Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Rules and Regulations 10597 

List of Subjects in 21 CFR Part 522 

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 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. Revise § 522.812 to read as follows: 

§ 522.812 Enrofloxacin. 

(a) Specifications. Each milliliter (mL) 

of solution contains: 

(1) 22.7 milligrams (mg) enrofloxacin 

or 

(2) 100 mg enrofloxacin. 

(b) Sponsor. See No. 000859 in 

§ 510.600(c) of this chapter. 

(c) Related tolerance. See § 556.228 of 

this chapter. 

(d) Special considerations. Federal 

law restricts this drug to use by or on 

the order of a licensed veterinarian. 

Federal law prohibits the extra-label use 

of this drug in food-producing animals. 

(e) Conditions of use—(1) Dogs. Use 

the product described in paragraph 

(a)(1) of this section as follows: 

(i) Amount. 2.5 mg per kilogram (/kg) 

of body weight (1.13 mg per pound) as 

a single, intramuscular, initial dose 

followed by use of tablets twice daily for 

2 to 3 days beyond cessation of clinical 

signs to a maximum of 10 days. 

(ii) Indications for use. For the 

management of diseases associated with 

bacteria susceptible to enrofloxacin. 

(2) Cattle. Use the product described 

in paragraph (a)(2) of this section as 

follows: 

(i) Amount. Single-dose therapy: 7.5 

to 12.5 mg/kg of body weight (3.4 to 5.7 

mL per 100 pounds) by subcutaneous 

injection. Multiple-day therapy: 2.5 to 

5.0 mg/kg of body weight (1.1 to 2.3 mL 

per 100 pounds) by subcutaneous 

injection once daily for 3 to 5 days. 

(ii) Indications for use. For the 

treatment of bovine respiratory disease 

(BRD) associated with Mannheimia 

haemolytica, Pasteurella multocida, and 

Haemophilus somnus. 

(iii) Limitations. Animals intended for 

human consumption must not be 

slaughtered within 28 days from the last 

treatment. Do not use in cattle intended 

for dairy production. A withdrawal 

period has not been establishedfor this 

product in pre-ruminating calves. Do 

not use in calves to be processed for 

veal. The effect of enrofloxacin on 

bovine reproductive performance, 

pregnancy, and lactation have not been 

determined. 

Dated: February 28, 2007. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. E7–4206 Filed 3–8–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 524 

Ophthalmic and Topical Dosage Form 

New Animal Drugs; Imidacloprid and 

Moxidectin 

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 two new animal drug 

applications (NADAs) filed by Bayer 

HealthCare LLC. The NADAs provide 

for the topical use by veterinary 

prescription of topical solutions 

containing imidacloprid and two 

strengths of moxidectin, one for use on 

dogs and the other for use on cats, for 

the prevention of heartworm disease, 

the treatment of flea infestations, and 

the treatment and control of several 

internal parasites. 

DATES: This rule is effective March 9, 

2007. 

FOR FURTHER INFORMATION CONTACT: 

Melanie R. Berson, Center for Veterinary 

Medicine (HFV-110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855; tel: 301–827–

7540; e-mail: 

melanie.berson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Bayer 

HealthCare LLC, Animal Health 

Division, P.O. Box 390, Shawnee 

Mission, KS 66201, filed NADA 141–

251 that provides for veterinary 

prescription use of ADVANTAGE 

MULTI (imidacloprid 10% and 

moxidectin 2.5%) for Dogs, a topical 

solution used for the prevention of 

heartworm disease, the treatment of flea 

infestations, and the treatment and 

control of several internal parasites. 

