New Animal Drugs For Use in Animal Feeds; Monensin, 9244-9245 [E7-3621]
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Federal Register / Vol. 72, No. 40 / Thursday, March 1, 2007 / Rules and Regulations
List of Subjects in 21 CFR Part 522
Animal drugs.
I 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 522 is amended as follows:
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
Authority: 21 U.S.C. 360b.
2. In § 522.2477, add paragraph
(d)(2)(i)(F) to read as follows:
I
Trenbolone acetate and
*
*
*
*
*
(d) * * *
(2) * * *
(i) * * *
(F) 200 mg trenbolone acetate and 20
mg estradiol (one implant consisting of
11 pellets, each of 10 pellets containing
20 mg trenbolone acetate and 2 mg
estradiol, and 1 pellet containing 29 mg
tylosin tartrate) per implant dose.
*
*
*
*
*
Dated: February 12, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E7–3620 Filed 2–28–07; 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; Monensin
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
rwilkins on PROD1PC63 with RULES
ACTION:
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 minor
revisions to labeling of monensin Type
A medicated articles for chickens. FDA
is also amending the regulations to
simplify the organization of special
labeling requirements for formulations
(Type A medicated articles, Type B and
Type C medicated feeds) containing
VerDate Aug<31>2005
15:44 Feb 28, 2007
Jkt 211001
DATES:
This rule is effective March 1,
2007.
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.
FOR FURTHER INFORMATION CONTACT:
Joan
2. In § 558.355, revise paragraphs (a),
(b)(1), (b)(4), (b)(6), (d)(4), (d)(5), and
(d)(8); and add paragraphs (d)(9)(iv)
through (d)(9)(vi), and (d)(10)(iv)
through (d)(10)(vi) to read as follows:
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.
I
Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285, filed a
supplement to NADA 38–878 that
provides for use of COBAN 60 and
COBAN 90 (monensin, USP) Type A
medicated articles in feed of chickens.
The supplement provides for minor
revisions to labeling. The supplemental
NADA is approved as of February 7,
2007, and the regulations in 21 CFR
558.355 are amended to reflect the
approval.
In addition, FDA is taking this
opportunity to amend the regulations to
simplify the organization of special
labeling requirements for formulations
(Type A medicated articles, Type B and
Type C medicated feeds) containing
monensin for poultry and game birds.
Similar restructuring was done recently
for monensin formulations used in
ruminants (71 FR 66231, November 14,
2006). This action is being taken to
improve the clarity of the regulations.
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.
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.
§ 558.355
SUPPLEMENTARY INFORMATION:
1. The authority citation for 21 CFR
part 522 continues to read as follows:
I
§ 522.2477
estradiol.
monensin for poultry and game birds.
This action is being taken to improve
the clarity of the regulations.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
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
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
Monensin.
(a) Specifications. Type A medicated
articles containing monensin, USP.
(b) * * *
(1) To No. 000986: 36.3 (for export
only), 44, 45, 60, or 90.7 grams per
pound for use as in paragraphs (f)(1)(i)
and (f)(4) of this section.
*
*
*
*
*
(4) To No. 000986: 45, 60, or 90.7
grams per pound for use as in paragraph
(f)(2) of this section.
*
*
*
*
*
(6) To No. 000986: 45, 60, or 90.7
grams per pound for use as in paragraph
(f)(5) of this section.
*
*
*
*
*
(d) * * *
(4) Liquid Type B feeds shall bear an
expiration date of 8 weeks after its date
of manufacture.
(5) All Type A medicated articles
containing monensin shall bear the
following warning statement: When
mixing and handling monensin Type A
medicated articles, use protective
clothing, impervious gloves, and a dust
mask. Operators should wash
thoroughly with soap and water after
handling. If accidental eye contact
occurs, immediately rinse thoroughly
with water.
*
*
*
*
*
(8) Type A medicated articles
containing monensin intended for use
in chickens, turkeys, and quail shall
bear the following statements:
(i) Do not allow horses, other equines,
mature turkeys, or guinea fowl access to
feed containing monensin. Ingestion of
monensin by horses and guinea fowl has
been fatal.
(ii) Must be thoroughly mixed in feeds
before use.
(iii) Do not feed undiluted.
(iv) Do not feed to laying chickens.
(v) Do not feed to chickens over 16
weeks of age.
(vi) For replacement chickens
intended for use as cage layers only.
(vii) Some strains of turkey coccidia
may be monensin tolerant or resistant.
Monensin may interfere with
development of immunity to turkey
coccidiosis.
