80 FR 15024 - Notice of Issuance of Final Determination Concerning Certain Oral Solution Products
DEPARTMENT OF HOMELAND SECURITY
U.S. Customs and Border Protection Federal Register Volume 80, Issue 54 (March 20, 2015)
U.S. Customs and Border Protection
Federal Register Volume 80, Issue 54 (March 20, 2015)
| Page Range | 15024-15026 | |
| FR Document | 2015-06434 |
[Federal Register Volume 80, Number 54 (Friday, March 20, 2015)] [Notices] [Pages 15024-15026] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06434] ----------------------------------------------------------------------- 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[supreg]; 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. Sec. 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[supreg] for [[Page 15025]] 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 Sec. 177.22(d)(1) and is entitled to request this final determination. Pursuant to 19 CFR Sec. 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 child-resistant 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\ --------------------------------------------------------------------------- \1\ See http://www.nlm.nih.gov/medlineplus/ency/article/002282.htm; see also http://www.nlm.nih.gov/medlineplus/druginfo/meds/a613020.html. --------------------------------------------------------------------------- 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. Sec. 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. Sec. 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. Sec. 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. Sec. 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 [[Page 15026]] Regulations (19 CFR Sec. 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. Sec. 1304. Section 134.1(b), CBP Regulations (19 CFR Sec. 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 Sec. 177.29. Any party-at-interest other than the party which requested this final determination may request, pursuant to 19 CFR Sec. 177.31, that CBP reexamine the matter anew and issue a new final determination. Pursuant to 19 CFR 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, 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
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are submitted will be summarized and SVRS Application Regulations (19 CFR part 177, subpart
included in the CBP request for OMB Estimated Number of Respondents: B), CBP issued a final determination
approval. All comments will become a 7,509. concerning the country of origin of
matter of public record. In this Estimated Number of Total Annual certain oral solution products known as
document, CBP is soliciting comments Responses: 7,509. Prepopik, which may be offered to the
concerning the following information Estimated Time per Response: 15 U.S. Government, Department of
collection: minutes. Veterans Affairs under its Federal
Title: Small Vessel Reporting System. Estimated Total Annual Burden Supply Schedule contract. This final
Hours: 1,877. determination, HQ H253443, was issued
OMB Number: 1651–0137.
under procedures set forth at 19 CFR
Abstract: The Small Vessel Reporting Float Plan part 177, subpart B, which implements
System (SVRS) is a pilot program that Estimated Number of Respondents: Title III of the Trade Agreements Act of
allows certain participants using small 2,589. 1979, as amended (19 U.S.C. 2511–18).
pleasure boats to report their arrival Estimated Number of Total Annual In the final determination, CBP
telephonically instead of having to Responses: 2,589. concluded that the processing in China
appear in person for inspection by a Estimated Time per Response: 10.6 results in a substantial transformation.
CBP officer each time they enter the minutes. Therefore, the country of origin of the
United States. In some cases, a Estimated Total Annual Burden oral solution is China for purposes of
participant may also be asked to report Hours: 457. U.S. Government procurement.
to CBP for an in person inspection upon Section 177.29, CBP Regulations (19
arrival. Participants may be U.S. Dated: March 11, 2015.
CFR 177.29), provides that a notice of
citizens, U.S. lawful permanent Tracey Denning, final determination shall be published
residents, Canadian citizens, and Agency Clearance Officer, U.S. Customs and in the Federal Register within 60 days
permanent residents of Canada who are Border Protection. of the date the final determination is
nationals of Visa Waiver Program [FR Doc. 2015–06374 Filed 3–19–15; 8:45 am] issued. Section 177.30, CBP Regulations
countries listed in 8 CFR 217.2(a). In BILLING CODE 9111–14–P (19 CFR 177.30), provides that any
addition, participants of one or more party-at-interest, as defined in 19 CFR
Trusted Traveler programs and current 177.22(d), may seek judicial review of a
Canadian Border Boater Landing Permit DEPARTMENT OF HOMELAND final determination within 30 days of
(CBP Form I–68) holders may SECURITY publication of such determination in the
participate in SVRS. Federal Register.
U.S. Customs and Border Protection
In order to register for the SVRS pilot Dated: March 13, 2015.
program, participants enter data via the Notice of Issuance of Final Glen E. Vereb,
SVRS Web site, which collects Determination Concerning Certain Oral Acting Executive Director, Regulations and
information such as biographical Solution Products Rulings, Office of International Trade.
information and vessel information.
