Coumarin from China, Inv. 731-TA-677 (Review)

=== FR: Determination That MEPHYTON (Phytonadione) Tablets, 5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (2023-12-19) === DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2023-P-4596] Determination That MEPHYTON (Phytonadione) Tablets, 5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that MEPHYTON (phytonadione) tablets, 5 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5236, Silver Spring, MD 20993-0002, 301-796-8363, Stacy.Kane@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. MEPHYTON (phytonadione) tablets, 5 mg, are the subject of NDA 010104, held by Bausch Health Americas, Inc., and initially approved in 1955. MEPHYTON is a vitamin K replacement indicated for the treatment of adults with the following coagulation disorders, which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity: • Anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives • Hypoprothrombinemia secondary to antibacterial therapy • Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis • Other drug-induced hypoprothrombinemia where it is definitively shown that the result is due to interference with vitamin K metabolism, e.g., salicylates MEPHYTON (phytonadione) tablets, 5 mg, are currently listed in the “Discontinued Drug Product List” section of the Orange Book. Lachman Consults submitted a citizen petition dated October 17, 2023 (Docket No. FDA-2023-P-4596), under 21 CFR 10.30, requesting that the Agency determine whether MEPHYTON (phytonadione) tablets, 5 mg, were withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that MEPHYTON (phytonadione) tablets, 5 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that MEPHYTON (phytonadione) tablets, 5 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of MEPHYTON (phytonadione) tablets, 5 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list MEPHYTON (phytonadione) tablets, 5 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: December 14, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023-27858 Filed 12-18-23; 8:45 am] BILLING CODE 4164-01-P ──────────────────────────────────────────────────────────── === FR: Foreign-Trade Zone (FTZ) 44-Trenton, New Jersey; Notification of Proposed Production Activity; International Flavors & Fragrances, Inc. (Flavor and Fragrance Products); Hazlet, New Jersey (2018-09-19) === DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-58-2018] Foreign-Trade Zone (FTZ) 44—Trenton, New Jersey; Notification of Proposed Production Activity; International Flavors & Fragrances, Inc. (Flavor and Fragrance Products); Hazlet, New Jersey International Flavors & Fragrances, Inc. (IFF) submitted a notification of proposed production activity to the FTZ Board for its facility in Hazlet, New Jersey. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on September 6, 2018. IFF already has authority to produce flavor and fragrance products within Subzone 44B. The current request would add sixteen foreign status materials/components to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status materials/components described in the submitted notification (as described below) and subsequently authorized by the FTZ Board. Production under FTZ procedures could exempt IFF from customs duty payments on the foreign-status materials/components used in export production. On its domestic sales, for the foreign-status materials/components noted below, IFF would be able to choose the duty rates during customs entry procedures that apply to flavor and fragrance products (duty-free to 10%). IFF would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment. The materials/components sourced from abroad include: Glycerides mixed decanoyl and octanoyl; musk ketone supra; aldehyde C-16 strawberry; octinoxate; ivy carbaldehyde/methyl anthranilate Schiff's base; hydroxycitronellal/methyl anthranilate Schiff's base; herbal pyran; alpha-amyl cinnamylidene/methyl anthranilate Schiff's base; leeral/methyl anthranilate Schiff's base; coumarin; ethylene dodecanoate; aldehyde C-18; octahydrocoumarin; gamma decalactone; muskalactone; and, gamma-undecalactone (duty rate ranges from duty-free to 7.7%, or 8.8¢ per kg.). Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is October 29, 2018. A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230-0002, and in the “Reading Room” section of the Board's website, which is accessible via www.trade.gov/ftz. For further information, contact Juanita Chen at juanita.chen@trade.gov or 202-482-1378. Dated: September 13, 2018. Andrew McGilvray, Executive Secretary. [FR Doc. 2018-20368 Filed 9-18-18; 8:45 am] BILLING CODE 3510-DS-P ──────────────────────────────────────────────────────────── === FR: Foreign-Trade Zone (FTZ) 44-Mount Olive, New Jersey; Notification of Proposed Production Activity; Robertet Inc. (Fragrance Compounds), Mt. Olive, New Jersey (2015-05-14) === DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-31-2015] Foreign-Trade Zone (FTZ) 44—Mount Olive, New Jersey; Notification of Proposed Production Activity; Robertet Inc. (Fragrance Compounds), Mt. Olive, New Jersey Robertet Inc. (Robertet) submitted a notification of proposed production activity to the FTZ Board for its facility within Site 1 of FTZ 44. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on May 6, 2015. The Robertet facility is used for the blending of fragrance ingredients into fragrance compounds for consumer goods such as perfumes, cosmetics, toiletries, soaps, and household products. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board. Production under FTZ procedures could exempt Robertet from customs duty payments on the foreign status components used in export production. On its domestic sales, Robertet would be able to choose the duty rates during customs entry procedures that apply to fragrance compounds (duty-free to 17 cents/kg + 1.9% duty rate) for the foreign status inputs noted below. Customs duties also could possibly be deferred or reduced on foreign status production equipment. The components and materials sourced from abroad include: (duty rate ranges from duty-free to 6.5%)—castoreum absolute; castoreum absolute resin; castoreum resin; civette absolute without fats; tabac abs balkan type ta-1060; tabac extract w/o nicotine; tabac leaf absolute; tabac resin inc on tec; tobacco absolute w/o nicotine; tobacco colorless dijon; rose de stearoptenes; ocimene natural; caryophyllene; terpinolene 20; octanol natural; octanol-3 natural; hexanol natural; tetrahydro linalool; citronellol a/j; dextro linalool nat ex coriand; dihydro myrcenol; geraniol intermediate 60; geraniol pure (980)/bba; laevo linalool natural; linalol ex bois de rose; linalool synthetic; nerolidol nat (cabreuva actif); tetrahydro myrcenol; alcohol oleique; cis-3-hexenol natural; ethyl linalool; santalex t (sandela); bornylcyclohexanol iso/rp; cedrol natural crystals; polysantol; sandalore; sandela; terpineol alpha; terpineol prime; timberol; cinnamyl alcohol fcc; phenyl ethyl alcohol; thymol natural; thymol natural dno; geranyl ethyl ether 220404us; cedranfix 221056us; anethol badiane chine nat; dimethyl hydroquinone; diphenyl oxide; estragole natural; nerolin crystals; yara-yara; eugenol; eugenol natural; citral diethyl acetal; corps jacinthe 220264us; cyclamen aldehyde ex 96%; aldehyde c12 lauric; aldehyde