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