E:\FR\FM\01MRR1.SGM
01MRR1
Federal Register / Vol. 72, No. 40 / Thursday, March 1, 2007 / Rules and Regulations
(viii) In the absence of coccidiosis in
broiler chickens the use of monensin
with no withdrawal period may limit
feed intake resulting in reduced weight
gain.
(9) * * *
(iv) Chickens: See paragraphs (d)(8)(i)
through (d)(8)(vi), and (d)(8)(viii) of this
section.
(v) Turkeys: See paragraphs (d)(8)(i),
(d)(8)(ii), (d)(8)(iii), and (d)(8)(vii) of this
section.
(vi) Quail: See paragraphs (d)(8)(i),
(d)(8)(ii), and (d)(8)(iii) of this section.
(10) * * *
(iv) Chickens: See paragraphs (d)(8)(i),
(d)(8)(iv), (d)(8)(v), (d)(8)(vi), and
(d)(8)(viii) of this section.
(v) Turkeys: See paragraphs (d)(8)(i)
and (d)(8)(vii) of this section.
(vi) Quail: See paragraph (d)(8)(i) of
this section.
*
*
*
*
*
Dated: February 12, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E7–3621 Filed 2–28–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
to NADA 141–258 for use of ZILMAX
(zilpaterol hydrochloride 4.8%) Type A
medicated article to formulate Type B
and Type C medicated cattle feeds. The
supplemental NADA provides for the
removal of a caution statement against
the formulation of pelleted feeds from
labeling. The supplemental NADA is
approved as of January 29, 2007, and the
regulations are amended in 21 CFR
558.665 to reflect the approval.
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.
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
Food and Drug Administration
Animal drugs, Animal feeds.
New Animal Drugs For Use in Animal
Feeds; Zilpaterol
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
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
Intervet Inc. The supplemental NADA
provides for the removal of a caution
statement against the formulation of
pelleted feeds from labeling of zilpaterol
hydrochloride Type A medicated article
and Type B and Type C medicated
feeds.
SUMMARY:
DATES:
This rule is effective March 1,
2007.
rwilkins on PROD1PC63 with RULES
FOR FURTHER INFORMATION CONTACT:
Charles J. Andres, Center for Veterinary
Medicine (HFV–120), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301 827–1600, email: charles.andres@.fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Intervet
Inc., P.O. Box 318, 29160 Intervet Ln.,
Millsboro, DE 19966, filed a supplement
VerDate Aug<31>2005
15:44 Feb 28, 2007
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
21 CFR Part 558
Jkt 211001
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.
§ 558.665
[Amended]
2. Remove paragraph (d)(3) of
§ 558.665.
I
Dated: February 12, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E7–3615 Filed 2–28–07; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
9245
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9314]
RIN 1545–BF37
Depreciation of MACRS Property That
Is Acquired in a Like-Kind Exchange or
as a Result of an Involuntary
Conversion
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations and removal of
temporary regulations.
AGENCY:
SUMMARY: This document contains final
regulations relating to the depreciation
of property subject to the accelerated
cost recovery system under section 168
of the Internal Revenue Code (MACRS
property). Specifically, these final
regulations provide guidance on how to
depreciate MACRS property acquired in
a like-kind exchange under section 1031
or as a result of an involuntary
conversion under section 1033 when
both the acquired and relinquished
property are subject to MACRS in the
hands of the acquiring taxpayer. These
final regulations will affect taxpayers
involved in a like-kind exchange under
section 1031 or an involuntary
conversion under section 1033. The
corresponding temporary regulations are
removed.
DATES: Effective Dates: These
regulations are effective on February 26,
2007.
Applicability Dates: For dates of
applicability, see §§ 1.168(a)-1(b),
1.168(b)-1(b), 1.168(d)-1(d)(3), 1.168(i)1(l), 1.168(i)-6(k), and 1.168(k)1(g)(3)(ii).
FOR FURTHER INFORMATION CONTACT:
Patrick S. Kirwan, (202) 622–3110 (not
a toll-free number).
SUPPLEMENTARY INFORMATION:
Background
This document contains amendments
to 26 CFR part 1 under section 168 of
the Internal Revenue Code (Code).
Section 168 provides the depreciation
deduction for tangible property
generally placed in service after
December 31, 1986.
