New Animal Drugs; Florfenicol, 70046-70047 [05-22935]
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70046
Federal Register / Vol. 70, No. 223 / Monday, November 21, 2005 / Rules and Regulations
Unsafe Condition
(d) This AD results from the discovery of
a hole in the upper frame of the firewall for
the auxiliary power unit (APU). We are
issuing this AD to ensure that the APU
compartment is isolated from the rest of the
airplane in the event of an APU fire. If the
APU compartment is not isolated, smoke
could enter the passenger cabin in the event
of an APU fire.
Compliance
(e) You are responsible for having the
actions required by this AD performed within
the compliance times specified, unless the
actions have already been done.
Modification
(f) Within 2,500 flight hours or 365 days
after the effective date of this AD, whichever
occurs later, modify the APU firewall upper
frame, part number 145–51249–001 or 120–
10731–001, in accordance with the
Accomplishment Instructions of EMBRAER
Service Bulletin 145LEG–53–0020, Revision
01, dated September 21, 2005 (for Model
EMB–135BJ airplanes); or EMBRAER Service
Bulletin 145–53–0057, Revision 01, dated
September 20, 2005 (for Model EMB–135ER,
–135KE, –135KL, and –135LR airplanes; and
Model EMB–145, –145ER, –145MR, –145LR,
–145XR, –145MP, and –145EP airplanes); as
applicable.
Modifications Accomplished According to
Previous Issue of Service Bulletins
(g) Modifications accomplished before the
effective date of this AD according to
EMBRAER Service Bulletin 145LEG–53–
0020, dated November 30, 2004; and
EMBRAER Service Bulletin 145–53–0057,
dated November 30, 2004; are considered
acceptable for compliance with the
corresponding action specified in this AD.
Alternative Methods of Compliance
(AMOCs)
(h)(1) The Manager, International Branch,
ANM–116, Transport Airplane Directorate,
FAA, has the authority to approve AMOCs
for this AD, if requested in accordance with
the procedures found in 14 CFR 39.19.
(2) Before using any AMOC approved in
accordance with § 39.19 on any airplane to
which the AMOC applies, notify the
appropriate principal inspector in the FAA
Flight Standards Certificate Holding District
Office.
Related Information
(i) Brazilian airworthiness directive 2005–
04–03, dated April 30, 2005, also addresses
the subject of this AD.
Material Incorporated by Reference
(j) You must use EMBRAER Service
Bulletin 145LEG–53–0020, Revision 01,
dated September 21, 2005; or EMBRAER
Service Bulletin 145–53–0057, Revision 01,
dated September 20, 2005; as applicable, to
perform the actions that are required by this
AD, unless the AD specifies otherwise. The
Director of the Federal Register approved the
incorporation by reference of these
documents in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Contact Empresa
Brasileira de Aeronautica S.A. (EMBRAER),
VerDate Aug<31>2005
16:13 Nov 18, 2005
Jkt 208001
P.O. Box 343—CEP 12.225, Sao Jose dos
Campos–SP, Brazil, for a copy of this service
information. You may review copies at the
Docket Management Facility, U.S.
Department of Transportation, 400 Seventh
Street, SW., room PL–401, Nassif Building,
Washington, DC; on the Internet at https://
dms.dot.gov; or at the National Archives and
Records Administration (NARA). For
information on the availability of this
material at the NARA, call (202) 741–6030,
or go to https://www.archives.gov/
federal_register/code_of_federal_regulations/
ibr_locations.html.
Issued in Renton, Washington, on
November 9, 2005.
Kalene C. Yanamura,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. 05–22792 Filed 11–18–05; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 556 and 558
New Animal Drugs; 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
approval of a new animal drug
application (NADA) filed by ScheringPlough Animal Health Corp. The NADA
provides for the use of florfenicol by
veterinary feed directive in catfish feed
for the control of mortality due to
enteric septicemia of catfish.
DATES: This rule is effective November
21, 2005.
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, email: joan.gotthardt@fda.gov.
SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 1095
Morris Ave., Union, NJ 07083, filed
NADA 141–246 that provides for use of
AQUAFLOR (florfenicol) Type A
medicated article by veterinary feed
directive to formulate Type C medicated
feeds for the control of mortality due to
enteric septicemia of catfish associated
with Edwardsiella ictaluri. The NADA
is approved as of October 24, 2005, and
the regulations are amended in 21 CFR
556.283 and in part 558 (21 CFR part
558) by revising § 558.4 and by adding
new § 558.261 to reflect the approval.
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
The basis of approval is discussed in the
freedom of information summary.
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 approval
qualifies for 7 years of exclusive
marketing rights beginning October 24,
2005, 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
21 CFR Part 556
Animal drugs, Foods.
