Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures; Extension of Effective Date With Modifications, 7731-7732 [2021-02102]
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Federal Register / Vol. 86, No. 19 / Monday, February 1, 2021 / Notices
issues related to the Commission’s
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limited oral comments (each no more
than 3 minutes in length) at this virtual
meeting. Virtual attendees who plan to
provide oral comments at the
Commission meeting during a
designated time must register prior to
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kauffmaninc.adobeconnect.com/nccc_
feb_2021/event/event_info.html.
Written comments are welcome
throughout the entire development
process of the Commission’s work and
may be emailed to OHQ@hhs.gov.
Written comments should not exceed
three pages in length.
Individuals who need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should indicate the
special accommodation when
registering online or by notifying
Jennifer Gillissen at jennifer.gillissen@
kauffmaninc.com by February 8, 2021.
Authority: The National Clinical Care
Commission is authorized by the
National Clinical Care Commission Act
(Pub. L. 115–80). The Commission is
governed by provisions of the Federal
Advisory Committee Act (FACA), Public
Law 92–463, as amended (5 U.S.C.,
App.) which sets forth standards for the
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Dated: January 25, 2021.
Dorothy A. Fink,
Deputy Assistant Secretary for Women’s
Health, Office of the Assistant Secretary for
Health.
[FR Doc. 2021–02037 Filed 1–29–21; 8:45 am]
BILLING CODE 4150–32–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Extension of Designation of Scarce
Materials or Threatened Materials
Subject to COVID–19 Hoarding
Prevention Measures; Extension of
Effective Date With Modifications
Department of Health and
Human Services (HHS).
ACTION: Notice.
AGENCY:
The Department of Health and
Human Services (HHS) provides notice
of the extension of the designation
issued on July 30, 2020 designating
health and medical resources necessary
to respond to the spread of the virus
associated with Coronavirus Disease
2019 (COVID–19) that are scarce or the
supply of which would be threatened by
excessive accumulation by people or
entities not needing the excess supplies.
This notice extends the designation and
SUMMARY:
VerDate Sep<11>2014
16:57 Jan 29, 2021
Jkt 253001
updates the list of scarce or threatened
materials to include certain classes and
sizes of hypodermic needles and
syringes.
DATES: This action took effect February
1, 2021 and terminates on June 30, 2021.
FOR FURTHER INFORMATION CONTACT:
Paige Ezernack: 202–260–0365;
PaigeEzernack@hhs.gov.
SUPPLEMENTARY INFORMATION: On March
23, 2020, and in response to the spread
of the virus associated with COVID–19,
President Trump signed Executive
Order 13910 (Executive Order) to
prevent hoarding of health and medical
resources necessary to respond to the
spread of COVID–19 within the United
States. As provided in the Executive
Order, it is the policy of the United
States that health and medical resources
needed to respond to the spread of
COVID–19, such as personal protective
equipment and sanitizing and
disinfecting products, are appropriately
distributed. This policy furthers the goal
of protecting the Nation’s healthcare
systems from undue strain.
Through the Executive Order, the
President delegated, to the Secretary of
Health and Human Services (the
Secretary), his authority under section
102 of the Defense Production Act of
1950, 50 U.S.C. 4512, as amended (the
Act), to prevent hoarding of health and
medical resources necessary to respond
to the spread of COVID–19 within the
United States, and his authority to
implement the Act in subsection III of
chapter 55 of title 50, United States
Code (50 U.S.C. 4554, 4555, 4556, and
4560). Under this delegation and the
Act, the Secretary may designate such
resources as scarce materials or
materials the supply of which would be
threatened by such accumulation
(threatened materials). The Secretary
may also prescribe conditions with
respect to accumulation of such
materials in excess of the reasonable
demands of business, personal, or home
consumption. The Act prohibits any
person or entity from accumulating
designated materials (1) in excess of the
reasonable demands of business,
personal, or home consumption, or (2)
for the purpose of resale at prices in
excess of prevailing market prices.
