Procurement of Certain Essential Medical Supplies To Address the COVID-19 Pandemic, 67443-67446 [2020-16475]
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Federal Register / Vol. 85, No. 206 / Friday, October 23, 2020 / Rules and Regulations
warrant preparation of a regulatory
evaluation as the anticipated impact is
so minimal. Since this is a routine
matter that only affects air traffic
procedures and air navigation, it is
certified that this rule, when
promulgated, does not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
Environmental Review
The FAA has determined that this
airspace action of amending VOR
Federal airway V–187 qualifies for
categorical exclusion under the National
Environmental Policy Act and its
implementing regulations at 40 CFR part
1500, and in accordance with FAA
Order 1050.1F, Environmental Impacts:
Policies and Procedures, paragraph 5–
6.5a, which categorically excludes from
further environmental impact review
rulemaking actions that designate or
modify classes of airspace areas,
airways, routes, and reporting points
(see 14 CFR part 71, Designation of
Class A, B, C, D, and E Airspace Areas;
Air Traffic Service Routes; and
Reporting Points). As such, this action
is not expected to result in any
potentially significant environmental
impacts. In accordance with FAA Order
1050.1F, paragraph 5–2 regarding
Extraordinary Circumstances, the FAA
has reviewed this action for factors and
circumstances in which a normally
categorically excluded action may have
a significant environmental impact
requiring further analysis. The FAA has
determined that no extraordinary
circumstances exist that warrant
preparation of an environmental
assessment or environmental impact
study.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
The Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for part 71
continues to read as follows:
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■
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.11E,
■
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Airspace Designations and Reporting
Points, dated July 21, 2020, and
effective September 15, 2020, is
amended as follows:
Counsel, USAID, 1300 Pennsylvania
Ave. NW, Washington, DC 20523,
GCFEDREGMailbox@usaid.gov.
SUPPLEMENTARY INFORMATION:
Paragraph 6010(a)
Airways.
I. Background
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Domestic VOR Federal
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V–187 [Amended]
From Socorrow, NM; via INT Socorrow
015° and Albuquerque, NM, 160° radials:
Albuquerque, Rattlesnake, NM; 50 miles, 62
miles, 115 MSL, Grand Junction, CO; 75
miles, 50 miles, 112 MSL, Rock Springs, WY;
20 miles, 37 miles, 95 MSL, INT Rock
Springs 026° and Riverton, WY, 180° radials;
Riverton; Boysen Reservoir, WY; 9 miles, 78
miles, 105 MSL, Billings, MT; INT Billings
317° and Great Falls, MT, 122° radials; Great
Falls; Missoula, MT; Nez Perce, ID; Pasco,
WA; INT Pasco 321° and Ellensburg, WA,
107° radials; Ellensburg; INT Yakima 331°
and Ellensburg 274° radials. From Olympia;
to Astoria, OR.
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Issued in Washington, DC, on October 14,
2020.
Scott M. Rosenbloom,
Acting Manager, Rules and Regulations
Group.
[FR Doc. 2020–23083 Filed 10–22–20; 8:45 am]
BILLING CODE 4910–13–P
AGENCY FOR INTERNATIONAL
DEVELOPMENT
22 CFR Part 228
RIN 0412–AB02
Procurement of Certain Essential
Medical Supplies To Address the
COVID–19 Pandemic
Agency for International
Development.
ACTION: Temporary final rule.
AGENCY:
The United States Agency for
International Development (USAID) is
issuing a Temporary Final Rule (TFR)
amending our regulations to allow
USAID to waive ‘‘Source and
Nationality’’ rules to provide for
increased flexibility, targeting, and
speed of procurement of Essential
Medical Supplies (EMS) required to
address the COVID–19 pandemic
worldwide.
DATES: Effective date: This rule is
effective October 23, 2020 through April
30, 2021.
ADDRESSES: You may review the docket
by searching for Docket ID [AID–2020–
0004], via the Federal eRulemaking
Portal: https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Natalie J. Freeman (or designee),
Attorney Advisor, Office of the General
SUMMARY:
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A. The Current COVID–19 Pandemic in
the United States
Coronavirus Disease 2019 (COVID–19)
is a highly communicable infectious
disease caused by Severe Acute
Respiratory Syndrome Coronavirus 2
(SARS–CoV–2). On January 30, 2020,
the Director-General of the World
Health Organization (WHO) declared
the outbreak of COVID–19 a Public
Health Emergency of International
Concern under the International Health
Regulations. On January 31, 2020, the
HHS Secretary declared COVID–19 a
Public Health Emergency under Section
319 of the Public Health Service (PHS)
Act. 42 U.S.C. 247d. On March 11, 2020,
the WHO declared the COVID–19
outbreak a pandemic. On March 13,
2020, the President issued a declaration
of a national emergency under Sections
201 and 301 of the National
Emergencies Act, 50 U.S.C. 1601–1651,
and consistent with Section 1135 of the
Social Security Act, 42 U.S.C. 1320b–5.
See Proclamation on Declaring a
National Emergency Concerning the
Novel Coronavirus Disease (COVID–19)
Outbreak.
