10816 Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations 

7 19 U.S.C. 1318(b)(1)(C) provides that 

‘‘[n]otwithstanding any other provision of law, the 

Secretary of the Treasury, when necessary to 

respond to a national emergency declared under the 

National Emergencies Act (50 U.S.C. 1601 et seq.) 

or to a specific threat to human life or national 

interests,’’ is authorized to ‘‘[t]ake any . . . action 

that may be necessary to respond directly to the 

national emergency or specific threat.’’ On March 

1, 2003, certain functions of the Secretary of the 

Treasury were transferred to the Secretary of 

Homeland Security. See 6 U.S.C. 202(2), 203(1). 

Under 6 U.S.C. 212(a)(1), authorities ‘‘related to 

Customs revenue functions’’ were reserved to the 

Secretary of the Treasury. To the extent that any 

authority under section 1318(b)(1) was reserved to 

the Secretary of the Treasury, it has been delegated 

to the Secretary of Homeland Security. See Treas. 

Dep’t Order No. 100–16 (May 15, 2003), 68 FR 

28322 (May 23, 2003). Additionally, 19 U.S.C. 

1318(b)(2) provides that ‘‘[n]otwithstanding any 

other provision of law, the Commissioner of U.S. 

Customs and Border Protection, when necessary to 

respond to a specific threat to human life or 

national interests, is authorized to close temporarily 

any Customs office or port of entry or take any other 

lesser action that may be necessary to respond to 

the specific threat.’’ Congress has vested in the 

Secretary of Homeland Security the ‘‘functions of 

all officers, employees, and organizational units of 

the Department,’’ including the Commissioner of 

CBP. 6 U.S.C. 112(a)(3). 

8 DHS is working closely with counterparts in 

Mexico and Canada to identify appropriate public 

health conditions to safely ease restrictions in the 

future and support U.S. border communities. 

risk of continued transmission and 

spread of the virus associated with 

COVID–19 between the United States 

and Canada poses an ongoing ‘‘specific 

threat to human life or national 

interests.’’ 

U.S. and Canadian officials have 

mutually determined that non-essential 

travel between the United States and 

Canada poses additional risk of 

transmission and spread of the virus 

associated with COVID–19 and places 

the populace of both nations at 

increased risk of contracting the virus 

associated with COVID–19. Moreover, 

given the sustained human-to-human 

transmission of the virus, returning to 

previous levels of travel between the 

two nations places the personnel 

staffing land ports of entry between the 

United States and Canada, as well as the 

individuals traveling through these 

ports of entry, at increased risk of 

exposure to the virus associated with 

COVID–19. Accordingly, and consistent 

with the authority granted in 19 U.S.C. 

1318(b)(1)(C) and (b)(2),7 I have 

determined that land ports of entry 

along the U.S.-Canada border will 

continue to suspend normal operations 

and will only allow processing for entry 

into the United States of those travelers 

engaged in ‘‘essential travel,’’ as defined 

below. Given the definition of ‘‘essential 

travel’’ below, this temporary alteration 

in land ports of entry operations should 

not interrupt legitimate trade between 

the two nations or disrupt critical 

supply chains that ensure food, fuel, 

medicine, and other critical materials 

reach individuals on both sides of the 

border. 

For purposes of the temporary 

alteration in certain designated ports of 

entry operations authorized under 19 

U.S.C. 1318(b)(1)(C) and (b)(2), travel 

through the land ports of entry and ferry 

terminals along the United StatesCanada border shall be limited to 

‘‘essential travel,’’ which includes, but 

is not limited to— 

• U.S. citizens and lawful permanent 

residents returning to the United States; 

• Individuals traveling for medical 

purposes (e.g., to receive medical 

treatment in the United States); 

• Individuals traveling to attend 

educational institutions; 

• Individuals traveling to work in the 

United States (e.g., individuals working 

in the farming or agriculture industry 

who must travel between the United 

States and Canada in furtherance of 

such work); 

• Individuals traveling for emergency 

response and public health purposes 

(e.g., government officials or emergency 

responders entering the United States to 

support federal, state, local, tribal, or 

territorial government efforts to respond 

to COVID–19 or other emergencies); 

• Individuals engaged in lawful crossborder trade (e.g., truck drivers 

supporting the movement of cargo 

between the United States and Canada); 

• Individuals engaged in official 

government travel or diplomatic travel; 

• Members of the U.S. Armed Forces, 

and the spouses and children of 

members of the U.S. Armed Forces, 

returning to the United States; and 

• Individuals engaged in militaryrelated travel or operations. 

