82 FR 40786 - Notice of Issuance of Final Determinations Concerning Certain Pharmaceutical Products
DEPARTMENT OF HOMELAND SECURITY
U.S. Customs and Border Protection Federal Register Volume 82, Issue 165 (August 28, 2017)
U.S. Customs and Border Protection
Federal Register Volume 82, Issue 165 (August 28, 2017)
| Page Range | 40786-40793 | |
| FR Document | 2017-18205 |
[Federal Register Volume 82, Number 165 (Monday, August 28, 2017)] [Notices] [Pages 40786-40793] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-18205] ----------------------------------------------------------------------- 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. 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 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 party-at-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. [[Page 40787]] ISSUE: What is the country of origin of the meloxicam tablets for purposes of U.S. Government procurement? 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). A substantial transformation occurs when an article emerges from a process with a new name, character, and use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Ass'n v. United States, 628 F.Supp. 978 (Ct. Int'l Trade 1986). 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 material. To that end, CBP has generally held that the processing of pharmaceutical products from bulk form into measured doses does not result in a substantial transformation of the product. See, e.g., Headquarters Ruling (``HQ'') 561975, dated April 3, 2002; HQ 561544, dated May 1, 2000; HQ 735146, dated November 15, 1993; HQ H267177, dated November 5, 2016; HQ H233356, dated December 26, 2012; and, HQ 561975, dated April 3, 2002. For example, in HQ H267177, CBP held that Indian- and Chinese- origin Acyclovir was not substantially transformed in the United States when it was combined with excipients and processed into tablets. In that case, the Indian or Chinese Acyclovir was the only active pharmaceutical ingredient in the final product. Accordingly, we found that the processing performed in the United States did not result in a change in the medicinal use of the finished product. Furthermore, the Acyclovir maintained its chemical and physical characteristics and did not undergo a change in name, character, or use. Consistent with our previous rulings, we held that processing the Acyclovir into dosage form and packaging it for sale in the United States did not constitute a substantial transformation. Accordingly, the country of origin of the final product for purposes of U.S. Government procurement was either China or India, where the active ingredient was produced. Similarly, in HQ H233356, CBP held that the processing and packaging of imported mefenamic acid into dosage form in the United States did not constitute substantial transformation. Based on previous CBP rulings, we found that the specific U.S. processing-- which involved blending the active ingredients with inactive ingredients in a tumbler and then encapsulating and packaging the product--did not substantially transform the mefenamic acid because its chemical character remained the same. Accordingly, we held that the country of origin of the final product was India, where the mefanamic acid was produced. In HQ 561975, we also held that the processing of imported bulk Japanese-origin anesthetic drugs into dosage form in the United States did not constitute substantial transformation. Although the bulk form of the drug underwent testing operations, filtering, and packaging in the United States, these processes did not change the chemical or physical properties of the drug. Furthermore, there was no change in the product's name, which was referred to as sevoflurane in both its bulk and processed form. Additionally, because the imported bulk drug had a predetermined medicinal use as an anesthetic drug, the processing in the United States did not result in a change in the product's use. The country of origin of the finished product was therefore Japan. Here, as in the cases cited above, the processing of bulk imported pharmaceuticals into dosage form will not result in a substantial transformation. In this case, the processing begins with Italian-origin bulk meloxicam and, after this product is combined with inactive ingredients from TAA-eligible countries in India, results in meloxicam tablets in individual doses of either 7.5 milligrams or 15 milligrams. Because the product is referred to as ``meloxicam'' both before and after the Indian processing, no change in name occurs in India. Furthermore, no change in character occurs in India because the meloxicam maintains the same chemical and physical properties both before and after the Indian processing. Finally, because the imported, bulk-form meloxicam had a predetermined medicinal use as a nonsteroidal anti-inflammatory, no change in use occurs after processing in India. Under these circumstances, and consistent with previous CBP rulings, we find that the country of origin of the final product is Italy, where the active ingredient was produced. HOLDING: The country of origin of the meloxicam tablets for purposes of U.S. Government procurement is Italy. 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-at-interest may, within 30 days of publication of the Federal Register Notice referenced above, seek judicial review of this final determination before the Court of International Trade. Sincerely, Alice A. Kipel, Executive Director, Regulations & Rulings, Office of Trade. ATTACHMENT B HQ H284691 August 22, 2017 OT:RR:CTF:VS H284691 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 Bimatoprost Ophthalmic Solution; 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 bimatoprost ophthalmic solution. As a U.S. importer, Lupin is a party-at- 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 bimatoprost ophthalmic solution (0.03%), which you describe as ``a `prostaglandin analog' used to reduce elevated intraocular pressure.'' The manufacturing process for Lupin's bimatoprost ophthalmic solution begins in Taiwan, where the active pharmaceutical ingredient (``API'') bimatoprost (chemical [[Page 40788]] formula C25H37NO4) is produced. You state that the Taiwanese bimatoprost 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 Taiwanese API in India during the manufacturing process. The ingredients include the following: [ ] [ ] [ ] [ ] [ ] [ ] The manufacturing processes performed in India include the following four steps: First, the weights of the API and inactive ingredients are verified. Second, the active and inactive ingredients are dissolved in water. Third, the inactive and active ingredient solutions are combined and the pH level is adjusted if necessary. Finally, in the fourth step, the solution is filtered and placed into approved packaging. You state that the processes performed to produce the finished bimatoprost ophthalmic solution do not result in any change to the chemical characteristics of the Taiwanese 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 0.03%-strength dosage form. ISSUE: What is the country of origin of the bimatoprost ophthalmic solution for purposes of U.S. Government procurement? 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. 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). A substantial transformation occurs when an article emerges from a process with a new name, character, and use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Ass'n v. United States, 628 F.Supp. 978 (Ct. Int'l Trade 1986). 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 material. To that end, CBP has generally held that the processing of pharmaceutical products from bulk form into measured doses does not result in a substantial transformation of the product. See, e.g., Headquarters Ruling (``HQ'') 561975, dated April 3, 2002; HQ 561544, dated May 1, 2000; HQ 735146, dated November 15, 1993; HQ H267177, dated November 5, 2016; HQ H233356, dated December 26, 2012; and, HQ 561975, dated April 3, 2002. For example, in HQ H267177, CBP held that Indian- and Chinese- origin Acyclovir was not substantially transformed in the United States when it was combined with excipients and processed into tablets. In that case, the Indian or Chinese Acyclovir was the only active pharmaceutical ingredient in the final product. Accordingly, we found that the processing performed in the United States did not result in a change in the medicinal use of the finished product. Furthermore, the Acyclovir maintained its chemical and physical characteristics and did not undergo a change in name, character, or use. Consistent with our previous rulings, we held that processing the Acyclovir into dosage form and packaging it for sale in the United States did not constitute a substantial transformation. Accordingly, the country of origin of the final product for purposes of U.S. Government procurement was either China or India, where the active ingredient was produced. Similarly, in HQ H233356, CBP held that the processing and packaging of imported mefenamic acid into dosage form in the United States did not constitute substantial transformation. Based on previous CBP rulings, we found that the specific U.S. processing-- which involved blending the active ingredients with inactive ingredients in a tumbler and then encapsulating and packaging the product--did not substantially transform the mefenamic acid because its chemical character remained the same. Accordingly, we held that the country of origin of the final product was India, where the mefanamic acid was produced. In HQ 561975, we also held that the processing of imported bulk Japanese-origin anesthetic drugs into dosage form in the United States did not constitute substantial transformation. Although the bulk form of the drug underwent testing operations, filtering, and packaging in the United States, these processes did not change the chemical or physical properties of the drug. Furthermore, there was no change in the product's name, which was referred to as sevoflurane in both its bulk and processed form. Additionally, because the imported bulk drug had a predetermined medicinal use as an anesthetic drug, the processing in the United States did not result in a change in the product's use. The country of origin of the finished product was therefore Japan. Here, as in the cases cited above, the processing of bulk imported pharmaceuticals into dosage form will not result in a substantial transformation. In this case, the processing begins with Taiwanese-origin bulk bimatoprost and, after this product is combined with inactive ingredients in India, results in bimatoprost ophthalmic solution in 0.03%-strength form. Because the product is referred to as ``bimatoprost'' both before and after the Indian processing, no change in name occurs in India. Furthermore, no change in character occurs in India because the bimatoprost maintains the same chemical and physical properties both before and after the Indian processing. Finally, because the imported, bulk- form bimatoprost had a predetermined medicinal use as a ``prostaglandin analog'' used to reduce elevated intraocular pressure, no change in use occurs after processing in India. Under these circumstances, and consistent with previous CBP rulings, we find that the country of origin of the final product is Taiwan, where the active ingredient was produced. HOLDING: The country of origin of the bimatoprost ophthalmic solution for purposes of U.S. Government procurement is Taiwan. 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-at-interest may, within 30 days of publication of the Federal Register Notice referenced above, seek judicial review of this final determination before the Court of International Trade. Sincerely, Alice A. Kipel, Executive Director, Regulations & Rulings, Office of Trade. ATTACHMENT C HQ H284692 August 22, 2017 OT:RR:CTF:VS H284692 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 Niacin ER 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 [[Page 40789]] 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 niacin ER tablets. As a U.S. importer, Lupin is a party-at-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 niacin ER tablets, in doses of 500 milligrams, 750 milligrams, and 1000 milligrams, which you describe as ``an antihyperlipidemic agent . . . used in patients with primary hyperlipidemia and mixed dyslipidemia.'' The manufacturing process for Lupin's niacin ER tablets begins in either Belgium or Switzerland, where the active pharmaceutical ingredient (``API'') nicotinic acid (chemical formula C6H5NO2) is produced. You state that the Belgian or Swiss nicotinic acid 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 Belgian or Swiss API in India during the manufacturing process. The ingredients include the following: [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] [ ] The manufacturing processes performed in India include the following four steps: First, the API and inactive ingredients are sifted and blended. Second, the materials are granulated, and then sieved. Third, the blend is compressed into tablets and the tablets are coated. Finally, in the fourth step, the finished tablets are packaged into approved packaging. You state that the processes performed to produce the finished niacin ER tablets do not result in any change to the chemical characteristics of the Belgian or Swiss 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 500-milligram, 750-milligram, and 1000-milligram dosage form. ISSUE: What is the country of origin of the niacin ER tablets for purposes of U.S. Government procurement? 