83 FR 44894 - Notice of Issuance of Final Determination Concerning the Visionary Advanced 2 Dietary Supplement Tablets
DEPARTMENT OF HOMELAND SECURITY
U.S. Customs and Border Protection Federal Register Volume 83, Issue 171 (September 4, 2018)
U.S. Customs and Border Protection
Federal Register Volume 83, Issue 171 (September 4, 2018)
| Page Range | 44894-44896 | |
| FR Document | 2018-19162 |
[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)] [Notices] [Pages 44894-44896] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19162] [[Page 44894]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Notice of Issuance of Final Determination Concerning the Visionary Advanced 2 Dietary Supplement Tablets AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of final determination. ----------------------------------------------------------------------- SUMMARY: This document provides notice that U.S. Customs and Border Protection (``CBP'') has issued a final determination concerning the country of origin of three Visionary Advanced 2 vitamin and mineral dietary supplement tablets. Based upon the facts presented, for purposes of U.S. Government procurement, CBP has concluded that the United States is the country of origin of the Advanced 2 vitamin and mineral dietary supplement tablets. DATES: The final determination was issued on August 27, 2018. A copy of the final determination is attached. Any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of this final determination within October 4, 2018. FOR FURTHER INFORMATION CONTACT: Robert Dinerstein, Valuation and Special Programs Branch, Regulations and Rulings, Office of Trade, at (202) 325-0132. SUPPLEMENTARY INFORMATION: Notice is hereby given that on August 27, 2018, pursuant to subpart B of part 177, U.S. Customs and Border Protection Regulations (19 CFR part 177, subpart B), CBP issued a final determination concerning the country of origin of three versions of the Visionary Advanced 2 vitamin and mineral dietary supplement tablets which may be offered to the U.S. Government under an undesignated government procurement contract. This final determination, HQ H299717, copy attached, was issued under procedures set forth at 19 CFR part 177, subpart B, which implements Title Ill of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511-18). The three products are Visionary Advanced 2 coated tablets, Visionary Orange Advanced 2 chewable tablets, and Visionary Cherry Advanced 2 chewable tablets. Each of the dietary supplement tablets contains the same basic formula of vitamins and minerals, but with different flavorings. In the final determination, CBP concluded that the combining of the various vitamins and minerals in one tablet in the United States results in a product that has a name, character and use that is distinct from the individual ingredients that are used to make the dietary supplement. Therefore, for purposes of U.S. Government procurement, the United States is the country of origin. Section 177.29, CBP Regulations (19 CFR 177.29), provides that a notice of final determination shall be published in the Federal Register within 60 days of the date the final determination is issued. Section 177.30, CBP Regulations (19 CFR 177.30), provides that any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of a final determination within 30 days of publication of such determination in the Federal Register. Dated: August 27, 2018. Alice A. Kipel, Executive Director, Regulations and Rulings, Office of Trade. HQ H299717 August 27, 2018 OT:RR:CTF:VS H299717 RSD CATEGORY: Origin Mr. Marino Apollinari Visionary Vitamin Co. P.O. Box 1825 Dearborn, Michigan 48122 RE: U.S. Government Procurement; Country of Origin of Advanced 2 Multiple Vitamin and Mineral Dietary Supplement Tablets; Substantial Transformation Dear Mr. Apollinari: This is in response to the Visionary Vitamin Company's (Visionary's) request of June 4, 2018, for a final determination concerning the country of origin of products known as the Visionary Advanced 2 dietary supplements pursuant to subpart B of Part 177 of the U.S. Customs and Border protection (``CBP'') Regulations (19 C.F.R. Part 177). The National Commodity Specialist Division forwarded your request to the Headquarters office of Regulations and Rulings to issue this final determination. As an importer, Visionary is a party-at-interest within the meaning of 19 C.F.R. Sec. 177.22(d)(1) and is entitled to request this final determination. FACTS: Visionary is a manufacturer of dietary supplements. At issue are three different multiple vitamin and mineral dietary supplement tablets. The three dietary supplement tablets are the Advanced 2 Coated tablets, the Visionary Orange Advanced 2 chewable tablets, and the Visionary Cherry Advanced 2 chewable tablets. The vitamin and mineral tablets contain the following raw materials: ------------------------------------------------------------------------ Country of origin ------------------------------------------------------------------------ Medicinal Ingredients: Vitamin C DC grade (Ascorbic Acid) (97%). China. Vitamin E (As DL-Alpha Tocopherol China. Acetate) 50%-Tab grad. Zinc (as oxide) (80.34%)................. India. Copper (as cupric oxide) (78.3%)......... USA. Lutein (5%) beadlets..................... China. Zeaxanthin (5%) beadlets from Omnixan.... USA. Other ingredients: DI Calcium Phosphate..................... China. Micro crystalline Cellulose.............. India. Croscarmellose Sodium.................... Brazil. Silicon Dioxide.......................... USA. Magnesium Stearate (vegetable source).... Spain. Stearic Acid Vegetable grade............. Malaysia. Pharmaceutical Glaze (only used for USA. coated tablets). ------------------------------------------------------------------------ Instead of pharmaceutical glaze, the chewable orange and cherry tablets contain a natural masking flavor from the United States, either in a natural orange flavor or natural cherry flavor. In addition, the chewable cherry and orange tablets also incorporate sucralose from China. You have indicated that the most expensive single ingredient used in making the Advanced 2 dietary supplement tablets is the Zeaxanthin Omnixan from the United States. [[Page 44895]] The manufacturing processes of the three products occurs at Visionary's facility in Michigan, United States. The same basic procedures are used to manufacture the three different dietary supplement tablets. A flow chart of the processes was submitted. The active and inactive ingredients in powder form are weighed and all vital information is logged in. Next, the ingredients are dispensed, and the dry mix is blended. A vibro sifter is used to pass the raw powder materials through a 40-mesh screen, while being added to a drum for mixing. Weight and yield are recorded. Mixing and lubrication is performed by a blender. The approved blend is then transferred to the compression area. The blend is loaded into the hopper of a tablet press. The tablet press is set for the specified parameters and the details are noted in a start-up test during the tablet compression. The weight of the first few tablets is taken and checked against the actual weight of the product. Adjustments in the weight of the tablets are made until the right weight is obtained. The hardness of the tablets is also adjusted by carefully turning the pressure rollers by hand until the correct hardness is obtained. The tablets are then compared to previous samples. A series of in-process quality checks are performed in various intervals while the tablets are produced. These include: 1) appearance; 2) average weight per 10 tablets; 3) tablet thickness); 4) disintegration of tablet; 5) friability; 6) hardness; and 7) temperature and humidity. The coating solution is prepared by loading the tablets in a pan and recording the actual weight. The tablets are pre-heated until the temperature reaches 100 degrees Fahrenheit. The coating solution is sprayed on the tablets until all surfaces of the tablets are covered. The tablets are unloaded into trays and placed in an oven room for drying. The tablets are then sorted and damaged tablets (such as broken, color or thickness variance, capping issues, or black/foreign material) are rejected. Next, the product moves to the packaging line using the following equipment: an unscrambler, a conveyor, a tablet counter, a cottoner, a capper labeler, induction sealer, heat tunnel, printer coder, accumulation table and weighing balance. A system of quality controls occurs to ensure that the tablets are properly packaged, coded, and labeled. ISSUE: What is the country of origin of the Visionary Advanced 2 Coated tablets, Visionary Orange Advanced 2 Chewable tablets, and Visionary Cherry Advanced 2 Chewable tablets for purposes of U.S. Government procurement? LAW AND ANALYSIS: CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain ``Buy American'' restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 C.F.R. Sec. 177.21 et seq., which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. Sec. 2511 et seq.) (``TAA''). Under the rule of origin set forth under 19 U.S.C. Sec. 2518(4)(8): An article is a product of a country or instrumentality only if (i) it is wholly the growth, product, or manufacture of that country or instrumentality, or (ii) in the case of an article which consists in whole or in part of materials from another country or instrumentality, it has been substantially transformed into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was so transformed. See also 19 C.F.R. Sec. 177.22(a). In rendering advisory rulings and final determinations for purposes of U.S. Government procurement, CBP applies the provisions of subpart B of Part 177 consistent with Federal Acquisition Regulations. See 19 C.F.R. Sec. 177.21. In this regard, CBP recognizes that the Federal Acquisition Regulations restrict the U.S. Government's purchase of products to U.S.