Federal Register / Vol. 69, No. 229 / Tuesday, November 30, 2004 / Rules and Regulations 69523

period and the inventory closing 

balance. 

(2) Notice of determination. If, based 

on a verification of a declaration of 

compliance filed under this section, 

CBP determines that the applicable 75 

or 85 percent standard specified in 

paragraph (b)(1)(i) or paragraph (b)(1)(ii) 

of this section was not met, CBP will 

publish a notice of that determination in 

the Federal Register.

PART 163—RECORDKEEPING

■ 5. The authority citation for Part 163 

continues to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 

1484, 1508, 1509, 1510, 1624.

■ 6. In the Appendix to Part 163 the 

listing under section IV of ‘‘§ 10.228 

CBTPA Declaration of Compliance for 

brassieres’’ is republished.

* * * * *

Approved: November 23, 2004. 

Robert C. Bonner, 

Commissioner of Customs and Border 

Protection. 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury.

[FR Doc. 04–26359 Filed 11–29–04; 8:45 am] 

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520 and 522

New Animal Drugs; Meloxicam

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 supplemental new 

animal drug applications (NADAs) filed 

by Boehringer Ingelheim Vetmedica, 

Inc. The first supplemental NADA 

provides for use of meloxicam injectable 

solution in cats for control of 

postoperative pain and inflammation 

associated with orthopedic surgery, 

ovariohysterectomy, and castration 

when administered prior to surgery. It 

also provides revised dosage labeling for 

this product in dogs. The other 

supplemental NADA provides revised 

dosage labeling for use of meloxicam 

oral suspension in dogs.

DATES: This rule is effective November 

30, 2004.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary 

Medicine (HFV–110), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.gov.

SUPPLEMENTARY INFORMATION:

Boehringer Ingelheim Vetmedica, Inc., 

2621 North Belt Hwy., St. Joseph, MO 

64506–2002, filed a supplement to 

NADA 141–219 that provides for use of 

METACAM (meloxicam) Solution for 

Injection in cats for control of 

postoperative pain and inflammation 

associated with orthopedic surgery, 

ovariohysterectomy, and castration 

when administered prior to surgery, and 

also revises dosage information for use 

of this product in dogs. Boehringer 

Ingelheim Vetmedica, Inc., also filed a 

supplement to NADA 141–213 that 

provides revised dosage information for 

use of METACAM (meloxicam) Oral 

Suspension in dogs. The supplemental 

NADAs are approved as of October 28, 

2004, and the regulations are amended 

in 21 CFR 520.1350 and 522.1367 to 

reflect the approval. The basis of 

approval is discussed in the freedom of 

information summaries.

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)(iii) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 360b(c)(2)(F)(iii)), 

the supplemental approval of 

meloxicam injectable solution for use in 

cats qualifies for 3 years of marketing 

exclusivity beginning October 28, 2004.

The agency has determined under 21 

CFR 25.33(d)(5) 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 Parts 520 and 

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 

parts 520 and 522 are amended as 

follows:

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows:

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

■ 2. Section 520.1350 is amended by 

revising paragraph (c)(1) to read as 

follows:

§ 520.1350 Meloxicam.

* * * * *

(c) * * *

(1) Amount. Administer orally as a 

single dose at 0.09 mg per pound (mg/

lb) body weight (0.2 mg per kilogram 

(mg/kg)) on the first day of treatment. 

For all treatment after day 1, administer 

0.045 mg/lb (0.1 mg/kg) body weight 

once daily.

* * * * *

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS

■ 3. The authority citation for 21 CFR 

part 522 continues to read as follows:

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

■ 4. Section 522.1367 is amended by 

revising paragraph (c) to read as follows:

§ 522.1367 Meloxicam.

* * * * *

(c) Conditions of use—(1) Dogs—(i) 

Amount. Administer 0.09 mg per pound 

(mg/lb) body weight (0.2 mg per 

kilogram (mg/kg)) by intravenous or 

subcutaneous injection on the first day 

of treatment. For treatment after day 1, 

administer meloxicam suspension orally 

at 0.045 mg/lb (0.1 mg/kg) body weight 

once daily as in § 520.1350(c) of this 

chapter.

(ii) Indications for use. For the control 

of pain and inflammation associated 

with osteoarthritis.

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian.

(2) Cats—(i) Amount. Administer 0.14 

mg/lb (0.3 mg/kg) body weight as a 

single, one-time subcutaneous injection.

(ii) Indications for use. For the control 

of postoperative pain and inflammation 

associated with orthopedic surgery, 

ovariohysterectomy, and castration 

when administered prior to surgery.

(iii) Limitations. Federal law restricts 

this drug to use by or on the order of 

a licensed veterinarian.

69524 Federal Register / Vol. 69, No. 229 / Tuesday, November 30, 2004 / Rules and Regulations 

Dated: November 18, 2004.

Steven D. Vaughn,

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine.

