[Federal Register: December 24, 2002 (Volume 67, Number 247)]
[Rules and Regulations]
[Page 78356-78357]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24de02-10]
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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:
jgotthar@cvm.fda.gov.
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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