The following travel does not fall 

within the definition of ‘‘essential 

travel’’ for purposes of this 

Notification— 

• Individuals traveling for tourism 

purposes (e.g., sightseeing, recreation, 

gambling, or attending cultural events). 

At this time, this Notification does not 

apply to air, freight rail, or sea travel 

between the United States and Canada, 

but does apply to passenger rail, 

passenger ferry travel, and pleasure boat 

travel between the United States and 

Canada. These restrictions are 

temporary in nature and shall remain in 

effect until 11:59 p.m. EDT on March 

21, 2021. This Notification may be 

amended or rescinded prior to that time, 

based on circumstances associated with 

the specific threat.8

The Commissioner of U.S. Customs 

and Border Protection (CBP) is hereby 

directed to prepare and distribute 

appropriate guidance to CBP personnel 

on the continued implementation of the 

temporary measures set forth in this 

Notification. The CBP Commissioner 

may determine that other forms of 

travel, such as travel in furtherance of 

economic stability or social order, 

constitute ‘‘essential travel’’ under this 

Notification. Further, the CBP 

Commissioner may, on an 

individualized basis and for 

humanitarian reasons or for other 

purposes in the national interest, permit 

the processing of travelers to the United 

States not engaged in ‘‘essential travel.’’ 

Alejandro N. Mayorkas, 

Secretary, U.S. Department of Homeland 

Security. 

[FR Doc. 2021–03774 Filed 2–19–21; 11:15 am] 

BILLING CODE 9112–FP–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

19 CFR Chapter I 

Notification of Temporary Travel 

Restrictions Applicable to Land Ports 

of Entry and Ferries Service Between 

the United States and Mexico 

AGENCY: Office of the Secretary, U.S. 

Department of Homeland Security; U.S. 

Customs and Border Protection, U.S. 

Department of Homeland Security. 

ACTION: Notification of continuation of 

temporary travel restrictions. 

SUMMARY: This document announces the 

decision of the Secretary of Homeland 

Security (Secretary) to continue to 

temporarily limit the travel of 

individuals from Mexico into the United 

States at land ports of entry along the 

United States-Mexico border. Such 

travel will be limited to ‘‘essential 

travel,’’ as further defined in this 

document. 

DATES: These restrictions go into effect 

at 12 a.m. Eastern Standard Time on 

February 22, 2021 and will remain in 

effect until 11:59 p.m. Eastern Daylight 

Time (EDT) on March 21, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Stephanie Watson, Office of Field 

Operations Coronavirus Coordination 

Cell, U.S. Customs and Border 

Protection (CBP) at 202–325–0840. 

SUPPLEMENTARY INFORMATION: 

Background 

On March 24, 2020, the Department of 

Homeland Security (DHS) published 

notice of its decision to temporarily 

Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations 10817 

1 85 FR 16547 (Mar. 24, 2020). That same day, 

DHS also published notice of its decision to 

temporarily limit the travel of individuals from 

Canada into the United States at land ports of entry 

along the United States-Canada border to ‘‘essential 

travel,’’ as further defined in that document. 85 FR 

16548 (Mar. 24, 2020). 

2See 86 FR 4967 (Jan. 19, 2021); 85 FR 83433 

(Dec. 22, 2020); 85 FR 74604 (Nov. 23, 2020); 85 

FR 67275 (Oct. 22, 2020); 85 FR 59669 (Sept. 23, 

2020); 85 FR 51633 (Aug. 21, 2020); 85 FR 44183 

(July 22, 2020); 85 FR 37745 (June 24, 2020); 85 FR 

31057 (May 22, 2020); 85 FR 22353 (Apr. 22, 2020). 

