81 FR 87805 - Import Restrictions Imposed on Certain Archaeological Material From Egypt
DEPARTMENT OF HOMELAND SECURITY
U.S. Customs and Border Protection
DEPARTMENT OF THE TREASURY Federal Register Volume 81, Issue 234 (December 6, 2016)
U.S. Customs and Border Protection
DEPARTMENT OF THE TREASURY
Federal Register Volume 81, Issue 234 (December 6, 2016)
| Page Range | 87805-87810 | |
| FR Document | 2016-29191 |
[Federal Register Volume 81, Number 234 (Tuesday, December 6, 2016)] [Rules and Regulations] [Pages 87805-87810] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29191] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection DEPARTMENT OF THE TREASURY 19 CFR Part 12 [CBP Dec. 16-23] RIN 1515-AE19 Import Restrictions Imposed on Certain Archaeological Material From Egypt AGENCY: U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This final rule amends the U.S. Customs and Border Protection (CBP) regulations to reflect the imposition of import restrictions on certain archaeological material from the Arab Republic of Egypt (Egypt). These restrictions are being imposed pursuant to an agreement between the United States and Egypt that has been entered into under the authority of the Convention on Cultural Property Implementation Act in accordance with the 1970 United Nations Educational, Scientific and Cultural Organization [[Page 87806]] (UNESCO) Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property. The final rule amends CBP regulations by adding Egypt to the list of countries for which a bilateral agreement has been entered into for imposing cultural property import restrictions. The final rule also contains the designated list that describes the types of archaeological material to which the restrictions apply. DATES: Effective December 5, 2016. FOR FURTHER INFORMATION CONTACT: For legal aspects, Lisa L. Burley, Chief, Cargo Security, Carriers and Restricted Merchandise Branch, Regulations and Rulings, Office of Trade, (202) 325-0030. For operational aspects, William Scopa, Branch Chief, Partner Government Agency Branch, Trade Policy and Programs, Office of Trade, (202) 863- 6554, William.R.Scopa@cbp.dhs.gov. SUPPLEMENTARY INFORMATION: Background The value of cultural property, whether archaeological or ethnological in nature, is immeasurable. Such items often constitute the very essence of a society and convey important information concerning a people's origin, history, and traditional setting. The importance and popularity of such items regrettably makes them targets of theft, encourages clandestine looting of archaeological sites, and results in their illegal export and import. The United States shares in the international concern for the need to protect endangered cultural property. The appearance in the United States of stolen or illegally exported artifacts from other countries where there has been pillage has, on occasion, strained our foreign and cultural relations. This situation, combined with the concerns of museum, archaeological, and scholarly communities, was recognized by the President and Congress. It became apparent that it was in the national interest for the United States to join with other countries to control illegal trafficking of such articles in international commerce. The United States joined international efforts and actively participated in deliberations resulting in the 1970 United Nations Educational, Scientific and Cultural Organization (UNESCO) Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property (823 U.N.T.S. 231 (1972)). U.S. acceptance of the 1970 UNESCO Convention was codified into U.S. law as the ``Convention on Cultural Property Implementation Act'' (Pub. L. 97-446, 19 U.S.C. 2601 et seq.) (the Act). This was done to promote U.S. leadership in achieving greater international cooperation towards preserving cultural treasures that are of importance to the nations from where they originate and contribute to greater international understanding of our common heritage. Since the Act entered into force, import restrictions have been imposed on the archaeological and ethnological materials of a number of State Parties to the 1970 UNESCO Convention. These restrictions have been imposed as a result of requests for protection received from those nations. More information on import restrictions can be found on the Cultural Property Protection Web site (http://eca.state.gov/cultural-heritage-center/cultural-property-protection). This rule announces that import restrictions are now being imposed on certain archaeological material from Egypt. Determinations Under 19 U.S.C. 2602(a)(1), the United States must make certain determinations before entering into an agreement to impose import restrictions under 19 U.S.C. 2602(a)(2). On November 14, 2014, the Assistant Secretary for Educational and Cultural Affairs, Department of