45226 Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of Patents and Trademarks may 

award (for example, half the testing 

phase must be subtracted as well as any 

time that may have occurred before the 

patent was issued), FDA’s determination 

of the length of a regulatory review 

period for a human drug product will 

include all of the testing phase and 

approval phase as specified in 35 U.S.C. 

156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product TAPENTADOL 

HYDROCHLORIDE (tapentadol 

hydrochloride). TAPENTADOL 

HYDROCHLORIDE is indicated for the 

relief of moderate to severe acute pain 

in patients 18 years of age or older. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

TAPENTADOL HYDROCHLORIDE (U.S. 

Patent No. RE 39,593) from Grunenthal 

GmbH, and the Patent and Trademark 

Office requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

February 26, 2009, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 

approval of TAPENTADOL 

HYDROCHLORIDE represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the Patent 

and Trademark Office requested that 

FDA determine the product’s regulatory 

review period. 

FDA has determined that the 

applicable regulatory review period for 

TAPENTADOL HYDROCHLORIDE is 

2,880 days. Of this time, 2,577 days 

occurred during the testing phase of the 

regulatory review period, while 303 

days occurred during the approval 

phase. These periods of time were 

derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355(i)) became effective: January 3, 

2001. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on January 3, 2001. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: January 23, 2008. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) 22–304 

was submitted on January 23, 2008, as 

the date the NDA for TAPENTADOL 

HYDROCHLORIDE (NDA 22–304) was 

initially submitted. 

3. The date the application was 

approved: November 20, 2008. FDA has 

verified the applicant’s claim that NDA 

22–304 was approved on November 20, 

2008. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 1,492 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by November 2, 2009. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

March 1, 2010. To meet its burden, the 

petition must contain sufficient facts to 

merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: June 8, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–21100 Filed 8–31–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Accreditation and Approval of 

Chemical and Petrochemical 

Inspections, LP, as a Commercial 

Gauger and Laboratory 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of accreditation and 

approval of Chemical and Petrochemical 

Inspections, LP, as a commercial gauger 

and laboratory. 

SUMMARY: Notice is hereby given that, 

pursuant to 19 CFR 151.12 and 19 CFR 

151.13, Chemical and Petrochemical 

Inspections, LP, 5300 39th Street, 

Groves, TX 77619, has been approved to 

gauge and accredited to test petroleum 

and petroleum products, organic 

chemicals and vegetable oils for 

customs purposes, in accordance with 

the provisions of 19 CFR 151.12 and 19 

CFR 151.13. Anyone wishing to employ 

this entity to conduct laboratory 

analyses and gauger services should 

request and receive written assurances 

from the entity that it is accredited or 

approved by the U.S. Customs and 

Border Protection to conduct the 

specific test or gauger service requested. 

Alternatively, inquires regarding the 

specific test or gauger service this entity 

is accredited or approved to perform 

may be directed to the U.S. Customs and 

Border Protection by calling (202) 344– 

1060. The inquiry may also be sent to 

cbp.labhq@dhs.gov. Please reference the 

Web site listed below for a complete 

listing of CBP approved gaugers and 

accredited laboratories. 

http://cbp.gov/xp/cgov/import/ 

operations_support/labs_scientific_svcs/ 

commercial_gaugers/. 

DATES: The accreditation and approval 

of Chemical and Petrochemical 

Inspections, LP, as commercial gauger 

and laboratory became effective on June 

02, 2009. The next triennial inspection 

date will be scheduled for June 2012. 

FOR FURTHER INFORMATION CONTACT: 

Anthony Malana, Laboratories and 

Scientific Services, U.S. Customs and 

Border Protection, 1300 Pennsylvania 

Avenue, NW., Suite 1500N, 

Washington, DC 20229, 202–344–1060. 

Dated: August 25, 2009. 

Ira S. Reese, 

Executive Director, Laboratories and 

Scientific Services. 

[FR Doc. E9–21106 Filed 8–31–09; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Accreditation and Approval of SGS 

North America, Inc., as a Commercial 

Gauger and Laboratory 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 168 / Tuesday, September 1, 2009 / Notices 45227 

ACTION: Notice of accreditation and 

approval of SGS North America, Inc., as 

a commercial gauger and laboratory. 

SUMMARY: Notice is hereby given that, 

pursuant to 19 CFR 151.12 and 19 CFR 

151.13, SGS North America, Inc., 614 

Heron Drive, Bridgeport, NJ 08014, has 

been approved to gauge and accredited 

to test petroleum and petroleum 

products, organic chemicals and 

vegetable oils for customs purposes, in 

accordance with the provisions of 19 

CFR 151.12 and 19 CFR 151.13. Anyone 

wishing to employ this entity to conduct 

laboratory analyses and gauger services 

should request and receive written 

assurances from the entity that it is 

accredited or approved by the U.S. 

