Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 40783 

ANNUAL BURDEN TABLE

Instrument/activity Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total hour 

burden 

Web Surveys 

SPC Web Survey ................................................................. 1 56 1 56 1 56 

PATH Intermediary Web Survey ......................................... 2 28 1 28 1 28 

PATH Provider Web Survey ................................................ 3 500 1 500 1 500 

Telephone Interviews 

SPC Telephone Interview .................................................... 4 28 1 28 1 28 

PATH Intermediary Telephone Interview ............................. 5 14 1 14 1 14 

PATH Provider Telephone Interview ................................... 6 60 1 60 1 60 

Site Visit Interviews 

Opening Session with State Staff ........................................ 7 25 1 25 2 50 

SPC Session ........................................................................ 8 5 1 5 2 10 

State Stakeholder Session .................................................. 9 25 1 25 1.5 37.5 

Opening Session with PATH Provider Staff ........................ 10 50 1 50 2 100 

PATH Provider PD Session ................................................. 11 10 1 10 2 20 

PATH Provider Direct Care Staff Session ........................... 12 50 1 50 2 100 

Provider Stakeholder Session ............................................. 13 50 1 50 1.5 75 

Consumer Focus Groups ..................................................... 14 100 1 100 1.5 150 

Total .............................................................................. 1,001 ........................ 1,001 ........................ 1,228.5 

1 1 respondent × 56 SPCs = 56 respondents. 2 1 respondent × 28 Intermediaries = 28 respondents. 3 1 respondent × 500 PATH providers =500 respondents. 4 1 respondent × 28 SPCs = 28 respondents. 5 1 respondent × 14 Intermediaries = 14 respondents. 6 1 respondent × 60 PATH providers = 60 respondents. 7 5 respondents × 5 site visits = 25 respondents. 8 1 respondent × 5 site visits = 5 respondents. 9 5 respondents × 5 site visits = 25 respondents. 10 5 respondents × 10 site visits (2 providers per state) = 50 respondents. 11 1 respondent × 10 site visits (2 providers per state) = 10 respondents. 12 5 respondents × 10 site visits (2 providers per state) = 50 respondents. 13 5 respondents × 10 site visits (2 providers per state) = 50 respondents. 14 10 respondents × 10 site visits (10 Consumers per provider (2 providers per state) = 100 respondents. 

Written comments and 

recommendations concerning the 

proposed collection should be sent by 

DATE to the SAMHSA Desk Officer at 

the Office of Information and Regulatory 

Affairs, Office of Management and 

Budget (OMB). To ensure timely receipt 

of comments, and to avoid potential 

delays in OMB’s receipt and processing 

of mail sent through the U.S. Postal 

Services, commenters are encouraged to 

submit their comments to OMB via 

email to: OIRA_Submission@

omb.eop.gov. Although commenters are 

encouraged to send their comments via 

email, commenters may also fax their 

comments to: 202–395–7285. 

Commenters may also mail them to: 

Office of Management and Budget, 

Office of Information and Regulatory 

Affairs, New Executive Office Building, 

Room 10102, Washington, DC 20503. 

Summer King, 

Statistician. 

[FR Doc. 2017–18136 Filed 8–25–17; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs And Border Protection 

Notice of Issuance of Final 

Determination Concerning Country of 

Origin of Tablet Computers for Health 

Mobile and Hub Platforms 

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 tablet computers known as 

Vivify Health Mobile and Hub 

Platforms. Based upon the facts 

presented, CBP has concluded in the 

final determination that for purposes of 

U.S. Government procurement in the 

installation of proprietary software on 

tablet computer does not substantially 

transform the imported tablet 

computers. 

DATES: The final determination was 

issued on August 22, 2017. 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 

September 27, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Robert Dinerstein, Valuation and 

Special Programs Branch, Regulations 

and Rulings, Office of Trade (202–325– 

0132). 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that on August 22, 2017, 

pursuant to subpart B of Part 177, 

Customs and Border Protection (CBP) 

Regulations (19 CFR part 177, subpart 

B), CBP issued a final determination 

concerning the country of origin of 

tablet computers which may be offered 

to the United States Government under 

an undesignated government 

procurement contract. This final 

determination, HQ H284523, was issued 

at the request of Vivify Health Inc. 

under procedures set forth at 19 CFR 

part 177, subpart B, which implements 


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40784 Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 

Title III of the Trade Agreements Act of 

1979, as amended (19 U.S.C. 2511–18). 

