New Animal Drugs For Use in Animal Feeds; Tylosin, 74466-74467 [E6-21021]
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74466
Federal Register / Vol. 71, No. 238 / Tuesday, December 12, 2006 / Rules and Regulations
part 51. Contact British Aerospace Regional
Aircraft American Support, 13850 Mclearen
Road, Herndon, Virginia 20171, 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
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federal_register/code_of_federal_regulations/
ibr_locations.html.
§ 39.13
Issued in Renton, Washington, on
December 1, 2006.
Kevin M. Mullin,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. E6–20952 Filed 12–11–06; 8:45 am]
BILLING CODE 4910–13–P
BILLING CODE 4910–13–P
[Corrected]
On page 682, in the first column, in
the PART 39—AIRWORTHINESS
DIRECTIVES Section, in the
Applicability paragraph, in the second
line, ‘‘UL29916’’ is corrected to read
‘‘UL26916’’.
I
Issued in Burlington, Massachusetts, on
December 5, 2006.
Diane M. Cook,
Acting Manager, Engine and Propeller
Directorate, Aircraft Certification Service.
[FR Doc. E6–21122 Filed 12–11–06; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
AGENCY:
14 CFR Part 39
RIN 2120–AA64
Airworthiness Directives; Rolls-Royce
plc RB211–524 Series Turbofan
Engines; Correction
Federal Aviation
Administration, DOT.
ACTION: Final rule; correction.
AGENCY:
SUMMARY: This document makes a
correction to airworthiness directive
(AD) 2004–26–05 applicable to certain
Rolls-Royce plc (RR) RB211–524 series
turbofan engines that was published in
the Federal Register on January 5, 2005.
The part number UL29916 in the
Applicability section is incorrect. This
document corrects that part number. In
all other respects, the original document
remains the same.
DATES: Effective Date: December 12,
2006.
Ian
Dargin, Aerospace Engineer, Engine
Certification Office, FAA, Engine and
Propeller Directorate, 12 New England
Executive Park, Burlington, MA 01803–
5299; telephone (781) 238–7178; fax
(781) 238–7199.
SUPPLEMENTARY INFORMATION: A final
rule airworthiness directive FR Doc, 05–
85 applicable to RR RB211–524 series
turbofan engines, was published in the
Federal Register on January 5, 2005 (70
FR 681). The following correction is
needed:
jlentini on PROD1PC65 with RULES
FOR FURTHER INFORMATION CONTACT:
17:58 Dec 11, 2006
Food and Drug Administration,
HHS.
[Docket No. 2004–NE–19–AD; Amendment
39–13197; AD 2004–26–05]
VerDate Aug<31>2005
New Animal Drugs For Use in Animal
Feeds; Tylosin
Jkt 211001
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, A Division of Eli
Lilly & Co. The supplemental NADA
provides for an alternate feeding
regimen for tylosin phosphate in Type
C medicated swine feeds used for the
control of swine proliferative
enteropathies.
DATES: This rule is effective December
12, 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.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 12–491 that
provides for use of TYLAN (tylosin
phosphate) Type A medicated articles.
The supplement provides for an
alternate feeding regimen for the control
of swine proliferative enteropathies
(ileitis) associated with Lawsonia
intracellularis. In addition, Elanco
Animal Health revised the names of
other enteric pathogens of swine to
reflect changes in the scientific
nomenclature for these bacteria. The
supplemental NADA is approved as of
November 7, 2006, and the regulations
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Frm 00012
Fmt 4700
Sfmt 4700
in 21 CFR 558.625 are amended 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)(iii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(iii)), this
approval qualifies for 3 years of
marketing exclusivity beginning
November 7, 2006.
FDA has determined under 21 CFR
25.33(a)(1) 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 § 558.625, revise paragraphs
(f)(1)(i)(b), (f)(1)(vi)(b)(1), (f)(1)(vi)(c)(1),
and (f)(1)(vi)(e)(1) to read as follows:
I
§ 558.625
Tylosin.
*
*
*
*
*
(f) * * *
(1) * * *
(i) * * *
(b) Indications for use. For reduction
of incidence of liver abscesses caused by
Fusobacterium necrophorum and
Arcanobacterium (Actinomyces)
pyogenes.
