Document ID: FDA-2008-N-0039-0034
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Florfenicol
Posted Date: 2008-04-18T04:00Z

[Federal Register: April 18, 2008 (Volume 73, Number 76)]
[Rules and Regulations]               
[Page 21041-21042]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ap08-5]                         

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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; 
Florfenicol

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 new animal drug application 
(NADA) filed by Schering-Plough Animal Health Corp. The NADA provides 
for use of florfenicol injectable solution for the treatment of bovine 
respiratory disease.

DATES: This rule is effective April 18, 2008.

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: Schering-Plough Animal Health Corp., 556 
Morris Ave., Summit, NJ 07901, filed NADA 141-265 for veterinary 
prescription use of NUFLOR GOLD (florfenicol) Injectable Solution by 
subcutaneous injection in beef and non-lactating dairy cattle for the 
treatment of bovine respiratory disease. The NADA is approved as of 
March 21, 2008, and the regulations are amended in 21 CFR 522.955 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(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.

0
2. Revise Sec.  522.955 to read as follows:

Sec.  522.955  Florfenicol.

    (a) Specifications. Each milliliter (mL) of solution contains:
    (1) 300 milligrams (mg) florfenicol in the inactive vehicles 2-
pyrrolidone and triacetin.
    (2) 300 mg florfenicol in the inactive vehicle n-methyl-2-
pyrrolidone.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter for 
use of product described in paragraph (a)(1) as in paragraph (d)(1)(i) 
and for use of product described in paragraph (a)(2) as in paragraph 
(d)(1)(ii).
    (c) Related tolerance. See Sec.  556.283 of this chapter.
    (d) Conditions of use--(1) Cattle--(i) 300 mg/mL florfenicol in 2-
pyrrolidone and triacetin (inactive vehicles).
    (A) Amount. 40 mg/kilogram (kg) body weight as a single 
subcutaneous injection.

[[Page 21042]]

    (B) Indications for use. For treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni in beef and non-lactating dairy 
cattle.
    (C) Limitations. Do not slaughter within 44 days of last treatment. 
Do not use in female dairy cattle 20 months of age or older. Use may 
cause milk residues. A withdrawal period has not been established in 
preruminating calves. Do not use in calves to be processed for veal. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (ii) 300 mg/mL florfenicol in n-methyl-2-pyrrolidone (inactive 
vehicle).
    (A)(1) Amount. 20 mg/kg of body weight as an intramuscular 
injection. A second dose should be administered 48 hours later. 
Alternatively, 40 mg/kg of body weight as a single subcutaneous 
injection may be used.
    (2) Indications for use. For treatment of BRD associated with 
Mannheimia (Pasteurella) haemolytica, P. multocida, and Haemophilus 
somnus. For treatment of bovine interdigital phlegmon (foot rot, acute 
interdigital necrobacillosis, infectious pododermatitis) associated 
with Fusobacterium necrophorum and Bacteroides melaninogenicus.
    (B)(1) Amount. 40 mg/kg of body weight as a single subcutaneous 
injection.
    (2) Indications for use. For control of respiratory disease in 
cattle at high risk of developing BRD associated with Mannheimia 
(Pasteurella) haemolytica, P. multocida, and Haemophilus somnus.
    (C) Limitations. Do not slaughter within 28 days of last 
intramuscular treatment or within 38 days of subcutaneous treatment. Do 
not use in female dairy cattle 20 months of age or older. Use may cause 
milk residues. A withdrawal period has not been established in 
preruminating calves. Do not use in calves to be processed for veal. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) [Reserved]

    Dated: April 4, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-8346 Filed 4-17-08; 8:45 am]

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