The March 25 Designation Notice
issued by HHS designates scarce
materials or threatened materials that
are subject to the hoarding prevention
measures authorized under the
Executive Order and the Act. See 85 FR
17592. (Mar. 30, 2020). Under 50 U.S.C.
4552(13), the term ‘‘materials’’ includes:
‘‘(A) any raw materials (including
minerals, metals, and advanced
processed materials), commodities,
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
7731
articles, components (including critical
components), products, and items of
supply; and (B) any technical
information or services ancillary to the
use of any such materials, commodities,
articles, components, products, or
items.’’ For purposes of the March 25
Designation Notice, the term ‘‘scarce
materials or threatened materials’’
means health or medical resources, or
any of their essential components,
determined by the Secretary to be
needed to respond to the spread of
COVID–19 and which are, or are likely
to be, in short supply or the supply of
which would be threatened by hoarding.
85 FR at 17592. Designated scarce
materials or threatened materials are
subject to periodic review by the
Secretary.
The designation is not a ‘‘regulation’’
under the Administrative Procedure Act
(APA). See 50 U.S.C. 4559 (providing an
exemption from the APA). To the extent
that it is, the Secretary finds that, in
light of the current pandemic, urgent
and compelling circumstances make
compliance with public comment
requirements impracticable. See Id.
The March 25 Designation Notice was
scheduled to terminate 120 days from
the date of publication, unless
superseded by a subsequent notice.
Given the ongoing pandemic, the
Secretary finds good cause to extend the
March 25 Designation Notice, as
modified by the June 30, 2020 and July
30, 2020 notices, through June 30, 2021.
The Secretary also finds good cause to
include the following modifications and
additions to the list of scarce or
threatened materials:
1. In FR Doc. 2020–06641 of March
30, 2020 (85 FR 17592), add the
following text:
(i) On page 17593, first column, (7)
Sterilization services, add ‘‘or are
authorized by FDA under section 564 of
the FD&C Act for purposes of
decontamination’’
(ii) On page 17593, first column, (11)
Face masks, remove ‘‘PPE’’
(iii) On page 17593, first column, (12)
Surgical masks, remove ‘‘PPE’’
2. Add ‘‘Syringes and hypodermic
needles (whether distributed separately
or attached together) generally used in
the United States for vaccinations that
are either:
(i) Piston syringes in 1 ml or 3 ml
sizes that allow for the controlled and
precise flow of liquid as described by 21
CFR 880.5860, that are compliant with
ISO 7886–1:2017 and use only Current
Good Manufacturing Practices (CGMP)
processes; or
(ii) Hypodermic single lumen needles
between 1″; and 1.5″ and 22 to 25 gauge
between 1″ and 1.5″ and 22 to 25 gauge
E:\FR\FM\01FEN1.SGM
01FEN1
7732
Federal Register / Vol. 86, No. 19 / Monday, February 1, 2021 / Notices
that have engineered sharps injury
protections as described in the
Needlestick Safety and Prevention Act,
Public Law 106–430, 114 Stat. 1901
(Nov. 6, 2000) and Occupational Safety
and Health Administration (OSHA)
standard 29 CFR 1910.1030, Bloodborne
Pathogens.’’
A copy of the Notice of the March 25
Designation, including the above
modifications and those included in the
June 30, 2020 and July 30, 2020 notices
is provided below and also can be found
on HHS’s website.
Notice of Designation of Scarce
Materials or Threatened Materials
Health or medical resources, or any of
their essential components, determined
by the Secretary of HHS to be needed to
respond to the spread of COVID–19 and
which are, or are likely to be, in short
supply (scarce materials) or the supply
of which would be threatened by
hoarding (threatened materials).
Designated scarce materials or
threatened materials are subject to
periodic review by the Secretary.
The following materials are
designated pursuant to section 102 of
the Defense Production Act (50 U.S.C.