On March 13, 2020, the President also
declared a nationwide emergency under
Section 501(b) of the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121–5207
(the ‘‘Stafford Act’’), authorizing FEMA
to provide assistance for emergency
protective measures to respond to the
COVID–19 pandemic. Under the
Stafford Act, FEMA may direct USAID,
through a Mission Assignment, to use
its authorities and resources to meet
domestic needs, including making
available any EMS to FEMA.
As of May 21, 2020, there were over
1.5 million confirmed cases of COVID–
19 in the United States, resulting in over
93,000 deaths due to the disease, with
new cases and fatalities being reported
daily. Worldwide, there have been over
5 million confirmed cases, resulting in
over 328,000 deaths. Presently, there is
no vaccine that can prevent infection
with COVID–19, nor is there currently
any FDA-approved post-exposure
prophylaxis for people who may have
been exposed to COVID–19. Treatment
is limited to supportive (or palliative)
care for patients who need it. Clinical
management for hospitalized patients
with COVID–19 is focused on
supportive care for complications,
including supplemental oxygen and
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B. USAID’s Response to COVID–19
USAID is responding to the COVID–
19 pandemic with decisive action at
home and abroad. Our priorities in the
response are to protect the safety and
health security of our global workforce,
ensure that we can continue our lifesaving mission across the world, and
support partner countries in their
response to COVID–19.
USAID, together with the Department
of State, launched the Strategy for
Supplemental Funding to Prevent,
Prepare for, and Respond to Coronavirus
Abroad. Under Pillar 2 of this Strategy,
USAID addresses three components—
the emergency health response,
strengthening health security capacities
in affected countries, and helping to
rebuild health systems as part of
addressing the second order health
effects of the pandemic. As of April 24,
the USAID Bureau for Global Health
(GH), in response to the pandemic,
obligated $99 million from the
Emergency Reserve Fund for Infectious
Disease Outbreaks, and another
approximately $90 million of the total
$435 million Global Health Programs
COVID–19 supplemental. GH
programming has focused on the
following technical areas: Risk
communication and community
engagement; surveillance, rapid
response teams, and contact tracing;
port of entry; infection prevention and
control; laboratory systems; case
management; and response operations
and coordination. The provision of
commodities is critical for the
laboratory systems, case management,
and infection prevention and control
components. Under Pillar 3 of the
Strategy, USAID will prevent, prepare
for, and respond to COVID–19 in
existing complex emergency responses
and address potential humanitarian
consequences of the pandemic. Further,
under Pillar 4 of the Strategy, USAID
will prepare for, mitigate and address
second order economic, civilian
security, stabilization, and governance
effects of COVID–19. The provision of
commodities will be components of
these activities. In total, USAID
estimates that approximately $137
million may be used for providing
Essential Medical Supplies for overseas
use.
generally requires an agency to publish
a notice of proposed rulemaking in the
Federal Register and provide an
opportunity for public comment. This
requirement does not apply, however, if
the agency ‘‘for good cause finds . . .
that notice and public procedure
thereon are impracticable, unnecessary,
or contrary to the public interest.’’ 5
U.S.C. 553(b)(3)(B). The APA also
generally requires that an agency
publish an adopted rule in the Federal
Register at least 30 days before it
becomes effective. This requirement
does not apply, however, if the agency
finds good cause for making the rule
effective sooner. Section 553(d)(3).
The rates of COVID–19 infections and
the number of deaths caused by COVID–
19 are significantly increasing on a daily
basis worldwide. The demand for EMS
is increasing worldwide given the rising
number of infections. Second and
possibly third waves are expected
according to the medical experts. The
courts have recognized that concern for
public safety can constitute good cause
to bypass notice and comment
procedures. (See, Jifry v. F.A.A., 370
F.3d 1174, 1179–80 (D.C. Cir. 2004).)
The courts have further found that
immediate threats to human life and
physical security typically constitute an
important enough interest to justify use
of the good cause exception. (See,
Hawaii Helicopter Operators Ass’n v.
Federal Aviation Administration, 51
F.3d 212 (9th Cir. 1995).) This rule is
intended to help protect the public from
this immediate health threat by
providing USAID increased flexibility,
targeting, and speed of procurement of
EMS required to address the COVID–19
pandemic worldwide. Given the
temporary nature of this rule, its narrow
application to EMS, and the significant
and immediate threat to public health
and safety in the United States and
worldwide, the Agency finds that this
emergency is sufficiently compelling to
constitute good cause to forgo notice
and comment. It would be contrary to
the interest of public health and
contrary to our national security and
foreign policy interests to delay this
rule.
The rule is issued accordance with
section 604 of the Foreign Assistance
Act (FAA) of 1961, as amended, 22
U.S.C. 2354.
Under the authority of the FAA and
the APA, USAID issues this temporary
final rule.
C. Authorities
USAID is issuing this temporary final
rule as part of its response to the
COVID–19 pandemic. The
Administrative Procedure Act (‘‘APA’’)
II. Provisions of Temporary Final Rule
USAID is working directly with
governments, multilateral organizations,
NGOs, the private sector, and other
organizations responding on the ground
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failure, septic shock, and multi-organ
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to combat this dangerous pathogen. This
includes working with front-line
workers to slow the spread, care for
those affected by, and equip local
communities with the tools needed to
fight back against COVID–19.
