The NRC may post materials related to this document, including public comments, on the Federal rulemaking website at https://www.regulations.gov under Docket ID NRC-2023-0069. In addition, the Federal rulemaking website allows members of the public to receive alerts when changes or additions occur in a docket folder. To subscribe: (1) navigate to the docket folder (NRC-2023-0069); (2) click the “Subscribe” button; and (3) enter an email address and click on the “Subscribe” button.

In the interest of clarity and transparency, the NRC is correcting the amount of “26,800” for Basic In Situ Recovery facilities in Table 2 to Paragraph (d) to 10 CFR 171.16 in the amendatory text to the final rule, published at 90 FR 26761 on June 24, 2025, to the amount of “27,700”. The correction to the typo in the amendatory text aligns with the amount of “27,700” as described in the preamble at Table V, Rebaselined Annual Fees, as published at 90 FR 26735, and in the second column, lines 11 and 12, and Table XIV, Annual Fees for Uranium Recovery Licensees, as published at 90 FR 26739.

In FR Doc. 2025-11544, published at 90 FR 26730 on June 24, 2025, the NRC makes the following correction to amendatory instruction 8, in table 2 to paragraph (d):

Background

The Convention on Cultural Property Implementation Act (Pub. L. 97-446, 19 U.S.C. 2601 et seq. ) (CPIA), which implements 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)) (Convention), allows for the conclusion of an agreement between the United States and another party to the Convention to impose import restrictions on certain archaeological and ethnological material. Pursuant to the CPIA, the United States entered into a bilateral agreement with the Republic of India (India) to impose import restrictions on certain archaeological and ethnological material of India. This rule announces that the United States is now imposing import restrictions on certain archaeological and ethnological material of India through July 26, 2029. This period may be extended for additional periods, each extension not to exceed five years, if it is determined that the factors justifying the initial agreement still pertain and no cause for suspension of the agreement exists (19 U.S.C. 2602(e); § 12.104g(a) of title 19 of the Code of Federal Regulations (19 CFR 12.104g(a))).

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 December 13, 2023, the Assistant Secretary for Educational and Cultural Affairs, United States Department of State, after consultation with and recommendation by the Cultural Property Advisory Committee, made the determinations required under the statute with respect to certain archaeological and ethnological material originating in India that is described in the Designated List set forth below in this document.

These determinations include the following: (1) that the cultural patrimony of India is in jeopardy from the pillage of archaeological material representing India's cultural heritage dating from approximately 1.7 million years ago to 1770 C.E., and ethnological material dating from approximately the 2nd century B.C.E. to 1947 C.E. (19 U.S.C. 2602(a)(1)(A)); (2) that the government of India 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 or ethnological material of the State Party” (19 U.S.C. 2601(2)).

On July 26, 2024, the Governments of the United States and India signed a bilateral agreement, “Agreement between the Government of the United States of America and the Government of the Republic of India Concerning the Imposition of Import Restrictions on Categories of Archaeological and Ethnological Material of India” (Agreement), pursuant to the provisions of 19 U.S.C. 2602(a)(2). The Agreement entered into force upon signature and enables the promulgation of import restrictions on certain categories of archaeological material ranging in date from approximately 1.7 million years ago to 1770 C.E., as well as certain categories of ethnological material dating from approximately the 2nd century B.C.E. to 1947 C.E. A list of the categories of archaeological and ethnological material subject to the import restrictions is set forth later in this document.

In accordance with the Agreement, importation of material designated below is subject to the restrictions of 19 U.S.C. 2606 and 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 19 CFR 12.104c are met. CBP is amending 19 CFR 12.104g(a) to indicate that these import restrictions have been imposed.

Import restrictions listed at 19 CFR 12.104g(a) are effective for no more than five years beginning on the date on which an agreement enters into force with respect to the United States. This period may be extended for additional periods of not more than five years if it is determined that the factors which justified the agreement still pertain and no cause for suspension of the agreement exists. Therefore, the import restrictions will expire on July 26, 2029, unless extended.

The Agreement between the United States and India includes, but is not limited to, the categories of objects described in the Designated List set forth below.

The Designated List includes archaeological and ethnological material from India. The archaeological material in the Designated List ranges in date from 1.7 million years ago through 1770 C.E. The ethnological material in the Designated List includes civic, religious, and royal architectural material; religious material and ceremonial items; and manuscripts, portions of manuscripts, and materials used to bind manuscripts dating from the 2nd century B.C.E. to 1947 C.E. The list set forth below is representative only. Any dates and dimensions are approximate.

Approximate simplified chronology of well-known periods:

Lower Paleolithic Era to Mesolithic Era: c. 1.7 million years ago-7000 B.C.E.

Neolithic Era: c. 7000-4500 B.C.E.

Chalcolithic Era (including, but not limited to, Indus Valley Civilization, also called Harappan Civilization; Southern Neolithic Era): c. 4500-1500 B.C.E.

Early Historic and Historic Periods (including, but not limited to, Southern Neolithic Era, Iron Age, and Southern Early Historic Period; Vedic Period, including the advent of Buddhism and Jainism; Mauryan, Shunga-Kushan, and Gupta Empires; Indo-Greek Period; Chera, Chola, and Pandya Dynasties): c. 1500 B.C.E.-550 C.E.

Medieval Period (including, but not limited to, Gurjara-Pratihara and Pala Dynasties; Chola, Rastrakuta, and Pallava Dynasties; Delhi Sultanate): 550-1526 C.E.

Mughal Empire or Early Modern Period (including, but not limited to, Nayaka kingdoms and Maratha Empire): 1526-1858 C.E.

Colonial Period: 1858-1947 C.E.

(1) Architectural Elements—Primarily in sandstone, limestone, marble, granite, basalt, slate, schist, quartzite, and khondalite, but includes other types of stone. Category includes, but is not limited to: arches; balustrades; beams; benches; brackets; bricks and blocks from walls, ceilings, gates, and floors; buttresses; columns, including capitals and bases; cornices; dentils; disks, including amalakas and chattras; domes; door frames and portals; false gables; finials and spires; friezes; fountains and fountainheads; gates; lintels; merlons; mihrabs; mosaics; niches; panels; pavilions, including semi-open domed pavilions ( chatris/chhatris); pilasters; pillars, including capitals and bases; plinths; railings; reliefs; screens and lattices ( jalis ); turrets; tympana; vaults; and windows. Elements may be plain, carved in relief, incised, inlaid, or inscribed in various languages and scripts; may be polished, painted, and/or gilded. Architectural elements may include relief sculptures, mosaics, and inlays that were part of a building, such as friezes, panels, or figures in the round. Includes architectural elements of Turkic, Persian, Arab, Hellenistic (Greek), Saracenic, European (British, Dutch, and Portuguese), and East Asian influence. May include depictions of floral, vegetal, animal, geometric, human, and mythological motifs and scenes from Hindu, Muslim, Buddhist, Jain, Sikh, Christian, Jewish, and Zoroastrian religious traditions. Approximate Date: 4500 B.C.E.-1770 C.E.

(2) Non-Architectural Monuments—Primarily in sandstone, limestone, marble, granite, basalt, schist, steatite, but includes other types of stone. Types include, but are not limited to: altars; bases; basins; cenotaphs; funerary headstones and monuments; fountains; free-standing pillars; libation platforms; linga; memorial stones; monoliths, including rooted sculptures; niches; plaques; portable shrines; ring stones; rock edicts; roundels; sarcophagi; slabs; stands; stelae; stelae bases; virikals (hero stones and sati stones); and yoni. Monuments may be plain, carved in relief, incised, inlaid, or inscribed in various languages and scripts; may be polished, painted, and/or gilded. Decorative elements may include geometric, floral, and/or vegetal motifs, as well as animal, mythological, and/or human figures in various poses from secular, as well as Megalithic, Hindu, Muslim, Buddhist, Jain, Sikh, Christian, Jewish, and Zoroastrian religious traditions. Approximate Date: 4500 B.C.E.-1770 C.E.

(3) Large Statuary—Primarily in sandstone, limestone, marble, granite, basalt, steatite, and schist, but includes other types of stone. Statuary includes seated, standing, reclining, amorous, or dancing human, animal, and/or mythological figures, as well as figures from Hindu, Buddhist, Jain, Sikh, Christian, Jewish, and Zoroastrian religious traditions. Large statuary may be polished, painted, and/or gilded, and may bear inscriptions in various languages and scripts. Approximate Date: 4500 B.C.E.-1770 C.E. Some well-known types include:

a. Early Historic and Historic Periods sculpture includes figures from Buddhist, Jain, and Hindu religious traditions, as well as influences from the Gandharan style. Sculptural styles can include robust, sensuous figures with intricate ornamentation, as well as stylized, angular figures. May depict scenes from Buddhist religious traditions, such as the Buddha, bodhisattvas, devotees, and vegetation. Other sculptural traditions include figures with long faces and ears and conical headdresses. Gupta Empire sculpture is notable for graceful, serene figures with broader shoulders and leaner builds depicting images and scenes from Hindu, Jain, and Buddhist religious traditions. Approximate Date: 1500 B.C.E.-550 C.E.

b. Medieval Period large sculpture reflects a wide spectrum of regional styles. Sculptures are highly elaborate, occasionally rigid in high relief. May also depict mythological, mundane, and/or spiritual scenes. Approximate Date: 550-1526 C.E.

(4) Small Statuary—Primarily in basalt, granite, jade, limestone, marble, sandstone, steatite, schist, but includes other types of stone. Animals, human figures, mythological forms, and architectural models may be stylized or naturalistic. Small statuary includes depictions from secular as well as Hindu, Buddhist, Jain, Sikh, Christian, Jewish, and Zoroastrian religious traditions. Small statuary may be polished, painted, inlaid, and/or gilded, and may bear inscriptions in various languages and scripts. Small statuary styles and design reflect some characteristics of large statuary. Approximate Date: 4500 B.C.E.-1770 C.E.

(5) Vessels and Containers—Primarily in alabaster, jade, marble, sandstone, steatite, but includes other types of stone. Vessel types may be conventional shapes such as: bowls; boxes; canisters; cups; cylindrical vessels; goblets; flasks; jars; jugs; lamps; platters; stands; trays; votive vessels; in addition to specialized shapes. May also include: caskets; cosmetic containers or palettes; inkpots; pen boxes; spittoons; reliquaries and their contents; and incense burners. Includes vessel lids. Some reliquaries may take the shape of a Buddhist stupa. Surfaces may be plain, painted, polished, and/or incised or carved in relief with geometric, floral, or vegetal decoration, elaborate figural scenes, and/or inscriptions in various languages and scripts. Vessels may be inlaid with stones or gilded. Approximate Date: 7000 B.C.E.-1770 C.E.

(6) Tools, Instruments, and Weights—Includes ground stone and flaked stone tools. Approximate Date: 1.7 million years ago-1770 C.E.

a. Ground stone tools, instruments, and weights are mainly made from chert, granite, sandstone, marble, quartz, limestone, but other types of stone are included. Types include, but are not limited to, adzes, anvils, axes, balls, celts, cleavers, grinding stones, hammerstones, maces, mills, molds, mortars, palettes, pestles, querns, rods, rubbers, scepters, scrapers, whetstones, and others. Also included are counters, dice, finials, fly whisk handles, game pieces, hilts, mirror frames and handles, spindle whorls, trays, and weights. Stone tools used to polish, shape, or sharpen other tools are included. Stone weights are found in various shapes, such as cubes, rectangular prisms, rings, spheres, and truncated spheres, and may be polished and/or decorated with incisions or relief carving and/or inscribed in various languages and scripts. Some handles, hilts, and others may be inlaid with precious or semi-precious stones, glass, and/or precious metals, and might be carved in zoomorphic, vegetal, floral, and/or mythological shapes.

b. Flaked stone tools are primarily made of chalcedony, chert or other cryptocrystalline silicates, limestone, flint, jasper, obsidian, or quartzite, but other types of stone are included. Types include axes, bifaces, blades, burins, borers, choppers, cleavers, cores, hammers, knives, microliths, points, projectiles, scrapers, sickles, unifaces, and others. Stone tools used to create flaked stone tools are included.

(7) Beads and Jewelry—Primarily in alabaster, agate, amazonite, amethyst, carnelian, chalcedony, coral, cryptocrystalline silicates, emerald, garnet, jade, jasper, lapis lazuli, onyx, quartz, rock crystal, ruby, steatite, and turquoise, but also includes other types of stone. Beads may be carved, cut, drilled, ground, etched, fired, glazed, painted and/or polished. Beads may be in animal, biconical, conical, cylindrical, disc, dumbbell, eye, faceted, scaraboid, spherical, teardrop, and other shapes. May bear geometric designs, images, and/or inscriptions in various languages and scripts. Jewelry includes amulets, anklets, bracelets, bangles, pectorals, pendants, rings, and other types. Approximate Date: 7000 B.C.E.-1770 C.E.

(8) Stamps, Seals, and Gems—Primarily in agate, amethyst, carnelian, chalcedony, hematite, jasper, rock crystal, sapphire, ruby, cat's eye, garnet, diamond, emerald, hessonite, moonstone, aquamarine, tourmaline, turquoise, steatite, but also includes other types of stone. Stamps, seals, and gems may have engravings that include animals, human figures, geometric, floral, or vegetal designs, and/or inscriptions in various languages and scripts. Includes cameos and intaglios. Particularly prevalent in the Chalcolithic Indus Valley Era. Well-known styles are from the Neolithic Era, Chalcolithic Era, Historic Period, Medieval Period, and Mughal Empire. Approximate Date: 4500 B.C.E.-1770 C.E.

a. Chalcolithic Era seals and stamps are primarily in steatite (usually fired or glazed) but also include other types of stone. May be square or rectangular, but may also be circular, cylindrical, oval, or triangular, and may have a pierced knob handle. Incised designs often feature inscriptions in the Indic script, either alone or together with animals, human, divine, and/or mythological figures, plants, and symbols. Designs may also be geometric. Approximate Date: 4500-1500 B.C.E.

b. Early Historic and Historic Periods seals and stamps are usually oval, rectangular, button-shaped, teardrop, or hemispherical. Stamps and seals may be incised, drilled, cut, or relief-carved with animals, human, divine, and/or mythological figures, plants, and symbols. May be perforated for suspension or set into a ring. May be inscribed in various languages and scripts. Approximate Date: 1500 B.C.E.-550 C.E.

c. Medieval Period seals and stamps are usually circular, oval, rectangular, square, or teardrop. Stamps and seals may be incised, drilled, cut, or relief-carved with animals, human, divine, and/or mythological figures, plants, and symbols. May be perforated for suspension or set into a ring. May be inscribed in various languages and scripts. Approximate Date: 550-1526 C.E.

d. Mughal Empire or Early Modern Period seals and stamps are usually rectangular, square, teardrop, polygonal, or circular. Stamps and seals may be drilled, cut, relief-carved, or and/or inscribed primarily with script or calligraphy. May be perforated for suspension or set into a ring. Approximate Date: 1526-1770 C.E.

(1) Statuary—Includes small and large-scale statuary in ceramic, faience, and terracotta. Includes, but is not limited to: auspicious emblems; cart frames or wheels; figurines; masks, for decoration or performance art; model boats; model carts; model houses; model stupas; plaques; rattles; reliefs; and roundels. Includes bases, plinths, or stands. May be associated with religious or spiritual activity, decoration, commemoration, games, or toys. May depict scenes of animals, deities, humans, hybrid animals/humans or other mythological figures, monuments, mandalas, or vegetation. May be painted or have traces of paint or pigment, as well as be stamped, incised, or inscribed in various languages and scripts. Forms may be stylized or naturalized. Well-known styles date to the Chalcolithic Era, Historic Period, Medieval Period, and Mughal Empire. Approximate Date: 4500 B.C.E.-1770 C.E.

(2) Architectural Elements—Primarily in terracotta. Includes, but is not limited to: arches; brackets; bricks; columns, including capitals and bases; eaves; floors; friezes; niches; panels; pipes; reliefs; tiles; and other elements used as functional or decorative elements in buildings or flooring. Bricks may be cut, carved, or molded to form decorative patterns on building exteriors. Panels and tiles may be painted, plastered, stuccoed, or have traces of paint or plaster. Tiles may bear carved, incised, impressed, or molded decoration in the form of animals, humans, geometric, floral, vegetal, and/or mythological motifs. Tiles may be square, rounded, polygonal, or specifically shaped. They may have been molded, incised, and/or painted with animal, geometric, floral, vegetal, and/or mythological motifs, arabesque (intertwining) motifs, and/or calligraphic writing in various scripts and languages before glazing. If glazed, glaze may be clear, monochrome, or polychrome. Approximate Date: 4500 B.C.E.-1770 C.E.