State, made the determinations required under the statute with respect to certain archaeological material originating in Egypt that are described in the designated list set forth below in this document. These determinations include the following: (1) That the cultural patrimony of Egypt is in jeopardy from the pillage of archaeological material representing Egypt's cultural heritage dating from the Predynastic period (5,200 B.C.) through 1517 A.D. (19 U.S.C. 2602(a)(1)(A)); (2) that the Egyptian government has taken measures consistent with the Convention to protect its cultural patrimony (19 U.S.C. 2602(a)(1)(B)); (3) that import restrictions imposed by the United States would be of substantial benefit in deterring a serious situation of pillage and remedies less drastic are not available (19 U.S.C. 2602(a)(1)(C)); and (4) that the application of import restrictions as set forth in this final rule is consistent with the general interests of the international community in the interchange of cultural property among nations for scientific, cultural, and educational purposes (19 U.S.C. 2602(a)(1)(D)). The Assistant Secretary also found that the material described in the determinations meets the statutory definition of ``archaeological material of the state party'' (19 U.S.C. 2601(2)). The Agreement The United States and Egypt entered into a bilateral agreement on November 30, 2016, pursuant to the provisions of 19 U.S.C. 2602(a)(2). The agreement enables the promulgation of import restrictions on categories of archaeological material representing Egypt's cultural heritage dating from the Predynastic period (5,200 B.C.) through 1517 A.D. A list of the categories of archaeological material subject to the import restrictions is set forth later in this document. Restrictions and Amendment to the Regulations In accordance with the Agreement, importation of material designated below is subject to the restrictions of 19 U.S.C. 2606 and Sec. 12.104g(a) of the CBP regulations (19 CFR 12.104g(a)) and will be restricted from entry into the United States unless the conditions set forth in 19 U.S.C. 2606 and Sec. 12.104c of the CBP regulations (19 CFR 12.104c) are met. CBP is amending Sec. 12.104g(a) of the CBP Regulations (19 CFR 12.104g(a)) to indicate that these import restrictions have been imposed. Designated List of Archaeological Material of Egypt The bilateral agreement between the United States and Egypt includes, but is not limited to, the categories of objects described in the designated list set forth below. These categories of objects are subject to the import restrictions set forth above, in accordance with the above explained applicable law and the regulation amended in this document (19 CFR 12.104(g)(a)). The import restrictions include complete examples of objects and fragments thereof. The archaeological material represent the following periods and cultures dating from 5,200 B.C. through 1517 A.D.: Predynastic, Pharaonic, Greco-Roman, Coptic, and Early Islamic through the Mamluk Dynasty. Many of the ancient place-names associated with the region of Egypt can be found in J. Baines and J. Malek, Cultural Atlas of Ancient Egypt (New York, 2000). I. Stone A. Sculpture 1. Architectural elements, from temples, tombs, palaces, commemorative monuments, and domestic architecture, including columns, capitals, bases, lintels, jambs, friezes, pilasters, engaged columns, mihrabs (prayer niches), fountains, and blocks from walls, floors, and ceilings. [[Page 87807]] Often decorated in relief with ornamental Pharaonic, Greco-Roman, and Coptic motifs and inscriptions. The most common architectural stones are limestone, sandstone and granite. 2. Statues, large- and small-scale, including human, animal, and hybrid figures with a human body and animal head. Human figures may be standing, usually with the left foot forward, seated on a block or on the ground, kneeling, or prone. Figures in stone may be supported by a slab of stone at the back. Greco-Roman examples use traditional Egyptian poses with Hellenistic modeling. The most popular stones are limestone, granite, basalt, sandstone, and diorite, and many other types of stone are used as well. 3. Relief sculpture, large- and small-scale, including Predynastic greywacke cosmetic palettes, limestone wall reliefs depicting scenes of daily life and rituals, and steles and plaques in a variety of stones for funerary and commemorative purposes. 4. Greco-Roman and Coptic tombstones. B. Vessels and Containers Includes conventional shapes such as bowls, cups, jars, and lamps, and vessels having the form of human, animal, hybrid, plant, hieroglyphic sign, and combinations or parts thereof. C. Funerary Objects and Equipment 1. Sarcophagi and coffins, with separate lid, either in the form of a large rectangular box, or human-shaped and carved with modeled human features. Both types are often decorated inside and outside with incised images and inscriptions. 