-made or designated country end products for acquisitions subject to the TAA. See 48 C.F.R. Sec. 25.403(c)(1). The Federal Acquisition Regulations define ``U.S.-made end product'' as: . . . an article that is mined, produced, or manufactured in the United States or that is substantially transformed in the United States into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed. 48 C.F.R. Sec. 25.003. A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and, National Juice Products Association v. United States, 628 F. Supp. 978 (Ct. lnt'I Trade 1986). With respect to whether combining and mixing different materials results in a substantial transformation, CBP held in Headquarters Ruling Letter (``HQ'') 731685, dated March 15, 1990, that converting fruit concentrates and other ingredients into fruit drinks in Mexico constituted a substantial transformation. The manufacturing process involved mixing the juice concentrates with other ingredients including water, artificial flavor, sodium benzoate, and food coloring. CBP held that, considering the totality of the circumstances, a substantial transformation had occurred because ``[t]he juice concentrates are subsumed into a product that is no longer considered a juice.'' This situation is distinguished from a situation considered in National Juice Products Ass'n v. United States, 628 F. Supp. 978 (Ct. lnt'I Trade 1986), in which the United States Court of International Trade (``CIT'') upheld CBP's decision in HQ 728557, dated September 4, 1985, that imported orange juice concentrate was not substantially transformed when it was mixed with water, essential oils, flavoring ingredients and domestic fresh juice in order to produce frozen concentrated orange juice and reconstituted orange juice. CBP found that the manufacturing process did not create an article with a new name, character or use. The CIT agreed that the manufacturing process did not change the ``fundamental character of the product'' as ``it was still essentially the juice of oranges``. See HQ H237605 dated June 25, 2014. In HQ 731685, a substantial transformation was found because the raw ingredients had been converted into a different article of commerce through a process beyond simple combining, packaging or mere diluting. In the context of the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. CBP has generally held that the processing of pharmaceutical products from bulk form into measured doses does not result in a substantial transformation. See, e.g., HQ 561975, dated April 3, 2002; HQ 561544, dated May 1, 2000; HQ 735146, dated November 15, 1993; HQ H267177, dated November 5, 2016; HQ H233356, dated December 26, 2012; and, HQ 561975, dated April 3, 2002. However, where the processing from bulk form into measured doses involves the combination of two or more active ingredients and the resulting combination offers additional medicinal benefits compared to taking each alone, CBP has held that a substantial transformation occurs. See, e.g., HQ 563207, dated June 1, 2005. For example, in HQ 563207, CBP held that the combination of two APls to form Actoplus Met, an alternative treatment for type 2 diabetes, constituted a substantial transformation. The first API, Pioglitazone HCI sourced from Japan or other countries, functioned as an insulin sensitizer that targets insulin resistance in the body. The second API, biguanide sourced from Japan, Spain, and other countries, functioned to decrease the amount of glucose produced by the liver and to make muscle tissue more sensitive to insulin so glucose can be absorbed. In Japan, the two APls were mixed together to form the Ectoplasm Met. In holding that a substantial transformation occurred when the two APl's were combined, CBP emphasized that ``[w]hile we note that pioglitazone and metformin may be prescribed separately, the final product, Actoplus Met, increases the individual effectiveness of piofliazone and metformin in treating type 2 diabetes patients.'' Similarly, in HQ H253443, dated March 13, 2015, CSP held that the combination of two APls in China to produce Prepopik, ``a dual- acting osmotic and stimulant laxative bowel preparation for a colonoscopy in adults,'' constituted a substantial transformation. CBP found that taking Prepopik had ``a more stimulative laxative effect'' than taking each of the APls individually. Further, in HQ H290684, dated July 2, 2018, CSP considered the country of origin of Malarone, a drug indicated for the prevention and treatment of acute, uncomplicated Plasmodium falciparum malaria. Two separate APls were [[Page 44896]] mixed to create a fixed combination drug that offered