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Current OMB 12 CFR part or section where identified and described control No.

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[FR Doc. 04–5902 Filed 3–15–04; 8:45 am] (UNESCO) Convention on the Means of The appearance in the United States of BILLING CODE 7535–01–P Prohibiting and Preventing the Illicit stolen or illegally exported artifacts Import, Export and Transfer of from other countries where there has Ownership of Cultural Property. The been pillage has, on occasion, strained DEPARTMENT OF HOMELAND document amends the CBP Regulations our foreign and cultural relations. This SECURITY by adding to the list of situation, combined with the concerns countries for which an agreement has of museum, archaeological, and Bureau of Customs and Border been entered into for imposing import scholarly communities, was recognized Protection restrictions. The document also contains by the President and Congress. It the Designated List of Pre-Colombian became apparent that it was in the DEPARTMENT OF THE TREASURY Archaeological Material from Honduras national interest for the United States to that describes the types of articles to join with other countries to control 19 CFR Part 12 which the restrictions apply. illegal trafficking of such articles in [CBP Dec. 04–08] EFFECTIVE DATE: March 16, 2004. international commerce. FOR FURTHER INFORMATION CONTACT: The United States joined international RIN 1505–AB50 (Legal Aspects) Joseph Howard, efforts and actively participated in Intellectual Property Rights Branch deliberations resulting in the 1970 Import Restrictions Imposed on (202) 572–8701; (Operational Aspects) UNESCO Convention on the Means of Archaeological Material Originating in Michael Craig, Trade Compliance and Prohibiting and Preventing the Illicit Honduras Facilitation (202) 927–0370. Import, Export and Transfer of AGENCY: Customs and Border Protection, SUPPLEMENTARY INFORMATION: Ownership of Cultural Property (823 Homeland Security. U.N.T.S. 231 (1972)). U.S. acceptance of Background ACTION: Final rule. the 1970 UNESCO Convention was The value of cultural property, codified into U.S. law as the SUMMARY: This document amends the whether archaeological or ethnological ‘‘Convention on Cultural Property Customs and Border Protection (CBP) in nature, is immeasurable. Such items Implementation Act’’ (Pub. L. 97–446, Regulations to reflect the imposition of often constitute the very essence of a 19 U.S.C. 2601 et seq.) (‘‘the Act’’). This import restrictions on certain society and convey important was done to promote U.S. leadership in archaeological material originating in information concerning a people’s achieving greater international the Republic of Honduras (Honduras). origin, history, and traditional setting. cooperation towards preserving cultural These restrictions are being imposed The importance and popularity of such treasures that are of importance to the pursuant to an agreement between the items regrettably make them targets of nations from where they originate and United States and Honduras that has theft, encourage clandestine looting of contribute to greater international been entered into under the authority of archaeological sites, and result in their understanding of mankind’s common the Convention on Cultural Property illegal export and import. heritage. Implementation Act in accordance with The United States shares in the During the past several years, import the United Nations Educational, international concern for the need to restrictions have been imposed on Scientific and Cultural Organization protect endangered cultural property. archaeological and ethnological