On March 1, 2004, the IRS and the
Treasury Department published in the
Federal Register (69 FR 9529)
temporary regulations (TD 9115)
relating to the depreciation allowable
for tangible property of a character
subject to the allowance for depreciation
provided in section 167(a) that is
generally placed in service after
E:\FR\FM\01MRR1.SGM
01MRR1
]]>Agencies
[Federal Register Volume 72, Number 40 (Thursday, March 1, 2007)]
[Rules and Regulations]
[Pages 9244-9245]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3621]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs For Use in Animal Feeds; Monensin
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 Elanco Animal Health. The supplemental NADA
provides for minor revisions to labeling of monensin Type A medicated
articles for chickens. FDA is also amending the regulations to simplify
the organization of special labeling requirements for formulations
(Type A medicated articles, Type B and Type C medicated feeds)
containing monensin for poultry and game birds. This action is being
taken to improve the clarity of the regulations.
DATES: This rule is effective March 1, 2007.
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 38-878 that provides for use of COBAN 60 and COBAN
90 (monensin, USP) Type A medicated articles in feed of chickens. The
supplement provides for minor revisions to labeling. The supplemental
NADA is approved as of February 7, 2007, and the regulations in 21 CFR
558.355 are amended to reflect the approval.
In addition, FDA is taking this opportunity to amend the
regulations to simplify the organization of special labeling
requirements for formulations (Type A medicated articles, Type B and
Type C medicated feeds) containing monensin for poultry and game birds.
Similar restructuring was done recently for monensin formulations used
in ruminants (71 FR 66231, November 14, 2006). This action is being
taken to improve the clarity of the regulations.
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.
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 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. 558.355, revise paragraphs (a), (b)(1), (b)(4), (b)(6),
(d)(4), (d)(5), and (d)(8); and add paragraphs (d)(9)(iv) through
(d)(9)(vi), and (d)(10)(iv) through (d)(10)(vi) to read as follows:
Sec. 558.355 Monensin.
(a) Specifications. Type A medicated articles containing monensin,
USP.
(b) * * *
(1) To No. 000986: 36.3 (for export only), 44, 45, 60, or 90.7
grams per pound for use as in paragraphs (f)(1)(i) and (f)(4) of this
section.
* * * * *
(4) To No. 000986: 45, 60, or 90.7 grams per pound for use as in
paragraph (f)(2) of this section.
* * * * *
(6) To No. 000986: 45, 60, or 90.7 grams per pound for use as in
paragraph (f)(5) of this section.
* * * * *
(d) * * *
(4) Liquid Type B feeds shall bear an expiration date of 8 weeks
after its date of manufacture.
(5) All Type A medicated articles containing monensin shall bear
the following warning statement: When mixing and handling monensin Type
A medicated articles, use protective clothing, impervious gloves, and a
dust mask. Operators should wash thoroughly with soap and water after
handling. If accidental eye contact occurs, immediately rinse
thoroughly with water.
* * * * *
(8) Type A medicated articles containing monensin intended for use
in chickens, turkeys, and quail shall bear the following statements:
(i) Do not allow horses, other equines, mature turkeys, or guinea
fowl access to feed containing monensin. Ingestion of monensin by
horses and guinea fowl has been fatal.
(ii) Must be thoroughly mixed in feeds before use.
(iii) Do not feed undiluted.
(iv) Do not feed to laying chickens.
(v) Do not feed to chickens over 16 weeks of age.
(vi) For replacement chickens intended for use as cage layers only.
(vii) Some strains of turkey coccidia may be monensin tolerant or
resistant. Monensin may interfere with development of immunity to
turkey coccidiosis.
[[Page 9245]]
(viii) In the absence of coccidiosis in broiler chickens the use of
monensin with no withdrawal period may limit feed intake resulting in
reduced weight gain.
(9) * * *
(iv) Chickens: See paragraphs (d)(8)(i) through (d)(8)(vi), and
(d)(8)(viii) of this section.
(v) Turkeys: See paragraphs (d)(8)(i), (d)(8)(ii), (d)(8)(iii), and
(d)(8)(vii) of this section.
(vi) Quail: See paragraphs (d)(8)(i), (d)(8)(ii), and (d)(8)(iii)
of this section.
(10) * * *
(iv) Chickens: See paragraphs (d)(8)(i), (d)(8)(iv), (d)(8)(v),
(d)(8)(vi), and (d)(8)(viii) of this section.
(v) Turkeys: See paragraphs (d)(8)(i) and (d)(8)(vii) of this
section.
(vi) Quail: See paragraph (d)(8)(i) of this section.
* * * * *
Dated: February 12, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. E7-3621 Filed 2-28-07; 8:45 am]
BILLING CODE 4160-01-S