additional medicinal benefits compared to taking each API alone. The first API, atovaquone, was not indicated for the prevention or treatment of malaria, the second API, proguanil hydrochloride, was used to treat malaria, but was less effective than Malarone. Because of the ``synergies in [the APls'] method of action,'' which resulted in a product that ``interfere[s] with 2 different pathways'' to prevent and treat malaria, CBP held that the combination of atovaquone, proguanil hydrochloride, and inactive ingredients to form the Malarone tablets in Canada resulted in a substantial transformation. In this case, to make the dietary supplement tablets, various ingredients from different countries of origin are mixed together based on a specific formula. This results in a finished product that differs from any of the individual ingredients. The vitamins and minerals are put together in one tablet for the purposes of creating a product that is designed to promote certain effects that are distinct from the effects if only the individual ingredients were taken. Similar to HQ H253443, the combination of the vitamins and minerals in a single tablet creates a product with a synergistic effect that promotes benefits that otherwise would only be possible by taking the individual ingredients separately. In other words, the combination of the various vitamins and minerals in one tablet results in a product that has an identity, character and use that is different from and more convenient to use than taking the individual raw materials. Accordingly, we find that the three Visionary dietary supplement tablets have a new name, character and use different from the individual vitamins, minerals, and the inert ingredients used in the production of the finished tablets. Therefore, we find that the country of origin of the Visionary Advanced 2 multiple vitamin and mineral dietary supplement tablets is the United States, where the manufacturing process take place. HOLDING: The country of origin of the Visionary Advanced 2 Coated Tablets, Visionary Orange Advanced 2 Chewable Tablets, and Visionary Cherry Advanced 2 Chewable Tablets for purpose of U.S. Government procurement is the United States. Notice of this final determination will be given in the Federal Register, as required by 19 C.F.R. Sec. 177.29. Any party-at- interest other than the party which requested this final determination may request, pursuant to 19 C.F.R. Sec. 177.31, that CBP reexamine the matter anew and issue a new final determination. Pursuant to 19 C.F.R. Sec. 177.30, any party-at-interest may, within 30 days of publication of the Federal Register Notice referenced above, seek judicial review of this final determination before the Court of International Trade. Sincerely, Alice A. Kipel, Executive Director Regulations & Rulings Office of Trade [FR Doc. 2018-19162 Filed 8-31-18; 8:45 am] BILLING CODE P
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The manufacturing processes of the three Part 177, 19 C.F.R. § 177.21 et seq., which essential oils, flavoring ingredients and
products occurs at Visionary’s facility in implements Title III of the Trade Agreements domestic fresh juice in order to produce
Michigan, United States. The same basic Act of 1979, as amended (19 U.S.C. § 2511 et frozen concentrated orange juice and
procedures are used to manufacture the three seq.) (‘‘TAA’’). reconstituted orange juice. CBP found that
different dietary supplement tablets. A flow Under the rule of origin set forth under 19 the manufacturing process did not create an
chart of the processes was submitted. The U.S.C. § 2518(4)(8): article with a new name, character or use.
active and inactive ingredients in powder An article is a product of a country or The CIT agreed that the manufacturing
form are weighed and all vital information is instrumentality only if (i) it is wholly the process did not change the ‘‘fundamental
logged in. growth, product, or manufacture of that character of the product’’ as ‘‘it was still
Next, the ingredients are dispensed, and country or instrumentality, or (ii) in the case essentially the juice of oranges‘‘. See HQ
the dry mix is blended. A vibro sifter is used of an article which consists in whole or in H237605 dated June 25, 2014. In HQ 731685,
to pass the raw powder materials through a part of materials from another country or a substantial transformation was found
40-mesh screen, while being added to a drum instrumentality, it has been substantially because the raw ingredients had been
for mixing. Weight and yield are recorded. transformed into a new and different article converted into a different article of commerce
Mixing and lubrication is performed by a of commerce with a name, character, or use through a process beyond simple combining,
blender. distinct from that of the article or articles packaging or mere diluting.