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artifacts/materials of a number of materials from Honduras. Importation of Beaudry-Corbett 1993; Baudez 1983; signatory nations. These restrictions these materials, described in the Baudez and Bequelin 1973; Beaudry have been imposed as a result of designated list below, are subject to the 1984; Canby 1949, 1951; Fash 1991; requests for protection received from restrictions of 19 U.S.C. 2606 and Glass 1966; Gordon 1898; Healy 1984; those nations, as well as pursuant to § 12.104g(a) of the Customs and Border Henderson 1997; Henderson et al 1979; bilateral agreements between the United Protection (CBP) Regulations (19 CFR Hirth, Kennedy, and Cliff 1989; Joyce States and other countries. More 12.104g(a)) and will be restricted from 1985, 1987, 1991, 1993a, 1993b; Joyce information on import restrictions can entry into the United States unless the and Henderson 2001; Longyear 1952; be found on the International Cultural conditions set forth in 19 U.S.C. 2606 Robinson 1978; papers in Robinson Property Protection Web site (http:// and § 12.104c of the regulations (19 CFR 1987; Stone 1957, 1941; Strong 1935; exchanges.state.gov/education/culprop). 12.104c) are met. CBP is amending Strong, Kidder, and Paul 1938; Urban Import restrictions are now being § 12.104g(a) of the CBP Regulations (19 and Schortman 1988; Veil 1978, 1983, imposed on certain archaeological CFR 12.104g(a)) to indicate that these 1993; Willey 1988; Willey et al. 1994; materials from the Republic of import restrictions have been imposed. Wonderley 1987; Yde 1938. Honduras (Honduras). A. Ceremonial Vessels Material Encompassed in Import Determinations 1. Cylinders Restrictions 2. Bowls Under 19 U.S.C. 2602(a)(1), the The bilateral agreement between 3. Dishes and plates United States must make certain Honduras and the United States covers 4. Jars determinations before entering into an the categories of artifacts described in a B. Common Vessels agreement to impose import restrictions Designated List of Pre-Colombian 1. Cylindrical vessels under 19 U.S.C. 2602(a)(2). On July 28, Archaeological Material from Honduras 2. Bowls 2003, the Assistant Secretary of State for that is set forth below. (Regarding 3. Dishes and plates Educational and Cultural Affairs made parenthetical references to authors in 4. Jars the determinations required under the the list below, see bibliography C. Special Forms statute with respect to certain immediately after the list.) 1. Drums—polychrome painted and archaeological materials originating in plain Honduras that are described in the Designated List of Pre-Colombian 2. Figurines—human and animal designated list set forth further below in Archaeological Material From forms this document, including the following: Honduras 3. Whistles—human and animal forms (1) That the unique cultural patrimony I. Ceramic 4. Rattles—human and animal forms of Honduras is in jeopardy from the 5. Miniature vessels pillage of these archaeological materials; Materials made from ceramic (e.g., 6. Stamps and seals—engraved (2) that Honduras has taken measures terracotta/fired clay) include a full range geometric designs, various sizes and consistent with the Convention to of surface treatments and appendages on shapes protect its cultural patrimony; (3) that various shapes of vessels, lids, figurines, 7. Effigy vessels—in human or animal import restrictions imposed by the and other ceramic objects (e.g., tools). form United States would be of substantial Decorative techniques used on these 8. Incense burners—elaborate painted, benefit in deterring a serious situation of materials include, but are not limited to, applied and modeled decoration in pillage and remedies less drastic are not fluting, dentate-stamping, incised form of human figures available; and (4) that the application of designs, modeled sculpting, polishing/ 9. Architectural elements burning, differentially fired areas, and import restrictions is consistent with the II. Stone/Stucco (marble, jade, obsidian, general interests of the international polychrome, bichrome and/or monochrome designs of human and flint, alabaster/calcite, limestone, slate, community in the interchange of the and other, including stucco materials) designated archaeological materials animal figures, mythological scenes among