New Animal Drugs; Ractopamine, 62570-62571 [E7-21816]
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62570
Federal Register / Vol. 72, No. 214 / Tuesday, November 6, 2007 / Rules and Regulations
Applicability
(c) This AD applies to Goodrich evacuation
systems approved under Technical Standard
Order (TSO) TSO–C69b, as installed on
Airbus Model A330–201, –202, –203, –223,
–243, –301, –321, –322, –323, –341, –342,
and –343 airplanes; Model A340–211, –212,
–213, –311, –312, and –313 airplanes; and
Model A340–541 and –642 airplanes;
certificated in any category.
Unsafe Condition
(d) This AD results from a report indicating
that, during maintenance testing, the
pressure relief valves on the affected
Goodrich evacuation systems did not seal
when activated, which caused the pressure in
the escape slide/raft to drop below the
minimum allowable raft mode pressure. We
are issuing this AD to prevent loss of
pressure in the escape slides/rafts after an
emergency evacuation, which could result in
inadequate buoyancy to support the raft’s
passenger capacity during ditching, and
increase the chance for injury to raft
passengers.
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.
Restatement of Requirements of AD 2006–
12–08
Inspection for Certain Part Number (P/N)
(f) For all airplanes: Within 36 months after
July 17, 2006 (the effective date of AD 2006–
12–08): Perform an inspection to determine
the part number of the pressure relief valve
on the Goodrich evacuation systems in
accordance with the Accomplishment
Instructions of Goodrich Service Bulletin 25–
355, dated July 25, 2005; or Goodrich Service
Bulletin 25–355, Revision 1, dated July 24,
2006. After the effective date of this AD, only
Goodrich Service Bulletin 25–355, Revision
1, dated July 24, 2006, may be used.
(1) If any pressure relief valve having P/N
4A3791–3 is installed, before further flight,
replace the valve with a new or serviceable
valve having P/N 4A3641–1 and mark the girt
adjacent to the placard, in accordance with
the Accomplishment Instructions of the
service bulletin.
(2) If any pressure release valve having P/
N 4A3641–1 is installed, before further flight,
mark the girt adjacent to the placard in
accordance with the Accomplishment
Instructions of the service bulletin.
mstockstill on PROD1PC66 with RULES
Part Installation for Airplanes Identified in
Original Issue of the Service Bulletin
(g) As of July 17, 2006, no person may
install a pressure relief valve having P/N
4A3791–3, on any airplane equipped with
Goodrich evacuation systems identified in
Goodrich Service Bulletin 25–355, dated July
25, 2005.
New Requirements of This AD
Inspection for Certain Other P/N
(h) For Model A340–541 airplanes: Within
36 months after the effective date of this AD,
perform an inspection to determine the part
VerDate Aug<31>2005
16:30 Nov 05, 2007
Jkt 214001
number of the pressure relief valve on the
Goodrich evacuation systems in accordance
with the Accomplishment Instructions of
Goodrich Service Bulletin 25–355, Revision
1, dated July 24, 2006.
(1) If any pressure relief valve having P/N
4A3791–6 is installed, before further flight,
replace the valve with a new or serviceable
valve having P/N 4A3641–26 and mark the
girt adjacent to the placard, in accordance
with the Accomplishment Instructions of the
service bulletin.
(2) If any pressure release valve having P/
N 4A3641–26 is installed, before further
flight, mark the girt adjacent to the placard
in accordance with the Accomplishment
Instructions of the service bulletin.
Parts Installation for All Airplanes
(i) As of the effective date of this AD, no
person may install a pressure relief valve
having P/N 4A3791–3, on any airplane
equipped with Goodrich evacuation systems
identified in Goodrich Service Bulletin 25–
355, Revision 1, dated July 24, 2006.
(j) As of the effective date of this AD, no
person may install a pressure relief valve
having P/N 4A3791–6, on any airplane
equipped with Goodrich evacuation systems
identified in Goodrich Service Bulletin 25–
355, Revision 1, dated July 24, 2006.
Alternative Methods of Compliance
(AMOCs)
(k)(1) The Manager, Los Angeles Aircraft
Certification Office, FAA, has the authority to
approve AMOCs for this AD, if requested in
accordance with the procedures found in 14
CFR 39.19.
(2) To request a different method of
compliance or a different compliance time
for this AD, follow the procedures in 14 CFR
39.19. Before using any approved AMOC on
any airplane to which the AMOC applies,
notify your appropriate principal inspector
(PI) in the FAA Flight Standards District
Office (FSDO), or lacking a PI, your local
FSDO.
(3) AMOCs approved previously in
accordance with AD 2006–12–08 are
approved as AMOCs for the corresponding
provisions of this AD.
