[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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Rules and Regulations
Federal Register
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[[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.
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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--
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Florfenicol in
grams/ton of Indications for use Limitations
feed
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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.
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(2) Fish--
[[Page 65886]]
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Florfenicol in
grams/ton of Indications for use Limitations
feed
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(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.
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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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