nations for scientific, cultural, and/or geometric motifs. Vessels and The range of stone materials includes, and educational purposes. figurines may include sculpted and/or but is not limited to, sculpture, vessels, applique appendages, such as handles, figurines, masks, jewelry, stelae, tools, The Agreement knobs, faces, fillets, and tripod, and weapons. On March 12, 2004, the United States quadruped, or ring supports. For reference, please consult the and Honduras entered into a bilateral Examples include, but are not limited following: Baudez 1983, 1994; Digby agreement (the Agreement) pursuant to to, polychromes (e.g., Copador, lxcanrio, 1972; Doonan 1996; Garber et al. 1993; the provisions of 19 U.S.C. 2602(a)(2) Gualpopa, Ejar, Cancique and other Gordon 1898, 1920, 1921; Hirth 1988; covering certain archaeological Copan styles, Ulu-Yojoa (e.g., Red, Hirth and Hirth 1993; Joyce and materials representing its pre- Maroon, Black, and Tenampua groups), Henderson 2001; Henderson 1992, 1997; Colombian cultural heritage. Dating Chichicaste, Fiopo, Las Flores, Sulaco, Luke 2002; Luke et al. 2003; Stone 1938, from approximately 1200 B.C. to Chameleon, Naco, and Bay Island), 1941, 1957, 1972, 1977; Strong, Kidder approximately 1500 A.D., these incised and punctuated designs (e.g., and Paul 1938. materials include, but are not limited to, Selin, Gualijoquito, and Escondido A. Figurines—human and animal objects of ceramic, metal, stone, shell, groups), Usulutan styles, Mammiform B. Masks—incised decoration and inlaid and animal bone representing, among vessels, monochromes (e.g., Cuymal, with shell, human and animal faces others, the Maya, Chorti Maya, Lenca, Limon, Higuerito, Talgua), incense C. Jewelry—various shapes and sizes Jicaque, and Pipil cultures. burners (Coner ceramics), Yaba-ding- 1. Pendants ding, Playa de los Muertos, Olmec style, 2. Ear spools Restrictions and Amendment to the and Formative period . Ceramics 3. Necklaces Regulations may also have post-fire pigment and/or 4. Pectoral In accordance with the Agreement, stucco. D. Stelae, Ritual Objects, Architectural import restrictions are now being For reference, please consult the Elements, Petroglyphs—Carved in imposed on these archaeological following: Chapters in Henderson and low relief with scenes of war, ritual,

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or political events, portraits of glyphs (for examples, consult: Baudez 1920 A Marble Vase from the Ulu´ a River, rulers or nobles, often inscribed 1983; Coggins 1988; Fash 1991). Honduras. Art and Archaeology 9: 141– with glyphic texts. Sometimes A. Tools—various sizes 45. covered with stucco and painted. 1. Needles 1898 Researches in the Uloa Valley, Honduras. Peabody Museum Memoirs The size of stelae and architectural 2. Scrapers B. Jewelry—various shapes and sizes 1(4). Harvard University, Cambridge, elements, such as lintels, posts, MA. steps, and decorative building 1. Pendants 2. Beads Healy, Paul 1984 The Archaeology of blocks, range from .5 meters to 2.5 Honduras. In The Archaeology of Lower 3. Ear spools meters in height; hachas, yokes, and , F. W. Lange and D. Z. Stone (eds.), pp. 113–64. University of other carved ritual objects are under Bibliography 1 meter in length or height but vary New Press, Albuquerque, NM. Baudez, Claude F. (ed) 1983 Introduccı´on a in size. Henderson, John S. 1997 World of the la Arqueologı´a de Copan, 3 volumes. Ancient Maya, 2nd ed. Cornell E. Tools and Weapons Secretaria de Estado en el Despacho de University Press, Ithaca, NY. 1. Arrowheads Cultura y Turismo, Tegucigalpa, 1992 Elites and Ethnicity along the 2. Axes, adzes, celts Honduras. Southeastern Fringe of . In 3. Blades 1994 Maya Sculpture of Copan: The Mesoamerican Elites: An Archaeological 4. Chisels Iconography. University of Oklahoma Assessment, D. Z. Chase and A. F. Chase 5. Spearpoints Press, Norman, OK. (eds.), pp. 155–68. University of 6. Eccentric shapes Baudez, Claude F. and Pierre Becquelin 1973 Oklahoma Press, Norman, OK. 