c-16; aldehyde c-8 (octyl aldehyde); bergamal toco; citral extra eoa; decanal 50% natural; hexanal (aldehyde c6) natural; trans-2-decenal natural; bourgeonal; citroxal 85 (muguet alde pure); cortex aldehyde 50 peomosa; cyclovertal; hexyl cinnamic aldehyde; lysmeral extra; myraldene; triplal; vanillin nf; ethyl vanillin; anisaldehyde natural; curgix pure; lyral; methyl nonyl ketone natural; menthone natural; beta ionone natural; methyl ionone gamma 70; methylionone gamma toco; beta damascenone natural; bucchu ketone natural; camphor usp; cashmeran; e super iso; iso e super clair; isophorone natural; nat replacer bucchu ketone 89%; natural product pulegone; ps 38; vertofix coeur; acetate vetyveryle haita extra; methyl napthyl ketone beta; raspberry ketone natural; musk ketone; acetic acid natural; ethyl acetate natural; n-butyl acetate natural; 1-octyl acetate natural; 3-octyl acetate natural; amyl acetate/iso; benzyl acetate fcc; benzyl acetate natural; bornyl acetate/iso; cassigreen r' touch; cedrenyl acetate; cis 3 hexenyl acetate natural; eugenol acetate; geranyl acetate natural; hexenyl acetate/cis 3; hexyl acetate; hexyl acetate natural; iso amyl acetate natural; isobutyl acetate natural; linalyl acetate natural; linalyl acetate synthetic; styrallyl acetate; terpinyl acetate extra; verdox; vertenex; cis-3-hexenyl propionate nat.; cycloprop; ethyl propionate natural; propionic acid natural; 2-methyl butyric acid natural; butyl 2-methyl butyrate; butyric acid natural; cis-3-hex-2-methyl buty nat; cis-3-hexenyl butyrate natural; cis-3-hexenyl iso valerate nat; dimethyl benzyl carbinyl butyr; ethyl 2-methyl butyrate nat.; ethyl butyrate natural; ethyl isobutyrate natural; ethyl isovalerate natural; ethyl-2-methyl butyrate; ethyl-2-methyl butyrate natural; geranyl butyrate natural; hexyl butyrate natural; isoamyl isobutyrate natural; isovaleric acid natural; octyl butyrate natural; phenoxy ethyl iso butyrate; phenyl ethyl iso butyrate; ethyl myristate natural; cis-3-hexenyl caproate natural; dimethylbenzyl carb acet; ethyl hexanoate natural; ethyl laurate; miglyol 812 (210019us); allyl cyclohexyl propionate; fruitate; benzyl benzoate usp; ethyl benzoate natural; methyl cinnamate natural; phenyl ethyl acetate; diethyl succinate; ethylene brassylate; diethyl phthalate; cis-3-hexenyl lactate natural; ethyl lactate natural; allyl amyl glycolate; amyl salicylate; amyl salicylate p (iso x)rp/g; benzyl salicylate; benzyl salicylate natural; hexenyl salicylate/cis 3; hexyl salicylate; methyl salicylate natural; hedione; dimethyl anthranilate natural; mandarol 230237; schiff base hydroxy citronnell; aldinyl; citronellyl nitrile; corps 1490; corps pamplemousse; dimethyl sulfide natural; furaneol(r) special natural; strawberry furanone; aldehyde c-14 (gamma undecal); aldehyde c-18; ambrettolide; coumarin; delta decalactone; delta dodecalactone; delta undecalactone; dihydro ambrettolide 230100us; gamma decalactone natural; gamma decalactone us natural; massoia lactone natural; ambroxan; calone 1951; eucalyptol; pyrazine complex natural; trimethyl pyrazines pure nat.; chlorophyll; clementine essential oil decolorized; oran florida 3con 3fois p&n; orange bitter oil; orange essence oil terpenes; orange essence sanguine; orange flower absolute; orange flower water absolute; orange leaf absolute; orange oil; orange oil dec fla 201013; orange oil distilled; lemon oil rect. stab.; lemon oil ss stabilized; lemon terpeneless; bergamot oil w/o furocoumarine; grapefruit oil; limagrume heart natural; limette oil stabilized; tangerine oil stabilized; menthe sechee absolute ma-1036; mint terpenes acetylated; peppermint oil; ambrarome