(3) Vessels and Containers—Includes utilitarian vessels, fine tableware, lamps, special-purpose vessels, and other ceramic objects of everyday use.

a. Mesolithic Era includes handmade plain and cord-impressed vessels and containers and/or fragments. Approximate Date: 10,000-7000 B.C.E.

b. Neolithic Era includes handmade and slow-wheel-thrown coarse earthenware vessels and/or fragments. Vessel types include bowls, jars, pots, and other forms. May be grey, buff, brown, pink, red, or black. May include decor and finishes such as red-, black-, or cream-slipped surfaces, paint or other pigments; herringbone, cross-hatched, and checkerboard patterns; incision, burnishing, impressions; among others. Approximate Date: 7000-4500 B.C.E.

c. Chalcolithic Era includes handmade and wheel-thrown coarse and fine earthenware vessels and/or fragments. Vessel types include bowls, canisters, cooking pots, goblets, jars, jugs, lids, plates, pedestalled stands, perforated strainers, flat dishes, storage vessels, urns, and other forms. Surface can be red, buff, gray, brown, cream, or black. May include decor and finishes such as red-, black-, or cream-slipped surfaces, paint or other pigments; incision, burnishing, impressions; among others. Designs include more ornate animal, geometric, floral, and/or vegetal motifs. May be incised with characters in the Indus script. Approximate Date: 4500-1500 B.C.E.

d. Early Historic and Historic Periods include handmade, molded, or wheel-made earthenware vessels and/or fragments. Vessel types include: conventional shapes such as basins; beakers; bottles; bowls; cooking pots; cups; jars; jugs and juglets; lids; pitchers; plates; storage vessels; saucers; thalis (a large plate with an upturned rim, c. 30 cm in diameter); trays; tubs; urns; and vases, as well as other forms such as incense burners; drinking horns; lamps; stands; and specialty pieces. Vessel forms may have pedestal bases, handles, and/or spouts. Some vessels may have been formed into elaborate shapes using molds. Lids may include spires. Surface treatments may include slip, burnishing, polishing, incising, impressing (including grooving, rouletting, and stamping), appliqué, painting, and/or glazing. Includes Iron Age black-, red-, and black and red-slip ware. Stamp impressions include simple geometric motifs, leaves, lotuses, rosettes, and/or elaborate scenes combining animal, human, geometric, floral, and/or vegetal motifs. Molded animal heads, human figures, or rosettes in clay may be applied to the exterior surface of a vessel or attached as a handle. Painted designs include geometric, floral, and vegetal motifs, as well as reliefs and narrative panels of humans, animals, and plants. May be inscribed or painted in various languages and scripts. Approximate Date: 1500 B.C.E.-550 C.E.

e. Medieval Period includes handmade, molded, or wheel-made earthenware vessels and/or fragments. Vessel types include: conventional shapes such as basins; beakers; bottles; bowls; cooking pots; cups; jars; jugs and juglets; lids; pitchers; plates; storage vessels; saucers; thalis; trays; tubs; urns; and vases, as well as other forms such as incense burners; drinking horns; lamps; stands; and specialty pieces. Painted designs include animal, geometric, floral, human, religious, and/or vegetal motifs, as well as reliefs and narrative panels of humans, animals, and plants. May be inscribed or painted in various languages and scripts. Approximate Date: 550-1526 C.E.

f. Mughal Empire or Early Modern Period includes handmade, molded, and wheel-made earthenware vessels, as well as porcelain and sgraffiato, and/or fragments. Vessel types include conventional shapes such as bowls, coasters, cooking pots, cups, ewers, flasks, jars, jugs, lamps, lids, pans, platters, trays, water vessels (lota), and other types such as hookah pots, incense burners, ashtrays, vessels with a pedestalled foot, kneading troughs, model stupas, pipes, and vessels in the shape of animals. Painted decoration includes animal, geometric, floral, and vegetal motifs, as well as inscriptions in various languages and scripts, variously applied on a slipped surface, under a colorless glaze, or over a colored glaze. Glazes may be colorless, monochrome, or polychrome. Common colors include green, yellow, blue, black, brown, indigo, turquoise, and white. Glazed pottery based on Persian models with Indian designs, white background with blue, green, red, and yellow floral, vegetal, and geometric motifs is a characteristic type. Approximate Date: 1526-1770 C.E.

(4) Beads, Jewelry, and Ornaments—Includes, but is not limited to, bangles, beads, bracelets, buttons, ear spools, earrings, hairpieces, inlays, masks and related decorative or theatrical costume elements, rings, and others made of faience and terracotta. Beads include barrel, biconical, cylindrical, segmented, and other shapes. Faience may be colored with blue, blue-green, red, and white glaze. Approximate Date: 4500 B.C.E.-1770 C.E.

(5) Tools and Instruments—Includes, but is not limited to, terracotta balls, buttons, coin molds, cones, cubes, dabbers, dice, discs, flutes, kiln setters, loom weights, musical and percussive instruments, net-sinkers, rattles, skin-rubbers, stamps, statuary and vessel molds, spindle whorls, scoops, spoons, stoppers, whistles (may take the shape of animals), and other objects. May be incised or stamped with inscriptions in various languages and scripts. Approximate Date: 7000 B.C.E.-1770 C.E.

(6) Stamps and Seals—Terracotta and faience stamps and seals can be square, rectangular, circular, or oval with geometric, animal, religious, calligraphic, floral, and/or vegetal motifs. May be incised or stamped with inscriptions in various languages and scripts. Includes sealings that result from use of stamps and seals. Approximate Date: 4500 B.C.E.-1770 C.E.

(7) Tablets and Sealings—Terracotta and faience tablets and sealings may be cylindrical, rectangular, or prismatic and molded in relief with images of animals, humans, deities, calligraphic, and other motifs, and/or inscriptions in various languages and scripts. Approximate Date: 4500 B.C.E.-1770 C.E.

Includes copper, gold, silver, iron, lead, tin, zinc, and alloys such as bronze, electrum, brass, pewter, and steel. Approximate Date: 4500 B.C.E.-1770 C.E.

(1) Containers and Vessels—Vessel types include: conventional shapes such as basins; bottles; bowls; boxes; canisters; cauldrons; chalices; cups; dishes; ewers; flasks; jars; jugs; lamps; pans; plates (including copper plate inscriptions); platters; pots; rosewater sprinklers; saucepans; stands; utensils; and vases, but also include forms such as ash trays; hookah pots; incense burners; padlocks; portable lidded boxes used to carry human remains; reliquaries and their contents; and spittoons. Some reliquaries may take the form of a Buddhist stupa. One end of some drinking vessels may take the form of an animal or mythical creature. They may include lids, spouts, and handles of vessels. Metal containers may have been decorated by chasing (embossing), engraving, gilding, inlaying, punching, and/or repoussé (relief hammering). Designs include, but are not limited to: inscriptions in various languages and scripts; arabesque (intertwining) motifs; geometric, filigree, floral, vegetal, and animal motifs; and portrait busts or scenes of human figures, such as ceremonial, banquet, or hunting scenes. Some containers and vessels, such as reliquaries, may be inlaid with precious or semi-precious stones, as well as precious metals such as gold and silver. Approximate Date: 4500 B.C.E.-1770 C.E.

(2) Jewelry and Personal Adornments—Types include, but are not limited to: amulets; amulet holders; armbands; bangles; beads; bracelets; belts; bracteates; brooches; buckles; buttons; chains; charms; clasps; collars; crowns; earrings; ear spools; discs; hair and turban ornaments; hairpins; headdress or hat ornaments; lockets; necklaces; pectoral ornaments; pendants; pins; finger, toe, and nose rings, including ring-seals; rosettes; and staffs. Includes metal ornaments, appliqués, clasps, and ornaments once attached to textiles or leather objects. Includes also metal scrolls inscribed in various languages and scripts. May have been decorated by chasing (embossing), cloisonné, enameling, engraving, filigree, gilding, granulation, inlaying, and/or repoussé (relief hammering). Decoration may include animal, human, religious, geometric, floral, calligraphic, and/or vegetal motifs. May include inlays of ivory, bone, animal teeth, enamel, other metals, precious stones, and/or semi-precious stones. Includes mixed media. Approximate Date: 4500 B.C.E.-1770 C.E.

(3) Tools and Instruments—Types include, but are not limited to: adzes; arrowheads; astrolabes; axes; backscratchers; bells; blades; celts; chisels; drills; fishhooks; goads; hinges; hoes; hooks; keys; knives; measuring rods; mirrors and mirror handles; nails; pickaxes; pins; rakes; rods; saws; scale weights; scythes; shears; shovelheads; sickles; spades; spoons; staffs; tongs; trowels; weights; and tools of craftspeople such as carpenters, masons, and metalsmiths, among others. Includes musical instruments. Approximate Date: 4500 B.C.E.-1770 C.E.

(4) Weapons and Armor—Includes, but is not limited to: body armor, such as chain mail; helmets; horse, camel, and elephant armor, bits, bridle, and ornamental elements; plate armor; scale armor; shin guards; and shields and shield bosses. Also includes: launching weapons (arrowheads, spearheads, javelin heads, and tridents); hand-to-hand combat weapons (axes, swords, including sabers and scimitars, daggers, including khanjars and katars, and maces); firearms, cannons, muskets, and ammunition; sheaths; and priming horns. Some weapons may be highly decorative and incorporate inlays of other types of metal, precious stones, or semi-precious stones in the sheaths and hilts. Some weapons, hilts, and sheaths may be engraved or embossed with inscriptions in various languages and scripts, arabesque (intertwining), geometric, floral, calligraphic, religious, and/or vegetal motifs, and/or human or animal scenes, such as hunting scenes. May also be gilded, polished, burnished, painted, and/or covered in cloth or other materials. Approximate Date: 4500 B.C.E.-1770 C.E.

(5) Coins—Ancient coins include gold, silver, copper, lead, and copper alloy coins in a variety of sizes and denominations. Includes gold and silver ingots and commemorative coins. Coins may be circular, oval, square, or polygonal in shape, may be punch-marked, hammered, cast, molded, and/or gilded. Coins may include designs on one or both sides, including edges. Designs may include portraits, crests, deities, and animal, floral, architectural, geometric, and/or vegetal motifs, and/or may be inscribed in various languages and scripts. Includes depictions of symbols and figures from Buddhist, Jain, Hindu, Christian, Sikh, and Zoroastrian religious traditions, among others. Includes Roman, Persian, Greek or Hellenistic, Gandharan, Central Asian, and other coins found in India. Includes coins that were reused or converted into decorative objects or objects of personal adornment. Approximate Date: 600 B.C.E.-1770 C.E.

a. Early Historic Period includes punch-marked coins, discs, tokens, among others in gold and silver. May include depictions of animals, geometric, floral, and/or vegetal motifs.

b. Historic Period includes, but is not limited to, Mauryan punch marked coins ( karshapana ) with various symbols such as suns, crescents, six-arm designs, hills, peacocks, human figures, animals, and others, and inscriptions in Brahmi script; Roman silver and bronze coins; Hellenistic and Gandharan drachms, tetradrachms, and gold staters featuring iconography of Hellenistic deities and human portraiture and inscriptions in Greek and Kharoshti; Kushan dinars, tetradrachms, and copper alloy denominations with iconography from Persian, Zoroastrian, Buddhist, and Hindu traditions; Western Satraps coins with bull-and-hill or elephant-and-hill images; Indo-Scythian coins; Satavahana coins with Prakrit inscriptions and animal, floral, geometric, star, Buddhist shrines or stupas, human, wheel, and/or maritime motifs; Ashokan stambha coins featuring a central pillar; Gupta dinaras and drachms and others with images of animals, human figures, mythological birds, archery, javelins, battle-axes, wheels and scepters, deities, and portraiture along with floral, geometric, and/or vegetal motifs, including inscriptions in Brahmi script.

c. Medieval Period includes, but is not limited to: Gurjara-Pratihara, Pallava, and other dynastic coins or tokens with portraiture and geometric, animal, and religious motifs; Chola coins with crests of animals and weapons, mythological icons, and inscriptions in the Nagari script; Vijayanagara pagoda coins featuring Hindu deities and related symbols; Delhi Sultanate tankas and jitals with animal, religious, floral, geometric, and/or vegetal motifs and calligraphic inscriptions in various languages and scripts such as Arabic.

d. Mughal Empire or Early Modern Period includes, but is not limited to, rupiya, dam, and mohur coins primarily featuring calligraphy and literary or religious verses, but also figures and portraits of rulers, zodiac signs, birds, animals, and other icons.

(6) Statuary, Ornaments, and other Decorated Objects—Primarily in copper, gold, silver, or alloys such as bronze and brass, but can include a mix of different metals. Includes finials; free-standing and supported statuary; oil lamps; reliefs or incised plaques or roundels; stands; votive ornaments; and other ornaments. Statuary may be fashioned as humans, animals, deities, hybrid, anthropomorphic, and/or mythological figures, and/or architectural or monumental figures, miniature chariots, wheeled carts, or other objects. Statuary may take naturalized or stylized forms, may be seated, standing, dancing, and/or with other figures and symbolic imagery. Includes bases or plinths. Decorative techniques for statuary, ornaments, and other decorated objects include embossing, gilding, engraving, repoussé (relief hammering), and/or inlaying with other materials. Decorative elements may include humans, deities, animals, mythological figures, scenes of activity, floral, geometric, and/or vegetal motifs, and/or inscriptions in various languages and scripts. Imagery includes figures from secular as well as Buddhist, Jain, Hindu, Christian, Sikh, Jewish, Zoroastrian, and Hellenistic (Greek) religious traditions. Approximate Date: 4500 B.C.E.-1770 C.E.

(7) Stamps, Seals, and Tablets—Primarily cast in copper and alloys such as bronze and brass; also includes stamps and seals in gold or silver. Types include, but are not limited to, amulets, flat tablets, rings, small devices with engraving on one side, and others. Stamps and seals may have engravings that include animals, humans, deities, mythological figures; geometric, floral, and vegetal motifs, symbols, and/or inscriptions in various languages and scripts. May be inlaid with other types of material. Approximate Date: 4500 B.C.E.-1770 C.E.

Includes, but is not limited to: bas-relief elements; ceiling decoration; columns; corbels; cornices; emblems; friezes; large- and small-scale figures of animals, humans, and deities; medallions; mihrabs; niches; ornaments; panels; plaques; reliefs; roundels; stupas; tracery; tiles; vaults; window screens; wall decorations; and other architectural and non-architectural decoration or sculpture. May be painted or bear traces of paint or glaze; gilded; inlaid with stones, glass, or other materials; and/or inscribed in various languages and scripts. Stucco usually used for sculpture and panels may depict elaborate scenes of animals and human activity (such as hunting, court life, female scenes) and/or arabesque (intertwining), geometric, floral, and/or vegetal patterns. Stucco panels may have been made with molds. Unfired clay may comprise figural sculpture, such as Buddhas, bodhisattvas, or goddesses. Approximate Date: 4500 B.C.E.-1770 C.E.

Includes paintings, frescoes, murals and wall paintings, and fragments on natural stones, cave walls, building walls and ceilings, and portable media, such as paper, cloth, canvas, leather, and others.

(1) Paleolithic Era rock paintings are usually in polychrome (black, green, white, and red) media depicting stylized animals, vegetation, simple human figures, and/or geometric designs. In the Mesolithic period, depictions are more detailed, including scenes of hunting, more naturalistic animals and birds, stylized human figures, and communal activities such as dance. Approximate Date: 1.7 million years ago-4500 B.C.E.

(2) Chalcolithic Era polychrome paintings appear on ceramics and rock faces depicting more abstract geometric motifs and ideas in addition to showing tool use, artisanal design, and more ornate organized human activities. May include inscriptions from various scripts and languages. Approximate Date: 4500-1500 B.C.E.

(3) Early Historic and Historic Periods paintings comprise polychrome cave paintings and murals in various styles with landscapes, religious scenes and motifs from Hindu, Buddhist, and Jain traditions (deities, devotees, naturalistic animal and hybrid figures, mythological scenes, and others), secular designs with floral, vegetal, geometric, ornamental, and/or other stylistic motifs and scenes from court life and battles, among others. Includes paintings on cloth and manuscripts and other portable media. May include inscriptions from various scripts and languages. Approximate Date: 1500 B.C.E-550 C.E.

(4) Medieval Period paintings and murals are characterized by polychrome arabesque, floral, vegetal, sculptural, and/or geometric patterns with elaborate religious and secular depictions, as well as paintings of human figures in profile and three-quarter view. Paintings may be highly finished and detailed. May include inscriptions in various scripts and languages. Paintings may also include embedded stones, beetle wings, or gilding. Stylistically influenced by Persian and Indian artistic traditions particular to regional courts and kingdoms. Approximate Date: 550-1526 C.E.

(5) Mughal Empire or Early Modern Period wall and ceiling frescoes contain polychrome arabesque, floral, vegetal, figural, and/or geometric patterns. Human figures mostly in profile view. Paintings may be highly detailed and finished. May include inscriptions in various scripts and languages. Paintings may also include gilding and/or beetle wings. Approximate Date: 1526-1770 C.E.

(1) Non-Architectural Elements—Includes decorated and engraved panels and plaques featuring low- and high-relief carvings. May include imagery of humans and human activities, deities, animals, mythological creatures, monuments, and human activity, as well as floral, geometric, architectural, and/or vegetal motifs. May be gilded and/or painted or bear traces of paint or pigment. Includes elements with ivory and/or bone inlay or finishing. Approximate Date: 4500 B.C.E-1770 C.E.

(2) Statuary—Includes depictions of animals, vehicles or implements, humans and human activities, deity or religious figures or architectural elements ( e.g., Buddhist, Hindu, and Christian subjects), and mythological creatures. Designs may include geometric, floral, and/or vegetal decorative elements. Includes statuary that is made of ivory and bone or includes ivory and/or bone inlay or finishing. Some statuary may have ivory or bone or wooden bases. Also includes ivory model boats and barges. Approximate Date: 4500 B.C.E.-1770 C.E.

(3) Containers, Tools, Handles, and other Instruments—Includes, but is not limited to: arrowheads; awls; bowls; boxes; buckles; buttons; candleholders; caskets; combs; dagger or sword handles or hilts; embroidery tools; flasks; game dice and other game pieces; gunstocks; hooks; jewelry caskets; manuscript covers; mirrors and mirror handles; mouthpieces; musical instruments; needles; pegs; points; polishers; powder primer flasks; reliquaries; rods; rosewater or perfume sprinklers; rulers; spatulas; spindles; stoppers; styluses and writing implements; trays and platters utensils; and other personal objects made of ivory and bone or includes ivory and/or bone inlay or finishing. May be incised, gilded, and/or painted with decorative motifs, inlaid with other materials, carved in relief, carved in zoomorphic shapes, and/or inscribed in various languages and scripts. Approximate Date: 4500 B.C.E.-1770 C.E.

(4) Furniture and Furniture Elements—Includes objects made entirely from or that contain elements of bone or ivory. Furniture types include, but are not limited to: beds; boxes; brackets; cabinets; chairs; chests; couches; finials; footstools; handles; lamps and lampshades; tables; trunks, and other types of furniture. Furniture elements include, but are not limited to: arms; feet; inlays; legs and throne legs; and panels. Includes objects that have ivory and/or bone inlay or finishing. Approximate Date: 4500 B.C.E.-1770 C.E.

(5) Jewelry and Ornaments—Types include, but are not limited to: bangles; beads; buckles; chains; combs; hairpins; pendants; pins; rings, and other objects made of ivory and bone or include ivory and/or bone inlay or finishing. Includes inlay and works that are gilded, painted, or combined with other materials. Approximate Date: 4500 B.C.E.-1770 C.E.

