[Federal Register Volume 68, Number 191 (Thursday, October 2, 2003)]
[Rules and Regulations]
[Page 56765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24928]



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  Federal Register / Vol. 68, No. 191 / Thursday, October 2, 2003 / 
Rules and Regulations  

[[Page 56765]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Dexamethasone 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 Veterinary Laboratories, Inc. The ANADA 
provides for the use of dexamethasone injectable solution for the 
treatment of primary bovine ketosis and as an anti-inflammatory agent 
in cattle and horses.

DATES: This rule is effective October 2, 2003.

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: Veterinary Laboratories, Inc., 12340 Santa 
Fe Dr., Lenexa, KS 66215, filed ANADA 200-324 that provides for use of 
Dexamethasone Injection for the treatment of primary bovine ketosis and 
as an anti-inflammatory agent in cattle and horses. Veterinary 
Laboratories' Dexamethasone Injection is approved as a generic copy of 
Schering-Plough Animal Health's AZIUM (dexamethasone) Solution 2 Mg., 
approved under NADA 012-559. The ANADA is approved as of August 19, 
2003, and the regulations are amended in Sec.  522.540 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.

0
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

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. Section 522.540 is amended by revising paragraph (a) to read as 
follows:


Sec.  522.540  Dexamethasone injection.

    (a)(1) Specifications. Each milliliter of solution contains 2 
milligrams (mg) dexamethasone.
    (2) Sponsors. See sponsors in Sec.  510.600(c) of this chapter:
    (i) Nos. 000061 and 059130 for use as in paragraph (a)(3) of this 
section.
    (ii) No. 000857 for use as in paragraphs (a)(3)(i)(C), 
(a)(3)(i)(D), (a)(3)(ii)(A), and (a)(3)(iii) of this section.
    (3) Conditions of use--(i) Amount. The drug is administered 
intravenously or intramuscularly and dosage may be repeated if 
necessary, as follows:
    (A) Dogs. 0.25 to 1 mg.
    (B) Cats. 0.125 to 0.5 mg.
    (C) Horses. 2.5 to 5 mg.
    (D) Cattle. 5 to 20 mg, depending on the severity of the condition.
    (ii) Indications for use. The drug is indicated:
    (A) For the treatment of primary bovine ketosis and as an anti-
inflammatory agent in cattle and horses;
    (B) As an anti-inflammatory agent in dogs and cats.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
* * * * *

    Dated: September 11, 2003.
Linda Tollefson,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 03-24928 Filed 10-1-03; 8:45 am]
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