15024 Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Notices 

are submitted will be summarized and 

included in the CBP request for OMB 

approval. All comments will become a 

matter of public record. In this 

document, CBP is soliciting comments 

concerning the following information 

collection: 

Title: Small Vessel Reporting System. 

OMB Number: 1651–0137. 

Abstract: The Small Vessel Reporting 

System (SVRS) is a pilot program that 

allows certain participants using small 

pleasure boats to report their arrival 

telephonically instead of having to 

appear in person for inspection by a 

CBP officer each time they enter the 

United States. In some cases, a 

participant may also be asked to report 

to CBP for an in person inspection upon 

arrival. Participants may be U.S. 

citizens, U.S. lawful permanent 

residents, Canadian citizens, and 

permanent residents of Canada who are 

nationals of Visa Waiver Program 

countries listed in 8 CFR 217.2(a). In 

addition, participants of one or more 

Trusted Traveler programs and current 

Canadian Border Boater Landing Permit 

(CBP Form I–68) holders may 

participate in SVRS. 

In order to register for the SVRS pilot 

program, participants enter data via the 

SVRS Web site, which collects 

information such as biographical 

information and vessel information. 

Participants will go through the in 

person CBP inspection process during 

SVRS registration, and in some cases, 

upon arrival in the United States. 

For each voyage, SVRS participants 

will be required to submit a float plan 

about their voyage via the SVRS Web 

site in advance of arrival in the United 

States. The float plan includes vessel 

information, a listing of all persons on 

board, estimated dates and times of 

departure and return, and information 

on the locations to be visited on the trip. 

Participants in SVRS can create a float 

plan for an individual voyage or a 

template for a float plan that can be 

used multiple times. 

SVRS is authorized by 8 U.S.C. 1225, 

8 CFR 235.1, 19 U.S.C. 1433, and 19 

CFR 4.2. The SVRS Web site is 

accessible at: https://svrs.cbp.dhs.gov/. 

Current Actions: CBP proposes to 

extend the expiration date of this 

information collection with a change to 

the burden hours resulting from 

updated estimates of the number of 

respondents. There is no change to the 

information being collected. 

Type of Review: Extension (with 

change). 

Affected Public: Individuals. 

SVRS Application 

Estimated Number of Respondents: 

7,509. 

Estimated Number of Total Annual 

Responses: 7,509. 

Estimated Time per Response: 15 

minutes. 

Estimated Total Annual Burden 

Hours: 1,877. 

Float Plan 

Estimated Number of Respondents: 

2,589. 

Estimated Number of Total Annual 

Responses: 2,589. 

Estimated Time per Response: 10.6 

minutes. 

Estimated Total Annual Burden 

Hours: 457. 

Dated: March 11, 2015. 

Tracey Denning, 

Agency Clearance Officer, U.S. Customs and 

Border Protection. 

[FR Doc. 2015–06374 Filed 3–19–15; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Notice of Issuance of Final 

Determination Concerning Certain Oral 

Solution Products 

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 certain oral solution products 

for cleansing of the colon known as 

Prepopik. Based upon the facts 

presented, CBP has concluded that, the 

country of origin of the oral solution is 

China for purposes of U.S. Government 

procurement. 

DATES: The final determination was 

issued on March 13, 2015. 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 April 20, 

2015. 

FOR FURTHER INFORMATION CONTACT: 

Grace A. Kim, Valuation and Special 

Programs Branch, Regulations and 

Rulings, Office of International Trade 

(202) 325–7941. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that on March 13, 2015, 

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 

certain oral solution products known as 

Prepopik, which may be offered to the 

U.S. Government, Department of 

Veterans Affairs under its Federal 

Supply Schedule contract. This final 

determination, HQ H253443, was 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 determination, CBP 

concluded that the processing in China 

results in a substantial transformation. 

Therefore, the country of origin of the 

oral solution is China for purposes of 

U.S. Government procurement. 

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: March 13, 2015. 

Glen E. Vereb, 

Acting Executive Director, Regulations and 

Rulings, Office of International Trade. 

HQ H253443 

March 13, 2015 

OT:RR:CTF:VS H253443 GaK 

CATEGORY: Origin 

Michael T. Shor 

Arnold & Porter LLP 

555 12th Street, NW 

Washington, DC 20004–1206 

RE: U.S. Government Procurement; Country 

of Origin of PREPOPIK®; Substantial 

Transformation 

Dear Mr. Shor: 

This is in response to your letter dated 

April 23, 2014, and your supplemental 

submission dated July 18, 2014, requesting a 

final determination on behalf of your client, 

Ferring Pharmaceuticals Inc. (‘‘Ferring’’), 

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 

practice for products offered for sale to the 

U.S. Government. 