*
*
*
*
*
(vi) * * *
E:\FR\FM\12DER1.SGM
12DER1
Federal Register / Vol. 71, No. 238 / Tuesday, December 12, 2006 / Rules and Regulations
(b) * * *
(1) Indications for use. For control of
swine dysentery associated with
Brachyspira hyodysenteriae, and for
control of porcine proliferative
enteropathies (ileitis) associated with
Lawsonia intracellularis.
*
*
*
*
*
(c) * * *
(1) Indications for use. For treatment
and control of swine dysentery
associated with B. hyodysenteriae.
*
*
*
*
*
(e) * * *
(1) Indications for use. For control of
porcine proliferative enteropathies
(ileitis) associated with L.
intracellularis.
Dated: November 29, 2006.
David R. Newkirk,
Acting Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–21021 Filed 12–11–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9301]
RIN 1545–BF89
Reduction in Taxable Income for
Housing Hurricane Katrina Displaced
Individuals
Internal Revenue Service (IRS),
Treasury.
ACTION: Temporary regulations.
jlentini on PROD1PC65 with RULES
AGENCY:
SUMMARY: This document contains
temporary regulations relating to the
reduction in taxable income under
section 302 of the Katrina Emergency
Tax Relief Act of 2005. The regulations
affect taxpayers who provide housing in
their principal residences to individuals
displaced by Hurricane Katrina. The
text of the temporary regulations also
serves as the text of the proposed
regulations set forth in the notice of
proposed rulemaking on this subject in
the Proposed Rules section in this issue
of the Federal Register.
DATES: Effective Date: These regulations
are effective December 11, 2006.
Applicability Date: For date of
applicability, see § 1.9300–1T(g).
FOR FURTHER INFORMATION CONTACT:
Marnette M. Myers, 202–622–4920 (not
a toll-free number).
SUPPLEMENTARY INFORMATION:
Background
This document contains amendments
to the Income Tax Regulations (26 CFR
VerDate Aug<31>2005
17:58 Dec 11, 2006
Jkt 211001
part 1) relating to the reduction in
taxable income for housing provided to
displaced individuals under section 302
of the Katrina Emergency Tax Relief Act
of 2005 (Pub. L. No. 109–73, 119 Stat.
2016) (KETRA).
For taxable years beginning in 2005
and 2006, a taxpayer may reduce taxable
income by $500 for each Hurricane
Katrina displaced individual to whom
the taxpayer provides free housing in
the taxpayer’s principal residence for a
period of 60 consecutive days that ends
in the taxable year. No reduction is
allowed if the taxpayer receives rent or
other compensation from any source for
providing the housing.
A taxpayer may not claim a reduction
in taxable income with respect to the
same Hurricane Katrina displaced
individual in more than one taxable
year and must include the Hurricane
Katrina displaced individual’s tax
identification number on the taxpayer’s
return. Generally, the total reduction for
all taxable years is $2,000.
A Hurricane Katrina displaced
individual is defined as a natural person
who was displaced from a principal
place of abode that, on August 28, 2005,
was in the Hurricane Katrina core
disaster area. A Hurricane Katrina
displaced individual also is defined as
an individual whose principal place of
abode was located in the Hurricane
Katrina disaster area, but outside the
core disaster area, if the abode was
damaged by Hurricane Katrina or the
individual was evacuated from the
abode because of Hurricane Katrina. A
Hurricane Katrina displaced individual
may not be the taxpayer’s spouse or
dependent.
Under section 2(1) of KETRA, the
Hurricane Katrina disaster area is the
area with respect to which a major
disaster by reason of Hurricane Katrina
has been declared by the President
before September 14, 2005, under
section 401 of the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act (42 U.S.C. 5170)
(Stafford Act). For purposes of relief
provided under KETRA, this area
comprises the states of Louisiana,
Mississippi, Alabama, and Florida.
Under section 2(2) of KETRA, the
Hurricane Katrina core disaster area is
the portion of the Hurricane Katrina
disaster area determined by the
President to warrant individual or
individual and public assistance from
the Federal government under the
Stafford Act. See Appendix to Notice
2005–73 (2005–42 I.R.B. 723) (Oct. 17,
2005) (listing parishes and counties
designated for assistance under the
Stafford Act).
