Procurement of Certain Essential Medical Supplies To Address the COVID-19 Pandemic; Correction
| Published date | 16 December 2020 |
| Citation | 85 FR 81390 |
| Record Number | 2020-27766 |
| Section | Rules and Regulations |
| Court | Agency For International Development |
81390
Federal Register / Vol. 85, No. 242 / Wednesday, December 16, 2020 / Rules and Regulations
product- and manufacturer-specific, and
the present order does not address any
other product currently listed in 21 CFR
1308.34.
This order does not apply to the final,
packaged, and labeled products
‘‘containing an anabolic steroid, that are
expressly intended for administration
through implants to cattle or other
nonhuman species’’ where the products
‘‘have been approved by the Secretary of
Health and Human Services for such
administration.’’ 21 CFR 1308.26(a).
Under 21 U.S.C. 802(41)(B)(i), such
products are excepted from the
definition of an anabolic steroid without
undergoing the exemption process
described in 21 CFR 1308.33, and
without any evaluation or determination
of their abuse potential.
Opportunity for Comment
Pursuant to 21 CFR 1308.33, any
interested person may submit written
comments on, or objections to, the
denial of an exemption for any product
listed in this order, within 60 days of
the date of publication of this order, as
specified above. If any comments or
objections raise significant issues
regarding any finding of fact or
conclusion of law upon which this
order is based, the Assistant
Administrator, Diversion Control
Division, may reconsider the
application in light of the comments
and objections filed. 21 CFR 1308.33.
Thereafter, the Assistant Administrator
shall amend his original order as he
determines appropriate. Id.
William T. McDermott,
Assistant Administrator.
[FR Doc. 2020–25288 Filed 12–15–20; 8:45 am]
BILLING CODE 4410–09–P
AGENCY FOR INTERNATIONAL
DEVELOPMENT
22 CFR Part 228
[AID–2020–0004]
RIN 0412–AB02
Procurement of Certain Essential
Medical Supplies To Address the
COVID–19 Pandemic; Correction
AGENCY
: Agency for International
Development.
ACTION
: Correcting amendments.
SUMMARY
: On October 23, 2020, the
United States Agency for International
Development (USAID) issued 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
Emergency Medical Supplies (EMS)
required to address the COVID–19
pandemic worldwide. That TFR
inadvertently resulted in the deletion of
defined terms. This document corrects
the TFR by restoring those definitions.
DATES
: The rule is effective on
December 16, 2020, through April 30,
2021, and is applicable beginning
October 23, 2020.
FOR FURTHER INFORMATION CONTACT
:
Natalie J. Freeman (or designee),
Attorney Advisor, Office of the General
Counsel, USAID, 1300 Pennsylvania
Ave. NW, Washington, DC 20523,
GCFEDREGMailbox@usaid.gov.
SUPPLEMENTARY INFORMATION
: This
document corrects 22 CFR 228.01,
which was amended by the TFR
published in the Federal Register on
October 23, 2020 (85 FR 67443). The
TFR revised the definitions in § 228.01
by adding a new definition for
‘‘Essential medical supplies.’’ This new
definition was intended to be added to
the existing list in alphabetical order,
but it inadvertently resulted in the
deletion of the terms previously defined
in § 228.01. After publication,
stakeholders notified USAID of the
missing definitions, which are used
throughout 22 CFR part 228. This
document effectuates the intent of the
TFR by restoring the definitions in
§ 228.01 and adding the definition of
‘‘Essential medical supplies’’ to the
alphabetical list. This correction does
not otherwise affect the changes made
by the TFR to 22 CFR part 228, or its
effective dates of October 23, 2020,
through April 30, 2021.
List of Subjects in 22 CFR Part 228
Government procurement.
For the reasons discussed above, 22
CFR part 228 is corrected by making the
following correcting amendments:
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.
As used in this part, the following
terms shall have the following
meanings:
Advanced developing countries mean
those countries that are categorized by
the World Bank as upper middle income
countries according to their gross
national income per capita, except for
those countries in which USAID
provides assistance. USAID will
maintain a list of advanced developing
countries primarily based on the most
recent World Bank determinations, and
will make the list available in USAID’s
Automated Directives System, ADS 310.
This list will include determinations
made under § 228.17 of this part.
Available for purchase means for
commodities, that the commodity is
offered for sale in a country in the
authorized principal geographic code at
the time of purchase from the supplier,
irrespective of the place of manufacture
or production, unless it is a prohibited
source country. If applicable, the
commodity must also be able to be
serviced, and, if warrantied, have a
valid warranty. For services, available
for purchase means the service is
offered from a vendor which has
complied with nationality and foreign
government-owned organization
requirements of this regulation, and is
otherwise organized in a country in the
authorized principal geographic code
designated in an implementing
instrument. This definition does not
apply to procurements under the
geographic Code 935, see § 228.03 of
this part, because that geographic code
is for any country or area except for
prohibited source countries.
Commission means any payment or
allowance by a supplier to any person
for the contribution which that person
has made to secure the sale or contract
for the supplier or which that person
makes to securing on a continuing basis
similar sales or contracts for the
supplier.
Commodities or goods means any
material, article, supply, good, or
equipment.
Commodity-related services means
delivery services and/or incidental
services.
Cooperating country or recipient
country means the country receiving the
USAID assistance subject to this part
228, and includes all the countries
receiving assistance under a regional
program or project.
Delivery means the transfer to, or for
the account of, an importer of the right
to possession of a commodity, or, with
respect to a commodity-related service,
the rendering to, or for the account of,
an importer of any such service.