7. Grinding stones (manos and Arche´ologie de los Naranjos, Honduras. Henderson, John S. and Marilyn Beaudry metates) Etudes Me´soame´ricaines 2. Mission Corbett (eds.) 1993 Pottery of Prehistoric 8. Maceheads Arche´ologique et Ethnologique Francaise Honduras. Institute of Archaeology, F. Vessels and Containers au Mexique, Mexico City, Mexico. Monograph 35. University of California, 1. Bowls Beaudry, Marilyn P. 1984 Ceramic Los Angeles, CA. 2. Plates/Dishes Production and Distribution in the Henderson, John S., Irene Sterns, Anthony 3. Vases Southeastern Maya Periphery: Late Wonderley, and Patricia A. Urban 1979 Classic Painted Serving Vessels. BAR Archaeological Investigations in the III. Metal (gold, silver, or other) International Series 203. British Valle de Naco, Northwestern Honduras: Archaeological Reports, Oxford, UK. A Preliminary Report. Journal of Field These objects are cast or beaten into Canby, Joel S. 1951 Possible Chronological Archaeology 6: 169–92. the desired form, decorated with Implications of the Long Ceramic Hirth, K., N. Kennedy, and Cliff 1989 engraving, inlay, punctured design, or Sequence Recovered at Yarumela, Chronology and Ceramic Variability attachments. Often in human or stylized Spanish Honduras. In Proceedings of the within the El Cajo´n Region. In animal forms (for examples, consult: Twentyninth International Congress of Archaeological Research in the el Cajo´ n Healy 1984; Stone 1941, 1957, 1972, Americanists, vol. 1, pp. 79–85. Region. Vol. 1: Prehistoric Cultural 1977). University of Chicago Press, Chicago, IL. Ecology, K. Hirth, G. Lara Pinto, and G. A. Jewelry.—various shapes and sizes 1949 Excavations at Yarumela, Spanish Haseman (eds.). Memoirs in Latin 1. Necklaces Honduras. Doctoral dissertation, American Archaeology 1. University of 2. Bracelets Department of Anthropology, Harvard Pittsburgh, Pittsburgh, PA. University, Cambridge, MA. 1988 The Central Honduras Corridor. In The 3. Disks Coggins, Clemency 1988 On the Historical Southeast Classic Maya Zone, E. H. 4. Ear spools Significance of Decorated Ceramics at Boone and G. R. Willey (eds.), pp. 297– 5. Pendants Copa´n and Quirigua´ and Related Classic 334. Dumbarton Oaks, Washington, DC. 6. Pectorals Maya Sites. In Southeast Classic Maya Hirth, Kenneth G. and Susan Grant Hirth B. Figurines Zone, E. H. Boone and G. R. Willey 1993 Ancient Currency: The Style and C. Masks (eds.), pp. 95–123. Smithsonian Use of Jade and Marble Carvings in D. Disks Institution Press, Washington, DC. Central Honduras. In Precolumbian Jade, E. Axes Digby, Adrian 1972 Maya Jades. British F. W. Lange (ed.), pp. 173–90. University F. Bells Museum, London, UK. of Utah Press, Salt Lake City, UT. Doonan, William F. 1996 The Artifacts of Joyce, Rosemary A. 1993a Appendix A: A IV. Shell Group 10L2, Copa´ n, Honduras: Variation Key to Ulu´ a Polychromes. In Pottery of These objects are worked and un- in Material Culture and Behavior in a Prehistoric Honduras, John S. Henderson worked and include, but are not limited Royal Residential Compound. Doctoral and Marilyn Beaudry Corbett (eds.), pp. to, conch, snail, spiny oyster, sting-ray, dissertation, Department of 257–79. Institute of Archaeology Anthropology, Tulane University, New University of California, Los Angeles, and sea urchin spines. Shell may be Orleans, LA. Monograph 35. decorated with cinnabar and incised Fash, William L., Jr. 1991 Scribes, Warriors 1993b The Construction of the Mesoamerican lines, sometimes with inlaid jade (for and Kings: The City of Copa´ n and the Frontier and the Mayoid Image of examples, consult: Baudez 1983; Fash Ancient Maya. Thames and Hudson, Honduran Polychromes. In 1991). London, UK. Reinterpreting Prehistory of Central A. Figurines—human and animal Glass, John B. 1966 Archaeological Survey of America, Mark Miller Graham (ed.), pp. B. Jewelry—various shapes and sizes Western Honduras. In Handbook of 51–101. University Press of Colorado, 1. Necklaces Middle American Indians, Vol. 4, Robert Niwot, CO. 