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). A substantial transformation occurs when an article emerges from a process with a new name, character, and use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Ass'n v. United States, 628 F.Supp. 978 (Ct. Int'l Trade 1986). 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 material. To that end, CBP has generally held that the processing of pharmaceutical products from bulk form into measured doses does not result in a substantial transformation of the product. See, e.g., Headquarters Ruling (``HQ'') 561975, dated April 3, 2002; HQ 561544, dated May 1, 2000; HQ 735146, dated November 15, 1993; HQ H267177, dated November 5, 2016; HQ H233356, dated December 26, 2012; and, HQ 561975, dated April 3, 2002. For example, in HQ H267177, CBP held that Indian- and Chinese- origin Acyclovir was not substantially transformed in the United States when it was combined with excipients and processed into tablets. In that case, the Indian or Chinese Acyclovir was the only active pharmaceutical ingredient in the final product. Accordingly, we found that the processing performed in the United States did not result in a change in the medicinal use of the finished product. Furthermore, the Acyclovir maintained its chemical and physical characteristics and did not undergo a change in name, character, or use. Consistent with our previous rulings, we held that processing the Acyclovir into dosage form and packaging it for sale in the United States did not constitute a substantial transformation. Accordingly, the country of origin of the final product for purposes of U.S. Government procurement was either China or India, where the active ingredient was produced. Similarly, in HQ H233356, CBP held that the processing and packaging of imported mefenamic acid into dosage form in the United States did not constitute substantial transformation. Based on previous CBP rulings, we found that the specific U.S. processing-- which involved blending the active ingredients with inactive ingredients in a tumbler and then encapsulating and packaging the product--did not substantially transform the mefenamic acid because its chemical character remained the same. Accordingly, we held that the country of origin of the final product was India, where the mefanamic acid was produced. In HQ 561975, we also held that the processing of imported bulk Japanese-origin anesthetic drugs into dosage form in the United States did not constitute substantial transformation. Although the bulk form of the drug underwent testing operations, filtering, and packaging in the United States, these processes did not change the chemical or physical properties of the drug. Furthermore, there was no change in the product's name, which was referred to as sevoflurane in both its bulk and processed form. Additionally, because the imported bulk drug had a predetermined medicinal use as an anesthetic drug, the processing in the United States did not result in a change in the product's use. The country of origin of the finished product was therefore Japan. Here, as in the cases cited above, the processing of bulk imported pharmaceuticals into dosage form will not result in a substantial transformation. In this case, the processing begins with Belgian- or Swiss-origin bulk nicotinic acid and, after this product is combined with inactive ingredients in India, results in niacin ER tablets in individual doses of 500 milligrams, 750 milligrams, or 1000 milligrams. Although Lupin refers to the final product as niacin, it is also commonly known as nicotinic acid. See WebMD, Niacin ER, http://webmd.com/drugs/2/drug-3745-9126/niacin-oral/niacin-extended-release-oral/details (last visited June 22, 2017). Because the product is referred to as nicotinic acid both before and after the Indian processing, no change in name occurs in India. Furthermore, no change in character occurs in India because the nicotinic acid maintains the same chemical and physical properties both before and after the Indian processing. Finally, because the imported, bulk-form nicotinic acid had a predetermined medicinal use as an antihyperlipidemic agent, no change in use occurs after processing in India. Under these circumstances, and consistent with previous CBP rulings, we find that the country of origin of the final product is [[Page 40790]] Belgium or Switzerland, where the active ingredient was produced. HOLDING: The country of origin of the niacin ER tablets for purposes of U.S. Government procurement is Belgium or Switzerland. ATTACHMENT D HQ H284694 August 22, 2017 OT:RR:CTF:VS H284694 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 Calcium Acetate Capsules; 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 calcium acetate capsules. As a U.S. importer, Lupin is a party-at-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 calcium acetate capsules, in doses of 667 milligrams, which you describe as a `` `antihyperphosphatemic' or `phosphate binder' that is used to reduce the levels of phosphate in the blood.'' The manufacturing process for Lupin's calcium acetate capsules begins in the Netherlands, where the active pharmaceutical ingredient (``API'') calcium acetate (chemical formula C4H6CaO4) is produced. You state that the Dutch calcium acetate is the only active ingredient in the finished pharmaceutical product. However, the finished product contains a number of other inactive ingredients. These ingredients are combined with the Dutch API in India during the manufacturing process. The ingredients include the following: [ ] [ ] [ ] The manufacturing processes performed in India include the following three steps: First, the API and inactive ingredients are sifted and blended. Second, the blend is filled in gelatin capsules. Finally, in the third step, the finished capsules are packaged into approved packaging. You state that the processes performed to produce the finished calcium acetate capsules do not result in any change to the chemical characteristics of the Dutch 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 667 milligram dosage form. ISSUE: What is the country of origin of the calcium acetate capsules for purposes of U.S. Government procurement? 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). A substantial transformation occurs when an article emerges from a process with a new name, character, and use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Ass'n v. United States, 628 F.Supp. 978 (Ct. Int'l Trade 1986). 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 material. To that end, CBP has generally held that the processing of pharmaceutical products from bulk form into measured doses does not result in a substantial transformation of the product. See, e.g., Headquarters Ruling (``HQ'') 561975, dated April 3, 2002; HQ 561544, dated May 1, 2000; HQ 735146, dated November 15, 1993; HQ H267177, dated November 5, 2016; HQ H233356, dated December 26, 2012; and, HQ 561975, dated April 3, 2002. For example, in HQ H267177, CBP held that Indian- and Chinese- origin Acyclovir was not substantially transformed in the United States when it was combined with excipients and processed into tablets. In that case, the Indian or Chinese Acyclovir was the only active pharmaceutical ingredient in the final product. Accordingly, we found that the processing performed in the United States did not result in a change in the medicinal use of the finished product. Furthermore, the Acyclovir maintained its chemical and physical characteristics and did not undergo a change in name, character, or use. Consistent with our previous rulings, we held that processing the Acyclovir into dosage form and packaging it for sale in the United States did not constitute a substantial transformation. Accordingly, the country of origin of the final product for purposes of U.S. Government procurement was either China or India, where the active ingredient was produced. Similarly, in HQ H233356, CBP held that the processing and packaging of imported mefenamic acid into dosage form in the United States did not constitute substantial transformation. Based on previous CBP rulings, we found that the specific U.S. processing-- which involved blending the active ingredients with inactive ingredients in a tumbler and then encapsulating and packaging the product--did not substantially transform the mefenamic acid because its chemical character remained the same. Accordingly, we held that the country of origin of the final product was India, where the mefanamic acid was produced. In HQ 561975, we also held that the processing of imported bulk Japanese-origin anesthetic drugs into dosage form in the United States did not constitute substantial transformation. Although the bulk form of the drug underwent testing operations, filtering, and packaging in the United States, these processes did not change the chemical or physical properties of the drug. Furthermore, there was no change in the product's name, which was referred to as sevoflurane in both its bulk and processed form. Additionally, because the imported bulk drug had a predetermined medicinal use as an anesthetic drug, the processing in the United States did not result in a change in the product's use. The country of origin of the finished product was therefore Japan. Here, as in the cases cited above, the processing of bulk imported pharmaceuticals into dosage form will not result in a substantial transformation. In this case, the processing begins with Dutch-origin bulk calcium acetate and, after this product is combined with inactive ingredients in India, results in calcium acetate capsules in individual doses of 667 milligrams. Because the product is referred to as ``calcium [[Page 40791]] acetate'' both before and after the Indian processing, no change in name occurs in India. Furthermore, no change in character occurs in India because the calcium acetate maintains the same chemical and physical properties both before and after the Indian processing. Finally, because the imported, bulk-form calcium acetate had a predetermined medicinal use as an antihyperphosphatemic or phosphate binder, no change in use occurs after processing in India. Under these circumstances, and consistent with previous CBP rulings, we find that the country of origin of the final product is the Netherlands, where the active ingredient was produced. HOLDING: The country of origin of the calcium acetate capsules for purposes of U.S. Government procurement is the Netherlands. 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-at-interest may, within 30 days of publication of the Federal Register Notice referenced above, seek judicial review of this final determination before the Court of International Trade. Sincerely, Alice A. Kipel, Executive Director, Regulations & Rulings, Office of Trade. 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-at-interest may, within 30 days of publication of the Federal Register Notice referenced above, seek judicial review of this final determination before the Court of International Trade. Sincerely, Alice A. Kipel, Executive Director, Regulations & Rulings, Office of Trade. ATTACHMENT E HQ H284695 August 22, 2017 OT:RR:CTF:VS H284695 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 Quinine Sulfate Capsules; 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 quinine sulfate capsules. As a U.S. importer, Lupin is a party-at-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 quinine sulfate capsules, in doses of 324 milligrams, which you describe as `` `cinchona alkaloid[s]' that [are] used for the treatment of malaria.'' The manufacturing process for Lupin's quinine sulfate capsules begins in Germany, where the active pharmaceutical ingredient (``API'') quinine sulfate (chemical formula ((C20H24N2O2)2H2SO42H2O) is produced. You state that the German quinine sulfate 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 German API in India during the manufacturing process. The ingredients include the following: [ ] [ ] [ ] [ ] The manufacturing processes performed in India include the following four steps: First, the API and inactive ingredients are sifted and blended. Second, the materials are granulated, and then sieved. Third, the blend is filled in gelatin capsules. Finally, in the fourth step, the finished capsules are packaged into approved packaging. You state that the processes performed to produce the finished quinine sulfate capsules do not result in any change to the chemical characteristics of the German 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 324 milligram dosage form. ISSUE: What is the country of origin of the quinine sulfate capsules for purposes of U.S. Government procurement? 