[Federal Register Volume 69, Number 116 (Thursday, June 17, 2004)]
[Rules and Regulations]
[Pages 33839-33840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-13602]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Acepromazine Maleate Injection

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an abbreviated new animal drug 
application (ANADA) filed by Boehringer Ingelheim Vetmedica, Inc. The 
ANADA provides for the veterinary prescription use of acepromazine 
maleate injectable solution in dogs, cats, and horses as a 
tranquilizer.

DATES: This rule is effective June 17, 2004.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Boehringer Ingelheim Vetmedica, Inc., 2621 
North Belt Hwy., St. Joseph, MO 64506-2002, filed ANADA 200-361 that 
provides for the veterinary prescription use of Acepromazine Maleate 
(acepromazine maleate) Injection in dogs, cats, and horses as a 
tranquilizer. Boehringer Ingelheim Vetmedica's Acepromazine Maleate 
Injection is approved as a generic copy of Fort Dodge Animal Health's 
PROMACE Injectable approved under NADA 15-030. The ANADA is approved as 
of April 14, 2004, and the regulations are amended in 21 CFR 522.23 to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    This rule 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.

List of Subjects in 21 CFR Part 522

    Animal drugs.

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 522 continues to read as 
follows:


[[Page 33840]]


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


Sec.  522.23  [Amended]

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2. Section 522.23 is amended in paragraph (b), introductory text, by 
removing ``000856 and 059130'' and by adding in its place ``000010, 
000856, and 059130''.

    Dated: May 18, 2004.
Andrew J. Beaulieu,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 04-13602 Filed 4-16-04; 8:45 am]
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