2. Bracelets Wauchope, Gordon F. Ekholm, and 1991 Cerro : Power and Identity on 3. Disks Gordon R. Willey (eds.), pp. 157–79. the Maya Periphery. University of Texas 4. Ear spools University of Texas Press, Austin, TX. Press, Austin, TX. Garber, James F., David C. Grove, Kenneth G. 1987 Intraregional Ceramic Variation and 5. Pendants Hirth, and John W. Hoopes 1993 Jade Social Class: Developmental Trajectories C. Natural Forms—often with incised Use in Portions of Mexico and Central of Classic Period Ceramic Complexes designs, various shapes and sizes America. In Precolumbian Jade, F. Lange from the Ulu´ a Valley. In Interaction on V. Bone (ed.), pp. 211–31. University of Utah the Southeast Mesoamerican Frontier: Press, Salt Lake City, UT. Prehistoric and Historic Honduras and These objects are carved or incised Gordon, G. B. 1921 The Ulu´ a Marble Vases. . Eugenia J. Robinson (ed.) with geometric and animal designs and The Museum Journal 12:53–74. BAR International Series 327 (ii): 280–

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303. British Archaeological Reports, The Southeast Classic Maya Zone, a bilateral agreement entered into in Oxford, UK. Elizabeth H. Boone and Gordon R. furtherance of the foreign affairs 1985 Cerro Palenque, Valle de Ulu´ a Willey (eds), pp. 223–68. Dumbarton interests of the United States, pursuant Honduras: Terminal Classic Interaction Oaks, Washington, DC. to 5 U.S.C. 553(a)(1), no notice of on the Mesoamerican Periphery. Viel, Rene´ 1993 Evolucio´ n de la cera´ mica de Doctoral dissertation, Department of Copa´ n, Honduras. Instituto Honduren˜ o proposed rulemaking or public Anthropology, University of Illinois, de Antropologı´a e Historia, Tegucigalpa, procedure is necessary. For the same Urbana, IL. Honduras. reason, a delayed effective date is not Joyce, Rosemary A. and John S. Henderson 1983 Evolucio´n de la cera´mica e Copa´n: required pursuant to 5 U.S.C. 553(d)(3). 2001 Beginnings of Village Life in Resultados preliminaries. In Eastern Mesoamerica. Latin American Introduccio´ n a la Arqueologı´a de Copa´ n, Regulatory Flexibility Act Antiquity 12 (1): 523. Honduras, Vol. I, Claude Baudez (ed.), Because no notice of proposed Longyear, John M., III 1952 Copa´ n Ceramics: pp. 473–549. SECTUR, Tegucigalpa, rulemaking is required, the provisions Honduras. A Study of Southeastern Maya Pottery. of the Regulatory Flexibility Act (5 Publication No. 597. Carnegie Institution 1978 Etude de la ce´ramique Ulu´ a Yojoa of Washington, Washington, DC. Polychrome (NordQuest de Honduras): U.S.C. 601 et seq.) do not apply. Luke, Christina 2002 Ulu´ a Marble Vases. Essai d’ analyse stylistique du Babilonia. Accordingly, this final rule is not Doctoral dissertation, Department of Doctoral dissertation, Universite´ Rene´ subject to the regulatory analysis or Anthropology, Cornell University, Descartes, Paris, France. other requirements of 5 U.S.C. 603 and Ithaca, NY. Willey, G. 1988 The Southeast Classic Maya 604. Luke, Christina, Rosemary A. Joyce, John S. Zone: A Summary. In The Southeast Henderson and Robert H. Tykot 2003 Classic Maya Zone, E.H. Boone and G.R. Executive Order 12866 Marble Carving Traditions in Honduras: Willey (eds.), pp. 395–408. Dumbarton Oaks, Washington, DC. This amendment does not meet the Formative through Terminal Classic. In criteria of a ‘‘significant regulatory ASMOSIA 6, Interdisciplinary Studies on Willey, G., R.M. Levanthal, A. Demarest, and Ancient Stone—Proceedings of the Sixth W.L. Fash, Jr. 1994 Ceramics and action’’ as described in E.O. 12866. Artifacts from Excavations in the Copan International Conference of the Drafting Information Association for the Study of Marble and Residential Zone. Papers of the Peabody Other Stones in Antiquity, Venice, June Museum of Archaeology and Ethnology, The principal author of this document 15–18, 2000, L. Lazzarini (ed.), pp. 485– Vol. 80. Harvard University, Cambridge, was Bill Conrad, Regulations Branch, 96. Bottega d’Erasmo, Padova, Italy. MA. Office of Regulations and Rulings, U.S. Wonderley, Anthony 1987 Imagery in Robinson, Eugenia J. 1987 (ed.) Interaction Customs and Border Protection. on the Southeast Mesoamerican Frontier: Household Pottery from ‘‘La Gran Provincia de Naco’’. In Interaction on the However, personnel from other offices Prehistoric and Historic Honduras and participated in its development. El Salvador. BAR International Series Southeast Mesoamerican Frontier: 327. British Archaeological Report, Prehistoric and Historic Honduras and List of Subjects in 19 CFR Part 12 Oxford, UK. El Salvador, Eugenia J. Robinson (ed.). 