In the final determination, CBP was 

asked to consider whether the loading of 

the specialized software onto a tablet 

computer that 

Section 177.29, CBP Regulations (19 

CFR 177.29), provides that notice of 

final determinations 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 22, 2017. 

Alice A. Kipel, 

Executive Director, Regulations and Rulings, 

Office of Trade. 

HQ H284523 

August 22, 2017 

OT:RR:CTF:VS: H2854523 RSD 

CATEGORY: Origin 

Stuart P. Seidel, Esq. 

Baker & McKenzie LLP 

815 Connecticut Avenue, 

Washington, DC 20006–4078 

RE: U.S. Government Procurement; Title III, 

Trade Agreements Act of 1979 (19 U.S.C. 

§ 2511); Subpart B, Part 177, CBP 

Regulations; Tablet Computers, Health 

Mobile and Hub Platforms 

Dear Mr. Seidel: 

This is in response to your letter of March 

20, 2017, on behalf of Vivify Health, Inc. 

(Vivify), requesting a final determination 

concerning the country origin of a product 

that you refer to as a ‘‘home health mobile 

platform and hub’’, pursuant to subpart B of 

Part 177, U.S. Customs and Border Protection 

(CBP) Regulations (19 CFR 177.21, et seq.). 

Under the pertinent regulations, which 

implement Title III of the Trade Agreements 

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

seq.), 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. You state in your letter that 

this request is being made pursuant to a letter 

from the Department of Veterans Affairs (VA) 

to the prime contractor, Iron Bow 

Technologies, LLC (Iron Bow), requiring the 

filing of a request for a substantial 

transformation ruling from U.S. CBP. 

As a domestic manufacturer, Vivify is a 

party-at-interest within the meaning of 19 

CFR 177.22(d)(1) and is entitled to request 

this final determination. 

FACTS: 

The specific product at issue, referred to as 

the Vivify Mobile Device Platform and Hub 

Platform, begins as a tablet computer. The 

tablet computers are produced in Vietnam by 

one of the leading tablet manufacturers. The 

tablets are intended for purchase by the 

Veterans Health Administration for use by 

patients at home who will collect their health 

data that is measured by other peripheral 

devices such as blood pressure monitors, 

blood glucose monitors etc. These other 

devices are not imported with the tablet. 

Vivify’s supplier purchases the tablets in 

the United States from an authorized reseller. 

In the United States, one of Vivify’s Hub 

production partners partially disassembles 

the case and adds a Bluetooth speaker 

microphone array that was assembled in 

Hong Kong, an ‘‘on-the-go’’ USB hub 

manufactured in China, and the housing, 

custom designed in the United States and 

Israel and manufactured in California, USA 

and Israel. All the above Hub Platform subcomponents are shipped to facilities in Texas 

and in California for a final test fit, assembly, 

configuration and, then shipped for Quality 

Assurance testing in Tempe Arizona. 

In order to collect the health data from 

each patient/user, Vivify installs specialized 

software (Vivify Health Pathways) onto the 

tablet computers. According to the 

information provided, the software was 

developed entirely in the United States, at 

Vivify’s corporate headquarters in Plano, 

Texas at a cost of several million dollars 

using a team of more than 30 persons. The 

software enables patients to provide vital 

sign data and their responses to clinical 

questions. This application is installed on the 

tablet to meet the VA’s requirements for 

medical devices, including patient 

confidentiality and interoperability with VA 

systems and protocols. In addition, this 

software disables the generic applications 

that would be normally used on the tablets. 

After the patient data is collected, it is next 

forwarded to VA clinicians over the VA 

intranet. 

ISSUE: 

Whether the imported tablets are 

substantially transformed by the installation 

of Vivify’s proprietary software, so as to make 

them a product of the United States. 

LAW AND ANALYSIS: 

Pursuant to subpart B of Part 177, 19 CFR 

177.21 et seq., which implements Title III of 

the Trade Agreements Act of 1979, as 

amended (19 U.S.C. § 2511 et seq.), 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. 

