Response to Comments on Revised Geographic Eligibility for Federal Office of Rural Health Policy Grants
| Citation | 86 FR 2418 |
| Record Number | 2021-00443 |
| Published date | 12 January 2021 |
| Section | Notices |
| Court | Health And Human Services Department,Health Resources And Services Administration |
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Federal Register / Vol. 86, No. 7 / Tuesday, January 12, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Response to Comments on Revised
Geographic Eligibility for Federal
Office of Rural Health Policy Grants
AGENCY
: Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION
: Revised definition of rural area;
final response to comments.
SUMMARY
: HRSA’s Federal Office of
Rural Health Policy (FORHP) is
modifying the definition it uses of rural
for the determination of geographic
areas eligible to apply for or receive
services funded by FORHP’s rural
health grants. This notice revises the
definition of rural and responds to
comments received on proposed
modifications to how FORHP designates
areas to be eligible for rural health grant
programs published in the Federal
Register on September 23, 2020. After
consideration of the public comments
received, FORHP is adding Metropolitan
Statistical Area (MSA) counties that
contain no Urbanized Area (UA)
population to the areas eligible for rural
health grant programs.
DATES
: All proposed changes will go
into effect for new rural health grant
opportunities anticipated to start in
Fiscal Year 2022.
FOR FURTHER INFORMATION CONTACT
:
Steve Hirsch, Public Health Analyst,
FORHP, HRSA, 5600 Fishers Lane,
Mailstop 17W59D, Rockville, MD
20857. Phone: (301) 443–0835. Email:
ruralpolicy@hrsa.gov.
SUPPLEMENTARY INFORMATION
: FORHP
published a notice in the Federal
Register on September 23, 2020, (85 FR
59806) seeking public comment on
proposed modifications to how it
designates areas eligible for its rural
health grant programs. FORHP proposed
a data-driven methodology connected to
existing geographic identifiers that
could be applied nationally and be
applicable to the wide variation in rural
areas across the U.S.
FORHP uses the Office of
Management and Budget (OMB)’s list of
counties designated as part of a MSA as
the basis for determining eligibility to
apply for, or receive services funded by,
its rural health grant programs.
Currently, all areas within non-metro
counties (both Micropolitan counties
and counties with neither designation)
are considered rural and eligible for
rural health grants. FORHP also
designates census tracts within MSAs as
rural for grant purposes using Rural-
Urban Commuting Area (RUCA) codes
from the Economic Research Service
(ERS) of the U.S. Department of
Agriculture (USDA). These include all
census tracts inside MSAs with RUCA
codes 4–10 and 132 large area census
tracts with RUCA codes 2 and 3. The
132 MSA census tracts with RUCA
codes 2–3 are at least 400 square miles
in area with a population density of no
more than 35 people per square mile.
Information regarding FORHP’s
designation of rural is publicly available
on its website at: https://www.hrsa.gov/
rural-health/about-us/definition/
index.html and https://data.hrsa.gov/
tools/rural-health.
In the Federal Register notice
published in September 2020, FORHP
proposed modifying its existing rural
definition by adding outlying MSA
counties with no UA population to its
list of areas eligible to apply for and
receive services funded by FORHP’s
rural health grants. UAs are defined by
the Census Bureau as densely settled
areas with a total population of at least
50,000 people.
FORHP received 67 comments in
response to the Federal Register notice.
Following is a summary of the
comments received.
Over three quarters of the comments
received supported the proposal to add
outlying MSA counties with no UA
population to the list of areas eligible for
rural health grants. While most
comments supported the proposal,
several advised against adoption of the
proposal. There were also several
commenters who neither supported nor
opposed the proposal.
The comments in favor of the
proposal agreed with FORHP that
proximity to a Metropolitan area does
not mean a county is not rural in
character and that shifts in employment
and job creation have drawn people to
commute to jobs in MSAs even though
they still live in rural areas. Many
commenters noted that FORHP’s
proposal appropriately identified
populations that were rural in character
and did not include areas or
populations that were not rural in
character.
Those who opposed the proposed
modification did so for a variety of
reasons. These included:
1. There are limited resources
currently available for rural
populations. Increasing the number of
people and areas eligible will dilute the
resources available.
2. The proposed modification does
not include some areas that used to be
considered rural, and still should be,
but are now part of MSAs.
3. The proposal is too limited and
should more expansively define what is
rural.
4. The proposal, and the current
definition of what is eligible for rural
health grants, is too expansive and
includes areas that are not truly rural.
5. Determination of need in rural
areas should include whether areas are
‘‘underserved,’’ alternatively, the
determination should factor in
unemployment as another criteria.
