New Animal Drugs for Use in Animal Feeds; Chlortetracycline, 27919-27920 [E9-13849]
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Federal Register / Vol. 74, No. 112 / Friday, June 12, 2009 / Rules and Regulations
Actions and Compliance
(f) Unless already done, do the following
actions within the next 20 hours time-inservice after July 17, 2009 (the effective date
of this AD) or within the next 30 days after
July 17, 2009 (the effective date of this AD),
whichever occurs first, following AEROMOT
Alert Service Bulletin No. 200–71–106, Rev.
B, dated December 20, 2006; ROTAX Aircraft
Engines Mandatory Service Bulletin SB–912–
043 R2/SB–914–029 R2, dated November 10,
2006; and ROTAX Aircraft Engines Service
Instruction SI–912–016/SI–914–019, dated
August 28, 2006:
(1) Replace the EVANS NPG + cooling
liquid with a conventional, FAA-approved
coolant for the ROTAX 912 and 914 series
engines.
(2) Apply a new red line marking on the
engine cylinder head temperature gauge at
120 degrees C/248 degrees F.
(3) Replace the radiator cap part number
(P/N) 922075 from the affected engines with
a new radiator cap P/N 922070.
(4) Insert into the AFM Limitations section
an amendment to include the new operation
limit of the cylinder head temperature to 120
degrees C/248 degrees F by inserting a copy
of AEROMOT Alert Service Bulletin No.
200–71–106, Rev. B, dated December 20,
2006, into the AFM, Limitations section,
Section 2 on item 2.4, power plant, fuel and
oil limitations and item 2.5, power plant
instrument markings.
FAA AD Differences
Note: This AD differs from the MCAI and/
or service information as follows: No
differences.
Other FAA AD Provisions
(g) The following provisions also apply to
this AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, Standards Office,
FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures
found in 14 CFR 39.19. Send information to
ATTN: Greg Davison, Glider Program
Manager, FAA, Small Airplane Directorate,
901 Locust, Room 301, Kansas City, Missouri
64106; telephone: (816) 329–4130; fax: (816)
329–4090. 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.
(2) Airworthy Product: For any requirement
in this AD to obtain corrective actions from
a manufacturer or other source, use these
actions if they are FAA-approved. Corrective
actions are considered FAA-approved if they
are approved by the State of Design Authority
(or their delegated agent). You are required
to assure the product is airworthy before it
is returned to service.
(3) Reporting Requirements: For any
reporting requirement in this AD, under the
provisions of the Paperwork Reduction Act
(44 U.S.C. 3501 et seq.), the Office of
Management and Budget (OMB) has
approved the information collection
requirements and has assigned OMB Control
Number 2120–0056.
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Related Information
(h) Refer to MCAI ANAC Brazilian
Airworthiness Directive AD No. 2007–01–01,
dated January 29, 2007; AEROMOT Alert
Service Bulletin No. 200–71–106, Rev. B,
dated December 20, 2006; ROTAX Aircraft
Engines Mandatory Service Bulletin SB–912–
043 R2/SB–914–029 R2, dated November 10,
2006; and ROTAX Aircraft Engines Service
Instruction SI–912–016/SI–914–019, dated
August 28, 2006, for related information.
Material Incorporated by Reference
(i) You must use AEROMOT Alert Service
Bulletin No. 200–71–106, Rev. B, dated
December 20, 2006; ROTAX Aircraft Engines
Mandatory Service Bulletin SB–912–043 R2/
SB–914–029 R2, dated November 10, 2006;
and ROTAX Aircraft Engines Service
Instruction SI–912–016/SI–914–019, dated
August 28, 2006, to do the actions required
by this AD, unless the AD specifies
otherwise.
(1) The Director of the Federal Register
approved the incorporation by reference of
this service information under 5 U.S.C.
552(a) and 1 CFR part 51.
(2) For service information identified in
this AD, contact Aeromot-Industria Mecanico
Metalurgica ltda., Av. das Industrias, 1210–
Bairro Anchieta, Caixa Postal 8031, 90 200–
290–Porto Alegre-RS–Brazil; telephone: +55
51 3357 8550; fax: +55 51 3371 1655;
Internet: https://www.aeromot.com.br.
(3) You may review copies of the service
information incorporated by reference for
this AD at the FAA, Central Region, Office of
the Regional Counsel, 901 Locust, Kansas
City, Missouri 64106. For information on the
availability of this material at the Central
Region, call (816) 329–3768.
(4) You may also review copies of the
service information incorporated by reference
for this AD at the National 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/federal_register/
code_of_federal_regulations/
ibr_locations.html.
27919
ACTION: Final rule; technical
amendment.
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
Alpharma Inc. The supplemental NADA
provides for revised Blue Bird labeling
for chlortetracycline Type A medicated
articles used to formulate Type B and
Type C medicated feeds in various
classes of livestock and poultry.
