Procurement of Certain Essential Medical Supplies To Address the COVID-19 Pandemic; Correction, 81390-81391 [2020-27766]

Download as PDF 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 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: AGENCY FOR INTERNATIONAL DEVELOPMENT 22 CFR Part 228 PART 228—RULES FOR PROCUREMENT OF COMMODITIES AND SERVICES FINANCED BY USAID [AID–2020–0004] RIN 0412–AB02 1. The authority citation for 22 CFR part 228 continues to read as follows: ■ Procurement of Certain Essential Medical Supplies To Address the COVID–19 Pandemic; Correction 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. Agency for International Development. ACTION: Correcting amendments. khammond on DSKJM1Z7X2PROD with RULES AGENCY: ■ 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 SUMMARY: VerDate Sep<11>2014 16:21 Dec 15, 2020 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. Jkt 253001 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 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 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 E:\FR\FM\16DER1.SGM 16DER1 khammond on DSKJM1Z7X2PROD with RULES 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 USAIDfinanced 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 VerDate Sep<11>2014 16:21 Dec 15, 2020 Jkt 253001 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. PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 81391 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 Internal Revenue Service (IRS), Treasury. ACTION: Final Regulations. AGENCY: This document contains final regulations to implement legislative SUMMARY: E:\FR\FM\16DER1.SGM 16DER1

Agencies

[Federal Register Volume 85, Number 242 (Wednesday, December 16, 2020)]
[Rules and Regulations]
[Pages 81390-81391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27766]


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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, [email protected].

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 Sec.  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 Sec.  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 Sec.  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

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.

    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 Sec.  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 Sec.  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

[[Page 81391]]

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 Sec.  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
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