absolute; ambrette extract liquid; ambrette seed abs colorless; ambrette seed colorless; ambrette seed oil; amyris essential oil; angelica root oil; angelica seed oil; arnica absolute; artemisia essential oil morocco; asafoetida oil; auriol; australian sandalwood; badiane ess oil (star anise); basil absolute; basil essential oil; beeswax absolute; beeswax absolute super; birch tar deph rectified; birch tar deph/rect ifra 44; birch tar rect. ifra 200143; bitter almond oil 065116; black currant buds absolute; black pepper oil; blue mallee essential oil; bran absolute butaflor; broom absolute; bucchu abs 321130; bucchu absolute; bucchu absolute 5000; bucchu essence; bucchu essential; cabreuva oil; cade ess rectified; cade oil rectified deph.; cajeput essential oil; camomille essential oil roman italy; cape snow bush essential oil; cardamom absolute; cardamone essential oil; caroube absolute; carrot seed terpeneless oil; cassia essential oil traditional, china; cassie absolute; castor oil; catnip essential oil; cedar 412 natural; cedarmoss absolute ifra 43; cedarwood 114 eo fractions; cedarwood atlas heart; cedarwood ess oil virginia; cedre altas he 020038us; celery absolute; cepes absolute ca-1081; chamomile ess. oil, roman fr; chamomile matricaira abs 5000; chamomille blue essential oil; chamomille ess. oil english; chamomille matricaire concrete; cinnamon leaf oil rectified; cire d'abeille absolute; cistambrol; ciste 300 colorless; clary sage absolute; clary sage oil; clove bud absolute; clove bud essential oil madagascar; clove essential oil; clove leaf eo 82% bleached id; clove leaf eo madagascar crude; clove leaf ess oil redistilled; clove leaf essential oil decolorized; coffee absolute; cognac green oil; cognac oil white; coriander oil stabilized; coriander terpl oil; coriandral natural stabilized; corn accord; cypress essential oil spain; cypress feuilles he 020332; cypress france expertise; cypress oil; cypriol essential oil india; cypriol heart essential oil rectified; davana oil; dynambre; elderflower absolute; elemi absolute; elemi absolute ea 220242; elemi coeur 200395; elemi heart natural stabilized; elemi oil extra; elemodor; eucalyptus absolute; eucalyptus bioabsolute; eucalyptus globulus 80%, china; eucalyptus radiata essential oil australia; fenugreek absolute; fenugreek absolute turkish; foin absolute; foin oil 200430 p&n; fucus resinoid; gaiac heart dm; galbanum absolute; galbanum essential oil; gayac wood alcohol; genieve essence 200488; gentian absolute; geranium absolute; geranium chinese ch 020072 us; geranium heart; geranium oil egypt; ginger absolute; ginger absolute butaflor; ginger absolute colorless dm; ginger extract; ginger oil; ginger oil 020779n; guaiacwood essential oil; guaiacwood essential oil paraguay; gurjum balsam oil, laos; gurjun balsam essential oil rectified; hay absolute; helichrysum absolute; helichrysum essence; herbor p31; ho leaf oil (shiu); honey absolute; hops oil; hydrocarbon resin sb; hyssop oil; hyssop oil 020830; iris buerre 3/1000; iris rde b 100% maroc 080002us; irone absolute; jasmin abs benzol 050084us; jasmin abs egyptian; jasmin absolute; jasmin absolute chassis; jasmin absolute sambac; jasmin floraline 73; jasmin grandiflorum absolute colorless; jasmin sambac colorless; jawa galanga oleoresin; juniperberry eo; juniperberry oil; juniperberry oil terpeneless; labdanum abs cistus sis; labdanum absolute; labdanum absolute epure; labdanum epure absolute; labdanum oil; labdanum resin giv; labdanum resinoid 5000 colorless; laminaria; laminaria absolute; laurel leaf oil; laurel leaves absolute; lavandin abrialis oil; lavandin absolute; lavandin absolute decolorized; lavandin