Pandemics know no borders, and
therefore international cooperation is
vital. We will not successfully defeat
this pandemic threat, and avoid a
second or third wave, unless we fight it
around the world. That is why our
approach must include the necessary
tools and resources to protect the safety
and interests of Americans and ensure
the United States continues to lead on
the global response. The United States
industry is uniquely positioned to
produce EMS to support the
achievement of COVID–19 domestic and
international objectives. USAID’s
primary reliance on these sources
ensures the availability of these critical
supplies to assist countries affected by
COVID–19. This temporary final rule
allows flexibility to ensure those in
need around the world will have access
to lifesaving EMS to address COVID–19
when and where they need it. The
measures described in this rule are
being issued on a temporary basis from
October 23, 2020 through April 30,
2021.
Current regulations authorize the
following:
22 CFR 228.03(a) authorizes purchases
from Geographic Code 937, which is defined
as the United States, the cooperating/
recipient country, and developing countries
other than advanced developing countries,
and excluding prohibited sources.
It further allows for certain purchases from
Geographic Code 935, which is defined as
any area or country except prohibited
countries, based on additional statutory
authority or otherwise approved via a waiver
in accordance with Subpart D. Section
228.03(b).
For purchases under Support for Economic
and Democratic Development of the
Independent States of the Former Soviet
Union, § 228.03(c), the authorized principal
geographic codes are Code 937 and Code 110
(New Independent States).
Under the current provisions of 22
CFR part 228, USAID only has the
authority to expand the authorized
geographic scope under the waiver
provisions. The temporary final rule
allows USAID to prioritize the purchase
of EMS: From the United States only,
from the cooperating/recipient country,
from the geographic region to avoid
diverting supplies in short supply in the
United States, or from a nearby country.
‘‘Nearby country’’ means any bordering
country or any country that is in the
same geographical region as the country
receiving assistance, as defined by the
Department of State’s regional system
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(i.e., Africa; East Asia and Pacific;
Europe and Eurasia; Near East; South
and Central Asia; Western Hemisphere).
However, if, as determined by USAID
on a case-by-case basis, EMS is
unavailable from the United States, the
cooperating/recipient country, and a
nearby country; or is unavailable in
sufficient, reasonable, and available
quantities, or sufficient and reasonable
quality that is fit for the intended
purpose, procurement from Code 935 is
authorized.
III. Temporary Changes to 22 CFR Part
228
The below changes will remain in
effect until October 23, 2020 through
April 30, 2021.
22 CFR 228.11 is being amended to
require implementing partners to
receive approval from USAID before
purchasing EMS. This will allow USAID
to issue a waiver for the purchase of
EMS from the United States only, from
the cooperating/recipient country, from
specific geographic region, or from a
nearby country.
22 CFR 228.30 is being amended to
add subsection (e) which allows waivers
to geographic areas necessary for the
purchase of EMS to address the COVID–
19 pandemic. For example, it authorizes
purchases from the United States only,
or from nearby countries that may not
be included in Geographic Code 937. It
also authorizes purchases from the
cooperating/recipient country or from
certain geographic areas when there are
shortages in the United States. The
Agency plans to issue a waiver to
prioritize geographic areas for the
purchase of EMS to address the COVID–
19 pandemic.
IV. Regulatory Considerations and
Determinations
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A. Executive Orders 12866 and 13563
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits,
reducing costs, harmonizing rules, and
promoting flexibility. Section 3(f) of
Executive Order 12866 defines a
‘‘significant regulatory action’’ as an
action that is likely to result in a
regulation (1) having an annual effect on
the economy of $100 million or more in
any one year, or adversely and
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materially affecting a sector of the
economy, productivity, competition,
jobs, the environment, public health or
safety, or State, local, or tribal
governments or communities (also
referred to as ‘‘economically
significant’’); (2) creating a serious
inconsistency or otherwise interfering
with an action taken or planned by
another agency; (3) materially altering
the budgetary effects of entitlement
grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) raising novel legal or
policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in the Executive
Order.
This rule change narrowly applies to
EMS purchased to address the COVID–
19 pandemic. The estimated amount of
funding potentially affected is
approximately $137 million. Buying
from the United States only would
positively affect the United States
economy and help development of our
manufacturing capacity to respond to
future crises. USAID’s foreign assistance
mandate is unchanged. This rule has
been designated a ‘‘significant
regulatory action,’’ but not
‘‘economically significant,’’ under
Section 3(f) of Executive Order 12866.
This rule has been reviewed by the
Office of Management and Budget.
67445
PART 228—RULES FOR
PROCUREMENT OF COMMODITIES
AND SERVICES FINANCED BY USAID
1. The authority citation for 22 CFR
part 228 continues to read as follows:
■
Authority: Sec. 621, Pub. L. 87–195, 75
Stat. 445 (22 U.S.C. 2381), as amended, E.O.
12163, Sept. 29, 1979, 44 FR 56673: 3 CFR
1979 Comp., p. 435.
■
2. Revise § 228.01 to read as follows:
§ 228.01
Definitions.