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). A substantial transformation occurs when an article emerges from a process with a new name, character, and use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Ass'n v. United States, 628 F.Supp. 978 (Ct. Int'l Trade 1986). 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 material. To that end, CBP has generally held that the processing of pharmaceutical products from bulk form into measured doses does not result in a substantial transformation of the product. See, e.g., Headquarters Ruling (``HQ'') 561975, dated April 3, 2002; HQ 561544, dated May 1, 2000; HQ 735146, dated November 15, 1993; HQ H267177, dated November 5, 2016; HQ H233356, dated December 26, 2012; and, HQ 561975, dated April 3, 2002. For example, in HQ H267177, CBP held that Indian- and Chinese- origin Acyclovir was not substantially transformed in the United States when it was combined with excipients and processed into tablets. In that case, the Indian or Chinese Acyclovir was the only active pharmaceutical ingredient in the final product. Accordingly, we found that the processing performed in the United States did not result in a change in the medicinal use of the finished product. Furthermore, the Acyclovir maintained its chemical and physical characteristics and did not undergo a change in name, character, or use. Consistent with our previous rulings, we [[Page 40792]] held that processing the Acyclovir into dosage form and packaging it for sale in the United States did not constitute a substantial transformation. Accordingly, the country of origin of the final product for purposes of U.S. Government procurement was either China or India, where the active ingredient was produced. Similarly, in HQ H233356, CBP held that the processing and packaging of imported mefenamic acid into dosage form in the United States did not constitute substantial transformation. Based on previous CBP rulings, we found that the specific U.S. processing-- which involved blending the active ingredients with inactive ingredients in a tumbler and then encapsulating and packaging the product--did not substantially transform the mefenamic acid because its chemical character remained the same. Accordingly, we held that the country of origin of the final product was India, where the mefanamic acid was produced. In HQ 561975, we also held that the processing of imported bulk Japanese-origin anesthetic drugs into dosage form in the United States did not constitute substantial transformation. Although the bulk form of the drug underwent testing operations, filtering, and packaging in the United States, these processes did not change the chemical or physical properties of the drug. Furthermore, there was no change in the product's name, which was referred to as sevoflurane in both its bulk and processed form. Additionally, because the imported bulk drug had a predetermined medicinal use as an anesthetic drug, the processing in the United States did not result in a change in the product's use. The country of origin of the finished product was therefore Japan. Here, as in the cases cited above, the processing of bulk imported pharmaceuticals into dosage form will not result in a substantial transformation. In this case, the processing begins with German-origin bulk quinine sulfate and, after this product is combined with inactive ingredients in India, results in quinine sulfate capsules in 324 milligram doses. Because the product is referred to as ``quinine sulfate'' both before and after the Indian processing, no change in name occurs in India. Furthermore, no change in character occurs in India because the quinine sulfate maintains the same chemical and physical properties both before and after the Indian processing. Finally, because the imported, bulk- form quinine sulfate had a predetermined medicinal use as an antimalarial drug, no change in use occurs after processing in India. Under these circumstances, and consistent with previous CBP rulings, we find that the country of origin of the final product is Germany, where the active ingredient was produced. HOLDING: The country of origin of the quinine sulfate capsules for purposes of U.S. Government procurement is Germany. 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-at-interest may, within 30 days of publication of the Federal Register Notice referenced above, seek judicial review of this final determination before the Court of International Trade. Sincerely, Alice A. Kipel, Executive Director, Regulations & Rulings, Office of Trade. ATTACHMENT F HQ H284697 August 22, 2017 OT:RR:CTF:VS H284697 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 Pravastatin Sodium 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 pravastatin sodium tablets. As a U.S. importer, Lupin is a party-at-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 pravastatin sodium tablets in doses of 10, 20, 40, and 80 milligrams, which you describe as a pharmaceutical product that is ``an antilipimic agent that is used to reduce the risk of myocardial infarction.'' The manufacturing process for Lupin's pravastatin sodium tablets begins in Taiwan, where the active pharmaceutical ingredient (``API'') pravastatin sodium (chemical formula C23H35NaO7) is produced. You state that the Taiwanese pravastatin sodium 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 Taiwanese API in India during the manufacturing process. The ingredients include the following: [ ] [ ] [ ] [ ] [ ] [ ] [ ] The manufacturing processes performed in India include the following three steps: First, the API and inactive ingredients are sifted and blended. Second, the blend is compressed into tablets and the tablets are coated. Finally, in the third step, the finished tablets are packaged into approved packaging. You state that the processes performed to produce the finished pravastatin sodium tablets do not result in any change to the chemical characteristics of the Taiwanese 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 10-, 20-, 40-, and 80-milligram dosage form. ISSUE: What is the country of origin of the pravastatin sodium tablets for purposes of U.S. Government procurement? 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). A substantial transformation occurs when an article emerges from a process with a new name, character, and use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining [[Page 40793]] process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Ass'n v. United States, 628 F.Supp. 978 (Ct. Int'l Trade 1986). 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 material. To that end, CBP has generally held that the processing of pharmaceutical products from bulk form into measured doses does not result in a substantial transformation of the product. See, e.g., Headquarters Ruling (``HQ'') 561975, dated April 3, 2002; HQ 561544, dated May 1, 2000; HQ 735146, dated November 15, 1993; HQ H267177, dated November 5, 2016; HQ H233356, dated December 26, 2012; and, HQ 561975, dated April 3, 2002. For example, in HQ H267177, CBP held that Indian- and Chinese- origin Acyclovir was not substantially transformed in the United States when it was combined with excipients and processed into tablets. In that case, the Indian or Chinese Acyclovir was the only active pharmaceutical ingredient in the final product. Accordingly, we found that the processing performed in the United States did not result in a change in the medicinal use of the finished product. Furthermore, the Acyclovir maintained its chemical and physical characteristics and did not undergo a change in name, character, or use. Consistent with our previous rulings, we held that processing the Acyclovir into dosage form and packaging it for sale in the United States did not constitute a substantial transformation. Accordingly, the country of origin of the final product for purposes of U.S. Government procurement was either China or India, where the active ingredient was produced. Similarly, in HQ H233356, CBP held that the processing and packaging of imported mefenamic acid into dosage form in the United States did not constitute substantial transformation. Based on previous CBP rulings, we found that the specific U.S. processing-- which involved blending the active ingredients with inactive ingredients in a tumbler and then encapsulating and packaging the product--did not substantially transform the mefenamic acid because its chemical character remained the same. Accordingly, we held that the country of origin of the final product was India, where the mefanamic acid was produced. In HQ 561975, we also held that the processing of imported bulk Japanese-origin anesthetic drugs into dosage form in the United States did not constitute substantial transformation. Although the bulk form of the drug underwent testing operations, filtering, and packaging in the United States, these processes did not change the chemical or physical properties of the drug. Furthermore, there was no change in the product's name, which was referred to as sevoflurane in both its bulk and processed form. Additionally, because the imported bulk drug had a predetermined medicinal use as an anesthetic drug, the processing in the United States did not result in a change in the product's use. The country of origin of the finished product was therefore Japan. Here, as in the cases cited above, the processing of bulk imported pharmaceuticals into dosage form will not result in a substantial transformation. In this case, the processing begins with Taiwanese-origin bulk pravastatin sodium and, after this product is combined with inactive ingredients in India, results in pravastatin sodium tablets in individual doses of 10, 20, 40, or 80 milligrams. Because the product is referred to as ``pravastatin sodium'' both before and after the Indian processing, no change in name occurs in India. Furthermore, no change in character occurs in India because the pravastatin sodium maintains the same chemical and physical properties both before and after the Indian processing. Finally, because the imported, bulk-form pravastatin sodium had a predetermined medicinal use as an antilipimic agent that is used to reduce the risk of myocardial infarction, no change in use occurs after processing in India. Under these circumstances, and consistent with previous CBP rulings, we find that the country of origin of the final product is Taiwan, where the active ingredient was produced. HOLDING: The country of origin of the pravastatin sodium tablets for purposes of U.S. Government procurement is Taiwan. 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-at-interest may, within 30 days of publication of the Federal Register Notice referenced above, seek judicial review of this final determination before the Court of International Trade. Sincerely, Alice A. Kipel, Executive Director, Regulations & Rulings, Office of Trade. [FR Doc. 2017-18205 Filed 8-25-17; 8:45 am] BILLING CODE 9111-14-P
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of the Federal Register Notice referenced pursuant to subpart B of Part 177, U.S. country or instrumentality for the purposes
above, seek judicial review of this final Customs and Border Protection of granting waivers of certain ‘‘Buy
determination before the Court of Regulations (19 CFR part 177, subpart American’’ restrictions in U.S. law or for
International Trade. B), CBP issued six final determinations products offered for sale to the U.S.
Sincerely, concerning the country of origin of Government. This final determination
concerns the country of origin of meloxicam
Alice A. Kipel,
certain pharmaceutical products, which
tablets. As a U.S. importer, Lupin is a party-
may be offered to the U.S. Government
Executive Director Regulations and Rulings, at-interest within the meaning of 19 CFR
Office of Trade.
under an undesignated government 177.22(d)(1) and is entitled to request this
procurement contract. These final final determination.