Bayer HealthCare LLC also filed NADA 

141–254 that provides for veterinary 

prescription use of ADVANTAGE 

MULTI (imidacloprid 10% and 

moxidectin 1%) for Cats, a topical 

solution used for the prevention of 

heartworm disease, the treatment of flea 

infestations, and the treatment and 

control of ear mites and several internal 

parasites. NADA 141–251 is approved 

as of December 20, 2006, and NADA 

141–254 is approved as of January 19, 

2007. Accordingly, the regulations are 

amended in part 524 (21 CFR part 524) 

by adding § 524.1146 to reflect these 

approvals. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), 

summaries of safety and effectiveness 

data and information submitted to 

support approval of these applications 

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)(ii) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(ii)), this 

approval under NADA 141–251 

qualifies for 3 years of marketing 

exclusivity beginning December 20, 

2006, and this approval under NADA 

141–254 qualifies for 3 years of 

marketing exclusivity beginning January 

19, 2007. 

The agency has determined under 21 

CFR 25.33(d)(1) that these actions are of 

a type that do 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 524 

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 524 is amended as follows: 

PART 524—OPHTHALMIC AND 

TOPICAL DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 524 continues to read as follows: 

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

■ 2. Add § 524.1146 to read as follows: 


erjones on PRODPC74 with RULES
10598 Federal Register / Vol. 72, No. 46 / Friday, March 9, 2007 / Rules and Regulations 

§ 524.1146 Imidacloprid and moxidectin. 

(a) Specifications—(1) Each milliliter 

of solution contains 100 milligrams (mg) 

imidacloprid and 25 mg moxidectin for 

use as in paragraph (d)(1) of this section. 

(2) Each milliliter of solution contains 

100 mg imidacloprid and 10 mg 

moxidectin for use as in paragraph 

(d)(2) of this section. 

(b) Sponsor. See No. 000859 in 

§ 510.600(c) of this chapter. 

(c) Special considerations. Federal 

law restricts this drug to use by or on 

the order of a licensed veterinarian. 

(d) Conditions of use—(1) Dogs—(i) 

Amount. Topically apply 4.5 mg/lb 

body weight (10 mg/kg) imidacloprid 

and 1.1 mg/lb (2.5 mg/kg) moxidectin, 

once a month. 

(ii) Indications for use. For the 

prevention of heartworm disease caused 

by Dirofilaria immitis; and the treatment 

and control of intestinal roundworms 

(Toxocara canis and Toxascaris 

leonina), hookworms (Ancylostoma 

caninum and Uncinaria stenocephala), 

and whipworms (Trichuris vulpis); kills 

adult fleas and treats flea infestations 

(Ctenocephalides felis). 

(2) Cats—(i) Amount. Topically apply 

4.5 mg/lb body weight (10 mg/kg) 

imidacloprid and 0.45 mg/lb (1.0 mg/kg) 

moxidectin, once a month. 

(ii) Indications for use. For the 

prevention of heartworm disease caused 

by Dirofilaria immitis; for the treatment 

and control of ear mite (Otodectes 

cynotis) infestations, intestinal 

roundworms (Toxocara cati), and 

hookworms (Ancylostoma tubaeforme); 

kills adult fleas and treats flea 

infestations (Ctenocephalides felis). 

Dated: February 27, 2007. 

Stephen F. Sundlof, 

Director, Center for Veterinary Medicine. 

[FR Doc. E7–4226 Filed 3–8–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Alcohol and Tobacco Tax and Trade 

Bureau 

27 CFR Part 9 

[T.D. TTB–59; Re: Notice No. 60] 

RIN 1513–AB22 

Establishment of the Snake River 

Valley Viticultural Area (2005R–463P) 

AGENCY: Alcohol and Tobacco Tax and 

Trade Bureau, Treasury. 

ACTION: Final rule; Treasury decision. 

SUMMARY: This Treasury decision 

establishes the 8,263-square mile 

‘‘Snake River Valley’’ viticultural area in 

southwestern Idaho and southeastern 

Oregon. We designate viticultural areas 

to allow vintners to better describe the 

origin of their wines and to allow 

consumers to better identify wines they 

may purchase. 

EFFECTIVE DATE: April 9, 2007. 

FOR FURTHER INFORMATION CONTACT: N.A. 

Sutton, Regulations and Rulings 

Division, Alcohol and Tobacco Tax and 

Trade Bureau, 925 Lakeville St., No. 