concrete c; lavandin grosso eo, france; lavandin sumian 112002d; lavandin sumian ess. oil, fr; lavandin super ess. oil, fr; lavender absolute; lavender eo bulgaria low linalyl acetate; lavender essential oil, ukraine; lavender oil 50/52; lavender oil bulgarian; lavender oil extra; lavender oil pure and natural; lemongrass ess. oil india; lemongrass oil guatemala; linden absolute; lisylang natural 345; litsea cubeba essential oil; lovage absolute 5000; lovage root ess oil; mace absolute; magnolia heart stabilized; marigold pure absolute; marjoram oil egypt; massoia bark oil; mate absolute 25% ethanol; melilot abs pur 050105us; melilot absolute; melissa essential oil; mimosa absolute; mimosa absolute india; myrrh essential oil; myrrh inc 100 abs. 050118us; myrrh resin; myrtle oil maroc 020285us; narcisse absolute; neroli essential oil morocco; neroli oil bigarade; neroli tunisie bigarde; nootka tree essential oil hp; nutmeg absolute; nutmeg essence oil terpeneless; nutmeg oil; nutmeg oil low safrol; oakmoss absolute; oakmoss absolute ifra 43; oakmoss dec absolute ifra 43a; olibanum absolute; olibanum dna; olibanum essential oil; olibanum essential oil, india; olibanum infusion; olibanum oil; olive fruit extract sr180; opoponax absolute; opoponax essential oil; opoponax oil; org rose water (hydro de rose); orris absolute; orris absolute butaflor; orris butter; orris concrete 15% irone p & n; orris concrete nat 8% irone; orris heart molecular distillation; orris resinoid; osmanthus absolute; osmanthus absolute p&n r22202; osmanthus gold abs 050066us; palmarosa essential oil; parsley herb oil; patchouli alpha guaiene rich fraction natural; patchouli coeur (heart); patchouli heart; patchouli oil light; patchouly absolute r21240; patchouly rectified oil; pepper colorless; peru balsam absolute; peru balsam oil; petitgrain heart essential oil; petitgrain lemon oil; petitgrain oil; petitgrain oil d.e.; petitgrain oil paraguay; pimento berry oil; pimento berry oil low meth eug; pine absolute; pine absolute decolorized; pine needle absolute pa-1041; poplar buds absolute; poplar buds colorless dm; rosalina essential oil; rose abs decolorized pure& nat; rose abs turque decolor r22211; rose absolute purifee; rose absolute semi decolorized; rose absolute turk p&n; rose essential oil, turkey; rose oil turk me <500ppm; rose turk absolute p&n; rose turk ess oil p&n; rose turkish absolute; rose turque bioabsolute; rosemary absolute; rosemary ess. oil, tunisia; rosemary extract ra 30 natural; rosemary nat antioxidant 20; rosemary oil stabilized; sage clary essential oil; sage eo spain; sage oil; sandalwood ess oil australian; sandalwood essence new caledonia; sandalwood essential oil new caledonia; sandalwood new caledonia md; sandalwood oil; sandalwood oil australian; sandalwood selection 8; santalol; seaweed pacific; seaweed resin; shinus molle; shinus molle oil; shinus molle, essence; shiso essential oil; shiso oil; sichuan pepper co2 abs; spike lavender oil spanish; star anise oil rectified; styrax absolute; styrax absolute low styrene honduras; styrax oil; styrax purified; styrax resin natural rifm; sunflower essential oil; tabac blond 100 abs burley; tagete afs 020178us; tagette absolute; tagette essence; tagette oil; tarragon absolute; tarragon oil (estragon); tea tree ess. oil australia; tea tree essential oil chinese; tea tree essential oil cinrich australia; tea tree essential oil high cineol; tea tree essential oil, australia certified organic; tea tree essential oil, south africa; thyme absolute 5000; thyme eo spain white redistilled; treemoss abs dec ifra 43a; treemoss abs ifra 43/miglyol; treemoss inc ifra 43; tuberose