DATES: This rule is effective June 12,
2009.
21 CFR Part 558
FOR FURTHER INFORMATION CONTACT:
Timothy Schell, Center for Veterinary
Medicine (HFV–128), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8116, email: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Alpharma
Inc., 440 Rte. 22, Bridgewater, NJ 08807,
filed a supplement to NADA 46–699
that provides revised Blue Bird labeling
for CHLORMAX (chlortetracycline)
Type A medicated articles used to
formulate Type B and Type C medicated
feeds in various classes of livestock and
poultry. The supplemental NADA is
approved as of May 22, 2009, and the
regulations are amended in § 558.128
(21 CFR 558.128) to reflect the approval.
In addition, § 558.128 is amended to
differentiate certain withdrawal times in
cattle for two chlortetracycline Type A
medicated articles sponsored by
Alpharma Inc. under separate NADAs
and to correct the spelling of a turkey
pathogen.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
The agency has determined under 21
CFR 25.33 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.
[Docket No. FDA–2009–N–0665]
List of Subjects in 21 CFR Part 558
New Animal Drugs for Use in Animal
Feeds; Chlortetracycline
■
Issued in Kansas City, Missouri, on June 4,
2009.
Kim Smith,
Manager, Small Airplane Directorate, Aircraft
Certification Service.
[FR Doc. E9–13575 Filed 6–11–09; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
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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
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27920
Federal Register / Vol. 74, No. 112 / Friday, June 12, 2009 / Rules and Regulations
Authority: 21 U.S.C. 360b, 371.
the Center for Veterinary Medicine, 21
CFR part 558 is amended as follows:
2. In § 558.128, in the table in
paragraph (e)(2)(iii), in the ‘‘Indications
for use’’ column, remove ‘‘meleagrides’’
and in its place add ‘‘meleagridis’’; and
revise paragraphs (e)(4)(iv), (e)(4)(v),
and (e)(4)(ix) to read as follows:
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Chlortetracycline amount
*
*
*
Chlortetracycline.
*
*
(e) * * *
(4) * * *
Indications for use
*
(iv) 10 mg/lb of body weight daily .............
§ 558.128
*
*
Limitations
*
*
*
Sponsor
*
*
Feed approximately 400 g/ton, varying
with body weight and feed consumption
to provide 10 mg/lb per day. Treat for
not more than 5 d; in feed including
milk replacers; withdraw 10 d prior to
slaughter. To sponsor No. 048164:
zero withdrawal time. See paragraph
(d)(1) of this section.
012286,
048164,
066104.
2. Calves (up to 250 lb): For the treatment of bacterial enteritis caused by E.
coli susceptible to chlortetracycline.
(v) 500 to 4,000 g/ton ...............................
1. Calves, beef and nonlactating dairy
cattle; treatment of bacterial enteritis
caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline.
See paragraph (d)(1) of this section.
012286,
046573,
048164,
066104.
Calves, beef and nonlactating dairy cattle; treatment of bacterial enteritis
caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline.
Feed continuously for not more than 5
days to provide 10 mg/lb body weight
per day. To sponsor No. 046573 under
NADA 046–699: 24-h withdrawal time.
To sponsor No. 046573 under NADA
048–761: zero withdrawal time.
046573.
*
*
(ix) 350 mg/head/day ................................
*
*
*
*
*
*
*
Withdraw 48 h prior to slaughter. To
sponsor No. 046573 under NADA 046–
699: 48-h withdrawal time. To sponsor
No. 046573 under NADA 048–761 and
No. 048164: zero withdrawal time.
012286,
046573,
048164,
066104.
2. Beef cattle (under 700 lb): For control
of active infection of anaplasmosis
caused by A. marginale susceptible to
chlortetracycline.
*
1. Beef cattle: For control of bacterial
pneumonia associated with shipping
fever complex caused by Pasteurella
spp. susceptible to chlortetracycline.
Withdraw 48 h prior to slaughter. To
sponsor No. 046573 under NADA 046–
699: 48-h withdrawal time. To sponsor
No. 046573 under NADA 048–761 and
No. 048164: zero withdrawal time.
012286,
046573,
048164,
066104.
*
DEPARTMENT OF THE TREASURY
Dated: June 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9–13849 Filed 6–11–09; 8:45 am]
Internal Revenue Service
26 CFR Part 1
[TD 9453]
BILLING CODE 4160–01–S
RIN 1545–BI81
Guidance Under Section 7874
Regarding Surrogate Foreign
Corporations
AGENCY: Internal Revenue Service (IRS),
Treasury.
ACTION: Final and temporary
regulations.