158, Petaluma, CA 94952; phone 415–

271–1254. 

SUPPLEMENTARY INFORMATION: 

Background on Viticultural Areas 

TTB Authority 

Section 105(e) of the Federal Alcohol 

Administration Act (FAA Act), 27 

U.S.C. 205(e), authorizes the Secretary 

of the Treasury to prescribe regulations 

for the labeling of wine, distilled spirits, 

and malt beverages. The FAA Act 

provides that these regulations should, 

among other things, prohibit consumer 

deception and the use of misleading 

statements on labels, and ensure that 

labels provide the consumer with 

adequate information as to the identity 

and quality of the product. The Alcohol 

and Tobacco Tax and Trade Bureau 

(TTB) administers the regulations 

promulgated under the FAA Act. 

Part 4 of the TTB regulations (27 CFR 

part 4) allows the establishment of 

definitive viticultural areas and the use 

of their names as appellations of origin 

on wine labels and in wine 

advertisements. Part 9 of the TTB 

regulations (27 CFR part 9) contains the 

list of approved viticultural areas. 

Definition 

Section 4.25(e)(1)(i) of the TTB 

regulations (27 CFR 4.25(e)(1)(i)) defines 

a viticultural area for American wine as 

a delimited grape-growing region 

distinguishable by geographical 

features, the boundaries of which have 

been recognized and defined in part 9 

of the regulations. These designations 

allow vintners and consumers to 

attribute a given quality, reputation, or 

other characteristic of a wine made from 

grapes grown in an area to its 

geographical origin. The establishment 

of viticultural areas allows vintners to 

describe more accurately the origin of 

their wines to consumers and helps 

consumers to identify wines they may 

purchase. Establishment of a viticultural 

area is neither an approval nor an 

endorsement by TTB of the wine 

produced in that area. 

Requirements 

Section 4.25(e)(2) of the TTB 

regulations outlines the procedure for 

proposing an American viticultural area 

and provides that any interested party 

may petition TTB to establish a grapegrowing region as a viticultural area. 

Section 9.3(b) of the TTB regulations 

requires the petition to include—

• Evidence that the proposed 

viticultural area is locally and/or 

nationally known by the name specified 

in the petition; 

• Historical or current evidence that 

supports setting the boundary of the 

proposed viticultural area as the 

petition specifies; 

• Evidence relating to the 

geographical features, such as climate, 

elevation, physical features, and soils, 

that distinguish the proposed 

viticultural area from surrounding areas; 

• A description of the specific 

boundary of the proposed viticultural 

area, based on features found on United 

States Geological Survey (USGS) maps; 

and 

• A copy of the appropriate USGS 

map(s) with the proposed viticultural 

area’s boundary prominently marked. 

Snake River Valley Viticultural Area 

Background 

The wine grape growers of the Snake 

River Valley in Idaho, the Idaho Grape 

Growers and Wine Producers 

Commission, and the Idaho Department 

of Commerce and Labor, collectively 

referred to as the ‘‘petitioner,’’

submitted a petition to establish the 

8,263-square mile Snake River Valley 

viticultural area. The proposed 

viticultural area includes Ada, Adams, 

Boise, Canyon, Elmore, Gem, Gooding, 

Jerome, Owyhee, Payette, Twin Falls, 

and Washington Counties in 

southwestern Idaho and Baker and 

Malheur Counties in southeastern 

Oregon. The proposed boundary 

encompasses 15 wineries, 46 vineyards, 

and 1,107 acres of commercial vineyard 

production. We summarize below the 

supporting evidence presented with the 

petition. 

Name Evidence 

The petitioner provided multiple 

sources of ‘‘Snake River Valley’’ name 

evidence for the proposed viticultural 

area. References include winemaking 

and vineyards, agriculture, early 

regional exploration, and other name 

uses. 

The Fall 2001 edition of Wine Press 

Northwest ran an article titled ‘‘Idaho 

Wineries at a Glance,’’ which states, ‘‘At 

first glance, the Snake River Valley 

seems an idyllic place to grow grapes 


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