New Animal Drugs For Use in Animal Feeds; Florfenicol, 70304-70305 [E6-20398]
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70304
Federal Register / Vol. 71, No. 232 / Monday, December 4, 2006 / Rules and Regulations
Dated: November 17, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–20404 Filed 12–1–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal
Feeds; Florfenicol
Food and Drug Administration,
AGENCY:
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 a florfenicol
Type A medicated article by veterinary
feed directive to formulate swine feed
used for the control of respiratory
disease.
DATES: This rule is effective December 4,
2006.
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.hhs.gov.
ScheringPlough Animal Health Corp., 556 Morris
Ave., Summit, NJ 07901, filed NADA
141–264 that provides for use of
NUFLOR (florfenicol), an antibiotic, a
Type A medicated article by veterinary
feed directive to formulate Type C
medicated feeds used 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. The NADA is
approved as of November 3, 2006, and
the regulations are amended in 21 CFR
558.4 and 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 512(c)(2)(F)(ii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(ii)), this
approval qualifies for 3 years of
marketing exclusivity beginning
November 3, 2006.
SUPPLEMENTARY INFORMATION:
The agency has determined under 21
CFR 25.33(d)(5) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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 paragraph (d) of § 558.4, in the
‘‘Category II’’ table, revise the entry for
‘‘Florfenicol’’ to read as follows:
I
§ 558.4 Requirement of a medicated feed
mill license.
*
*
*
(d) * * *
*
*
CATEGORY II
Assay limits percent1 Type A
Drug
*
Florfenicol
*
*
*
*
*
90–110
*
Assay limits percent1 Type B/C2
Type B maximum (100x)
*
*
Swine feed: n/a
Catfish feed: n/a
*
*
*
*
Swine feed: 85–115
Catfish feed: 80–110
*
1Percent
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.
2Values
*
*
*
*
*
3. In § 558.261, revise paragraphs (a)
and (c)(2); redesignate paragraph (e)(1)
as paragraph (e)(2); and add new
paragraphs (c)(3) and (e)(1) to read as
follows:
I
mstockstill on PROD1PC61 with RULES
§ 558.261
Florfenicol.
(a) Specifications. Type A medicated
articles containing florfenicol in the
following concentrations:
(1) 40 grams per kilogram for use as
in paragraph (e)(1) of this section.
VerDate Aug<31>2005
12:11 Dec 01, 2006
Jkt 211001
(2) 500 grams per kilogram for use as
in paragraph (e)(2) of this section.
*
*
*
*
*
(c) * * *
(2) The expiration date of veterinary
feed directives (VFDs) for florfenicol
medicated feeds:
(i) For catfish must not exceed 15
days from the date of issuance;
(ii) For swine must not exceed 90
days from the date of issuance.
(3) VFDs for florfenicol shall not be
refilled.
*
*
*
*
*
(e) * * *
PO 00000
Frm 00030
Fmt 4700
Sfmt 4700
(1) Swine—(i) Amount. Feed 182
grams per ton of feed (200 parts per
million) continuously as the sole ration
for 5 days.
(ii) Indications for use. 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.
(iii) Limitations. The safety of
florfenicol on swine reproductive
performance, pregnancy, and lactation
E:\FR\FM\04DER1.SGM
04DER1
Federal Register / Vol. 71, No. 232 / Monday, December 4, 2006 / Rules and Regulations
has not been determined. Feeds
containing florfenicol must be
withdrawn 13 days prior to slaughter.
*
*
*
*
*
Dated: November 17, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6–20398 Filed 12–1–06; 8:45 am]
BILLING CODE 4160–01–S
for this rulemaking (68 FR 18922). We
received 11 letters commenting on the
NPRM. All comments were addressed in
a supplemental notice of proposed
rulemaking (SNPRM) published in the
Federal Register on May 17, 2006 (71
FR 28629). No comments were received
regarding the SNPRM. No public
meeting was requested and none was
held.
Background and Purpose
DEPARTMENT OF HOMELAND
SECURITY
The last major update to the
drawbridge regulations in 33 CFR Part
117 was in 1984. The Coast Guard
determined that updates and
clarifications to the present regulations
are necessary to meet the competing
needs of land and navigational traffic as
well as meeting the needs of bridges that
have become structurally deficient and
functionally obsolete.