Response to Comment 1: FORHP
understands commenters concerns that
expanding the number of areas eligible
to apply for rural health grants has the
potential to dilute available resources
for existing rural areas. At the same
time, it is important to identify the
entire rural population as objectively
and accurately as possible so that
resource allocation decisions can be
based on complete and accurate
information. The modification is
intended to more accurately identify
rural populations within MSAs.
Response to Comment 2: After every
Census, there is a process to identify
areas where population has increased or
decreased. Urban Clusters, which have
increased in population above the
49,999 limit, are re-designated as UA
and, vice versa, some UA may lose
population and be re-designated as
Urban Clusters. FORHP’s intent, with
the use of RUCA codes and this
proposed modification for counties with
no UA population, is to correctly
identify rural populations inside of
MSAs.
Response to Comment 3: FORHP is
proposing clear, quantitative criteria
using nationally available data for an
expansion of areas eligible for rural
health grants. FORHP has not identified
clear, quantitative criteria beyond what
was proposed.
Response to Comment 4: FORHP will
continue to use the best available means
it can to define rural areas.
Response to Comment 5: FORHP is
modifying its identification of rural
areas with this notice, consistent with
its program authority to award grants to
support rural health and rural health
care services. While rural areas are
frequently underserved and may
experience shortages of health care
providers, rurality and underservice are
not the same thing. Unemployment is
also a factor that does not determine
rurality since a rural area could have
high or low unemployment. Both could
be used as factor in grant awards, given
programmatic goals, but do not indicate
rurality.
Many of the commenters, both those
who supported and those who opposed
the proposed FORHP modifications,
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Federal Register / Vol. 86, No. 7 / Tuesday, January 12, 2021 / Notices
also suggested further modifications or
adjustments to the way FORHP defines
rural areas.
Comment: The most common
suggestion was that FORHP identify
difficult and mountainous terrain
because travel on roads through such
terrain is more difficult and time-
consuming.
Response to Comment: FORHP
recognizes that travel in difficult and
mountainous terrain, along with
distance, are often barriers to access to
health care.
The ERS of U.S. Department of
Agriculture was charged with
researching the feasibility of identifying
census tracts with difficult and
mountainous terrain in Senate Report
116–110—Agriculture, Rural
Development, Food and Drug
Administration, and related Agencies
Appropriations Bill, 2020. ERS
produces the RUCA codes that FORHP
uses to identify rural areas insides
MSAs. ERS has greater experience and
resources to analyze geography than
FORHP does. If ERS does add identifiers
for difficult and mountainous terrain to
the RUCA codes, FORHP will examine
the feasibility of using this information
to designate rural census tracts in
MSAs.
Comment: Many commenters
suggested specific Metropolitan
counties by name that they believed
should be designated as rural.
Response to Comment: Consistent
with other federal geographic standards,
FORHP seeks only to use appropriate
objective data to assess a geographic
unit to determine whether a place meets
those standards. FORHP cannot define
individual counties as rural without
having clear, data-driven criteria that
can be equitably applied.
Comment: Many commenters
suggested that FORHP consider
expanding eligibility to urban health
centers that primarily serve rural
populations.
Response to Comment: FORHP
implemented this suggestion after the
Coronavirus Aid, Relief, and Economic
Security Act (the CARES ACT, Pub. L.
116–136) reauthorized the Rural Health
Care Services Outreach, Rural Health
Network Development, and Small
Health Care Provider Quality
Improvement grant programs created by
Section 330A of the Public Health
Service Act (42 U.S.C. 254c). The
CARES Act changed the statutory
authority for Rural Health Care Services
Outreach and Rural Health Network
Development grants and expanded
eligibility to allow urban entities to
apply as the lead applicant for these
rural health grants as long as they serve
eligible rural populations.
Comment: Some commenters
suggested that FORHP should accept
state government-designated rural areas
for the purpose of eligibility for rural
health grant programs.
Response to Comment: FORHP
understands and supports the right of
states to develop definitions of rural that
meet their specific needs. In
determining eligibility for a federal
grant program that is national in scope,
the challenge for FORHP is having
consistent and objective standards that
can be applied consistently across the
entire country. For that reason, FORHP
uses quantitative standards that can be
applied nationally and consistently in
an administratively efficient manner.
Comment: Some commenters
suggested that FORHP allow individual
counties to request designations as
rural.
Response to Comment: FORHP
applies consistent quantitative
standards to identify rural areas and
populations across the nation as a
whole. An exception process for
individual counties would yield
inconsistent results.
Comment: Commenters suggested that
all providers with specific certifications
or special payment designations (e.g.,
Rural Health Clinics, Critical Access
Hospitals, etc.) from the Centers for
Medicare & Medicaid Services (CMS)
should be designated as eligible for rural
health grant programs and that FORHP
should coordinate the definition of rural
with CMS.