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Fmt 4700
Sfmt 4700
74467
Explanation of Provisions
Provision of Housing
The temporary regulations provide
that a taxpayer is considered to provide
housing if the housing is provided
either in, or on the site of, the taxpayer’s
principal residence. In addition, the
taxpayer must be an owner or lessee of
the residence to be treated as providing
housing to a Hurricane Katrina
displaced individual. The term
principal residence has the same
meaning as in section 121 and the
regulations thereunder. Amounts in
connection with the provision of
housing (for which the taxpayer may not
be reimbursed or compensated) include
rent and utilities. Amounts for
telephone calls, food, clothing and
transportation are not amounts in
connection with the provision of
housing for this purpose.
Limitations on Amount of Reduction
The temporary regulations provide
that the $2,000 aggregate limit on the
reduction in taxable income applies to
unmarried individuals and married
taxpayers filing a joint tax return.
Married taxpayers who file separate
returns may reduce taxable income by
$1,000 each for all taxable years.
The temporary regulations clarify that
a taxpayer may reduce taxable income
with respect to a specific Hurricane
Katrina displaced individual in 2005 or
2006, but not both years. Additionally,
the temporary regulations provide that a
Hurricane Katrina displaced individual
may be taken into account by only one
taxpayer occupying the same principal
residence.
Effective Date
The temporary regulations apply to
taxable years beginning after December
31, 2004, and before January 1, 2007,
and ending on or after December 11,
2006, which is the date the temporary
regulations were filed with the Federal
Register. Taxpayers may rely on the
temporary regulations with respect to
taxable years ending before the filing
date, but may not rely on the absence of
regulations for taxable years ending
before the filing date for a result
contrary to that under the temporary
regulations.
Special Analyses
It has been determined that this
Treasury decision is not a significant
regulatory action as defined in
Executive Order 12866. Therefore, a
regulatory assessment is not required. It
also has been determined that section
553(b) of the Administrative Procedure
Act (5 U.S.C. chapter 5) does not apply
E:\FR\FM\12DER1.SGM
12DER1
Agencies
[Federal Register Volume 71, Number 238 (Tuesday, December 12, 2006)]
[Rules and Regulations]
[Pages 74466-74467]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21021]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal Feeds; Tylosin
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, A Division of Eli
Lilly & Co. The supplemental NADA provides for an alternate feeding
regimen for tylosin phosphate in Type C medicated swine feeds used for
the control of swine proliferative enteropathies.
DATES: This rule is effective December 12, 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: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a
supplement to NADA 12-491 that provides for use of TYLAN (tylosin
phosphate) Type A medicated articles. The supplement provides for an
alternate feeding regimen for the control of swine proliferative
enteropathies (ileitis) associated with Lawsonia intracellularis. In
addition, Elanco Animal Health revised the names of other enteric
pathogens of swine to reflect changes in the scientific nomenclature
for these bacteria. The supplemental NADA is approved as of November 7,
2006, and the regulations in 21 CFR 558.625 are amended 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)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval qualifies
for 3 years of marketing exclusivity beginning November 7, 2006.
FDA has determined under 21 CFR 25.33(a)(1) 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 Sec. 558.625, revise paragraphs (f)(1)(i)(b), (f)(1)(vi)(b)(1),
(f)(1)(vi)(c)(1), and (f)(1)(vi)(e)(1) to read as follows:
Sec. 558.625 Tylosin.
* * * * *
(f) * * *
(1) * * *
(i) * * *
(b) Indications for use. For reduction of incidence of liver
abscesses caused by Fusobacterium necrophorum and Arcanobacterium
(Actinomyces) pyogenes.
* * * * *
(vi) * * *
[[Page 74467]]
(b) * * *
(1) Indications for use. For control of swine dysentery associated
with Brachyspira hyodysenteriae, and for control of porcine
proliferative enteropathies (ileitis) associated with Lawsonia
intracellularis.
* * * * *
(c) * * *
(1) Indications for use. For treatment and control of swine
dysentery associated with B. hyodysenteriae.
* * * * *
(e) * * *
(1) Indications for use. For control of porcine proliferative
enteropathies (ileitis) associated with L. intracellularis.
Dated: November 29, 2006.
David R. Newkirk,
Acting Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. E6-21021 Filed 12-11-06; 8:45 am]
BILLING CODE 4160-01-S