Essential medical supplies means
personal protective equipment, medical
products and equipment,
pharmaceuticals, and other medical
countermeasures needed to address the
COVID–19 pandemic, which are in short
supply, as identified in the ‘‘Notice of
Designation of Scarce Materials or
Threatened Materials Subject to COVID–
19 Hoarding Prevention Measures’’
issued by the Department of Health and
Human Services (HHS) on March 25,
2020, as updated. USAID may designate
additional materials as ‘‘emergency
medical supplies’’ if deemed necessary
and will publish notice of these
additional materials in the Federal
Register.
■ 3. Revise § 228.11 to read as follows:
§ 228.11
Source of commodities.
There is no reporting or
documentation or other information
collection requirements under the Final
Rule that require analysis under the
Paperwork Reduction Act. 44 U.S.C.
3501–3583.
The source of all commodities
financed with Federal program funds
appropriated under the Foreign
Assistance Act of 1961, as amended,
shall be Code 937 (unless Code 935 or
110 are designated in the implementing
instrument), except for essential
medical supplies purchased to address
the COVID–19 pandemic, the source of
which must be approved by USAID
prior to purchase unless otherwise
directed by USAID. Procurements of
agricultural commodities, motor
vehicles, and pharmaceuticals must also
comply with the special procurement
rules in § 228.19. Recipients and
contractors are prohibited from engaging
suppliers of commodities in an
authorized country to import
commodities from a country outside of
the authorized principal geographic
codes for the purposes of circumventing
the requirements of this rule. Any
violation of this prohibition will result
in the disallowance by USAID of the
cost of the procurement of the subject
commodity.
■ 4. Revise § 228.30 to read as follows:
List of Subjects in 22 CFR Part 228
§ 228.30
B. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), the Office of
Information and Regulatory Affairs
designated this rule as not a ‘major rule’,
as defined by 5 U.S.C. 804(2).
C. Regulatory Flexibility Act
Pursuant to requirements set forth in
the Regulatory Flexibility Act (RFA), 5
U.S.C. 601–612, USAID has considered
the economic effect of the Temporary
Final Rule and has certified that its
provisions would not have a significant
economic effect on a substantial number
of small entities.
D. Paperwork Reduction Act
Government procurement.
For the reasons discussed in the
preamble, USAID amends 22 CFR part
228 as set forth below:
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General.
USAID may waive the rules contained
in subparts A, B, and C of this part
(except for prohibited sources as
defined in § 228.01, and §§ 228.21 and
228.22), in order to accomplish project
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or program objectives. Except for
paragraph (e) of this section, for any
waivers authorized, the principal
geographic code shall be Code 935, any
area or country but excluding prohibited
sources. All waivers must be in writing,
and where applicable, are limited to the
term established by the waiver. All
waiver decisions will be made solely on
the basis of the following criteria:
(a) Waivers to permit procurement
outside of Code 937 or 110 must be
based on a case by case determination
that:
(1) The provision of assistance
requires commodities or services of the
type that are not produced in and
available for purchase in Code 937 or
110;
(2) It is important to permit
procurement from a country not
specified in Code 937 or 110 to meet
unforeseen circumstance; or
(3) To promote efficiency in the use
of United States foreign assistance
resources, including to avoid
impairment of foreign assistance
objectives.
(b) Case by case waivers under
paragraph (a) of this section may be
made on the basis of a commodity or
service type or category, rather than
processing repeat, individual waivers
for an identical or substantially similar
commodity or service. Such waivers
may be approved on a regional, country,
or program basis. For purposes of
paragraph (a)(1) of this section,
‘‘produced in and available for purchase
in’’ shall have the same meaning as the
definition of ‘‘available for purchase’’ in
§ 228.01. A waiver under paragraph
(a)(1) of this section may also be based
on the fact that a commodity is not
available for purchase in Code 937 or
110 in sufficient, reasonable, and
available quantities or sufficient and
reasonable quality that is fit for the
intended purpose.
(c) A waiver to authorize procurement
from outside the United States of
agricultural commodities, motor
vehicles, and pharmaceuticals must
meet the requirements of § 228.19.
(d) Any individual transaction not
exceeding $25,000 (excluding essential
medical supplies purchased to address
the COVID–19 pandemic), excluding
those covered by special procurement
rules in § 228.19, and excluding
procurements from prohibited sources)
does not require a waiver and is hereby
authorized.
(e) For purchases of essential medical
supplies to address the COVID–19
pandemic, waivers shall be authorized
to the United States only, to the
cooperating/recipient country, and/or to
a nearby country. Nearby country means
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any bordering country or any country
that is in the same geographical region
as the country receiving assistance, as
defined by the Department of State’s
regional system. If, as determined by
USAID on a case by case basis, essential
medical supplies are unavailable from
the United States, the cooperating/
recipient country, and a nearby country,
or are unavailable in sufficient,
reasonable, and available quantities or
sufficient and reasonable quality that is
fit for the intended purpose,
procurement from Code 935 is
authorized.
Suk J. Jin,
Deputy General Counsel, U.S. Agency for
International Development.
[FR Doc. 2020–16475 Filed 10–22–20; 8:45 am]
BILLING CODE 6116–02–P
DEPARTMENT OF JUSTICE
Office of the Attorney General
28 CFR Part 0
AG Order No. 4877–2020
Department of Justice.
