[Federal Register Volume 67, Number 41 (Friday, March 1, 2002)]
[Rules and Regulations]
[Page 9400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4891]


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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 
Meglumine Solution

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 abbreviated new 
animal drug application (ANADA) filed by Phoenix Scientific, Inc. The 
supplemental ANADA provides for use of flunixin meglumine solution by 
intravenous injection for control of fever and inflammation in beef 
cattle and nonlactating dairy cattle.

DATES: This rule is effective March 1, 2002.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Ter., P.O. Box 6457, St. Joseph, MO 64506-0457, filed 
supplemental ANADA 200-124 that provides for veterinary prescription 
use of Flunixin Meglumine Injection by intravenous administration for 
control of fever and inflammation in beef cattle and nonlactating dairy 
cattle. The supplemental ANADA is approved as of November 1, 2001, and 
the regulations are amended in Sec. 522.970 (21 CFR 522.970) to reflect 
the approval. The basis of approval is discussed in the freedom of 
information summary.
    In addition, Sec. 522.970 is being amended to add the drug labeler 
code (DLC) for Agri Laboratories, Ltd., which is the sponsor of 
approved ANADA 200-061 (62 FR 22888, April 28, 1997), but whose DLC 
(057561) was inadvertently omitted in a subsequent revision (63 FR 
38749, July 20, 1998).
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 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 Dockets Management Branch (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.

    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

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

    Authority: 21 U.S.C. 360b.
    2. Section 522.970 is amended by redesignating paragraph (d) as 
paragraph (e); by adding new paragraph (d); and by revising paragraphs 
(a), (b), and newly redesignated paragraphs (e)(1)(i), (e)(1)(iii), 
(e)(2)(i), and (e)(2)(iii) to read as follows:


Sec. 522.970  Flunixin meglumine solution.

    (a) Specifications. Each milliliter of solution contains flunixin 
meglumine equivalent to 50 milligrams (mg) flunixin.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
use as in paragraph (e) of this section.
    (1) See Nos. 000061 and 059130 for use as in paragraph (e) of this 
section.
    (2) See Nos. 000856 and 057561 for use as in paragraph (e)(1) of 
this section.
* * * * *
    (d) Special considerations. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (e) * * * 
    (1) * * * 
    (i) Amount. 0.5 mg per pound (/lb) of body weight per day, 
intravenously or intramuscularly, for up to 5 days.
* * * * *
    (iii) Limitations. Not for use in horses intended for food.
    (2) * * * 
    (i) Amount. 1.1 to 2.2 mg/kilogram (0.5 to 1.0 mg/lb) of body 
weight per day, as a single dose or divided into 2 doses administered 
at 12-hour intervals, intravenously, for up to 3 days.
* * * * *
    (iii) Limitations. Do not slaughter for food use within 4 days of 
last treatment. Not for use in lactating or dry dairy cows. A 
withdrawal period has not been established for use in preruminating 
calves. Do not use in calves to be processed for veal.

    Dated: February 8, 2002.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 02-4891 Filed 2-28-02; 8:45 am]
BILLING CODE 4160-01-S