This final determination concerns the 

country of origin of Ferring’s PREPOPIK® for 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Notices 15025 

1See http://www.nlm.nih.gov/medlineplus/ency/

article/002282.htm; see also http://

www.nlm.nih.gov/medlineplus/druginfo/meds/

a613020.html. 

Oral Solution (‘‘Prepopik’’), which is a 

powder for oral solution for cleansing of the 

colon. We note that as a U.S. importer, 

Ferring is a party-at-interest within the 

meaning of 19 CFR § 177.22(d)(1) and is 

entitled to request this final determination. 

Pursuant to 19 CFR § 177.22(b)(7), you 

requested confidential treatment with respect 

to certain information submitted. As that 

information constitutes privileged or 

confidential matters, it has been bracketed 

and will be redacted from any published 

versions. 

FACTS: 

Prepopik is a dual-acting osmotic and 

stimulant laxative bowel preparation for a 

colonoscopy in adults. Prepopik is imported 

in packets containing one dose, to which a 

dosing cup is added in the U.S. Prepopik is 

ingested by dissolving the powder in water, 

using the supplied plastic dosing cup. To 

produce Prepopik, sodium picosulfate 

(manufactured in Country A [******]), 

magnesium oxide (manufactured in Country 

B [******]), anhydrous citric acid 

(manufactured in Country C [******]), and 

three inactive ingredients (sourced from 

Country C and Country D [******]) are sent 

to China in powder form or in fine particles. 

The manufacturing process, described in 

detail to CBP, consists of sieving, wet mixing 

the sodium picosulfate to form granules, 

mixing magnesium oxide and citric acid into 

a granule formulation, product flavoring, and 

final blending which is stated not to result 

in a chemical reaction during any of the steps 

carried out in China. The final product is 

placed into single dosage packets. Each 

Prepopik packet contains 10mg sodium 

picosulfate, 3.5g magnesium oxide, and 12g 

citric acid. The packets are sent to a third 

party in the U.S. to be packaged into childresistant pouches along with the pre-marked, 

plastic dosing cup. 

After importation, once water is added, the 

magnesium oxide and citric acid combine to 

form magnesium citrate. The magnesium 

citrate, is an osmotic laxative that stimulates 

the absorption of water into the bowel, while 

the sodium picosulfate stimulates peristalsis 

in the bowel to expel its contents.1

ISSUE: 

What is the country of origin of the 

Prepopik for purposes of U.S. government 

procurement and marking? 

LAW AND ANALYSIS: 

Country of Origin 

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 determining whether a substantial 

transformation occurs in 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 materials. To that 

end, CBP has generally held that the 

processing of pharmaceutical products from 

bulk form into measured doses, filtering and 

packaging does not result in a substantial 

transformation. See Headquarters Rulings 

Letter (‘‘HQ’’) H197582, dated August 9, 

2012; HQ H561975, dated April 3, 2002; and 

HQ H561544, dated May 1, 2000. 

In HQ H215656, dated January 11, 2013, a 

pain reliever medicine called Rybix ODT was 

imported from France. The active 

pharmaceutical ingredient (‘‘API’’) was 

manufactured in India, which was shipped to 

France and processed in four stages. In the 

first stage, the API was de-lumped and 

granulated with a suspension of inactive 

ingredients then sieved and sized. In the 

second stage, several inactive ingredients 

designed to assist in drug administration 

were added to the API to make a flavor 

preblend. In the third stage, the tablets were 

formed and collected in polyethylene-lined 

foil bags. In the last stage, the tablets were 

packaged in child-resistant blister packs and 

prepared for shipment to the U.S. CBP found 

that the imported good did not undergo a 

substantial transformation in France, because 

the processing in France did not result in a 

change in the medicinal use of the product 

and the API retained its chemical and 

physical properties. 

