Animal drugs, feeds, and related products: Florfenicol,
[Federal Register: November 26, 2007 (Volume 72, Number 226)]
[Rules and Regulations]
[Page 65885-65886]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26no07-1]
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[[Page 65885]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
New Animal Drugs For Use in Animal Feeds; Florfenicol
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the approval of a supplemental new animal drug application (NADA) filed by Schering-Plough Animal Health Corp. The supplemental NADA provides for the use of florfenicol by veterinary feed directive (VFD) for the control of mortality in freshwater-reared salmonids due to furunculosis associated with Aeromonas salmonicida.
DATES: This rule is effective November 26, 2007.
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: joan.gotthardt@fda.gov.
SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901, filed a supplement to NADA 141-246 that provides for use of AQUAFLOR (florfenicol), a Type A medicated article, by VFD to formulate Type C medicated feed for the control of mortality in freshwater-reared salmonids due to furunculosis associated with Aeromonas salmonicida. The supplemental application is approved as of October 26, 2007, and the regulations are amended in 21 CFR 558.261 to reflect the approval and a current format.
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 573(c) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360ccc-2), this supplemental approval qualifies for 7 years of exclusive marketing rights beginning on the date of approval because the new animal drug has been declared a designated new animal drug by FDA under section 573(a) of the act.
The agency has carefully considered the potential environmental impact of this action and has concluded that the action will not have a significant impact on the human environment and that an environmental impact statement is not required. FDA's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
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 558
Animal drugs, Animal feeds.
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 558 is amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0 1. The authority citation for 21 CFR part 558 continues to read as follows:
Authority: 21 U.S.C. 360b, 371.
0 2. In Sec. 558.261, revise paragraph (e) to read as follows:
Sec. 558.261 Florfenicol.
* * * * *
(e) Conditions of use--
(1) Swine--
Florfenicol in grams/ton of Indications for use
Limitations feed
182
For the control of swine Feed continuously as a sole respiratory disease (SRD) ration for 5 consecutive associated with
days. The safety of Actinobacillus
florfenicol on swine pleuropneumoniae,
reproductive performance, Pasteurella multocida, pregnancy, and lactation Streptococcus suis, and have not been determined. Bordetella bronchiseptica Feeds containing in groups of swine in
florfenicol must be buildings experiencing an withdrawn 13 days prior to outbreak of SRD.
slaughter.
(2) Fish--
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Florfenicol in grams/ton of Indications for use
Limitations feed
(i) 182 to Catfish: For the control of Feed as a sole ration for 1,816
mortality due to enteric 10 consecutive days to septicemia of catfish
deliver 10 milligrams associated with
florfenicol per kilogram Edwardsiella ictaluri. of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose-related decrease in hematopoietic/ lymphopoietic tissue may occur. The time required for hematopoietic/ lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 12 days prior to slaughter. (ii) 182 to Freshwater-reared
Feed as a sole ration for 1,816
salmonids: For the control 10 consecutive days to of mortality due to
deliver 10 milligrams coldwater disease
florfenicol per kilogram associated with
of fish. Feed containing Flavobacterium
florfenicol shall not be psychrophilum and
fed for more than 10 days. furunculosis associated Following administration, with Aeromonas
fish should be reevaluated salmonicida.
by a licensed veterinarian before initiating a further course of therapy. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter.
Dated: November 9, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-22942 Filed 11-23-07; 8:45 am]
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