[Federal Register Volume 71, Number 62 (Friday, March 31, 2006)]
[Rules and Regulations]
[Pages 16221-16222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3118]


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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; Flunixin

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 Cross Vetpharm Group Ltd. The ANADA 
provides for the veterinary prescription use of flunixin meglumine 
injectable solution for the control of inflammation in horses and 
cattle.

DATES: This rule is effective March 31, 2006.

FOR FURTHER INFORMATION CONTACT: Christopher Melluso, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Cross Vetpharm Group Ltd., Broomhill Rd., 
Tallaght, Dublin 24, Ireland, filed ANADA 200-387 for the use of 
Flunixin Injectable Solution by veterinary

[[Page 16222]]

prescription for the control of inflammation in horses and cattle. 
Cross Vetpharm Group's Flunixin Injectable Solution is approved as a 
generic copy of Schering-Plough Animal Health's BANAMINE (flunixin) 
Solution, approved under NADA 101-479. The ANADA is approved as of 
March 2, 2006, and the regulations in 21 CFR 522.970 are amended 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

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

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


Sec.  522.970  [Amended]

0
2. Section 522.970 is amended in paragraphs (b)(2) and (e)(2)(iii) by 
removing ``and 059130'' and by adding in its place ``059130, and 
061623''.

    Dated: March 13, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 06-3118 Filed 3-30-06; 8:45 am]
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