[FR Doc. 2017–18202 Filed 8–25–17; 8:45 am] determinations (HQ H284690, HQ You have asked that certain information
BILLING CODE 9111–14–P H284961, HQ H284692, HQ H284694, submitted in connection with this ruling
HQ H284695, and HQ H284697), were request be treated as confidential. Inasmuch
issued under procedures set forth at 19 as this request conforms to the requirements
DEPARTMENT OF HOMELAND CFR part 177, subpart B, which of 19 CFR 177.2(b)(7), the request for
SECURITY implements Title III of the Trade confidentiality is approved. The information
Agreements Act of 1979, as amended contained within brackets and all
U.S. Customs and Border Protection (19 U.S.C. 2511–18). In the final attachments to this ruling request, forwarded
determinations, CBP concluded that the to our office, will not be released to the
Notice of Issuance of Final public and will be withheld from published
Determinations Concerning Certain processing in India does not result in a
substantial transformation. Therefore, versions of this ruling.
Pharmaceutical Products
the country of origin for purposes of FACTS:
AGENCY: U.S. Customs and Border U.S. Government procurement of the Lupin is a subsidiary of Lupin Limited, one
Protection, Department of Homeland pharmaceutical products is the country of the five largest pharmaceutical companies
Security. in which the active pharmaceutical in India. At issue in this case are meloxicam
ACTION: Notice of final determinations. ingredient was produced. tablets, in doses of 7.5 milligrams and 15
Section 177.29, CBP Regulations (19 milligrams, which you describe as
SUMMARY: This document provides CFR 177.29), provides that a notice of ‘‘nonsteroidal anti-inflammator[ies] used for
notice that U.S. Customs and Border final determination shall be published the relief of the signs and symptoms of
Protection (‘‘CBP’’) has issued six final in the Federal Register within 60 days rheumatoid arthritis and osteoarthritis.’’
determinations concerning the country of the date the final determination is The manufacturing process for Lupin’s
of origin of certain pharmaceutical issued. Section 177.30, CBP Regulations meloxicam tablets begins in Italy, where the
products produced by Lupin (19 CFR 177.30), provides that any active pharmaceutical ingredient (‘‘API’’)
Pharmaceuticals, Inc. Based upon the party-at-interest, as defined in 19 CFR meloxicam (chemical formula
facts presented, CBP has concluded that 177.22(d), may seek judicial review of a C14H13N3O4S2) is produced. You state that
the country of origin of the meloxicam final determination within 30 days of the Italian meloxicam is the only active
tablets is Italy for purposes of U.S. publication of such determination in the ingredient in the finished pharmaceutical
Government procurement, that the product. However, the finished product
Federal Register.
country of origin of the bimatoprost contains a number of other inactive
Dated: August 22, 2017. ingredients, which you describe as
ophthalmic solution is Taiwan for
purposes of U.S. Government Alice A. Kipel, excipients. These ingredients are combined
Executive Director, Regulations and Rulings, with the Italian API in India during the
procurement, that the country of origin
Office of Trade. manufacturing process. The ingredients
of the niacin ER tablets is Belgium or
include the following chemicals, which you
Switzerland for purposes of U.S. ATTACHMENT A note are products of TAA-eligible countries:
Government procurement, that the • [ ]
country of origin of the calcium acetate HQ H284690
• [ ]
capsules is the Netherlands for purposes August 22, 20917 • [ ]
of U.S. Government procurement, that OT:RR:CTF:VS H284690 RMC • [ ]
the country of origin of the quinine • [ ]
sulfate capsules is Germany for CATEGORY: Origin • [ ]
purposes of U.S. Government Kevin J. Maynard • [ ]
procurement, and that the country of Wiley Rein LLP The manufacturing process in India
origin of the pravastatin sodium tablets 1776 K St. NW involves four steps. First, the API and
is Taiwan for purposes of U.S. Washington, DC 20006 inactive ingredients are sifted and blended.
Government procurement. Re: U.S. Government Procurement; Country Second, the materials are granulated, and the
of Origin of Meloxicam Tablets; wet granulates are then sieved and dried.
DATES: These final determinations were
Substantial Transformation Third, the product is compressed into tablets.
issued on August 22, 2017. Copies of the Finally, in the fourth step, the finished
Dear Mr. Maynard:
final determinations are attached. Any tablets are packaged into approved
party-at-interest, as defined in 19 CFR This is in response to your letter, dated
March 20, 2017, requesting a final packaging.
177.22(d), may seek judicial review of determination on behalf of Lupin You state that the processes performed to
these final determinations within Pharmaceuticals, Inc. (‘‘Lupin’’) pursuant to produce the finished meloxicam tablets do
asabaliauskas on DSKBBXCHB2PROD with NOTICES
September 27, 2017. subpart B of Part 177 of the U.S. Customs and not result in any change to the chemical
FOR FURTHER INFORMATION CONTACT: Ross Border Protection (‘‘CBP’’) Regulations (19 characteristics of the Italian API or to any
M. Cunningham, Valuation and Special CFR Part 177). Under these regulations, other ingredients. You also state that the
Programs Branch, Regulations and which implement Title III of the Trade medicinal use, molecular formula, and
Rulings, Office of Trade, (202) 325– Agreements Act of 1979 (‘‘TAA’’), as solubility of the API are unchanged by the
amended (19 U.S.C. § 2511 et seq.), CBP manufacturing operations in India. In short,
0034.
issues country of origin advisory rulings and you characterize the Indian operations as
SUPPLEMENTARY INFORMATION: Notice is final determinations as to whether an article mere processing of bulk API into 7.5
hereby given that on August 22, 2017 is or would be a product of a designated milligram and 15 milligram dosage form.
VerDate Sep<11>2014 18:45 Aug 25, 2017 Jkt 241001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\28AUN1.SGM 28AUN1](https://thefederalregister.org/doc/82_FR_40951/page/1.svg)
![40788 Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices
formula C25H37NO4) is produced. You state process that leaves the identity of the article United States did not result in a change in
that the Taiwanese bimatoprost is the only intact. See United States v. Gibson-Thomsen the product’s use. The country of origin of
active ingredient in the finished Co., 27 C.C.P.A. 267 (1940); and National the finished product was therefore Japan.
pharmaceutical product. However, the Juice Products Ass’n v. United States, 628 Here, as in the cases cited above, the
finished product contains a number of other F.Supp. 978 (Ct. Int’l Trade 1986). processing of bulk imported pharmaceuticals
inactive ingredients, which you describe as In determining whether a substantial into dosage form will not result in a
excipients. These ingredients are combined transformation occurs in the manufacture of substantial transformation. In this case, the
with the Taiwanese API in India during the chemical products such as pharmaceuticals, processing begins with Taiwanese-origin
manufacturing process. The ingredients CBP has consistently examined the bulk bimatoprost and, after this product is
include the following: complexity of the processing and whether the combined with inactive ingredients in India,
• [ ] final article retains the essential identity and results in bimatoprost ophthalmic solution in
• [ ] character of the raw material. To that end, 0.03%-strength form. Because the product is
• [ ] CBP has generally held that the processing of referred to as ‘‘bimatoprost’’ both before and
• [ ] pharmaceutical products from bulk form into after the Indian processing, no change in
• [ ] measured doses does not result in a name occurs in India. Furthermore, no
• [ ] substantial transformation of the product. change in character occurs in India because
The manufacturing processes performed in See, e.g., Headquarters Ruling (‘‘HQ’’) the bimatoprost maintains the same chemical
India include the following four steps: First, 561975, dated April 3, 2002; HQ 561544, and physical properties both before and after
the weights of the API and inactive dated May 1, 2000; HQ 735146, dated the Indian processing. Finally, because the
ingredients are verified. Second, the active November 15, 1993; HQ H267177, dated imported, bulk-form bimatoprost had a
and inactive ingredients are dissolved in November 5, 2016; HQ H233356, dated predetermined medicinal use as a
water. Third, the inactive and active December 26, 2012; and, HQ 561975, dated ‘‘prostaglandin analog’’ used to reduce
ingredient solutions are combined and the April 3, 2002. elevated intraocular pressure, no change in
pH level is adjusted if necessary. Finally, in For example, in HQ H267177, CBP held use occurs after processing in India. Under
the fourth step, the solution is filtered and that Indian- and Chinese-origin Acyclovir these circumstances, and consistent with
placed into approved packaging. was not substantially transformed in the previous CBP rulings, we find that the
You state that the processes performed to United States when it was combined with country of origin of the final product is
produce the finished bimatoprost ophthalmic excipients and processed into tablets. In that Taiwan, where the active ingredient was
solution do not result in any change to the case, the Indian or Chinese Acyclovir was the produced.
chemical characteristics of the Taiwanese only active pharmaceutical ingredient in the HOLDING:
API or to any other ingredients. You also final product. Accordingly, we found that the
state that the medicinal use, molecular processing performed in the United States The country of origin of the bimatoprost
formula, and solubility of the API are did not result in a change in the medicinal ophthalmic solution for purposes of U.S.
unchanged by the manufacturing operations use of the finished product. Furthermore, the Government procurement is Taiwan.
in India. In short, you characterize the Indian Acyclovir maintained its chemical and Notice of this final determination will be
operations as mere processing of bulk API physical characteristics and did not undergo given in the Federal Register, as required by
into 0.03%-strength dosage form. a change in name, character, or use. 19 CFR 177.29. Any party-at-interest other
Consistent with our previous rulings, we than the party which requested this final
ISSUE: held that processing the Acyclovir into determination may request, pursuant to 19
What is the country of origin of the dosage form and packaging it for sale in the CFR 177.31, that CBP reexamine the matter
bimatoprost ophthalmic solution for United States did not constitute a substantial anew and issue a new final determination.
purposes of U.S. Government procurement? transformation. Accordingly, the country of Pursuant to 19 CFR 177.30, any party-at-
origin of the final product for purposes of interest may, within 30 days of publication
LAW AND ANALYSIS: of the Federal Register Notice referenced
U.S. Government procurement was either
Pursuant to subpart B of Part 177, 19 CFR China or India, where the active ingredient above, seek judicial review of this final
177.21 et seq., which implements Title III of was produced. determination before the Court of
the Trade Agreements Act of 1979, as Similarly, in HQ H233356, CBP held that International Trade.
amended (19 U.S.C. § 2511 et seq.), CBP the processing and packaging of imported Sincerely,
issues country of origin advisory rulings and mefenamic acid into dosage form in the Alice A. Kipel,
final determinations as to whether an article United States did not constitute substantial
is or would be a product of a designated Executive Director, Regulations & Rulings,
transformation. Based on previous CBP Office of Trade.
country or instrumentality for the purposes rulings, we found that the specific U.S.
of granting waivers of certain ‘‘Buy processing—which involved blending the ATTACHMENT C
American’’ restrictions in U.S. law or active ingredients with inactive ingredients HQ H284692
practice for products offered for sale to the in a tumbler and then encapsulating and
U.S. Government. packaging the product—did not substantially August 22, 2017
Under the rule of origin set forth under 19 transform the mefenamic acid because its
U.S.C. § 2518(4)(B): OT:RR:CTF:VS H284692 RMC
chemical character remained the same.