(6) Stamps and Seals—Bone and ivory seals and stamps include button-shaped, cylindrical, architectural, square, among other shapes. May be engraved with animals, humans, deities, architectural, mythological, geometric, floral, and/or vegetal designs, symbols, and/or inscriptions in various languages and scripts. Approximate Date: 4500 B.C.E.-1770 C.E.

(1) Architectural Elements—Includes mosaics, panes, stained glass, and tiles with various colors and designs, including geometric, floral, mythological, scenic, and/or vegetal motifs on architectural surfaces or in windows. Includes secular and religious imagery. Includes glass inlay used in architectural elements. Glass may be mirrored or stained. Approximate Date: 1500 B.C.E.-1770 C.E.

(2) Beads and Jewelry—Includes beads in the form of animals, cylinders, cones, discs, spheres, and other shapes. Decorations may include bevels, incisions, and/or raised decoration. Glass beads may be used to adorn clothing, jewelry, ornaments, idols, or other figures. Includes glass inlay used in other types of beads, jewelry, and decorated items. Includes stamp seals or gems incised with decorative and/or figural designs. Includes beads with silver-plated caps, enamel, and other materials. Approximate Date: 4500 B.C.E.-1770 C.E.

(3) Vessels—Vessel types include, but are not limited to: conventional shapes such as beakers; bottles; bowls; cups; dishes; flasks; goblets; jars; mugs; perfume bottles; plates; and vases, and other forms such as cosmetic containers; lamps; medicine droppers; reliquaries; and others. Some vessels may be formed in molds, stamped, or using mosaic techniques. May be monochrome or polychrome. Approximate Date: 4500 B.C.E.-1770 C.E.

(4) Ornaments—Includes glass bangles, mirrors, and figurines. May have molded and/or inlaid decorations including, but not limited to, animals, humans, geometric, floral, and vegetal motifs. Approximate Date: 4500 B.C.E.-1770 C.E.

(1) Books and Manuscripts—Includes scrolls, sheets, bound volumes and their bindings, playing cards and other small items, as well as fragments and portions. May be inscribed on materials such as, but not limited to: birch bark; handmade paper, cloth or fabric; palm-leaf; parchment; and vellum. May be gathered into bindings, albums, and folios composed of leather, wood, cloth, paper, and/or paste or pulp board. May use ink, paint, and/or metals (gold and silver). Bindings may be decorated with paint, lacquer, and/or inlay; may be gilded, engraved, tooled, impressed, inscribed, and/or stamped. May have monochrome, bichrome, polychrome, and/or gold handmade decorations, decoupage and stenciled motifs, illustrations, and/or hand-made illuminations, such as decorative borders, margins, frames, medallions, cartouches, frontispieces or headpieces, paintings, panels, or scientific, astronomical, artistic, or mathematical diagrams. Decorative elements include arabesque (intertwining), geometric, floral, mythological, and/or vegetal motifs. Base media may be tinted, marbleized, embellished, and/or flecked with gold or paint. Illustrations and illuminations may depict animals, plants, human figures, hybrids, religious iconography, and portraiture; landscapes and architectural scenes; and/or scenes of human activities, such as court audiences and ceremonies, encounters, hunting, falconry, battles, travel, and historical, religious, mythological, or legendary events or scenes. Includes secular and religious texts. Texts may be written in various scripts, calligraphies, and languages. Scripts include, but are not limited to, Arabic, Bactrian, Brahmi, Devanagari, Gandhari, Gupta (or Gupta Brahmi or Late Brahmi), Gurmukhi, Kadamba, Kharoshti, Landa, Nagari (or Eastern Nagari or Bengali-Assamese), Odia, Pallava (or Pallava Grantha or Grantha), Persian, Sharada (also spelled Sarada), Siddham (or Siddhamatrka), Tamil, Tibetan, Vatteluttu (also spelled Vattezhuthu), as well as any dialectic sub-branches of script. Languages include, but are not limited to, Assamese, Bengali, Chakma, Dogri, Gujarati, Harappan, Hindi, Kannada, Kashmiri, Konkani, Maithili, Malayalam, Meithei/Manipuri, Marathi, Nepali, Newari/Nepal Bhasa, Odia, Pali, Prakrit, Punjabi, Sanskrit, Tamil, Telugu, and Urdu. Topics include, but are not limited to, astronomy, astrology, biography, botany, civic matters, court proceedings, edicts, genealogy, history, law and legislation, letters and other correspondence, literature, mathematics, medicine, memoir, musical or artistic works or treatises, natural and hard sciences, philosophy, poetry, records of any kind, religious scriptures and epics, theology, trade, and travel. Approximate Date: 1500 B.C.E.-1770 C.E.

(2) Items of Personal Adornment—Primarily in leather, including arm bands, bracelets, earrings, necklaces, and other types of jewelry; belts; headpieces; sandals; sheaths; shoes; vests; and other types of clothing. May be embroidered, stamped, or embellished with other materials. Leather goods may also be used in conjunction with other textiles. Approximate Date: 1500 B.C.E.-1770 C.E.

(3) Weapons and armor—Primarily in leather, including: armor; bow cases; quivers; saddles; sheaths; and ornaments for humans and cavalry animals, such as horses, camels, and elephants.

Includes cotton, silk, flax, wool, linen, hemp, and other woven materials used in, but not limited to: artistic or theatrical costumes; basketry and other household goods; burial shrouds; carpets; clothing, shawls, hats, shoes, jewelry, and items of personal adornment; decorative hangings, covers, or carpets; sheaths; tent coverings, tent hangings, blankets, covers, and other domestic textiles; textiles specific to religious rituals or practice; textiles intended to decorate cattle; and others. Textile patterns may be undecorated, decorated, or may be woven into the body of the textile. Textiles may be dyed, stamped, painted, quilted, and/or embroidered, including embroidery with metal (gold and/or silver) threads or ribbons, mirrors, gems, or others. Decorative elements may include stylized or naturalistic animal, geometric, vegetal, floral, human, and/or mythological motifs as well as inscriptions in various languages and scripts. Approximate Date: 4500 B.C.E.-1770 C.E.

(1) Architectural Elements—Wooden elements primarily in teak, walnut, blackwood, rosewood, sandalwood, mahogany, ebony, mango, jackfruit, and neem, but includes other types of wood. Category includes, but is not limited to: arches; balconies; balustrades; bases; beams; benches; brackets; columns; dentils; doors and door frames; eaves; finials; floors and floor boards; friezes; gables; gates; latches; lamps; lintels; jambs; mihrabs; minbars; ornamental freestanding archways or gateways; palisades; panels; partitions; posts; rafters; roofs and related elements; screens and lattices; shutters; stilts; swings; window frames and fittings; or pieces of architectural objects. Architectural elements may be plain, painted, carved, incised, inlaid, lacquered, and/or inscribed in various languages and scripts. May include relief carvings and/or inlay. Decorative elements may include depictions or motifs from secular as well as religious traditions, including animals, human figures, hybrids, mythological forms, vegetation, and stylized and/or geometric designs. Approximate Date: 1500 B.C.E.-1770 C.E.

(2) Non-Architectural Elements—Wooden elements primarily in sandalwood, walnut, rosewood, teak, blackwood, mahogany, but includes other types of wood. Category includes, but is not limited to: animal husbandry and agricultural objects such as ploughs, scythes, yokes, and others; bookstands; boxes; chests; coffins; figurines and statues; finials; furniture; jewelry and other items of personal adornment; lamps; musical instruments; stamps and seals with engraved designs and/or inscriptions in various languages and scripts; toys and game pieces; vessels and containers; weapons, such as arrows, bows, clubs, harpoons, hilts and sheaths, shields, spears; and others objects. May include relief carvings and/or inlay. Jewelry and ornaments made of shell, mother-of-pearl, pearl, resin, seeds, shells, tusks, and other organic material, may include, but are not limited to: anklets; arm bands; bangles; beads; bracelets; cones; earrings; headpieces and hair ornaments; inlays; necklaces; pendants; rings; studs; and other types. Vessels made of shell or set with mother-of-pearl panels may include, but are not limited to: bowls; ewers; ladles; libation vessels; plates; trays; utensils; and others. Decorative elements may include depictions or motifs from secular as well as religious traditions, including animals, human figures, hybrids, mythological forms, vegetation, and stylized and/or geometric designs. Non-architectural elements may be plain, painted, carved, incised, inlaid, lacquered, and/or inscribed in various languages and scripts. Approximate Date: 1500 B.C.E.-1770 C.E.

(3) Statuary and figurines—Can be of wood, ivory, shell, tusk, mother-of-pearl, pearl, and other organic materials. Examples may include stylized and/or naturalistic depictions of human, animal, hybrid, mythological, abstract, and/or vegetal motifs from secular as well as Hindu, Buddhist, Jain, Sikh, Christian, Jewish, and Zoroastrian religious traditions. Statuary may be polished, painted, inlaid, gilded, incised, and/or lacquered. Approximate Date: 1500 B.C.E.-1770 C.E.

Includes human remains, fragments of human remains, and fragments of hominin remains. Includes skeletal remains, soft tissue, and ash from the human body that may be preserved in burials, reliquaries, and other contexts. Approximate Date: 1.7 million years ago-1770 C.E.

Ethnological material in the Designated List includes civic, religious, and royal architectural materials, religious material and ceremonial items, and manuscripts ranging in date from 2nd century B.C.E. to 1947 C.E.

Architectural materials include non-industrial and/or handmade elements of civic, religious, and royal architecture, such as material from forts, mausoleums, and palaces. They may be made of stone, ceramic or terracotta, plaster and stucco, glass, and/or wood, and painted media. Approximate Date: 2nd century B.C.E.-1924 C.E.

(1) Stone—Primarily in sandstone, limestone, marble, granite, basalt, slate, schist, quartzite, and khondalite, but includes other types of stone. Includes altars; arches; balustrades; benches; brackets; bricks and blocks from walls, ceilings, and floors; columns, including capitals and bases; corbels; cornices; dentils; disks, including amalakas and chattras; domes; door frames, portals, and jambs; false gables; finials and spires; fountains and fountainheads; friezes; gates and freestanding archways; lintels; merlons; mihrabs; minarets; mosaics; niches; panels; pavilions, including semi-open domed pavilions ( chatris/chhatris ); pilasters; pillars, including capitals and bases; plinths; portable shrines; railings; reliefs; ringstones; stupas; tiles; tombstones; vaults; window screens and lattices ( jalis ); and others. May be plain, carved in relief, incised, inlaid, or inscribed in various languages and scripts. May be painted, polished, and/or gilded. May include relief sculptures, mosaics, and inlays that were part of civic, religious, and/or royal architecture, such as friezes, panels, or figures in the round. Imagery may be civic or religious. Mosaic and architectural designs include depictions of animal, human, religious, floral, vegetal, geometric, mythological, and/or calligraphic motifs.

(2) Ceramic and Fired Clay—Includes terracotta (fired clay) arches; brackets; bricks; columns, including capitals and bases; niches; panels; pipes; reliefs; shrines; tiles; window screens and lattices ( jali s), and others used as decorative elements in civic, religious, and royal architecture. Bricks may be cut or molded to form decorative patterns on building exteriors. Mosaic designs include animal, human, religious, calligraphic, and geometric, floral, and/or vegetal motifs. Panels and tiles may be painted, plastered, stuccoed, or have traces of paint or plaster. Tiles may be square, polygonal, or specifically shaped, and may be carved, incised, impressed, or molded with decorations in the form of animal, human, religious, geometric, arabesque (intertwining), floral, and/or vegetal motifs, and/or calligraphic writing in various scripts and languages, and/or then glazed. Glaze may be clear, monochrome, and/or polychrome.

(3) Plaster and Stucco—Includes ceiling decoration; columns; corbels; cornices; friezes; large- and small-scale figures of animals, humans, and deities; mihrabs; niches; ornaments; panels; plaques; reliefs; roundels; shrines; small-scale architectural elements; stupas; tracery; vaults; window screens; and other types. May be painted or bear traces of paint; glazed; gilded; inlaid with stones or other materials; and/or inscribed in various languages and scripts. Designs may include arabesque (intertwining), geometric, floral, and/or vegetal patterns. May have been made using molds.

(4) Paintings and Frescoes—Includes paintings, murals, frescoes on civic, religious, and royal building walls and ceilings, and fragments thereof. Frescoes with polychrome arabesque (intertwining), floral, vegetal, sculptural, geometric and/or calligraphic patterns and inscriptions are typical of the Historic Period through the Mughal Period. Jain and Hindu temples, Mughal palaces, and Sikh gurdwaras are sometimes adorned with frescoes depicting human and animal figures and scenes, as well as floral, vegetal, religious, and geometric motifs. Approximate Date: 2nd century B.C.E.-1947 C.E.

(5) Glass—Includes glass panes, stained glass, and pieces or tiles arranged in mosaic fashion to create geometric, floral, religious, and/or vegetal designs on architectural surfaces or in windows. Glass may be mirrored or stained. Includes glass inlay.

(6) Wood—Includes hand-carved altars; arches; balconies; balustrades; bases; beams; benches; brackets; columns, including capitals and bases; dentils; doors and door frames; eaves; friezes; gables; gates; latches; lamps; lintels; jambs; mihrabs; minbars; ornamental freestanding archways or gateways; palisades; panels; partitions; posts; roofs and related elements; screens and lattices; shrines; shutters; stupas; swings; window frames and fittings; or parts thereof, used as structural elements in and/or to decorate civic, religious, and royal architecture. These architectural elements may have been reused for new purposes, such as a wood panel used as a table, or a door jamb used as a bench. May be painted, carved, incised, inlaid, lacquered, and/or inscribed in various languages and scripts. Includes relief carvings and/or inlay.

Includes non-industrial and/or handmade moveable objects typically associated with use in religious and ceremonial settings, such as temples, mosques, communal shrines, monasteries, synagogues, gurdwaras, churches, funerary areas and cemeteries. Includes, but is not limited to, objects from Hindu, Buddhist, Jain, Sikh, Christian, Jewish, and Zoroastrian religious traditions. Primarily in stone, metal, ceramic or clay, glass, wood, bone, ivory, textiles, leather, and other organic materials. Approximate Date: 7th century B.C.E.-1924 C.E.

(1) Furniture, Sculpture, and Ceremonial Objects—Includes non-architectural objects used in communal religious and ceremonial settings. Examples include decorated Quran stands in mosques; Jain altarpieces; sculpture from Hindu temple fragments or idols used in regular or special religious ceremonies. Primarily in stone (especially limestone, marble, sandstone, basalt, and others), metal (especially copper, bronze, and brass), wood, bone, and ivory. Types include, but are not limited to: altars; baldachins; basins; bells (freestanding and affixed); biers; bookstands; candelabras; canopies; chandeliers; funerary headstones and monuments; grills; lecterns; libation platforms; palanquins and processional chariots; mihrabs; minbars; pillars; plaques; portable shrines; screens; statues and idols; and stelae. May be polished, gilded, carved in relief, painted, incised, inlaid, or inscribed in various languages and scripts. Decorative elements may include floral, geometric, vegetal, and/or arabesque (intertwining) motifs, as well as animal, mythological, divine, architectural, and/or human figures in various poses.

(2) Vessels and Containers—Includes vessels and containers of particular significance used in communal religious and ceremonial settings in stone, metal (especially silver, iron, copper, bronze, steel, brass, and other alloys), ceramic, glass, wood, bone, ivory, leather, lacquer papier-mâché, and other materials. Types include, but are not limited to: boxes; bowls; caskets, urns, and coffins (and their contents); ceremonial trays or plates; ritual flasks and jars; incense burners and braziers; prayer lamps; reliquaries (and their contents); and scroll, book, or manuscript containers. May be polished, gilded, painted, incised, inlaid, covered in cloth or other materials, or inscribed in various languages and scripts. Decorative elements may include floral, geometric, vegetal, and/or arabesque (intertwining) motifs, as well as animal, mythological, divine, architectural, and/or human figures in various poses.

(3) Textiles—Includes textiles used for religious and ceremonial purposes, primarily in cotton, silk, flax, wool, linen, hemp, animal hair. Types include, but are not limited to: banners; covers for notable sacred texts; parasols; sacred garments for religious idols or icons; shrine covers; and shrouds and casket covers. May be dyed, stamped, painted, quilted, and/or embroidered, including embroidery with metal (gold and/or silver) threads or ribbons, mirrors, gems, or others. Decorative elements may include floral, geometric, vegetal, and/or arabesque (intertwining) motifs, as well as animal, mythological, divine, architectural, and/or human figures in various poses. May be inscribed in various languages and scripts.

(4) Ornaments—Includes ornaments used in specific communal religious or ceremonial functions or settings. Primarily in metal, wood, ceramic, leather, bone, ivory, glass, and other organic material. Types include, but are not limited to: amulets; conches and antelope horns; crowns; daggers and blades; hair pieces and ornaments; headgear, headpieces, and assorted regalia; jewelry such as arm bands, necklaces, pendants, rings, earrings, bracelets, and bangles for decorating religious figures or icons; masks for ceremonial or ritual use; paintings and effigies; prayer beads. May be polished, gilded, carved, painted, incised, inlaid, or inscribed in various languages and scripts. Decorative elements may include floral, geometric, vegetal, and/or arabesque (intertwining) motifs, as well as animal, mythological, divine, architectural, and/or human figures in various poses.

(5) Musical Instruments—Includes musical instruments used in specific communal religious or ceremonial functions or settings. Primarily in wood, metal, leather, ceramic, bone, and other organic material. Types include, but are not limited to: brass; conches; gongs; harmoniums; percussive; strings; and winds. May be polished, gilded, carved, painted, incised, inlaid, or inscribed in various languages and scripts. Decorative elements may include floral, geometric, vegetal, and/or arabesque (intertwining) motifs, as well as animal, mythological, divine, architectural, and/or human figures in various poses.

