[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Notices]
[Pages 45895-45897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16458]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Extension of Designation of Scarce Materials or Threatened
Materials Subject to COVID-19 Hoarding Prevention Measures Under
Executive Order 13910 and Section 102 of the Defense Production Act of
1950
AGENCY: Department of Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Department of Health and Human Services (HHS) provides
notice of the extension of the designation issued March 25, 2020 under
Executive Order 13910 (Executive Order) and section 102 of the Defense
Production Act of 1950 (the Act), 50 U.S.C. 4512,
[[Page 45896]]
as amended, 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 (March 25 Designation Notice). These designated
materials are subject to the hoarding prevention measures authorized
under the Executive Order and the Act. The March 25 Designation Notice
was subsequently published in the Federal Register on March 30, 2020.
See 85 FR 17592. On June 30, 2020, HHS updated the March 25 Designation
Notice to change the information contact and to remove chloroquine
phosphate and hydroxychloroquine HCl as a scarce or threated material.
This update was published in the Federal Register on July 7, 2020. See
85 FR 40667. Without extension, the March 25 Designation Notice would
terminate 120 days from publication. This notice, issued on July 23,
2020, extends the March 25 Designation Notice for an additional 120
days. This notice also includes modifications and additions to the
original list of scarce or threatened materials.
DATES: This action took effect July 23, 2020 and terminates January 19,
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 4660). 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 were, the Secretary finds that, in
light of the current global pandemic, urgent and compelling
circumstances make compliance with public comment requirements
impracticable. See id.
The March 25 Designation Notice was scheduled to terminate after
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 notice, for an additional 120 days. The Secretary also
finds good cause to include the following modifications and additions
to list of scarce or threatened materials:
1. Add ``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'';
2. Add ``drug products currently recommended by the NIH COVID-19
Treatment Guidelines Panel, including (as of July 23, 2020) remdesivir
and dexamethasone''; and
3. Add ``alcohol-based hand sanitizer and rubs.''
A copy of the Notice of the March 25 Designation, including the
above modifications and additions and as modified by the June 30, 2020
notice, 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 an N95 filtration efficiency level per 42 CFR 84.181
3. Elastomeric, air-purifying respirators and appropriate particulate
filters/cartridges
4. Powered Air Purifying Respirator (PAPR)
5. Portable Ventilators, including portable devices intended to
[[Page 45897]]
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 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
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. PPE 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. PPE 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 23, 2020) remdesivir and
dexamethasone
17. Alcohol-based hand sanitizer and rubs
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.
Dated: July 23, 2020.
Ann C. Agnew,
Executive Secretary, Department of Health and Human Services.
[FR Doc. 2020-16458 Filed 7-27-20; 4:15 pm]
BILLING CODE 4150-03-P