4512) and Executive Order 13190 of
March 23, 2020 (Preventing Hoarding of
Health and Medical Resources to
Respond to the Spread of COVID–19) as
scarce materials or threatened materials:
1. N–95 Filtering Facepiece
Respirators, including devices that are
disposable half-face-piece non-powered
air-purifying particulate respirators
intended for use to cover the nose and
mouth of the wearer to help reduce
wearer exposure to pathogenic
biological airborne particulates
2. Other Filtering Facepiece
Respirators (e.g., those designated as
N99, N100, R95, R99, R100, or P95, P99,
P100), including single-use, disposable
half-mask respiratory protective devices
that cover the user’s airway (nose and
mouth) and offer protection from
particulate materials at or greater than
an N95 filtration efficiency level per 42
CFR 84.181.
3. Elastomeric, air-purifying
respirators and appropriate particulate
filters/cartridges
4. Powered Air Purifying Respirators
(PAPR)
5. Portable Ventilators, including
portable devices intended to
mechanically control or assist patient
breathing by delivering a predetermined
percentage of oxygen in the breathing
gas
6. Sterilization services for any device
as defined in section 201(h) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) and sterilizers as defined in
VerDate Sep<11>2014
16:57 Jan 29, 2021
Jkt 253001
21 CFR 880.6860, 880.6870, and
880.6880, including devices that already
have FDA marketing authorization and
those that do not have FDA marketing
authorization but are intended for the
same uses, or are authorized by FDA
under section 564 of the FD&C Act for
purposes of decontamination
7. Disinfecting devices intended to
kill pathogens and other kinds of
microorganisms by chemical means or
physical means, including those defined
in 21 CFR 876.1500, 880.6992, and
892.1570 and other sanitizing and
disinfecting products suitable for use in
a clinical setting
8. Medical gowns or apparel, e.g.,
surgical gowns or isolation gowns
9. Personal protective equipment
(PPE) coveralls, e.g., Tyvek Suits
10. Face masks, including any masks
that cover the user’s nose and mouth
and may or may not meet fluid barrier
or filtration efficiency levels
11. Surgical masks, including masks
that covers the user’s nose and mouth
and provides a physical barrier to fluids
and particulate materials
12. PPE face shields, including those
defined at 21 CFR 878.4040 and those
intended for the same purpose
13. PPE gloves or surgical gloves,
including those defined at 21 CFR
880.6250 (exam gloves) and 878.4460
(surgical gloves) and such gloves
intended for the same purposes
14. Ventilators, anesthesia gas
machines modified for use as
ventilators, and positive pressure
breathing devices modified for use as
ventilators (collectively referred to as
‘‘ventilators’’), ventilator tubing
connectors, and ventilator accessories as
those terms are described in FDA’s
March 2020 Enforcement Policy for
Ventilators and Accessories and Other
Respiratory Devices During the
Coronavirus Disease 2019 (COVID–19)
Public Health Emergency located at
https://www.fda.gov/media/136318/
download.
15. Laboratory reagents and materials
used for isolation of viral genetic
material and testing, such as transport
media, collection swabs, test kits and
reagents specific to those kits, and
consumables such as plastic pipette tips
and plastic tubes
16. Drug products currently
recommended by the NIH COVID–19
Treatment Guidelines Panel, including
(as of July 30, 2020) remdesivir and
dexamethasone
17. Alcohol-based (over 60 percent)
hand sanitizer and rubs.
18. Syringes and hypodermic needles
(whether distributed separately or
attached together) generally used in the
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
United States for vaccinations that are
either:
(i) Piston syringes in 1 ml or 3 ml
sizes that allow for the controlled and
precise flow of liquid as described by 21
CFR 880.5860, that are compliant with
ISO 7886–1:2017 and use only Current
Good Manufacturing Practices (CGMP)
processes; or
(ii) Hypodermic single lumen needles
between 1″ and 1.5″ and 22 to 25 gauge
between 1″ and 1.5″ and 22 to 25 gauge
that have engineered sharps injury
protections as described in the
Needlestick Safety and Prevention Act,
Public Law 106–430, 114 Stat. 1901
(Nov. 6, 2000) and OSHA standard 29
CFR 1910.1030, Bloodborne Pathogens.’’