An article is a product of a country or Accordingly, we held that the country of CATEGORY: Origin
instrumentality only if (i) it is wholly the origin of the final product was India, where Kevin J. Maynard
growth, product, or manufacture of that the mefanamic acid was produced. Wiley Rein LLP
country or instrumentality, or (ii) in the case In HQ 561975, we also held that the 1776 K St. NW
of an article which consists in whole or in processing of imported bulk Japanese-origin Washington, DC 20006
part of materials from another country or anesthetic drugs into dosage form in the
instrumentality, it has been substantially Re: U.S. Government Procurement; Country
United States did not constitute substantial
transformed into a new and different article of Origin of Niacin ER Tablets;
transformation. Although the bulk form of
of commerce with a name, character, or use Substantial Transformation
the drug underwent testing operations,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
distinct from that of the article or articles filtering, and packaging in the United States, Dear Mr. Maynard:
from which it was so transformed. these processes did not change the chemical This is in response to your letter, dated
See also 19 CFR 177.22(a). or physical properties of the drug. March 20, 2017, requesting a final
A substantial transformation occurs when Furthermore, there was no change in the determination on behalf of Lupin
an article emerges from a process with a new product’s name, which was referred to as Pharmaceuticals, Inc. (‘‘Lupin’’) pursuant to
name, character, and use different from that sevoflurane in both its bulk and processed subpart B of Part 177 of the U.S. Customs and
possessed by the article prior to processing. form. Additionally, because the imported Border Protection (‘‘CBP’’) Regulations (19
A substantial transformation will not result bulk drug had a predetermined medicinal use CFR part 177). Under these regulations,
from a minor manufacturing or combining as an anesthetic drug, the processing in the which implement Title III of the Trade
VerDate Sep<11>2014 18:45 Aug 25, 2017 Jkt 241001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\28AUN1.SGM 28AUN1](https://thefederalregister.org/doc/82_FR_40951/page/3.svg)
![Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 40789
Agreements Act of 1979 (‘‘TAA’’), as you characterize the Indian operations as use of the finished product. Furthermore, the
amended (19 U.S.C. 2511 et seq.), CBP issues mere processing of bulk API into 500- Acyclovir maintained its chemical and
country of origin advisory rulings and final milligram, 750-milligram, and 1000- physical characteristics and did not undergo
determinations as to whether an article is or milligram dosage form. a change in name, character, or use.
would be a product of a designated country Consistent with our previous rulings, we
or instrumentality for the purposes of ISSUE: held that processing the Acyclovir into
granting waivers of certain ‘‘Buy American’’ What is the country of origin of the niacin dosage form and packaging it for sale in the
restrictions in U.S. law or for products ER tablets for purposes of U.S. Government United States did not constitute a substantial
offered for sale to the U.S. Government. This procurement? transformation. Accordingly, the country of
final determination concerns the country of origin of the final product for purposes of
LAW AND ANALYSIS:
origin of niacin ER tablets. As a U.S. U.S. Government procurement was either
importer, Lupin is a party-at-interest within Pursuant to subpart B of Part 177, 19 CFR China or India, where the active ingredient
the meaning of 19 CFR 177.22(d)(1) and is 177.21 et seq., which implements Title III of was produced.
entitled to request this final determination. the Trade Agreements Act of 1979, as Similarly, in HQ H233356, CBP held that
You have asked that certain information amended (19 U.S.C. 2511 et seq.), CBP issues the processing and packaging of imported
submitted in connection with this ruling country of origin advisory rulings and final mefenamic acid into dosage form in the
request be treated as confidential. Inasmuch determinations as to whether an article is or United States did not constitute substantial
as this request conforms to the requirements would be a product of a designated country transformation. Based on previous CBP
of 19 CFR 177.2(b)(7), the request for or instrumentality for the purposes of rulings, we found that the specific U.S.
confidentiality is approved. The information granting waivers of certain ‘‘Buy American’’ processing—which involved blending the
contained within brackets and all restrictions in U.S. law or practice for active ingredients with inactive ingredients
attachments to this ruling request, forwarded products offered for sale to the U.S. in a tumbler and then encapsulating and
to our office, will not be released to the Government. packaging the product—did not substantially
public and will be withheld from published Under the rule of origin set forth under 19 transform the mefenamic acid because its
versions of this ruling. U.S.C. 2518(4)(B): chemical character remained the same.
An article is a product of a country or Accordingly, we held that the country of
FACTS: instrumentality only if (i) it is wholly the origin of the final product was India, where
Lupin is a subsidiary of Lupin Limited, one growth, product, or manufacture of that the mefanamic acid was produced.
of the five largest pharmaceutical companies country or instrumentality, or (ii) in the case In HQ 561975, we also held that the
in India. At issue in this case are niacin ER of an article which consists in whole or in processing of imported bulk Japanese-origin
tablets, in doses of 500 milligrams, 750 part of materials from another country or anesthetic drugs into dosage form in the
milligrams, and 1000 milligrams, which you instrumentality, it has been substantially United States did not constitute substantial
describe as ‘‘an antihyperlipidemic agent transformed into a new and different article transformation. Although the bulk form of
. . . used in patients with primary of commerce with a name, character, or use the drug underwent testing operations,
hyperlipidemia and mixed dyslipidemia.’’ distinct from that of the article or articles filtering, and packaging in the United States,
The manufacturing process for Lupin’s from which it was so transformed. these processes did not change the chemical
niacin ER tablets begins in either Belgium or See also 19 CFR 177.22(a). or physical properties of the drug.
Switzerland, where the active A substantial transformation occurs when Furthermore, there was no change in the
pharmaceutical ingredient (‘‘API’’) nicotinic an article emerges from a process with a new product’s name, which was referred to as
acid (chemical formula C6H5NO2) is name, character, and use different from that sevoflurane in both its bulk and processed
produced. You state that the Belgian or Swiss possessed by the article prior to processing. form. Additionally, because the imported
nicotinic acid is the only active ingredient in A substantial transformation will not result bulk drug had a predetermined medicinal use
the finished pharmaceutical product. from a minor manufacturing or combining as an anesthetic drug, the processing in the
However, the finished product contains a process that leaves the identity of the article United States did not result in a change in
number of other inactive ingredients, which intact. See United States v. Gibson-Thomsen the product’s use. The country of origin of
you describe as excipients. These ingredients Co., 27 C.C.P.A. 267 (1940); and National the finished product was therefore Japan.
are combined with the Belgian or Swiss API Juice Products Ass’n v. United States, 628 Here, as in the cases cited above, the
in India during the manufacturing process. F.Supp. 978 (Ct. Int’l Trade 1986). processing of bulk imported pharmaceuticals
The ingredients include the following: In determining whether a substantial into dosage form will not result in a
• [ ] transformation occurs in the manufacture of substantial transformation. In this case, the
• [ ] chemical products such as pharmaceuticals, processing begins with Belgian- or Swiss-
• [ ] CBP has consistently examined the origin bulk nicotinic acid and, after this
• [ ] complexity of the processing and whether the product is combined with inactive
• [ ] final article retains the essential identity and ingredients in India, results in niacin ER
• [ ] character of the raw material. To that end, tablets in individual doses of 500 milligrams,
• [ ] CBP has generally held that the processing of 750 milligrams, or 1000 milligrams. Although
• [ ] pharmaceutical products from bulk form into Lupin refers to the final product as niacin, it
• [ ] measured doses does not result in a is also commonly known as nicotinic acid.
• [ ] substantial transformation of the product. See WebMD, Niacin ER, http://webmd.com/
The manufacturing processes performed in See, e.g., Headquarters Ruling (‘‘HQ’’) drugs/2/drug-3745–9126/niacin-oral/niacin-
India include the following four steps: First, 561975, dated April 3, 2002; HQ 561544, extended-release-oral/details (last visited
the API and inactive ingredients are sifted dated May 1, 2000; HQ 735146, dated June 22, 2017). Because the product is
and blended. Second, the materials are November 15, 1993; HQ H267177, dated referred to as nicotinic acid both before and
granulated, and then sieved. Third, the blend November 5, 2016; HQ H233356, dated after the Indian processing, no change in
is compressed into tablets and the tablets are December 26, 2012; and, HQ 561975, dated name occurs in India. Furthermore, no
coated. Finally, in the fourth step, the April 3, 2002. change in character occurs in India because
finished tablets are packaged into approved For example, in HQ H267177, CBP held the nicotinic acid maintains the same
asabaliauskas on DSKBBXCHB2PROD with NOTICES
packaging. that Indian- and Chinese-origin Acyclovir chemical and physical properties both before
You state that the processes performed to was not substantially transformed in the and after the Indian processing. Finally,
produce the finished niacin ER tablets do not United States when it was combined with because the imported, bulk-form nicotinic
result in any change to the chemical excipients and processed into tablets. In that acid had a predetermined medicinal use as
characteristics of the Belgian or Swiss API or case, the Indian or Chinese Acyclovir was the an antihyperlipidemic agent, no change in
to any other ingredients. You also state that only active pharmaceutical ingredient in the use occurs after processing in India. Under
the medicinal use, molecular formula, and final product. Accordingly, we found that the these circumstances, and consistent with
solubility of the API are unchanged by the processing performed in the United States previous CBP rulings, we find that the
manufacturing operations in India. In short, did not result in a change in the medicinal country of origin of the final product is
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![40790 Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices
Belgium or Switzerland, where the active are combined with the Dutch API in India pharmaceutical products from bulk form into
ingredient was produced. during the manufacturing process. The measured doses does not result in a
ingredients include the following: substantial transformation of the product.