Final rule.
AGENCY:
ACTION:
This final rule authorizes the
Assistant Attorney General in charge of
the Criminal Division to perform the
functions of the ‘‘Designated Authority’’
under executive agreements on access to
data by foreign governments that either
designate the Attorney General or the
Department of Justice (the
‘‘Department’’) as such authority or
authorize the Attorney General to
specify a Designated Authority, and for
which the Attorney General has
designated the Criminal Division as
such authority. It also authorizes the
Assistant Attorney General to further
delegate that authority to officials in the
Criminal Division, including officials in
the Office of International Affairs
(‘‘OIA’’).
DATES: Effective: October 23, 2020.
FOR FURTHER INFORMATION CONTACT:
Vaughn Ary, Director, Office of
International Affairs, Criminal Division,
U.S. Department of Justice, Washington,
DC 20005; Telephone (202) 514–0000.
SUPPLEMENTARY INFORMATION: Congress
authorized the United States to enter
into executive agreements with foreign
governments under which the parties
afford each other reciprocal rights of
access to data covered by such
agreements in response to qualifying,
lawful orders. See Clarifying Lawful
Overseas Use of Data Act, Public Law
115–141, Div. V, Section 105(a) (March
SUMMARY:
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23, 2018), 18 U.S.C. 2523 (‘‘CLOUD
Act’’). The first such executive
agreement was concluded between the
Government of the United States of
America and the Government of the
United Kingdom of Great Britain and
Northern Ireland. See Agreement
between the Government of the United
States of America and the Government
of the United Kingdom of Great Britain
and Northern Ireland on Access to
Electronic Data for the Purpose of
Countering Serious Crime (October 3,
2019), available at https://
www.justice.gov/dag/cloudact (the
‘‘U.S.–U.K. Agreement’’). The U.S.–U.K.
Agreement provides that a ‘‘Designated
Authority’’ for each country shall
perform certain, specified functions
necessary to implement the agreement.
As applied to the United States,
‘‘Designated Authority’’ is defined
under the agreement as ‘‘the
governmental entity designated . . . by
the Attorney General. Id. at Article 1.8.
To address the requirements of this
executive agreement, the Attorney
General has designated the Criminal
Division as the ‘‘Designated Authority’’
in a Federal Register notice published
concurrently with this rule. The final
rule authorizes the Assistant Attorney
General in charge of the Criminal
Division to exercise the responsibilities
of the Designated Authority and
provides that the Assistant Attorney
General may further delegate those
responsibilities to officials within the
Criminal Division, including officials in
OIA. OIA serves as the Central
Authority for the United States with
respect to requests for information,
evidence and other assistance received
from and made to foreign authorities
under mutual legal assistance treaties,
multilateral conventions, and executive
agreements regarding legal assistance in
criminal matters. See 28 CFR 0.64–1
(authorizing the Assistant Attorney
General in charge of the Criminal
Division to re-delegate the duties of the
‘‘Central Authority’’ to certain officials
in OIA). Thus, OIA already carries out
responsibilities similar to those of a
Designated Authority under executive
agreements negotiated pursuant to 18
U.S.C. 2523.
To address future agreements of this
nature, this final rule applies to any
executive agreement under 18 U.S.C.
2523 that either designates the Attorney
General or the Department of Justice as
the Designated Authority or authorizes
the Attorney General to designate a
Designated Authority, and for which the
Attorney General has designated the
Criminal Division as such authority.
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]]>Agencies
[Federal Register Volume 85, Number 206 (Friday, October 23, 2020)]
[Rules and Regulations]
[Pages 67443-67446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16475]
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AGENCY FOR INTERNATIONAL DEVELOPMENT
22 CFR Part 228
RIN 0412-AB02
Procurement of Certain Essential Medical Supplies To Address the
COVID-19 Pandemic
AGENCY: Agency for International Development.
ACTION: Temporary final rule.
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SUMMARY: The United States Agency for International Development (USAID)
is issuing a Temporary Final Rule (TFR) amending our regulations to
allow USAID to waive ``Source and Nationality'' rules to provide for
increased flexibility, targeting, and speed of procurement of Essential
Medical Supplies (EMS) required to address the COVID-19 pandemic
worldwide.
DATES: Effective date: This rule is effective October 23, 2020 through
April 30, 2021.
ADDRESSES: You may review the docket by searching for Docket ID [AID-
2020-0004], via the Federal eRulemaking Portal: https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Natalie J. Freeman (or designee),
Attorney Advisor, Office of the General Counsel, USAID, 1300
Pennsylvania Ave. NW, Washington, DC 20523, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
A. The Current COVID-19 Pandemic in the United States
Coronavirus Disease 2019 (COVID-19) is a highly communicable
infectious disease caused by Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2). On January 30, 2020, the Director-General
of the World Health Organization (WHO) declared the outbreak of COVID-
19 a Public Health Emergency of International Concern under the
International Health Regulations. On January 31, 2020, the HHS
Secretary declared COVID-19 a Public Health Emergency under Section 319
of the Public Health Service (PHS) Act. 42 U.S.C. 247d. On March 11,
2020, the WHO declared the COVID-19 outbreak a pandemic. On March 13,
2020, the President issued a declaration of a national emergency under
Sections 201 and 301 of the National Emergencies Act, 50 U.S.C. 1601-
1651, and consistent with Section 1135 of the Social Security Act, 42
U.S.C. 1320b-5. See Proclamation on Declaring a National Emergency
Concerning the Novel Coronavirus Disease (COVID-19) Outbreak.
