[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]


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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; Extension 
of Effective Date With Modifications

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 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; 
<a href="/cdn-cgi/l/email-protection#0e5e6f67696b4b746b7c606f6d654e66667d20696178"><span class="__cf_email__" data-cfemail="1e4e7f77797b5b647b6c707f7d755e76766d30797168">[email protected]</span></a>.

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


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