2418 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 RuralUrban 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 2419 

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 timeconsuming. 

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 reauthorization 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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2420 Federal Register / Vol. 86, No. 7 / Tuesday, January 12, 2021 / Notices 

1FDA, 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. 

5An 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-covid19. 

6This 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 setasides 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-theCounter 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-thecounter 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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