On March 13, 2020, the President also declared a nationwide
emergency under Section 501(b) of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the
``Stafford Act''), authorizing FEMA to provide assistance for emergency
protective measures to respond to the COVID-19 pandemic. Under the
Stafford Act, FEMA may direct USAID, through a Mission Assignment, to
use its authorities and resources to meet domestic needs, including
making available any EMS to FEMA.
As of May 21, 2020, there were over 1.5 million confirmed cases of
COVID-19 in the United States, resulting in over 93,000 deaths due to
the disease, with new cases and fatalities being reported daily.
Worldwide, there have been over 5 million confirmed cases, resulting in
over 328,000 deaths. Presently, there is no vaccine that can prevent
infection with COVID-19, nor is there currently any FDA-approved post-
exposure prophylaxis for people who may have been exposed to COVID-19.
Treatment is limited to supportive (or palliative) care for patients
who need it. Clinical management for hospitalized patients with COVID-
19 is focused on supportive care for complications, including
supplemental oxygen and
[[Page 67444]]
advanced organ support for respiratory failure, septic shock, and
multi-organ failure.
B. USAID's Response to COVID-19
USAID is responding to the COVID-19 pandemic with decisive action
at home and abroad. Our priorities in the response are to protect the
safety and health security of our global workforce, ensure that we can
continue our life-saving mission across the world, and support partner
countries in their response to COVID-19.
USAID, together with the Department of State, launched the Strategy
for Supplemental Funding to Prevent, Prepare for, and Respond to
Coronavirus Abroad. Under Pillar 2 of this Strategy, USAID addresses
three components--the emergency health response, strengthening health
security capacities in affected countries, and helping to rebuild
health systems as part of addressing the second order health effects of
the pandemic. As of April 24, the USAID Bureau for Global Health (GH),
in response to the pandemic, obligated $99 million from the Emergency
Reserve Fund for Infectious Disease Outbreaks, and another
approximately $90 million of the total $435 million Global Health
Programs COVID-19 supplemental. GH programming has focused on the
following technical areas: Risk communication and community engagement;
surveillance, rapid response teams, and contact tracing; port of entry;
infection prevention and control; laboratory systems; case management;
and response operations and coordination. The provision of commodities
is critical for the laboratory systems, case management, and infection
prevention and control components. Under Pillar 3 of the Strategy,
USAID will prevent, prepare for, and respond to COVID-19 in existing
complex emergency responses and address potential humanitarian
consequences of the pandemic. Further, under Pillar 4 of the Strategy,
USAID will prepare for, mitigate and address second order economic,
civilian security, stabilization, and governance effects of COVID-19.
The provision of commodities will be components of these activities. In
total, USAID estimates that approximately $137 million may be used for
providing Essential Medical Supplies for overseas use.
C. Authorities
USAID is issuing this temporary final rule as part of its response
to the COVID-19 pandemic. The Administrative Procedure Act (``APA'')
generally requires an agency to publish a notice of proposed rulemaking
in the Federal Register and provide an opportunity for public comment.
This requirement does not apply, however, if the agency ``for good
cause finds . . . that notice and public procedure thereon are
impracticable, unnecessary, or contrary to the public interest.'' 5
U.S.C. 553(b)(3)(B). The APA also generally requires that an agency
publish an adopted rule in the Federal Register at least 30 days before
it becomes effective. This requirement does not apply, however, if the
agency finds good cause for making the rule effective sooner. Section
553(d)(3).
The rates of COVID-19 infections and the number of deaths caused by
COVID-19 are significantly increasing on a daily basis worldwide. The
demand for EMS is increasing worldwide given the rising number of
infections. Second and possibly third waves are expected according to
the medical experts. The courts have recognized that concern for public
safety can constitute good cause to bypass notice and comment
procedures. (See, Jifry v. F.A.A., 370 F.3d 1174, 1179-80 (D.C. Cir.
2004).) The courts have further found that immediate threats to human
life and physical security typically constitute an important enough
interest to justify use of the good cause exception. (See, Hawaii
Helicopter Operators Ass'n v. Federal Aviation Administration, 51 F.3d
212 (9th Cir. 1995).) This rule is intended to help protect the public
from this immediate health threat by providing USAID increased
flexibility, targeting, and speed of procurement of EMS required to
address the COVID-19 pandemic worldwide. Given the temporary nature of
this rule, its narrow application to EMS, and the significant and
immediate threat to public health and safety in the United States and
worldwide, the Agency finds that this emergency is sufficiently
compelling to constitute good cause to forgo notice and comment. It
would be contrary to the interest of public health and contrary to our
national security and foreign policy interests to delay this rule.