absolute; tuberose absolute cream; valeriane, essence; vanilla absolute; vanilla co2 extract on tec; vanilla colorless; vanilla extract concentrate; vanilla resin colorless; vanilla surabsolute colorless; verbena absoluite; vetiver acetate; vetiver ess. oil java; vetiver haiti dm; vetiver haiti he 020185; vetiver oil java 021890; vetiveryl acetate extra; vetyver coeur natural; vetyveryl acetate; violet leaf absolute; wheat absolute; wild red thyme essence rect.; wood 49 essential oil; ylang complete essential oil low mpc; ylang complete nosy be ess oil; ylang eo extra comoros p & n; ylang essence extra; ylang flower; ylang i nosy be essential oil; ylang iii comoros p & n; ylang iii essential oil; ylang iii nosy be ess. oil; ylang ylang; ylang ylang iii oil; arnica resinoid colorless; asa foetida absolute; benzoin siam resin; clove buds absolute; elemi resin; fir balsam abs resin; labdanum a resin; labdanum resin colorless; lentisque absolute; mushroom res(champignon)mr1050; opoponax resin; peru balsam resinoid; saffron resinoid; tolu balsam res nat ta-1040; tonka bean resinoid; tonka feves absolute; gurjun essential oil; benzoin siam lot 2 resin; benzoin sumatra resin; black currant buds abs subst.; boronia absolute type; boronia type absolute; bucchu essential oil type; bucchu ketone @1% castor oil; cacao clear liposoluble extract; cassie absolute type; castoreum resin; chamomille rom hydrodispersibl; clementine natural; cocoa absolute; cocoa absolute on pg; cocoa clear lipsoluble; cocoa colorless reinforced; cocoa extract; cocoa extract (88% pg); cocoa extract natural 80.5760; cocoa extract on pg; cocoa extract on pg 80.5742; cocoa extract reinforced; cocoa extract rs6; cocoa extract uop 11197; coffee colorless dm; cucumber abs on mygliol; cucumber alcoholate wonf 78%; cucumber extract; cucumber natural on crodamol; elemi type oil; eucalyptus forte colorless dm; fenugrec absolute; fenugreek colorless; fenugreek infusion; fir balsam substitute; gentiane nat ext 25% vol805912; ginger nhs; green key e3; green key t5; hazelnut infusion natural wonf; herbor o25; jambu oleo 30% spil/ethanol; jambu oleo 30% spil/pg; jambu oleo 30% spil/triacetine; jambu oleo 30%spil/triethyl ci; jambu oleo c'less 15% spil/mig; jambu oleo cless 15% spil/tec; labdanum claire dep free; labdanum cless on triacetine; lavandin absolute type natural; lavender fleurs; liquorice specialty (carensac); mate absolute; mate absolute on pg; mate absolute w/o pg; mate colorless absolute; mate nhs; mimosa flowers olessence; mint nat hydrodispersible; mint natural flavor wonf 88.2766; mushroom concentrate; myrrhanol t; myrtle nat hydrodispersible; nat allyl caproate 25%; natural cocoa flavor wonf 38%; natural nut flavor type 80.7768; natural tuberose flavoring with other natural flavorings; neroli n ess; neroli oil; nutmeg nhs; olibanol c; olibanum oil dm colorless; orange flower absolute; orange flower absolute type; orange flower hydrodispersible; orange olessence; orris butter 15% irone; orris butter italian; orris concrete type 8% irone; orris concrete 15% irone; orris concrete 8% irone; orris liquid; orris type concrete florentine; peach natural; peach natural w/o acetaldehyde; peach odoressence w/o acetalde; peppermint absolute; peru balsam colorless; pineapple natural; raspberry fortifier nat 816061; rhodinol subs sp; rose absolute type maroc; rose de mai absolute; rose essence petals; rose petals natural; rose petals turk oilnat me<500; rose type oil; rosemary nat hydrodispersible; rosewood oil subst natural; saffron colorless; sage officinalis nat hydro.; strawberry heart; strawberry nat w/o acetaldehyd; styrax absolute colorless; succan (rum) absolute; succan (rum) absolute type; tea absolute; tea black c'less on tec; tea colorless on pg; thyme absolute 10% pg; thyme oil red te-1020; tocopherols d-mixed 50% e306; tolu balsam; tolu balsam res type ifra; tolu balsam resin 5000 t5-1020; tolu balsam resin type; undecatriene at 5% tria; vanilla absolute colorless; violet leaf absolute colorless; whiskey extract nat wonf; whiskey nat extract 80.5512; ylang petal natural; actiscent rose cardinale #g11413375; alcool cinnamifur reconstitute; aldehyde icl b 220126us; algenone p.b.; aloe; amber incense; animalis 1745-3; anthrarose; apple natural w/o acetaldehyde; apricot absolute natural; apricot fragrance; apricot nat 4938/7 w/o acetald; apricot nat w/o acetald.grasse; apricot nat w/o acetaldehyde; apricot natural; aquarama/7—no formula; armoise; armoise ex 253591us; aromatic cucumber; base pomme 44%vstat p&n 838358; base schiff helional 50% dpg; basil spec w/o methyl chavicol; berg deterp n/coco base 191; bergamot; bergamot 115 000115us; bergamot 677 250136us; bergamot oil type; bergamot reconstituted; bergamot subs sp; bergamote 153 000153us; black tea colorless natural; blackcurrant bud composition; blanc gardenia/4—no formula; body creator 2 k/64708—no fo; bois des landes (pine wood); broom absolute type; cacao clair 254117us; cajeput oil substitute; cascarilla substitute oil; cassis 02087/d 475612us; cassis 1-706 250172us; cassis 731 (000731us); cassis bourgeons abs pure; cassis feuilles 101(000101us); cassis p 101199 french version; castoreum reco syn 09 254658us; cedar hyper conc 50% dpg; cedrat (citron tree) heart nat; chloe g10636399—no formula; cinnamon bark oliffac (b) 230520; citrix 130 000130us; citrus & sage/plug in frag; clementine 5829/3; cocoa dpg; concombre hesperide; concombre nat; concombre ss salicylate exad7903 l'oreal 0067t470; corp geranium nt 812; corps prepare 230085us; costus oliffac; cucumber; cucumber chamomile 5986; cucumber nat; cucumber nat grasse version; cucumber rose; cypress type oil; damasflor 615b 250180us; deo natural; dewfruit 040201; eau de chloe g110 27210—no f; ecocert lavande p10822—no fo; eucalyptus mint lavender 6146; fairy dance g11012679—no fo; fauvalone sp w/o nitro musks; fig specialty ifra; figuene; fir balsam colorless subst.; fir balsam subst abs nat kosh; fir balsam substitute abs nat; fir bud type; fleur de carotte frag/french; flo jasmin 62-812h 251177us; flo jasmin benzol 79-818; flo narcisse 9-800 250011us; flo neroli 74825 250053us; flo rose 61-813b 251013us; flo rosessence80-819b 251014us; flo tuberose 55-842 250075us; flo.ylang 110104us; fragrance; fragrance p10729—no formula; fragrance p10784—no formula; fraise arome (french version); fraise poivree p11044—no for; framboise d'ete p110122—no f; fruity base; galaxolide dpg 50 070076; galaxolide ipm 50; galbanodor; galbanum colorless; galbanum savoy sub 480223us; galbanum synth r (s/a 2374); galbanum synthy ess 131; galbanum top 18326 saf; gardenia odoressence; geranium absolute ni; ginger sushi 4566; grapefruit nat; grapefruit nat (grasse); hay abs.b.a. colorless p&n; helichrysum flavor; jasmarol 000120us; jasmin 132-121 000121us; jasmin absolute ifra sp; jasmin m; jasmin petal natural; jonquil hyaciinth absolute type; jonquil hyacinth type wo dep; juniperberry oil type; karine g 9743268; karo karounde abs subs natural; karo karounde sub natural; karo karounde subst w/o champ; karolina scent strip oil g108-; kukui nut; labdanum absolute 50% dpg; labdanum claire; labdanum colorless; labdanum colorless dep free; labdanum resin 20% dpg; labdanum resin pays; labdanum resinoid; lait; lavender oil 50/52 030081us; lavender oil for aromatic note; lemon oil; lentisque