Coast Guard
33 CFR Part 117
[USCG–2001–10881]
RIN 1625–AA36
Drawbridge Operation Regulations;
Amendment
Discussion of Changes
Coast Guard, DHS.
Final rule.
AGENCY:
mstockstill on PROD1PC61 with RULES
ACTION:
SUMMARY: The Coast Guard revises its
drawbridge regulations by lengthening
the period for which a deviation from
published bridge opening requirements
is authorized, and by reorganizing and
clarifying some provisions. These
changes promote intermodal mobility,
safety, and security while balancing the
reasonable needs of land and marine
traffic.
DATES: This rule is effective January 3,
2007.
ADDRESSES: Comments and material
received from the public, as well as
documents mentioned in this preamble
as being available in the docket, are part
of docket USCG–2001–10881 and are
available for inspection or copying at
the Docket Management Facility, U.S.
Department of Transportation, room PL–
401, 400 Seventh Street, SW.,
Washington, DC, between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays. You may also find this
docket on the Internet at https://
dms.dot.gov.
FOR FURTHER INFORMATION CONTACT: Mr.
Chris Jaufmann, Office of Bridge
Administration, United States Coast
Guard Headquarters, 202–372–1511. If
you have questions on viewing or
submitting material to the docket, call
Renee V. Wright, Program Manager,
Dockets Operations, Department of
Transportation, telephone 202–493–
0402.
SUPPLEMENTARY INFORMATION:
Regulatory History
On April 17, 2003, we published a
notice of proposed rulemaking (NPRM)
VerDate Aug<31>2005
12:11 Dec 01, 2006
Jkt 211001
The changes made by this final rule
are grouped by subject and discussed
below.
Deviations
At present, the Coast Guard has two
deviations that allow bridge owners to
change operating schedules for 60 days
for maintenance and repair needs, and
up to 90 days to test a new operating
schedule. In our final rule, we are
consolidating all temporary changes to a
drawbridge operating schedule into one
of two categories: (1) A deviation, when
the temporary change will be for a
period of 180 days or less, or; (2) a
rulemaking, when the temporary change
will be for a period greater then 180
days. This change amends § 117.35 and
removes §§ 117.37, 117.43, and 117.45.
This deviation provision would allow
the District Commanders the flexibility
to maximize waterway use for
navigation prior to and during varying
weather conditions, repair/maintenance
situations, reasons of public health and
safety and public events. Any temporary
change of an operating schedule lasting
greater then 180 days or any permanent
change to an operating schedule will
require a full rulemaking under the
Administrative Procedure Act. This will
not affect the bridge owners’
responsibility to notify the Coast Guard
in a timely manner with their request to
change an operating schedule or the
discretion of the District Commander to
accept the request.
Bridge Owner Responsibility
We are changing the requirements in
§ 117.7 to clarify the bridge owner’s
responsibility in maintaining their
drawbridges in operable condition.
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Frm 00031
Fmt 4700
Sfmt 4700
70305
Appendix A
In the NPRM, the Coast Guard
proposed to remove Appendix A to 33
CFR 117 ‘‘Drawbridges Equipped with
Radiotelephones’’. Appendix A
provided information that is already
contained in other sources and does not
need to be repeated in 33 CFR 117. No
comments were received regarding this
issue so Appendix A is removed.
However, the information formerly
contained in Appendix A is available on
the Bridge Administration (G–PWB)
Web site, https://www.uscg.mil/hq/g-o/gopt/g-opt.htm, and also in the National
Oceanographic and Atmospheric
Administration’s (NOAA) nine volume
publication of the ‘‘United States Coast
Pilot’’ or on NOAA’s Web site. We are
also removing a note in § 117.15 that
referenced Appendix A.
Definitions
The Coast Guard is adding eight
definitions in Subpart A to be used
throughout part 117. These definitions
clarify the terms ‘‘Automated
drawbridge’’, ‘‘Deviation’’,
‘‘Drawbridge’’, Drawspan’’, ‘‘Public
vessel’’, ‘‘Remotely operated
drawbridge’’, ‘‘Removable drawspan
bridge’’, and ‘‘Untended’’ in this part.
