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Final Rule; Treasury Decision

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Final Rule; Treasury Decision 24142 Federal Register / Vol. 51, No. 127 / Wednesday, July 2, 1986 / Rules and Regulations change of sponsor for a new animal drug ACTION: Final rule; Treasury decision. viticultural area with boundaries application (NADA) from Parke-Davis, generally as stated in the petition. The Division of Warner-Lambert Co., to SUMMARY: The Bureau of Alcohol, notice also solicited public comment A.H. Robins Co. Tobacco and Firearms (ATF) has concerning the proposed viticultural decided to establish a viticultural area area. EFFECTIVE DATE: July 2, 1986. in Arkansas, Missouri, and Oklahoma to FOR FURTHER INFORMATION CONTACT: be known as "Ozark Mountain." This Comments David L. Gordon, Center for Veterinary decision is the result of a petition Medicine (HFV-238), Food and Drug submitted by Mr. Al Wiederkehr, a The principal commenter was Mr. Administration, 5600 Fishers Lane, grape grower and winery proprietor in Robert G. Cowie, Secretary-Treasurer of Rockville, MD 20857, 301-443-6243. the area. The establishment of the Arkansas Wine Producers Association and proprietor of a winery SUPPLEMENTARY INFORMATION: AH. viticultural areas and the subsequent Robins Co., 1407 Cummings Dr., P.O. use of viticultural area names in wine located just outside the boundaries Box 26609, Richmond, VA 23261-6609, labeling and advertising enables proposed in Notice No. 569. Mr. Cowie filed a supplement to NADA 106-111 winemakers to label wines more requested extension of the boundaries in (TelazolO injection, tiletamine precisely and helps consumers to better order to include an area south of the hydrochloride and zolazepam identify the wines they purchase. Arkansas River, in which his winery is located. This area is generally located hydrochloride, for dogs and cats) EFFECTIVE DATE: August 1, 1986. for a change of sponsor from between the Arkansas and Petit Jean providing FOR FURTHER INFORMATION CONTACT: Parke-Davis, Division of Warner- Rivers and includes Mt. Magazine, the Steve Simon, FAA, Wine and Beer highest mountain in Arkansas. Mr. Lambert Co. Parke-Davis confirmed the Branch, Bureau of Alcohol, Tobacco and change. FDA is amending the Cowie presented evidence to show that Firearms, 1200 Pennsylvania Avenue, this area is locally known as being part regulations to reflect the sponsor NW., Washington, DC 20226 (202-566- of the "Ozark Mountain" region and change. 7626). contains the same distinguishing List of Subjects in 21 CFR Part 522 SUPPLEMENTARY INFORMATION: geographical features as the "Ozark Animal drugs. Background Mountain" area proposed by the under the Federal Food, petitioner. Comments supportive of Mr. Therefore, ATF regulations in 27 CFR Part 4 Drug, and Cosmetic Act and under provide for the establishment of definite Cowie's request were received from two authority delegated to the Commissioner viticultural areas. The regulations also members of the Arkansas legislature, a of Food and Drugs and redelegated to allow the name of an approved geologist from the Arkansas Geological the Center for Veterinary Medicine, Part viticultural area to be used as an Commission, a geography professor at 522 is amended to read as follows: appellation of origin on wine labels and Arkansas Tech University, and eight in wine advertisements. others who are residents of Mr. Cowie's PART 522-IMPLANTATION OR local area. The additional area proposed INJECTABLE DOSAGE FORM NEW Part 9 of 27 CFR provides for the listing of approved American viticultural by Mr. Cowie contains about 800 square ANIMAL DRUGS NOT SUBJECT TO miles, of which about 60 acres are CERTIFICATION areas, the names of which may be used as appellations of origin. planted to grapes. At one time, as many 1. The authority citation for 21 CFR Section 4.25a(e)(1), Title 27 CFR, as seven wineries were operating in that Part 522 continues to read as follows: defines an American viticultural area as area, but at present the Cowie Wine Authority: Sec. 512(i), 82 Stat. 347 (21 U.S.C. a delimited grape-growing region Cellars is the only one left. 360b(i)); 21 CFR 5.10 and 5.83. distinguishable by geographical After considering the evidence features. Section 4.25(e)(2) outlines the presented by the commenters, ATF has § 522.2470 [Amended] procedures for proposing an American determined that it would be proper to 2. § 522.2470 Tiletamine hydrochloride viticultural area. Any interested person extend the boundaries of the "Ozark and zolazepam hydrochloridefor may petition ATF to establish a grape- Mountain" area. Accordingly, this injection is amended in paragraph (b) by growing region as a viticultural area. document prescribes boundaries for the removing the sponsor number "000071" Petition "Ozark Mountain" viticultural area that and inserting in its place "000031." include the area advocated by Mr. Dated: June 26, 1986. ATF received a petition from Mr. Al Cowie. Wiederkehr of Altus, Arkansas, Marvin A. Norcross, southern Missouri, Name Associate Directorfor New Animal Drug proposing an area