National Heart, Lung, and Blood Institute; Notice of Closed Meeting
| Published date | 12 January 2021 |
| Citation | 86 FR 2421 |
| Record Number | 2021-00344 |
| Section | Notices |
| Court | National Institutes Of Health |
2421
Federal Register / Vol. 86, No. 7 / Tuesday, January 12, 2021 / Notices
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-the-
counter 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.
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