Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Notices 1221 

the CBP Regulations). This is a proposed 

extension of an information collection 

that was previously approved. CBP is 

proposing that this information 

collection be extended with no change 

to the burden hours. This document is 

published to obtain comments from the 

public and affected agencies. This 

information collection was previously 

published in the Federal Register (77 

FR 64533) on October 22, 2012, 

allowing for a 60-day comment period. 

Two comments were received. This 

notice allows for an additional 30 days 

for public comments. This process is 

conducted in accordance with 5 CFR 

1320.10. 

DATES: Written comments should be 

received on or before February 7, 2013. 

ADDRESSES: Interested persons are 

invited to submit written comments on 

this information collection to the Office 

of Information and Regulatory Affairs, 

Office of Management and Budget. 

Comments should be addressed to the 

OMB Desk Officer for U.S. Customs and 

Border Protection, Department of 

Homeland Security, and sent via 

electronic mail to 

oira_submission@omb.eop.gov or faxed 

to (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information 

should be directed to Tracey Denning, 

U.S. Customs and Border Protection, 

Regulations and Rulings, Office of 

International Trade, 799 9th Street NW., 

5th Floor, Washington, DC 20229–1177, 

at 202–325–0265. 

SUPPLEMENTARY INFORMATION: CBP 

invites the general public and affected 

Federal agencies to submit written 

comments and suggestions on proposed 

and/or continuing information 

collection requests pursuant to the 

Paperwork Reduction Act (Pub. L. 104– 

13). Your comments should address one 

of the following four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency/component, 

including whether the information will 

have practical utility; 

(2) Evaluate the accuracy of the 

agency/component estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collections of information on those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

techniques or other forms of 

information. 

Title: Regulations Relating to 

Recordation and Enforcement of 

Trademark and Copyrights (Part 133 of 

the CBP Regulations). 

OMB Number: 1651–0123. 

Form Number: None. 

Abstract: In accordance with 19 CFR 

part 133, trademark and trade name 

owners and those claiming copyright 

protection may submit information to 

CBP to enable CBP officers to identify 

violating articles at the borders. Parties 

seeking to have merchandise excluded 

from entry must provide proof to CBP of 

the validity of the rights they seek to 

protect. The information collected by 

CBP is used to identify infringing goods 

at the borders and determine if such 

goods infringe on intellectual property 

rights for which federal law provides 

import protection. Respondents may 

submit their information to CBP 

electronically at https://apps.cbp.gov/erecordations/, or they may submit their 

information on paper in accordance 

with 19 CFR 133.2 and 133.3 for 

trademarks, or 19 CFR 133.32 and 

133.33 for copyrights. 

Current Actions: This submission is 

being made to extend the expiration 

date. 

Type of Review: Extension (without 

change). 

Affected Public: Businesses and 

Individuals. 

Estimated Number of Respondents: 

2,000. 

Estimated Time per Respondent: 2 

hours. 

Estimated Total Annual Burden 

Hours: 4,000. 

Dated: January 3, 2013. 

Tracey Denning, 

Agency Clearance Officer, U.S. Customs and 

Border Protection. 

[FR Doc. 2013–00144 Filed 1–7–13; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Notice of Issuance of Final 

Determination Concerning Ponstel®

(Mefenamic Acid) Capsules 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of final determination. 

SUMMARY: This document provides 

notice that U.S. Customs and Border 

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

determination concerning the country of 

origin of Ponstel® (mefenamic acid) 

capsules. Based upon the facts 

presented, CBP has concluded in the 

final determination that India is the 

country of origin of the Ponstel 

(mefenamic acid) capsules for purposes 

of U.S. Government procurement. 

DATES: The final determination was 

issued on December 26, 2012. A copy of 

the final determination is attached. Any 

party-at-interest, as defined in 19 CFR 

177.22(d), may seek judicial review of 

this final determination on or before 

February 7, 2013. 

