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9244 Federal Register / Vol. 72, No.

40 / Thursday, March 1, 2007 / Rules and Regulations

List of Subjects in 21 CFR Part 522 monensin for poultry and game birds. PART 558—NEW ANIMAL DRUGS FOR
Animal drugs. This action is being taken to improve USE IN ANIMAL FEEDS
■ Therefore, under the Federal Food,
the clarity of the regulations.
■ 1. The authority citation for 21 CFR
Drug, and Cosmetic Act and under the DATES: This rule is effective March 1, part 558 continues to read as follows:
authority delegated to the Commissioner 2007.
of Food and Drugs and redelegated to Authority: 21 U.S.C. 360b, 371.
the Center for Veterinary Medicine, 21 FOR FURTHER INFORMATION CONTACT: Joan
C. Gotthardt, Center for Veterinary ■ 2. In § 558.355, revise paragraphs (a),
CFR part 522 is amended as follows: (b)(1), (b)(4), (b)(6), (d)(4), (d)(5), and
Medicine (HFV–130), Food and Drug
Administration, 7500 Standish Pl., (d)(8); and add paragraphs (d)(9)(iv)
PART 522—IMPLANTATION OR
Rockville, MD 20855, 301–827–7571, e- through (d)(9)(vi), and (d)(10)(iv)
INJECTABLE DOSAGE FORM NEW
mail: joan.gotthardt@fda.hhs.gov. through (d)(10)(vi) to read as follows:
ANIMAL DRUGS
■ 1. The authority citation for 21 CFR SUPPLEMENTARY INFORMATION: Elanco § 558.355 Monensin.
part 522 continues to read as follows: Animal Health, A Division of Eli Lilly (a) Specifications. Type A medicated
& Co., Lilly Corporate Center, articles containing monensin, USP.
Authority: 21 U.S.C. 360b.
Indianapolis, IN 46285, filed a (b) * * *
■ 2. In § 522.2477, add paragraph supplement to NADA 38–878 that (1) To No. 000986: 36.3 (for export
(d)(2)(i)(F) to read as follows: provides for use of COBAN 60 and only), 44, 45, 60, or 90.7 grams per
§ 522.2477 Trenbolone acetate and COBAN 90 (monensin, USP) Type A pound for use as in paragraphs (f)(1)(i)
estradiol. medicated articles in feed of chickens. and (f)(4) of this section.
The supplement provides for minor * * * * *
* * * * *
(d) * * * revisions to labeling. The supplemental (4) To No. 000986: 45, 60, or 90.7
(2) * * * NADA is approved as of February 7, grams per pound for use as in paragraph
(i) * * * 2007, and the regulations in 21 CFR (f)(2) of this section.
(F) 200 mg trenbolone acetate and 20 558.355 are amended to reflect the * * * * *
mg estradiol (one implant consisting of approval. (6) To No. 000986: 45, 60, or 90.7
11 pellets, each of 10 pellets containing In addition, FDA is taking this grams per pound for use as in paragraph
20 mg trenbolone acetate and 2 mg opportunity to amend the regulations to (f)(5) of this section.
estradiol, and 1 pellet containing 29 mg simplify the organization of special * * * * *
tylosin tartrate) per implant dose. labeling requirements for formulations (d) * * *
* * * * * (Type A medicated articles, Type B and (4) Liquid Type B feeds shall bear an
Dated: February 12, 2007. Type C medicated feeds) containing expiration date of 8 weeks after its date
monensin for poultry and game birds. of manufacture.
Steven D. Vaughn,