Material Incorporated by Reference
(l) You must use Goodrich Service Bulletin
25–355, dated July 25, 2005; or Goodrich
Service Bulletin 25–355, Revision 1, dated
July 24, 2006; as applicable, to perform the
actions that are required by this AD, unless
the AD specifies otherwise.
(1) The Director of the Federal Register
approved the incorporation by reference of
Goodrich Service Bulletin 25–355, Revision
1, dated July 24, 2006, in accordance with 5
U.S.C. 552(a) and 1 CFR part 51.
(2) On July 17, 2006 (71 FR 33606, June 12,
2006), the Director of the Federal Register
approved the incorporation by reference of
Goodrich Service Bulletin 25–355, dated July
25, 2005.
(3) Contact Goodrich, Aircraft Interior
Products, ATTN: Technical Publications,
3414 South Fifth Street, Phoenix, AZ 85040,
for a copy of this service information. You
may review copies at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue,
SW., Renton, Washington; or at the National
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
Archives and Records Administration
(NARA). For information on the availability
of this material at NARA, call 202–741–6030,
or go to: https://www.archives.gov/federalregister/cfr/ibr-locations.html.
Issued in Renton, Washington, on October
27, 2007.
Stephen P. Boyd,
Assistant Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. E7–21685 Filed 11–5–07; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs; Ractopamine
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 supplemental new animal
drug application (NADA) filed by
Elanco Animal Health. The
supplemental NADA provides for an
increased level of monensin in threeway combination Type C medicated
feeds containing ractopamine,
monensin, and tylosin for cattle fed in
confinement for slaughter and a revision
to bacterial pathogen nomenclature.
DATES: This rule is effective November
6, 2007.
FOR FURTHER INFORMATION CONTACT:
Daniel A. Benz, Center for Veterinary
Medicine (HFV–126), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–0223,
e-mail: daniel.benz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 141–224 that
provides for use of OPTAFLEXX
(ractopamine hydrochloride),
RUMENSIN (monensin USP), and
TYLAN (tylosin phosphate) Type A
medicated articles to make dry and
liquid three-way combination
medicated feeds for cattle fed in
confinement for slaughter. The
supplemental NADA provides for an
increased level of monensin in
combination Type C medicated feeds
and a revision to bacterial pathogen
nomenclature. The supplemental NADA
is approved as of October 12, 2007, and
the regulations in 21 CFR 558.500 are
amended to reflect the approval.
E:\FR\FM\06NOR1.SGM
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62571
Federal Register / Vol. 72, No. 214 / Tuesday, November 6, 2007 / Rules and Regulations
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.
The agency has determined under 21
CFR 25.33(a)(2) 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
Ractopamine in grams/
ton
*
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
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
*
*
*
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R08–OAR–2007–0622; FRL–8490–6]
Approval and Promulgation of Air
Quality Implementation Plans; State of
Colorado; Revised Denver PM10
Maintenance Plan
Environmental Protection
Agency (EPA).
AGENCY:
16:30 Nov 05, 2007
Jkt 214001
Cattle fed in confinement for slaughter: As in paragraph (e)(2)(vi) of
this section; for prevention and
control of coccidiosis due to
Eimeria bovis and E. zuernii; and
for reduction of incidence of liver
abscesses caused by
Fusobacterium necrophorum and
Arcanobacterium (Actinomyces)
pyogenes.
§ 558.500
*
Direct final rule.
Frm 00013
Fmt 4700
Ractopamine.
*
*
(e) * * *
(2) * * *
Sfmt 4700
*
*
*
Sponsor
*
As in paragraph (e)(2)(i) of this
section; see §§ 558.355(d)
and 558.625(c) of this chapter.
*
000986
*
As in paragraph (e)(2)(vi) of this
section; see §§ 558.355(d)
and 558.625(c) of this chapter.
*
SUMMARY: EPA is taking direct final
action approving a State
Implementation Plan (SIP) revision
submitted by the State of Colorado. On
September 25, 2006, the Governor’s
designee submitted a revised plan for
particulate matter with an aerodynamic
diameter, less than or equal to 10
microns (PM10) for the Denver
metropolitan area for the PM10 National
Ambient Air Quality Standard
(NAAQS). This revised maintenance
plan addresses maintenance of the
PM10 standard for a second ten-year
period beyond redesignation, extends
the horizon years, and contains revised
transportation conformity budgets. EPA
is approving the removal of Regulation
No. 11, ‘‘Motor Vehicle Emissions
PO 00000
2. In § 558.500, in the table in
paragraph (e)(2), revise paragraphs
(e)(2)(iv) and (e)(2)(ix) to read as
follows:
I
*
*
ACTION:
Authority: 21 U.S.C. 360b, 371.