Under the rule of origin set forth under 19 

U.S.C. § 2518(4)(B): 

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 CFR 177.22(a). 

In rendering final determinations for 

purposes of U.S. Government procurement, 

CBP applies the provisions of subpart B of 

Part 177 consistent with the Federal 

Procurement Regulations. See 19 CFR 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 Trade 

Agreements Act. See 48 CFR 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 name, 

character, or use distinct from that of the 

article or articles from which it was 

transformed.’’ See 48 CFR 25.003. 

‘‘The term ‘character’ is defined as ‘one of 

the essentials of structure, form, materials, or 

function that together make up and usually 

distinguish the individual.’’’ Uniden America 

Corporation v. United States, 120 F. Supp. 

2d. 1091, 1096 (citations omitted) (Ct. Int’l 

Trade 2000), citing National Hand Tool Corp. 

v. United States, 16 Ct. Int’l Trade 308, 311 

(1992). In Uniden, concerning whether the 

assembly of cordless telephones and the 

installation of their detachable A/C 

(alternating current) adapters constituted 

instances of substantial transformation, the 

Court of International Trade applied the 

‘‘essence test’’ and found that ‘‘[t]he essence 

of the telephone is housed in the base and 

the handset.’’ 

In Data General v. United States, 4 Ct. Int’l 

Trade 182 (1982), the court determined that 

for purposes of determining eligibility under 

item 807.00, Tariff Schedules of the United 

States (predecessor to subheading 

9802.00.80, Harmonized Tariff Schedule of 

the United States), the programming of a 

foreign PROM (Programmable Read-Only 

Memory chip) in the United States 

substantially transformed the PROM into a 

U.S. article. In programming the imported 

PROMs, the U.S. engineers systematically 

caused various distinct electronic 

interconnections to be formed within each 

integrated circuit. The programming 

bestowed upon each circuit its electronic 

function, that is, its ‘‘memory’’ which could 

be retrieved. A distinct physical change was 

effected in the PROM by the opening or 

closing of the fuses, depending on the 

method of programming. This physical 

alteration, not visible to the naked eye, could 

be discerned by electronic testing of the 

PROM. The court noted that the programs 

were designed by a U.S. project engineer 

with many years of experience in ‘‘designing 

and building hardware.’’ In addition, the 

court noted that while replicating the 

program pattern from a ‘‘master’’ PROM may 

be a quick one-step process, the development 

of the pattern and the production of the 

‘‘master’’ PROM required much time and 

expertise. The court noted that it was 

undisputed that programming altered the 

character of a PROM. The essence of the 

article, its interconnections or stored 


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Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 40785 

memory, was established by programming. 

The court concluded that altering the nonfunctioning circuitry comprising a PROM 

through technological expertise in order to 

produce a functioning read only memory 

device, possessing a desired distinctive 

circuit pattern, was no less a ‘‘substantial 

transformation’’ than the manual 

interconnection of transistors, resistors and 

diodes upon a circuit board creating a similar 

pattern. 

In Texas Instruments v. United States, 681 

F.2d 778, 782 (CCPA 1982), the court 

observed that the substantial transformation 

issue is a ‘‘mixed question of technology and 

customs law.’’ Accordingly, the programming 

of a device that confers its identity as well 

as defines its use generally constitutes a 

substantial transformation. See also 

Headquarters Ruling Letter (‘‘HQ’’) 558868, 

dated February 23, 1995 (programming of 

SecureID Card substantially transforms the 

card because it gives the card its character 

and use as part of a security system, and the 

programming is a permanent change that 

cannot be undone); HQ 735027, dated 

September 7, 1993 (programming blank 

media (EEPROM) with instructions that 

allow it to perform certain functions that 

prevent piracy of software constitutes a 

substantial transformation); and, HQ 733085, 

dated July 13, 1990; but see HQ 732870, 

dated March 19, 1990 (formatting a blank 

diskette does not constitute a substantial 

transformation because it does not add value, 

does not involve complex or highly technical 

operations, and does not create a new or 

different product); and, HQ 734518, dated 

June 28, 1993 (motherboards are not 

substantially transformed by the implanting 

of the central processing unit on the board 

because, whereas in Data General use was 

being assigned to the PROM, the use of the 

motherboard has already been determined 

when the importer imported it). 