21 CFR Part 558
Animal drugs, Animal feeds.
I 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 556 and 558 are amended as
follows:
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
1. The authority citation for 21 CFR
part 556 continues to read as follows:
I
Authority: 21 U.S.C. 342, 360b, 371.
2. Add paragraphs (b)(3) and (c) in
§ 556.283 to read as follows:
I
§ 556.283
Florfenicol.
*
*
E:\FR\FM\21NOR1.SGM
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21NOR1
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*
70047
Federal Register / Vol. 70, No. 223 / Monday, November 21, 2005 / Rules and Regulations
(b) * * *
(3) Catfish. The tolerance for
florfenicol amine (the marker residue) in
muscle (the target tissue) is 1 ppm.
(c) Related conditions of use. See
§§ 520.955, 522.955, and 558.261 of this
chapter.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
alphabetical order for ‘‘Florfenicol’’ to
read as follows:
3. The authority citation for 21 CFR
part 558 continues to read as follows:
§ 558.4 Requirement of a medicated feed
mill license.
I
*
Authority: 21 U.S.C. 360b, 371.
4. In paragraph (d) of § 558.4, in the
‘‘Category II’’ table, add an entry in
I
*
*
(d) * * *
*
*
CATEGORY II
Assay limits percent 1 Type A
Drug
*
Florfenicol
*
*
*
*
Assay limits percent 1 Type B/C 2
Type B maximum (100x)
*
90–110
*
*
*
*
*
*
n/a
80–110
*
*
1 Percent
of labeled amount.
given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a
Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for
the possibility of dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed.
2 Values
*
I
Feeds containing florfenicol must be
withdrawn 12 days prior to slaughter.
(2) [Reserved]
*
*
*
*
5. Add § 558.261 to read as follows:
§ 558.261
Florfenicol.
(a) Specifications. Type A medicated
article containing 500 grams florfenicol
per kilogram.
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
(c) Special considerations—(1)
Federal law limits this drug to use
under the professional supervision of a
licensed veterinarian. See § 558.6 of this
chapter for additional requirements.
(2) The expiration date of veterinary
feed directives (VFDs) for florfenicol
must not exceed 15 days from the date
of issuance. VFDs for florfenicol shall
not be refilled.
(d) Related tolerances. See § 556.283
of this chapter.
(e) Conditions of use—(1) Catfish—(i)
Amount. 10 milligrams per kilogram of
fish daily for 10 consecutive days.
(ii) Indications for use. For the control
of mortality due to enteric septicemia of
catfish associated with Edwardsiella
ictaluri.
(iii) Limitations. Feed containing
florfenicol shall not be fed to catfish for
more than 10 days. Following 10 days
administration, fish should be reevaluated by a licensed veterinarian
before reinitiating a further course of
therapy. A dose-related decrease in
hematopoietic/lymphopoietic tissue
may occur. The time required for the
hematopoietic/lymphopoietic tissues to
regenerate was not evaluated. The
effects of florfenicol on reproductive
performance have not been determined.
VerDate Aug<31>2005
16:13 Nov 18, 2005
Jkt 208001
Dated: November 8, 2005.
Andrew J. Beaulieu,
Acting Director, Center for Veterinary
Medicine.
[FR Doc. 05–22935 Filed 11–18–05; 8:45 am]
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
[R04–OAR–2005–KY–0001–200521(c); FRL–
7999–5]
Approval and Promulgation of
Implementation Plans and Designation
of Areas for Air Quality Planning
Purposes; Kentucky; Redesignation of
the Christian County, Kentucky Portion
of the Clarksville-Hopkinsville 8-Hour
Ozone Nonattainment Area to
Attainment for Ozone; Correction
Environmental Protection
Agency (EPA).
ACTION: Final rule; correction.
AGENCY:
SUMMARY: On October 21, 2005, at 70 FR
61232, EPA published a withdrawal
action of a direct final rule approving
the redesignation of the Christian
County, Kentucky portion of the
Clarksville-Hopkinsville 8-hour ozone
nonattainment area to attainment for
ozone. This document corrects a Code of
Federal Regulations (CFR) reference
contained in the withdrawal action.
Frm 00017
Fmt 4700
Mr.
Sean Lakeman, Regulatory Development
Section, Air Planning Branch, Air,
Pesticides and Toxics Management
Division, U.S. Environmental Protection
Agency Region 4, 61 Forsyth Street,
SW., Atlanta, Georgia 30303–8960. The
telephone number is (404) 562–9043.
Mr. Lakeman can also be reached via
electronic mail at
lakeman.sean@epa.gov.