This document contains final
and temporary regulations under section
7874 of the Internal Revenue Code
(Code) concerning the determination of
SUMMARY:
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whether a foreign corporation shall be
treated as a surrogate foreign
corporation. The temporary regulations
primarily affect domestic corporations
or partnerships (and certain parties
related thereto), and certain foreign
corporations that acquire substantially
all of the properties of such domestic
corporations or partnerships. The text of
these temporary regulations serves as
the text of the proposed regulations set
forth in the notice of proposed
rulemaking on this subject also
published in this issue of the Federal
Register.
DATES: Effective Dates: The regulations
are effective on June 12, 2009.
Applicability Date: For dates of
applicability, see §§ 1.7874–1T(g) and
1.7874–2T(o).
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]]>Agencies
[Federal Register Volume 74, Number 112 (Friday, June 12, 2009)]
[Rules and Regulations]
[Pages 27919-27920]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13849]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2009-N-0665]
New Animal Drugs for Use in Animal Feeds; Chlortetracycline
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
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 Alpharma Inc. The supplemental NADA
provides for revised Blue Bird labeling for chlortetracycline Type A
medicated articles used to formulate Type B and Type C medicated feeds
in various classes of livestock and poultry.
DATES: This rule is effective June 12, 2009.
FOR FURTHER INFORMATION CONTACT: Timothy Schell, Center for Veterinary
Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8116, e-mail: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Alpharma Inc., 440 Rte. 22, Bridgewater, NJ
08807, filed a supplement to NADA 46-699 that provides revised Blue
Bird labeling for CHLORMAX (chlortetracycline) Type A medicated
articles used to formulate Type B and Type C medicated feeds in various
classes of livestock and poultry. The supplemental NADA is approved as
of May 22, 2009, and the regulations are amended in Sec. 558.128 (21
CFR 558.128) to reflect the approval.
In addition, Sec. 558.128 is amended to differentiate certain
withdrawal times in cattle for two chlortetracycline Type A medicated
articles sponsored by Alpharma Inc. under separate NADAs and to correct
the spelling of a turkey pathogen.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
The agency has determined under 21 CFR 25.33 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
[[Page 27920]]
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. 558.128, in the table in paragraph (e)(2)(iii), in the
``Indications for use'' column, remove ``meleagrides'' and in its place
add ``meleagridis''; and revise paragraphs (e)(4)(iv), (e)(4)(v), and
(e)(4)(ix) to read as follows:
Sec. 558.128 Chlortetracycline.
* * * * *
(e) * * *
(4) * * *
----------------------------------------------------------------------------------------------------------------
Chlortetracycline amount Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(iv) 10 mg/lb of body weight daily...... 1. Calves, beef and Feed approximately 400 g/ 012286,
nonlactating dairy cattle; ton, varying with body 048164,
treatment of bacterial weight and feed 066104.
enteritis caused by E. coli consumption to provide 10
and bacterial pneumonia mg/lb per day. Treat for
caused by P. multocida not more than 5 d; in feed
organisms susceptible to including milk replacers;
chlortetracycline. withdraw 10 d prior to
slaughter. To sponsor No.
048164: zero withdrawal
time. See paragraph (d)(1)
of this section.
2. Calves (up to 250 lb): See paragraph (d)(1) of 012286,
For the treatment of this section. 046573,
bacterial enteritis caused 048164,
by E. coli susceptible to 066104.
chlortetracycline.
----------------------------------------------------------------------------------------------------------------
(v) 500 to 4,000 g/ton.................. Calves, beef and Feed continuously for not 046573.
nonlactating dairy cattle; more than 5 days to
treatment of bacterial provide 10 mg/lb body
enteritis caused by E. coli weight per day. To sponsor
and bacterial pneumonia No. 046573 under NADA 046-
caused by P. multocida 699: 24-h withdrawal time.
organisms susceptible to To sponsor No. 046573
chlortetracycline. under NADA 048-761: zero
withdrawal time.
----------------------------------------------------------------------------------------------------------------
* * * * * * *
----------------------------------------------------------------------------------------------------------------
(ix) 350 mg/head/day.................... 1. Beef cattle: For control Withdraw 48 h prior to 012286,
of bacterial pneumonia slaughter. To sponsor No. 046573,
associated with shipping 046573 under NADA 046-699: 048164,
fever complex caused by 48-h withdrawal time. To 066104.
Pasteurella spp. sponsor No. 046573 under
susceptible to NADA 048-761 and No.
chlortetracycline. 048164: zero withdrawal
time.
2. Beef cattle (under 700 Withdraw 48 h prior to 012286,
lb): For control of active slaughter. To sponsor No. 046573,
infection of anaplasmosis 046573 under NADA 046-699: 048164,
caused by A. marginale 48-h withdrawal time. To 066104.
susceptible to sponsor No. 046573 under
chlortetracycline. NADA 048-761 and No.
048164: zero withdrawal
time.
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: June 8, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E9-13849 Filed 6-11-09; 8:45 am]
BILLING CODE 4160-01-S
