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– 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 7 / Tuesday, January 12, 2021 / Notices 2421 

72(a)(1)(A). An ‘‘OTC drug monograph 

facility’’ is defined, in relevant part, as 

‘‘a foreign or domestic business or other 

entity that is under one management, 

either direct or indirect; and at one 

geographic location or address engaged 

in manufacturing or processing the 

finished dosage form of an OTC 

monograph drug.’’ FD&C Act 

744L(10)(A)(i)(I)–(II), 21 U.S.C. 379j– 

71(10)(A)(i)(I)–(II). 

The Department has concluded that 

persons that entered the over-thecounter drug market in order to produce 

hand sanitizers in reliance on the 

guidance cited above are not ‘‘identified 

as . . . OTC drug monograph 

facilit[ies]’’ and are thus not subject to 

the facility fees authorized under 

section 744M of the FD&CT Act, 21 

U.S.C. 379j–72. The Department reached 

this conclusion for two reasons. First, as 

the guidance itself acknowledges, the 

parties at issue are not in the drug 

manufacturing business. Many of them 

produce alcoholic beverages. These 

entities do not hold themselves out to 

the public as drug makers nor does the 

public generally encounter them as 

such. Under the extraordinary 

circumstances presented by the COVID– 

19 pandemic, the Department declines 

to identify these entities as OTC drug 

manufacturing facilities. 

Second, imposing facility fees on 

these entities is inconsistent with 

Congress’ stated intent elsewhere in the 

CARES Act. Section 2308 of the Act 

provides a temporary exemption from 

excise taxes for distilled spirits ‘‘use[d] 

in or contained in hand sanitizer 

produced and distributed in a manner 

consistent with any guidance issued by 

the Food and Drug Administration that 

is related to the outbreak of virus SARS– 

CoV–2 or coronavirus disease 2019 

(COVID–19).’’ It is unlikely Congress 

intended to save these entities from 

excise taxes only to impose tens of 

thousands of dollars in facility fees from 

an unfamiliar regulator. The Department 

declines to discern such a design under 

these circumstances. 

In conclusion, the Department 

clarifies that persons that were not 

registered with FDA as drug 

manufacturers prior to the COVID–19 

Public Health Emergency, which then 

later registered with FDA for the 

purpose of producing hand sanitizers, 

are not ‘‘identified’’ as ‘‘OTC drug 

manufacturing facilit[ies]’’ under 

section 744M of the FD&C Act, 21 

U.S.C. 379j–72, and are thus not subject 

to the facility fee contained therein. The 

Department’s conclusion does not apply 

to such persons which (1) manufacture, 

distribute, and sell over-the-counter 

drugs in addition to hand sanitizer or (2) 

continue to manufacture (as opposed to 

hold, distribute, or sell existing 

inventories) hand sanitizer products as 

of December 31 of the year immediately 

following the year during which the 

COVID–19 Public Health Emergency is 

terminated. In those cases, the 

Department may identify such persons 

as OTC drug manufacturing facilities. 

Dated: January 5, 2021. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–00237 Filed 1–8–21; 1:30 pm] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Heart, Lung, and 

Blood Initial Review Group; Clinical Trials 

Review Committee. 

Date: February 25–26, 2021. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6705 

Rockledge Drive, Bethesda, MD 20817 

(Virtual Meeting). 

Contact Person: Keary A. Cope, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, National Institutes of Health, 

6705 Rockledge Drive, Room 209–A, 

Bethesda, MD 20892–7924, (301) 827–7912, 

copeka@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: January 6, 2021. 

David W. Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–00344 Filed 1–11–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Cell Biology 

Integrated Review Group; Development—1 

Study Section. 

Date: February 8–9, 2021. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Zubaida Saifudeen, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20817, zubaida.saifudeen@nih.gov. 

Name of Committee: Brain Disorders and 

Clinical Neuroscience Integrated Review 

Group; Brain Injury and Neurovascular 

Pathologies Study Section. 

Date: February 8–9, 2021. 

Time: 10:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Alexander Yakovlev, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5206, 

MSC 7846, Bethesda, MD 20892, 301–435– 

1254, yakovleva@csr.nih.gov. 

Name of Committee: Cell Biology 

Integrated Review Group; Nuclear and 

Cytoplasmic Structure/Function and 

Dynamics Study Section. 

Date: February 8–9, 2021. 

Time: 11:00 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 


khammond on DSKJM1Z7X2PROD with NOTICES