Participants will go through the in AGENCY: U.S. Customs and Border HQ H253443
person CBP inspection process during Protection, Department of Homeland
March 13, 2015
SVRS registration, and in some cases, Security.
upon arrival in the United States. ACTION: Notice of final determination. OT:RR:CTF:VS H253443 GaK
For each voyage, SVRS participants CATEGORY: Origin
SUMMARY: This document provides
will be required to submit a float plan Michael T. Shor
notice that U.S. Customs and Border Arnold & Porter LLP
about their voyage via the SVRS Web Protection (‘‘CBP’’) has issued a final
site in advance of arrival in the United 555 12th Street, NW
determination concerning the country of Washington, DC 20004–1206
States. The float plan includes vessel origin of certain oral solution products
information, a listing of all persons on RE: U.S. Government Procurement; Country
for cleansing of the colon known as of Origin of PREPOPIK®; Substantial
board, estimated dates and times of Prepopik. Based upon the facts Transformation
departure and return, and information presented, CBP has concluded that, the
on the locations to be visited on the trip. country of origin of the oral solution is Dear Mr. Shor:
Participants in SVRS can create a float China for purposes of U.S. Government This is in response to your letter dated
plan for an individual voyage or a procurement. April 23, 2014, and your supplemental
template for a float plan that can be submission dated July 18, 2014, requesting a
DATES: The final determination was final determination on behalf of your client,
used multiple times.
issued on March 13, 2015. A copy of the Ferring Pharmaceuticals Inc. (‘‘Ferring’’),
SVRS is authorized by 8 U.S.C. 1225, final determination is attached. Any pursuant to subpart B of part 177 of the U.S.
8 CFR 235.1, 19 U.S.C. 1433, and 19 party-at-interest, as defined in 19 CFR Customs and Border Protection (‘‘CBP’’)
CFR 4.2. The SVRS Web site is 177.22(d), may seek judicial review of Regulations (19 CFR part 177). Under these
accessible at: https://svrs.cbp.dhs.gov/. this final determination within April 20, regulations, which implement Title III of the
Current Actions: CBP proposes to Trade Agreements Act of 1979 (‘‘TAA’’), as
2015.
amended (19 U.S.C. § 2511 et seq.), CBP
extend the expiration date of this FOR FURTHER INFORMATION CONTACT: issues country of origin advisory rulings and
information collection with a change to Grace A. Kim, Valuation and Special
mstockstill on DSK4VPTVN1PROD with NOTICES
final determinations as to whether an article
the burden hours resulting from Programs Branch, Regulations and is or would be a product of a designated
updated estimates of the number of Rulings, Office of International Trade country or instrumentality for the purposes
respondents. There is no change to the (202) 325–7941. of granting waivers of certain ‘‘Buy
information being collected. American’’ restrictions in U.S. law or
SUPPLEMENTARY INFORMATION: Notice is practice for products offered for sale to the
Type of Review: Extension (with hereby given that on March 13, 2015, U.S. Government.
change). pursuant to subpart B of Part 177, U.S. This final determination concerns the
Affected Public: Individuals. Customs and Border Protection country of origin of Ferring’s PREPOPIK® for
VerDate Sep<11>2014 20:14 Mar 19, 2015 Jkt 235001 PO 00000 Frm 00120 Fmt 4703 Sfmt 4703 E:\FR\FM\20MRN1.SGM 20MRN1](https://thefederalregister.org/doc/80_FR_15078/page/1.svg)
![Federal Register / Vol. 80, No. 54 / Friday, March 20, 2015 / Notices 15025
Oral Solution (‘‘Prepopik’’), which is a Under the rule of origin set forth under 19 Japan where the two APIs were combined to
powder for oral solution for cleansing of the U.S.C. § 2518(4)(B): produce Actoplus MetTM.