HQ H258960, dated May 19, 2016, 

reviewed the country of origin of hardware 

components of certain transceivers in two 

scenarios that are instructive to the case at 

issue here. The hardware components of the 

transceivers were wholly manufactured in a 

foreign country and imported into the United 

States. In the first scenario, the transceivers 

were ‘‘blanks’’ and were completely nonfunctional and specialized proprietary 

software was developed and downloaded in 

the United States, making the transceivers 

functional and compatible with the OEM 

technology. In the second scenario, the 

transceivers were preprogrammed with a 

generic program that was replaced with the 

specialized proprietary software. It was 

argued that in both scenarios, the imported 

hardware was substantially transformed by 

the development, configuration, and 

downloading operations of the United States 

origin software. As in this case, the expenses 

for the work performed in the United States 

were noted to far outweigh the work 

performed abroad. In the first scenario, we 

found that the non-functional transceivers 

were substantially transformed as a result of 

downloading performed in the United States, 

with proprietary software developed in the 

United States. However, in the second 

scenario, it was determined that since the 

transceivers had generic network 

functionality, programming them merely to 

customize their network compatibility would 

not actually change the identity of the 

imported transceivers. See also HQ H241177 

supra. Accordingly, it was determined that 

the country where the last substantial 

transformation occurred was China or 

another Asian country where the hardware 

components were manufactured. 

In this case, you contend that the software 

downloading operations performed in the 

United States transform the generic tablet 

computers into medical devices. You further 

explain that the cost of writing the software 

programming far outweighs the cost of the 

imported generic tablets. You emphasize that 

the U.S. operations disable the Android 

applications and install health monitoring 

software that cannot be undone by third 

parties during the normal course of 

operations. Therefore, you contend that this 

operation changes the classification of the 

tablet from Heading 8471 of the Harmonized 

Tariff Schedule of the United States (HTSUS) 

to a medical device of Heading 9018, HTSUS. 

In essence, what is being done by the 

installation of the software in the United 

States, is to limit the original capacity of the 

imported tablets for the purpose of 

facilitating the reception, collection and 

transmission of a patient’s medical data to 

VA clinicians for their review. The original 

tablet has the ability to perform these 

functions, but it was determined that for ease 

of use and for other reasons it is best to 

disable these functions and to consolidate 

them in one function via the specialized 

software. It is stated that the general 

functionality of the tablet is removed and 

replaced so that it is easier for patients to use 

the device and access the system. It is also 

stated that the security of the patient’s 

medical data will be better protected. 

It is clear that loading the specialized 

software onto the tablet computer that 

remains fully functional as a computer would 

be insufficient to constitute a new and 

different article of commerce, since all of the 

functionality of the original computer would 

be retained. In this case, however, in addition 

to the addition of the software, we are being 

asked to consider the effect of disabling the 

general applications that have been 

programmed onto the tablet. In our judgment, 

this added factor does not cause or require 

a different result. The functions of the 

original tablet produced in Vietnam that are 

necessary to receive and transmit data are in 

essence still present on the modified tablet, 

as aided by the software. While the tablet is 

no longer a freely programmable machine, we 

find the imposition of this limitation is 

insufficient to constitute a substantial 

transformation of the imported tablets. 

Furthermore, we note that the converted 

tablets loaded with the Vivify Pathway 

Software do not actually measure any health 

related functions, such as blood pressure, or 

oxygen saturation levels, nor do they provide 

any medical treatment to patients. Instead, 

the converted tablets function to receive 

medical data that is obtained from other 

peripheral devices, such as a blood pressure 

cuff or an oxygen sensor, and to transmit that 

medical data to a clinician for review. 

Therefore, it appears that after the 

proprietary software is downloaded onto the 

tablets, they function basically as a type of 

communications device. 

