44894 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices 

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-atinterest, 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-atinterest within the meaning of 19 C.F.R. 

§ 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 Acetate) 50%-Tab grad .................................................................................................. China. 

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 coated tablets) ............................................................................................................... USA. 

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. 


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Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices 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. § 177.21 et seq., which 

implements Title III of the Trade Agreements 

Act of 1979, as amended (19 U.S.C. § 2511 et 

seq.) (‘‘TAA’’). 

Under the rule of origin set forth under 19 

U.S.C. § 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. § 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. § 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. § 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. § 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 dualacting 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 


sradovich on DSK3GMQ082PROD with NOTICES
44896 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices 

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. § 177.29. Any party-at-interest other 

than the party which requested this final 

determination may request, pursuant to 19 

C.F.R. § 177.31, that CBP reexamine the 

matter anew and issue a new final 

determination. Pursuant to 19 C.F.R. 

§ 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 

INTER-AMERICAN FOUNDATION 

Sunshine Act Meetings 

TIME AND DATE: September 6, 2018, 11:00 

a.m.–12:00 p.m. 

PLACE: Via tele-conference hosted at 

Inter-American Foundation, 1331 

Pennsylvania Ave. NW, Suite 1200, 

Washington, DC 20004. 

STATUS: Meeting of the Board of 

Directors, Open to the public. 

MATTERS TO BE CONSIDERED: 

• Commemorating the IAF’s 50th 

Anniversary 

FOR DIAL-IN INFORMATION CONTACT: Karen 

Vargas, Executive Assistant, (202) 524– 

8869. 

CONTACT PERSON FOR MORE INFORMATION: 

Paul Zimmerman, General Counsel, 

(202) 683–7118. 

Paul Zimmerman, 

General Counsel. 

[FR Doc. 2018–19190 Filed 8–30–18; 11:15 am] 

BILLING CODE 7025–01–P 

DEPARTMENT OF THE INTERIOR 

Bureau of Land Management 

[LLES930000.LLES1320000.EL0000] 

Notice of Competitive Coal Lease Sale 

ALES–55199, Alabama 

AGENCY: Bureau of Land Management, 

Interior. 

ACTION: Notice. 

SUMMARY: Notice is hereby given that 

the coal resources in the lands described 

below in Jefferson County, Alabama, 

will be re-offered for competitive lease 

by sealed bid in accordance with the 

provisions of the Mineral Leasing Act of 

1920, as amended. 

DATES: The coal lease sale will be held 

at 1 p.m. Central Daylight Time (CDT) 

on a date to be determined by the BLM 

Eastern States Deputy State Director, no 

sooner than October 4, 2018. Sealed 

bids must be received on or before 10 

a.m. CDT on the date of sale. 

ADDRESSES: The date of the sale will be 

posted at https://www.blm.gov/easternstates. The lease sale will be held at the 

Bureau of Land Management (BLM) 

Southeastern States District Office 

located at 273 Market Street, Flowood, 

MS 39232. The Detailed Statement of 

Lease Sale, the proposed coal lease, and 

Casefile ALES–55199 are available at 

this address. Sealed bids must be 

submitted to the Cashier, BLM 

Southeastern States District Office, at 

this same address. 

FOR FURTHER INFORMATION CONTACT: 

Contact Randall Mills, BLM Mining 

Engineer, by telephone at 601–919– 

4668, by email to ramills@blm.gov, or at 

the address indicated above. Persons 

who use a telecommunications device 

for the deaf (TDD) may call the Federal 

Relay Service (FRS) at 1–800–877–8339 

to contact the above individual during 

normal business hours. The FRS is 

available 24 hours a day, 7 days a week, 

to leave a message or question with the 

above individual. You will receive a 

reply during normal business hours. 

SUPPLEMENTARY INFORMATION: This coal 

lease sale is being held in response to 

a lease by application (LBA) filed by 

Best Coal Company. The Federal coal 

reserves to be re-offered consist of all 

reserves recoverable by surface mining 

methods in the following described 

lands located approximately 5 miles 

north of Mt. Olive, Alabama, in Jefferson 

County, Alabama: 

Huntsville Meridian, Alabama 

T. 15 S, R. 4 W, 

Sec. 24, SW1⁄4NW1⁄4, N1⁄2SW1⁄4, and 

SE1⁄4SW1⁄4. 

The areas described aggregate 160.82 acres. 

The Narley Mine Coal Tract contains 

three minable coal beds known as the 

New Castle, Mary Lee, and Blue Creek 

seams of the Mary Lee coal group. The 

seams are under private surface lands. 

The minable thickness of these coal 

beds for this tract are approximately 4 

to 5 feet. The tract contains 

approximately 469,000 tons of 

recoverable high-volatile bituminous 

coal. The estimated average coal quality 

on an ‘‘as received basis’’ is as follows: 

12,500 ......... British Thermal Unit (Btu/lb). 

3.50 ............. Percent moisture.* 

12.00 ........... Percent ash. 

34 ................ Percent volatile matter. 

50.50 ........... Percent fixed carbon. 

1.50 ............. Percent sulfur. 

* Estimated as received moisture; also 

used for calculating as received from dry 

basis. 

The tract will be leased to the 

qualified bidder of the highest cash 

amount, provided that the bid meets or 

exceeds the BLM’s estimate of the fair 

market value of the tract. The minimum 

bid established by regulation is $100 per 

acre or fraction thereof. The minimum 

bid is not intended to represent fair 

market value. The fair-market value will 

be determined by the authorized officer 

after the sale. 

The sealed bids should be sent by 

certified mail, return-receipt requested, 

or be hand delivered to the cashier, 

BLM Southeastern States District Office, 

at the address given above and clearly 

marked ‘‘Sealed Bid for ALES–55199 

Coal Sale—Not to be opened before 1 

p.m. CDT on (date of Sale), 2018.’’ The 


sradovich on DSK3GMQ082PROD with NOTICES