Authority: The authority for this Notice is
Executive Order 13910 and section 102 of the
Defense Production Act of 1950, 50 U.S.C.
4512, as amended.
Norris Cochran,
Acting Secretary, Department of Health and
Human Services.
[FR Doc. 2021–02102 Filed 1–29–21; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Annual Update of the HHS Poverty
Guidelines
Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
This notice provides an
update of the Department of Health and
Human Services (HHS) poverty
guidelines to account for last calendar
year’s increase in prices as measured by
the Consumer Price Index.
DATES: Applicable: January 13, 2021
unless an office administering a
program using the guidelines specifies a
different effective date for that
particular program.
ADDRESSES: Office of the Assistant
Secretary for Planning and Evaluation,
Room 404E, Humphrey Building,
Department of Health and Human
Services, Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: For
information about how the guidelines
are used or how income is defined in a
particular program, contact the Federal,
state, or local office that is responsible
for that program. For information about
poverty figures for immigration forms,
the Hill-Burton Uncompensated
Services Program, and the number of
people in poverty, use the specific
telephone numbers and addresses given
below.
SUMMARY:
E:\FR\FM\01FEN1.SGM
01FEN1
]]>Agencies
[Federal Register Volume 86, Number 19 (Monday, February 1, 2021)]
[Notices]
[Pages 7731-7732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02102]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Extension of Designation of Scarce Materials or Threatened
Materials Subject to COVID-19 Hoarding Prevention Measures; Extension
of Effective Date With Modifications
AGENCY: Department of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Human Services (HHS) provides
notice of the extension of the designation issued on July 30, 2020
designating health and medical resources necessary to respond to the
spread of the virus associated with Coronavirus Disease 2019 (COVID-19)
that are scarce or the supply of which would be threatened by excessive
accumulation by people or entities not needing the excess supplies.
This notice extends the designation and updates the list of scarce or
threatened materials to include certain classes and sizes of hypodermic
needles and syringes.
DATES: This action took effect February 1, 2021 and terminates on June
30, 2021.
FOR FURTHER INFORMATION CONTACT: Paige Ezernack: 202-260-0365;
[email protected].
SUPPLEMENTARY INFORMATION: On March 23, 2020, and in response to the
spread of the virus associated with COVID-19, President Trump signed
Executive Order 13910 (Executive Order) to prevent hoarding of health
and medical resources necessary to respond to the spread of COVID-19
within the United States. As provided in the Executive Order, it is the
policy of the United States that health and medical resources needed to
respond to the spread of COVID-19, such as personal protective
equipment and sanitizing and disinfecting products, are appropriately
distributed. This policy furthers the goal of protecting the Nation's
healthcare systems from undue strain.
Through the Executive Order, the President delegated, to the
Secretary of Health and Human Services (the Secretary), his authority
under section 102 of the Defense Production Act of 1950, 50 U.S.C.
4512, as amended (the Act), to prevent hoarding of health and medical
resources necessary to respond to the spread of COVID-19 within the
United States, and his authority to implement the Act in subsection III
of chapter 55 of title 50, United States Code (50 U.S.C. 4554, 4555,
4556, and 4560). Under this delegation and the Act, the Secretary may
designate such resources as scarce materials or materials the supply of
which would be threatened by such accumulation (threatened materials).
The Secretary may also prescribe conditions with respect to
accumulation of such materials in excess of the reasonable demands of
business, personal, or home consumption. The Act prohibits any person
or entity from accumulating designated materials (1) in excess of the
reasonable demands of business, personal, or home consumption, or (2)
for the purpose of resale at prices in excess of prevailing market
prices.