FOR FURTHER INFORMATION CONTACT:
EPA is
making a correction to the document
published October 21, 2005 (70 FR
61232), which withdrew the direct final
rule published September 22, 2005, (70
FR 55550) approving the redesignation
of the Christian County, Kentucky
portion of the Clarksville-Hopkinsville
8-hour ozone nonattainment area to
attainment for ozone. EPA is correcting
the citation to the CFR contained in the
October 21, 2005, withdrawal action to
exclude an erroneous reference to 40
CFR 52.919. The last paragraph after the
signature block on page 61232 should
read as follows: ‘‘Accordingly, the
amendment to 40 CFR 52.920 and 40
CFR 81.318 (which published in the
Federal Register on September 22, 2005,
at 70 FR 55550) is withdrawn as of
October 21, 2005.’’
SUPPLEMENTARY INFORMATION:
40 CFR Part 52
PO 00000
This correction is effective
November 21, 2005.
DATES:
Sfmt 4700
Dated: November 15, 2005.
J.I. Palmer Jr.,
Regional Administrator, Region 4.
[FR Doc. 05–23086 Filed 11–18–05; 8:45 am]
BILLING CODE 6560–50–P
E:\FR\FM\21NOR1.SGM
21NOR1
]]>Agencies
[Federal Register Volume 70, Number 223 (Monday, November 21, 2005)]
[Rules and Regulations]
[Pages 70046-70047]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-22935]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 556 and 558
New Animal Drugs; 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 approval of a new animal drug application
(NADA) filed by Schering-Plough Animal Health Corp. The NADA provides
for the use of florfenicol by veterinary feed directive in catfish feed
for the control of mortality due to enteric septicemia of catfish.
DATES: This rule is effective November 21, 2005.
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., 1095
Morris Ave., Union, NJ 07083, filed NADA 141-246 that provides for use
of AQUAFLOR (florfenicol) Type A medicated article by veterinary feed
directive to formulate Type C medicated feeds for the control of
mortality due to enteric septicemia of catfish associated with
Edwardsiella ictaluri. The NADA is approved as of October 24, 2005, and
the regulations are amended in 21 CFR 556.283 and in part 558 (21 CFR
part 558) by revising Sec. 558.4 and by adding new Sec. 558.261 to
reflect the approval. The basis of approval is discussed in the freedom
of information summary.
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 approval qualifies for 7 years of
exclusive marketing rights beginning October 24, 2005, 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
21 CFR Part 556
Animal drugs, Foods.
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 parts 556 and
558 are amended as follows:
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
1. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
2. Add paragraphs (b)(3) and (c) in Sec. 556.283 to read as follows:
Sec. 556.283 Florfenicol.
* * * * *
[[Page 70047]]
(b) * * *
(3) Catfish. The tolerance for florfenicol amine (the marker
residue) in muscle (the target tissue) is 1 ppm.
(c) Related conditions of use. See Sec. Sec. 520.955, 522.955, and
558.261 of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
4. In paragraph (d) of Sec. 558.4, in the ``Category II'' table, add
an entry in alphabetical order for ``Florfenicol'' to read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
CATEGORY II
----------------------------------------------------------------------------------------------------------------
Assay limits percent \1\ Assay limits percent \1\ Type B/C
Drug Type A Type B maximum (100x) \2\
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Florfenicol 90-110 n/a 80-110
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
medicated feed with lower assay limits to make Type C medicated feed.
* * * * *
0
5. Add Sec. 558.261 to read as follows:
Sec. 558.261 Florfenicol.
(a) Specifications. Type A medicated article containing 500 grams
florfenicol per kilogram.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Special considerations--(1) Federal law limits this drug to use
under the professional supervision of a licensed veterinarian. See
Sec. 558.6 of this chapter for additional requirements.
(2) The expiration date of veterinary feed directives (VFDs) for
florfenicol must not exceed 15 days from the date of issuance. VFDs for
florfenicol shall not be refilled.
(d) Related tolerances. See Sec. 556.283 of this chapter.
(e) Conditions of use--(1) Catfish--(i) Amount. 10 milligrams per
kilogram of fish daily for 10 consecutive days.
(ii) Indications for use. For the control of mortality due to
enteric septicemia of catfish associated with Edwardsiella ictaluri.
(iii) Limitations. Feed containing florfenicol shall not be fed to
catfish for more than 10 days. Following 10 days administration, fish
should be re-evaluated by a licensed veterinarian before reinitiating a
further course of therapy. A dose-related decrease in hematopoietic/
lymphopoietic tissue may occur. The time required for the
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.
(2) [Reserved]
Dated: November 8, 2005.
Andrew J. Beaulieu,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 05-22935 Filed 11-18-05; 8:45 am]
BILLING CODE 4160-01-S