(6) Modified Human Remains—Includes skeletal remains and soft tissue that may be combined with other material and/or non-human remains. Well known examples include Naga tribal trophy skulls, which consist of a composite of human skulls and animal horns or antlers bound together with leather, rope, or palm fibers and may include other decorative elements, such as feathers and snakeskin.

Includes non-industrial and/or handmade, handwritten, hand-illustrated, and illuminated scrolls, sheets, and bound volumes important to the cultural heritage of a community, people, belief system, or literary or artistic tradition. Examples include original royal court or government documents, original folios or treatises or musical scores, including illustrations that may be unbound (not to be confused with miniature paintings), first editions of books, and sacred texts of particular historical significance. May be made from various media, such as paper, palm-leaf, parchment, vellum, birchbark, cotton, or cloth. May be bound in leather, hide, cloth, or wood. Texts may be written in various languages and scripts, such as Arabic, Assamese, Bengali, Chakma, Devanagari, Dogri, Gandhari, Gujarati, Hindi, Kannada, Kharoshti, Kashmiri, Konkani, Maithili, Malayalam, Meithei/Manipuri, Marathi, Nepali, Newari/Nepal Bhasa, Odia, Pali, Prakrit, Punjabi, Sanskrit, Sharada (also spelled Sarada), Tamil, Telugu, Tibetan, and Urdu. May include sacred texts from Hinduism, Islam, Jainism, Buddhism, Sikhism, Christianity, Judaism, and Zoroastrianism. Other topics include, but are not limited to, art, astrology, astronomy, ayurveda, botany, games, history, linguistics, literature, mathematics, medicine, music, poetry, religion, sciences, and/or theology. May be embellished or decorated with monochrome, bichrome, or polychrome handmade illustrations and/or illuminations. These may include arabesque (intertwining), geometric, floral, or vegetal motifs; images of animals, plants, deities, and humans, including portraiture; landscapes; and/or scenes of human activities, such as courtly gatherings and ceremonies, hunting, falconry, battles, and historical, mythological, or legendary events. Approximate Date: 7th century B.C.E.-1947 C.E.

This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure under 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).

Executive Order 12866 (Regulatory Planning and Review) directs agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). CBP has determined that this document is not a regulation or rule subject to the provisions of Executive Order 12866 because it pertains to a foreign affairs function of the United States, as described above, and therefore is specifically exempted by section 3(d)(2) of Executive Order 12866.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, requires an agency to prepare and make available to the public a regulatory flexibility analysis that describes the effect of a proposed rule on small entities ( i.e., small businesses, small organizations, and small governmental jurisdictions) when the agency is required to publish a general notice of proposed rulemaking for a rule. Since a general notice of proposed rulemaking is not necessary for this rule, CBP is not required to prepare a regulatory flexibility analysis for this rule.

In accordance with Treasury Order 100-20, the Secretary of the Treasury delegated to the Secretary of Homeland Security the authority related to the customs revenue functions vested in the Secretary of the Treasury as set forth in 6 U.S.C. 212 and 215, subject to certain exceptions. This regulation is being issued in accordance with DHS Directive 07010.3, Revision 03.2, which delegates to the Commissioner of CBP the authority to prescribe and sign regulations related to cultural property import restrictions.

Rodney S. Scott, Commissioner, having reviewed and approved this document, has delegated the authority to electronically sign this document to the Director (or Acting Director, if applicable) of the Regulations and Disclosure Law Division of CBP, for purposes of publication in the Federal Register .

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:

Subject to OSMRE's oversight, section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations. See 30 U.S.C. 1253(a)(1) and (7).

Based on these criteria, the Secretary of the Interior conditionally approved the West Virginia program on January 21, 1981. You can find background information on the West Virginia program, including the Secretary's findings, the disposition of comments, and conditions of approval of the West Virginia program in the January 21, 1981, Federal Register (46 FR 5915). You can also find later actions concerning the West Virginia program and program amendments at 30 CFR 948.10, 948.12, 948.13, 948.15, and 948.16.

By letter dated August 23, 2021 (Administrative Record No. 1658), we required the West Virginia Department of Environmental Protection (WVDEP) to submit a program amendment that ensures appropriate tracking of existing reclamation liabilities (including water treatment) at coal mining operations. This tracking must ensure that information about existing reclamation liabilities is accurate and up-to-date and must enable an accurate assessment of the solvency of the State's Special Reclamation Fund and the Special Reclamation Water Trust Fund. To comply with our request, the West Virginia Legislature passed a revision to WVSCMRA contained in House Bill 4758 of 2022 (H.B. 4758) (approved March 28, 2022). See 2022 W. Va. Acts ch. 130. H.B. 4758 amends section 22-3-11(i)(2) of WVSCMRA, W. Va. Code 22-3-11(i)(2), to require WVDEP to develop and maintain a database to track existing reclamation liabilities, including water treatment, at coal mining operations in the state of West Virginia that were permitted after August 3, 1977, and for which the SCMRA permit has yet to be completely released.

By letter dated March 29, 2022 (Administrative Record No. 1666), West Virginia sent us the amendment to its program under SMCRA, which we docketed as WV-128-FOR. We announced receipt of the proposed amendment in the May 23, 2023, Federal Register (88 FR 33025) (Administrative Record No. 1670). This can be viewed at www.regulations.gov by searching the Docket ID Number OSM-2022-000 or SATS No. WV-128-FOR.

In the same notice, we opened a public comment period and provided an opportunity for a public hearing on this provision. The public comment period closed on June 22, 2023. We did not hold a public hearing or meeting because one was not requested. Letters were sent to various Federal agencies requesting comments (Administrative Record No. 1618), but none were received.

In the January 12, 2024, Federal Register (89 FR 2133), we deferred our decision on West Virginia's proposal (WV-125-FOR) to delete provisions from W. Va. Code 22-3-11(g)(2) regarding the development of a long-range planning process for the selection and prioritization of sites to be reclaimed. Id. at 2134-35 and 2138 (codifying our deferral at 30 CFR 948.12(k)(1)). Likewise, in the March 18, 2024, Federal Register (89 FR 19262), we did not approve West Virginia's proposal (WV-126-FOR) to delete from its regulations subsections a. and e. of CSR 38-2-12.5, which direct WVDEP's collection, analysis and reporting on sites where bond has been forfeited, including data relating to the quality of water being discharged from the forfeited sites. Id. at 19270-71 and 19273 (codifying our decision at 30 CFR 948.12(k)(10), later corrected to (l)(10) by notice in the Federal Register on January 17, 2025 (90 FR 5628). With West Virginia's submission of WV-128-FOR, we will revisit these proposed changes to the West Virginia program.

We are approving the revisions proposed in WV-128-FOR as described below, as well as those revisions initially proposed in WV-125-FOR and WV-126-FOR. The following are our findings concerning West Virginia's amendment under SMCRA and the Federal regulations at 30 CFR 730.5, 732.15 and 732.17.

New subparagraph (C) of W. Va. Code 22-3-11(i)(2) requires the Secretary of the WVDEP to develop and maintain a database to track existing reclamation liabilities, including water treatment, at coal mining operations in West Virginia that were permitted after August 3, 1977, and for which the SCMRA permit has yet to be completely released. The proposed addition also requires that this information be updated on a quarterly basis beginning July 2022 to ensure that actuarial studies of the special reclamation fund and special reclamation water trust fund are based on current data.

OSMRE Findings: In our August 23, 2021, letter to WVDEP, we acknowledged the complexity and potential impacts of bond forfeitures on the West Virginia-approved State program, particularly on the solvency of WVDEP's financial assurance program, which ensures funds are available to carry out reclamation responsibilities if a permittee is no longer able to do so. We also indicated that the West Virginia program had not taken sufficient steps to ensure the compilation of complete and accurate estimations of all outstanding reclamation obligations on active permits.

SMCRA requires that, before issuing a SMCRA permit, an applicant must obtain a bond that is “sufficient to assure the completion of the reclamation plan if the work had to be performed by the regulatory authority in the event of forfeiture.” 30 U.S.C. 1259(a). The West Virginia program has historically relied on two principal sources of funding to ensure that sufficient funds are available for reclamation: financial assurances backed by third-party providers ( e.g., surety bonds) and two State funds—the State's Special Reclamation Fund (SRF) and Special Reclamation Water Trust Fund (SRWTF), which are funded mostly through a reclamation tax on coal produced in the State.

Through our recent review with WVDEP of the West Virginia financial assurance program, we determined that the West Virginia program contained the same or similar deficiencies that we described in our approval of various amendments to West Virginia's program in the May 29, 2002, Federal Register (67 FR 37610) (Administrative Record Number 1308). Our 2002 approval relied on the justification that WVDEP's methods for collecting and maintaining this information would improve and that the amendments would provide the recently created Special Reclamation Fund Advisory Council (Advisory Council), auditors, and ultimately the West Virginia Legislature with accurate and up-to-date information regarding the extent of reclamation obligations that could fall to the State. However, our recent review revealed that the program required additional improvements and that various deficiencies had since been raised between WVDEP and the Advisory Council but had not been corrected. We elaborated in our August 23, 2021, letter to DEP that the programmatic deficiencies may have resulted in leaving unfunded environmental liabilities that may not have been discovered until after forfeiture.

The information from existing permits and bond forfeited permits must be up-to-date and accurate to adequately inform the Advisory Council's projections and recommendations. The accuracy of that information is also vital to our joint review of the West Virginia program, as well as our ultimate ability to determine whether the West Virginia program complies with 30 CFR 800.11(e)(1), which provides that OSMRE may approve a State's alternative bonding system only if it assures “that the regulatory authority will have available sufficient money to complete the reclamation plan for any areas which may be in default at any time.” Therefore, we had determined, in accordance with 30 CFR 732.17(c), that West Virginia was required to submit a program amendment to ensure tracking of existing reclamation liabilities (including water treatment) at mining operations. We also explained that this improvement to tracking liabilities must reflect revisions or changes to the activities occurring at relevant sites and occur with such frequency that the actuarial studies are informed by current data.

The addition of subparagraph (C) to W. Va. Code 22-3-11(i)(2) effectively supersedes what the West Virginia program had attempted to accomplish through the existing provision at W. Va. Code 22-3-11(g)(2) and its implementing regulations at CSR 38-2-12.5. Section 22-3-11(g)(2) of WVSCMRA previously required WVDEP to develop a long-range planning process for the selection and prioritization of bond forfeiture sites for reclamation, and CSR 38-2-12.5 required, among other things, that WVDEP create an inventory of all bond forfeiture sites and report annually to the West Virginia Legislature data regarding acid mine drainage at these sites. Unlike these existing provisions, West Virginia's current amendment focuses not simply on the list of bond forfeiture sites and the associated reclamation liabilities but also on the current SMCRA permits and the reclamation liabilities that those mines entail. Reclamation liability, as we have used that term with respect to the West Virginia ABS, constitutes the cost to the State to complete reclamation, including the cost of water treatment, where necessary. See 60 FR 51900, 51903 (Oct. 4, 1995) (disapproving West Virginia provision imposing special reclamation tax only when bond forfeiture liabilities of the State exceed assets of the Special Reclamation Fund); 66 FR 67446, 67450 (Dec. 28, 2001) (discussing same). This amendment also specifies that the information in the inventory is to be updated quarterly. Tracking reclamation liability in a way that ensures that the cost to the State is informed and up-to-date necessarily requires tracking several different factors, including existing site conditions and the type of work that remains to be performed, the quality and nature of discharges, if any, and capital, operating, and maintenance cost of any anticipated treatment measures. All of these factors may change over time and affect the overall liability. See also CSR 38-2-12.5 (discussing various factors relevant in determining site specific bond amounts). For these reasons, this amendment is an improvement from the existing provisions and provides clearer benchmarks the State must meet regarding the collection, tracking, and reporting of information in its inventory of SMCRA permits and the liabilities on all Title V related bond forfeiture sites. We are approving this provision with the understanding that WVDEP will make the database available to the public consistent with its State open records laws and that WVDEP will use the database to report annually to the Advisory Council, which, in turn, satisfies its obligations under W.Va. Code 22-1-17 by reporting to the Governor and the West Virginia Legislature.

In the January 12, 2024, Federal Register (89 FR 2133), we deferred our decision on West Virginia's proposed deletion of language from W. Va. Code 22-3-11(g)(2) that had required the development of a long-range planning process for the selection and prioritization of sites to be reclaimed to avoid inordinate short-term obligations of the fund's assets of such magnitude that the solvency of the fund was jeopardized. Relying on the same reason that they comprise a necessary component of fulfilling the requirements of an alternative bonding system— i.e., the ability to compile, review, and report data relevant to the financial health of the system on a regular basis, we also did not approve West Virginia's proposed deletion of its implementing regulations at CSR 38-2-12.5, particularly subsection a., which required the Secretary of WVDEP to create an inventory of all sites for which bonds had been forfeited, and subsection e., which required the Secretary of WVDEP to submit a detailed annual report to the West Virginia Legislature of acid mine drainage from bond forfeiture sites. See 89 FR 19262, 19270-71 (Mar. 18, 2024). In light of our approval of W.Va. Code 22-3-11(i)(2)(C) above, we are now revisiting those decisions.

OSMRE's Findings: West Virginia's long-range planning process for selection and prioritization of sites to be reclaimed has been addressed by us in previous decisions, specifically in the Federal Register notices of October 4, 1995, (60 FR 51900) and May 29, 2002, (67 FR 37610). In both instances, we explained in detail that for West Virginia's Special Reclamation Fund and its Special Reclamation Water Trust Fund to remain solvent requires an inventory of sites requiring reclamation. Without this inventory, it is virtually impossible for the Special Reclamation Advisory Council to accurately assess the liabilities that would be included in its alternative bonding system. We further emphasized this fact in our letter to the WVDEP dated August 23, 2021, (Administrative Record No. 1659). On March 29, 2022, WVDEP submitted WV-128-FOR, discussed above, to develop and maintain a database to track all Title V liabilities of SMCRA permits and bond forfeiture sites to better inform the management and operation of the WVDEP's Special Reclamation Program (Administrative Record No. 1666). Because we are approving West Virginia's creation and maintenance of an inventory to track reclamation liabilities, including water treatment, we find that the long-range planning process is no longer necessary to ensure the sufficiency of West Virginia's alternative bonding system. Therefore, we approve the deletion of that language from W.Va. Code 22-3-11(g)(2). Likewise, because reclamation liabilities entail the cost to the State of completing the reclamation plans and, therefore, necessarily include tracking several factors relevant to cost in addition to water quality, we find the provisions at CSR 38-2-12.5.a and e are no longer necessary and approve their deletion.

We asked for public comments on the amendment and received a letter from Appalachian Mountain Advocates (AMA) dated June 22, 2023 (Administrative Record No. 1671), as counsel for the Sierra Club and the West Virginia Highlands Conservancy (together, Community Groups).

AMA states in its letter that the Community Groups are concerned that the amendment is “insufficient to ensure compliance with SMCRA implementing regulations.” The Community Groups raised concerns that the amendment does not provide West Virginia or OSMRE with enough detail to make an informed determination that West Virginia will have sufficient money to complete any reclamation plan for any areas that may be in default at any time. The Community Groups requested that OSMRE require two additional points—first, that WVDEP make the database publicly available online, and second, that WVDEP makes a written determination and analysis, based on the database, on January 1 of each year about whether West Virginia Special Reclamation Fund and Special Reclamation Water Trust Fund have sufficient funds to complete the reclamation plan for any areas which may be in default at that time. The Community Groups further assert that their concerns are exacerbated by a lack of indication by WVDEP that it has completed its database and by certain actions or omissions by the Advisory Council in its annual report filed January 1, 2023.

First, while SMCRA does dictate the manner in which certain records are made available to the public, see, e.g., 30 CFR 700.14, 840.14 and 842.16 (availability of records), it does not generally supersede State open records laws, which would cover the availability of the database. Thus, we are approving this provision with the understanding that WVDEP will make information from the database available to the public in a manner that is, at a minimum, consistent with West Virginia's open records law at W. Va. Code 29B-1-1 et seq. and that WVDEP will use the database to report annually to the Advisory Council, which, in turn, will report to the Governor and the West Virginia Legislature.

Second, although we understand the commenter's concern, we decline to require an annual written determination by WVDEP as to the sufficiency of the West Virginia Special Reclamation Fund and the Special Reclamation Water Trust Fund. When conducting our oversight, we rely on the actuarial reports, the Advisory Commission reports, and our regular inspections, and other activities to determine whether West Virginia's alternative bonding system is capable of satisfying the requirements of 30 CFR 800.11. While a finding, such as the commenter's suggest, may provide additional information for our oversight, that requirement is not contained within the statutory text submitted to us by West Virginia; thus, we cannot approve or disapprove such a requirement and the lack of such a requirement does not make the proposed amendment not in accordance with SMCRA or inconsistent with the Federal regulations. Our subsequent oversight of West Virginia's implementation of the database will focus on the accuracy of the data, the solvency of the Funds, and whether any future amendments may be necessary.

On April 12, 2022, under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA or 884.14(a)(2) and 884.15(a), we requested comments on the amendment from various Federal agencies with an actual or potential interest in the West Virginia program (Administrative Record No. 1672). We did not receive any comments.

Under 30 CFR 732.17(h)(11)(ii), we are required to get a written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). None of the revisions West Virginia proposed in this amendment pertain to air or water quality standards. Therefore, we did not ask the EPA to concur on the amendment.

Under 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On April 12, 2022, we requested comments on West Virginia's amendment (Administrative Record No.1672). We did not receive comments.

Based on the above findings, we find that the proposed amendment is in accordance with SMCRA and consistent with the Federal regulations, and we are approving this amendment to the West Virginia regulatory program under WVSCMRA, sent to us on March 29, 2022 (Administrative Record No. 1666). We are approving this provision with the understanding that WVDEP will make information from the database available to the public consistent with State open records laws and use such information to report annually to the Advisory Council, which in turn reports to the West Virginia Governor and the West Virginia Legislature. We are also approving West Virginia's deletion of language from W. Va. Code 22-3-11(g)(2) and CSR 32-2-12.5.a and 12.5.e, which we did not approve from amendments docketed at WV-125-FOR and WV-126-FOR, respectively, in anticipation of reviewing those revisions in concert with the current amendment. To implement this decision, we are amending the Federal regulations at 30 CFR part 948 that codify decisions concerning the West Virginia program. In accordance with the Administrative Procedure Act, this rule will take effect 30 days after the date of publication.

