Document ID: FDA-2019-N-5405-0005
Agency: fda
Document Type: Rule
Title: New Animal Drug Applications; BetaAminopropionitrile Fumarate; n-Butyl Chloride; Cupric Glycinate Injection; Dichlorophene and Toluene; Orgotein for Injection; Tetracycline Tablets
Posted Date: 2021-02-23T05:00Z

[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Rules and Regulations]
[Pages 10818-10819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03251]

=======================================================================
-----------------------------------------------------------------------

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; Beta-Aminopropionitrile 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and amendments thereto, is withdrawn, effective February 23, 2021, for 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             Table 1--NADAs for Which Approval Is Withdrawn
------------------------------------------------------------------------
                          Trade name
   Application No.          (drug)          Sponsor       21 CFR section
------------------------------------------------------------------------
031-971..............  CUPRATE (cupric  Walco                    522.518
                        glycinate).      International,
                                         Inc., 15 West
                                         Putnam,
                                         Porterville,
                                         CA 93257.
045-863..............  PALOSEIN         OXIS                    522.1620
                        (orgotein).      International,
                                         Inc., 6040 N
                                         Cutter Circle,
                                         Suite 317,
                                         Portland, OR
                                         97217-3935.
046-922..............  SERGEANTS SURE   ConAgra Pet              520.260
                        SHOT             Products Co.,
                        (n[dash]butyl    3902
                        chloride)        Leavenworth
                        Capsules.        St., Omaha, NE
                                         68105.
046-923..............  SERGEANTS (n-    ConAgra Pet              520.260
                        butyl            Products Co.,
                        chloride)        3902
                        Puppy Worm       Leavenworth
                        Capsules.        St., Omaha, NE
                                         68105.
065-067..............  Tetracycline     Premo               Not codified
                        HCl Tablets.     Pharmaceutical
                                         Laboratories,
                                         Inc., 111
                                         Leuning St.,
                                         South
                                         Hackensack, NJ
                                         07606.
140-850..............  ELITE            RSR                      520.580
                        (dichlorophene   Laboratories,
                        and toluene)     Inc., 501
                        Dog and Cat      Fifth St.,
                        Wormer.          Bristol, TN
                                         37620.
141-107..............  BAPTEN for       Alaco, Inc.,              522.84
                        Injection        1500 North
                        ([szlig][dash]   Wilmot Rd.,
                        aminopropionit   Suite 290-C,
                        rile fumarate).  Tucson, AZ
                                         85712.
------------------------------------------------------------------------

    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.

[[Page 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

0
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.

Sec.  510.600  [Amended]

0
2. In Sec.  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

0
3. The authority citation for part 520 continues to read as follows:

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

0
4. Revise Sec.  520.260 to read as follows:

Sec.  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 Sec.  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 1\1/
4\ pounds of body weight.
    (ii) Capsules containing 442 mg: Under 5 pounds, 1 capsule per 2\1/
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.

Sec.  520.580  [Amended]

0
5. In Sec.  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

0
6. The authority citation for part 522 continues to read as follows:

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

Sec.  522.84  [Removed]

0
7. Remove Sec.  522.84.

Sec.  522.518  [Removed]

0
8. Remove Sec.  522.518.

Sec.  522.1620  [Removed]

0
9. Remove Sec.  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