[Federal Register Volume 67, Number 247 (Tuesday, December 24, 2002)]
[Rules and Regulations]
[Pages 78356-78357]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32341]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 556


Oral 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 a florfenicol concentrate solution to make medicated 
drinking water for administration to swine for the treatment of 
respiratory disease. FDA is also amending the regulations to add 
tolerances for residues of florfenicol in edible tissues of swine.

DATES: This rule is effective December 24, 2002.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 1095 
Morris Ave., Union, NJ 07083, filed NADA 141-206 for NUFLOR 
(florfenicol) 2.3% Concentrate Solution used to make medicated drinking 
water for administration to swine for the treatment of respiratory 
disease associated with several bacterial pathogens. The NADA is 
approved as of September 4, 2002, and the regulations are amended in 21 
CFR part 520 by adding Sec.  520.955 to reflect the approval. The basis 
of approval is discussed in the freedom of information summary.
    In addition, the regulations are amended in 21 CFR 556.283 to 
establish tolerances for residues of florfenicol in edible tissues of 
treated swine and to reflect a current format.
    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.
    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 September 4, 2002.
    The agency has determined under 21 CFR 25.33(d)(5) 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.

[[Page 78357]]

List of Subjects

21 CFR Part 520

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

    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 parts 520 and 
556 are amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.
    2. Section 520.955 is added to read as follows:


Sec.  520.955  Florfenicol.

    (a) Specifications. Each milliliter (mL) contains 23 milligrams 
(mg) florfenicol.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.283 of this chapter.
    (d) Conditions of use in swine--(1) Amount. Administer in drinking 
water ad libitum at 400 mg per gallon (100 parts per million (ppm)) for 
5 consecutive days.
    (2) Indications for use. For the treatment of swine respiratory 
disease (SRD) associated with Actinobacillus pleuropneumoniae, 
Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis 
Type 2.
    (3) Limitations. Do not slaughter within 16 days of last treatment. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

    3. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.
    4. Section 556.283 is amended by revising paragraph (b) to read as 
follows:


Sec.  556.283  Florfenicol.

* * * * *
    (b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The 
tolerance for florfenicol amine (the marker residue) is 3.7 parts per 
million (ppm).
    (ii) Muscle. The tolerance for florfenicol amine (the marker 
residue) is 0.3 ppm.
    (2) Swine--(i) Liver (the target tissue). The tolerance for parent 
florfenicol (the marker residue) is 2.5 ppm.
    (ii) Muscle. The tolerance for parent florfenicol (the marker 
residue) is 0.2 ppm.

    Dated: December 13, 2002.
Stephen F. Sundolf,
Director, Center for Veterinary Medicine.
[FR Doc. 02-32341 Filed 12-23-02; 8:45 am]
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