1978 Maya Design Features of Mayoid BAR International Series 327 (ii):304– Customs duties and inspections, Vessels of the Ulua Yojoa Polchromes. 326. British Archaeological Reports, Imports, Cultural property. MA, thesis, Department of Anthropology, Oxford, UK. Tulane University, New Orleans, LA. Yde, Jens 1938 An Archaeological Amendment to the Regulations Reconnaissance of Northwestern Stone, Doris Z. 1977 Pre-Columbian Man in ■ Accordingly, part 12 of the Customs Costa Rica. Peabody Museum Press, Honduras: A report of the Work of the Harvard University, Cambridge, MA. Tulane University Danish National Regulations (19 CFR part 12) is amended Museum Expedition to Central America 1972 Pre-Columbian Man Finds Central as set forth below: 1935. Levin and Munksgaard, America. Peabody Museum Press, Copenhagen, Denmark. Harvard University, Cambridge, MA. PART 12—SPECIAL CLASSES OF 1957 The Archaeology of Central and CBP Decision 03–24: Delegations of MERCHANDISE Southern Honduras. Papers of the Authority ■ Peabody Museum of Archaeology and 1. The general authority and specific Ethnology 29 (3). Harvard University, This amendment to the regulations is authority citations for part 12, in part, Cambridge, MA. being issued in accordance with continue to read as follows: 1941 Archaeology of the North Coast of § 0.1(a)(1) of the CBP Regulations (19 Authority: 5 U.S.C. 301, 19 U.S.C. 66, 1202 Honduras. Peabody Museum Memoirs CFR 0.1(a)(1)) as a regulation the subject (General Note 23, Harmonized Tariff 9(l). Harvard University, Cambridge, MA. of which the Secretary of the Treasury Schedule of the United States (HTSUS)), 1938 Masters in Marble, Middle American has retained the sole authority to 1624; Research Series, Pub. 8, Pt. 1. Tulane approve. Accordingly, the document is University, New Orleans, LA. * * * * * Strong, Duncan. 1935 Archaeological signed by the Commissioner of Customs and Border Protection as the delegate of Sections 12.104 through 12.104i also Investigations in the Bay Islands, issued under 19 U.S.C. 2612; the Department of Homeland Security Spanish Honduras. Smithsonian * * * * * Miscellaneous Collection, Vol. 92, No. and the Deputy Assistant Secretary of 14. Smithsonian Institution, Washington, the Treasury as the delegate of the ■ 2. In § 12.104g, paragraph (a), DC. Secretary of the Treasury to indicate containing the list of agreements Strong, William Duncan, Alfred Kidder III, approval. (see CBP Dec. 03–24; 68 FR imposing import restrictions on and A.J. Drexel Paul 1938 Preliminary 51868). described articles of cultural property of Report on the Smithsonian Institution Harvard University Archaeological Inapplicability of Notice and Delayed State Parties, is amended by adding Expedition to Northwestern Honduras. Effective Date Honduras to the list in appropriate Smithsonian Miscellaneous Collections alphabetical order as follows: Vol. 97, No. 1. Smithsonian Institution, Because the amendment to the CBP § 12.104(g) Specific items or categories Washington, DC. Regulations contained in this document designated by agreements or emergency Urban, Patricia A. and Edward M. Schortman imposing import restrictions on the actions. 1988 The Southeast Zone Viewed from above-listed cultural property of the East: Lower MotaguaNaco Valleys. In Honduras is being made in response to (a) * * *

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State party Cultural property Decision No.