Response to Comment: Many of the
providers identified as ‘‘rural’’ by CMS
are classified using different standards
that are specific to each special
designation. In addition, some
designated providers are no longer
located in rural areas due to population
growth over time. They have maintained
their status due to reclassification or
grandfathering provisions specific to
those certification and payment
programs. In contrast, the purpose of
FORHP grants is to provide services to
the rural population, as determined by
a consistent, quantitative standard.
FORHP notes that hospitals or clinics
that have the CMS rural designation can
still apply for FORHP rural health grant
funding as long as they propose to serve
an eligible rural population. This
change was part of the recent re-
authorization of the Section 330A
programs described above. FORHP
believes this change will address some
of the concerns raised by commenters.
Comment: Several commenters
suggested grandfathering providers, as
legacy rural sites of care which would
enable those organizations to apply for
rural health grants even if they were no
longer located in a rural area.
Response to Comment: This comment
is similar, but not precisely the same as
the earlier comment that FORHP should
accept all providers with specific
certifications or special payment
designations from CMS as eligible for
rural health grants. The change in
statutory authority for the Section 330A
programs will allow these providers to
continue to apply for rural health grants
as long as they continue to serve rural
populations. Identifying and tracking
legacy rural sites of care would be
administratively unworkable and is not
needed to target services to rural
populations.
Comment: Several commenters
suggested that FORHP remove
incarcerated people from the total
population that makes up the UA core
of a MSA in cases where the UA
population would fall below the floor of
50,000.
Response to Comment: FORHP has
not identified a data source to
consistently determine the populations
of incarcerated people within the UA
boundaries. Without a standard,
national data source, FORHP cannot
calculate the number of incarcerated
people for every UA and determine
whether removal of this population
from a UA core would reduce the total
population below 50,000. In addition,
prison populations can fluctuate year to
year and there are administrative
challenges in validating data from local
sources.
Comment: Several commenters
suggested that FORHP remove college
students from UA population totals.
Response to Comment: As with the
population of incarcerated people
mentioned above, FORHP does not have
a national data source to identify the
student population of an UA. Students
are also able to access health care
resources in the community. Without a
standard, national data source, FORHP
cannot calculate the number of college
students for every UA and determine
whether removal of this population
from a UA core would reduce the total
population below 50,000. In addition,
there are administrative challenges in
validating data from local sources.
Comment: Several commenters
suggested that if FORHP does adopt the
proposed modification and increases the
number of people eligible to be served
by rural health grants, FORHP should
increase the funding available for grants.
Response to Comment: The level of
resources available for any federal
program is determined by Congress.
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Federal Register / Vol. 86, No. 7 / Tuesday, January 12, 2021 / Notices
1
FDA, Temporary Policy for Preparation of
Certain Alcohol-Based Hand Sanitizer Products
During the Public Health Emergency (COVID–19)
Guidance for Industry (Mar. 2020; updated Aug. 7,
2020).
2
Id. at 3.
3
Id.
4
Id.
5
An archived version of the website shows the
language at issue was not on the website as late as
December 29, 2020. See: https://web.archive.org/
web/20201229105739/https://www.fda.gov/drugs/
coronavirus-covid-19-drugs/hand-sanitizers-covid-
19.
6
This surprise, coupled with the guidance’s
silence on facility fees, raises reliance interests
concerns under the Supreme Court’s decision in
Department of Homeland Security v. Regents of the
University of California, 140 S. Ct. 1891 (2020).
Comment: Several Tribal
organizations wrote comments objecting
to the modification. They suggested that
all Tribal lands be defined as rural and
that funds be set aside solely for awards
to Tribal health providers.
Response to Comment: The statutory
authority for rural health grant programs
directs services at rural areas and
populations. FORHP understands the
unique challenges faced by Tribal
entities. Rural health grants can be and
have been awarded to Tribal
organizations located in rural areas.
With the changes in the authorization
for 330A programs, urban Tribal
providers can also apply for rural health
grants to serve rural populations.
FORHP cannot change rural health
funding to direct it to urban
populations, even if they are
underserved, or specify funding set-
asides for Tribal organizations.
Comment: Different commenters
suggested that FORHP use a
combination of population density,
travel time or distance, geographic
isolation, and access to resources to
designate rural areas, or that FORHP use
Frontier and Remote Area (FAR) Codes
to determine rurality.
Response to Comment: Commenters
did not suggest data sources that would
combine population density, travel time
or distance, geographic isolation, and
access to resources to provide a
consistent, nationally standard
definition of rural areas. FAR Codes
utilize population density and travel
time to designate different levels of
‘‘frontier’’ or remoteness. However,
much of the rural U.S. that is currently
eligible for rural health grants is not
designated as frontier and remote and
would lose eligibility if only FAR codes
were used.
