Federal Register / Vol. 71, No. 169 / Thursday, August 31, 2006 / Rules and Regulations 51727 

shall be declared when a claim is made 

about them. Any other vitamins or 

minerals listed in § 101.9(c)(8)(iv) or 

(c)(9) may be declared, but they shall be 

declared when they are added to the 

product for purposes of 

supplementation, or when a claim is 

made about them. Any (b)(2)-dietary 

ingredients that are not present, or that 

are present in amounts that can be 

declared as zero in § 101.9(c), shall not 

be declared (e.g., amounts 

corresponding to less than 2 percent of 

the RDI for vitamins and minerals). 

Protein shall not be declared on labels 

of products that, other than ingredients 

added solely for technological reasons, 

contain only individual amino acids. 

* * * * * 

Dated: August 25, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–7306 Filed 8–30–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 529 

Certain Other Dosage Form New 

Animal Drugs; Gentamicin Sulfate 

Intrauterine Solution 

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 an abbreviated new animal 

drug application (ANADA) filed by 

Sparhawk Laboratories, Inc. The 

ANADA provides for use of a generic 

gentamicin sulfate solution as an 

intrauterine infusion for the control of 

bacterial metritis and as an aid in 

improving conception in mares. 

DATES: This rule is effective August 31, 

2006. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–0169, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Sparhawk 

Laboratories, Inc., 12340 Santa Fe Trail 

Dr., Lenexa, KS 66215, filed ANADA 

200–395 for the use of Gentamicin 

Sulfate Solution for the control of 

bacterial infections of the uterus 

(metritis) and as an aid in improving 

conception in mares with uterine 

infections caused by bacteria sensitive 

to gentamicin. Sparhawk Laboratories, 

Inc.’s gentamicin sulfate solution is 

approved as a generic copy of ScheringPlough Animal Health Corp.’s 

GENTOCIN (gentamicin sulfate) 

solution veterinary, approved under 

NADA 46–724. The ANADA is 

approved as of July 31, 2006, and the 

regulations in 21 CFR 529.1044a are 

amended to reflect the approval and a 

current format. 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. 

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 529 

Animal drugs. 

■ 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 529 is amended as follows: 

PART 529—CERTAIN OTHER DOSAGE 

FORM NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 529 continues to read as follows: 

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

■ 2. Revise § 529.1044a to read as 

follows: 

§ 529.1044a Gentamicin sulfate 

intrauterine solution. 

(a) Specifications. Each milliliter of 

solution contains 50 or 100 milligrams 

gentamicin sulfate. 

(b) Sponsors. See Nos. 000010, 

000061, 000856, 057561, 058005, 

059130, and 061623 in § 510.600(c) of 

this chapter. 

(c) Conditions of use in horses—(1) 

Amount. Infuse 2 to 2.5 grams per day 

for 3 to 5 days during estrus. 

(2) Indications for use. For control of 

bacterial infections of the uterus 

(metritis) and as an aid in improving 

conception in mares with uterine 

infections caused by bacteria sensitive 

to gentamicin. 

(3) Limitations. Do not use in horses 

intended for human consumption. 

Federal law restricts this drug to use by 

or on the order of a licensed 

veterinarian. 

Dated: August 11, 2006. 

Stephen F. Sundlof, 

Director, Center for Veterinary Medicine. 

[FR Doc. 06–7307 Filed 8–30–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9283] 

RIN 1545–BB57 

Special Depreciation Allowance 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final and temporary 

regulations. 

SUMMARY: This document contains final 

regulations relating to the depreciation 

of property subject to section 168 of the 

Internal Revenue Code (MACRS 

property) and the depreciation of 

computer software subject to section 

167. Specifically, these final regulations 

provide guidance regarding the 

additional first year depreciation 

allowance provided by sections 168(k) 

and 1400L(b) for certain MACRS 

property and computer software. The 

regulations reflect changes to the law 

made by the Job Creation and Worker 

Assistance Act of 2002, the Jobs and 

Growth Tax Relief Reconciliation Act of 

2003, the Working Families Tax Relief 

Act of 2004, the American Jobs Creation 

Act of 2004, and the Gulf Opportunity 

Zone Act of 2005. 

DATES: Effective Dates: These 

regulations are effective August 31, 

2006. 

Applicability Dates: For dates of 

applicability, see §§ 1.167(a)–14(e), 

1.168(d)–1(d), 1.168(d)–1T(d), 1.168(k)–

1(g), 1.169–3(g), and 1.1400L(b)–1(g). 

FOR FURTHER INFORMATION CONTACT: 

Douglas Kim, (202) 622–3110 (not a tollfree number). 

SUPPLEMENTARY INFORMATION: 


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