The rule is issued accordance with section 604 of the Foreign
Assistance Act (FAA) of 1961, as amended, 22 U.S.C. 2354.
Under the authority of the FAA and the APA, USAID issues this
temporary final rule.
II. Provisions of Temporary Final Rule
USAID is working directly with governments, multilateral
organizations, NGOs, the private sector, and other organizations
responding on the ground to combat this dangerous pathogen. This
includes working with front-line workers to slow the spread, care for
those affected by, and equip local communities with the tools needed to
fight back against COVID-19. Pandemics know no borders, and therefore
international cooperation is vital. We will not successfully defeat
this pandemic threat, and avoid a second or third wave, unless we fight
it around the world. That is why our approach must include the
necessary tools and resources to protect the safety and interests of
Americans and ensure the United States continues to lead on the global
response. The United States industry is uniquely positioned to produce
EMS to support the achievement of COVID-19 domestic and international
objectives. USAID's primary reliance on these sources ensures the
availability of these critical supplies to assist countries affected by
COVID-19. This temporary final rule allows flexibility to ensure those
in need around the world will have access to lifesaving EMS to address
COVID-19 when and where they need it. The measures described in this
rule are being issued on a temporary basis from October 23, 2020
through April 30, 2021.
Current regulations authorize the following:
22 CFR 228.03(a) authorizes purchases from Geographic Code 937,
which is defined as the United States, the cooperating/recipient
country, and developing countries other than advanced developing
countries, and excluding prohibited sources.
It further allows for certain purchases from Geographic Code
935, which is defined as any area or country except prohibited
countries, based on additional statutory authority or otherwise
approved via a waiver in accordance with Subpart D. Section
228.03(b).
For purchases under Support for Economic and Democratic
Development of the Independent States of the Former Soviet Union,
Sec. 228.03(c), the authorized principal geographic codes are Code
937 and Code 110 (New Independent States).
Under the current provisions of 22 CFR part 228, USAID only has the
authority to expand the authorized geographic scope under the waiver
provisions. The temporary final rule allows USAID to prioritize the
purchase of EMS: From the United States only, from the cooperating/
recipient country, from the geographic region to avoid diverting
supplies in short supply in the United States, or from a nearby
country. ``Nearby country'' means any bordering country or any country
that is in the same geographical region as the country receiving
assistance, as defined by the Department of State's regional system
[[Page 67445]]
(i.e., Africa; East Asia and Pacific; Europe and Eurasia; Near East;
South and Central Asia; Western Hemisphere). However, if, as determined
by USAID on a case-by-case basis, EMS is unavailable from the United
States, the cooperating/recipient country, and a nearby country; or is
unavailable in sufficient, reasonable, and available quantities, or
sufficient and reasonable quality that is fit for the intended purpose,
procurement from Code 935 is authorized.
III. Temporary Changes to 22 CFR Part 228
The below changes will remain in effect until October 23, 2020
through April 30, 2021.
22 CFR 228.11 is being amended to require implementing partners to
receive approval from USAID before purchasing EMS. This will allow
USAID to issue a waiver for the purchase of EMS from the United States
only, from the cooperating/recipient country, from specific geographic
region, or from a nearby country.
22 CFR 228.30 is being amended to add subsection (e) which allows
waivers to geographic areas necessary for the purchase of EMS to
address the COVID-19 pandemic. For example, it authorizes purchases
from the United States only, or from nearby countries that may not be
included in Geographic Code 937. It also authorizes purchases from the
cooperating/recipient country or from certain geographic areas when
there are shortages in the United States. The Agency plans to issue a
waiver to prioritize geographic areas for the purchase of EMS to
address the COVID-19 pandemic.
IV. Regulatory Considerations and Determinations
A. Executive Orders 12866 and 13563
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Section 3(f) of Executive Order 12866 defines a ``significant
regulatory action'' as an action that is likely to result in a
regulation (1) having an annual effect on the economy of $100 million
or more in any one year, or adversely and materially affecting a sector
of the economy, productivity, competition, jobs, the environment,
public health or safety, or State, local, or tribal governments or
communities (also referred to as ``economically significant''); (2)
creating a serious inconsistency or otherwise interfering with an
action taken or planned by another agency; (3) materially altering the
budgetary effects of entitlement grants, user fees, or loan programs or
the rights and obligations of recipients thereof; or (4) raising novel
legal or policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in the Executive Order.
This rule change narrowly applies to EMS purchased to address the
COVID-19 pandemic. The estimated amount of funding potentially affected
is approximately $137 million. Buying from the United States only would
positively affect the United States economy and help development of our
manufacturing capacity to respond to future crises. USAID's foreign
assistance mandate is unchanged. This rule has been designated a
``significant regulatory action,'' but not ``economically
significant,'' under Section 3(f) of Executive Order 12866. This rule
has been reviewed by the Office of Management and Budget.
B. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a `major rule', as defined by 5 U.S.C. 804(2).
C. Regulatory Flexibility Act
Pursuant to requirements set forth in the Regulatory Flexibility
Act (RFA), 5 U.S.C. 601-612, USAID has considered the economic effect
of the Temporary Final Rule and has certified that its provisions would
not have a significant economic effect on a substantial number of small
entities.
