Extension of Designation of Scarce Materials or Threatened Materials Subject to COVID-19 Hoarding Prevention Measures; Extension of Effective Date With Modifications, 35810-35812 [2021-14383]
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35810
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
The Maternal, Infant, and Early
Childhood Home Visiting Program
Quarterly Performance Report, OMB No.
0906–0016, Revision
Abstract: This clearance request is for
continued approval of the Maternal,
Infant, and Early Childhood Home
Visiting (MIECHV) Program Quarterly
Performance Report. The MIECHV
Program, administered by HRSA in
partnership with the Administration for
Children and Families, supports
voluntary, evidence-based home visiting
services during pregnancy and to
parents with young children up to
kindergarten entry. States, certain nonprofit organizations, and tribal entities
are eligible to receive funding from the
MIECHV Program and have the
flexibility to tailor the program to serve
the specific needs of their communities.
HRSA is revising the data collection
forms for the MIECHV Program by
making the following changes:
• Form 4, reporting guidance: Revise
reporting instructions to reflect
updated reporting requirements
• Form 4, Definition of Key Terms:
Update definitions for Table A.1
• Form 4, Definition of Key Terms: Add
definitions for Table A.2
HRSA is also requesting approval to
expand the use of Form 4 in order to
collect quarterly performance data from
awardees who receive MIECHV funding
appropriated by section 9101 of the
American Rescue Plan Act (Pub. L. 117–
2).
Need and Proposed Use of the
Information: HRSA uses quarterly
performance information to demonstrate
program accountability and
continuously monitor and provide
oversight to MIECHV Program awardees.
The information is also used to provide
quality improvement guidance and
technical assistance to awardees and
help inform the development of early
childhood systems at the national, state,
and local level. HRSA is seeking to
revise reporting instructions and
definitions of key terms and to expand
the use of Form 4 in order to collect
distinct quarterly performance data
related to the use of the American
Rescue Plan Act funds. This notice is
subject to the appropriation of funds,
and is a contingency action taken to
ensure that, should funds become
available for this purpose, information
can be collected in a timely manner.
Likely Respondents: MIECHV Program
awardees that are states, territories, and,
where applicable, nonprofit
organizations receiving MIECHV
funding to provide home visiting
services within states.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden
per response
(in hours)
Number
of respondents
Number of
responses per
respondent
Form 4: Section A—Quarterly Performance Report ............
Form 4: Section B Quarterly Benchmark Performance
Measures ..........................................................................
56
8
448
24
10,752
10
4
40
200
8,000
Total ..............................................................................
* 56
........................
488
........................
18,752
Form
name
Total
responses
Total burden
hours
khammond on DSKJM1Z7X2PROD with NOTICES
* The 10 responses for Section B are a sub-set of 56 total awardees funded through the MIECHV Program.
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Maria G. Button,
Director, Executive Secretariat.
ACTION:
[FR Doc. 2021–14412 Filed 7–6–21; 8:45 am]
SUMMARY:
17:44 Jul 06, 2021
Extension of Designation of Scarce
Materials or Threatened Materials
Subject to COVID–19 Hoarding
Prevention Measures; Extension of
Effective Date With Modifications
Department of Health and
Human Services (HHS).
AGENCY:
Temporary notice; solicitation
of comments.
BILLING CODE 4165–15–P
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Office of the Secretary
Jkt 253001
The Department of Health and
Humans Services (HHS) provides notice
of the extension of the designation
issued on February 1, 2021, under
Executive Order 13910 (Executive
Order) and section 102 of the Defense
Production Act of 1950 (the Act), as
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
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. These
designated materials are subject to the
hoarding prevention measures
authorized under the Executive Order
and the Act.
DATES: This action took effect on July 1,
2021, and terminates on November 15,
2021. To be assured consideration,
comments on this extension and update
to the list of scarce or threatened
materials must be received at the
address provided below by August 6,
2021.
In commenting, please refer
to Paige Ezernack: 202–260–0365;
ADDRESSES:
E:\FR\FM\07JYN1.SGM
07JYN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices
paige.ezernack@hhs.gov. Comments,
including mass comment submissions,
must be submitted electronically. You
may submit electronic comments on this
regulation to https://
www.regulations.gov. Follow the
‘‘Submit a comment’’ instructions.
FOR FURTHER INFORMATION CONTACT:
Paige Ezernack: 202–260–0365;
paige.ezernack@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
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
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17:44 Jul 06, 2021
Jkt 253001
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 subject to the
Administrative Procedure Act (APA).
See 50 U.S.C. 4559(a) (providing an
exemption from the APA). Pursuant to
50 U.S.C. 4559(b)(2), the Secretary finds
that, in light of the current pandemic
and need to ensure Americans have
access to critical and life-saving health
resources, urgent and compelling
circumstances make compliance with
public comment requirements
impracticable prior to issuance. This
temporary Notice is therefore effective
immediately upon issuance, but the
Secretary will provide an opportunity
for 30 days of public comment before
finalizing. 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, July 30,
2020, and February 1, 2021 notices,
through November 15, 2021. The
Secretary also finds good cause to
remove the following materials from the
list because they are no longer scarce or
threatened materials:
1. In FR Doc. 2020–06641 of March
30, 2020 (85 FR 17592), remove the
following text:
1. N–95 Filtering Facepiece Respirators,
including devices that are
disposable half-face-piece nonpowered 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,
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
35811
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
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.