colon. We note that as a U.S. importer, An article is a product of a country or Ferring states that as imported, the only
Ferring is a party-at-interest within the instrumentality only if (i) it is wholly the API present in Prepopik is the sodium
meaning of 19 CFR § 177.22(d)(1) and is growth, product, or manufacture of that picosulfate which retains its chemical and
entitled to request this final determination. country or instrumentality, or (ii) in the case physical properties and is merely put into a
Pursuant to 19 CFR § 177.22(b)(7), you of an article which consists in whole or in dosage form and packaged. Ferring further
requested confidential treatment with respect part of materials from another country or contends that the processing in China does
to certain information submitted. As that instrumentality, it has been substantially not result in a change in the medicinal use
information constitutes privileged or transformed into a new and different article of the finished product. However, we note
confidential matters, it has been bracketed of commerce with a name, character, or use that magnesium oxide may be used for
and will be redacted from any published distinct from that of the article or articles different reasons, as an antacid to relieve
versions. from which it was so transformed. heartburn, sour stomach, or acid indigestion;
FACTS: See also 19 CFR 177.22(a). or as a laxative for short-term, rapid
In determining whether a substantial emptying of the bowel. See http://
Prepopik is a dual-acting osmotic and transformation occurs in the manufacture of www.nlm.nih.gov/medlineplus/druginfo/
stimulant laxative bowel preparation for a chemical products such as pharmaceuticals, meds/a601074.html; see also http://
colonoscopy in adults. Prepopik is imported CBP has consistently examined the pubchem.ncbi.nlm.nih.gov/compound/
in packets containing one dose, to which a complexity of the processing, and whether magnesium_oxide (Magnesium oxide (MgO)
dosing cup is added in the U.S. Prepopik is the final article retains the essential identity is an inorganic compound that occurs in
ingested by dissolving the powder in water, and character of the raw materials. To that nature as the mineral periclase and in
using the supplied plastic dosing cup. To end, CBP has generally held that the aqueous media combines quickly with water
produce Prepopik, sodium picosulfate processing of pharmaceutical products from to form magnesium hydroxide. It is used as
(manufactured in Country A [******]), bulk form into measured doses, filtering and an antacid and mild laxative and has many
magnesium oxide (manufactured in Country packaging does not result in a substantial nonmedicinal uses). We note that combining
B [******]), anhydrous citric acid transformation. See Headquarters Rulings magnesium oxide with water results in
(manufactured in Country C [******]), and Letter (‘‘HQ’’) H197582, dated August 9, magnesium hydroxide which is also known
three inactive ingredients (sourced from 2012; HQ H561975, dated April 3, 2002; and for its laxative effect. While the combination
Country C and Country D [******]) are sent HQ H561544, dated May 1, 2000. with water by the user may cause the
to China in powder form or in fine particles. In HQ H215656, dated January 11, 2013, a ‘‘chemical reaction,’’ we note that most
The manufacturing process, described in pain reliever medicine called Rybix ODT was
detail to CBP, consists of sieving, wet mixing medicines are taken with water, so we do not
imported from France. The active find that the addition of water in this case
the sodium picosulfate to form granules,
pharmaceutical ingredient (‘‘API’’) was is what makes the magnesium oxide to
mixing magnesium oxide and citric acid into
manufactured in India, which was shipped to function as a laxative. The combination of
a granule formulation, product flavoring, and
France and processed in four stages. In the the magnesium oxide, citric acid and water
final blending which is stated not to result
first stage, the API was de-lumped and may form the osmotic effect; however, the
in a chemical reaction during any of the steps
granulated with a suspension of inactive fundamental laxative property is already
carried out in China. The final product is
ingredients then sieved and sized. In the found in the magnesium oxide. Accordingly,
placed into single dosage packets. Each
second stage, several inactive ingredients we find that as in HQ 563207, the two
Prepopik packet contains 10mg sodium
designed to assist in drug administration ingredients (sodium picosulfate and
picosulfate, 3.5g magnesium oxide, and 12g
citric acid. The packets are sent to a third were added to the API to make a flavor magnesium oxide) contribute to the purpose
party in the U.S. to be packaged into child- preblend. In the third stage, the tablets were of Prepopik. As the two ingredients are
resistant pouches along with the pre-marked, formed and collected in polyethylene-lined combined in China, we find that as in HQ
plastic dosing cup. foil bags. In the last stage, the tablets were 563207 a substantial transformation occurs in
After importation, once water is added, the packaged in child-resistant blister packs and China. Individually, the sodium picosulfate
magnesium oxide and citric acid combine to prepared for shipment to the U.S. CBP found and the magnesium oxide may be used to
form magnesium citrate. The magnesium that the imported good did not undergo a alleviate constipation, and together, when
citrate, is an osmotic laxative that stimulates substantial transformation in France, because combined to form Prepopik, these ingredients
the absorption of water into the bowel, while the processing in France did not result in a have a more stiumlative effect. Therefore, we
the sodium picosulfate stimulates peristalsis change in the medicinal use of the product find that the country of origin of Prepopik is
in the bowel to expel its contents.1 and the API retained its chemical and China.
physical properties.