We also reworded the four definitions
currently in § 117.4 for plain language.
Lindsey Slough
The Coast Guard is removing the
word ‘‘maintenance’’ from § 117.165
thereby requiring any vessel wanting to
pass through the removable span bridge,
across Lindsey Slough, to give a 72-hour
advance notice.
The bridge was constructed in the
1960s and the permit to build the bridge
dictated that the drawbridge open for
maintenance vessels. A final rule setting
a time requirement of 72 hours advance
notice for passage was published in the
Federal Register on April 24, 1984 (49
FR 17452). At the time of publication,
the primary focus was on access for
maintenance barges and the term
maintenance was included in the rule.
However, the removable span has never
been removed for any vessel and to do
so would require a barge with a crane
to be brought in to remove the span.
Because the bridge has not had a request
to open since 1984, the requirement for
all vessels to provide 72-hours advance
notice will meet the reasonable needs of
navigation and will not cause any
undue burden on navigation.
Clarifications
The Coast Guard is adding three new
sections to clarify existing requirements
in part 117. We are adding § 117.8 to
explain how to request a permanent
E:\FR\FM\04DER1.SGM
04DER1
]]>Agencies
[Federal Register Volume 71, Number 232 (Monday, December 4, 2006)]
[Rules and Regulations]
[Pages 70304-70305]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20398]
-----------------------------------------------------------------------
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 approval of a new animal drug application
(NADA) filed by Schering-Plough Animal Health Corp. The NADA provides
for the use of a florfenicol Type A medicated article by veterinary
feed directive to formulate swine feed used for the control of
respiratory disease.
DATES: This rule is effective December 4, 2006.
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.hhs.gov.
SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556
Morris Ave., Summit, NJ 07901, filed NADA 141-264 that provides for use
of NUFLOR (florfenicol), an antibiotic, a Type A medicated article by
veterinary feed directive to formulate Type C medicated feeds used 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. The NADA is approved as of November 3,
2006, and the regulations are amended in 21 CFR 558.4 and 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 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity beginning November 3, 2006.
The agency has determined under 21 CFR 25.33(d)(5) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
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 paragraph (d) of Sec. 558.4, in the ``Category II'' table,
revise the entry for ``Florfenicol'' to read as follows:
Sec. 558.4 Requirement of a medicated feed mill license.
* * * * *
(d) * * *
CATEGORY II
--------------------------------------------------------------------------------------------------------------------------------------------------------
Drug Assay limits percent\1\ Type A Type B maximum (100x) Assay limits percent\1\ Type B/C\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * * * *
Florfenicol 90-110 Swine feed: n/a Swine feed: 85-115
.................................. Catfish feed: n/a Catfish feed: 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
3. In Sec. 558.261, revise paragraphs (a) and (c)(2); redesignate
paragraph (e)(1) as paragraph (e)(2); and add new paragraphs (c)(3) and
(e)(1) to read as follows:
Sec. 558.261 Florfenicol.
(a) Specifications. Type A medicated articles containing
florfenicol in the following concentrations:
(1) 40 grams per kilogram for use as in paragraph (e)(1) of this
section.
(2) 500 grams per kilogram for use as in paragraph (e)(2) of this
section.
* * * * *
(c) * * *
(2) The expiration date of veterinary feed directives (VFDs) for
florfenicol medicated feeds:
(i) For catfish must not exceed 15 days from the date of issuance;
(ii) For swine must not exceed 90 days from the date of issuance.
(3) VFDs for florfenicol shall not be refilled.
* * * * *
(e) * * *
(1) Swine--(i) Amount. Feed 182 grams per ton of feed (200 parts
per million) continuously as the sole ration for 5 days.
(ii) Indications for use. 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.
(iii) Limitations. The safety of florfenicol on swine reproductive
performance, pregnancy, and lactation
[[Page 70305]]
has not been determined. Feeds containing florfenicol must be withdrawn
13 days prior to slaughter.
* * * * *
Dated: November 17, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-20398 Filed 12-1-06; 8:45 am]
BILLING CODE 4160-01-S
