[Federal Register Volume 85, Number 61 (Monday, March 30, 2020)]
[Notices]
[Pages 17592-17593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06641]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Notice of Designation of Scarce Materials or Threatened Materials 
Subject to COVID-19 Hoarding Prevention Measures

AGENCY: Department of Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Department of Health and Human Services (HHS) announces 
the issuance of a Notice under Executive Order 13910 (Executive order) 
and section 102 of the Defense Production Act of 1950 (the Act), as 
amended, designating health and medical resources necessary to respond 
to the spread of Coronavirus Disease 2019 (COVID-19) that are scarce or 
the supply of which would be threatened by excessive accumulation. 
These designated materials are subject to the hoarding prevention 
measures authorized under the Executive order and the Act. The Notice 
was issued on March 25, 2020.

DATES: This action took effect March 25, 2020.

FOR FURTHER INFORMATION CONTACT: Bryan Shuy: 202-703-8610; 
[email protected].

SUPPLEMENTARY INFORMATION: On March 23, 2020, and in response to the 
spread of 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 
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.
    HHS is issuing this Notice designating scarce materials or 
threatened materials that are subject to the hoarding prevention 
measures authorized under the Executive order and the Act. Under 50 
U.S.C. 4552(13), the term ``materials'' includes any raw materials 
(including minerals, metals, and advanced processed materials), 
commodities, articles, components (including critical components), 
products, and items of supply; and any technical information or 
services ancillary to the use of any such materials, commodities, 
articles, components, products, or items. For purposes of this 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. Designated scarce materials or 
threatened materials are subject to periodic review by the Secretary.
    This designation is not a ``regulation'' under the Act. See 50 
U.S.C. 4559. 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. This designation shall terminate after 120 days from the date 
of publication, unless superseded by a subsequent notice.
    A copy of the 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

[[Page 17593]]

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 
mechanically control or assist patient breathing by delivering a 
predetermined percentage of oxygen in the breathing gas
6. Drug product with active ingredient chloroquine phosphate or 
hydroxychloroquine HCl
7. 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
8. 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
9. Medical gowns or apparel, e.g., surgical gowns or isolation gowns
10. Personal protective equipment (PPE) coveralls, e.g., Tyvek Suits
11. 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
12. PPE surgical masks, including masks that covers the user's nose and 
mouth and provides a physical barrier to fluids and particulate 
materials
13. PPE face shields, including those defined at 21 CFR 878.4040 and 
those intended for the same purpose
14. 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
15. 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

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.

Wilma M. Robinson,
Deputy Executive Secretary, Department of Health and Human Services.
[FR Doc. 2020-06641 Filed 3-26-20; 11:15 am]
 BILLING CODE 4150-03-P