It is also claimed that the FDA considers 

the Mobile Device Platform and the Hub 

Platform to be medical devices, and thus 

counsel contends that CBP should also 

consider the tablets loaded with the Vivify 

software to be medical devices rather than 

tablets. We note, however, that FDA’s 

determinations on whether any items are 

considered medical devices are based upon 

different criteria from what CBP must apply 

in determining the country of origin of a 

product using the substantial transformation 

test. In HQ H019436, dated March 17, 2008, 

CBP considered the tariff classification of a 

SONA Sleep Apnea Avoidance Pillow 

(pillow), imported from China. The ruling 

noted that while the subject merchandise was 

considered a Class II therapeutic cervical 

pillow for snoring and mild sleep apnea by 

the FDA, this determination, did not control 

the tariff classification. Similarly in this case, 

the FDA’s determination that the imported 

tablets are medical devices is of limited 

relevance to CBP’s determination as to the 

country of origin of the devices. 

In reviewing the processing performed in 

the United States on the imported tablets 

under consideration, we note that it is 

analogous to the situation of the transceivers 

described by the second scenario of HQ 

H258960. The imported tablets are 

preprogrammed with a generic program, 

which is the standard android operating 

system, prior to their importation. When they 

are first imported, the tablets can perform all 

of the standard functions of an android 

tablet, and could in their imported condition 

be used in conjunction with the proprietary 

software, but are customized for use. 

Accordingly, like the transceivers described 

in the second scenario of HQ H258960, we 

find that the name, character, and use of the 

imported tablet computers remain the same. 

Therefore, we further find that the imported 

tablets are not substantially transformed in 

the United States by the downloading of the 

proprietary software, which allows them to 

function with the VA Healthcare network. 

After the Vivify Health Pathways software is 

downloaded, the country of origin of the 

imported tablets remains the country where 

they were originally manufactured, which in 

this case is Vietnam. 

HOLDING: 

Based on the facts of this case, the 

imported tablets used with Home Health Hub 

platform are not substantially transformed by 

the installation of the proprietary Vivify 

Health Pathways software. Therefore, the 

country of origin of the tablets will remain 

the country where they were originally 

manufactured. 

Notice of this final determination will be 

given in the Federal Register, as required by 

19 CFR 177.29. Any party-at-interest other 

than the party which requested this final 

determination may request, pursuant to 19 

CFR 177.31, that CBP reexamine the matter 

anew and issue a new final determination. 

Pursuant to 19 CFR 177.30, any party-atinterest may, within 30 days of publication 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
40786 Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 

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 and Rulings, 

Office of Trade. 

[FR Doc. 2017–18202 Filed 8–25–17; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Notice of Issuance of Final 

Determinations Concerning Certain 

Pharmaceutical Products 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of final determinations. 

SUMMARY: This document provides 

notice that U.S. Customs and Border 

Protection (‘‘CBP’’) has issued six final 

determinations concerning the country 

of origin of certain pharmaceutical 

products produced by Lupin 

Pharmaceuticals, Inc. Based upon the 

facts presented, CBP has concluded that 

the country of origin of the meloxicam 

tablets is Italy for purposes of U.S. 

Government procurement, that the 

country of origin of the bimatoprost 

ophthalmic solution is Taiwan for 

purposes of U.S. Government 

procurement, that the country of origin 

of the niacin ER tablets is Belgium or 

Switzerland for purposes of U.S. 

Government procurement, that the 

country of origin of the calcium acetate 

capsules is the Netherlands for purposes 

of U.S. Government procurement, that 

the country of origin of the quinine 

sulfate capsules is Germany for 

purposes of U.S. Government 

procurement, and that the country of 

origin of the pravastatin sodium tablets 

is Taiwan for purposes of U.S. 

Government procurement. 

DATES: These final determinations were 

issued on August 22, 2017. Copies of the 

final determinations are attached. Any 

party-at-interest, as defined in 19 CFR 

177.22(d), may seek judicial review of 

these final determinations within 

September 27, 2017. 

FOR FURTHER INFORMATION CONTACT: Ross 

M. Cunningham, Valuation and Special 

Programs Branch, Regulations and 

Rulings, Office of Trade, (202) 325– 

0034. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that on August 22, 2017 

pursuant to subpart B of Part 177, U.S. 