The March 25 Designation Notice issued by HHS designates scarce
materials or threatened materials that are subject to the hoarding
prevention measures authorized under the Executive Order and the Act.
See 85 FR 17592. (Mar. 30, 2020). Under 50 U.S.C. 4552(13), the term
``materials'' includes: ``(A) any raw materials (including minerals,
metals, and advanced processed materials), commodities, articles,
components (including critical components), products, and items of
supply; and (B) any technical information or services ancillary to the
use of any such materials, commodities, articles, components, products,
or items.'' For purposes of the March 25 Designation Notice, the term
``scarce materials or threatened materials'' means health or medical
resources, or any of their essential components, determined by the
Secretary to be needed to respond to the spread of COVID-19 and which
are, or are likely to be, in short supply or the supply of which would
be threatened by hoarding. 85 FR at 17592. Designated scarce materials
or threatened materials are subject to periodic review by the
Secretary.
The designation is not a ``regulation'' under the Administrative
Procedure Act (APA). See 50 U.S.C. 4559 (providing an exemption from
the APA). To the extent that it is, the Secretary finds that, in light
of the current pandemic, urgent and compelling circumstances make
compliance with public comment requirements impracticable. See Id.
The March 25 Designation Notice was scheduled to terminate 120 days
from the date of publication, unless superseded by a subsequent notice.
Given the ongoing pandemic, the Secretary finds good cause to extend
the March 25 Designation Notice, as modified by the June 30, 2020 and
July 30, 2020 notices, through June 30, 2021. The Secretary also finds
good cause to include the following modifications and additions to the
list of scarce or threatened materials:
1. In FR Doc. 2020-06641 of March 30, 2020 (85 FR 17592), add the
following text:
(i) On page 17593, first column, (7) Sterilization services, add
``or are authorized by FDA under section 564 of the FD&C Act for
purposes of decontamination''
(ii) On page 17593, first column, (11) Face masks, remove ``PPE''
(iii) On page 17593, first column, (12) Surgical masks, remove
``PPE''
2. Add ``Syringes and hypodermic needles (whether distributed
separately or attached together) generally used in the United States
for vaccinations that are either:
(i) Piston syringes in 1 ml or 3 ml sizes that allow for the
controlled and precise flow of liquid as described by 21 CFR 880.5860,
that are compliant with ISO 7886-1:2017 and use only Current Good
Manufacturing Practices (CGMP) processes; or
(ii) Hypodermic single lumen needles between 1''; and 1.5'' and 22
to 25 gauge between 1'' and 1.5'' and 22 to 25 gauge
[[Page 7732]]
that have engineered sharps injury protections as described in the
Needlestick Safety and Prevention Act, Public Law 106-430, 114 Stat.
1901 (Nov. 6, 2000) and Occupational Safety and Health Administration
(OSHA) standard 29 CFR 1910.1030, Bloodborne Pathogens.''
A copy of the Notice of the March 25 Designation, including the
above modifications and those included in the June 30, 2020 and July
30, 2020 notices is provided below and also can be found on HHS's
website.
Notice of Designation of Scarce Materials or Threatened Materials
Health or medical resources, or any of their essential components,
determined by the Secretary of HHS to be needed to respond to the
spread of COVID-19 and which are, or are likely to be, in short supply
(scarce materials) or the supply of which would be threatened by
hoarding (threatened materials). Designated scarce materials or
threatened materials are subject to periodic review by the Secretary.
The following materials are designated pursuant to section 102 of
the Defense Production Act (50 U.S.C. 4512) and Executive Order 13190
of March 23, 2020 (Preventing Hoarding of Health and Medical Resources
to Respond to the Spread of COVID-19) as scarce materials or threatened
materials:
1. N-95 Filtering Facepiece Respirators, including devices that are
disposable half-face-piece non-powered air-purifying particulate
respirators intended for use to cover the nose and mouth of the wearer
to help reduce wearer exposure to pathogenic biological airborne
particulates
2. Other Filtering Facepiece Respirators (e.g., those designated as
N99, N100, R95, R99, R100, or P95, P99, P100), including single-use,
disposable half-mask respiratory protective devices that cover the
user's airway (nose and mouth) and offer protection from particulate
materials at or greater than an N95 filtration efficiency level per 42
CFR 84.181.
