9244 Federal Register / Vol. 72, No. 40 / Thursday, March 1, 2007 / Rules and Regulations 

List of Subjects in 21 CFR Part 522 

Animal drugs. 

■ 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 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. In § 522.2477, add paragraph 

(d)(2)(i)(F) to read as follows: 

§ 522.2477 Trenbolone acetate and 

estradiol. 

* * * * * 

(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. 

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, 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 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. 

■ 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 

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

■ 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: 

§ 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. 


rwilkins on PROD1PC63 with RULES
Federal Register / Vol. 72, No. 40 / Thursday, March 1, 2007 / Rules and Regulations 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

New Animal Drugs For Use in Animal 

Feeds; Zilpaterol 

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 

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. 

DATES: This rule is effective March 1, 

2007. 

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 

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 

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: 

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS 

■ 1. The authority citation for 21 CFR 

part 558 continues to read as follows: 

Authority: 21 U.S.C. 360b, 371. 

§ 558.665 [Amended] 

■ 2. Remove paragraph (d)(3) of 

§ 558.665. 

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 

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 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations and removal of 

temporary regulations. 

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 


rwilkins on PROD1PC63 with RULES