New Animal Drug Applications; Beta-Aminopropionitrile Fumarate; n-Butyl Chloride; Cupric Glycinate Injection; Dichlorophene and Toluene; Orgotein for Injection; Tetracycline Tablets
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 co...
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, FDA gave notice that approval of the seven NADAs listed in table 1, and all supplements and amendments thereto, is withdrawn, effective February 23, 2021, for lack of compliance with reporting requirements in 21 CFR 514.80.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Table 1—NADAs for Which Approval Is Withdrawn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
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. 551et 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.”
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:
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:
(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.