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 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 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 

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 


khammond on DSKJM1Z7X2PROD with RULES