Customs and Border Protection 

Regulations (19 CFR part 177, subpart 

B), CBP issued six final determinations 

concerning the country of origin of 

certain pharmaceutical products, which 

may be offered to the U.S. Government 

under an undesignated government 

procurement contract. These final 

determinations (HQ H284690, HQ 

H284961, HQ H284692, HQ H284694, 

HQ H284695, and HQ H284697), were 

issued under procedures set forth at 19 

CFR part 177, subpart B, which 

implements Title III of the Trade 

Agreements Act of 1979, as amended 

(19 U.S.C. 2511–18). In the final 

determinations, CBP concluded that the 

processing in India does not result in a 

substantial transformation. Therefore, 

the country of origin for purposes of 

U.S. Government procurement of the 

pharmaceutical products is the country 

in which the active pharmaceutical 

ingredient was produced. 

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 22, 2017. 

Alice A. Kipel, 

Executive Director, Regulations and Rulings, 

Office of Trade. 

ATTACHMENT A 

HQ H284690 

August 22, 20917 

OT:RR:CTF:VS H284690 RMC 

CATEGORY: Origin 

Kevin J. Maynard 

Wiley Rein LLP 

1776 K St. NW 

Washington, DC 20006 

Re: U.S. Government Procurement; Country 

of Origin of Meloxicam Tablets; 

Substantial Transformation 

Dear Mr. Maynard: 

This is in response to your letter, dated 

March 20, 2017, requesting a final 

determination on behalf of Lupin 

Pharmaceuticals, Inc. (‘‘Lupin’’) pursuant to 

subpart B of Part 177 of the U.S. Customs and 

Border Protection (‘‘CBP’’) Regulations (19 

CFR Part 177). Under these regulations, 

which implement Title III of the Trade 

Agreements Act of 1979 (‘‘TAA’’), as 

amended (19 U.S.C. § 2511 et seq.), 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 for 

products offered for sale to the U.S. 

Government. This final determination 

concerns the country of origin of meloxicam 

tablets. As a U.S. importer, Lupin is a partyat-interest within the meaning of 19 CFR 

177.22(d)(1) and is entitled to request this 

final determination. 

You have asked that certain information 

submitted in connection with this ruling 

request be treated as confidential. Inasmuch 

as this request conforms to the requirements 

of 19 CFR 177.2(b)(7), the request for 

confidentiality is approved. The information 

contained within brackets and all 

attachments to this ruling request, forwarded 

to our office, will not be released to the 

public and will be withheld from published 

versions of this ruling. 

FACTS: 

Lupin is a subsidiary of Lupin Limited, one 

of the five largest pharmaceutical companies 

in India. At issue in this case are meloxicam 

tablets, in doses of 7.5 milligrams and 15 

milligrams, which you describe as 

‘‘nonsteroidal anti-inflammator[ies] used for 

the relief of the signs and symptoms of 

rheumatoid arthritis and osteoarthritis.’’ 

The manufacturing process for Lupin’s 

meloxicam tablets begins in Italy, where the 

active pharmaceutical ingredient (‘‘API’’) 

meloxicam (chemical formula 

C14H13N3O4S2) is produced. You state that 

the Italian meloxicam is the only active 

ingredient in the finished pharmaceutical 

product. However, the finished product 

contains a number of other inactive 

ingredients, which you describe as 

excipients. These ingredients are combined 

with the Italian API in India during the 

manufacturing process. The ingredients 

include the following chemicals, which you 

note are products of TAA-eligible countries: 

• [ ] 

• [ ] 

• [ ] 

• [ ] 

• [ ] 

• [ ] 

• [ ] 

The manufacturing process in India 

involves four steps. First, the API and 

inactive ingredients are sifted and blended. 

Second, the materials are granulated, and the 

wet granulates are then sieved and dried. 

Third, the product is compressed into tablets. 

Finally, in the fourth step, the finished 

tablets are packaged into approved 

packaging. 

You state that the processes performed to 

produce the finished meloxicam tablets do 

not result in any change to the chemical 

characteristics of the Italian API or to any 

other ingredients. You also state that the 

medicinal use, molecular formula, and 

solubility of the API are unchanged by the 

manufacturing operations in India. In short, 

you characterize the Indian operations as 

mere processing of bulk API into 7.5 

milligram and 15 milligram dosage form. 


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