HOLDING: • [ ] See, e.g., Headquarters Ruling (‘‘HQ’’)
The country of origin of the niacin ER • [ ] 561975, dated April 3, 2002; HQ 561544,
tablets for purposes of U.S. Government • [ ] dated May 1, 2000; HQ 735146, dated
procurement is Belgium or Switzerland. The manufacturing processes performed in November 15, 1993; HQ H267177, dated
ATTACHMENT D India include the following three steps: First, November 5, 2016; HQ H233356, dated
the API and inactive ingredients are sifted December 26, 2012; and, HQ 561975, dated
HQ H284694 and blended. Second, the blend is filled in April 3, 2002.
August 22, 2017 gelatin capsules. Finally, in the third step, For example, in HQ H267177, CBP held
the finished capsules are packaged into that Indian- and Chinese-origin Acyclovir
OT:RR:CTF:VS H284694 RMC approved packaging. was not substantially transformed in the
You state that the processes performed to United States when it was combined with
CATEGORY: Origin
produce the finished calcium acetate excipients and processed into tablets. In that
Kevin J. Maynard capsules do not result in any change to the case, the Indian or Chinese Acyclovir was the
Wiley Rein LLP chemical characteristics of the Dutch API or only active pharmaceutical ingredient in the
1776 K St. NW to any other ingredients. You also state that final product. Accordingly, we found that the
Washington, DC 20006 the medicinal use, molecular formula, and processing performed in the United States
Re: U.S. Government Procurement; Country solubility of the API are unchanged by the did not result in a change in the medicinal
of Origin of Calcium Acetate Capsules; manufacturing operations in India. In short, use of the finished product. Furthermore, the
Substantial Transformation you characterize the Indian operations as Acyclovir maintained its chemical and
Dear Mr. Maynard: mere processing of bulk API into 667 physical characteristics and did not undergo
milligram dosage form. a change in name, character, or use.
This is in response to your letter, dated
Consistent with our previous rulings, we
March 20, 2017, requesting a final ISSUE: held that processing the Acyclovir into
determination on behalf of Lupin What is the country of origin of the dosage form and packaging it for sale in the
Pharmaceuticals, Inc. (‘‘Lupin’’) pursuant to
calcium acetate capsules for purposes of U.S. United States did not constitute a substantial
subpart B of Part 177 of the U.S. Customs and
Government procurement? transformation. Accordingly, the country of
Border Protection (‘‘CBP’’) Regulations (19
CFR Part 177). Under these regulations, origin of the final product for purposes of
LAW AND ANALYSIS:
which implement Title III of the Trade U.S. Government procurement was either
Pursuant to subpart B of Part 177, 19 CFR China or India, where the active ingredient
Agreements Act of 1979 (‘‘TAA’’), as 177.21 et seq., which implements Title III of
amended (19 U.S.C. 2511 et seq.), CBP issues was produced.
the Trade Agreements Act of 1979, as Similarly, in HQ H233356, CBP held that
country of origin advisory rulings and final amended (19 U.S.C. 2511 et seq.), CBP issues
determinations as to whether an article is or the processing and packaging of imported
country of origin advisory rulings and final mefenamic acid into dosage form in the
would be a product of a designated country determinations as to whether an article is or
or instrumentality for the purposes of United States did not constitute substantial
would be a product of a designated country transformation. Based on previous CBP
granting waivers of certain ‘‘Buy American’’
or instrumentality for the purposes of rulings, we found that the specific U.S.
restrictions in U.S. law or for products
granting waivers of certain ‘‘Buy American’’ processing—which involved blending the
offered for sale to the U.S. Government. This
restrictions in U.S. law or practice for active ingredients with inactive ingredients
final determination concerns the country of
products offered for sale to the U.S. in a tumbler and then encapsulating and
origin of calcium acetate capsules. As a U.S.
Government. packaging the product—did not substantially
importer, Lupin is a party-at-interest within
Under the rule of origin set forth under 19 transform the mefenamic acid because its
the meaning of 19 CFR 177.22(d)(1) and is
U.S.C. 2518(4)(B): chemical character remained the same.
entitled to request this final determination.
An article is a product of a country or Accordingly, we held that the country of
You have asked that certain information
submitted in connection with this ruling instrumentality only if (i) it is wholly the origin of the final product was India, where
request be treated as confidential. Inasmuch growth, product, or manufacture of that the mefanamic acid was produced.
as this request conforms to the requirements country or instrumentality, or (ii) in the case In HQ 561975, we also held that the
of 19 CFR 177.2(b)(7), the request for of an article which consists in whole or in processing of imported bulk Japanese-origin
confidentiality is approved. The information part of materials from another country or anesthetic drugs into dosage form in the
contained within brackets and all instrumentality, it has been substantially United States did not constitute substantial
attachments to this ruling request, forwarded transformed into a new and different article transformation. Although the bulk form of
to our office, will not be released to the of commerce with a name, character, or use the drug underwent testing operations,
public and will be withheld from published distinct from that of the article or articles filtering, and packaging in the United States,
versions of this ruling. from which it was so transformed. these processes did not change the chemical
See also 19 CFR 177.22(a). or physical properties of the drug.
FACTS: A substantial transformation occurs when Furthermore, there was no change in the
Lupin is a subsidiary of Lupin Limited, one an article emerges from a process with a new product’s name, which was referred to as
of the five largest pharmaceutical companies name, character, and use different from that sevoflurane in both its bulk and processed
in India. At issue in this case are calcium possessed by the article prior to processing. form. Additionally, because the imported
acetate capsules, in doses of 667 milligrams, A substantial transformation will not result bulk drug had a predetermined medicinal use
which you describe as a from a minor manufacturing or combining as an anesthetic drug, the processing in the
‘‘ ‘antihyperphosphatemic’ or ‘phosphate process that leaves the identity of the article United States did not result in a change in
binder’ that is used to reduce the levels of intact. See United States v. Gibson-Thomsen the product’s use. The country of origin of
phosphate in the blood.’’ Co., 27 C.C.P.A. 267 (1940); and National the finished product was therefore Japan.
The manufacturing process for Lupin’s Juice Products Ass’n v. United States, 628 Here, as in the cases cited above, the
asabaliauskas on DSKBBXCHB2PROD with NOTICES
calcium acetate capsules begins in the F.Supp. 978 (Ct. Int’l Trade 1986). processing of bulk imported pharmaceuticals
Netherlands, where the active In determining whether a substantial into dosage form will not result in a
pharmaceutical ingredient (‘‘API’’) calcium transformation occurs in the manufacture of substantial transformation. In this case, the
acetate (chemical formula C4H6CaO4) is chemical products such as pharmaceuticals, processing begins with Dutch-origin bulk
produced. You state that the Dutch calcium CBP has consistently examined the calcium acetate and, after this product is
acetate is the only active ingredient in the complexity of the processing and whether the combined with inactive ingredients in India,
finished pharmaceutical product. However, final article retains the essential identity and results in calcium acetate capsules in
the finished product contains a number of character of the raw material. To that end, individual doses of 667 milligrams. Because
other inactive ingredients. These ingredients CBP has generally held that the processing of the product is referred to as ‘‘calcium
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![Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 40791
acetate’’ both before and after the Indian Pharmaceuticals, Inc. (‘‘Lupin’’) pursuant to ISSUE:
processing, no change in name occurs in subpart B of Part 177 of the U.S. Customs and What is the country of origin of the quinine
India. Furthermore, no change in character Border Protection (‘‘CBP’’) Regulations (19 sulfate capsules for purposes of U.S.
occurs in India because the calcium acetate CFR Part 177). Under these regulations, Government procurement?
maintains the same chemical and physical which implement Title III of the Trade
properties both before and after the Indian Agreements Act of 1979 (‘‘TAA’’), as LAW AND ANALYSIS:
processing. Finally, because the imported, amended (19 U.S.C. 2511 et seq.), CBP issues Pursuant to subpart B of Part 177, 19 CFR
bulk-form calcium acetate had a country of origin advisory rulings and final 177.21 et seq., which implements Title III of
predetermined medicinal use as an determinations as to whether an article is or the Trade Agreements Act of 1979, as
antihyperphosphatemic or phosphate binder, would be a product of a designated country amended (19 U.S.C. 2511 et seq.), CBP issues
no change in use occurs after processing in or instrumentality for the purposes of country of origin advisory rulings and final
India. Under these circumstances, and granting waivers of certain ‘‘Buy American’’ determinations as to whether an article is or
consistent with previous CBP rulings, we restrictions in U.S. law or for products would be a product of a designated country
find that the country of origin of the final offered for sale to the U.S. Government. This or instrumentality for the purposes of
product is the Netherlands, where the active final determination concerns the country of granting waivers of certain ‘‘Buy American’’
ingredient was produced. origin of quinine sulfate capsules. As a U.S. restrictions in U.S. law or practice for
importer, Lupin is a party-at-interest within products offered for sale to the U.S.
HOLDING: the meaning of 19 CFR 177.22(d)(1) and is Government.
