Document ID: FDA-2009-N-0665-0083
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol and Flunixin
Posted Date: 2010-01-11T05:00Z

[Federal Register: January 11, 2010 (Volume 75, Number 6)]
[Rules and Regulations]               
[Page 1274-1275]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ja10-5]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2009-N-0665]

 
Implantation or Injectable Dosage Form New Animal Drugs; 
Florfenicol and 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 original new animal drug 
application (NADA) filed by Intervet, Inc. The NADA provides for 
veterinary prescription use of a combination injectable solution 
containing

[[Page 1275]]

florfenicol and flunixin meglumine in cattle.

DATES:  This rule is effective January 11, 2010.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: 
cindy.burnsteel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet, Inc., 56 Livingston Ave., 
Roseland, NJ 07068, filed NADA 141-299 that provides for use RESFLOR 
GOLD (florfenicol and flunixin meglumine), a combination injectable 
solution, for treatment of bovine respiratory disease (BRD) associated 
with Mannheimia haemolytica, Pasteurella multocida, and Histophilus 
somni, and control of BRD-associated pyrexia in beef and non-lactating 
dairy cattle. The NADA is approved as of November 23, 2009, and the 
regulations in 21 CFR part 522 are amended by adding Sec.  522.956 to 
reflect the approval.
    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)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 
3 years of marketing exclusivity beginning on the date of approval.
    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. Add Sec.  522.956 to read as follows:

Sec.  522.956   Florfenicol and flunixin.

    (a) Specifications. Each milliliter (mL) of solution contains 300 
milligrams (mg) florfenicol and 16.5 mg flunixin (27.37 mg flunixin 
meglumine).
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter for 
use as in paragraph (d) of this section.
    (c) Tolerances. See Sec. Sec.  556.283 and 556.286 of this chapter.
    (d) Conditions for use in cattle--(1) Amount. 40 mg florfenicol/kg 
body weight (BW) and 2.2 mg flunixin/kg BW (equivalent to 2 mL/15 kg BW 
or 6 mL/100 lbs) once, by subcutaneous injection.
    (2) Indications for use. For treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni, and control of BRD-associated pyrexia 
in beef and non-lactating dairy cattle.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Animals intended for human 
consumption must not be slaughtered within 38 days of treatment. Do not 
use in female dairy cattle 20 months of age or older. Use of 
florfenicol in this class of cattle may cause milk residues. A 
withdrawal period has not been established in preruminating calves. Do 
not use in calves to be processed for veal.

    Dated: December 31, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-209 Filed 1-8-10; 8:45 am]
BILLING CODE 4160-01-S