Procurement of Certain Essential Medical Supplies To Address the COVID-19 Pandemic
| Published date | 10 May 2021 |
| Citation | 86 FR 24708 |
| Record Number | 2021-09821 |
| Section | Rules and Regulations |
| Court | Agency For International Development |
24708
Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Rules and Regulations
§ 1310.09 Temporary exemption from
registration.
* * * * *
(q)(1) Each person required under 21
U.S.C. 822 and 957 to obtain a
registration to manufacture, distribute,
import, or export regulated forms of 3,4-
MDP-2-P methyl glycidate (PMK
glycidate), 3,4-MDP-2-P methyl glycidic
acid (PMK glycidic acid), and alpha-
phenylacetoacetamide (APAA),
including regulated chemical mixtures
pursuant to § 1310.12, is temporarily
exempted from the registration
requirement, provided that DEA
receives a properly completed
application for registration or
application for exemption for a
chemical mixture containing regulated
forms of 3,4-MDP-2-P methyl glycidate
(PMK glycidate), 3,4-MDP-2-P methyl
glycidic acid (PMK glycidic acid), or
alpha-phenylacetoacetamide (APAA)
pursuant to § 1310.13 on or before (30
days after publication of a rule
implementing regulations regarding
these three chemicals). The exemption
will remain in effect for each person
who has made such application until
the Administration has approved or
denied that application. This exemption
applies only to registration; all other
chemical control requirements set forth
in the Act and parts 1309, 1310, 1313,
and 1316 of this chapter remain in full
force and effect.
(2) Any person who manufactures,
distributes, imports or exports a
chemical mixture containing regulated
forms of 3,4-MDP-2-P methyl glycidate
(PMK glycidate), 3,4-MDP-2-P methyl
glycidic acid (PMK glycidic acid), or
alpha-phenylacetoacetamide (APAA)
whose application for exemption is
subsequently denied by DEA must
obtain a registration with DEA. A
temporary exemption from the
registration requirement will also be
provided for those persons whose
applications for exemption are denied,
provided that DEA receives a properly
completed application for registration
on or before 30 days following the date
of official DEA notification that the
application for exemption has been
denied. The temporary exemption for
such persons will remain in effect until
DEA takes final action on their
registration application.
■5. In § 1310.12, in paragraph (c), add
in alphanumerical order entries for 3,4-
MDP-2-P methyl glycidate (PMK
glycidate), 3,4-MDP-2-P methyl glycidic
acid (PMK glycidic acid), and alpha-
phenylacetoacetamide (APAA) in the
table ‘‘Table of Concentration Limits’’ to
read as follows:
§ 1310.12 Exempt chemical mixtures.
* * * * *
(c) * * *
T
ABLE OF
C
ONCENTRATION
L
IMITS
DEA
chemical
code no. Concentration Special conditions
*******
3,4-MDP-2-P methyl glycidate (PMK glycidate) and
its optical and geometric isomers. 8535 Not exempt at any con-
centration. Chemical mixtures containing any amount of this
chemical are not exempt.
3,4-MDP-2-P methyl glycidic acid (PMK glycidic
acid) and its salts, optical and geometric iso-
mers, and salts of isomers.
8525 Not exempt at any con-
centration. Chemical mixtures containing any amount of this
chemical are not exempt.
Alpha-phenylacetoacetamide (APAA) and its opti-
cal isomers. 8515 Not exempt at any con-
centration. Chemical mixtures containing any amount of this
chemical are not exempt.
*******
* * * * *
D. Christopher Evans,
Acting Administrator.
[FR Doc. 2021–09697 Filed 5–7–21; 8:45 am]
BILLING CODE 4410–09–P
AGENCY FOR INTERNATIONAL
DEVELOPMENT
22 CFR Part 228
[AID–2020–0004]
RIN 0412–AB09
Procurement of Certain Essential
Medical Supplies To Address the
COVID–19 Pandemic
AGENCY
: Agency for International
Development.
