Document ID: FDA-2010-N-0002-0083
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs: Flunixin
Posted Date: 2010-12-08T05:00Z

[Federal Register Volume 75, Number 235 (Wednesday, December 8, 2010)]
[Rules and Regulations]
[Page 76260]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30769]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2010-N-0002]

Implantation or Injectable Dosage Form New Animal Drugs; Flunixin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

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 Agri Laboratories, Ltd. The 
supplemental ANADA provides for use of flunixin meglumine solution by 
intravenous injection in lactating dairy cows for control of pyrexia 
associated with acute bovine mastitis.

DATES: This rule is effective December 8, 2010.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Agri Laboratories, Ltd., P.O. Box 3103, St. 
Joseph, MO 64503, filed a supplement to ANADA 200-061 that provides for 
veterinary prescription use of FLU-NIX (flunixin meglumine) Injectable 
Solution. The supplemental ANADA provides for use of flunixin meglumine 
solution by intravenous injection in lactating dairy cows for control 
of pyrexia associated with acute bovine mastitis. The supplemental 
application is approved as of September 27, 2010, and the regulations 
are amended in 21 CFR 522.970 to reflect the approval.
    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 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. In Sec.  522.970, revise paragraphs (b), (e)(1)(iii), and (e)(2) to 
read as follows:

Sec.  522.970  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, 055529, and 061623 for use as in paragraph (e) 
of this section.
    (2) See No. 000856 for use as in paragraph (e)(1) of this section.
    (3) See Nos. 057561 and 059130 for use as in paragraphs (e)(1) and 
(2) of this section.
* * * * *
    (e) * * *
    (1) * * *
    (iii) Limitations. Do not use in horses intended for human 
consumption.
    (2) Cattle--(i) Amounts and indications for use--(A) Administer 1.1 
to 2.2 mg/kilogram (kg) (0.5 to 1.0 mg/lb) of body weight per day 
intravenously, as a single dose or divided into two doses administered 
at 12-hour intervals, for up to 3 days for control of pyrexia 
associated with bovine respiratory disease and endotoxemia or for 
control of inflammation in endotoxemia.
    (B) Administer 2.2 mg/kg (1.0 mg/lb) of body weight once 
intravenously for control of pyrexia associated with acute bovine 
mastitis.
    (ii) Limitations. Cattle must not be slaughtered for human 
consumption within 4 days of last treatment. Milk that has been taken 
during treatment and for 36 hours after the last treatment must not be 
used for food. Do not use in 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: December 1, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-30769 Filed 12-7-10; 8:45 am]
BILLING CODE 4160-01-P