The country of origin of the calcium entitled to request this final determination. Under the rule of origin set forth under 19
acetate capsules for purposes of U.S. You have asked that certain information U.S.C. 2518(4)(B):
Government procurement is the Netherlands. submitted in connection with this ruling An article is a product of a country or
Notice of this final determination will be request be treated as confidential. Inasmuch instrumentality only if (i) it is wholly the
given in the Federal Register, as required by as this request conforms to the requirements growth, product, or manufacture of that
19 CFR 177.29. Any party-at-interest other of 19 CFR 177.2(b)(7), the request for country or instrumentality, or (ii) in the case
than the party which requested this final confidentiality is approved. The information of an article which consists in whole or in
determination may request, pursuant to 19 contained within brackets and all part of materials from another country or
CFR 177.31, that CBP reexamine the matter attachments to this ruling request, forwarded instrumentality, it has been substantially
anew and issue a new final determination. to our office, will not be released to the transformed into a new and different article
Pursuant to 19 CFR 177.30, any party-at- public and will be withheld from published of commerce with a name, character, or use
interest may, within 30 days of publication versions of this ruling. distinct from that of the article or articles
of the Federal Register Notice referenced from which it was so transformed.
FACTS:
above, seek judicial review of this final See also 19 CFR 177.22(a).
determination before the Court of Lupin is a subsidiary of Lupin Limited, one A substantial transformation occurs when
International Trade. of the five largest pharmaceutical companies an article emerges from a process with a new
Sincerely, in India. At issue in this case are quinine name, character, and use different from that
sulfate capsules, in doses of 324 milligrams, possessed by the article prior to processing.
Alice A. Kipel, which you describe as ‘‘ ‘cinchona A substantial transformation will not result
Executive Director, Regulations & Rulings, alkaloid[s]’ that [are] used for the treatment from a minor manufacturing or combining
Office of Trade. of malaria.’’ process that leaves the identity of the article
Notice of this final determination will be The manufacturing process for Lupin’s intact. See United States v. Gibson-Thomsen
given in the Federal Register, as required by quinine sulfate capsules begins in Germany, Co., 27 C.C.P.A. 267 (1940); and National
19 CFR 177.29. Any party-at-interest other where the active pharmaceutical ingredient Juice Products Ass’n v. United States, 628
than the party which requested this final (‘‘API’’) quinine sulfate (chemical formula F.Supp. 978 (Ct. Int’l Trade 1986).
determination may request, pursuant to 19 ((C20H24N2O2)2H2SO42H2O) is produced. In determining whether a substantial
CFR 177.31, that CBP reexamine the matter You state that the German quinine sulfate is transformation occurs in the manufacture of
anew and issue a new final determination. the only active ingredient in the finished chemical products such as pharmaceuticals,
Pursuant to 19 CFR 177.30, any party-at- pharmaceutical product. However, the CBP has consistently examined the
interest may, within 30 days of publication finished product contains a number of other complexity of the processing and whether the
of the Federal Register Notice referenced inactive ingredients, which you describe as final article retains the essential identity and
above, seek judicial review of this final excipients. These ingredients are combined character of the raw material. To that end,
determination before the Court of with the German API in India during the CBP has generally held that the processing of
International Trade. manufacturing process. The ingredients pharmaceutical products from bulk form into
Sincerely, include the following: measured doses does not result in a
• [ ] substantial transformation of the product.
Alice A. Kipel,
• [ ] See, e.g., Headquarters Ruling (‘‘HQ’’)
Executive Director, Regulations & Rulings,
• [ ] 561975, dated April 3, 2002; HQ 561544,
Office of Trade.
• [ ] dated May 1, 2000; HQ 735146, dated
ATTACHMENT E The manufacturing processes performed in November 15, 1993; HQ H267177, dated
HQ H284695 India include the following four steps: First, November 5, 2016; HQ H233356, dated
the API and inactive ingredients are sifted December 26, 2012; and, HQ 561975, dated
August 22, 2017 and blended. Second, the materials are April 3, 2002.
granulated, and then sieved. Third, the blend For example, in HQ H267177, CBP held
OT:RR:CTF:VS H284695 RMC
is filled in gelatin capsules. Finally, in the that Indian- and Chinese-origin Acyclovir
CATEGORY: Origin fourth step, the finished capsules are was not substantially transformed in the
Kevin J. Maynard packaged into approved packaging. United States when it was combined with
Wiley Rein LLP You state that the processes performed to excipients and processed into tablets. In that
produce the finished quinine sulfate capsules case, the Indian or Chinese Acyclovir was the
asabaliauskas on DSKBBXCHB2PROD with NOTICES
1776 K St. NW
Washington, DC 20006 do not result in any change to the chemical only active pharmaceutical ingredient in the
characteristics of the German API or to any final product. Accordingly, we found that the
Re: U.S. Government Procurement; Country other ingredients. You also state that the processing performed in the United States
of Origin of Quinine Sulfate Capsules; medicinal use, molecular formula, and did not result in a change in the medicinal
Substantial Transformation solubility of the API are unchanged by the use of the finished product. Furthermore, the
Dear Mr. Maynard: manufacturing operations in India. In short, Acyclovir maintained its chemical and
This is in response to your letter, dated you characterize the Indian operations as physical characteristics and did not undergo
March 20, 2017, requesting a final mere processing of bulk API into 324 a change in name, character, or use.
determination on behalf of Lupin milligram dosage form. Consistent with our previous rulings, we
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![40792 Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices
held that processing the Acyclovir into anew and issue a new final determination. formula C23H35NaO7) is produced. You
dosage form and packaging it for sale in the Pursuant to 19 CFR 177.30, any party-at- state that the Taiwanese pravastatin sodium
United States did not constitute a substantial interest may, within 30 days of publication is the only active ingredient in the finished
transformation. Accordingly, the country of of the Federal Register Notice referenced pharmaceutical product. However, the
origin of the final product for purposes of above, seek judicial review of this final finished product contains a number of other
U.S. Government procurement was either determination before the Court of inactive ingredients, which you describe as
China or India, where the active ingredient International Trade. excipients. These ingredients are combined
was produced. Sincerely, with the Taiwanese API in India during the
Similarly, in HQ H233356, CBP held that manufacturing process. The ingredients
Alice A. Kipel,
the processing and packaging of imported include the following:
mefenamic acid into dosage form in the Executive Director, Regulations & Rulings, • [ ]
United States did not constitute substantial Office of Trade. • [ ]
transformation. Based on previous CBP ATTACHMENT F • [ ]
rulings, we found that the specific U.S. • [ ]
HQ H284697 • [ ]
processing—which involved blending the
active ingredients with inactive ingredients August 22, 2017 • [ ]
in a tumbler and then encapsulating and • [ ]
packaging the product—did not substantially OT:RR:CTF:VS H284697 RMC The manufacturing processes performed in
transform the mefenamic acid because its CATEGORY: Origin India include the following three steps: First,
chemical character remained the same. the API and inactive ingredients are sifted
Kevin J. Maynard and blended. Second, the blend is
Accordingly, we held that the country of
Wiley Rein LLP compressed into tablets and the tablets are
origin of the final product was India, where
1776 K St. NW coated. Finally, in the third step, the finished
the mefanamic acid was produced.
Washington, DC 20006 tablets are packaged into approved
In HQ 561975, we also held that the
processing of imported bulk Japanese-origin Re: U.S. Government Procurement; Country packaging.
anesthetic drugs into dosage form in the of Origin of Pravastatin Sodium Tablets; You state that the processes performed to
United States did not constitute substantial Substantial Transformation produce the finished pravastatin sodium
transformation. Although the bulk form of Dear Mr. Maynard: tablets do not result in any change to the
the drug underwent testing operations, This is in response to your letter, dated chemical characteristics of the Taiwanese
filtering, and packaging in the United States, March 20, 2017, requesting a final API or to any other ingredients. You also
these processes did not change the chemical determination on behalf of Lupin state that the medicinal use, molecular
or physical properties of the drug. Pharmaceuticals, Inc. (‘‘Lupin’’) pursuant to formula, and solubility of the API are
Furthermore, there was no change in the subpart B of Part 177 of the U.S. Customs and unchanged by the manufacturing operations
product’s name, which was referred to as Border Protection (‘‘CBP’’) Regulations (19 in India. In short, you characterize the Indian
sevoflurane in both its bulk and processed CFR Part 177). Under these regulations, operations as mere processing of bulk API
form. Additionally, because the imported which implement Title III of the Trade into 10-, 20-, 40-, and 80-milligram dosage
bulk drug had a predetermined medicinal use Agreements Act of 1979 (‘‘TAA’’), as form.
as an anesthetic drug, the processing in the amended (19 U.S.C. 2511 et seq.), CBP issues ISSUE:
United States did not result in a change in country of origin advisory rulings and final
the product’s use. The country of origin of determinations as to whether an article is or What is the country of origin of the
the finished product was therefore Japan. would be a product of a designated country pravastatin sodium tablets for purposes of
Here, as in the cases cited above, the or instrumentality for the purposes of U.S. Government procurement?
processing of bulk imported pharmaceuticals granting waivers of certain ‘‘Buy American’’ LAW AND ANALYSIS:
into dosage form will not result in a restrictions in U.S. law or for products
substantial transformation. In this case, the offered for sale to the U.S. Government. This Pursuant to subpart B of Part 177, 19 CFR
processing begins with German-origin bulk final determination concerns the country of 177.21 et seq., which implements Title III of
quinine sulfate and, after this product is origin of pravastatin sodium tablets. As a the Trade Agreements Act of 1979, as
combined with inactive ingredients in India, U.S. importer, Lupin is a party-at-interest amended (19 U.S.C. 2511 et seq.), CBP issues
results in quinine sulfate capsules in 324 within the meaning of 19 CFR 177.22(d)(1) country of origin advisory rulings and final
milligram doses. Because the product is and is entitled to request this final determinations as to whether an article is or
referred to as ‘‘quinine sulfate’’ both before determination. would be a product of a designated country
and after the Indian processing, no change in You have asked that certain information or instrumentality for the purposes of
name occurs in India. Furthermore, no submitted in connection with this ruling granting waivers of certain ‘‘Buy American’’
change in character occurs in India because request be treated as confidential. Inasmuch restrictions in U.S. law or practice for
the quinine sulfate maintains the same as this request conforms to the requirements products offered for sale to the U.S.