This rule would not result in a taking of private property or otherwise have taking implications that would result in private property being taken for government use without just compensation under the law. Therefore, a takings implication assessment is not required. This determination is based on an analysis of the Federal regulations that set minimum performance standards for alternative bonding systems.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB) will review all significant rules. Pursuant to OMB guidance dated October 12, 1993 (OMB Memo M-94-3), the approval of State program amendments is exempted from OMB review under Executive Order 12866. Executive Order 13563, which reaffirms and supplements Executive Order 12866, retains this exemption.

The Department of the Interior has reviewed this rule as required by section 3 of Executive Order 12988. The Department determined that this Federal Register document meets the criteria of section 3 of Executive Order 12988, which is intended to ensure that the agency review its legislation and proposed regulations to eliminate drafting errors and ambiguity; that the agency write its legislation and regulations to minimize litigation; and that the agency's legislation and regulations provide a clear legal standard for affected conduct rather than a general standard, and promote simplification and burden reduction. Because section 3 focuses on the quality of Federal legislation and regulations, the Department limited its review under this Executive Order to the quality of this Federal Register document and changes to the Federal regulations. The review under this Executive Order did not extend to the language of the State regulatory program amendment that West Virginia drafted.

This rule has potential Federalism implications as defined under section 1(a) of Executive Order 13132. Executive Order 13132 directs agencies to “grant the States the maximum administrative discretion possible” with respect to Federal statutes and regulations administered by the States. West Virginia, through its approved regulatory program, implements and administers SMCRA and its implementing regulations at the State level. This rule approves an amendment to the West Virginia program submitted and drafted by the State and thus is consistent with the direction to provide maximum administrative discretion to States.

The Department of the Interior strives to strengthen its government-to-government relationship with Tribes through a commitment to consultation with Tribes and recognition of their right to self-governance and Tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has no substantial direct effects on the distribution of power and responsibilities between the Federal government and Tribes. The basis for this determination is that our decision on the West Virginia program does not include Indian lands as defined by SMCRA or other Tribal lands, and it does not affect the regulation of activities on Indian lands or other Tribal lands. Indian lands under SMCRA are regulated independently under the applicable Federal Indian program. The Department's consultation policy also acknowledges that our rules may have Tribal implications where the State proposing the amendment encompasses ancestral lands in areas with mineable coal. We are currently working to identify and engage appropriate Tribal stakeholders to devise a constructive approach for consulting on these amendments.

Executive Order 13211 requires agencies to prepare a Statement of Energy Effects for a rulemaking that is (1) considered significant under Executive Order 12866 and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not significant energy action under the definition in Executive Order 13211, a Statement of Energy Effects is not required.

Consistent with sections 501(a) and 702(d) of SMCRA (30 U.S.C. 1251(a) and 1292(d), respectively) and the U.S. Department of the Interior Departmental Manual, part 516, section 13.5(A), State program amendments are not major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).

This rule does not include requests and requirements of an individual, partnership, or corporation to obtain information and report it to a Federal agency. As this rule does not contain information collection requirements, a submission to the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ) is not required.

This rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The State submittal, which is the subject of this rule, is based upon Federal regulations that set minimum performance standards for alternative bonding systems, for which an economic analysis was prepared, and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the related Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) does not have an annual effect on the economy of $100 million; (b) will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based on an analysis of the Federal regulations that set minimum performance standards for alternative bonding systems, which were determined not to constitute a major rule.

This rule does not impose an unfunded mandate on State, local, or Tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. This determination is based on an analysis of the Federal regulations that set minimum performance standards for alternative bonding systems, which were determined not to impose an unfunded mandate. Therefore, a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq. ) is not required.

For the reasons set out in the preamble, 30 CFR part 948 is amended as follows:

The IFR titled “TRICARE Coverage of Certain Medical Benefits in Response to the COVID-19 Pandemic” published in the Federal Register on September 3, 2020 (85 FR 54914-54924), and public comments were allowed for 60 days. A total of four comments were submitted. Two comments were generally supportive of the provisions implemented in that IFR; the DoD is grateful to the public for their support. Comments specific to provisions of that IFR not covered in this final rule were discussed in full in a final rule titled “TRICARE Coverage and Reimbursement of Certain Services Resulting From Temporary Program Changes in Response to the COVID-19 Pandemic” that published on June 1, 2022 (87 FR 33001-33015). In the IFR of September 3, 2020, the DoD specifically asked for comments on potentially making coverage of treatment use of investigational drugs under FDA EA programs for the treatment of COVID-19 permanent and on permanently covering the drugs for all diseases. No comments were received specific to the coverage of treatment use of investigational drugs on a permanent basis, either for the treatment of COVID-19 or for the treatment of other diseases. This final rule clarifies the DoD's decision not to add permanent coverage of investigational drugs authorized for treatment use under FDA EA programs when prescribed for the treatment of COVID-19 or for other diseases. This decision was based primarily on analysis discussed later in this rule rather than the lack of comments received on this provision. The COVID-19 national emergency terminated on April 10, 2023. As the DoD is not making the provision authorizing investigational drugs for COVID-19 under FDA EA programs permanent, this final rule will remove the temporary provision from Title 32, Code of Federal Regulation (CFR), Part 199. This final rule also modifies language in the note to § 199.4(g)(15)(i)(A) by replacing the terms “Treatment Investigational New Drugs (INDs)” and “Treatment INDs” with “investigational drugs authorized for treatment use under FDA expanded access programs” to better reflect updated practices and terminology associated with FDA EA programs.

The IFR titled “TRICARE Coverage of National Institute of Allergy and Infectious Disease Coronavirus Disease 2019 Clinical Trials,” which discussed temporary coverage of NIAID-sponsored clinical trials for the treatment of COVID-19, published in the Federal Register on October 30, 2020 (85 FR 68753-68758). Comments were accepted for 30 days, and the DoD received four comments. The DoD thanks all commenters for their submissions. In the COVID-19 Clinical Trials IFR, the DoD specifically solicited comments on the potential expansion of TRICARE's clinical trial benefit beyond cancer clinical trials and NIAID-sponsored COVID-19 clinical trials. Two comments were generally supportive of expanding the clinical trial benefit, while the other two comments discussed the TRICARE benefit in general. The DoD received one comment discussing the importance of clinical trials in assisting with the development of products to prevent COVID-19 cases, treat COVID-19 more efficaciously, and treat severe COVID-19 complications. This comment also recommended covering expenses related to clinical trials for other life-threatening conditions that impact a large number of beneficiaries, such as cardiovascular diseases, to improve health outcomes for beneficiaries, and to support the advancement of effective clinical treatments. The DoD received one comment recommending that coverage of COVID-19 clinical trials be made permanent.

Due in part to these comments and the DoD's comprehensive review of TRICARE's clinical trials and other investigational treatment benefits, which is discussed further in-depth within the Discussion and Regulatory Impact Analysis sections of this final rule preamble, the Department is making COVID-19 clinical trial provisions permanent. As the COVID-19 national emergency terminated on April 10, 2023, before the publication of this final rule, TRICARE will only cover routine services and supplies associated with NIAID-sponsored COVID-19 clinical trials for beneficiaries who enroll in eligible clinical trials after the effective date of this rule or who previously enrolled in an eligible clinical trial before April 11, 2023. Due to low enrollment in this benefit and the fact that beneficiaries who enroll in eligible clinical trials before the termination of the national emergency will still have routine care associated with the clinical trial covered after the termination of the national emergency, the Department expects this temporary gap in coverage to impact few, if any, beneficiaries.

The Department is also expanding the provisions to include coverage of services and supplies provided in conjunction with clinical trials sponsored or approved by any NIH Center or Institute for the treatment or prevention of infectious diseases that cause a pandemic or epidemic and result in a Government-recognized health emergency, rather than continuing to only cover services and supplies provided in conjunction with NIAID-sponsored clinical trials for treatment or prevention of COVID-19. The DoD is promulgating this change to prepare for future health emergencies caused by infectious diseases beyond the COVID-19 pandemic, as coverage for clinical trials investigating a novel infectious disease is critical to both advancing initial research into treatments and preventive measures and fostering beneficiary access to emerging treatments. The Department is also expanding this benefit to include all NIH Centers and Institutes except for the NIH Clinical Center because NIH Centers and Institutes other than NIAID have begun conducting research on COVID-19, particularly on how the disease affects specific organ systems. Likewise, the DoD expects other NIH Centers and Institutes to conduct research on previous, current, or future pandemics and epidemics that result from infectious pathogens and cause the declaration of a national emergency or public health emergency (PHE). This change also adds authorization of NIH-approved clinical trials where NIH serves as a collaborator, rather than only NIH-sponsored clinical trials, in order to further expand access to clinical trials for TRICARE beneficiaries. This expansion of TRICARE's clinical trial benefit therefore includes coverage of NIH-sponsored or approved clinical trials for the treatment or prevention of infectious diseases that cause a pandemic or epidemic and result in a Government-recognized health emergency, including COVID-19 clinical trials, rather than just NIAID-sponsored COVID-19 clinical trials. If the Government-recognized health emergency was declared before the effective date of this rule, only services and supplies provided in conjunction with eligible clinical trials after this rule's effective date may be covered.

Lastly, the Department is expanding and modernizing the TRICARE clinical trial benefit to cover services and supplies provided in conjunction with NIH-sponsored or approved Phase I-IV clinical trials that involve a new treatment or cure for a specific condition or the treatment of a currently uncontrolled symptom or aspect of that condition, provided that the condition or uncontrolled symptom of the condition under study in the clinical trial is severely debilitating, life-threatening, or a rare disease. This includes expanding coverage of cancer clinical trials to National Cancer Institute (NCI)-sponsored or approved Phase I-IV clinical trials, rather than only NCI-sponsored Phase I-III clinical trials, as cancer is itself a life-threatening condition. This expansion of TRICARE's clinical trial benefit conforms to statutory authority and is supported by the DoD's review into the clinical trials reimbursement landscape and the comments the DoD received in response to the COVID-19 Clinical Trials IFR.

In 2020, the DoD published three IFRs with request for comments to respond to the COVID-19 pandemic, which included two provisions addressed in this final rule: temporary coverage of investigational drugs authorized for treatment use under FDA EA programs and temporary coverage of services and supplies provided in conjunction with NIAID-sponsored clinical trials for the treatment or prevention of COVID-19; both provisions were originally effective for the duration of the President's declared national emergency. All other provisions of those IFRs, including the first COVID-19 IFR published by the DoD on May 12, 2020 (85 FR 27921-27927), titled “TRICARE Coverage and Payment for Certain Services in Response to the COVID-19 Pandemic,” were finalized in a final rule, titled “TRICARE Coverage and Reimbursement of Certain Services Resulting From Temporary Program Changes in Response to the COVID-19 Pandemic,” published on June 1, 2022 (87 FR 33001-33015). The DoD published a fourth IFR titled “Expanding TRICARE Access to Care in Response to the COVID-19 Pandemic” on January 12, 2023 (88 FR 1992-2002); its provisions have not yet been finalized in a final rule.

In addition to rulemaking, before the COVID-19 clinical trial provisions could be published, Title 10, United States Code (U.S.C.), Section 1079(a)(12) also required the DoD to first enter into an inter-agency agreement with the Secretary of the Department of Health and Human Services (HHS). Instead of entering into an agreement with NIAID only, the Department foresaw the possibility of expanding the TRICARE clinical trial benefit as authorized under 10 U.S.C. 1079(a)(12) to cover studies sponsored or approved by other NIH Centers and Institutes. The DoD therefore entered into an agreement with NIH to cover certain routine costs associated with clinical trials; this inter-agency agreement is not limited to NIAID or clinical trials related to COVID-19, although the IFR published by the DoD on October 30, 2020 (85 FR 68753-68758), titled “TRICARE Coverage of National Institute of Allergy and Infectious Disease Coronavirus Disease 2019 Clinical Trials,” only authorized coverage of services and supplies provided in conjunction with certain NIAID-sponsored clinical trials for the treatment or prevention of COVID-19. The inter-agency agreement includes clinical trials sponsored or approved by NIH, is effective from September 19, 2020, through September 18, 2029, and provides for both parties to review the agreement every three years.

This final rule promulgates three major changes to the provisions enacted in the IFRs in response to public comments, the COVID-19 pandemic, and the DoD's comprehensive review of the clinical trials reimbursement landscape:

First, this final rule considered permanent TRICARE coverage of investigational drugs authorized for treatment use under FDA EA programs for the treatment of COVID-19. This temporary coverage was authorized in the IFR published September 3, 2020, but that authorization expired when the President's national emergency for COVID-19 ended April 10, 2023. In the IFR, the ASD(HA) stated that the DoD would consider if any permanent coverage was appropriate and publish a final rule detailing the Department's analysis and decision. While the DoD recognizes the value of access to emerging therapies, as demonstrated by its coverage of investigational drugs during the early part of the COVID-19 pandemic, there is insufficient statutory authority to permit permanent coverage. This final rule discusses the DoD's decision and adds clarifying language regarding coverage of care associated with such drugs for any disease.

The IFR authorizing temporary coverage of these drugs permitted that temporary coverage in response to the COVID-19 pandemic and stated that the DoD would consider permanent coverage after thoroughly examining the FDA-authorized EA program and determining what coverage, if any, was appropriate given TRICARE's statutory requirement to only cover medically necessary care under 10 U.S.C. 1079(a)(12).

To determine what coverage was appropriate, the DoD examined its own regulatory history for coverage of FDA-approved drugs, as well as changes to FDA EA programs since the DoD's regulatory provisions were enacted. The DoD, under the Civilian Health and Medical Programs of the Uniformed Services (CHAMPUS) Program (now TRICARE), first established an “absolute requirement for approval by the [FDA] of all prescription drugs and medicines” as a criterion for coverage on November 26, 1991 (56 FR 59870). The 1991 final rule established that care associated with certain Group “C” cancer drugs and treatment INDs could be covered, while the treatment IND itself could not. The 1991 rule placed these provisions in § 199.2, under the definitions for “experimental” and “prescription drugs and medicines,” with the prescription drugs and medicines provision repeated in § 199.4. That rule concluded that any use of a drug that had not been approved for general use by the FDA was necessarily experimental and could not be covered. In a final rule published January 6, 1997 (62 FR 625), the DoD issued clarifying language regarding the exclusion of unproven drugs, devices, and medical treatments and procedures. The requirement for FDA approval of drugs remained, though the definition of experimental was removed from § 199.2, and the language in § 199.4 was substantially revised. However, none of those changes had a substantive impact on coverage criteria. FDA approval remained a key requirement for coverage of drugs, and treatment INDs could not be covered although care associated with them could be covered. Since that time, no significant changes have been made to TRICARE regulations that would impact the FDA-approval requirement for drugs, or the exclusion of cost-sharing treatment INDs. Importantly, no changes have been made to the DoD's statutory authority for coverage of care under TRICARE, which mandates that such care be medically necessary in order to be eligible for TRICARE coverage. The statutory provision concerning medical necessity (10 U.S.C. 1079(a)(12)) specifically exempts care provided in certain NIH clinical trials (in which investigational drugs are often administered). Because Congress specifically carved out circumstances under which drugs and other treatments not otherwise coverable were permitted to be cost-shared, the Department has historically read the statute to mean that the carve-out represents the only exemption Congress intended to make for TRICARE coverage in investigational settings. Based on this interpretation, the DoD finds that Congress did not intend for the DoD to include unproven care in its coverage of medically necessary care.

In evaluating whether it would be appropriate for TRICARE to cost share investigational drugs authorized for treatment use under EA programs, the DoD next evaluated changes to FDA's regulation of its EA programs to determine if those changes were such that this care could be considered medically necessary under TRICARE. The FDA first formalized the treatment use of investigation drugs on May 22, 1987 (52 FR 19466), in a final rule that included the establishment of treatment INDs. The DoD's 1991 rule published after that rule, and the DoD found that treatment INDs were unproven and, thus, could not be covered under its statutory authority. The FDA revised its regulations authorizing the treatment use of investigational drugs in a final rule establishing its EA programs, which published on August 13, 2009 (74 FR 40900). FDA's rule was published under new authority granted by Congress in the FDA Modernization Act of 1997 (Pub. L. 105-115), which contained provisions specific to expanding access to treatment use of investigational drugs. In the final rule implementing its EA programs, the FDA established three categories of treatment uses of investigational drugs: single patients, including for emergency use; intermediate-size patient populations; and treatment INDs or treatment protocols. Each category of EA established criteria for authorization, with single patient access requiring the lowest level of evidence and treatment INDs and treatment protocols requiring the highest levels of evidence. The evidence for treatment INDs was not substantially different than it was in the earlier 1987 rule.

According to 21 CFR 312.320, established by the 2009 final rule, in order for the FDA to authorize a treatment IND or protocol for the treatment of a serious disease or condition, there must be “sufficient clinical evidence of safety and effectiveness to support the [EA] use.” The FDA states this would ordinarily be data from a Phase III trial, though compelling data from completed Phase II trials may be used. Section 312.320 further states that when the treatment IND or protocol is for a life-threatening disease or condition, “the available scientific evidence, taken as a whole, provides a reasonable basis to conclude that the investigational drug may be effective and would not expose patients to an unreasonable and significant risk of illness or injury.” The FDA expects this level of evidence would typically come from Phase III or Phase II trials but could be based on more preliminary clinical evidence. Additionally, in its preamble to the 2009 final rule, the FDA acknowledges “that drugs made available under expanded access programs are typically investigational” (74 FR 40907) and that “it is likely that some drugs made available for treatment use will ultimately be shown to have no benefit, and in fact cause harm” (74 FR 40911). Further, all EA drugs require an Institutional Review Board (IRB) review, similar to such reviews for clinical trials, underlining the unproven nature of these drugs.