ACTION
: Final rule; technical
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
Essential Medical Supplies required to
address the COVID–19 pandemic
worldwide. The TFR was effective
through April 30, 2021. This document
reverts the amended sections to the text
of those sections as they existed prior to
the issuance of the TFR, with minor
technical updates. This reversion to the
original text is applicable upon the
expiration of the TFR.
DATES
: This rule is effective May 10,
2021. As stated in the October 23, 2020,
final rule, the TFR was effective from
October 23, 2020, through April 30,
2021. The amendments in this rule are
applicable beginning May 1, 2021, after
the expiration of the TFR.
ADDRESSES
: You may review the docket
by searching for Docket ID [AID–2020–
0004], via the Federal eRulemaking
Portal: http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT
: Greg
Marchand, Assistant General Counsel,
Office of the General Counsel, USAID,
1300 Pennsylvania Ave. NW,
Washington, DC 20523, 202–215–3409,
GCFEDREGMailbox@usaid.gov.
SUPPLEMENTARY INFORMATION
: This
document affects 22 CFR 228.01, which
was amended by the TFR published in
the Federal Register on October 23,
2020 (85 FR 67443) and subsequently
corrected on December 16, 2020 (85 FR
81390). The TFR and its subsequent
correction revised the definitions in
§ 228.01 by adding a new definition for
‘‘Essential medical supplies.’’ This
document reinstates the definitions in
§ 228.01 exactly as they existed prior to
the issuance of the TFR. This document
also reverts 22 CFR 228.11 and 228.30,
which were also amended by the TFR
published in the Federal Register on
October 23, 2020 (85 FR 67443). The
TFR amended these sections to create a
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Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Rules and Regulations
new approval requirement and basis for
waivers for the source and nationality of
essential medical supplies. This
document reverts the language of both
sections to the text as it existed prior to
the issuance of the TFR, with minor
technical updates.
List of Subjects in 22 CFR Part 228
Government procurement.
The Deputy General Counsel of
USAID, Suk J. Jin, having reviewed and
approved this document, is delegating
the authority to electronically sign this
document to Gregory A. Marchand,
Assistant General Counsel for USAID,
for purposes of publication in the
Federal Register.
Gregory A. Marchand,
Assistant General Counsel, U.S. Agency for
International Development.
For reasons stated in the preamble,
USAID amends 22 CFR part 228 as
follows:
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.
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,
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,
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
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.
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 of this part, 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
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Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Rules and Regulations
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.
■3. Revise § 228.11 to read as follows:
§ 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). 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 section. Any
violation of the prohibition in the
preceding sentence 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:
§ 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 § 228.01, and §§ 228.21 and
228.22), in order to accomplish project
or program objectives. 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 circumstances; 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 those
covered by special procurement rules in
§ 228.19, and excluding procurements
from prohibited sources) does not
require a waiver and is hereby
authorized.
[FR Doc. 2021–09821 Filed 5–7–21; 8:45 am]
BILLING CODE 6116–02–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2021–0287]
RIN 1625–AA00
Safety Zone; Lower Mississippi River,
Mile Marker 770, Randolph Bluff, TN
AGENCY
: Coast Guard, DHS.
ACTION
: Temporary final rule.
SUMMARY
: The Coast Guard is
establishing a temporary safety zone for
all navigable waters of the Lower
Mississippi River (LMR), Mile Marker
762 through 782. The safety zone is
needed to protect persons, property, and
the marine environment from the
potential safety hazards associated with
a rock replacement project in the
vicinity of Randolph Bluff, TN. Entry of
persons or vessels into this zone is
prohibited unless authorized by the
Captain of the Port Sector Lower
Mississippi River or a designated
representative.
DATES
: This rule is effective without
actual notice from May 10, 2021 until
May 31, 2021. For the purposes of
enforcement, actual notice will be used
from April 27, 2021, until May 10, 2021.
ADDRESSES
: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2021–
0287 in the ‘‘SEARCH’’ box and click
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