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thereto, is withdrawn, effective 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TABLE 1—NADAS FOR WHICH APPROVAL IS WITHDRAWN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. 

Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations 10819 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR parts 510, 

520, and 522 are amended as follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for part 510 

continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

§ 510.600 [Amended] 

■ 2. In § 510.600, in the table in 

paragraph (c)(1), remove the entries for 

‘‘Alaco, Inc.’’, ‘‘OXIS International, 

Inc.’’, ‘‘RSR Laboratories, Inc.’’, and 

‘‘Walco International, Inc.’’; and in the 

table in paragraph (c)(2), remove the 

entries for ‘‘024991’’, ‘‘049185’’, 

‘‘058670’’, and ‘‘064146’’. 

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS 

■ 3. The authority citation for part 520 

continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 4. Revise § 520.260 to read as follows: 

§ 520.260 n-Butyl chloride. 

(a) Specifications. Each capsule 

contains 221, 442, 884, or 1,768 

milligrams (mg); or 4.42 grams of nbutyl chloride. 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter: 

(1) No. 023851 for capsules containing 

221, 442, 884, or 1,768 mg, or 4.42 

grams (g); and 

(2) No. 054771 for capsules containing 

221 mg. 

(c) Conditions of use in dogs—(1) 

Amount. Administer capsules orally 

based on body weight as follows: 

(i) Capsules containing 221 mg: Under 

5 pounds, 1 capsule per 11⁄4 pounds of 

body weight. 

(ii) Capsules containing 442 mg: 

Under 5 pounds, 1 capsule per 21⁄2

pounds of body weight. 

(iii) Capsules containing 884 mg: 

(A) Under 5 pounds, 1 capsule; 

(B) 5 to 10 pounds, 2 capsules; 

(C) 10 to 20 pounds, 3 capsules; 

(D) 20 to 40 pounds, 4 capsules; 

(E) Over 40 pounds, 5 capsules. 

(iv) Capsules containing 1,768 mg: 

Dogs weighing 5 to 10 pounds, 1 

capsule. 

(v) Capsules containing 4.42 g: Dogs 

weighing 40 pounds or over, 1 capsule. 

(2) Indications for use. For the 

removal of ascarids (Toxocara canis and 

Toxascaris leonina) and hookworms 

(Ancylostoma caninum, Ancylostoma 

braziliense, and Uncinaria 

stenocephala) from dogs. 

(3) Limitations. Dogs should not be 

fed for 18 to 24 hours before being given 

the drug. Administration of the drug 

should be followed in 1⁄2 to 1 hour with 

a mild cathartic. Normal feeding may be 

resumed 4 to 8 hours after treatment. 

Animals subject to reinfection may be 

retreated in 2 weeks. A veterinarian 

should be consulted before using in 

severely debilitated dogs. 

§ 520.580 [Amended] 

■ 5. In § 520.580, in paragraph (b)(1), 

remove ‘‘Nos. 017135, 023851, and 

058670’’ and in its place add ‘‘Nos. 

017135 and 023851’’. 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 6. The authority citation for part 522 

continues to read as follows: 

Authority: 21 U.S.C. 360b. 

§ 522.84 [Removed] 

■ 7. Remove § 522.84. 

§ 522.518 [Removed] 

■ 8. Remove § 522.518. 

§ 522.1620 [Removed] 

■ 9. Remove § 522.1620. 

Dated: February 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03251 Filed 2–22–21; 8:45 am] 

BILLING CODE 4164–01–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 Drugs; Withdrawal of 

Approval of New Animal Drug 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of seven new animal drug 

applications (NADAs) from multiple 

holders of these applications. The basis 

for the withdrawals is that the holders 

of these applications have repeatedly 

failed to file required annual reports for 

the applications. 

DATES: Withdrawal of approval 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: The 

holders of approved applications to 

market new animal drugs are required to 

submit annual reports to FDA 

concerning each of their approved 

applications in accordance with 

§ 514.80 (21 CFR 514.80). 

In the Federal Register of January 8, 

2020 (85 FR 919), FDA published a 

notice offering an opportunity for a 

hearing (NOOH) on a proposal to 

withdraw approval of seven NADAs 

because the sponsors had failed to 

submit the required annual reports for 

these applications. The holders of these 

applications did not respond to the 

NOOH. Failure to file a written notice 

of participation and request for a 

hearing as required by § 514.200(b) (21 

CFR 514.200(b)) constitutes an election 

by the applicant not to make use of the 

opportunity for a hearing concerning the 

proposal to withdraw approval of the 

applications and a waiver of any 

contentions concerning the legal status 

of the drug products. Therefore, 

approval of the seven applications listed 

in table 1 is being withdrawn. 

TABLE 1—NADAS FOR WHICH APPROVAL IS WITHDRAWN

Application No. Trade name 

(drug) Sponsor 

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

93257.