[Federal Register Volume 67, Number 31 (Thursday, February 14, 2002)]
[Rules and Regulations]
[Page 6866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-3680]


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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 supplemental new animal drug 
application (NADA) filed by Schering-Plough Animal Health Corp. The 
supplement provides for changing a pathogen genus from Pasteurella to 
Mannheimia on labeling of florfenicol injectable solution.

DATES: This rule is effective February 14, 2002.

FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary 
Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-7569, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., P.O. Box 3182, Union, NJ 07083, is the sponsor of NADA 
141-063 that provides for use of NUFLOR (florfenicol) Injectable 
Solution in cattle. Schering-Plough Animal Health Corp. filed a 
supplemental NADA providing for changing a pathogen genus from 
Pasteurella to Mannheimia on product labeling. The NADA is approved as 
of November 8, 2001, and the regulations are amended in Sec. 522.955 
(21 CFR 522.955) to reflect the approval. Section 522.955 is also being 
amended to reflect an updated format. Approval of this supplemental 
NADA did not require review of safety or effectiveness data; therefore, 
a freedom of information summary is not required.
    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 522.955 is amended by revising the section heading and 
by revising paragraphs (a), (d)(1)(i), (d)(1)(ii), and (d)(1)(iii) to 
read as follows:


Sec.  522.955  Florfenicol.

    (a) Specifications. Each milliliter of solution contains 300 
milligrams (mg) of florfenicol.
* * * * *
    (d) * * * 
    (1) * * * 
    (i) Amount. 20 mg per kilogram (/kg) of body weight as an 
intramuscular injection. A second dose should be administered 48 hours 
later.
    (A) Indications for use. For treatment of bovine respiratory 
disease (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 
andBacteroides melaninogenicus.
    (B) [Reserved]
    (ii) Amount. 40 mg/kg body weight as a single subcutaneous 
injection.
    (A) Indications for use. As in paragraph (d)(1)(i)(A) of this 
section; for control of respiratory disease in cattle at high risk of 
developing BRD associated with M. (Pasteurella) haemolytica, P. 
multocida, and H. somnus.
    (B) [Reserved]
    (iii) 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.
* * * * *

    Dated: January 31, 2002.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 02-3680 Filed 2-13-02; 8:45 am]
BILLING CODE 4160-01-S