2. Canopic shrines, in the form of a box with space inside for four canopic jars. 3. Canopic jars with lids in the form of human or animal heads. A full set includes four jars. Sometimes these jars are dummies, carved from a single piece of stone with no interior space. D. Objects of Daily Use Including chests and boxes, headrests, writing and painting equipment, games and game pieces. E. Tools and Weapons Chipped stone includes large and small blades, borers, scrapers, sickles, awls, harpoons, cores, loom weights, and arrow heads. Ground stone types include mortars, pestles, millstones, whetstones, choppers, axes, hammers, molds, and mace heads. F. Jewelry, Amulets, and Seals 1. Jewelry of colored and semi-precious stones for personal adornment, including necklaces, chokers, pectorals, pendants, crowns, earrings, bracelets, anklets, belts, girdles, aprons, and rings. 2. Amulets of colored and semi-precious stones in the form of humans, animals, hybrids, plants, hieroglyphic signs, and combinations or parts thereof. 3. Stamp and cylinder seals. The most common type is the scarab, in the form of a beetle with an inscription on the flat base. G. Ostraca Chips of stone used as surface for writing or drawing. II. Metal A. Sculpture 1. Statues, large- and small-scale, including human, animal, and hybrid figures similar to those in stone. Metal statues usually lack the support at the back. The most common material is bronze and copper alloys, and gold and silver are used as well. 2. Relief sculpture, including plaques, appliques, and mummy masks. B. Vessels and Containers Includes conventional shapes such as bowls, cups, jars, plates, cauldrons, and lamps, and vessels in the form of humans, animals, hybrids, plants, hieroglyphic signs, and combinations or parts thereof. C. Objects of Daily Use Musical instruments, including trumpets, clappers, and sistra. D. Tools Including axes, adzes, saws, drills, chisels, knives, hooks, needles, tongs, tweezers, and weights. Usually in bronze and copper alloys, later joined by iron. E. Weapons and Armor 1. Weapons include mace heads, knives, swords, curved swords, axes, arrows, and spears. Usually in bronze and copper alloys, later joined by iron. 2. Early armor consisted of small metal scales, originally sewn to a backing of cloth or leather, later augmented by helmets, body armor, shields, and horse armor. F. Jewelry, Amulets, and Seals 1. Jewelry of gold, silver, copper, and iron for personal adornment, including necklaces, pectorals, pendants, crowns, earrings, bracelets, anklets, belts, and rings. 2. Amulets in the form of humans, animals, hybrids, plants, hieroglyphic signs, and combinations or parts thereof. G. Coptic Liturgical Objects In metal, including censers, crosses, Bible caskets, and lamps. H. Coins In copper or bronze, silver, and gold. 1. General--There are a number of references that list Egyptian coin types. Below are some examples. Most Hellenistic and Ptolemaic coin types are listed in R.S. Poole, A Catalogue of Greek Coins in the British Museum: Alexandria and the Nomes (London, 1893); J.N. Svoronos, [Tgr][alpha] N[ogr][mu][iota][sigma][mu][alpha][tau][alpha] [tau][ogr][upsi] [Kgr][rho][alpha][tau][ogr][upsi][sigma] [tau][omega][nu] [Pi][tau][ogr][lambda]e[mu][alpha][iota][omega][nu] (M[uuml]nzen der Ptolem[auml]er) (Athens 1904); and R.A. Hazzard, Ptolemaic Coins: An Introduction for Collectors (Toronto, 1985). Examples of catalogues listing the Roman coinage in Egypt are J.G. Milne, Catalogue of Alexandrian Coins (Oxford, 1933); J.W. Curtis, The Tetradrachms of Roman Egypt (Chicago, 1969); A. Burnett, M. Amandry, and P.P Ripoll[egrave]s, Roman Provincial Coinage I: From the Death of Caesar to the Death of Vitellius (44 BC-AD 69) (London, 1998--revised edition); and A. Burnett, M. Amandry, and I. Carradice, Roman Provincial Coinage II: From Vespasian to Domitian (AD 69-96) (London, 1999). There are also so-called nwb-nfr coins, which may date to Dynasty 30. See T. Faucher, W. Fischer-Bossert, and S. Dhennin, ``Les Monnaies en or aux types hi[eacute]roglyphiques nwb nfr,'' Bulletin de l'institut fran[ccedil]ais d'arch[eacute]ologie orientale 112 (2012), pp. 147-169. 2. Dynasty 30--Nwb nfr coins have the hieroglyphs nwb nfr on one side and a horse on the other. 