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Federal Register / Vol. 86, No. 19 / Monday, February 1, 2021 / Notices issues related to the Commissions charge. There will be an opportunity for limited oral comments each no more than 3 minutes in length at this virtual meeting. Virtual attendees who plan to provide oral comments at the Commission meeting during a designated time must register prior to the meeting at: https
kauffmaninc.adobeconnect.com/nccc_
feb_2021/event/event_info.html.
Written comments are welcome throughout the entire development process of the Commissions work and may be emailed to OHQ@hhs.gov.
Written comments should not exceed three pages in length.
Individuals who need special assistance, such as sign language interpretation or other reasonable accommodations, should indicate the special accommodation when registering online or by notifying Jennifer Gillissen at jennifer.gillissen@
kauffmaninc.com by February 8, 2021.
Authority: The National Clinical Care Commission is authorized by the National Clinical Care Commission Act Pub. L. 11580. The Commission is governed by provisions of the Federal Advisory Committee Act FACA, Public Law 92463, as amended 5 U.S.C., App. which sets forth standards for the formation and use of federal advisory committees.
Dated: January 25, 2021.
Dorothy A. Fink, Deputy Assistant Secretary for Womens Health, Office of the Assistant Secretary for Health.
FR Doc. 202102037 Filed 12921; 8:45 am BILLING CODE 415032P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID19 Hoarding Prevention Measures; Extension of Effective Date With Modifications Department of Health and Human Services HHS.
ACTION: Notice.
AGENCY:

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 COVID19 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
SUMMARY:

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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: 2022600365;
PaigeEzernack@hhs.gov.
SUPPLEMENTARY INFORMATION: On March 23, 2020, and in response to the spread of the virus associated with COVID19, President Trump signed Executive Order 13910 Executive Order to prevent hoarding of health and medical resources necessary to respond to the spread of COVID19 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 COVID19, such as personal protective equipment and sanitizing and disinfecting products, are appropriately distributed. This policy furthers the goal of protecting the Nations 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 COVID19 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.
455213, the term materials includes:
A any raw materials including minerals, metals, and advanced processed materials, commodities,
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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 COVID19 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. 202006641 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 78861:2017 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
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