However, in HQ 563207, dated June 1, 

2005, Actoplus MetTM was produced in Japan 

by combining two APIs: pioglitazone HCl 

(pioglitazone), an insulin sensitizer 

metformin, a biguanide used to decrease the 

amount of glucose produced by the liver and 

make muscle tissue more sensitive to insulin 

so glucose can be absorbed. The two APIs 

were mixed together to form a fix 

combination drug. The decision noted that 

with the combination of the two APIs, type 

2 diabetes patients will receive more medical 

benefits than taking metformin alone. CBP 

held that the finished pharmaceutical, 

Actoplus MetTM had a new name, character 

and use distinct from the two APIs used in 

the production of the finished product. It was 

noted that while pioglitazone and metformin 

could be prescribed separately, the final 

product, Actoplus MetTM, increased the 

individual effectiveness of pioglitazone and 

metformin in treating type 2 diabetes 

patients. Therefore, a substantial 

transformation was found to take place in 

Japan where the two APIs were combined to 

produce Actoplus MetTM. 

Ferring states that as imported, the only 

API present in Prepopik is the sodium 

picosulfate which retains its chemical and 

physical properties and is merely put into a 

dosage form and packaged. Ferring further 

contends that the processing in China does 

not result in a change in the medicinal use 

of the finished product. However, we note 

that magnesium oxide may be used for 

different reasons, as an antacid to relieve 

heartburn, sour stomach, or acid indigestion; 

or as a laxative for short-term, rapid 

emptying of the bowel. See http://

www.nlm.nih.gov/medlineplus/druginfo/

meds/a601074.html; see also http://

pubchem.ncbi.nlm.nih.gov/compound/

magnesium_oxide (Magnesium oxide (MgO) 

is an inorganic compound that occurs in 

nature as the mineral periclase and in 

aqueous media combines quickly with water 

to form magnesium hydroxide. It is used as 

an antacid and mild laxative and has many 

nonmedicinal uses). We note that combining 

magnesium oxide with water results in 

magnesium hydroxide which is also known 

for its laxative effect. While the combination 

with water by the user may cause the 

‘‘chemical reaction,’’ we note that most 

medicines are taken with water, so we do not 

find that the addition of water in this case 

is what makes the magnesium oxide to 

function as a laxative. The combination of 

the magnesium oxide, citric acid and water 

may form the osmotic effect; however, the 

fundamental laxative property is already 

found in the magnesium oxide. Accordingly, 

we find that as in HQ 563207, the two 

ingredients (sodium picosulfate and 

magnesium oxide) contribute to the purpose 

of Prepopik. As the two ingredients are 

combined in China, we find that as in HQ 

563207 a substantial transformation occurs in 

China. Individually, the sodium picosulfate 

and the magnesium oxide may be used to 

alleviate constipation, and together, when 

combined to form Prepopik, these ingredients 

have a more stiumlative effect. Therefore, we 

find that the country of origin of Prepopik is 

China. 

Marking 

Section 304 of the Tariff Act of 1930, as 

amended (19 U.S.C. § 1304), provides that, 

unless excepted, every article of foreign 

origin (or its container) imported into the 

United States shall be marked in a 

conspicuous place as legibly, indelibly and 

permanently as the nature of the article (or 

its container) will permit, in such a manner 

as to indicate to the ultimate purchaser in the 

United States the English name of the 

country of origin of the article. Congressional 

intent in enacting 19 U.S.C. § 1304 was ‘‘that 

the ultimate purchaser should be able to 

know by an inspection of the marking on the 

imported goods the country of which the 

goods is the product. The evident purpose is 

to mark the goods so that at the time of 

purchase the ultimate purchaser may, by 

knowing where the goods were produced, be 

able to buy or refuse to buy them, if such 

marking should influence his will.’’ United 

States v. Friedlaender & Co., 27 CCPA 297, 

302, C.A.D. 104 (1940). Part 134, CBP 

mstockstill on DSK4VPTVN1PROD with NOTICES

15026 Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Notices 

Regulations (19 CFR § 134) implements the 

country of origin marking requirements and 

exceptions of 19 U.S.C. § 1304. 

Section 134.1(b), CBP Regulations (19 CFR 

§ 134.1(b)), defines ‘‘country of origin’’ as: 

the country of manufacture, production or 

growth of any article of foreign origin 

entering the United States. Further work or 

material added to an article in another 

country must effect a substantial 

transformation in order to render such other 

country the ‘‘country of origin’’ within the 

meaning of this part; . . . 

The country of origin of an article for U.S. 

tariff purposes is the country in which the 

last substantial transformation took place. A 

substantial transformation occurs when an 

article is used in a manufacturing process or 

operation that results in a new article that 

has a new name, character or use different 

from that of the original imported article. 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 

Hand Tool Corp. v. United States, 989 F.2d 

1201 (Fed. Cir. 1992). 

In the instant case, Ferring mixes all the 

ingredients by blending, sieving, and mixing. 