ISSUE: However, in HQ 563207, dated June 1, Marking
What is the country of origin of the 2005, Actoplus MetTM was produced in Japan Section 304 of the Tariff Act of 1930, as
Prepopik for purposes of U.S. government by combining two APIs: pioglitazone HCl amended (19 U.S.C. § 1304), provides that,
procurement and marking? (pioglitazone), an insulin sensitizer unless excepted, every article of foreign
LAW AND ANALYSIS: metformin, a biguanide used to decrease the origin (or its container) imported into the
amount of glucose produced by the liver and United States shall be marked in a
Country of Origin make muscle tissue more sensitive to insulin conspicuous place as legibly, indelibly and
Pursuant to Subpart B of Part 177, 19 CFR so glucose can be absorbed. The two APIs permanently as the nature of the article (or
177.21 et seq., which implements Title III of were mixed together to form a fix its container) will permit, in such a manner
the Trade Agreements Act of 1979, as combination drug. The decision noted that as to indicate to the ultimate purchaser in the
amended (19 U.S.C. § 2511 et seq.), CBP with the combination of the two APIs, type United States the English name of the
issues country of origin advisory rulings and 2 diabetes patients will receive more medical country of origin of the article. Congressional
final determinations as to whether an article benefits than taking metformin alone. CBP intent in enacting 19 U.S.C. § 1304 was ‘‘that
is or would be a product of a designated held that the finished pharmaceutical, the ultimate purchaser should be able to
country or instrumentality for the purposes Actoplus MetTM had a new name, character know by an inspection of the marking on the
and use distinct from the two APIs used in imported goods the country of which the
mstockstill on DSK4VPTVN1PROD with NOTICES
of granting waivers of certain ‘‘Buy
American’’ restrictions in U.S. law or the production of the finished product. It was goods is the product. The evident purpose is
practice for products offered for sale to the noted that while pioglitazone and metformin to mark the goods so that at the time of
U.S. Government. could be prescribed separately, the final purchase the ultimate purchaser may, by
product, Actoplus MetTM, increased the knowing where the goods were produced, be
1 See http://www.nlm.nih.gov/medlineplus/ency/ individual effectiveness of pioglitazone and able to buy or refuse to buy them, if such
article/002282.htm; see also http:// metformin in treating type 2 diabetes marking should influence his will.’’ United
www.nlm.nih.gov/medlineplus/druginfo/meds/ patients. Therefore, a substantial States v. Friedlaender & Co., 27 CCPA 297,
a613020.html. transformation was found to take place in 302, C.A.D. 104 (1940). Part 134, CBP
VerDate Sep<11>2014 20:14 Mar 19, 2015 Jkt 235001 PO 00000 Frm 00121 Fmt 4703 Sfmt 4703 E:\FR\FM\20MRN1.SGM 20MRN1](https://thefederalregister.org/doc/80_FR_15078/page/2.svg)
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Regulations (19 CFR § 134) implements the Pursuant to 19 CFR § 177.30, any party-at- FOR FURTHER INFORMATION CONTACT:
country of origin marking requirements and interest may, within 30 days of publication Approved Gauger and Accredited
exceptions of 19 U.S.C. § 1304. of the Federal Register Notice referenced Laboratories Manager, Laboratories and
Section 134.1(b), CBP Regulations (19 CFR above, seek judicial review of this final
§ 134.1(b)), defines ‘‘country of origin’’ as: determination before the Court of
Scientific Services Directorate, U.S.
the country of manufacture, production or International Trade. Customs and Border Protection, 1300
growth of any article of foreign origin Sincerely, Pennsylvania Avenue NW., Suite
entering the United States. Further work or 1500N, Washington, DC 20229, tel. 202–
material added to an article in another Glen E. Vereb,
Acting Executive Director, Regulations and 344–1060.
