New Animal Drugs For Use in Animal Feeds; Florfenicol, 65885-65886 [E7-22942]
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65885
Rules and Regulations
Federal Register
Vol. 72, No. 226
Monday, November 26, 2007
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
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
Florfenicol in grams/
ton of feed
182
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7571, email: joan.gotthardt@fda.gov.
ScheringPlough 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.
SUPPLEMENTARY INFORMATION:
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.
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:
I
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
2. In § 558.261, revise paragraph (e) to
read as follows:
I
§ 558.261
*
Florfenicol.
*
*
*
*
(e) Conditions of use—
(1) Swine—
Indications for use
Limitations
For the control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella
multocida, Streptococcus suis, and Bordetella
bronchiseptica in groups of swine in buildings experiencing an outbreak of SRD.
Feed continuously as a sole ration for 5 consecutive days.
The safety of florfenicol on swine reproductive performance, pregnancy, and lactation have not been determined. Feeds containing florfenicol must be withdrawn 13
days prior to slaughter.
ebenthall on PROD1PC69 with RULES
(2) Fish—
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15:37 Nov 23, 2007
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65886
Federal Register / Vol. 72, No. 226 / Monday, November 26, 2007 / Rules and Regulations
Florfenicol in grams/
ton of feed
Indications for use
Limitations
(i) 182 to 1,816
Catfish: For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri.
(ii) 182 to 1,816
Freshwater-reared salmonids: For the control of mortality
due to coldwater disease associated with Flavobacterium
psychrophilum and furunculosis associated with
Aeromonas salmonicida.
Dated: November 9, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–22942 Filed 11–23–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[CGD01–07–157]
RIN 1625–AA00
Safety Zone: Ambrose Light, Offshore
Sandy Hook, NJ, Atlantic Ocean
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a temporary safety zone in
the waters of the Atlantic Ocean within
a 250 yard radius of Ambrose Light
(LLNR 720) located at position
40°27′00″ N, 073°48′00″ W,
approximately 8.35 nautical miles east
of Sandy Hook, NJ. This safety zone is
necessary to provide for the safety of
life, property and the environment on
navigable waters of the United States
during survey and reconstruction of the
Ambrose Light that was recently
damaged. This safety zone is intended
to keep vessels a safe distance from
Ambrose Light during the survey and
reconstruction operations.
DATES: This rule is effective from 12:01
a.m. on November 5, 2007 through 11:59
p.m. on May 5, 2008.
ADDRESSES: Documents indicated in this
preamble as being available in the
ebenthall on PROD1PC69 with RULES
SUMMARY:
VerDate Aug<31>2005
15:37 Nov 23, 2007
Jkt 214001
Feed as a sole ration for 10 consecutive days to deliver 10
milligrams florfenicol per kilogram 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.
Feed as a sole ration for 10 consecutive days to deliver 10
milligrams florfenicol per kilogram 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. The effects of florfenicol on reproductive performance have not been determined. Feeds containing
florfenicol must be withdrawn 15 days prior to slaughter.
docket are part of docket CGD01–07–
157 and are available for inspection or
copying at Coast Guard Sector New
York, Room 209, Staten Island, New
York 10305 between 8 a.m. and 3 p.m.,
Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT:
Lieutenant Commander Mike McBrady,
Waterways Management Division, Coast
Guard Sector New York (718) 354–2353.
SUPPLEMENTARY INFORMATION:
Regulatory Information
We did not publish a notice of
proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B), the
Coast Guard finds that good cause exists
for not publishing an NPRM. A notice
and comment period was not held for
this rulemaking because the safety zone
is needed in response to an emergency
situation created when the Ambrose
Light was struck and damaged by a
vessel. A survey and repairs are needed
immediately in order to restore the light
to normal operations. Delaying the
necessary survey and repairs in order to
conduct a notice and comment period
would be contrary to the public interest.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register as immediate action is needed
to protect vessels transiting the area
from the hazards of the damaged light
tower and from the hazards associated
with survey and reconstruction
operations. Any delay in implementing
this rule would be contrary to public
interest since immediate action is
needed due to the potential hazards
associated with the unstable light, the
possibility of it collapsing, or a vessel
PO 00000
Frm 00002
Fmt 4700
Sfmt 4700
grounding on the remains of Ambrose
Light (LLNR 720).
Background and Purpose
On Saturday, November 3, 2007, the
M/T AXEL SPIRIT allided with
Ambrose Light (LLNR 720) in position
40°27′00″ N, 073°48′00″ W
approximately 8.35 nautical miles east
of Sandy Hook, NJ. Initial damage
assessment indicates that the Ambrose
Light is no longer watching properly
and in danger of collapse, creating an
additional hazard to vessels operating in
the area. This safety zone is being
created in response to this emergency
situation in order to keep mariners away
from the hazards associated with the
damaged structure and from the hazards
associated with survey and
reconstruction operations.
Discussion of Rule
This rule will provide for the safety of
vessel traffic in and around Ambrose
Light (LLNR 720). This regulation
establishes a temporary safety zone on
the navigable waters of the Atlantic
Ocean within a 250-yard radius of
position 40°27′00″ N, 073°48′00″ W,
approximately 8.35 nautical miles east
of Sandy Hook, NJ. The rule described
herein prohibits the transit of vessels
through the safety zone unless
specifically authorized by the Captain of
the Port, New York. This safety zone is
in effect from 12:01 a.m. on November
5, 2007 until 11:59 p.m. on May 5, 2008.
The zone will be enforced during the
entire effective period unless the survey
and reconstruction work is completed
prior to the last effective date. If survey
and reconstruction is completed before
May 5, 2008, the Coast Guard will cease
enforcement of the safety zone.
E:\FR\FM\26NOR1.SGM
26NOR1
]]>Agencies
[Federal Register Volume 72, Number 226 (Monday, November 26, 2007)]
[Rules and Regulations]
[Pages 65885-65886]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22942]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
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:
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--
[[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]
BILLING CODE 4160-01-S