FORHP thanks the public for their
comments. After consideration of the
public comments we received, FORHP
is implementing the modification as
proposed to expand its list of rural
areas. FORHP will add MSA counties
that contain no UA population to the
areas eligible for rural health grant
programs. Using the March 2020 update
of MSA delineations released by OMB,
295 counties will meet this criteria as
outlying MSA counties with no UA
population. The expanded eligibility
will go into effect for new rural health
grants awarded in fiscal year 2022.
FORHP will ensure information about
the expanded eligibility is available to
the public and update the Rural Health
Grants Eligibility Analyzer at https://
data.hrsa.gov/tools/rural-health for
fiscal year 2022 funding opportunities.
These changes reflect FORHP’s desire to
accurately identify areas that are rural in
character using a data-driven
methodology that relies on existing
geographic identifiers and utilizes
standard, national level data sources.
Thomas J. Engels,
Administrator.
[FR Doc. 2021–00443 Filed 1–11–21; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2020–N–2246]
Notice That Persons That Entered the
Over-the-Counter Drug Market To
Supply Hand Sanitizer During the
COVID–19 Public Health Emergency
Are Not Subject to the Over-the-
Counter Drug Monograph Facility Fee
AGENCY
: Food and Drug Administration
(FDA), Department of Health and
Human Services (HHS).
ACTION
: Notice.
SUMMARY
: The Department of Health and
Human Services is issuing this Notice to
clarify that persons that entered into the
over-the-counter drug industry for the
first time in order to supply hand
sanitizers during the COVID–19 Public
Health Emergency are not persons
subject to the facility fee the Secretary
is authorized to collect under section
744M of the Food, Drug, and Cosmetic
Act.
DATES
: January 12, 2021.
FOR FURTHER INFORMATION CONTACT
:
David Haas, Office of Financial
Management, Food and Drug
Administration, 4041 Powder Mill Rd.,
Rm. 61075, Beltsville, MD 20705–4304,
240–402 4585.
SUPPLEMENTARY INFORMATION
: On
December 29, 2020, FDA published a
Notice in the Federal Register entitled
Fee Rates Under the Over-the-Counter
Monograph User Fee Program for Fiscal
Year 2021. 85 FR 85646. The
Department since withdrew that Notice
because it was not approved by the
Secretary. For the reasons provided
below, the Department is clarifying that
persons that entered the over-the-
counter drug market to supply hand
sanitizer products in response to the
COVID–19 Public Health Emergency are
not subject to the facility fee the
Secretary is authorized to collect under
section 744M of the Food, Drug, and
Cosmetic Act (FD&C Act).
In March 2020, FDA issued a
temporary policy to enable increased
production of alcohol-based hand
sanitizers.
1
The agency acknowledged
‘‘that some consumers and health care
personnel are currently experiencing
difficulties accessing alcohol-based
hand sanitizers,’’ and that some were
relying on home-made hand sanitizers
as a result.
2
FDA issued the guidance in
response to requests from ‘‘certain
entities that are not currently regulated
by FDA as drug manufacturers’’ that
nevertheless rose up to meet this public
health need.
3
FDA stated it ‘‘does not
intend to take action against firms that’’
produce hand sanitizer products during
the COVID–19 Public Health
Emergency, provided the firm’s
activities are consistent with the
guidance.
4
The guidance, which FDA amended
after the Coronavirus Aid, Relief, and
Economic Security Act (‘‘CARES Act’’),
Public Law 116–136, 134 Stat. 281
(March 27, 2020) became law, contains
no mention of user or facility fees.
FDA’s website on Hand Sanitizers and
COVID–19, contains a sub-bullet under
the link to the guidance announcing that
‘‘the facility fee applies to all OTC hand
sanitizer manufacturers registered with
FDA, including facilities that
manufacture or process hand sanitizer
products under this temporary policy,’’
but that language was added about the
same time as the aforementioned
withdrawn Notice was published in the
Federal Register.
5
Entities that began
producing hand sanitizers in reliance on
the guidance were understandably
surprised when FDA contacted them to
collect an establishment fee in excess of
$14,000.
6
FDA’s purported authority for these
facility fees comes from the CARES Act.
In section 3862 of the CARES Act,
Congress provided the Secretary with
the authority to assess user and facility
fees from ‘‘each person that owns a
facility identified as an OTC drug
monograph facility on December 31 of
the fiscal year or at any time during the
preceding 12-month period.’’ FD&C Act
744M(a)(1)(A), 21 U.S.C. 379j–
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