[Federal Register Volume 72, Number 226 (Monday, November 26, 2007)]
[Rules and Regulations]
[Pages 65885-65886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22942]



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  Federal Register / Vol. 72, No. 226 / Monday, November 26, 2007 / 
Rules and Regulations  

[[Page 65885]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


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: 
[email protected].

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--

[[Page 65886]]



------------------------------------------------------------------------
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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