FOR FURTHER INFORMATION CONTACT: 

Heather K. Pinnock, Valuation and 

Special Programs Branch: (202) 325– 

0034. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that on December 26, 2012, 

pursuant to subpart B of part 177, 

Customs and Border Protection 

Regulations (19 CFR part 177, subpart 

B), CBP issued a final determination 

concerning the country of origin of 

Ponstel (mefenamic acid) capsules, 

which may be offered to the U.S. 

Government under an undesignated 

government procurement contract. This 

final determination, in HQ H233356, 

was issued at the request of West-Ward 

Pharmaceutical Corp., under procedures 

set forth at 19 CFR part 177, subpart B, 

which implements Title III of the Trade 

Agreements Act of 1979, as amended 

(19 U.S.C. 2511–18). In the final 

determination CBP concluded that, 

based upon the facts presented, 

mefenamic acid from India, blended 

with excipients and packaged into 

dosage form in the United States, was 

not substantially transformed in the 

United States, such that India is the 

country of origin of the finished Ponstel 

(mefenamic acid) capsules for purposes 

of U.S. Government procurement. 

Section 177.29, CBP Regulations (19 

CFR 177.29), provides that a notice of 

final determination shall be published 

in the Federal Register within 60 days 

of the date the final determination is 

issued. Section 177.30, CBP Regulations 

(19 CFR 177.30), provides that any 

party-at-interest, as defined in 19 CFR 

177.22(d), may seek judicial review of a 

final determination within 30 days of 

publication of such determination in the 

Federal Register. 

Dated: January 3, 2013. 

Jeremy Baskin, 

Acting Executive Director, Regulations and 

Rulings, Office of International Trade. 

Attachment 

HQ H233356 

December 26, 2012 

MAR-2 OT:RR:CTF:VS H233356HkP 


srobinson on DSK4SPTVN1PROD with 
1222 Federal Register / Vol. 78, No. 5 / Tuesday, January 8, 2013 / Notices 

CATEGORY: Origin 

Ms. Susan Todd 

Senior Manager, Regulatory Affairs 

West-Ward Pharmaceutical Corp. 

435 Industrial Way West 

Eatontown, NJ 07724 

RE: Government Procurement; Trade 

Agreements Act; Country of Origin of 

Ponstel® (mefenamic acid) Capsules; 

Substantial Transformation 

Dear Ms. Todd: 

This is in response to your letter, dated 

August 21, 2012, requesting a final 

determination on behalf of West-Ward 

Pharmaceutical Corp. (‘‘West-Ward’’) 

pursuant to subpart B of part 177 of the U.S. 

Customs and Border Protection (‘‘CBP’’) 

Regulations (19 C.F.R. Part 177). Under these 

regulations, which implement Title III of the 

Trade Agreements Act of 1979 (‘‘TAA’’), as 

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

issues country of origin advisory rulings and 

final determinations as to whether an article 

is or would be a product of a designated 

country or instrumentality for the purposes 

of granting waivers of certain ‘‘Buy 

American’’ restrictions in U.S. law or 

practice for products offered for sale to the 

U.S. Government. 

This final determination concerns the 

country of origin of Ponstel (mefenamic acid) 

capsules. As a U.S. importer, West-Ward is 

a party-at-interest within the meaning of 19 

C.F.R. § 177.22(d)(1) and is entitled to request 

this final determination. 

FACTS: 

West-Ward imports mefenamic acid 

powder in bulk form from India, where it is 

manufactured. Mefenamic acid is the active 

pharmaceutical ingredient (‘‘API’’) in the 

pharmaceutical product Ponstel. Ponstel is 

indicated for the relief of mild to moderate 

pain caused by primary dysmenorrhea and is 

approved by the U.S. Food and Drug 

Administration, NDA no. 015034. 

After importation, West-Ward combines 

the API, mefenamic acid, with inactive 

ingredients and processes it into dosage form. 