DHS also published parallel notifications of its 

decisions to continue temporarily limiting the 

travel of individuals from Canada into the United 

States at land ports of entry along the United StatesCanada border to ‘‘essential travel.’’ See 86 FR 4969 

(Jan. 19, 2021); 85 FR 83432 (Dec. 22, 2020); 85 FR 

74603 (Nov. 23, 2020); 85 FR 67276 (Oct. 22, 2020); 

85 FR 59670 (Sept. 23, 2020); 85 FR 51634 (Aug. 

21, 2020); 85 FR 44185 (July 22, 2020); 85 FR 37744 

(June 24, 2020); 85 FR 31050 (May 22, 2020); 85 FR 

22352 (Apr. 22, 2020. 

3WHO, Coronavirus disease 2019 (COVID–19) 

Weekly Epidemiological Update (Feb. 16, 2021), 

available at https://www.who.int/publications/m/ 

item/weekly-epidemiological-update---16-february2021. 

4CDC, COVID Data Tracker (accessed Feb. 18, 

2021), available at https://covid.cdc.gov/covid-datatracker/. 

5WHO, COVID–19 Weekly Epidemiological 

Update (Feb. 16, 2021). 

6 Id. 

7 19 U.S.C. 1318(b)(1)(C) provides that 

‘‘[n]otwithstanding any other provision of law, the 

Secretary of the Treasury, when necessary to 

respond to a national emergency declared under the 

National Emergencies Act (50 U.S.C. 1601 et seq.) 

or to a specific threat to human life or national 

interests,’’ is authorized to ‘‘[t]ake any . . . action 

that may be necessary to respond directly to the 

national emergency or specific threat.’’ On March 

1, 2003, certain functions of the Secretary of the 

Treasury were transferred to the Secretary of 

Homeland Security. See 6 U.S.C. 202(2), 203(1). 

Under 6 U.S.C. 212(a)(1), authorities ‘‘related to 

Customs revenue functions’’ were reserved to the 

Secretary of the Treasury. To the extent that any 

authority under section 1318(b)(1) was reserved to 

the Secretary of the Treasury, it has been delegated 

to the Secretary of Homeland Security. See Treas. 

Dep’t Order No. 100–16 (May 15, 2003), 68 FR 

28322 (May 23, 2003). Additionally, 19 U.S.C. 

1318(b)(2) provides that ‘‘[n]otwithstanding any 

other provision of law, the Commissioner of U.S. 

Customs and Border Protection, when necessary to 

respond to a specific threat to human life or 

national interests, is authorized to close temporarily 

any Customs office or port of entry or take any other 

lesser action that may be necessary to respond to 

the specific threat.’’ Congress has vested in the 

Secretary of Homeland Security the ‘‘functions of 

all officers, employees, and organizational units of 

the Department,’’ including the Commissioner of 

CBP. 6 U.S.C. 112(a)(3). 

8 DHS is working closely with counterparts in 

Mexico and Canada to identify appropriate public 

health conditions to safely ease restrictions in the 

future and support U.S. border communities. 

limit the travel of individuals from 

Mexico into the United States at land 

ports of entry along the United StatesMexico border to ‘‘essential travel,’’ as 

further defined in that document.1 The 

document described the developing 

circumstances regarding the COVID–19 

pandemic and stated that, given the 

outbreak and continued transmission 

and spread of the virus associated with 

COVID–19 within the United States and 

globally, DHS had determined that the 

risk of continued transmission and 

spread of the virus associated with 

COVID–19 between the United States 

and Mexico posed a ‘‘specific threat to 

human life or national interests.’’ DHS 

later published a series of notifications 

continuing such limitations on travel 

until 11:59 p.m. EST on February 21, 

2021.2

DHS continues to monitor and 

respond to the COVID–19 pandemic. As 

of the week of February 14, 2021, there 

have been over 108.2 million confirmed 

cases globally, with over 2.3 million 

confirmed deaths.3 There have been 

over 27.6 million confirmed and 

probable cases within the United 

States,4 over 820,000 confirmed cases in 

Canada,5 and over 1.9 million 

confirmed cases in Mexico.6

Notice of Action 

Given the outbreak and continued 

transmission and spread of COVID–19 

within the United States and globally, 

the Secretary has determined that the 

risk of continued transmission and 

spread of the virus associated with 

COVID–19 between the United States 

and Mexico poses an ongoing ‘‘specific 

threat to human life or national 

interests.’’ 