[FR Doc. 04–26380 Filed 11–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF THE TREASURY

Alcohol and Tobacco Tax and Trade 

Bureau 

27 CFR Part 9 

[TTB T.D.–18; Re: Notice No. 14] 

RIN: 1513–AA50 

Establishment of the Dundee Hills 

Viticultural Area (2002R–218P)

AGENCY: Alcohol and Tobacco Tax and 

Trade Bureau (TTB), Treasury.

ACTION: Final rule; Treasury decision.

SUMMARY: This Treasury decision 

establishes the Dundee Hills viticultural 

area in Yamhill County, Oregon. This 

new area is entirely within the existing 

Willamette Valley viticultural area. 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 DATES: January 31, 2005.

FOR FURTHER INFORMATION CONTACT: N. 

A. Sutton, Regulations and Procedures 

Division, Alcohol and Tobacco Tax and 

Trade Bureau, 925 Lakeville St., #158, 

Petaluma, CA 94952; telephone 415–

271–1254.

SUPPLEMENTARY INFORMATION: 

Background on Viticultural Areas 

TTB Authority 

Section 105(e) of the Federal Alcohol 

Administration Act (the FAA Act, 27 

U.S.C. 201 et seq.) requires that alcohol 

beverage labels provide the consumer 

with adequate information regarding a 

product’s identity and prohibits the use 

of misleading information on such 

labels. The FAA Act also authorizes the 

Secretary of the Treasury to issue 

regulations to carry out its provisions. 

The Alcohol and Tobacco Tax and 

Trade Bureau (TTB) administers these 

regulations. 

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 

geographic 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, 

soils, elevation, and physical features, 

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. 

Dundee Hills Petition 

General Background 

In 2002, TTB received a petition from 

Alex Sokol Blosser, secretary of the 

North Willamette Valley AVA Group, 

proposing the establishment of the 

6,490-acre ‘‘Red Hills’’ viticultural area 

in Yamhill County, Oregon. As 

explained below, the petitioner 

subsequently amended the area’s name 

to ‘‘Dundee Hills.’’ Located in northwest 

Oregon near the town of Newberg, the 

Dundee Hills viticultural area is about 

28 miles southwest of Portland and 40 

miles inland from the Pacific Ocean. 

The Dundee Hills area is entirely within 

the established Willamette Valley 

viticultural area (27 CFR 9.90). At the 

time of the petition, the Dundee area 

had 1,264 acres planted to grapes, with 

another 800 acres available for future 

vineyard use. 

The Dundee Hills rise above the low, 

flat floors of the surrounding Willamette 

and Chehalem Valleys. These hills 

generally have peaks above 700 feet, 

with the highest peak rising to 1,067 

feet. In addition to their higher 

elevation, warmer nighttime 

temperatures and less low-elevation fog 

and frost distinguish the Dundee Hills 

area from the surrounding valleys. 

Below, we summarize the evidence 

presented in the petition. 

Name Evidence 

The North Willamette Valley AVA 

Group originally proposed the name 

‘‘Red Hills,’’ for this area, but after 

learning of other petitioners proposing 

the same (or a similar) name for other 

viticultural areas, the Group amended 

its petitioned name to ‘‘Red Hills of 

Dundee.’’ The Group later amended its 

petitioned name to ‘‘Dundee Hills’’ to 

avoid possible confusion with other 

domestic and international ‘‘Red Hill’’

or ‘‘Red Hills’’ viticultural regions. 

The amended petition included 

evidence showing that local residents, 

vintners, and others know the region as 

the ‘‘Dundee Hills.’’ The October 2002 

Yamhill County, Oregon, Verizon Super 

Pages telephone book includes ‘‘Dundee 

Hills Estate,’’ while the ‘‘Shop 

Newberg’’ Web site lists ‘‘Dundee Hills 

Farm.’’ Ellen McCornack’s March 1912, 

Oregon Historical Society Quarterly 

article, ‘‘A Glimpse into Prehistoric 

Oregon,’’ explains the Willamette Valley 

was a large, prehistoric body of water, 

and that ‘‘[a]cross a narrow straight from 

Chehalem was the island of the Dundee 

Hills * * *.’’

‘‘In with the New World,’’ an article 

in the fall/winter 1998 issue of Wine 

Press Northwest, lists several pioneer 

Oregon wine growers, including David 

Lett, who arrived in 1965 with:

a degree in viticulture from the University of 

California-Davis and a plan to find a cool 

climate suitable for planting pinot noir and 

other varieties from Burgundy. Lett decided 

on the Dundee Hills in the Willamette Valley 

* * *. Another early pioneer is Dick Erath of 

Erath Vineyards, also still producing great 

wine in the Dundee Hills near Newberg.

Fred Delkin, in a 2002 Oregon 

Magazine article, ‘‘Papa Pinot Still 

Preaching Gospel That Created an 

Industry,’’ also notes that, in 1966, Lett 

planted ‘‘Pinot Noir and its cousin, 

Pinot Gris, in the Dundee hills area.’’ A