3. Elastomeric, air-purifying respirators and appropriate
particulate filters/cartridges
4. Powered Air Purifying Respirators (PAPR)
5. Portable Ventilators, including portable devices intended to
mechanically control or assist patient breathing by delivering a
predetermined percentage of oxygen in the breathing gas
6. Sterilization services for any device as defined in section
201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and
sterilizers as defined in 21 CFR 880.6860, 880.6870, and 880.6880,
including devices that already have FDA marketing authorization and
those that do not have FDA marketing authorization but are intended for
the same uses, or are authorized by FDA under section 564 of the FD&C
Act for purposes of decontamination
7. Disinfecting devices intended to kill pathogens and other kinds
of microorganisms by chemical means or physical means, including those
defined in 21 CFR 876.1500, 880.6992, and 892.1570 and other sanitizing
and disinfecting products suitable for use in a clinical setting
8. Medical gowns or apparel, e.g., surgical gowns or isolation
gowns
9. Personal protective equipment (PPE) coveralls, e.g., Tyvek Suits
10. Face masks, including any masks that cover the user's nose and
mouth and may or may not meet fluid barrier or filtration efficiency
levels
11. Surgical masks, including masks that covers the user's nose and
mouth and provides a physical barrier to fluids and particulate
materials
12. PPE face shields, including those defined at 21 CFR 878.4040
and those intended for the same purpose
13. PPE gloves or surgical gloves, including those defined at 21
CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such
gloves intended for the same purposes
14. Ventilators, anesthesia gas machines modified for use as
ventilators, and positive pressure breathing devices modified for use
as ventilators (collectively referred to as ``ventilators''),
ventilator tubing connectors, and ventilator accessories as those terms
are described in FDA's March 2020 Enforcement Policy for Ventilators
and Accessories and Other Respiratory Devices During the Coronavirus
Disease 2019 (COVID-19) Public Health Emergency located at https://www.fda.gov/media/136318/download.
15. Laboratory reagents and materials used for isolation of viral
genetic material and testing, such as transport media, collection
swabs, test kits and reagents specific to those kits, and consumables
such as plastic pipette tips and plastic tubes
16. Drug products currently recommended by the NIH COVID-19
Treatment Guidelines Panel, including (as of July 30, 2020) remdesivir
and dexamethasone
17. Alcohol-based (over 60 percent) hand sanitizer and rubs.
18. Syringes and hypodermic needles (whether distributed separately
or attached together) generally used in the United States for
vaccinations that are either:
(i) Piston syringes in 1 ml or 3 ml sizes that allow for the
controlled and precise flow of liquid as described by 21 CFR 880.5860,
that are compliant with ISO 7886-1:2017 and use only Current Good
Manufacturing Practices (CGMP) processes; or
(ii) Hypodermic single lumen needles between 1'' and 1.5'' and 22
to 25 gauge between 1'' and 1.5'' and 22 to 25 gauge that have
engineered sharps injury protections as described in the Needlestick
Safety and Prevention Act, Public Law 106-430, 114 Stat. 1901 (Nov. 6,
2000) and OSHA standard 29 CFR 1910.1030, Bloodborne Pathogens.''
Authority: The authority for this Notice is Executive Order
13910 and section 102 of the Defense Production Act of 1950, 50
U.S.C. 4512, as amended.
Norris Cochran,
Acting Secretary, Department of Health and Human Services.
[FR Doc. 2021-02102 Filed 1-29-21; 8:45 am]
BILLING CODE 4150-37-P