3. Hellenistic and Ptolemaic coins--Struck in gold, silver, and bronze at Alexandria and any other mints that operated within the borders of the modern Egyptian state. Gold coins of and in honor of Alexander the Great, struck at Alexandria and Memphis, depict a helmeted bust of Athena on the obverse and a winged Victory on the reverse. Silver coins of Alexander the Great, struck at Alexandria and Memphis, depict a bust of Herakles wearing the lion skin on the obverse, or ``heads'' side, and a seated statue of Olympian Zeus on the reverse, or ``tails'' side. Gold coins of the Ptolemies from Egypt will have jugate portraits on both obverse and reverse, a portrait of the king on the obverse and a cornucopia on the reverse, or a jugate portrait of the king and queen on the obverse and cornucopiae on the reverse. Silver coins of the Ptolemies coins from Egypt tend to depict a portrait of Alexander wearing an elephant skin on the obverse and Athena on the reverse or a portrait [[Page 87808]] of the reigning king with an eagle on the reverse. Some silver coins have jugate portraits of the king and queen on the obverse. Bronze coins of the Ptolemies commonly depict a head of Zeus (bearded) on the obverse and an eagle on the reverse. These iconographical descriptions are non-exclusive and describe only some of the more common examples. There are other types and variants. Approximate date: ca. 332 B.C. through ca. 31 B.C. 4. Roman coins--Struck in silver or bronze at Alexandria and any other mints that operated within the borders of the modern Egyptian state in the territory of the modern state of Egypt until the monetary reforms of Diocletian. The iconography of the coinage in the Roman period varied widely, although a portrait of the reigning emperor is almost always present on the obverse of the coin. Approximate date: ca. 31 B.C. through ca. A.D. 294. III. Ceramic and Clay A. Sculpture Terracotta statues and statuettes, including human, animal, and hybrid figures. B. Islamic Architectural Decorations Including carved and molded brick, and tile wall ornaments and panels. C. Vessels and Containers 1. Predynastic pottery, typically having a burnished red body with or without a white-painted decoration, or a burnished red body and black top, or a burnished black body sometimes with incised decoration, or an unburnished light brown body with dark red painted decoration, including human and animal figures and boats, spirals, or an abstract design. 2. Dynastic period pottery features primarily utilitarian but also ornate forms, typically undecorated, sometimes burnished. New Kingdom examples may have elaborate painted, incised, and molded decoration, especially floral motifs depicted in blue paint. 3. Roman period pottery includes vessels with rilled decoration, pilgrim flasks and terra sigillata, a high quality table ware made of red to reddish brown clay, and covered with a glossy slip. 4. Coptic pilgrim flasks, and decorated ceramic jars and bowls. 5. Islamic glazed, molded, and painted ceramics. D. Objects of Daily Use Including game pieces, loom weights, toys, and lamps. E. Writing 1. Ostraca, pottery shards used as surface for writing or drawing. 2. Cuneiform tablets, typically small pillow-shaped rectangles of unbaked clay incised with patterns of wedge-shaped cuneiform symbols. IV. Wood A. Sculpture 1. Statues, large- and small-scale, including human, animal, and hybrid figures. Shabti statuettes, small mummiform human figures, are especially popular. Wood statues usually lack the support at the back. 2. Relief sculpture, large- and small-scale, including relief plaques for funerary purposes. B. Architectural Elements 1. Coptic carved and inlaid wood panels, doors, ceilings, and altars, often decorated with floral, geometric, and Christian motifs. 2. Islamic carved and inlaid wood rooms, balconies, stages, panels, ceilings, and doors. C. Funerary Objects and Equipment 1. Sarcophagi and coffins, with separate lid, either in the form of a large rectangular box, or human-shaped and carved with modeled human features. Both types are often decorated inside and outside with painted, inlaid or incised images, and inscriptions. 2. Mummy masks, often painted, inlaid, and covered with gold foil. 3. Funerary models, including boats, buildings, food, and activities from everyday life. 4. Shrines to house sarcophagi or statuettes of deities. 5. Food containers in the shape of the product they contain, such as bread or a duck. D. Objects of Daily Use Including furniture such as chairs, stools, beds, chests and boxes, headrests, writing and painting equipment, musical instruments, game boxes and pieces, walking sticks, chariots and chariot fittings. E. Tools and Weapons Including adzes, axes, bow drills, carpenter's levels and squares, bows, arrows, spears. V. Faience and Glass A. Egyptian Faience A glossy, silicate-based fired material, is usually blue or turquoise, but other colors are found as well. It was popular for statuettes, including human, animal, and hybrid figures, vessels and containers, canopic jars, game pieces, seals, amulets, jewelry, and inlays in all types of objects. B. Glass 1. Pharaonic glass containers are typically small and often elaborately decorated with multi-colored bands. 2. The Roman period introduced a great variety of hand-blown shapes. 