The approved blend is then transferred to from which it was so transformed. In the context of the manufacture of
the compression area. The blend is loaded See also 19 C.F.R. § 177.22(a). chemical products such as pharmaceuticals,
into the hopper of a tablet press. The tablet In rendering advisory rulings and final CBP has consistently examined the
press is set for the specified parameters and determinations for purposes of U.S. complexity of the processing and whether the
the details are noted in a start-up test during Government procurement, CBP applies the final article retains the essential identity and
the tablet compression. The weight of the provisions of subpart B of Part 177 consistent character of the raw material. CBP has
first few tablets is taken and checked against with Federal Acquisition Regulations. See 19 generally held that the processing of
the actual weight of the product. C.F.R. § 177.21. In this regard, CBP pharmaceutical products from bulk form into
Adjustments in the weight of the tablets are recognizes that the Federal Acquisition measured doses does not result in a
made until the right weight is obtained. The Regulations restrict the U.S. Government’s substantial transformation. See, e.g., HQ
hardness of the tablets is also adjusted by purchase of products to U.S.-made or 561975, dated April 3, 2002; HQ 561544,
carefully turning the pressure rollers by hand designated country end products for dated May 1, 2000; HQ 735146, dated
until the correct hardness is obtained. The acquisitions subject to the TAA. See 48 November 15, 1993; HQ H267177, dated
tablets are then compared to previous C.F.R. § 25.403(c)(1). The Federal Acquisition November 5, 2016; HQ H233356, dated
samples. A series of in-process quality checks Regulations define ‘‘U.S.-made end product’’ December 26, 2012; and, HQ 561975, dated
are performed in various intervals while the as: April 3, 2002. However, where the processing
tablets are produced. These include: 1) . . . an article that is mined, produced, or from bulk form into measured doses involves
appearance; 2) average weight per 10 tablets; manufactured in the United States or that is the combination of two or more active
3) tablet thickness); 4) disintegration of substantially transformed in the United ingredients and the resulting combination
tablet; 5) friability; 6) hardness; and 7) States into a new and different article of offers additional medicinal benefits
temperature and humidity. commerce with a name, character, or use compared to taking each alone, CBP has held
The coating solution is prepared by loading distinct from that of the article or articles that a substantial transformation occurs. See,
the tablets in a pan and recording the actual from which it was transformed. e.g., HQ 563207, dated June 1, 2005.
weight. The tablets are pre-heated until the 48 C.F.R. § 25.003. For example, in HQ 563207, CBP held that
temperature reaches 100 degrees Fahrenheit. A substantial transformation occurs when the combination of two APls to form
The coating solution is sprayed on the tablets an article emerges from a process with a new Actoplus Met, an alternative treatment for
until all surfaces of the tablets are covered. name, character or use different from that type 2 diabetes, constituted a substantial
The tablets are unloaded into trays and possessed by the article prior to processing. transformation. The first API, Pioglitazone
placed in an oven room for drying. The A substantial transformation will not result HCI sourced from Japan or other countries,
tablets are then sorted and damaged tablets from a minor manufacturing or combining functioned as an insulin sensitizer that
(such as broken, color or thickness variance, process that leaves the identity of the article targets insulin resistance in the body. The
capping issues, or black/foreign material) are intact. See United States v. Gibson-Thomsen second API, biguanide sourced from Japan,
rejected. Co., 27 C.C.P.A. 267 (1940); and, National Spain, and other countries, functioned to
Next, the product moves to the packaging Juice Products Association v. United States, decrease the amount of glucose produced by
line using the following equipment: an 628 F. Supp. 978 (Ct. lnt’I Trade 1986). the liver and to make muscle tissue more
unscrambler, a conveyor, a tablet counter, a With respect to whether combining and sensitive to insulin so glucose can be
cottoner, a capper labeler, induction sealer, mixing different materials results in a absorbed. In Japan, the two APls were mixed
heat tunnel, printer coder, accumulation substantial transformation, CBP held in together to form the Ectoplasm Met. In
table and weighing balance. A system of Headquarters Ruling Letter (‘‘HQ’’) 731685, holding that a substantial transformation
quality controls occurs to ensure that the dated March 15, 1990, that converting fruit occurred when the two APl’s were combined,
tablets are properly packaged, coded, and concentrates and other ingredients into fruit CBP emphasized that ‘‘[w]hile we note that
labeled. drinks in Mexico constituted a substantial pioglitazone and metformin may be
transformation. The manufacturing process prescribed separately, the final product,
ISSUE: involved mixing the juice concentrates with Actoplus Met, increases the individual
What is the country of origin of the other ingredients including water, artificial effectiveness of piofliazone and metformin in
Visionary Advanced 2 Coated tablets, flavor, sodium benzoate, and food coloring. treating type 2 diabetes patients.’’
