2021-03251. New Animal Drug Applications; Beta-Aminopropionitrile Fumarate; n

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FDA gave notice that approval of the seven NADAs listed in table 1, and all supplements and amendments thereto, is withdrawn, effective February 23, 2021, for lack of compliance with reporting requirements in 21 CFR 514.80.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Table 1—NADAs for Which Approval Is Withdrawn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 (ß-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

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 n-butyl 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.

(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;

(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”.