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, 45895-45897 [2020-16458]
Download as PDF
<![CDATA[
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Notices
I. Background
Human Prescription Drug and Biological
Products—Content and Format.’’ The
final rule, Content and Format of
Labeling for Human Prescription Drug
and Biological Products; Requirements
for Pregnancy and Lactation Labeling,
referred to as the PLLR, which
published December 4, 2014 (79 FR
72063), modified the labeling
requirements for human prescription
drug and biological products. The PLLR
amended FDA’s regulations governing
the content and format of the
‘‘Pregnancy,’’ ‘‘Labor and Delivery,’’ and
‘‘Nursing Mothers’’ subsections of the
‘‘Use in Specific Populations’’ section of
the existing labeling for human
prescription drug and biological
products. This guidance is intended to
assist applicants in complying with the
content and format requirements of the
‘‘Pregnancy,’’ ‘‘Lactation,’’ and
‘‘Females and Males of Reproductive
Potential’’ subsections of labeling for
human prescription drug and biological
products, as described in the PLLR. This
draft guidance revises the draft guidance
of the same name issued December 4,
2014 (79 FR 72104). The revisions
provide clarification and additional
information on recommendations in
response to public comments and the
Agency’s regulatory experience
implementing the PLLR. Changes to this
draft guidance from the previous draft
guidance include the addition of the
following:
• Information on formatting, omitting
information, and pregnancy registries.
• Clarifying information related to the
Risk Summary heading, risk statements,
and human and animal data.
• Information on labeling for section
8.3 Females and Males of Reproductive
Potential, including information on
pregnancy testing, contraception, and
infertility.
• Procedural information on
implementation and submission of draft
labeling to the Agency for review.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Pregnancy, Lactation, and
Reproductive Potential: Labeling for
Human Prescription Drug and Biological
Products—Content and Format.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Pregnancy, Lactation, and
Reproductive Potential: Labeling for
II. Paperwork Reduction Act of 1995
FDA tentatively concludes that this
draft guidance contains no collection of
information. Therefore, clearance by the
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or Office of Communication,
Outreach, and Development, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Denise Johnson-Lyles, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6469,
Silver Spring, MD 20993–0002, 301–
796–6169; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:38 Jul 29, 2020
Jkt 250001
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
45895
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required.
However, this draft guidance refers to
previously approved collections of
information. These collections of
information are subject to review by the
OMB under the PRA. The collection of
information in 21 CFR 201.56 and
201.57 for preparing and submitting
labeling has been approved under OMB
control number 0910–0572. The
collections of information in 21 CFR
314.70 and 314.97 for submitting
supplements to an approved
application, in 21 CFR 314.50(e) for
submitting labeling for an application,
and in 21 CFR 314.90 for submitting
waiver requests for an application have
been approved under OMB control
number 0910–0001. The collection of
information in 21 CFR 601.12 for
submitting supplements to an approved
application has been approved under
OMB control number 0910–0338. In
addition, the information collection
provisions of the PLLR have been
approved under OMB control number
0910–0624.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, or https://
www.regulations.gov.
Dated: July 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–16530 Filed 7–29–20; 8:45 am]
BILLING CODE 4164–01–P
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
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 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,
SUMMARY:
E:\FR\FM\30JYN1.SGM
30JYN1
khammond on DSKJM1Z7X2PROD with NOTICES
45896
Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Notices
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;
PaigeEzernack@hhs.gov.
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
VerDate Sep<11>2014
16:38 Jul 29, 2020
Jkt 250001
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
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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 airpurifying 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 halfmask 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
E:\FR\FM\30JYN1.SGM
30JYN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 85, No. 147 / Thursday, July 30, 2020 / Notices
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
VerDate Sep<11>2014
16:38 Jul 29, 2020
Jkt 250001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on Combating AntibioticResistant Bacteria
Office of the Secretary, Office
of the Assistant Secretary for Health,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that a meeting is scheduled to be held
for the Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria
(PACCARB). The meeting will be open
to the public via webex and
teleconference; a pre-registered public
comment session will be held during
the meeting. Pre-registration is required
for members of the public who wish to
attend the meeting via webex/
teleconference. Individuals who wish to
send in their pre-recorded or written
public comments should send an email
to CARB@hhs.gov. Registration
information is available on the website
https://www.hhs.gov/paccarb and must
be completed by September 2, 2020.
Additional information about registering
for the meeting and providing public
comment can be obtained at https://
www.hhs.gov/paccarb on the Meetings
page.
SUMMARY:
The meeting is scheduled to be
held on September 9, 2020, from 12:00
p.m. to 3:30 p.m. and September 10,
2020, from 12:00 p.m. to 3:30 p.m. ET
(times are tentative and subject to
change). The confirmed times and
agenda items for the meeting will be
posted on the website for the PACCARB
at https://www.hhs.gov/paccarb when
this information becomes available. Preregistration for attending the meeting is
required to be completed no later than
September 2, 2020.
DATES:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
45897
Instructions regarding
attending this meeting virtually will be
posted one week prior to the meeting at:
https://www.hhs.gov/paccarb.
FOR FURTHER INFORMATION CONTACT:
Jomana Musmar, M.S., Ph.D.,
Designated Federal Officer, Presidential
Advisory Council on Combating
Antibiotic-Resistant Bacteria, Office of
the Assistant Secretary for Health, U.S.
Department of Health and Human
Services, Room L616, Switzer Building,
330 C. St. SW, Washington, DC 20201.
Phone: 202–746–1512; Email: CARB@
hhs.gov.
SUPPLEMENTARY INFORMATION: The
Presidential Advisory Council on
Combating Antibiotic-Resistant Bacteria
(PACCARB), established by Executive
Order 13676, is continued by Section
505 of Public Law 116–22, the
Pandemic and All-Hazards
Preparedness and Advancing Innovation
Act of 2019 (PAHPAIA). Activities and
duties of the Advisory Council are
governed by the provisions of the
Federal Advisory Committee Act
(FACA), Public Law 92–463, as
amended (5 U.S.C. App.), which sets
forth standards for the formation and
use of federal advisory committees.
The PACCARB shall advise and
provide information and
recommendations to the Secretary
regarding programs and policies
intended to reduce or combat antibioticresistant bacteria that may present a
public health threat and improve
capabilities to prevent, diagnose,
mitigate, or treat such resistance. The
PACCARB shall function solely for
advisory purposes.
Such advice, information, and
recommendations may be related to
improving: The effectiveness of
antibiotics; research and advanced
research on, and the development of,
improved and innovative methods for
combating or reducing antibiotic
resistance, including new treatments,
rapid point-of-care diagnostics,
alternatives to antibiotics, including
alternatives to animal antibiotics, and
antimicrobial stewardship activities;
surveillance of antibiotic-resistant
bacterial infections, including publicly
available and up-to-date information on
resistance to antibiotics; education for
health care providers and the public
with respect to up-to-date information
on antibiotic resistance and ways to
reduce or combat such resistance to
antibiotics related to humans and
animals; methods to prevent or reduce
the transmission of antibiotic-resistant
bacterial infections; including
stewardship programs; and coordination
with respect to international efforts in
ADDRESSES:
E:\FR\FM\30JYN1.SGM
30JYN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