Visionary Orange Advanced 2 Chewable CBP held that, considering the totality of the Similarly, in HQ H253443, dated March 13,
tablets, and Visionary Cherry Advanced 2 circumstances, a substantial transformation 2015, CSP held that the combination of two
Chewable tablets for purposes of U.S. had occurred because ‘‘[t]he juice APls in China to produce Prepopik, ‘‘a dual-
Government procurement? concentrates are subsumed into a product acting osmotic and stimulant laxative bowel
that is no longer considered a juice.’’ This preparation for a colonoscopy in adults,’’
LAW AND ANALYSIS: situation is distinguished from a situation constituted a substantial transformation. CBP
sradovich on DSK3GMQ082PROD with NOTICES
CBP issues country of origin advisory considered in National Juice Products Ass’n found that taking Prepopik had ‘‘a more
rulings and final determinations as to v. United States, 628 F. Supp. 978 (Ct. lnt’I stimulative laxative effect’’ than taking each
whether an article is or would be a product Trade 1986), in which the United States of the APls individually. Further, in HQ
of a designated country or instrumentality for Court of International Trade (‘‘CIT’’) upheld H290684, dated July 2, 2018, CSP considered
the purposes of granting waivers of certain CBP’s decision in HQ 728557, dated the country of origin of Malarone, a drug
‘‘Buy American’’ restrictions in U.S. law or September 4, 1985, that imported orange indicated for the prevention and treatment of
practice for products offered for sale to the juice concentrate was not substantially acute, uncomplicated Plasmodium
U.S. Government, pursuant to subpart B of transformed when it was mixed with water, falciparum malaria. Two separate APls were
VerDate Sep<11>2014 17:54 Aug 31, 2018 Jkt 244001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\04SEN1.SGM 04SEN1](https://thefederalregister.org/doc/83_FR_45065/page/2.svg)
![44896 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices
mixed to create a fixed combination drug that INTER-AMERICAN FOUNDATION Engineer, by telephone at 601–919–
offered additional medicinal benefits 4668, by email to ramills@blm.gov, or at
compared to taking each API alone. The first Sunshine Act Meetings the address indicated above. Persons
API, atovaquone, was not indicated for the
prevention or treatment of malaria, the
who use a telecommunications device
TIME AND DATE: September 6, 2018, 11:00 for the deaf (TDD) may call the Federal
second API, proguanil hydrochloride, was a.m.–12:00 p.m.
used to treat malaria, but was less effective Relay Service (FRS) at 1–800–877–8339
than Malarone. Because of the ‘‘synergies in PLACE: Via tele-conference hosted at to contact the above individual during
[the APls’] method of action,’’ which resulted Inter-American Foundation, 1331 normal business hours. The FRS is
in a product that ‘‘interfere[s] with 2 different Pennsylvania Ave. NW, Suite 1200, available 24 hours a day, 7 days a week,
pathways’’ to prevent and treat malaria, CBP Washington, DC 20004. to leave a message or question with the
held that the combination of atovaquone, STATUS: Meeting of the Board of above individual. You will receive a
proguanil hydrochloride, and inactive Directors, Open to the public.
ingredients to form the Malarone tablets in reply during normal business hours.
Canada resulted in a substantial MATTERS TO BE CONSIDERED: SUPPLEMENTARY INFORMATION: This coal
transformation. • Commemorating the IAF’s 50th lease sale is being held in response to
In this case, to make the dietary Anniversary a lease by application (LBA) filed by
supplement tablets, various ingredients from FOR DIAL-IN INFORMATION CONTACT: Karen Best Coal Company. The Federal coal
different countries of origin are mixed Vargas, Executive Assistant, (202) 524– reserves to be re-offered consist of all
together based on a specific formula. This 8869. reserves recoverable by surface mining
results in a finished product that differs from
CONTACT PERSON FOR MORE INFORMATION: methods in the following described
any of the individual ingredients. The
vitamins and minerals are put together in one Paul Zimmerman, General Counsel, lands located approximately 5 miles
tablet for the purposes of creating a product (202) 683–7118. north of Mt. Olive, Alabama, in Jefferson
that is designed to promote certain effects Paul Zimmerman,
County, Alabama:
that are distinct from the effects if only the
General Counsel. Huntsville Meridian, Alabama
individual ingredients were taken. Similar to
HQ H253443, the combination of the [FR Doc. 2018–19190 Filed 8–30–18; 11:15 am] T. 15 S, R. 4 W,
vitamins and minerals in a single tablet BILLING CODE 7025–01–P Sec. 24, SW1⁄4NW1⁄4, N1⁄2SW1⁄4, and
creates a product with a synergistic effect SE1⁄4SW1⁄4.
that promotes benefits that otherwise would The areas described aggregate 160.82 acres.
only be possible by taking the individual
DEPARTMENT OF THE INTERIOR The Narley Mine Coal Tract contains
ingredients separately. In other words, the
combination of the various vitamins and three minable coal beds known as the
minerals in one tablet results in a product
Bureau of Land Management New Castle, Mary Lee, and Blue Creek
that has an identity, character and use that [LLES930000.LLES1320000.EL0000] seams of the Mary Lee coal group. The
is different from and more convenient to use seams are under private surface lands.