in Evaluation. northern Arkansas, and northeastern The following evidence demonstrates as a viticultural area to be [FR Doc. 86-14880 Filed 7-1-86; 8:45 am] Oklahoma that the viticultural area established by known as "Ozark Mountain." The area is known by the BILLING CODE 4160-01-M that was proposed contains about 55,000 this Treasu'y decision square miles. There are about 4,280 name of "Ozark Mountain": acres of grapes planted in the area (a) Wine labels from Wiederkehr TREASURY DEPARTMENT OF THE proposed by Mr. Wiederkehr, and Wine Cellars and others have borne the approximately 35 wineries are operating appellation "Ozark Mountain" since as Bureau of Alcohol, Tobacco and far back as 1959. Firearms within that area. (b) This area has been referred to as Notice of Proposed Rulemaking 27 CFR Part 9 the "Ozark Mountain" region in many In response to the petition, ATF geographical books, including Natural [T.D. ATF-231; Ref. Notice No. 569] published a notice of proposed Regions of the United States and rulemaking, Notice No. 569, in the Canada by C.B. Hunt (W.H. Freeman & Ozark Mountain Viticultural Area Federal Register on Tuesday, September Co., San Francisco, 1974) and The AGENCY: Bureau of Alcohol, Tobacco 17, 1985. That notice proposed Ozarks by Richard Rhodes (Time-Life and Firearms, Treasury. establishment of the "Ozark Mountain" Books, New York, 1974). Federal Register / Vol. 51, No. 127 / Wednesday, July 2, 1986 / Rules and Regulations 24143 (c) The Ozark Mountain area is well- temperature zones. This is demonstrated establishing a large viticultural area known as a winE making region, as is by the following quote from Milton D. based on geographical features which shown by this quote: "Like all of the Rafferty in The Ozarks, Land and Life affect viticultural features, ATF other American wine regions, the (University of Oklahoma Press, Norman, recognizes that the distinctions between Ozarks [Mountains] are quietly seething 1980), p. 29; a small area and its surroundings are with new ideas, new personalities, new Within the Ozarks, temperatures will vary more refined than the differences grape varieties and a new sense of widely with the orientation of slope, nature of between a large area and its direction." (Restaurateurs'Guide to surface materials, relief, and presence of surroundings. It is possible for a large American Wines, PartIV: The Wines water. South and west-facing slopes receive viticultural area to contain approved and Wineries of the Ozarks. "Dining," the greatest amount of sunlight and are viticultural areas, if each area fulfills the April-May 1973, p. 58.) subject to higher rates of evaporation... In requirements for establishment of a winter, perhaps the most noticeable effect of Geography temperature differences within a small area viticultural area. is the duration of snow and icicles on the Miscellaneous The following evidence demonstrates north-facing slopes. that the viticultural area is distinguished Air drainage creates the most readily ATF does not want to give the geographically from the surrounding observed temperature differences in summer. impression by approving "Ozark areas: Nights are notable for the cool breeze that Mountain" as a viticultural area that it (a) In his book, The Ozarks, Richard drains down the slopes, beginning an hour or is approving or endorsing the quality of Rhodes states (pp. 19, 22), as quoted by two before sunset... the wine from this area. ATF is the petitioner: ... As a rule, frosts occur in the valleys several weeks earlier in fall and later in approving this area as being distinct but Stretching from the forests of southern spring than they do on the uplands, especially not better than other areas. By Missouri outside St. Louis through northern in the case of the larger valleys lying in the approving this area, ATF allows wine Arkansas to the Oklahoma plains near Tulsa, hill regions. The margins of the uplands have producers to claim a distinction on the 55,000 square miles of the Ozarks are the best air drainage and are least subject to labels and advertisements as to the bounded by five major rivers: the Mississippi, frosts. the Missouri, the Osage, the Neosho, and the origin of the grapes. Any commercial Arkansas. The Ozark highlands, the only Ozark viticulturists rely on their advantage can only come from extensive elevated area in the United States knowledge of local microclimatic consumer acceptance of "Ozark between the Appalachians and the Rocky conditions to select the best sites for Mountain" wines. Mountains, consist of low mountains and their vineyards. Such sites possess Regulatory Flexibility Act hills shaped by springfed streams and rivers generally similar conditions of soil and ...cutting their way thorugh the elevated The provisions of the Regulatory bed rock... climate, thus giving Ozark viticulture a ... These boundaries do not merely locate distinctive character. Favorable Flexibility Act relating to a final the Ozarks on the map, but also serve to conditions for viticulture can be found at regulatory flexibility analysis (5 U.S.C.
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