U.S. and Mexican officials have 

mutually determined that non-essential 

travel between the United States and 

Mexico poses additional risk of 

transmission and spread of the virus 

associated with COVID–19 and places 

the populace of both nations at 

increased risk of contracting the virus 

associated with COVID–19. Moreover, 

given the sustained human-to-human 

transmission of the virus, returning to 

previous levels of travel between the 

two nations places the personnel 

staffing land ports of entry between the 

United States and Mexico, as well as the 

individuals traveling through these 

ports of entry, at increased risk of 

exposure to the virus associated with 

COVID–19. Accordingly, and consistent 

with the authority granted in 19 U.S.C. 

1318(b)(1)(C) and (b)(2),7 I have 

determined that land ports of entry 

along the U.S.-Mexico border will 

continue to suspend normal operations 

and will only allow processing for entry 

into the United States of those travelers 

engaged in ‘‘essential travel,’’ as defined 

below. Given the definition of ‘‘essential 

travel’’ below, this temporary alteration 

in land ports of entry operations should 

not interrupt legitimate trade between 

the two nations or disrupt critical 

supply chains that ensure food, fuel, 

medicine, and other critical materials 

reach individuals on both sides of the 

border. 

For purposes of the temporary 

alteration in certain designated ports of 

entry operations authorized under 19 

U.S.C. 1318(b)(1)(C) and (b)(2), travel 

through the land ports of entry and ferry 

terminals along the United StatesMexico border shall be limited to 

‘‘essential travel,’’ which includes, but 

is not limited to— 

• U.S. citizens and lawful permanent 

residents returning to the United States; 

• Individuals traveling for medical 

purposes (e.g., to receive medical 

treatment in the United States); 

• Individuals traveling to attend 

educational institutions; 

• Individuals traveling to work in the 

United States (e.g., individuals working 

in the farming or agriculture industry 

who must travel between the United 

States and Mexico in furtherance of 

such work); 

• Individuals traveling for emergency 

response and public health purposes 

(e.g., government officials or emergency 

responders entering the United States to 

support federal, state, local, tribal, or 

territorial government efforts to respond 

to COVID–19 or other emergencies); 

• Individuals engaged in lawful crossborder trade (e.g., truck drivers 

supporting the movement of cargo 

between the United States and Mexico); 

• Individuals engaged in official 

government travel or diplomatic travel; 

• Members of the U.S. Armed Forces, 

and the spouses and children of 

members of the U.S. Armed Forces, 

returning to the United States; and 

• Individuals engaged in militaryrelated travel or operations. 

The following travel does not fall 

within the definition of ‘‘essential 

travel’’ for purposes of this 

Notification— 

• Individuals traveling for tourism 

purposes (e.g., sightseeing, recreation, 

gambling, or attending cultural events). 

At this time, this Notification does not 

apply to air, freight rail, or sea travel 

between the United States and Mexico, 

but does apply to passenger rail, 

passenger ferry travel, and pleasure boat 

travel between the United States and 

Mexico. These restrictions are 

temporary in nature and shall remain in 

effect until 11:59 p.m. EDT on March 

21, 2021. This Notification may be 

amended or rescinded prior to that time, 

based on circumstances associated with 

the specific threat.8

The Commissioner of U.S. Customs 

and Border Protection (CBP) is hereby 

directed to prepare and distribute 

10818 Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations 

appropriate guidance to CBP personnel 

on the continued implementation of the 

temporary measures set forth in this 

Notification. The CBP Commissioner 

may determine that other forms of 

travel, such as travel in furtherance of 

economic stability or social order, 

constitute ‘‘essential travel’’ under this 

Notification. Further, the CBP 

Commissioner may, on an 

individualized basis and for 

humanitarian reasons or for other 

purposes in the national interest, permit 

the processing of travelers to the United 

States not engaged in ‘‘essential travel.’’ 

Alejandro N. Mayorkas, 

Secretary, U.S. Department of Homeland 

Security. 

[FR Doc. 2021–03776 Filed 2–19–21; 11:15 am] 

BILLING CODE 9111–FP–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 520, and 522 

[Docket No. FDA–2019–N–5405] 

New Animal Drug Applications; BetaAminopropionitrile Fumarate; n-Butyl 

Chloride; Cupric Glycinate Injection; 

Dichlorophene and Toluene; Orgotein 

for Injection; Tetracycline Tablets 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule, technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect the 

withdrawal of approval of seven new 

animal drug applications (NADAs) for 

lack of compliance with the reporting 

requirements in an FDA regulation. 