Although the DoD appreciates the value of early access to drugs for patients with serious or life-threatening diseases, the DoD does not have the statutory authority that would allow it to permanently cover investigational therapies, even for severe illnesses. The level of evidence required by the FDA for widespread treatment use of INDs, the most stringent evidence requirement of the three EA drug categories, is insufficient to meet the DoD's statutory requirement for medically necessary care, as implemented through the regulation excluding unproven care at 32 CFR 199.4(g)(15) from TRICARE coverage as determined by a review of the available literature that falls under the categories of the hierarchy of reliable evidence in § 199.2. The DoD lacks statutory authority to treat serious or life-threatening diseases differently than other diseases when determining medical necessity. In fact, the rule that formalized the criteria for a treatment to be considered “proven” was prompted by a treatment for life-threatening breast cancer. The therapy in question, high dose chemotherapy with stem cell rescue, was seen by some in the medical community at the time as the best and only treatment available to patients with certain types of breast cancer resistant to other treatments. However, the DoD excluded coverage due to lack of evidence of efficacy and the presence of evidence that the therapy may actually cause harm. Over 25 years later, the therapy remains unproven and is excluded from coverage under TRICARE. The DoD noted in the 1997 rule that the purpose of its process for determining whether care should be covered is “to prevent CHAMPUS beneficiaries from being exposed to less than fully developed and tested medical procedures and to avoid the associated risk of unnecessary and unproven treatment” (62 FR 628). Based on the above analysis, investigational drugs authorized for treatment use by the FDA must continue to be excluded under the TRICARE Program.

While the DoD cannot permanently cover investigational drugs authorized by the FDA for treatment use, care associated with these therapies may continue to be covered when long-standing program requirements are met: (1) that the patient's medical condition warrants the treatment, and (2) the care is provided in accordance with the generally accepted standards of medical practice. The DoD is updating the regulation to clarify that this care may be covered for any investigational drug authorized for treatment use by the FDA under its EA programs, not just treatment INDs ( i.e., this coverage applies also to single-patient use, including emergency access, and intermediate access). This clarification is not a change in coverage, as the DoD has long interpreted the regulation regarding care associated with treatment INDs to include the other categories of EA treatment uses.

Second, this final rule authorizes coverage of services and supplies provided in conjunction with Phase I, II, III, and IV clinical trials sponsored or approved by any NIH Center or Institute other than the NIH Clinical Center for the treatment or prevention of an infectious disease that results in a Government-recognized infectious disease health emergency, rather than only covering NIAID-sponsored studies for the treatment or prevention of COVID-19. In this context, a Government-recognized infectious disease health emergency means that the President of the United States has declared a national emergency, or the HHS Secretary has declared a PHE for a pandemic or epidemic that occurs as a result of an infectious disease. For care rendered overseas (defined as locations outside of the 50 United States and the District of Columbia) to TRICARE beneficiaries, this definition also includes epidemics and pandemics recognized by foreign governments and by the World Health Organization, although only NIH-approved clinical trials in the region experiencing the Government-recognized epidemic or pandemic qualify for TRICARE coverage. An NIH-approved clinical trial means a clinical trial for which NIH, including an NIH Center or Institute, serves as a collaborator, as the term “collaborator” is defined by NIH. 1 At the time this rule's publication, NIH defines a collaborator as “An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.” As 10 U.S.C. 1079(a)(12) requires clinical trials covered under the TRICARE program to be either NIH-sponsored or NIH-approved, but does not define the term “NIH-approved,” the DoD finds it appropriate to use the current NIH definition of “collaborator” as meaning “NIH-approved” when an NIH Center or Institute is listed as a collaborator for a clinical trial that is otherwise eligible for TRICARE coverage. Should NIH update this definition or cease listing collaborators, the DoD would determine if a change in TRICARE regulation would be beneficial to TRICARE's beneficiary population and, if so, make appropriate changes through rulemaking. The National Library of Medicine's registry of clinical trials, available from https://www.ClinicalTrials.gov at the time of this final rule's publication, lists information about trials, including sponsors and collaborators. These changes will ensure that TRICARE beneficiaries receive access to all clinical trials sponsored or approved by NIH Centers or Institutes for the treatment or prevention of infectious diseases associated with Government-recognized infectious disease health emergencies, including COVID-19, not only NIAID-sponsored clinical trials studying the treatment or prevention of COVID-19. In the absence of this change, beneficiaries may opt not to participate in COVID-19 clinical trials sponsored or approved by other NIH Centers and Institutes due to the potential for large out-of-pocket costs when they would have participated had TRICARE covered these costs. Many of these NIH Centers and Institutes study specific organ systems or areas of research ( e.g., diabetes and aging), and COVID-19 clinical trials sponsored or approved by these Centers and Institutes tend to study the short-term and long-term impact of COVID-19 in these specific areas of research, including specific short-term and long-term health problems caused by COVID-19, whereas NIAID COVID-19 clinical trials tend to study the virus and disease as a whole.

COVID-19 patients experience increased risk of complications such as severe fatigue and muscle weakness, anosmia and ageusia ( i.e., loss of taste and smell), dyspnea ( i.e., difficulty breathing), cognitive impairment, encephalitis, pneumonia, acute respiratory distress syndrome, acute liver injury, acute myocardial injury, cytokine storms, and stroke during or shortly after infection and recovery. Long-term or chronic health consequences ( i.e., sequelae) of COVID-19 are often referred to as “long COVID” and include myocarditis, multisystem inflammatory syndrome, autoimmune disorders, venous thromboembolism, diabetes mellitus, Guillain-Barre syndrome, kidney damage, lung damage, and psychiatric disorders. These short-term and long-term complications impact both individual and population health. For example, health systems, providers, and public health officials must prepare to treat and mitigate higher rates of pulmonary, cardiovascular, and kidney disease and to prevent, diagnose, and treat these conditions in populations not previously thought to be higher risk.

In addition, this change will not expire upon the termination of the President's declared national emergency for COVID-19, as is stated in the IFR published by the DoD on October 30, 2020 (85 FR 68753-68758). Continuing to cover services and supplies provided in conjunction with NIH-sponsored or approved Phase I, II, III, and IV clinical trials for the treatment or prevention of COVID-19 will ensure that TRICARE beneficiaries have the ability to participate in COVID-19 clinical trials after the termination of the national emergency without fear of significant out-of-pocket costs. Due to the novel nature of COVID-19 and the large number of COVID-19 cases since the advent of the pandemic, it is crucial that researchers continue to study treatments (including preventive treatments) for the disease and short-term and long-term health impacts of the disease and its treatments in order to improve treatment for individuals with complications from COVID-19; to better support population health efforts ( e.g., chronic disease management and identification of high-risk patients); and to better prepare public health experts and clinicians to mitigate future diseases and pandemics. Likewise, TRICARE coverage of clinical trials investigating treatments for and prevention of future infectious diseases that are associated with Government-recognized health emergencies will allow TRICARE to quickly and efficiently maximize beneficiary access to emerging treatments in the event of future epidemics and pandemics, as well as support the societal need for research into emerging treatments and preventive medicine, including vaccinations.

These changes will greatly expand beneficiaries' access to clinical trials beyond the termination of the President's national emergency and will further DoD support of research studying COVID-19 and other infectious diseases that may cause a pandemic or an epidemic, including investigating treatments to improve the long-term prognosis or symptoms in sufferers of the disease.

Lastly, this final rule authorizes coverage of services and supplies provided in conjunction with Phase I, II, III, and IV clinical trials sponsored or approved by any NIH Center or Institute (except the NIH Clinical Center, which already provides all care free of charge to participating patients) for which the clinical trial studies a new treatment or cure for a specific condition or the treatment of a currently uncontrolled symptom or aspect of that condition, provided that the condition is severely debilitating, life-threatening, or a rare disease. This provision modernizes the TRICARE benefit by expanding existing coverage of clinical trials and will result in increased access to emerging therapies for beneficiaries with serious conditions and ineffective or no viable treatment options. This change will also add coverage of Phase IV NCI-sponsored and approved clinical trials and remove existing requirements specific to Phase I NCI clinical trials to maintain parity between the clinical trial benefits. TRICARE's Phase I-specific requirements are no longer necessary, as requirements in this final rule and changes to how Phase I clinical trial protocols are approved result in the existing Phase I requirements being duplicative, which may also duplicate administrative costs and increase patient, provider, and Government burden without any improvement to patient safety or access to eligible clinical trials. Phase IV trials are critical in continuing to assess a treatment's safety and efficacy, especially safety and efficacy within specific sub-populations and in conjunction with certain drugs, even after the treatment is FDA-approved.

As used in this provision, “uncontrolled” refers to a symptom or aspect of a specific condition that cannot be effectively managed or cured with existing medications, durable medical equipment, surgery, or other therapies. This can mean, for example, that an existing treatment has a high likelihood of harmful side effects experienced by a significant proportion of patients, including chemical dependence, elevated risk of mortality, or teratogenic effects. It can also mean that the existing treatment has a relatively miniscule probability of successfully treating a specific condition or is only palliative in nature. It does not mean that harmful side effects have the potential to occur with a specific treatment or that a specific treatment has a possibility of failure.

A “rare disease” refers to any disease or condition that has a prevalence of fewer than 200,000 persons in the United States; TRICARE already uses this definition for regulatory and policy requirements specific to rare diseases. “Severely debilitating” is defined as “diseases or conditions that cause major irreversible morbidity” and “life-threatening” is defined as “diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival.” The FDA uses both definitions in 21 CFR 312.81 for classifying treatments, developing clinical trials and emergency use requirements, and creating drug development guidelines. As the FDA is directly involved in the regulation and approval of new drugs and devices, the DoD finds it appropriate to use the FDA's definitions to determine which clinical trials are most appropriate to cover in writing this rule and to determine which clinical trials will be eligible for coverage under this rule. While the DoD is mirroring the FDA's definitions in implementing these provisions, the DoD's determination that these categories of diseases and corresponding definitions should be included under the TRICARE clinical trial benefit is based on the Department's evaluation of the needs of the TRICARE beneficiary population. Should the FDA update either definition, the DoD would evaluate the changes to determine if a similar change in TRICARE regulation would be beneficial to TRICARE's beneficiary population and, if so, make appropriate changes through rulemaking.

Severely debilitating conditions may have existing treatments that manage certain aspects of the condition but have no curative treatments for aspects of the disease that severely decrease the patient's health and quality of life. New clinical trials generally seek to improve upon existing treatments by improving patient outcomes, reducing side effects, or improving cost efficiency. Examples of severely debilitating conditions include Canavan Disease and Cystic Fibrosis. Like severely debilitating conditions, many life-threatening diseases have existing treatments, but these treatments may increase expected life expectancy for patients with the disease while resulting in serious side effects or not curing the disease ( e.g., open surgery to treat cardiovascular diseases, thrombolytics or anticoagulants to treat blood clots, insulin injections for diabetes); provide a chance of remission or disease reversal but not restore life expectancy in all patients ( e.g., chemotherapy); or manage symptoms associated with the disease but not increase life expectancy ( e.g., treatments for Alzheimer's Disease). Examples of life-threatening diseases include Hepatic Encephalopathy and Amyotrophic Lateral Sclerosis. Researchers conducting clinical trials on treatments for rare diseases experience difficulty in recruiting sufficient patient sample sizes, so it is especially important that TRICARE facilitate beneficiary participation in rare disease trials. Examples of rare diseases include Acquired Hemophilia and Guillain-Barré Syndrome. Many diseases may fall into multiple categories; for example, many rare diseases such as Duchenne Muscular Dystrophy and Creutzfeldt Jakob Disease are also severely debilitating and life-threatening. These examples are used in the context of the time of this rule's publication with the understanding that treatments for these conditions may advance over time. Additionally, these clinical trials may involve participation by vulnerable populations, such as children and pregnant individuals. As this benefit is not intended to influence beneficiaries into participating or not participating in a clinical trial, only to remove financial barriers to participation for certain clinical trials, the Department emphasizes that IRB approval and full informed consent for patients continues to be required for these clinical trials. When appropriate, the Director, DHA, may issue additional requirements for these populations in TRICARE's implementing instructions.

Requirements for TRICARE coverage of these clinical trials are similar to existing requirements for the COVID-19 and cancer clinical trial benefits, namely that TRICARE will cost-share all routine medical care and testing required for participation in the clinical trial; that participants meet entry criteria for said protocol; that providers rendering care as part of the clinical trial be TRICARE-authorized providers; that TRICARE will not cover care rendered in the NIH Clinical Center or costs associated with non-treatment research activities; and that cost-shares and deductibles apply to TRICARE coverage of clinical trials. Like the COVID-19 and cancer clinical trial benefits, this provision also does not permit coverage of any services or supplies that are already covered under the investigational protocol, including the treatment being studied through the clinical trial. For example, TRICARE will not reimburse costs for a biologic used in clinical trials testing the efficacy of that biologic. Only routine care, meaning those supplies and services that TRICARE otherwise would have covered during the normal course of treatment (including costs for screening tests to determine clinical trial eligibility), will be eligible for coverage. Routine care includes services such as examinations, imaging, and blood tests to monitor or assess patient health during the clinical trial and supplies such as drugs that TRICARE would cover in the absence of the clinical trial that are medically necessary to treat side effects associated with the treatment under study in the clinical trial. Routine care may differ in frequency and magnitude than care would have otherwise in the absence of the investigational treatment. For example, a patient with lung cancer might receive monthly blood tests as part of a standard treatment but require weekly tests while undergoing an investigational treatment that is part of an eligible clinical trial to monitor adverse events. To further distinguish between coverage of routine services and supplies and other services and supplies provided as part of a clinical trial, this final rule amends § 199.4(g)(14) to clarify that the exclusion of “services and supplies provided as a part of or under a scientific or medical study, grant, or research program” does not apply to routine services and supplies provided in conjunction with clinical trials as authorized in § 199.4(e)(26). The exclusion still applies to non-routine services and supplies provided under clinical trials subject to § 199.4(e)(26), e.g., the investigational treatment being studied within the clinical trial. However, TRICARE may cover treatments for complications ( i.e., unfortunate sequelae) related to unproven care, including care received as part of a clinical trial eligible under this benefit, as authorized in § 199.4(e)(9). Lastly, as with the COVID-19 and cancer clinical trial benefits, this provision authorizes the Director, DHA, to issue procedures and guidelines regarding the administrative process by which individual patients may be eligible for this benefit. Additional examples of requirements for the types of clinical trials, conditions, and routine costs eligible for coverage under this change to the TRICARE benefit will be detailed in the TRICARE implementing instructions ( i.e., the TRICARE manuals), which are available at https://manuals.health.mil/ at the time of this final rule's publication.

All provisions of this final rule support NIH research by expanding the potential pool of patients who can participate in clinical trials for emerging treatments and expand TRICARE beneficiary access to emerging treatments and therapies for serious conditions. Participation of patients in clinical trials is crucial to the development of new treatments, particularly for conditions with few or no effective existing treatments. Patients with severely debilitating, life-threatening, or rare conditions may also seek early access to investigational treatments by participating in clinical trials, which may improve their symptoms, quality of life, and/or prognosis. While participation in clinical trials must always be voluntary and participants must be provided with full and informed consent, it is likewise critical that beneficiaries with severely debilitating, rare, or life-threatening conditions have access to and choice in available potential treatments offered through clinical trials in order to maximize their opportunity to receive available treatments, especially when the standard treatment may not successfully treat or cure the condition, or when no treatment exists. The provisions in this final rule provide additional options for and access to emerging treatments for these beneficiaries by decreasing some financial barriers to clinical trials. The Department initially established a demonstration to test the benefits and feasibility of the NCI cancer clinical trials benefit, which subsequently became a permanent benefit through rulemaking. Due to the success of that demonstration at expanding access to emerging treatments and the similarities to the types of conditions eligible under this final rule ( i.e., like cancer, such conditions are likewise severely debilitating, life-threatening, and/or rare diseases), the Department finds that an initial demonstration for this benefit is unnecessary and that promulgating a permanent benefit for clinical trials studying emerging treatments for these conditions under the requirements specified in this final rule will provide beneficiaries with the most efficient access to emerging treatments in the safest manner possible.

The DoD also acknowledges that clinical trial participation carries risks as well as benefits and therefore this final rule includes several components to protect patients while offering expanded coverage for clinical trials. First, the Department is limiting the clinical trial benefit to those trials studying new treatments or treatments for an uncontrolled symptom or aspect of conditions that are severely debilitating, life-threatening, and/or a rare disease. This will ensure that the DoD is only covering care that beneficiaries could not receive in the absence of the clinical trial and that may improve their symptoms or prognosis. Second, clinical trials eligible for DoD coverage must be sponsored or approved by an NIH Center or Institute. This provision, which is also required in the statutory authority for coverage of clinical trials at 10 U.S.C. 1079(a)(12), will ensure that covered clinical trials meet conventional ethical, safety, quality, and general Good Clinical Practice standards, such as IRB approval and informed consent for all participants. Lastly, Phase 0 clinical trials (exploratory IND studies that assess pharmacokinetics and pharmacodynamics) will not be eligible for coverage. TRICARE coverage of routine services associated with clinical trials that meet these standards will be the safest way for beneficiaries to pursue emerging treatments.

This rule is issued under 10 U.S.C. 1073(a)(2) giving authority and responsibility to the Secretary of Defense to administer the TRICARE Program. The text of 10 U.S.C. chapter 55 can be found at https://manuals.health.mil/.

Beneficiaries who enroll in NIAID-sponsored COVID-19 clinical trials after the expiration of the COVID-19 national emergency will benefit from TRICARE continuing to reimburse costs for services and supplies provided in conjunction with eligible clinical trials, instead of having to pay for these costs out-of-pocket. Likewise, under the new provisions within this final rule, beneficiaries who enroll in future COVID-19 clinical trials sponsored or approved by other NIH Centers and Institutes will also be able to participate in such trials without paying for costs related to the clinical trials out-of- pocket. In the event of a future pandemic or epidemic, TRICARE beneficiaries will benefit from being able to enroll in clinical trials studying the treatment or prevention of the infectious disease causing the Government-recognized infectious disease health emergency.