Similar restructuring was done recently (5) All Type A medicated articles
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
for monensin formulations used in containing monensin shall bear the
ruminants (71 FR 66231, November 14, following warning statement: When
[FR Doc. E7–3620 Filed 2–28–07; 8:45 am]
2006). This action is being taken to mixing and handling monensin Type A
BILLING CODE 4160–01–S
improve the clarity of the regulations. medicated articles, use protective
Approval of this supplemental NADA clothing, impervious gloves, and a dust
DEPARTMENT OF HEALTH AND did not require review of additional mask. Operators should wash
HUMAN SERVICES safety or effectiveness data or thoroughly with soap and water after
information. Therefore, a freedom of handling. If accidental eye contact
Food and Drug Administration information summary is not required. occurs, immediately rinse thoroughly
FDA has determined under 21 CFR with water.
21 CFR Part 558 25.33(a)(1) that this action is of a type * * * * *
that does not individually or (8) Type A medicated articles
New Animal Drugs For Use in Animal cumulatively have a significant effect on containing monensin intended for use
Feeds; Monensin the human environment. Therefore, in chickens, turkeys, and quail shall
AGENCY: Food and Drug Administration, neither an environmental assessment bear the following statements:
HHS. nor an environmental impact statement (i) Do not allow horses, other equines,
Final rule; technical
ACTION: is required. mature turkeys, or guinea fowl access to
amendment. This rule does not meet the definition feed containing monensin. Ingestion of
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because monensin by horses and guinea fowl has
SUMMARY: The Food and Drug been fatal.
it is a rule of ‘‘particular applicability.’’
Administration (FDA) is amending the Therefore, it is not subject to the (ii) Must be thoroughly mixed in feeds
animal drug regulations to reflect congressional review requirements in 5 before use.
approval of a supplemental new animal U.S.C. 801–808. (iii) Do not feed undiluted.
drug application (NADA) filed by (iv) Do not feed to laying chickens.
Elanco Animal Health. The List of Subjects in 21 CFR Part 558 (v) Do not feed to chickens over 16
supplemental NADA provides for minor weeks of age.
Animal drugs, Animal feeds.
revisions to labeling of monensin Type (vi) For replacement chickens
A medicated articles for chickens. FDA ■ Therefore, under the Federal Food, intended for use as cage layers only.
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is also amending the regulations to Drug, and Cosmetic Act and under the (vii) Some strains of turkey coccidia
simplify the organization of special authority delegated to the Commissioner may be monensin tolerant or resistant.
labeling requirements for formulations of Food and Drugs and redelegated to Monensin may interfere with
(Type A medicated articles, Type B and the Center for Veterinary Medicine, 21 development of immunity to turkey
Type C medicated feeds) containing CFR part 558 is amended as follows: coccidiosis.