type resinoid; liatrix subst abs dec ni; l'oreal p107637—no formula; l'oreal sr176—no formula; loriana g-10029374 grasse; loriana g10323250—no formula; loriana mod g10029374—no for; loriana mod g10323250—no for; lt.hair frag; mandarinix 246 000246us; mate abs 40% citroflex a2; mate absolute dec 40%citroflex; mate absolute decolore; mate absolute green 10% dpg; mate dec special abs. 220896; mate tobacco 253414us; mauve guimauve; miel des pyrenes p 991198; mimosa abs cp sape chv 1423; mimosa flo 56/827h 254365us; mimosa type absolute; mousse d'arbre absolute; muscine type resinoid; musk sv; my hair frag; narcisse floaline 79/800 b; narcisse sans pe 00426/1; natural peche 673609; neroli oil ex chr; neroli water stabilized flavor; oakmoss 50% citroflex ifra 43; oakmoss abs ifra 43; oakmoss absolute ifra 43 colorless; ocean breeze/plug in frag; olibanol; olibanol lot ii; olibanum absolute on dpg; olibanum resin claire; olibanum wood natural; olivade without dep; olive natural g108 8988; opoponax wood natural; orange mint 5979; orchidee thai ghg 674(116100); orchidee vanille p110108—no; oriental spice(g996385); orris 243 resin; orris liquid; osmanthus abs substitute; osmanthus odoresence(hs); osmanthus type absolute 7600; p100441—no formula—for rec; p107624 l'oreal—no formula; passion ginger p110113—no fo; pasteque/french version; patchouli sub ess oil 934184; patchouly subs essential oil; patchouly substitute; pear natural; peche 657 ifra 44; peche; peche natural 3845/1—no form; petale de camelia (grasse); petitgrain citronnier; pin bt resin; pineapple nectar; pomme oliffac depr 0407b; premix 2c base; prunella 118 000118us; raspberry; raspberry natural; reseda absolute; revitaleaf cs (grasse); rose conc abs t23/45 116089us; rose concentree de'leau; rose ecoconcentrate; rose flavor w/o paraben; rose oil low m.e. content; rose patchouly (french oil); rose violette p110105—no for; rose wt 19s 000195us; rum extract on crodamol; santal s pcf free; santal sb; seaweed nhs; sensa; sleeptime; stay asleep; strawberry; strawberry natural two; strawberry w/o dep; styrax low styrene; styrax type resin; styrolene; synanitrile; tagette absolute type; tangenil 06265b 230304us; tangerine 00372/td 471596us; tetrahydro mugol; the bryant park; the matcha i p001062; tobacco abs type w/o nicotine; toliris; tolu inc type abs. 050150us; tolu type abs. 050149us; tomato natural; tonka feves; tonka feves resin 50% dep; tonka infusion; tonkarome rifm; treemoss abs a 50% citroflex; treemoss abs type ifra 43; treemoss absolute type 43a; treemoss conc ifra 43; treemoss ifra 43a; treemoss ifra abs ti-1110 dno; treemoss inc ifra 43a; treemoss resinoid ifra 43; treemoss type absolute ifra 43; treemoss type conc ifra 43; tubereuse 55 ss pe floraline; tuberose 258b 000508us; tuberose 32 ussp; tuberose enfl type abs lot ii; tuberose floraline 99; tulipe floraline 040588; vahine 9645/14 (french oil); vanila; vanilla 90% volume infusion; vanilla infusion; vanille 704 250170us; vanille 75% v infusion—no fo; vanille arome 050266us; vanille surfina ex sol abs.; vergel base; west side candle oil (grasse); wormwood oil type; ylang iii extender; ylang type essence; young skin 3 fragrance; yuzu reco t 20/87 110107us; elisa coeur g103 15460; elfapur lm75s lavreth 221453us; and, ethomeen c25 220040us. Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is June 23, 2015. A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible via www.trade.gov/ftz. For further information, contact Kathleen Boyce at Kathleen.Boyce@trade.gov or (202) 482-1346. Dated: May 7, 2015. Andrew McGilvray, Executive Secretary. [FR Doc. 2015-11578 Filed 5-13-15; 8:45 am] BILLING CODE 3510-DS-P