3. Islamic vessels and containers in glass, including glass and enamel mosque lamps. VI. Ivory, Bone, and Shell A. Sculpture Statuettes of ivory, including human, animal, and hybrid figures, and parts thereof. Some of the earliest Egyptian sculpture is in ivory. B. Objects of Daily Use Ivory, bone, and shell were used either alone or as inlays in luxury objects including furniture, chests and boxes, writing and painting equipment, musical instruments, games, cosmetic containers, combs, jewelry, amulets, and seals. VII. Plaster and Cartonnage A. Plaster Typically molded and then decorated with paint or gilding for mummy masks, jewelry, and other objects in imitation of expensive materials. Also used by itself for life masks and sculptor's models. B. Cartonnage Pieces of papyrus or linen covered with plaster and molded into a shape, similar to papier-m[acirc]ch[eacute], and then painted or gilded. Used for coffins and mummy masks. Today, cartonnage objects are sometimes dismantled in hopes of extracting inscribed papyrus fragments. C. Stucco Islamic architectural decoration in stucco. VIII. Textile, Basketry, and Rope A. Textile 1. Linen cloth was used in Pharaonic and Greco-Roman times for mummy wrapping, shrouds, garments, and sails. 2. Coptic textiles in linen and wool, including garments and hangings. 3. Islamic textile fragments. B. Basketry Plant fibers were used to make baskets and containers in a variety of shapes and sizes, as well as sandals and mats. C. Rope Rope and string were used for a great variety of purposes, including binding [[Page 87809]] planks together in shipbuilding, rigging, lifting water for irrigation, fishing nets, measuring, and stringing beads for jewelry and garments. IX. Leather and Parchment A. Leather Used for shields, sandals, clothing, including undergarments, and horse trappings. It was also used occasionally as an alternative to papyrus as a writing surface, a function later assumed by parchment. B. Parchment In the Coptic period, documents such as illuminated ritual manuscripts occur in single leaves or bound as a book or ``codex'' and are written or painted on specially prepared animal skins (cattle, sheep/goat, camel) known as parchment. X. Papyrus Scrolls, books, manuscripts, and documents, including religious, ceremonial, literary, and administrative texts. Scripts include hieroglyphic, hieratic, Aramaic, Hebrew, Greek, Latin, Coptic, and Arabic. XI. Painting and Drawing A. Tomb Paintings Paintings on plaster or stone, either flat or carved in relief. Typical subjects include the tomb owner and family, gods, and scenes from daily life. B. Domestic Wall Painting These are painted on mud plaster or lime plaster. Types include simple applied color, bands and borders, landscapes, and scenes of people and/or animals in natural or built settings. C. Rock Art Chipped and incised drawings on natural rock surfaces, from prehistoric to Pharaonic periods. D. Ostraca Paintings and drawings on stone chips and pottery shards. E. Mummy Portrait Panels and Funerary Masks In wood, plaster, and cartonnage, often painted with the head and upper body of the deceased. F. Coptic Painting 1. Wall and ceiling paintings--On various kinds of plaster and which generally portray religious images and scenes of Biblical events. Surrounding paintings may contain animal, floral, or geometric designs, including borders and bands. 2. Panel Paintings (Icons)--Smaller versions of the scenes on wall paintings, and may be partially covered with gold or silver, sometimes encrusted with semi-precious or precious stones and are usually painted on a wooden panel, often for inclusion in a wooden screen (iconastasis). May also be painted on ceramic. XII. Mosaics A. Floor Mosaics Greco-Roman, including landscapes, scenes of humans or gods, and activities such as hunting and fishing. There may also be vegetative, floral, or decorative motifs. They are made from stone cut into small bits (tesserae) and laid into a plaster matrix. B. Wall and Ceiling Mosaics Generally portray religious images and scenes of Biblical events. Surrounding panels may contain animal, floral, or geometric designs. Similar technique to floor mosaics, but may include teserae of both stone and glass. XIII. Writing On papyrus, wood, ivory, stone, metal, textile, clay, and ceramic, in hieroglyphic, hieratic, Aramaic, Assyrian, Babylonian, Persian, Hebrew, Greek, Latin, Coptic, and Arabic scripts. XIV. Human and Animal Remains Human and animal mummies. Inapplicability of Notice and Delayed Effective Date This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure (5 U.S.C. 553(a)(1)). For the same reason, a delayed effective date is not required under 5 U.S.C. 553(d)(3). Regulatory Flexibility Act Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do not apply. Executive Order 12866 Because