chemical and physical properties both before of 19 CFR 177.2(b)(7), the request for Government.
and after the Indian processing. Finally, confidentiality is approved. The information Under the rule of origin set forth under 19
because the imported, bulk-form quinine contained within brackets and all U.S.C. 2518(4)(B):
sulfate had a predetermined medicinal use as attachments to this ruling request, forwarded An article is a product of a country or
an antimalarial drug, no change in use occurs to our office, will not be released to the instrumentality only if (i) it is wholly the
after processing in India. Under these public and will be withheld from published growth, product, or manufacture of that
circumstances, and consistent with previous versions of this ruling. country or instrumentality, or (ii) in the case
CBP rulings, we find that the country of of an article which consists in whole or in
FACTS: part of materials from another country or
origin of the final product is Germany, where
the active ingredient was produced. Lupin is a subsidiary of Lupin Limited, one instrumentality, it has been substantially
of the five largest pharmaceutical companies transformed into a new and different article
HOLDING: in India. At issue in this case are pravastatin of commerce with a name, character, or use
asabaliauskas on DSKBBXCHB2PROD with NOTICES
The country of origin of the quinine sulfate sodium tablets in doses of 10, 20, 40, and 80 distinct from that of the article or articles
capsules for purposes of U.S. Government milligrams, which you describe as a from which it was so transformed.
procurement is Germany. pharmaceutical product that is ‘‘an See also 19 CFR 177.22(a).
Notice of this final determination will be antilipimic agent that is used to reduce the A substantial transformation occurs when
given in the Federal Register, as required by risk of myocardial infarction.’’ an article emerges from a process with a new
19 CFR 177.29. Any party-at-interest other The manufacturing process for Lupin’s name, character, and use different from that
than the party which requested this final pravastatin sodium tablets begins in Taiwan, possessed by the article prior to processing.
determination may request, pursuant to 19 where the active pharmaceutical ingredient A substantial transformation will not result
CFR 177.31, that CBP reexamine the matter (‘‘API’’) pravastatin sodium (chemical from a minor manufacturing or combining
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![Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 40793
process that leaves the identity of the article United States did not result in a change in The role of the Board in funding
intact. See United States v. Gibson-Thomsen the product’s use. The country of origin of decisions.
Co., 27 C.C.P.A. 267 (1940); and National the finished product was therefore Japan.
FOR DIAL-IN INFORMATION CONTACT: Karen
Juice Products Ass’n v. United States, 628 Here, as in the cases cited above, the
F.Supp. 978 (Ct. Int’l Trade 1986). processing of bulk imported pharmaceuticals Vargas, Executive Assistant, (202) 524–
In determining whether a substantial into dosage form will not result in a 8869.
transformation occurs in the manufacture of substantial transformation. In this case, the CONTACT PERSON FOR MORE INFORMATION:
chemical products such as pharmaceuticals, processing begins with Taiwanese-origin Paul Zimmerman, General Counsel,
CBP has consistently examined the bulk pravastatin sodium and, after this (202) 683–7118.
complexity of the processing and whether the product is combined with inactive
final article retains the essential identity and ingredients in India, results in pravastatin Paul Zimmerman,
character of the raw material. To that end, sodium tablets in individual doses of 10, 20, General Counsel.
CBP has generally held that the processing of 40, or 80 milligrams. Because the product is [FR Doc. 2017–18263 Filed 8–24–17; 4:15 pm]
pharmaceutical products from bulk form into referred to as ‘‘pravastatin sodium’’ both BILLING CODE 7025–01–P
measured doses does not result in a before and after the Indian processing, no
substantial transformation of the product. change in name occurs in India. Furthermore,
See, e.g., Headquarters Ruling (‘‘HQ’’) no change in character occurs in India
561975, dated April 3, 2002; HQ 561544, because the pravastatin sodium maintains the DEPARTMENT OF THE INTERIOR
dated May 1, 2000; HQ 735146, dated same chemical and physical properties both
November 15, 1993; HQ H267177, dated before and after the Indian processing. Fish and Wildlife Service
November 5, 2016; HQ H233356, dated Finally, because the imported, bulk-form
December 26, 2012; and, HQ 561975, dated [FWS–R8–ES–2017–N084; FF08EVEN00–
pravastatin sodium had a predetermined FXFR1337088SSO0]
April 3, 2002. medicinal use as an antilipimic agent that is
For example, in HQ H267177, CBP held used to reduce the risk of myocardial
that Indian- and Chinese-origin Acyclovir
Marine Mammal Protection Act; Stock
infarction, no change in use occurs after Assessment Report for the Southern
was not substantially transformed in the processing in India. Under these
United States when it was combined with circumstances, and consistent with previous
Sea Otter in California
excipients and processed into tablets. In that CBP rulings, we find that the country of AGENCY: Fish and Wildlife Service,
case, the Indian or Chinese Acyclovir was the origin of the final product is Taiwan, where
only active pharmaceutical ingredient in the
Interior.
the active ingredient was produced.
final product. Accordingly, we found that the ACTION: Notice of availability; response
processing performed in the United States HOLDING: to comments.
did not result in a change in the medicinal The country of origin of the pravastatin
use of the finished product. Furthermore, the sodium tablets for purposes of U.S. SUMMARY: In accordance with the
Acyclovir maintained its chemical and Government procurement is Taiwan. Marine Mammal Protection Act of 1972,
physical characteristics and did not undergo Notice of this final determination will be as amended (MMPA), and its
a change in name, character, or use. given in the Federal Register, as required by implementing regulations, we, the U.S.
Consistent with our previous rulings, we 19 CFR 177.29. Any party-at-interest other Fish and Wildlife Service (Service),
held that processing the Acyclovir into than the party which requested this final announce that we have revised our
dosage form and packaging it for sale in the determination may request, pursuant to 19 stock assessment report (SAR) for the
United States did not constitute a substantial CFR 177.31, that CBP reexamine the matter southern sea otter stock in the State of
transformation. Accordingly, the country of anew and issue a new final determination. California, including incorporation of
origin of the final product for purposes of Pursuant to 19 CFR 177.30, any party-at-
U.S. Government procurement was either public comments. We now make our
interest may, within 30 days of publication
China or India, where the active ingredient of the Federal Register Notice referenced final revised SAR available to the
was produced. above, seek judicial review of this final public.
Similarly, in HQ H233356, CBP held that determination before the Court of ADDRESSES: Document Availability: You
the processing and packaging of imported International Trade. may obtain a copy of the SAR from our
mefenamic acid into dosage form in the Sincerely, Web site at https://www.fws.gov/
United States did not constitute substantial
transformation. Based on previous CBP Alice A. Kipel, ventura/endangered/species/info/
rulings, we found that the specific U.S. Executive Director, sso.html. Alternatively, you may contact
processing—which involved blending the Regulations & Rulings, the Ventura Fish and Wildlife Office,
active ingredients with inactive ingredients Office of Trade. U.S. Fish and Wildlife Service, 2493
in a tumbler and then encapsulating and [FR Doc. 2017–18205 Filed 8–25–17; 8:45 am] Portola Road, Suite B, Ventura, CA
packaging the product—did not substantially BILLING CODE 9111–14–P 93003; telephone: 805–644–1766.
transform the mefenamic acid because its FOR FURTHER INFORMATION CONTACT: For
chemical character remained the same. information on the methods, data, and
Accordingly, we held that the country of
results of the stock assessment, contact
origin of the final product was India, where INTER-AMERICAN FOUNDATION
the mefanamic acid was produced. Lilian Carswell by telephone (805–677–
In HQ 561975, we also held that the 3325) or by email (Lilian_Carswell@
Sunshine Act Meetings
processing of imported bulk Japanese-origin fws.gov). Persons who use a
anesthetic drugs into dosage form in the TIME AND DATE: September 6, 2017, telecommunications device for the deaf
United States did not constitute substantial 11:00 a.m.–12:00 p.m. (TDD) may call the Federal Relay
transformation. Although the bulk form of Service at 800–877–8339.
the drug underwent testing operations, PLACE: Via tele-conference hosted at
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUPPLEMENTARY INFORMATION: We are
filtering, and packaging in the United States, Inter-American Foundation, 1331
Pennsylvania Ave. Suite 1200, NW., announcing the availability of the final
these processes did not change the chemical
or physical properties of the drug. Washington, DC 20004. revised SAR for the southern sea otter
Furthermore, there was no change in the (Enhydra lutris nereis) stock in the State
STATUS: Meeting of the Board of
product’s name, which was referred to as of California.
Directors, Open to the public.
sevoflurane in both its bulk and processed Background
form. Additionally, because the imported MATTERS TO BE CONSIDERED: Next steps
bulk drug had a predetermined medicinal use for updating advisory council Under the MMPA (16 U.S.C. 1361 et
as an anesthetic drug, the processing in the membership. seq.) and its implementing regulations
VerDate Sep<11>2014 18:45 Aug 25, 2017 Jkt 241001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\28AUN1.SGM 28AUN1](https://thefederalregister.org/doc/82_FR_40951/page/8.svg)
Document Created: 2017-08-28 11:30:08
Document Modified: 2017-08-28 11:30:08
| 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 determinations. | |
| 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. | |
| Contact | Ross M. Cunningham, Valuation and Special Programs Branch, Regulations and Rulings, Office of Trade, (202) 325-0034. | |
| FR Citation | 82 FR 40786 |
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