DATES: This rule is effective February 

23, 2021. 

FOR FURTHER INFORMATION CONTACT: 

David Alterman, Center for Veterinary 

Medicine (HFV–212), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–402–5720, 

david.alterman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Elsewhere in this issue of the Federal 

Register, FDA gave notice that approval 

of the seven NADAs listed in table 1, 

and all supplements and amendments 

thereto, is withdrawn, effective 

February 23, 2021, for lack of 

compliance with reporting requirements 

in 21 CFR 514.80. As provided in the 

regulatory text of this document, the 

animal drug regulations are amended to 

reflect withdrawal of approval of the 

following applications and a current 

format. Withdrawal of approval of 

NADA 065–067 for Tetracycline 

Hydrochloride (HCl) Tablets did not 

require amending the regulations. 

TABLE 1—NADAS FOR WHICH APPROVAL IS WITHDRAWN

Application No. Trade name 

(drug) Sponsor 21 CFR section 

031–971 ............ CUPRATE (cupric glycinate) ..................................... Walco International, Inc., 15 West Putnam, Porterville, CA 93257.522.518 

045–863 ............ PALOSEIN (orgotein) ................................................ OXIS International, Inc., 6040 N Cutter Circle, Suite 

317, Portland, OR 97217–3935.

522.1620 

046–922 ............ SERGEANTS SURE SHOT (n-butyl chloride) Capsules.ConAgra Pet Products Co., 3902 Leavenworth St., 

Omaha, NE 68105.

520.260 

046–923 ............ SERGEANTS (n-butyl chloride) Puppy Worm Capsules.ConAgra Pet Products Co., 3902 Leavenworth St., 

Omaha, NE 68105.

520.260 

065–067 ............ Tetracycline HCl Tablets ........................................... Premo Pharmaceutical Laboratories, Inc., 111 

Leuning St., South Hackensack, NJ 07606.

Not codified 

140–850 ............ ELITE (dichlorophene and toluene) Dog and Cat 

Wormer.

RSR Laboratories, Inc., 501 Fifth St., Bristol, TN 

37620.

520.580 

141–107 ............ BAPTEN for Injection (+-aminopropionitrile fumarate).Alaco, Inc., 1500 North Wilmot Rd., Suite 290–C, 

Tucson, AZ 85712.

522.84 

Following these withdrawals of 

approval, Alaco, Inc.; ConAgra Pet 

Products Co.; OXIS International, Inc.; 

RSR Laboratories, Inc.; and Walco 

International, Inc., are no longer the 

sponsors of an approved application. 

Accordingly, 21 CFR 510.600(c) is being 

amended to remove the entries for these 

firms. 

II. Legal Authority 

This rule sets forth technical 

amendments to the regulations to codify 

recent actions on approved new animal 

drug applications and corrections to 

improve the accuracy of the regulations, 

and as such does not impose any burden 

on regulated entities. This rule is issued 

under section 512(i) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 360b(i)), which requires 

Federal Register publication of the 

conditions of use of an approved or 

conditionally approved new animal 

drug and the name and address of the 

drug’s sponsor in a ‘‘notice, which upon 

publication shall be effective as a 

regulation.’’ A notice published 

pursuant to section 512(i) is not subject 

to the notice-and-comment rulemaking 

requirements of the Administrative 

Procedure Act, 5 U.S.C. 551 et seq. See 

section 512(i) of the FD&C Act (21 

U.S.C. 360b(i)); 21 CFR 10.40(e)(3); S. 

Rep. 90–1308, at 5 (1968). 

This document does not meet the 

definition of ‘‘rule’’ in 5 U.S.C. 

804(3)(A) because it is a ‘‘rule of 

particular applicability.’’ Therefore, it is 

not subject to the congressional review 

requirements in 5 U.S.C. 801–808. 

Likewise, this is not a rule subject to 

Executive Order 12866, which defines a 

rule as ‘‘an agency statement of general 

applicability and future effect, which 

the agency intends to have the force and 

effect of law, that is designed to 

implement, interpret, or prescribe law 

or policy or to describe the procedure or 

practice requirements of an agency.’’ 

List of Subjects 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Parts 520 and 522 

Animal drugs.