than taking the individual raw materials. Notice of Competitive Coal Lease Sale The minable thickness of these coal
Accordingly, we find that the three Visionary ALES–55199, Alabama beds for this tract are approximately 4
dietary supplement tablets have a new name, to 5 feet. The tract contains
character and use different from the AGENCY: Bureau of Land Management,
approximately 469,000 tons of
individual vitamins, minerals, and the inert Interior.
ingredients used in the production of the recoverable high-volatile bituminous
ACTION: Notice. coal. The estimated average coal quality
finished tablets. Therefore, we find that the
country of origin of the Visionary Advanced SUMMARY: Notice is hereby given that on an ‘‘as received basis’’ is as follows:
2 multiple vitamin and mineral dietary the coal resources in the lands described
supplement tablets is the United States, below in Jefferson County, Alabama, 12,500 ......... British Thermal Unit (Btu/lb).
where the manufacturing process take place. 3.50 ............. Percent moisture.*
will be re-offered for competitive lease
HOLDING: by sealed bid in accordance with the 12.00 ........... Percent ash.
34 ................ Percent volatile matter.
The country of origin of the Visionary provisions of the Mineral Leasing Act of 50.50 ........... Percent fixed carbon.
Advanced 2 Coated Tablets, Visionary 1920, as amended. 1.50 ............. Percent sulfur.
Orange Advanced 2 Chewable Tablets, and DATES: The coal lease sale will be held * Estimated as received moisture; also
Visionary Cherry Advanced 2 Chewable at 1 p.m. Central Daylight Time (CDT) used for calculating as received from dry
Tablets for purpose of U.S. Government on a date to be determined by the BLM basis.
procurement is the United States.
Notice of this final determination will be
Eastern States Deputy State Director, no The tract will be leased to the
given in the Federal Register, as required by sooner than October 4, 2018. Sealed qualified bidder of the highest cash
19 C.F.R. § 177.29. Any party-at-interest other bids must be received on or before 10 amount, provided that the bid meets or
than the party which requested this final a.m. CDT on the date of sale. exceeds the BLM’s estimate of the fair
determination may request, pursuant to 19 ADDRESSES: The date of the sale will be market value of the tract. The minimum
C.F.R. § 177.31, that CBP reexamine the posted at https://www.blm.gov/eastern- bid established by regulation is $100 per
matter anew and issue a new final states. The lease sale will be held at the acre or fraction thereof. The minimum
determination. Pursuant to 19 C.F.R.
Bureau of Land Management (BLM) bid is not intended to represent fair
§ 177.30, any party-at-interest may, within 30
days of publication of the Federal Register Southeastern States District Office market value. The fair-market value will
Notice referenced above, seek judicial review located at 273 Market Street, Flowood, be determined by the authorized officer
of this final determination before the Court MS 39232. The Detailed Statement of after the sale.
Lease Sale, the proposed coal lease, and The sealed bids should be sent by
sradovich on DSK3GMQ082PROD with NOTICES
of International Trade.
Sincerely, Casefile ALES–55199 are available at certified mail, return-receipt requested,
this address. Sealed bids must be or be hand delivered to the cashier,
Alice A. Kipel, Executive Director submitted to the Cashier, BLM BLM Southeastern States District Office,
Regulations & Rulings
Southeastern States District Office, at at the address given above and clearly
Office of Trade
this same address. marked ‘‘Sealed Bid for ALES–55199
[FR Doc. 2018–19162 Filed 8–31–18; 8:45 am] FOR FURTHER INFORMATION CONTACT: Coal Sale—Not to be opened before 1
BILLING CODE P Contact Randall Mills, BLM Mining p.m. CDT on (date of Sale), 2018.’’ The
VerDate Sep<11>2014 17:54 Aug 31, 2018 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\04SEN1.SGM 04SEN1](https://thefederalregister.org/doc/83_FR_45065/page/3.svg)
Document Created: 2018-09-01 02:59:40
Document Modified: 2018-09-01 02:59:40
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of final determination. | |
| Dates | The final determination was issued on August 27, 2018. A copy of the final determination is attached. Any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of this final determination within October 4, 2018. | |
| Contact | Robert Dinerstein, Valuation and Special Programs Branch, Regulations and Rulings, Office of Trade, at (202) 325-0132. | |
| FR Citation | 83 FR 44894 |
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