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

Published date30 July 2020
Citation85 FR 45895
Record Number2020-16458
SectionNotices
CourtHealth And Human Services Department
Federal Register, Volume 85 Issue 147 (Thursday, July 30, 2020)
[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
                

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