this rule involves a foreign affairs function of the United States, it is not subject to Executive Order 12866. Signing Authority This regulation is being issued in accordance with 19 CFR 0.1(a)(1). List of Subjects in 19 CFR Part 12 Cultural property, Customs duties and inspection, Imports, Prohibited merchandise, Reporting and recordkeeping requirements. Amendment to CBP Regulations For the reasons set forth above, part 12 of Title 19 of the Code of Federal Regulations (19 CFR part 12), is amended as set forth below: PART 12--SPECIAL CLASSES OF MERCHANDISE 0 1. The general authority citation for part 12 and the specific authority citation for Sec. 12.104g continue to read as follows: Authority: 5 U.S.C. 301; 19 U.S.C. 66, 1202 (General Note 3(i), Harmonized Tariff Schedule of the United States (HTSUS)), 1624. * * * * * Sections 12.104 through 12.104i also issued under 19 U.S.C. 2612; * * * * * 0 2. In Sec. 12.104g, paragraph (a), the table is amended by adding the Arab Republic of Egypt to the list in appropriate alphabetical order as follows: Sec. 12.104g Specific items or categories designated by agreements or emergency actions. (a) * * * ---------------------------------------------------------------------------------------------------------------- State party Cultural property Decision No. ---------------------------------------------------------------------------------------------------------------- * * * * * * * Egypt................................. Archaeological material representing CBP Dec. 16-23. Egypt's cultural heritage from Predynastic period (5,200 B.C.) through 1517 A.D. * * * * * * * ---------------------------------------------------------------------------------------------------------------- [[Page 87810]] * * * * * R. Gil Kerlikowske, Commissioner, U.S. Customs and Border Protection. Approved: December 1, 2016. Timothy E. Skud, Deputy Assistant Secretary of the Treasury. [FR Doc. 2016-29191 Filed 12-5-16; 8:45 am] BILLING CODE 9111-14-P
![Federal Register / Vol. 81, No. 234 / Tuesday, December 6, 2016 / Rules and Regulations 87805
materials from Bolivia to which the exchanged reflecting the extension of PART 12—SPECIAL CLASSES OF
restrictions apply. those restrictions for an additional five- MERCHANDISE
DATES: Effective December 2, 2016. year period. Accordingly, CBP is
amending 19 CFR 12.104g(a) to reflect ■ 1. The general authority citation for
FOR FURTHER INFORMATION CONTACT: For
the extension of the import restrictions. part 12 and the specific authority
legal aspects, Lisa L. Burley, Chief,
The Designated List of Archaeological citation for § 12.104g continue to read as
Cargo Security, Carriers and Restricted
and Ethnological Material from Bolivia follows:
Merchandise Branch, Regulations and
Rulings, Office of Trade, (202) 325– covered by these import restrictions is Authority: 5 U.S.C. 301; 19 U.S.C. 66,
0215. For operational aspects, William set forth in T.D. 01–86. The Designated 1202 (General Note 3(i), Harmonized Tariff
R. Scopa, Branch Chief, Partner List may also be found at the following Schedule of the United States (HTSUS)),
Web site address: https://eca.state.gov/ 1624;
Government Agency Branch, Trade
Policy and Programs, Office of Trade, cultural-heritage-center/cultural- * * * * *
(202) 863–6554, William.R.Scopa@ property-protection/bilateral- Sections 12.104 through 12.104i also
issued under 19 U.S.C. 2612;
cbp.dhs.gov. agreements/bolivia.
* * * * *
SUPPLEMENTARY INFORMATION: The restrictions on the importation of
these archaeological and ethnological § 12.104g [Amended]
Background
materials from Bolivia are to continue in ■ 2. In § 12.104g, paragraph (a), the table
Pursuant to the provisions of the 1970 effect through December 4, 2021. is amended in the entry for Bolivia by
United Nations Educational, Scientific Importation of such material continues removing the words ‘‘CBP Dec. 11–24’’
and Cultural Organization (UNESCO) to be restricted unless the conditions set in the column headed ‘‘Decision No.’’
Convention, codified into U.S. law as forth in 19 U.S.C. 2606 and 19 CFR and adding in their place the words
the Convention on Cultural Property 12.104c are met. ‘‘CBP Dec. 16–24.’’
Implementation Act (Pub. L. 97–446, 19
U.S.C. 2601 et seq.), the United States Inapplicability of Notice and Delayed R. Gil Kerlikowske,
entered into a bilateral agreement with Effective Date Commissioner, U.S. Customs and Border
Bolivia 1 on December 4, 2001, Protection.
This amendment involves a foreign
concerning the imposition of import Approved: December 1, 2016.
affairs function of the United States and
restrictions on certain archaeological Timothy E. Skud,
is, therefore, being made without notice
and ethnological materials from Bolivia. Deputy Assistant Secretary of the Treasury.
On December 7, 2001, the U.S. Customs or public procedure under 5 U.S.C.