Customs and Border Protection to 

conduct the specific test or gauger 

service requested. Alternatively, 

inquires regarding the specific test or 

gauger service this entity is accredited 

or approved to perform may be directed 

to the U.S. Customs and Border 

Protection by calling (202) 344–1060. 

The inquiry may also be sent to 

cbp.labhq@dhs.gov. Please reference the 

Web site listed below for a complete 

listing of CBP approved gaugers and 

accredited laboratories. http://cbp.gov/ 

xp/cgov/import/operations_support/ 

labs_scientific_svcs/ 

commercial_gaugers/. 

DATES: The accreditation and approval 

of SGS North America, Inc., as 

commercial gauger and laboratory 

became effective on June 10, 2009. The 

next triennial inspection date will be 

scheduled for June 2012. 

FOR FURTHER INFORMATION CONTACT: 

Anthony Malana, Laboratories and 

Scientific Services, U.S. Customs and 

Border Protection, 1300 Pennsylvania 

Avenue, NW., Suite 1500N, 

Washington, DC 20229, 202–344–1060. 

Dated: August 25, 2009. 

Ira S. Reese, 

Executive Director, Laboratories and 

Scientific Services. 

[FR Doc. E9–21102 Filed 8–31–09; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form N–600K, Extension of 

a Currently Approved Information 

Collection; Comment Request 

ACTION: 30-Day Notice of Information 

Collection Under Review: Form N– 

600K, Application for Citizenship and 

Issuance of Certificate Under Section 

322; OMB Control No. 1615–0087. 

The Department of Homeland 

Security, U.S. Citizenship and 

Immigration Services (USCIS) has 

submitted the following information 

collection request to the Office of 

Management and Budget (OMB) for 

review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection was 

previously published in the Federal 

Register on June 11, 2009, at 74 FR 

27810, allowing for a 60-day public 

comment period. USCIS did not receive 

any comments for this information 

collection. 

The purpose of this notice is to allow 

an additional 30 days for public 

comments. Comments are encouraged 

and will be accepted until October 1, 

2009. This process is conducted in 

accordance with 5 CFR 1320.10. 

Written comments and/or suggestions 

regarding the item(s) contained in this 

notice, especially regarding the 

estimated public burden and associated 

response time, should be directed to the 

Department of Homeland Security 

(DHS), and to the Office of Management 

and Budget (OMB) USCIS Desk Officer. 

Comments may be submitted to: USCIS, 

Chief, Regulatory Products Division, 

Clearance Office, 111 Massachusetts 

Avenue, Washington, DC 20529–2210. 

Comments may also be submitted to 

DHS via facsimile to 202–272–8352 or 

via e-mail at rfs.regs@dhs.gov, and OMB 

USCIS Desk Officer via facsimile at 

202–395–5806 or via 

oira_submission@omb.eop.gov. 

When submitting comments by e-mail 

please make sure to add OMB Control 

Number 1615–0087 in the subject box. 

Written comments and suggestions from 

the public and affected agencies should 

address one or more 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, including 

whether the information will have 

practical utility; 

(2) Evaluate the accuracy of the 

agencies 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 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of This Information 

Collection 

(1) Type of Information Collection: 

Extension of a currently approved 

information collection. 

(2) Title of the Form/Collection: 

Application for Citizenship and 

Issuance of Certificate Under section 

322. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Homeland Security 

sponsoring the collection: Form N– 

600K. U.S. Citizenship and Immigration 

Services (USCIS). 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Individuals or 

Households. This form provides an 

organized framework for establishing 

the authenticity of an applicant’s 

eligibility and is essential for providing 

prompt, consistent and correct 

processing of such applications for 

citizenship under section 322 of the Act. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 1,500 responses at 1 hour and 

35 minutes (1.583 hours) per response. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: 2,374 annual burden hours. 

If you need a copy of the information 

collection instrument, please visit the 

Web site at: http://www.regulations.gov. 

We may also be contacted at: USCIS, 

Regulatory Products Division, 111 

Massachusetts Avenue, NW., 

Washington, DC 20529–2210; 

Telephone 202–272–8377. 

Dated: August 26, 2009. 

Stephen Tarragon, 

Deputy Chief, Regulatory Products Division, 

U.S. Citizenship and Immigration Services, 

Department of Homeland Security. 

[FR Doc. E9–20992 Filed 8–31–09; 8:45 am] 

BILLING CODE 9111–97–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Citizenship and Immigration 

Services 

Agency Information Collection 

Activities: Form I–865, Extension of a 

Currently Approved Information 

Collection; Comment Request 

AGENCY: U.S. Citizenship and 

Immigration Services, DHS. 

ACTION: 30-Day Notice of Information 

Collection under Review: Form I–865, 

mstockstill on DSKH9S0YB1PROD with NOTICES