Delivery service means any service
customarily performed in a commercial
export or import transaction which is
necessary to affect a physical transfer of
commodities to the cooperating/
recipient country. Examples of such
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Federal Register / Vol. 85, No. 242 / Wednesday, December 16, 2020 / Rules and Regulations
services are the following: Export
packing, local drayage in the source
country (including waiting time at the
dock), ocean and other freight, loading,
heavy lift, wharfage, tollage, switching,
dumping and trimming, lighterage,
insurance, commodity inspection
services, and services of a freight
forwarder. ‘‘Delivery service’’ may also
include work and materials necessary to
meet USAID marking requirements.
Developing countries means those
countries that are categorized by the
World Bank as low or lower middle
income economies according to their
gross national income per capita, and
also includes all countries to which
USAID provides assistance. USAID will
maintain a list of developing countries
primarily based on the most recent
World Bank determinations, and will
make the list available in USAID’s
Automated Directives System, ADS 310.
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.
Free Port or Bonded Warehouse is a
special customs area with favorable
customs regulations (or no customs
duties and controls for transshipment).
Implementing instrument means a
binding relationship established
between USAID and an outside party or
parties to carry out USAID programs, by
authorizing the use of USAID funds
and/or nonfinancial resources for the
procurement of services or commodities
and/or commodity related services.
Implementing instruments include
specific conditions that apply to each
such procurement. Examples of such
instruments include contracts, grants,
cooperating agreements, and
interagency agreements.
Incidental services means services
such as installation, erection,
maintenance, or upgrading of USAID-
financed equipment, or the training of
personnel in the maintenance, operation
and use of such equipment, or similar
services provided for the authorized
disposition of such commodities.
Long term lease means, for purposes
of subpart B, a single lease of more than
180 calendar days; or repetitive or
intermittent leases under a single award
within a one-year period, which
cumulatively total more than 180
calendar days. A single lease may
consist of lease of one or more of the
same type of commodity within the
same lease term.
Motor vehicles means self-propelled
vehicles with passenger carriage
capacity, such as highway trucks,
passenger cars and buses, motorcycles,
scooters, motorized bicycles, ATVs, and
utility vehicles. Excluded from this
definition are ambulances,
snowmobiles, industrial vehicles for
materials handling and earthmoving,
such as lift trucks, tractors, graders,
scrapers, off-the-highway trucks (such
as off-road dump trucks), boats, and
other vehicles that are not designed for
travel at normal road speeds (40
kilometers per hour and above).
Mission means the USAID Mission,
office or representative in a cooperating/
recipient country.
Nationality refers to the place of legal
organization, ownership, citizenship, or
lawful permanent residence (or
equivalent immigration status to live
and work on a continuing basis) of
suppliers of commodities and services.
Pharmaceutical means any substance
intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of
diseases in humans or animals; any
substances (other than food) intended to
affect the structure or any function of
the body of humans or animals; and,
any substance intended for use as a
component in the above. The term
includes drugs, vitamins, oral
rehydration salts, biologicals, and some
in-vitro diagnostic reagents/test kits; but
does not include devices or their
components, parts, or accessories.
Contraceptives, including condoms, are
not included in this definition.
Prohibited sources means countries to
which assistance is prohibited by the
annual appropriations acts of Congress
or other statutes, or those subject to
other executive branch restrictions, such
as applicable sanctions administered by
the U.S. Treasury Department’s Office of
Foreign Assets Control. USAID
maintains a list of prohibited sources,
available in USAID’s Automated
Directives System, ADS 310.
Recipients and contractors. Recipient
has the same meaning as defined in 22
CFR 226.02, except that it shall include
non-U.S. individuals, entities and
organizations, as well as subrecipients.
Contractors mean those entities which
enter into a contract, as the term is
defined in 48 CFR part 2, with the U.S.
Government, and includes
subcontractors.
Services means the performance of
identifiable tasks, rather than the
delivery of an end item of supply.
Source means the country from which
a commodity is shipped to the
cooperating/recipient country or the
cooperating/recipient country itself if
the commodity is located therein at the
time of the purchase, irrespective of the
place of manufacture or production,
unless it is a prohibited source country.
Where, however, a commodity is
shipped from a free port or bonded
warehouse in the form in which
received therein, ‘‘source’’ means the
country from which the commodity was
shipped to the free port or bonded
warehouse.
Supplier means any person or
organization, governmental or
otherwise, who furnishes services,
commodities, and/or commodity related
services, including delivery or
incidental services, financed by USAID.
United States means the United States
of America, any State(s) of the United
States, the District of Columbia, and
areas of U.S. associated sovereignty,
including commonwealths, territories
and possessions.
USAID means the United States
Agency for International Development
or any successor agency, including
when applicable, each USAID Mission
or office abroad.
USAID Principal Geographic Code
means a USAID code which designates
a country, a group of countries, or an
otherwise defined area. The USAID
principal geographic codes for purposes
of procurement are described in
§ 228.03 of this part.
Suk J. Jin,
Deputy General Counsel, U.S. Agency for
International Development.
[FR Doc. 2020–27766 Filed 12–15–20; 8:45 am]
BILLING CODE 6116–02–P
DEPARTMENT OF TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9939]
RIN 1545–BP49
Qualified Transportation Fringe,
Transportation and Commuting
Expenses Under Section 274
AGENCY
: Internal Revenue Service (IRS),
Treasury.
ACTION
: Final Regulations.
SUMMARY
: This document contains final
regulations to implement legislative
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