553(a)(1). In addition, CBP has [FR Doc. 2016–29279 Filed 12–2–16; 11:15 am]
Service (U.S. Customs and Border
Protection’s predecessor agency) determined that such notice or public BILLING CODE 9111–14–P
published Treasury Decision (T.D.) procedure would be impracticable and
01–86 in the Federal Register (66 FR contrary to the public interest because
the action being taken is essential to DEPARTMENT OF HOMELAND
63490), which amended 19 CFR SECURITY
12.104g(a) to reflect the imposition of avoid interruption of the application of
these restrictions and included a list the existing import restrictions (5 U.S.C. U.S. Customs and Border Protection
designating the types of articles covered 553(b)(B)). For the same reason, a
by the restrictions. delayed effective date is not required DEPARTMENT OF THE TREASURY
Import restrictions listed in 19 CFR under 5 U.S.C. 553(d)(3).
12.104g(a) are effective for no more than Regulatory Flexibility Act 19 CFR Part 12
five years beginning on the date on
which the agreement enters into force [CBP Dec. 16–23]
Because no notice of proposed
with respect to the United States. This rulemaking is required, the provisions RIN 1515–AE19
period can be extended for additional of the Regulatory Flexibility Act (5
periods not to exceed five years if it is U.S.C. 601 et seq.) do not apply. Import Restrictions Imposed on
determined that the factors which Certain Archaeological Material From
justified the initial agreement still Executive Order 12866 Egypt
pertain and no cause for suspension of Because this rule involves a foreign
the agreement exists (19 CFR AGENCY: U.S. Customs and Border
affairs function of the United States, it Protection, Department of Homeland
12.104g(a)).
is not subject to Executive Order 12866. Security; Department of the Treasury.
On October 11, 2016, after reviewing
the findings and recommendations of Signing Authority ACTION: Final rule.
the Cultural Property Advisory
This regulation is being issued in SUMMARY: This final rule amends the
Committee, the Assistant Secretary for
accordance with 19 CFR 0.1(a)(1). U.S. Customs and Border Protection
Educational and Cultural Affairs, United
(CBP) regulations to reflect the
States Department of State, concluding List of Subjects in 19 CFR Part 12 imposition of import restrictions on
that the cultural heritage of Bolivia
certain archaeological material from the
continues to be in jeopardy from pillage Cultural property, Customs duties and Arab Republic of Egypt (Egypt). These
of certain archaeological and inspection, Imports, Prohibited restrictions are being imposed pursuant
ethnological materials, made the merchandise.
mstockstill on DSK3G9T082PROD with RULES
to an agreement between the United
necessary determination to extend the
Amendment to CBP Regulations States and Egypt that has been entered
import restrictions for an additional five
into under the authority of the
years. Diplomatic notes have been For the reasons set forth above, part Convention on Cultural Property
1 In2009, the new constitution of Bolivia changed
12 of title 19 of the Code of Federal Implementation Act in accordance with
the country’s official name from the ‘‘Republic of Regulations (19 CFR part 12), is the 1970 United Nations Educational,
Bolivia’’ to the ‘‘Plurinational State of Bolivia.’’ amended as set forth below: Scientific and Cultural Organization
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* * * * * amendments devices, are classified classification will be the initial
automatically by statute into class III classification of the device.
R. Gil Kerlikowske,
without any FDA rulemaking process. On August 11, 2015, ImPACT
Commissioner, U.S. Customs and Border These devices remain in class III and
Protection. Applications, Inc., submitted a request
require premarket approval, unless and for classification of the ImPACT and
Approved: December 1, 2016. until the device is classified or
Timothy E. Skud, ImPACT Pediatric under section
reclassified into class I or II, or FDA 513(f)(2) of the FD&C Act.
Deputy Assistant Secretary of the Treasury. issues an order finding the device to be
[FR Doc. 2016–29191 Filed 12–5–16; 8:45 am] substantially equivalent, in accordance In accordance with section 513(f)(2) of
BILLING CODE 9111–14–P with section 513(i) of the FD&C Act, to the FD&C Act, FDA reviewed the
a predicate device that does not require request in order to classify the device
premarket approval. The Agency under the criteria for classification set
DEPARTMENT OF HEALTH AND determines whether new devices are forth in section 513(a)(1). FDA classifies
HUMAN SERVICES substantially equivalent to predicate devices into class II if general controls
devices by means of premarket by themselves are insufficient to
Food and Drug Administration notification procedures in section 510(k) provide reasonable assurance of safety
of the FD&C Act (21 U.S.C. 360(k)) and and effectiveness, but there is sufficient
21 CFR Part 882 part 807 (21 CFR part 807) of the information to establish special controls
regulations. to provide reasonable assurance of the
[Docket No. FDA–2015–N–2737] safety and effectiveness of the device for
Section 513(f)(2) of the FD&C Act, as
Medical Devices; Neurological amended by section 607 of the Food and its intended use. After review of the
Devices; Classification of the Drug Administration Safety and information submitted in the request,
Computerized Cognitive Assessment Innovation Act (Pub. L. 112–144), FDA determined that the device can be
Aid for Concussion provides two procedures by which a classified into class II with the
person may request FDA to classify a establishment of special controls. FDA
AGENCY: Food and Drug Administration, device under the criteria set forth in believes these special controls, in
HHS. section 513(a)(1). Under the first addition to general controls, will
ACTION: Final order. procedure, the person submits a provide reasonable assurance of the
premarket notification under section safety and effectiveness of the device.