This final rule also expands clinical trial coverage to services and supplies provided in conjunction with clinical trials that are sponsored or approved by NIH Centers and Institutes and that involve a new treatment or cure for a specific condition or the treatment of a currently uncontrolled symptom or aspect of that condition for severely debilitating, life-threatening, and rare diseases. TRICARE beneficiaries with a severely debilitating or life-threatening condition, or who have a rare disease, will benefit from the ability to enroll in clinical trials studying investigational treatments for their condition without worrying about paying for significant medical costs related to the clinical trial out-of-pocket. This final rule will also positively impact research institutions, including NIH Centers and Institutes, by improving access for these beneficiaries to participate in valuable research, which expands the participant pool for clinical trials; this research will likewise benefit the public, who may be able to access emerging treatments for a severely debilitating, life-threatening, or rare disease depending on the results for each clinical trial. The public may also benefit from improved treatment of these conditions, which often result in higher rates of disability and lower life expectancy. Lastly, this final rule will impact the TRICARE managed care support contractors, who will be responsible for ensuring the requirements set out in these provisions are met. DHA will delineate the full extent of these responsibilities in contract modifications.

Each of the sections under which TRICARE is administered are revised periodically to ensure requirements continue to align with the evolving health care field. The DoD most recently updated 32 CFR 199.4 on June 1, 2022 (87 FR 33001) by permanently adopting coverage of telephonic services. The coverage of care associated with treatment INDs in the second paragraph of the note to § 199.4(g)(15)(A)(i) has not been permanently revised since the 1997 final rule (62 FR 625) discussed earlier in this final rule, which clarified the coverage criteria for proven therapies under TRICARE to include that treatment INDs were not eligible for coverage but care associated with their administration could be covered when certain criteria were met. The clinical trials provision modified in this final rule last changed due to the IFR establishing the COVID-19 clinical trial benefit (85 FR 68753-68758).

TRICARE covered investigational drugs for treatment use when authorized by the FDA under its EA programs through a previous IFR; this coverage was temporary, limited to treatments of COVID-19, and expired upon the termination of the President's national emergency for COVID-19 on April 10, 2023. The FDA granted emergency use authorization for several COVID-19 therapies such as Remdesivir shortly after their initial authorization under FDA EA programs, and therefore TRICARE coverage of EA drugs has been very limited. Likewise, Government costs due to coverage of EA treatments have been minimal. Due to a lack of statutory authority to continue the benefit in perpetuity or to expand it for treatments other than COVID-19, the DoD is not considering continuing or expanding coverage of EA treatments in the potential courses of action below.

TRICARE also currently covers routine costs associated with Phase I, II, and III NCI-sponsored Cancer Clinical trials and Phase I, II, III, and IV clinical trials sponsored by NIAID for the treatment or prevention of COVID-19. TRICARE coverage of routine costs associated with the current clinical trial benefit, which includes NCI-sponsored Phase I, II, and III Cancer Clinical Trials, is estimated to cost $18.0M in Fiscal Year 2022 (FY22), and we estimate that this baseline cost will increase by 4.5% annually to $20.4M in FY24. These estimates were calculated using historical expenditures, current NCI clinical trials available from ClinicalTrials.gov, and projections of increases for medical costs and beneficiary demand.

TRICARE coverage of NIAID-sponsored COVID-19 clinical trials also expired upon the termination of the President's national emergency for COVID-19, although this final rule resumes coverage for NIAID-sponsored COVID-19 clinical trials starting on the final rule's effective date. Because this rule published after the termination of the national emergency, all costs related to COVID-19 clinical trials will represent incremental costs to the Government, but costs associated with NIAID-sponsored COVID-19 clinical trials are included here as baseline costs to distinguish them from the costs associated with other clinical trials. Upon examining TRICARE Encounter Data (TED) Records through July 2022, only two claims exist for TRICARE beneficiaries participating in NIAID-sponsored COVID-19 clinical trials; both claims totaled $28,683 over a 22-month period, equaling an average of $1,366 per month, or an expected average annual cost of $16,392 in FY22. Using the expected value approach, we anticipate that the Government will incur this monthly cost, on average, in the future. This low utilization is likely because most COVID-19 clinical trials were fully funded by sponsors and therefore no claims were filed for other TRICARE beneficiaries participating in COVID-19 clinical trials; therefore, we anticipate that $1,366 per month is likely over-estimating actual baseline costs.

The DoD's final regulation expands TRICARE's clinical trial benefit to (1) make the coverage of NIAID-sponsored COVID-19 clinical trials permanent and cover all NIH-sponsored or approved COVID-19 trials; (2) expand coverage of NCI Cancer clinical trials to include Phase IV trials and NCI-approved Cancer clinical trials; (3) cover services and supplies provided in conjunction with Phase I, II, III, and IV clinical trials sponsored or approved by any NIH Center or Institute for the treatment or prevention of an infectious disease that results in a Government-recognized infectious disease health emergency, as defined above in the Statement of Need for this Rule section; and (4) cover services and supplies provided in conjunction with Phase I, II, III, and IV clinical trials sponsored or approved by any NIH Center or Institute in which the clinical trial studies a new treatment or cure for a specific condition or the treatment of a currently uncontrolled symptom or aspect of that condition, provided that the condition is severely debilitating, life-threatening, or a rare disease, as these terms are defined in this final rule. This expansion of clinical trial benefits creates several requirements for coverage of each type of trial.

Through this final rule, current coverage of COVID-19 clinical trials becomes permanent and is further expanded with coverage of NIH-sponsored and approved clinical trials for treatment or prevention of COVID-19, rather than NIAID-sponsored clinical trials only. This final rule also broadens the benefit in anticipation of future infectious diseases that result in a pandemic or epidemic and result in the declaration of a national emergency or PHE. Additionally, this final rule expands coverage of NCI Cancer clinical trials to include NCI-approved Cancer clinical trials and Phase IV clinical trials, and adds coverage for clinical trials for severely debilitating, life-threatening, and rare diseases. Coverage requirements will reflect those currently in effect for NIAID-sponsored COVID-19 clinical trials. For example, the clinical trial must study a specific treatment (including preventive treatments) rather than the infectious disease or population health in general, and TRICARE will only cover routine costs associated with eligible clinical trials ( e.g., TRICARE will not reimburse the cost of an investigational drug or new imaging method). These clinical trials may study treatments for short or long-term health complications from the infectious disease, as well as treatments that prevent the infection or transmission of a contagion that causes the infectious disease.

This targeted approach greatly expands the clinical trial benefit to NIH-sponsored or approved Phase I, II, III, and IV clinical trials while specifying TRICARE's clinical trial benefit by imposing requirements on the types of eligible treatments ( i.e., the clinical trial study of a new treatment or cure for a specific condition or the treatment of a currently uncontrolled symptom or aspect of that condition) and types of eligible diseases and conditions ( i.e., those that are severely debilitating, life-threatening, or a rare disease). In this rule, a severely debilitating disease is defined as causing major irreversible morbidity; a life-threatening disease is defined as a disease or condition where the likelihood of death is high unless the course of the disease is interrupted or a disease with potentially fatal outcomes in which the end point of clinical trial analysis is survival; and a rare disease is defined as having a prevalence of fewer than 200,000 persons in the United States. Definitions for “severely debilitating conditions” and “life-threatening conditions” will be added to 32 CFR 199.2, as well as definitions for “NIH-sponsored clinical trial” and “NIH-approved clinical trial.” Additional discussion and examples of eligible treatments and diseases are provided earlier in the Background section of this preamble.

In addition to these changes, the termination of coverage of EA treatments for COVID-19 is also discussed in this rule. An in-depth analysis of this decision is discussed in the Background section of this preamble.

By (1) making the coverage of NIAID COVID-19 clinical trials permanent and covering all NIH-sponsored or approved COVID-19 trials, beneficiaries would be able to enroll in any NIH-sponsored or approved COVID-19 clinical trial for the treatment or prevention of COVID-19 after the termination of the President's national emergency for COVID-19 and be eligible for coverage of routine costs associated with such trials. Clinical trials studying treatments for short- or long-term health complications ( i.e., sequelae) caused by COVID-19 would also be eligible for coverage under this benefit ( e.g., a clinical trial studying a new oral steroid to treat Acute Respiratory Distress Syndrome caused by COVID-19 pneumonia would be eligible for coverage). Clinical trials that are solely observational or that are not studying a specific drug, vaccine, device, or other treatment would continue to be ineligible for coverage. Other coverage requirements would mirror existing regulatory requirements for NIAID COVID-19 clinical trials. For example, clinical trials conducted at the NIH Clinical Center would be ineligible for TRICARE coverage of any costs. Requirements for (2) Phase IV Cancer clinical trials will largely mirror existing regulatory requirements for NCI Cancer clinical trials, including requiring pre-authorization before the initial evaluation; requiring that providers be TRICARE-authorized; requiring that care rendered in the NIH Clinical Center be excluded from coverage; and applying normal cost-share procedures.

Additionally, this final rule financially supports clinical trial research sponsored or approved by any NIH Center or Institute for the (3) prevention and treatment for future Government-recognized infectious disease emergencies, as well as for (4) severely debilitating, life-threatening, and rare diseases. It also improves access to treatments for such diseases in the safest manner possible for TRICARE beneficiaries with the greatest need for emerging treatments, i.e., beneficiaries with severely debilitating, life-threatening and rare conditions when the treatment has limited efficacy or when no treatment exists. These treatments may significantly improve beneficiary health outcomes (including symptoms, quality of life, prognosis, and life expectancy), and support of this research may assist with the full approval of emerging treatments, which would also improve the health outcomes for the general public and may reduce public and private spending due to death and disability that result from these conditions. Through expanded coverage for routine costs, clinical trials may receive higher application rates from TRICARE beneficiaries. Additionally, many groups are underrepresented in clinical trials research; this expansion in access may contribute to increased diversity within the clinical trial sample population. As discussed above, both factors are necessary to determine the actual efficacy of a treatment, especially across sub-populations ( e.g., is a treatment less effective for men over the age of 75 or more effective for female Indigenous Americans). For Phase IV trials studying a treatment already covered by TRICARE, the Government may realize cost-savings by paying for routine costs only, rather than also paying for the treatment. Likewise, the Government may realize cost savings from beneficiaries receiving an experimental treatment through a clinical trial, which is paid for by the investigator, over potentially less effective treatments covered by the TRICARE Program. This is especially relevant for novel infectious diseases such as COVID-19, which have few non-investigational treatments for short-term or long-term complications from the disease. Continuing the COVID-19 clinical trial benefit and expanding it to future infectious diseases that result in a pandemic or epidemic to the extent that a national emergency or PHE is declared will also support the development of treatment options for individuals who experience these complications.

The Government-recognized infectious disease health emergency clinical trial benefit, including continued coverage of COVID-19 clinical trials, will also support research efforts that may mitigate future pandemics and epidemics, including the development of treatments (as well as vaccines or other preventive treatments) for future novel infectious diseases and their associated short-term and long-term complications. While most of these benefits are intangible or otherwise infeasible to quantify, this benefit is also expected to save beneficiaries who were otherwise inclined to participate in a particular clinical trial hundreds to thousands of dollars per trial, although this amount is highly variable based on the specific type of trial. This cost is transferred from TRICARE beneficiaries participating in clinical trials to the Government and is further discussed in the cost analysis below.

As participation in this benefit is optional for clinical trial investigators, providers, and beneficiaries, this change imposes no direct burden on the public, but the pre-authorization requirement for clinical trials studying treatments for severely debilitating, life-threatening, or rare diseases will impose a minor barrier to this benefit. Pre-authorization provides some assurance that the beneficiary will not be financially liable for routine care provided under the trial. The Department finds that pre-authorization is necessary to ensure that these clinical trials meet all requirements set forth in this rule and does not anticipate pre-authorization imposing a significant burden, as most clinical trials require months to years to complete recruitment and enrollment, and a significant number of clinical trials for these categories of diseases utilize rolling enrollment. Additionally, TRICARE coverage of NCI Cancer Clinical Trials currently requires pre-authorization, and many treatments for severely debilitating, life-threatening, and rare diseases likewise have existing pre-authorization requirements under public and private health insurance plans. This requirement will also impose administrative costs to the Government; these costs are discussed in this analysis. TRICARE coverage of clinical trials studying treatments for Government-recognized infectious disease health emergencies will continue to not require pre-authorization due to the emergent, fast-paced, and novel nature of infectious diseases that cause pandemics and epidemics.

As discussed above, coverage of clinical trials carries risks to beneficiaries, who may experience mild or severe adverse events due to clinical trial participation or who may be randomly assigned to the control group. However, this rule limits eligible clinical trials to those studying a new treatment or cure for a specific condition or the treatment of a currently uncontrolled symptom or aspect of that condition, provided that the condition is severely debilitating, life-threatening, or a rare disease. These requirements therefore restrict the TRICARE clinical trial benefit to those beneficiaries in the greatest need of emerging treatments. Additionally, pursuing emerging treatments provided under an NIH-sponsored or approved clinical trial generally carries less risk to patients than unproven treatments pursued outside of clinical trial protocols due to the safety parameters required by NIH-sponsored or approved clinical trial protocols and requirements, such as IRB approval and informed consent for all patients. The Background section of this preamble further discusses patient protection.

As discussed in the baseline cost section, we estimate average annual costs at $16,392 for FY22 for NIAID-sponsored COVID-19 clinical trials. Due to low utilization and because COVID-19 clinical trials sponsored or approved by non-NIAID NIH Centers and Institutes tend to incur similar or lower costs than NIAID-sponsored COVID-19 clinical trials, we assume that costs for all NIH-sponsored or approved COVID-19 clinical trials will not exceed those for NIAID-sponsored COVID-19 clinical trials. However, we estimate a potential increase in demand and medical costs, so we projected a 4.5% increase in costs annually. Therefore, we estimate costs to be $18,704 in FY24 and estimate 5-year costs to be $102,323 from FY24-FY28. We estimate no incremental start-up or incremental administrative costs, as any administrative requirements ( e.g., eligibility determinations and customer support) are within the existing scope of the Managed Care Support contracts, which have already been modified to include the COVID-19 clinical trial benefit.

To approximate TRICARE costs for NCI Phase IV trials, we used a cost ratio approach to calculate the relative costs of NCI Phase IV trials compared to NCI Phase I-III clinical trials. Direct costs to the Government were calculated by first analyzing historical TRICARE expenditures for NCI-sponsored Cancer Phase I, II, and III clinical trials from TED records, representing baseline costs for this rule ($18.0M in FY22). We chose this approach because NCI Phase IV clinical trial costs are an unknown variable, but we know TRICARE-specific costs for NCI-sponsored Phase I-III trials and total enrollment in NCI-sponsored clinical trials. To accomplish this, we first analyzed public data on ClinicalTrials.gov for active, non-recruiting NCI-sponsored or approved Phase I-IV clinical trials and identified the number of participants in each trial. Each trial was also classified into one of 11 categories representing various types of clinical trials and their associated costs, including a category that represented no costs. The historical TRICARE expenditures for the NCI Phase I-III trials were then used to calculate an annual average TRICARE cost per trial enrollee for each category; this average cost per enrollee for each specific category was also used to estimate TRICARE costs for the NCI Phase IV trials. This estimate, therefore, assumes that the average cost per enrollee will be the same from NCI Phase I-III to NCI Phase IV trials in a given category, as there is no other visibility into NCI Phase IV clinical trial costs. For example, we assume that an NCI Phase IV clinical trial studying a pharmaceutical drug would incur the same costs, on average, as an NCI Phase I, II, or III clinical trial studying a pharmaceutical drug.

The annual average TRICARE cost per trial enrollee for each category was then multiplied by the total number of non-NCI, non-COVID-19 clinical trial enrollees in each category (as reported on ClinicalTrials.gov) to estimate total costs for each category. Costs were calculated separately for Phase I-III and for Phase IV trials, and then Phase IV trial costs were divided by Phase I-III trial costs to calculate an estimated cost ratio of 3.53%, meaning that NCI Phase IV trial costs for all enrollees are 3.53% of the cost of non-NCI, non-COVID-19 Phase I-III trials for all enrollees. Note that these costs represent routine costs associated with clinical trials for all patients, not TRICARE beneficiaries alone, using TRICARE cost data from NCI clinical trials. This calculation is, therefore, not intended to estimate total NCI clinical trial costs for all participants. Instead, using this methodology provides an unbiased estimate of relative costs for NCI Phase IV trials compared to NCI Phase I-III clinical trials. To estimate incremental TRICARE costs for NCI Phase IV clinical trials, we multiplied the 3.53% cost ratio by the TRICARE costs for NCI Phase I, II, and III clinical trials, which equals $0.7M in projected FY24 costs for NCI Phase IV trials.

To estimate costs for coverage of Government-recognized infectious disease health emergencies, we first identified all national emergencies and PHEs due to infectious diseases within the last ten years. The Zika virus epidemic was declared a PHE on August 12, 2016, and lasted ten months. The mpox (initially referred to as monkeypox) outbreak was declared a PHE on August 2, 2022, and the PHE lasted nearly six months. The COVID-19 pandemic was declared a PHE on January 31, 2020, and a national emergency on March 13, 2020; the national emergency ended on April 10, 2023, and the PHE ended on May 11, 2023. Using historical data, we assume that the COVID-19 pandemic is a 100-year event, like the 1918 H1N1 flu pandemic. Additionally, using NIAID COVID-19 claims data and the total duration of the three Government-recognized infectious disease health emergencies in the United States from 2012 to 2022, we assume that expenditures for clinical trials will average approximately $735 per month ($8,820 annually in 2022 dollars). Like other estimates discussed in this rule, we assume a 4.5% increase in costs annually, based on projections made by the Centers for Medicare and Medicaid Services (CMS) Office of the Actuary. As with COVID-19 clinical trials, it is difficult to project the incidence and duration of future national emergencies and PHEs caused by pandemics and epidemics, as well as the number, duration, and type of clinical trials constructed to study each infectious disease and the participation in by TRICARE beneficiaries, so this estimate should be interpreted as an expected value over time. Therefore, we expect incremental Government costs of approximately $10,065 in FY24 and five-year costs of $55,063 from FY24-FY28.

