts by State is
included in table 2.
Only tracts that meet all criteria--RRS 5 and RUCA 2-3 with an area
over 20 square miles--would be newly eligible under this proposed
update. Tracts with RRS 5 and RUCA code 1 could not be classified as
rural areas as tracts with RUCA code 1 contain populations from urban
areas with over 50,000 residents. Additionally, the RUCA code 1 tracts
located in metro counties are part of the metropolitan area core and
have primary commuting flow within the urban area.\6\ For example, San
Francisco, California has 31 census tracts with RRS 5 and RUCA code 1,
and these small areas with rugged terrain inside the metropolitan area
core are not rural in character.
---------------------------------------------------------------------------
\6\ See the description of Rural-Urban Commuting Area Codes at
https://www.ers.usda.gov/data-products/rural-urban-commuting-area-codes.
Table 2--Number of Census Tracts With RRS 5 and RUCA Code 2 or 3 and
Area Over 20 Sq. Miles, by State
------------------------------------------------------------------------
State New tracts
------------------------------------------------------------------------
CA...................................................... 24
OR...................................................... 16
NC...................................................... 12
WA...................................................... 9
TN...................................................... 7
CO...................................................... 6
WV...................................................... 6
MT...................................................... 2
AK...................................................... 1
MD...................................................... 1
---------------
Total............................................... 84
------------------------------------------------------------------------
Note: Data in this table are based on 2010 census tract geographies. For
a complete list of impacted census tracts see: https://www.hrsa.gov/rural-health/about-us/what-is-rural/data-files.
FORHP's proposal to modify our definition of rural area for
purposes of FORHP's grant programs reflects efforts to be responsive to
stakeholder feedback and target programs towards the intended
communities. Other rural definitions for other purposes may be set by
statute or regulation or be designed to meet different program goals.
Notification of FORHP's Technical Clarification in Response to the U.S.
Census Bureau's 2020 Census Terminology Changes Removing Urban Clusters
and Urbanized Areas
Prior to the 2020 Census, the U.S. Census Bureau designated two
categories of urban areas--Urban Clusters (with a population of 2,500
to 49,999) and Urbanized Areas (with a population of 50,000 or more).
With the elimination of these sub-categories to differentiate urban
areas with large and small populations, the U.S. Census Bureau now only
designates urban areas (population of 5,000 and up or housing units of
2,000 or more) and does not sub-categorize urban areas by size. FORHP's
rural definition excludes outlying metro counties with an Urbanized
Area. To retain the distinction between urban areas with population
over and under 50,000 in FORHP's definition of rural area, FORHP will
identify and categorize urban areas based on population size. With this
technical clarification, the definition, ``all outlying metro counties
with no urban population from an urban area of 50,000 or more people,''
will replace ``all outlying metro counties without an urbanized area.''
FORHP will use the urban area population counts published by the
U.S. Census Bureau in the list of qualifying urban areas for the 2020
Census (https://www.census.gov/programs-surveys/geography/guidance/geo-areas/urban-rural.html) to sub-categorize urban areas as less than
50,000 people (e.g., a population of 49,999 or fewer) and as 50,000 or
more people in the next update to rural area data files. Consistent
with our current definition, FORHP will consider outlying metro
counties without population from urban areas with 50,000 or more people
as rural areas, and the entire county would be considered a rural area
for our grant programs.
There are 327 outlying metro counties in the Office of Management
and Budget's Bulletin No. 23-01, released July 21, 2023, that have no
population part of an urban area with 50,000 or more people. Outlying
metro counties with any population from urban areas with 50,000 or more
people would not be considered rural areas, however census tracts
within those counties would be considered rural areas if they meet the
RUCA criteria or the RUCA and RRS criteria, as applicable.
Proposed FORHP Definition of Rural Area Incorporating the RRS and the
Technical Clarification in Response to Census Terminology Changes
FORHP proposes to designate the following areas as rural for
purposes of FORHP's grant programs:
(1) Non-metro counties,
(2) Outlying metro counties with no urban population from an urban
area of 50,000 or more people,
(3) Census tracts in metro counties with RUCA codes 4-10,
(4) Census tracts in metro counties of at least 400 square miles in
area with population density of 35 or less per square mile with RUCA
codes 2-3, and
(5) Census tracts in metro counties with RRS 5 and RUCA codes 2-3
that are at least 20 square miles in area.
Request for Public Comment
FORHP is proposing to modify the current definition of rural area
for purposes of FORHP's grant programs. FORHP seeks comments from the
public on the proposed use of the RRS to identify rural areas as
described above.
This request for comments is issued solely for information and
planning purposes; it does not constitute a Request for Proposal,
applications, proposal abstracts, or quotations. This request does not
commit the Government to contract for any supplies or services or make
a grant or cooperative agreement award or take any other official
action. Further, HRSA is not seeking proposals through this request for
comments and will not accept unsolicited proposals.
Carole Johnson,
Administrator.
[FR Doc. 2024-08931 Filed 4-25-24; 8:45 am]
BILLING CODE 4165-15-P