SUMMARY: The Food and Drug 510(k) of the FD&C Act for a device that
Administration (FDA) is classifying the Therefore, on August 22, 2016, FDA
has not previously been classified and, issued an order to the requestor
Computerized Cognitive Assessment within 30 days of receiving an order
Aid for Concussion into class II (special classifying the device into class II. FDA
classifying the device into class III is codifying the classification of the
controls). The special controls that will under section 513(f)(1) of the FD&C Act,
apply to the device are identified in this device by adding 21 CFR 882.1471.
the person requests a classification
order and will be part of the codified under section 513(f)(2). Under the Following the effective date of this
language for the computerized cognitive second procedure, rather than first final classification order, any firm
assessment aid for concussion’s submitting a premarket notification submitting a premarket notification
classification. The Agency is classifying under section 510(k) of the FD&C Act (510(k)) for a computerized cognitive
the device into class II (special controls) and then a request for classification assessment aid for concussion will need
in order to provide a reasonable under the first procedure, the person to comply with the special controls
assurance of safety and effectiveness of determines that there is no legally named in this final order. The device is
the device. marketed device upon which to base a assigned the generic name computerized
DATES: This order is effective December determination of substantial cognitive assessment aid for concussion,
6, 2016. The classification was equivalence and requests a classification and it is identified as a prescription
applicable on August 22, 2016. under section 513(f)(2) of the FD&C Act. device that uses an individual’s score(s)
FOR FURTHER INFORMATION CONTACT: If the person submits a request to on a battery of cognitive tasks to provide
Stacie Gutowski, Center for Devices and classify the device under this second an indication of the current level of
Radiological Health, Food and Drug procedure, FDA may decline to cognitive function in response to
Administration, 10903 New Hampshire undertake the classification request if concussion. The computerized cognitive
Ave., Bldg. 66, Rm. 2656, Silver Spring, FDA identifies a legally marketed device assessment aid for concussion is used
MD 20993–0002, 240–402–6032, that could provide a reasonable basis for only as an assessment aid in the
Stacie.Gutowski@fda.hhs.gov. review of substantial equivalence with management of concussion to determine
the device or if FDA determines that the cognitive function for patients after a
SUPPLEMENTARY INFORMATION:
device submitted is not of ‘‘low- potential concussive event where other
I. Background moderate risk’’ or that general controls diagnostic tools are available and does
In accordance with section 513(f)(1) of would be inadequate to control the risks not identify the presence or absence of
the Federal Food, Drug, and Cosmetic and special controls to mitigate the risks concussion. It is not intended as a
Act (the FD&C Act) (21 U.S.C. cannot be developed. stand-alone diagnostic device.
360c(f)(1)), devices that were not in In response to a request to classify a FDA has identified the following risks
commercial distribution before May 28, device under either procedure provided to health associated specifically with
1976 (the date of enactment of the by section 513(f)(2) of the FD&C Act, this type of device, as well as the
mstockstill on DSK3G9T082PROD with RULES
Medical Device Amendments of 1976), FDA shall classify the device by written mitigation measures required to mitigate
generally referred to as post- order within 120 days. This these risks in table 1.
VerDate Sep<11>2014 16:27 Dec 05, 2016 Jkt 241001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\06DER1.SGM 06DER1](https://thefederalregister.org/doc/81_FR_88039/page/6.svg)
Document Created: 2016-12-06 02:18:15
Document Modified: 2016-12-06 02:18:15
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | Effective December 5, 2016. | |
| Contact | For legal aspects, Lisa L. Burley, Chief, Cargo Security, Carriers and Restricted Merchandise Branch, Regulations and Rulings, Office of Trade, (202) 325-0030. For operational aspects, William Scopa, Branch Chief, Partner Government Agency Branch, Trade Policy and Programs, Office of Trade, (202) 863- 6554, [email protected] | |
| FR Citation | 81 FR 87805 | |
| RIN Number | 1515-AE19 | |
| CFR Associated | Cultural Property; Customs Duties and Inspection; Imports; Prohibited Merchandise and Reporting and Recordkeeping Requirements |
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