******* Honduras ...... Archaeological Material of Pre-Colombian cultures ranging approximately from 1200 B.C. to 1500 CBP Dec. 04–-08. A.D. *******

* * * * * milligrams tylosin tartrate to the § 522.2477 Trenbolone acetate and approved implant. estradiol. Robert C. Bonner, The supplemental application is * * * * * Commissioner, Customs and Border (d) * * * Protection. approved as of February 13, 2004, and the regulations are amended in 21 CFR (1) * * * Approved: March 12, 2004. 522.2477 to reflect the approval. The (i) * * * Timothy E. Skud, basis of approval is discussed in the (F) 80 mg trenbolone acetate and 16 Deputy Assistant Secretary of the Treasury. freedom of information summary. mg estradiol (one implant consisting of [FR Doc. 04–6017 Filed 3–12–04; 2:31 pm] In accordance with the freedom of 5 pellets, each of 4 pellets containing 20 BILLING CODE 4820–02–M information provisions of 21 CFR part mg trenbolone acetate and 4 mg 20 and 514.11(e)(2)(ii), a summary of estradiol, and 1 pellet containing 29 mg safety and effectiveness data and tylosin tartrate) per implant dose. DEPARTMENT OF HEALTH AND information submitted to support * * * * * HUMAN SERVICES approval of this supplemental Dated: March 2, 2004. application may be seen in the Division Food and Drug Administration of Dockets Management (HFA–305), Steven D. Vaughn, Food and Drug Administration, 5630 Director, Office of New Animal Drug 21 CFR Part 522 Fishers Lane, rm. 1061, Rockville, MD Evaluation, Center for Veterinary Medicine. 20852, between 9 a.m. and 4 p.m., [FR Doc. 04–5863 Filed 3–15–04; 8:45 am] Implantation or Injectable Dosage BILLING CODE 4160–01–S Form New Animal Drugs; Trenbolone Monday through Friday. and Estradiol Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act DEPARTMENT OF HEALTH AND AGENCY: Food and Drug Administration, (21 U.S.C. 360b(c)(2)(F)(iii)), this HUMAN SERVICES HHS. supplemental approval qualifies for 3 ACTION: Final rule. years of marketing exclusivity beginning Food and Drug Administration February 13, 2004. SUMMARY: The Food and Drug The agency has determined under 21 21 CFR Part 864 Administration (FDA) is amending the CFR 25.33(a)(1) that this action is of a animal drug regulations to reflect type that does not individually or [Docket No. 2004P–0044] approval of a supplemental abbreviated cumulatively have a significant effect on new animal drug application (ANADA) the human environment. Therefore, Medical Devices; Hematology and filed by Ivy Laboratories, Division of Ivy neither an environmental assessment Pathology Devices; Classification of Animal Health, Inc. The supplemental nor an environmental impact statement the Factor V Leiden DNA Mutation ANADA provides for the addition of is required. Detection Systems Devices tylosin tartrate to an approved This rule does not meet the definition AGENCY: Food and Drug Administration, subcutaneous implant containing of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because trenbolone and estradiol used for HHS. it is a rule of ‘‘particular applicability.’’ ACTION: Final rule. increased rate of weight gain and Therefore, it is not subject to the improved feed efficiency in feedlot congressional review requirements in 5 SUMMARY: The Food and Drug steers. U.S.C. 801–808. Administration (FDA) is classifying the DATES: This rule is effective March 16, List of Subjects in 21 CFR Part 522 Factor V Leiden deoxyribonucleic acid 2004. (DNA) mutation detections systems FOR FURTHER INFORMATION CONTACT: Eric Animal drugs. device into class II (special controls). S. Dubbin, Center for Veterinary ■ Therefore, under the Federal Food, The special control that will apply to Medicine (HFV–126), Food and Drug Drug, and Cosmetic Act and under the device is the guidance document Administration, 7500 Standish Pl., authority delegated to the Commissioner entitled ‘‘Class II Special Controls Rockville, MD 20855, 301–827–0232, e- of Food and Drugs and redelegated to the Guidance Document: Factor V Leiden mail: [email protected]. Center for Veterinary Medicine, 21 CFR DNA Mutation Detection Systems.’’ The SUPPLEMENTARY INFORMATION: Ivy part 522 is amended as follows: agency is taking this action in response Laboratories, Division of Ivy Animal to a petition submitted under the Health, Inc., 8857 Bond St., Overland PART 522—IMPLANTATION OR Federal Food, Drug, and Cosmetic Act Park, KS 66214, filed a supplement to INJECTABLE DOSAGE FORM NEW (the act) as amended by the Medical ANADA 200–221 for COMPONENT TE– ANIMAL DRUGS Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices IS (trenbolone acetate and estradiol) ■ 1. The authority citation for 21 CFR Act of 1990 (SMDA), the Food and Drug with TYLAN, a subcutaneous implant part 522 continues to read as follows: used for increased rate of weight gain Administration Modernization Act of and improved feed efficiency in steers Authority: 21 U.S.C. 360b. 1997 (FDAMA), and the Medical Device fed in confinement for slaughter. ■ 2. Section 522.2477 is amended by User Fee and Modernization Act of The supplemental ANADA provides adding paragraph (d)(1)(i)(F) to read as 2002. The agency is classifying this for the addition of a pellet containing 29 follows: device into class II (special controls) in

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