*
*
*
Dated: October 26, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–21816 Filed 11–5–07; 8:45 am]
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Limitations
Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this
section; for prevention and control
of coccidiosis due to Eimeria bovis
and E. zuernii; and for reduction of
incidence of liver abscesses
caused by Fusobacterium
necrophorum and Arcanobacterium
(Actinomyces) pyogenes.
*
Monensin 10 to 40 to provide
0.14 to 0.42 mg monensin/lb
of body weight, depending on
severity of coccidiosis challenge, up to 480 mg/head/
day, plus tylosin 8 to 10
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
Indications for use
*
*
(ix) 9.8 to 24.6
mstockstill on PROD1PC66 with RULES
Animal drugs, Animal feeds.
Monensin 10 to 40 to provide
0.14 to 0.42 mg monensin/lb
of body weight, depending on
severity of coccidiosis challenge, up to 480 mg/head/
day, plus tylosin 8 to 10
*
VerDate Aug<31>2005
List of Subjects in 21 CFR Part 558
Combination in grams/ton
*
(iv) 8.2 to 24.6
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.
*
000986
*
Inspection Program’’ from Denver’s
revised PM10 maintenance plan. In
addition, EPA is approving a
transportation budget trading protocol
for estimating the PM10 and nitrogen
oxides (NOx) for each conformity
determination. This action is being
taken under section 110 of the Clean Air
Act.
This direct final rule is effective
on January 7, 2008 without further
notice, unless EPA receives adverse
comment by December 6, 2007. If
adverse comment is received, EPA will
publish a timely withdrawal of the
direct final rule in the Federal Register
informing the public that the rule will
not take effect.
DATES:
Submit your comments,
identified by Docket Number EPA–R08–
ADDRESSES:
E:\FR\FM\06NOR1.SGM
06NOR1
]]>Agencies
[Federal Register Volume 72, Number 214 (Tuesday, November 6, 2007)]
[Rules and Regulations]
[Pages 62570-62571]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-21816]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs; Ractopamine
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 supplemental new animal drug
application (NADA) filed by Elanco Animal Health. The supplemental NADA
provides for an increased level of monensin in three-way combination
Type C medicated feeds containing ractopamine, monensin, and tylosin
for cattle fed in confinement for slaughter and a revision to bacterial
pathogen nomenclature.
DATES: This rule is effective November 6, 2007.
FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-0223, e-mail: daniel.benz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 141-224 that provides for use of OPTAFLEXX
(ractopamine hydrochloride), RUMENSIN (monensin USP), and TYLAN
(tylosin phosphate) Type A medicated articles to make dry and liquid
three-way combination medicated feeds for cattle fed in confinement for
slaughter. The supplemental NADA provides for an increased level of
monensin in combination Type C medicated feeds and a revision to
bacterial pathogen nomenclature. The supplemental NADA is approved as
of October 12, 2007, and the regulations in 21 CFR 558.500 are amended
to reflect the approval.
[[Page 62571]]
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.
The agency has determined under 21 CFR 25.33(a)(2) 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 the
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. 558.500, in the table in paragraph (e)(2), revise
paragraphs (e)(2)(iv) and (e)(2)(ix) to read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(2) * * *
----------------------------------------------------------------------------------------------------------------
Ractopamine in
grams/ton Combination in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(iv) 8.2 to 24.6 Monensin 10 to 40 to Cattle fed in confinement As in paragraph 000986
provide 0.14 to 0.42 mg for slaughter: As in (e)(2)(i) of this
monensin/lb of body paragraph (e)(2)(i) of this section; see Sec. Sec.
weight, depending on section; for prevention and 558.355(d) and
severity of coccidiosis control of coccidiosis due 558.625(c) of this
challenge, up to 480 mg/ to Eimeria bovis and E. chapter.
head/day, plus tylosin 8 zuernii; and for reduction
to 10 of incidence of liver
abscesses caused by
Fusobacterium necrophorum
and Arcanobacterium
(Actinomyces) pyogenes.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(ix) 9.8 to 24.6 Monensin 10 to 40 to Cattle fed in confinement As in paragraph 000986
provide 0.14 to 0.42 mg for slaughter: As in (e)(2)(vi) of this
monensin/lb of body paragraph (e)(2)(vi) of section; see Sec. Sec.
weight, depending on this section; for 558.355(d) and
severity of coccidiosis prevention and control of 558.625(c) of this
challenge, up to 480 mg/ coccidiosis due to Eimeria chapter.
head/day, plus tylosin 8 bovis and E. zuernii; and
to 10 for reduction of incidence
of liver abscesses caused
by Fusobacterium
necrophorum and
Arcanobacterium
(Actinomyces) pyogenes.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
Dated: October 26, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-21816 Filed 11-5-07; 8:45 am]
BILLING CODE 4160-01-S