country must effect a substantial
transformation in order to render such other Rulings, Office of International Trade. SUPPLEMENTARY INFORMATION: Notice is
country the ‘‘country of origin’’ within the [FR Doc. 2015–06434 Filed 3–19–15; 8:45 am] hereby given pursuant to 19 CFR 151.12
meaning of this part; . . . BILLING CODE 9111–14–P and 19 CFR 151.13, that AmSpec
The country of origin of an article for U.S. Services, LLC, 4075 Sprig Driver, Suite
tariff purposes is the country in which the
last substantial transformation took place. A A, Concord, CA 94520, has been
DEPARTMENT OF HOMELAND approved to gauge petroleum and
substantial transformation occurs when an
article is used in a manufacturing process or SECURITY certain petroleum products and
operation that results in a new article that accredited to test petroleum and certain
has a new name, character or use different U.S. Customs and Border Protection
petroleum products for customs
from that of the original imported article. A purposes, in accordance with the
substantial transformation will not result Accreditation and Approval of Amspec
from a minor manufacturing or combining Services, LLC, as a Commercial provisions of 19 CFR 151.12 and 19 CFR
process that leaves the identity of the article Gauger and Laboratory 151.13. AmSpec Services, LLC is
intact. See United States v. Gibson-Thomsen approved for the following gauging
Co., 27 C.C.P.A. 267 (1940); and National AGENCY: U.S. Customs and Border procedures for petroleum and certain
Hand Tool Corp. v. United States, 989 F.2d Protection, Department of Homeland petroleum products from the American
1201 (Fed. Cir. 1992). Security. Petroleum Institute (API):
In the instant case, Ferring mixes all the ACTION: Notice of accreditation and
ingredients by blending, sieving, and mixing.
We find that this processing results in a
approval of AmSpec Services, LLC, as a API Chap- Title
commercial gauger and laboratory. ters
substantial transformation. The combination
of the two ingredients results in a more
stimulative laxative effect for purposes of SUMMARY: Notice is hereby given, 1 .............. Vocabulary.
cleansing the bowels. Therefore, we find that pursuant to CBP regulations, that 3 .............. Tank gauging.
the country of origin of Prepopik is China for AmSpec Services, LLC, has been 7 .............. Temperature determination.
country of origin marking purposes. approved to gauge petroleum and 8 .............. Sampling.
HOLDING: certain petroleum products and 11 ............ Physical Properties.
accredited to test petroleum and certain 12 ............ Calculations.
Based on the facts in this case, we find that
petroleum products for customs 17 ............ Maritime measurement.
the imported Prepopik is substantially
transformed in China. The country of origin purposes for the next three years as of
for government procurement and marking October 27, 2014. AmSpec Services, LLC is accredited
purposes is China. DATES: Effective Dates: The for the following laboratory analysis
Notice of this final determination will be accreditation and approval of AmSpec procedures and methods for petroleum
given in the Federal Register, as required by and certain petroleum products set forth
19 CFR § 177.29. Any party-at-interest other
Services, LLC, as commercial gauger
than the party which requested this final and laboratory became effective on by the U.S. Customs and Border
determination may request, pursuant to 19 October 27, 2014. The next triennial Protection Laboratory Methods (CBPL)
CFR § 177.31, that CBP reexamine the matter inspection date will be scheduled for and American Society for Testing and
anew and issue a new final determination. October 2017. 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 petro-
leum 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 inquiries regarding the specific test or a complete listing of CBP approved
mstockstill on DSK4VPTVN1PROD with NOTICES
to conduct laboratory analyses and gauger service this entity is accredited gaugers and accredited laboratories.
gauger services should request and or approved to perform may be directed http://www.cbp.gov/about/labs-
receive written assurances from the to the U.S. Customs and Border scientific/commercial-gaugers-and-
entity that it is accredited or approved Protection by calling (202) 344–1060. laboratories
by the U.S. Customs and Border The inquiry may also be sent to
Protection to conduct the specific test or CBPGaugersLabs@dhs.gov. Please
gauger service requested. Alternatively, reference the Web site listed below for
VerDate Sep<11>2014 20:14 Mar 19, 2015 Jkt 235001 PO 00000 Frm 00122 Fmt 4703 Sfmt 4703 E:\FR\FM\20MRN1.SGM 20MRN1](https://thefederalregister.org/doc/80_FR_15078/page/3.svg)
Document Created: 2015-12-18 11:34:40
Document Modified: 2015-12-18 11:34:40
| 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 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. | |
| Contact | Grace A. Kim, Valuation and Special Programs Branch, Regulations and Rulings, Office of International Trade (202) 325-7941. | |
| FR Citation | 80 FR 15024 |
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