[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,

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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

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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