We find that this processing results in a 

substantial transformation. The combination 

of the two ingredients results in a more 

stimulative laxative effect for purposes of 

cleansing the bowels. Therefore, we find that 

the country of origin of Prepopik is China for 

country of origin marking purposes. 

HOLDING: 

Based on the facts in this case, we find that 

the imported Prepopik is substantially 

transformed in China. The country of origin 

for government procurement and marking 

purposes is China. 

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 

of the Federal Register Notice referenced 

above, seek judicial review of this final 

determination before the Court of 

International Trade. 

Sincerely, 

Glen E. Vereb, 

Acting Executive Director, Regulations and 

Rulings, Office of International Trade. 

[FR Doc. 2015–06434 Filed 3–19–15; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Accreditation and Approval of Amspec 

Services, LLC, as a Commercial 

Gauger and Laboratory 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of accreditation and 

approval of AmSpec Services, LLC, as a 

commercial gauger and laboratory. 

SUMMARY: Notice is hereby given, 

pursuant to CBP regulations, that 

AmSpec Services, LLC, has been 

approved to gauge petroleum and 

certain petroleum products and 

accredited to test petroleum and certain 

petroleum products for customs 

purposes for the next three years as of 

October 27, 2014. 

DATES: Effective Dates: The 

accreditation and approval of AmSpec 

Services, LLC, as commercial gauger 

and laboratory became effective on 

October 27, 2014. The next triennial 

inspection date will be scheduled for 

October 2017. 

FOR FURTHER INFORMATION CONTACT: 

Approved Gauger and Accredited 

Laboratories Manager, Laboratories and 

Scientific Services Directorate, U.S. 

Customs and Border Protection, 1300 

Pennsylvania Avenue NW., Suite 

1500N, Washington, DC 20229, tel. 202– 

344–1060. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given pursuant to 19 CFR 151.12 

and 19 CFR 151.13, that AmSpec 

Services, LLC, 4075 Sprig Driver, Suite 

A, Concord, CA 94520, has been 

approved to gauge petroleum and 

certain petroleum products and 

accredited to test petroleum and certain 

petroleum products for customs 

purposes, in accordance with the 

provisions of 19 CFR 151.12 and 19 CFR 

151.13. AmSpec Services, LLC is 

approved for the following gauging 

procedures for petroleum and certain 

petroleum products from the American 

Petroleum Institute (API): 

API Chapters Title 

1 .............. Vocabulary. 

3 .............. Tank gauging. 

7 .............. Temperature determination. 

8 .............. Sampling. 

11 ............ Physical Properties. 

12 ............ Calculations. 

17 ............ Maritime measurement. 

AmSpec Services, LLC is accredited 

for the following laboratory analysis 

procedures and methods for petroleum 

and certain petroleum products set forth 

by the U.S. Customs and Border 

Protection Laboratory Methods (CBPL) 

and American Society for Testing and 

Materials (ASTM): 

CBPL No. ASTM Title 

27–13 .............................................. ASTM D–4294 ............................... Standard test method for sulfur in petroleum and petroleum products 

by energy-dispersive x-ray fluorescence spectrometry. 

27–06 .............................................. ASTM D–473 ................................. Standard test method for sediment in crude oils and fuel oils by the 

extraction method. 

27–01 .............................................. ASTM D–287 ................................. Standard test method for API gravity of crude petroleum and petroleum products (hydrometer method). 

27–46 .............................................. ASTM D–5002 ............................... Standard test method for density and relative density of crude oils by 

digital density analyzer. 

27–05 .............................................. ASTM D–4928 ............................... Standard test method for water in crude oils by Coulometric Karl 

Fischer Titration. 

27–48 .............................................. D–4052 .......................................... Density and Relative density of liquids by digital density meter. 

Anyone wishing to employ this entity 

to conduct laboratory analyses and 

gauger services should request and 

receive written assurances from the 

entity that it is accredited or approved 

by the U.S. Customs and Border 

Protection to conduct the specific test or 

gauger service requested. Alternatively, 

inquiries regarding the specific test or 

gauger service this entity is accredited 

or approved to perform may be directed 

to the U.S. Customs and Border 

Protection by calling (202) 344–1060. 

The inquiry may also be sent to 

CBPGaugersLabs@dhs.gov. Please 

reference the Web site listed below for 

a complete listing of CBP approved 

gaugers and accredited laboratories. 

http://www.cbp.gov/about/labsscientific/commercial-gaugers-andlaboratories 

mstockstill on DSK4VPTVN1PROD with NOTICES