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
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07JYN1
35812
Federal Register / Vol. 86, No. 127 / Wednesday, July 7, 2021 / Notices
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.
17. Alcohol-based (over 60 percent)
hand sanitizer and rubs.
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. Medical gowns or apparel, e.g.,
surgical gowns or isolation gowns
2. 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
3. Drug products currently
recommended by the National Institutes
of Health COVID–19 Treatment
Guidelines Panel, including (as of April
21, 2021) remdesivir and
dexamethasone
4. 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.
Dated: June 30, 2021.
Xavier Becerra
Secretary, Department of Health and Human
Services.
[FR Doc. 2021–14383 Filed 7–2–21; 4:15 pm]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–4040–0001]
Agency Information Collection
Request: 60-Day Public Comment
Request
Office of the Secretary, Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before September 7,
2021.
SUMMARY:
Submit your comments
sagal.musa@hhs.gov or by calling (202)
205–2634.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 4040–0001–
Revision–60D and project title for
reference, to Sagal Musa, email:
sagal.musa@hhs.gov, or call (202) 205–
2634 the Reports Clearance Officer.
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: SBIR/STTR
Information.
Type of Collection: Revision of A
Currently Approved Collection.
OMB No.: 4040–0001.
Abstract: The SBIR (Small Business
Innovation Research)/STTR (Small
Business Technology Transfer) program
is designed to stimulate technological
innovation in the private sector by
strengthening the role of small business,
increasing the commercial application
of federally supported research results,
as well as fostering and encouraging
participation by socially and
economically disadvantaged and
women-owned small businesses. This
form is used by grant applicants to
apply for SBIR/STTR-related grants.
Grants.gov seeks to include a question
regarding the use of SBIR/STTR funds
for Technical and Business Assistance
(TABA).
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
ANNUALIZED BURDEN HOUR TABLE
Average
burden per
response
Respondents
(If necessary)
SBIR/STTR Information ....................
Grant Applicants ...............................
6,376
1
1
6,376
Total ...........................................
...........................................................
6,376
1
1
6,376
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17:44 Jul 06, 2021
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Frm 00084
Fmt 4703
Number of
respondents
Number of
responses per
respondents
Forms
(If necessary)
Sfmt 4703
E:\FR\FM\07JYN1.SGM
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Total
burden hours
]]>Agencies
[Federal Register Volume 86, Number 127 (Wednesday, July 7, 2021)]
[Notices]
[Pages 35810-35812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14383]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
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: Temporary notice; solicitation of comments.
-----------------------------------------------------------------------
SUMMARY: The Department of Health and Humans Services (HHS) provides
notice of the extension of the designation issued on February 1, 2021,
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 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.
These designated materials are subject to the hoarding prevention
measures authorized under the Executive Order and the Act.
DATES: This action took effect on July 1, 2021, and terminates on
November 15, 2021. To be assured consideration, comments on this
extension and update to the list of scarce or threatened materials must
be received at the address provided below by August 6, 2021.
ADDRESSES: In commenting, please refer to Paige Ezernack: 202-260-0365;
[[Page 35811]]
[email protected]. Comments, including mass comment submissions,
must be submitted electronically. You may submit electronic comments on
this regulation to https://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
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 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 subject to the Administrative Procedure Act
(APA). See 50 U.S.C. 4559(a) (providing an exemption from the APA).
Pursuant to 50 U.S.C. 4559(b)(2), the Secretary finds that, in light of
the current pandemic and need to ensure Americans have access to
critical and life-saving health resources, urgent and compelling
circumstances make compliance with public comment requirements
impracticable prior to issuance. This temporary Notice is therefore
effective immediately upon issuance, but the Secretary will provide an
opportunity for 30 days of public comment before finalizing. 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, July
30, 2020, and February 1, 2021 notices, through November 15, 2021. The
Secretary also finds good cause to remove the following materials from
the list because they are no longer scarce or threatened materials:
1. In FR Doc. 2020-06641 of March 30, 2020 (85 FR 17592), remove
the following text:
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
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.
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
[[Page 35812]]
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.
17. Alcohol-based (over 60 percent) hand sanitizer and rubs.
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. Medical gowns or apparel, e.g., surgical gowns or isolation
gowns
2. 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
3. Drug products currently recommended by the National Institutes
of Health COVID-19 Treatment Guidelines Panel, including (as of April
21, 2021) remdesivir and dexamethasone
4. 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.
Dated: June 30, 2021.
Xavier Becerra
Secretary, Department of Health and Human Services.
[FR Doc. 2021-14383 Filed 7-2-21; 4:15 pm]
BILLING CODE 4150-37-P