D. Paperwork Reduction Act
There is no reporting or documentation or other information
collection requirements under the Final Rule that require analysis
under the Paperwork Reduction Act. 44 U.S.C. 3501-3583.
List of Subjects in 22 CFR Part 228
Government procurement.
For the reasons discussed in the preamble, USAID amends 22 CFR part
228 as set forth below:
PART 228--RULES FOR PROCUREMENT OF COMMODITIES AND SERVICES
FINANCED BY USAID
0
1. The authority citation for 22 CFR part 228 continues to read as
follows:
Authority: Sec. 621, Pub. L. 87-195, 75 Stat. 445 (22 U.S.C.
2381), as amended, E.O. 12163, Sept. 29, 1979, 44 FR 56673: 3 CFR
1979 Comp., p. 435.
0
2. Revise Sec. 228.01 to read as follows:
Sec. 228.01 Definitions.
Essential medical supplies means personal protective equipment,
medical products and equipment, pharmaceuticals, and other medical
countermeasures needed to address the COVID-19 pandemic, which are in
short supply, as identified in the ``Notice of Designation of Scarce
Materials or Threatened Materials Subject to COVID-19 Hoarding
Prevention Measures'' issued by the Department of Health and Human
Services (HHS) on March 25, 2020, as updated. USAID may designate
additional materials as ``emergency medical supplies'' if deemed
necessary and will publish notice of these additional materials in the
Federal Register.
0
3. Revise Sec. 228.11 to read as follows:
Sec. 228.11 Source of commodities.
The source of all commodities financed with Federal program funds
appropriated under the Foreign Assistance Act of 1961, as amended,
shall be Code 937 (unless Code 935 or 110 are designated in the
implementing instrument), except for essential medical supplies
purchased to address the COVID-19 pandemic, the source of which must be
approved by USAID prior to purchase unless otherwise directed by USAID.
Procurements of agricultural commodities, motor vehicles, and
pharmaceuticals must also comply with the special procurement rules in
Sec. 228.19. Recipients and contractors are prohibited from engaging
suppliers of commodities in an authorized country to import commodities
from a country outside of the authorized principal geographic codes for
the purposes of circumventing the requirements of this rule. Any
violation of this prohibition will result in the disallowance by USAID
of the cost of the procurement of the subject commodity.
0
4. Revise Sec. 228.30 to read as follows:
Sec. 228.30 General.
USAID may waive the rules contained in subparts A, B, and C of this
part (except for prohibited sources as defined in Sec. 228.01, and
Sec. Sec. 228.21 and 228.22), in order to accomplish project
[[Page 67446]]
or program objectives. Except for paragraph (e) of this section, for
any waivers authorized, the principal geographic code shall be Code
935, any area or country but excluding prohibited sources. All waivers
must be in writing, and where applicable, are limited to the term
established by the waiver. All waiver decisions will be made solely on
the basis of the following criteria:
(a) Waivers to permit procurement outside of Code 937 or 110 must
be based on a case by case determination that:
(1) The provision of assistance requires commodities or services of
the type that are not produced in and available for purchase in Code
937 or 110;
(2) It is important to permit procurement from a country not
specified in Code 937 or 110 to meet unforeseen circumstance; or
(3) To promote efficiency in the use of United States foreign
assistance resources, including to avoid impairment of foreign
assistance objectives.
(b) Case by case waivers under paragraph (a) of this section may be
made on the basis of a commodity or service type or category, rather
than processing repeat, individual waivers for an identical or
substantially similar commodity or service. Such waivers may be
approved on a regional, country, or program basis. For purposes of
paragraph (a)(1) of this section, ``produced in and available for
purchase in'' shall have the same meaning as the definition of
``available for purchase'' in Sec. 228.01. A waiver under paragraph
(a)(1) of this section may also be based on the fact that a commodity
is not available for purchase in Code 937 or 110 in sufficient,
reasonable, and available quantities or sufficient and reasonable
quality that is fit for the intended purpose.
(c) A waiver to authorize procurement from outside the United
States of agricultural commodities, motor vehicles, and pharmaceuticals
must meet the requirements of Sec. 228.19.
(d) Any individual transaction not exceeding $25,000 (excluding
essential medical supplies purchased to address the COVID-19 pandemic),
excluding those covered by special procurement rules in Sec. 228.19,
and excluding procurements from prohibited sources) does not require a
waiver and is hereby authorized.
(e) For purchases of essential medical supplies to address the
COVID-19 pandemic, waivers shall be authorized to the United States
only, to the cooperating/recipient country, and/or to a nearby country.
Nearby country means any bordering country or any country that is in
the same geographical region as the country receiving assistance, as
defined by the Department of State's regional system. If, as determined
by USAID on a case by case basis, essential medical supplies are
unavailable from the United States, the cooperating/recipient country,
and a nearby country, or are unavailable in sufficient, reasonable, and
available quantities or sufficient and reasonable quality that is fit
for the intended purpose, procurement from Code 935 is authorized.
Suk J. Jin,
Deputy General Counsel, U.S. Agency for International Development.
[FR Doc. 2020-16475 Filed 10-22-20; 8:45 am]
BILLING CODE 6116-02-P