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Federal Register / Vol. 72, No. 40 / Thursday, March 1, 2007 / Rules and Regulations 9245

(viii) In the absence of coccidiosis in to NADA 141–258 for use of ZILMAX DEPARTMENT OF THE TREASURY
broiler chickens the use of monensin (zilpaterol hydrochloride 4.8%) Type A
with no withdrawal period may limit medicated article to formulate Type B Internal Revenue Service
feed intake resulting in reduced weight and Type C medicated cattle feeds. The
gain. supplemental NADA provides for the 26 CFR Part 1
(9) * * * removal of a caution statement against [TD 9314]
(iv) Chickens: See paragraphs (d)(8)(i) the formulation of pelleted feeds from
through (d)(8)(vi), and (d)(8)(viii) of this RIN 1545–BF37
labeling. The supplemental NADA is
section. approved as of January 29, 2007, and the
(v) Turkeys: See paragraphs (d)(8)(i), Depreciation of MACRS Property That
regulations are amended in 21 CFR Is Acquired in a Like-Kind Exchange or
(d)(8)(ii), (d)(8)(iii), and (d)(8)(vii) of this
558.665 to reflect the approval. as a Result of an Involuntary
section.
(vi) Quail: See paragraphs (d)(8)(i), Approval of this supplemental NADA Conversion
(d)(8)(ii), and (d)(8)(iii) of this section. did not require review of additional AGENCY: Internal Revenue Service (IRS),
(10) * * * safety or effectiveness data or Treasury.
(iv) Chickens: See paragraphs (d)(8)(i), information. Therefore, a freedom of ACTION: Final regulations and removal of
(d)(8)(iv), (d)(8)(v), (d)(8)(vi), and information summary is not required. temporary regulations.
(d)(8)(viii) of this section. FDA has determined under 21 CFR
(v) Turkeys: See paragraphs (d)(8)(i) SUMMARY: This document contains final
25.33(a)(1) that this action is of a type
and (d)(8)(vii) of this section. regulations relating to the depreciation
(vi) Quail: See paragraph (d)(8)(i) of that does not individually or
cumulatively have a significant effect on of property subject to the accelerated
this section. cost recovery system under section 168
the human environment. Therefore,
* * * * * of the Internal Revenue Code (MACRS
neither an environmental assessment
Dated: February 12, 2007. property). Specifically, these final
nor an environmental impact statement
Steven D. Vaughn, regulations provide guidance on how to
is required. depreciate MACRS property acquired in
Director, Office of New Animal Drug
This rule does not meet the definition a like-kind exchange under section 1031
Evaluation, Center for Veterinary Medicine.
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because or as a result of an involuntary
[FR Doc. E7–3621 Filed 2–28–07; 8:45 am]
it is a rule of ‘‘particular applicability.’’ conversion under section 1033 when
BILLING CODE 4160–01–S
Therefore, it is not subject to the both the acquired and relinquished
congressional review requirements in 5 property are subject to MACRS in the
DEPARTMENT OF HEALTH AND U.S.C. 801–808. hands of the acquiring taxpayer. These
HUMAN SERVICES final regulations will affect taxpayers
List of Subjects in 21 CFR Part 558 involved in a like-kind exchange under
Food and Drug Administration Animal drugs, Animal feeds. section 1031 or an involuntary
conversion under section 1033. The
21 CFR Part 558 ■ Therefore, under the Federal Food, corresponding temporary regulations are
Drug, and Cosmetic Act and under removed.
New Animal Drugs For Use in Animal authority delegated to the Commissioner DATES: Effective Dates: These
Feeds; Zilpaterol of Food and Drugs and redelegated to regulations are effective on February 26,
the Center for Veterinary Medicine, 21 2007.
AGENCY: Food and Drug Administration,
CFR part 558 is amended as follows: Applicability Dates: For dates of
HHS.
applicability, see §§ 1.168(a)-1(b),
ACTION: Final rule. PART 558—NEW ANIMAL DRUGS FOR 1.168(b)-1(b), 1.168(d)-1(d)(3), 1.168(i)-
SUMMARY: The Food and Drug USE IN ANIMAL FEEDS 1(l), 1.168(i)-6(k), and 1.168(k)-
Administration (FDA) is amending the 1(g)(3)(ii).
■ 1. The authority citation for 21 CFR FOR FURTHER INFORMATION CONTACT:
animal drug regulations to reflect
approval of a supplemental new animal part 558 continues to read as follows: Patrick S. Kirwan, (202) 622–3110 (not
drug application (NADA) filed by Authority: 21 U.S.C. 360b, 371. a toll-free number).
Intervet Inc. The supplemental NADA SUPPLEMENTARY INFORMATION:
provides for the removal of a caution § 558.665 [Amended]
statement against the formulation of Background
■ 2. Remove paragraph (d)(3) of
pelleted feeds from labeling of zilpaterol § 558.665. This document contains amendments
hydrochloride Type A medicated article to 26 CFR part 1 under section 168 of
Dated: February 12, 2007. the Internal Revenue Code (Code).
and Type B and Type C medicated
feeds. Steven D. Vaughn, Section 168 provides the depreciation
DATES: This rule is effective March 1, Director, Office of New Animal Drug deduction for tangible property
2007.
Evaluation, Center for Veterinary Medicine. generally placed in service after
[FR Doc. E7–3615 Filed 2–28–07; 8:45 am] December 31, 1986.
FOR FURTHER INFORMATION CONTACT: On March 1, 2004, the IRS and the
BILLING CODE 4160–01–S
Charles J. Andres, Center for Veterinary Treasury Department published in the
Medicine (HFV–120), Food and Drug Federal Register (69 FR 9529)
Administration, 7500 Standish Pl., temporary regulations (TD 9115)
Rockville, MD 20855, 301 827–1600, e-
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relating to the depreciation allowable


mail: charles.andres@.fda.hhs.gov. for tangible property of a character
SUPPLEMENTARY INFORMATION: Intervet subject to the allowance for depreciation
Inc., P.O. Box 318, 29160 Intervet Ln., provided in section 167(a) that is
Millsboro, DE 19966, filed a supplement generally placed in service after

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