The inactive ingredients are lactose 

monohydrate, D&C Yellow No. 10, FD&C 

Yellow No. 6, gelatin, titanium dioxide, and 

food-grade inks. The mefenamic acid is 

added to a tumbler and blended. Lactose 

monohydrate, a diluent, is then added to the 

tumbler and blended with the API. The blend 

is transferred to an encapsulating machine 

and used to fill capsules purchased from a 

U.S. supplier. The capsules are packed into 

bottles of 30 capsules each, which are 

packaged and shipped to the U.S.-holder of 

the New Drug Application for Ponstel. 

ISSUE: 

What is the country of origin of Ponstel 

(mefenamic acid) 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 C.F.R. § 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 Association 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 Letter (‘‘HQ’’) 

561975, dated April 3, 2002; HQ 561544, 

dated May 1, 2000; and, HQ 735146, dated 

November 15, 1993. 

For instance, in HQ 561975, the anesthetic 

drug sevoflurane imported into the U.S. in 

bulk form and processed into dosage form by 

extensive testing operations, followed by 

filtering and packaging into bottles, was 

found not to have undergone a substantial 

transformation in the U.S. There was no 

change in name (the product was identified 

as sevoflurane in both its bulk and processed 

form). The sevoflurane retained its chemical 

and physical properties after the U.S. 

processing. Lastly, because the imported bulk 

sevoflurane had a predetermined medicinal 

use as an inhalable anesthetic drug, the 

processing in the United States resulted in no 

change in the product’s use. 

Likewise, in HQ 561544, the testing, 

filtering and sterile packaging of Geneticin 

Sulfate bulk powder, to create Geneticin 

Selective Antibiotic, was not found to have 

substantially transformed the antibiotic 

substance because the processing only 

involved the removal of impurities from the 

bulk chemical and the placement of the 

chemical into smaller packaging. 

In HQ 735146, 100 percent pure 

acetaminophen imported from China was 

blended with excipients in the United States, 

granulated and sold to pharmaceutical 

companies to process into tablets for retail 

sale under private labels. U.S. Customs (now 

CBP) found that the process in the United 

States did not substantially transform the 

imported product because the product was 

referred to as acetaminophen both before 

importation and after U.S. processing, as 

imported the acetaminophen was used for 

medicinal purposes and continued to be so 

used after U.S. processing, and the 

granulating process minimally affected the 

chemical and physical properties of the 

acetaminophen. 

In this case, the mefenamic acid imported 

from India is blended with excipients and 

packaged into dosage form in the United 

States. Based on the rulings above, we find 

that this process does not substantially 

transform the mefenamic acid because its 

chemical character remains the same. As 

such, we find that the country of origin of the 

Ponstel (mefenamic acid) capsules is India, 

where the mefanamic acid was 

manufactured. 

HOLDING: 

Based on the facts in this case, the 

blending and packaging operations 

performed in the United States do not 

substantially transform the mefenamic acid 

imported from India. Therefore, the country 

of origin of the Ponstel® (mefenamic acid) 

capsules is India for purposes of U.S. 

Government procurement. 

Notice of this final determination will be 

given in the Federal Register, as required by 

19 C.F.R. § 177.29. Any party-at-interest other 

than the party which requested this final 

determination may request, pursuant to 19 

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

matter anew and issue a new final 

determination. Pursuant to 19 C.F.R. 

§ 177.30, any party-at-interest may, within 30 

days of publication of the Federal Register 

Notice referenced above, seek judicial review 

of this final determination before the Court 

of International Trade. 

Sincerely, 

Jeremy Baskin, 

Acting Executive Director, Regulations and 

Rulings, Office of International Trade. 

[FR Doc. 2013–00140 Filed 1–7–13; 8:45 am] 

BILLING CODE;P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Quarterly IRS Interest Rates Used in 

Calculating Interest on Overdue 

Accounts and Refunds on Customs 

Duties 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: General notice. 

SUMMARY: This notice advises the public 

of the quarterly Internal Revenue 

Service interest rates used to calculate 

interest on overdue accounts 

(underpayments) and refunds 

(overpayments) of customs duties. For 

the calendar quarter beginning January 

1, 2013, the interest rates for 


srobinson on DSK4SPTVN1PROD with