We also used the same overall cost ratio methodology as the estimate for other NIH-sponsored or approved clinical trials to begin our estimate of covering the subset of NIH clinical trials that study severely debilitating, life-threatening, or rare diseases. After calculating costs for each category of clinical trial, we estimated the probability that each of the 556 clinical trials would meet eligibility criteria, i.e., study a new treatment or cure for a specific condition or the treatment of a currently uncontrolled symptom or aspect of that condition, provided that the condition or the uncontrolled symptom of the condition under study in the clinical trial is severely debilitating, life-threatening, or a rare disease. The probabilities for each trial were multiplied by the average cost for that trial's category to estimate an expected value for the annual probability-adjusted costs for all participants. As discussed above, these costs represent Government costs for all participants if TRICARE had covered all routine costs; this calculation is also not intended to estimate total national costs for this subset of clinical trials. This methodology is instead intended to provide an unbiased estimate of relative costs to use in projecting TRICARE-specific costs for this subset of NIH clinical trials. Dividing the costs for NCI Cancer Phase I-IV clinical trials by the costs for this subset of NIH clinical trials resulted in a cost-adjustment ratio of 8.6%. In other words, we estimated that the costs of covering this subset of NIH clinical trials would be 8.6% of the costs of covering NCI Cancer Phase I-IV clinical trials. Multiplying this adjustment ratio by projected TRICARE costs for NCI Cancer Phase I-IV clinical trials equals an estimated TRICARE cost of $1.81M in FY24 to cover this subset of NIH clinical trials, including NCI-approved Cancer Phase I-III clinical trials. Adding this total to the costs of covering routine care associated with NCI Cancer Phase IV clinical trials ($0.72M), NIAID COVID-19 clinical trials ($0.02M), and Government-recognized health emergency clinical trials ($0.01M) equals a total estimated cost of $2.56M in FY24 to the Government for covering NIH-sponsored and approved clinical trials. We assume that these costs will increase 4.5% annually and project $14.00M in direct costs to the Government over five years from FY24-FY28.

Additionally, we anticipate administrative costs related to coverage of NIH-sponsored or approved clinical trials for severely debilitating, life-threatening, and rare diseases. Administrative costs represent the value of labor incurred by Government employees (including military and civilian DoD employees) and Government contractors (including sub-contractors) who administer the TRICARE benefit. One-time start-up costs and recurring administrative costs are therefore estimated at $445,510 and $88,344, respectively, in FY24; we also project a 4.5% increase in recurring administrative costs each following year. Start-up costs refer to resources used before implementing this final rule, including an impact assessment and development of requirements, administrative components, and information technology system changes. We project that approximately 1,810 full-time equivalent (FTE) hours will be required to implement all changes associated with this final rule, for an estimated one-time start-up cost of $445,510. For recurring resources required to implement these changes, we anticipate approximately one hour of labor per claim; this recurring labor includes care management, referral and pre-authorization requirements, eligibility reviews, and customer support. We assume no administrative costs will be incurred due to coverage of NIAID COVID-19 clinical trials or Government-recognized infectious disease health emergency clinical trials.

This final rule impacts four direct medical cost components: (1) NIAID-sponsored and approved COVID-19 clinical trials, (2) NCI-sponsored and approved Cancer Phase IV clinical trials, (3) Government-recognized infectious disease health emergency clinical trials, and (4) other NIH-sponsored and approved clinical trials, which includes NCI-approved Cancer clinical trials. The subtotal for direct medical cost is estimated at $2.56M in FY24 and the five-year direct cost subtotal is estimated at $14.00M from FY24-FY28, assuming a 4.5% increase in costs annually based on projections made by the CMS Office of the Actuary. Costs for NCI-sponsored Cancer Phase I, II, and III trials are existing baseline costs and are therefore excluded. Start-up and recurring administrative costs for FY24 are estimated at $445,510 and $88,344, respectively, for a FY24 administrative cost total of $0.53M. Start-up costs are one-time costs occurring before the implementation of these provisions, while recurring administrative costs are projected to increase by 4.5% annually.

Table 1 summarizes the direct medical and administrative costs discussed above. These costs do not include any potential cost-savings, intangible benefits, or intangible costs to either the Government or non-Government entities. Additionally, healthcare providers and the general public are expected to incur zero costs, while costs to patients and Government contractors are transferred to the Government as direct medical costs or administrative costs, respectively.

Compared to the TRICARE baseline, this final rule provides greater assistance to federally funded or approved clinical studies. It also allows a greater number of beneficiaries to benefit from emerging treatments, and, based on public comments, the COVID-19 pandemic, and the clinical trials reimbursement landscape, the Department finds it appropriate to expand TRICARE's clinical trial benefit. Making the coverage of NIAID-sponsored COVID-19 clinical trials permanent and covering all NIH-sponsored or approved COVID-19 trials will further support scientific efforts into studying COVID-19, provide beneficiaries with access to emerging treatments for COVID-19 treatments that are not yet proven, and would remove some financial barriers for TRICARE beneficiaries who wish to participate in a clinical trial for an emerging treatment. Removing these financial barriers may encourage participation in NIH-sponsored or approved COVID-19 clinical trials over riskier, unproven treatments outside the safety parameters required by clinical trial protocols. Additionally, our targeted approach to expanded clinical trial coverage better protects patients by selecting certain diseases and conditions, as discussed above; patient safety is a key reason TRICARE generally only covers treatments proven safe and effective. As a Government-funded health program, TRICARE must also strive to use Government dollars in a cost-effective manner. The Department believes access to emerging, unproven treatments should be provided to beneficiaries who may substantially benefit from emerging treatments, namely beneficiaries with severely debilitating, life-threatening, or rare conditions for which treatments are limited, as well as conditions that result in epidemics or pandemics. Treatments for these conditions also tend to have limited reliable evidence and the Department's coverage of routine costs will further research into treatments for these conditions by improving beneficiary access to these clinical trials.

Additionally, the Patient Protection and Affordable Care Act (PPACA) requires health plans subject to PPACA requirements to cover routine patient costs for items and services furnished in connection with participation in the trials only if the clinical trial is federally approved or funded; studies the prevention, detection, or treatment of cancer or another life-threatening disease or condition; and either has an investigational new drug application or is exempt from investigational new drug application requirements. This rule, therefore, more closely aligns TRICARE's clinical trial benefit with clinical trial coverage offered by many private health plans. Ultimately, the DoD included these provisions to achieve a balance between assisting more beneficiaries—as well as the general public—at a lower cost to the Government while also protecting patient safety and ensuring that coverage of clinical trials is provided only to individuals who have a need for emerging treatments because they have a debilitating or life-threatening disease or condition or a rare disease.

Executive Order 12866 and Executive Order 13563 direct agencies to assess all costs, benefits, and available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, safety effects, distributive impacts, and equity). These Executive Orders emphasize the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated not significant, under section 3(f) of Executive Order 12866.

This rule is not an Executive Order 14192 regulatory action because this rule is not significant under Executive Order 12866.

Pursuant to the Congressional Review Act, this rule has not been designated a major rule, as defined by 5 U.S.C. 804(2).

The ASD(HA) certified that this rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

Section 202 of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532) requires agencies to assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. This rule will not mandate any requirements for state, local, or tribal governments, and will not affect private sector costs.

It has been determined that this rule does not impose reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications. This rule will not have a substantial effect on State and local governments.

Executive Order 13175 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct compliance costs on one or more Indian tribes, preempts tribal law, or effects the distribution of power and responsibilities between the Federal Government and Indian tribes. This rule will not have a substantial effect on Indian tribal governments.

For the reasons stated in the preamble, the DoD adopts the interim final rules amending 32 CFR part 199, which were published at 85 FR 54914-54924 on September 3, 2020 and 85 FR 68753-68758 on October 30, 2020 as final with the following changes:

This proposed rule published in the Federal Register (89 FR 42408) on May 15, 2024. Comments were accepted for 60 days until July 15, 2024. Only two comments were received, neither of which necessitated any changes to the rule. One commenter appeared to generally agree with DoD's proposed rule. The other commenter acknowledged the necessity for the exemptions being claimed, but also offered some suggestions seemingly designed to enhance transparency, accountability, record accuracy, and safeguarding. DoD agrees with these general goals and responds that it follows the requirements of the Privacy Act and DoD policy for maintaining a system of records, both of which serve to effectuate similar objectives. This final rule adds to the DoD's Privacy Act exemptions for Department-wide systems of records found in 32 CFR 310.13.

In finalizing this rule, DoD is seeking to exempt portions of this system of records titled, DoD-0020, Military Human Resource Records, from certain provisions of the Privacy Act. This system of records describes DoD's collection, use, and maintenance of records about members of the armed forces, including active duty, reserve, and guard personnel. Records support Department requirements and individual Service members’ careers, through the collection and management of personnel and employment data. This information includes individual's pay and compensation, education, assignment history, rank and promotion determinations, separation and retirement actions, and career milestones.

The Privacy Act allows Federal agencies to exempt eligible records in a system of records from certain provisions of the Act, including those that provide individuals with a right to request access to and amendment of their own records. If an agency intends to exempt a particular system of records, it must first go through the rulemaking process pursuant to 5 U.S.C. 553(b)(1)-(3), (c), and (e). The DoD is amending 32 CFR part 310 to add a new Privacy Act exemption rule for the DoD-0020, Military Human Resource Records system of records. The DoD is adding exemptions for this system of records pursuant to 5 U.S.C. 552a(k)(1) and (k)(7) because some of its records may contain classified national security information or evaluation material, including from other systems of records, that is used to determine potential for promotion in the armed services. In some cases, such records may contain information pertaining to the identity of a source who furnished information to the Government under an express promise that the source's identity would be held in confidence (or prior to the effective date of the Privacy Act, under an implied promise). The DoD is claiming an exemption from several provisions of the Privacy Act, including various access, amendment, disclosure of accounting, and certain recordkeeping and notice requirements, to avoid, among other harms, frustrating the underlying purposes for which the information was gathered.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. It has been determined that this rule is not a significant regulatory action.

This rule is not an Executive Order 14192 regulatory action because this rule is not significant under Executive Order 12866.

Pursuant to the Congressional Review Act, this rule has not been designated a major rule, as defined by 5 U.S.C. 804(2). This rule does not have an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532(a)) requires agencies to assess anticipated costs and benefits before issuing any rule whose mandates may result in the expenditure by State, local, and tribal governments in the aggregate, or by the private sector, in any one year of $100 million in 1995 dollars, updated annually for inflation. This rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.

The Acting Assistant to the Secretary of Defense for Privacy, Civil Liberties, and Transparency has certified that this rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. This rule is concerned only with the administration of Privacy Act systems of records within the DoD. Therefore, the Regulatory Flexibility Act, as amended, does not require DoD to prepare a regulatory flexibility analysis.

The Paperwork Reduction Act (44 U.S.C. 3501 et seq. ) was enacted to minimize the paperwork burden for individuals; small businesses; educational and nonprofit institutions; Federal contractors; State, local, and tribal governments; and other persons resulting from the collection of information by or for the Federal government. The Act requires that agencies obtain approval from the Office of Management and Budget before using identical questions to collect information from ten or more persons. This rule does not impose reporting or recordkeeping requirements on the public.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that has federalism implications, imposes substantial direct compliance costs on State and local governments, and is not required by statute, or has federalism implications and preempts state law. This rule will not have a substantial effect on State and local governments.

Executive Order 13175 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct compliance costs on one or more Indian tribes, preempts tribal law, or affects the distribution of power and responsibilities between the Federal government and Indian tribes. This rule will not have a substantial effect on Indian tribal governments.

Accordingly, 32 CFR part 310 is amended as follows:

The Coast Guard will enforce the regulated navigation area in 33 CFR 165.1341 immediately before and after Seafair events from 8 a.m. to 8 p.m., each day from July 31, 2025, through August 3, 2025. This action is being taken to provide for the safety of life on navigable waterways during this event. Seafair will be having several events sporadically throughout the day. Before and after these events, the Coast Guard will be enforcing the regulated navigation area to protect the public from the potential hazards of excessive vessel traffic associated with these events. The regulation, § 165.1341(a), specifies the location of the regulated navigation area encompassing portions of Lake Washington, Seattle, Washington. During the enforcement periods, as reflected in § 165.1341(c), all vessels transiting the regulated navigation area must proceed at a speed which creates minimum wake, seven (7) miles per hour or less, unless a higher minimum speed is necessary to maintain bare steerageway.

In addition to this notification of enforcement in the Federal Register , the Coast Guard plans to provide notification of the enforcement period via marine information broadcast and Local Notice to Mariners.

The Coast Guard is issuing this temporary rule under the authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are impracticable. The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM). Publishing an NPRM would be impracticable and contrary to the public interest because these temporary safety zones must be established by July 24, 2025, when bridge construction activities will impact the waterway. The Coast Guard did not have sufficient information regarding the construction schedule to publish an NPRM and consider comments before this date. However, the Coast Guard is preparing an NPRM for a separate rulemaking project to establish a larger safety zone that will be in effect for the duration of the bridge construction and demolition activities, which are anticipated to last until 2030. Also, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying this rule would be contrary to the public interest because it must be established to ensure safety on the waterway during bridge construction work beginning July 24, 2025.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Houston-Galveston (COTP) has determined that potential hazards associated with Beltway 8 Bridge construction starting July 24, 2025, will be a safety concern for anyone within a 120-yard radius of construction activities on the north shore of the Houston Ship Channel at 29°44.233′ N, 95°8.767′ W, and the south shore of the Houston Ship Channel at 29°44.067′ N, 95°8.783′ W. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zones while the bridge is being constructed.

This rule establishes safety zones from July 24, 2025, through October 22, 2025. The safety zones will cover all navigable waters within 120-yard radius of Beltway 8 bridge construction, located in Houston, TX on the north shore at 29°44.233′ N, 95°8.767′ W and south shore at 29°44.067′ N, 95°8.783′ W, in the Houston Ship Channel. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the new bridge is being constructed. No vessel or person will be permitted to enter the safety zones without obtaining permission from COTP or a designated representative.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analysis based on a number of these statutes and Executive orders.

Executive Orders 12866 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

The Office of Management and Budget (OMB) has not designated this rule a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it. The Coast Guard has reviewed this rule and has determined that it is not a “significant regulatory action” under E.O. 12866.

This regulatory action determination is based on the size and location of the safety zones. While these temporary safety zones will be in effect for 90 days, they only restrict entry in small areas of a 120 yard radius, along the north and south shores of the Houston Ship Channel. The zone does not restrict vessel traffic in the main navigational channel of the Houston Ship Channel, and impact to vessel navigation in the area will be minimal. It also allows mariners to seek permission from the COTP to enter or transit through the zones, when safe to do so.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves safety zones lasting only 90 days that will prohibit entry within 120 yards of Beltway 8 Bridge construction. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

On May 20, 2025, the Department published a notice in the Federal Register (90 FR 21441) proposing a waiver and extension of the project period with funding in order to enable one project under ALN 84.351A to receive continuation funding for an additional 12-month period, not to exceed September 30, 2026. The proposed waiver and extension of the project period with funding would allow the Department to comply with the directive in the Full-Year Continuing Appropriations and Extensions Act, 2025 and align with the dates of the Assistance for Arts Education (AAE) awards funded in FY 2021 under ALN 84.351A, which are scheduled to receive their final year of funding in FY 2025, and end on September 30, 2026. The waiver will allow the Department to issue a continuation award in FY 2025, as directed by Congress, to the currently funded 84.351A Arts in Education National Program (AENP) project at an amount consistent with the amount awarded in FY 2024.

There are no differences between the notice of proposed waiver and extension of the project period with funding and this notice of final waiver and extension of the project period with funding, as discussed in the Analysis of Comments and Changes section of this document.

Public Comment: In response to our invitation in the notice of proposed waiver and extension of the project period with funding, five parties submitted a comment.

Generally, we do not address technical and other minor changes or suggested changes the law does not authorize us to make under the applicable statutory authority. In addition, we do not address general comments that raised concerns not directly related to the proposed waiver and extension with funding.

An analysis of the comments and of any changes in the priority since publication of the notice of proposed waiver and extension of the project period with funding follows.

Comment: Two commenters submitted comments that were not relevant to the waiver and extension.

Discussion: The Department does not address general comments not directly related to the proposed waiver and extension with funding.

Change: None.

Comment: Three commenters submitted comments in support of the extension of funding stating the funding is necessary to advance students' artistic development and to develop well-rounded students.

Discussion: We appreciate the commenters' support for the funding extension for AENP and agree that funding this extension will continue to advance students' artistic development.

Change: None.

The Department intends to comply with the directive in the Full-Year Continuing Appropriations and Extensions Act, 2025 and align with the dates of the AAE awards funded in FY 2021 under ALN 84.351A, which are scheduled to receive their final year of funding in FY 2025, and end on September 30, 2026.

Consequently, the Secretary waives the requirements in 34 CFR 75.261(a) and (b)(2), which allow the extension of a project period only if the extension does not involve the obligation of additional Federal funds. This waiver allows the Department to issue a one-year FY 2025 continuation award to the currently funded 84.351A project at an amount consistent with the amount awarded in FY 2024.

Any activities carried out during the year of this continuation award must be consistent with, or a logical extension of, the scope, goals, and objectives of the grantee's application as approved in the FY 2022 competition. The requirements for continuation awards are set forth in 34 CFR 75.253.

The Secretary certifies that this proposed regulatory action would not have a substantial economic impact on a substantial number of small entities.

The U.S. Small Business Administration Size Standards define proprietary institutions as small businesses if they are independently owned and operated, are not dominant in their field of operation, and have total annual revenue below $7,000,000. Nonprofit institutions are defined as small entities if they are independently owned and operated and not dominant in their field of operation. Public institutions are defined as small organizations if they are operated by a government overseeing a population below 50,000.

This notice of final waiver and extension of the project period with funding does not contain any information collection requirements.

This action is subject to Executive Order 12372 and the regulations in 34 CFR part 79.

Accessible Format: On request to the program contact person listed under FOR FURTHER INFORMATION CONTACT , individuals with disabilities can obtain this document in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, braille, large print, audiotape, or compact disc, or other accessible format.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . You may access the official edition of the Federal Register and the Code of Federal Regulations at www.govinfo.gov. At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.