[Federal Register Volume 70, Number 226 (Friday, November 25, 2005)]
[Rules and Regulations]
[Pages 70998-70999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23294]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556


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 a supplemental new animal drug 
application (NADA) filed by Schering-Plough Animal Health Corp. The 
supplemental NADA provides for the veterinary prescription use of 
flunixin meglumine solution by intramuscular injection for the control 
of pyrexia associated with swine respiratory disease.

DATES: This rule is effective November 25, 2005.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., Union, NJ 07083, filed a supplement to NADA 101-479 that 
provides for the veterinary prescription use of BANAMINE-S (flunixin 
meglumine) Injectable Solution by intramuscular injection for the 
control of pyrexia associated with swine respiratory disease. The 
supplemental NADA is approved as of November 1, 2005, and the 
regulations are amended in 21 CFR 522.970 and 556.286 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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(iii)), this 
supplemental approval qualifies for 3 years of marketing exclusivity 
beginning November 1, 2005.
    FDA has determined under Sec.  25.33(d)(5) 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

21 CFR Part 522

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

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 parts 522 and 
556 are 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 522.970 is amended by adding paragraph (e)(3) to read as 
follows:


Sec.  522.970  Flunixin.

* * * * *

[[Page 70999]]

    (e) * * *
    (3) Swine--(i) Amount. Administer 2.2 mg/kg (1.0 mg/lb) of body 
weight as a single intramuscular injection.
    (ii) Indications for use. For the control of pyrexia associated 
with swine respiratory disease.
    (iii) Limitations. Swine must not be slaughtered for human 
consumption within 12 days of last treatment.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
3. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

0
4. Section 556.286 is amended by adding paragraph (b)(2) to read as 
follows:


Sec.  556.286  Flunixin.

* * * * *
    (b) * * *
    (2) Swine. The tolerance for flunixin free acid (the marker 
residue) is:
    (i) Liver (the target tissue). 30 ppb.
    (ii) Muscle. 25 ppb.
* * * * *

    Dated: November 15, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-23294 Filed 11-23-05; 8:45 am]
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