Federal Register / Vol. 78, No. 21 / Thursday, January 31, 2013 / Notices 6827 

the regulatory review period for BEYAZ 

and is publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of an application to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent which claims that 

human drug product. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6284, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

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 BEYAZ 

(drospirenone, ethinyl estradiol, and 

levomefolate calcium). BEYAZ is 

indicated for use in women to: Prevent 

pregnancy; treat symptoms of 

premenstrual dysphoric disorder for 

women who choose to use an oral 

contraceptive for contraception; treat 

moderate acne for women at least 14 

years old only if the patient desires an 

oral contraceptive for birth control; and 

raise folate levels in women who choose 

to use an oral contraceptive for 

contraception. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for BEYAZ (U.S. Patent No. 

6,441,168) from Eprova AG, and the 

Patent and Trademark Office requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated March 28, 

2012, FDA advised the Patent and 

Trademark Office that this human drug 

product had undergone a regulatory 

review period and that the approval of 

BEYAZ 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 

BEYAZ is 1,271 days. Of this time, 874 

days occurred during the testing phase 

of the regulatory review period, while 

397 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 FD&C Act) (21 

U.S.C. 355(i)) became effective: April 4, 

2007. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on April 4, 2007. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: August 24, 

2009. The applicant claims August 21, 

2009, as the date the new drug 

application (NDA) for BEYAZ (NDA 22– 

532) was initially submitted. However, 

FDA records indicate that NDA 22–532 

was submitted on August 24, 2009. 

3. The date the application was 

approved: September 24, 2010. FDA has 

verified the applicant’s claim that NDA 

22–532 was approved on September 24, 

2010. 

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 834 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) either 

electronic or written comments and ask 

for a redetermination by April 1, 2013. 

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 

July 30, 2013. 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. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written petitions. It is 

only necessary to send one set of 

comments. However, if you submit a 

written petition, you must submit three 

copies of the petition. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. Comments and petitions that 

have not been made publicly available 

on http://www.regulations.gov may be 

viewed in the Division of Dockets 

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

Monday through Friday. 

Dated: January 24, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–02086 Filed 1–30–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Public Availability of DHS Fiscal Year 

2012 Service Contract Inventory 

AGENCY: Office of the Chief Procurement 

Officer, DHS. 

ACTION: Notice of availability. 

SUMMARY: In accordance with Section 

743 of Division C of the Consolidated 

Appropriations Act of 2010 (Pub. L. 

111–117), the Department of Homeland 

Security (DHS) is publishing this notice 

to advise the public of the availability 

of the FY 2012 Service Contract 

inventory. This inventory provides 

information on service contract actions 

over $25,000 that were made in FY 

2012. The information is organized by 

function to show how contracted 

resources are distributed throughout the 

agency. The inventory has been 

developed in accordance with guidance 

issued on November 5, 2010 and 


srobinson on DSK4SPTVN1PROD with 
6828 Federal Register / Vol. 78, No. 21 / Thursday, January 31, 2013 / Notices 

December 19, 2011 available at http:// 

www.whitehouse.gov/omb/procurementservice-contract-inventories by the 

Office of Management and Budget’s 

Office of Federal Procurement Policy 

(OFPP). The guidance for preparing and 

analyzing FY 2012 inventories is 

unchanged from OFFP’s November 5, 

2010 and December 19, 2011 guidance 

for preparing the inventories. DHS has 

posted its FY 2012 inventory for public 

review at: http://www.dhs.gov/xopnbiz/ 

regulations/editorial_0504.shtm under 

‘‘Acquisition Reports and Notices.’’ 

FOR FURTHER INFORMATION CONTACT: For 

questions about this notice, please 

contact Gail Carter at 

Gail.A.Carter1@dhs.gov, or telephone 

202–447–5302. 

Anne Terry, 

Acting Chief Procurement Officer. 

[FR Doc. 2013–01674 Filed 1–30–13; 8:45 am] 

BILLING CODE 9110–9B–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Accreditation and Approval of AmSpec 

Services, LLC, as a Commercial 

Gauger and Laboratory 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of accreditation and 

approval of AmSpec Services, LLC, as a 

commercial gauger and laboratory. 

SUMMARY: Notice is hereby given, 

pursuant to CBP regulations, that 

AmSpec Services, LLC, has been 

approved to gauge and accredited to test 

petroleum and petroleum products, 

organic chemicals and vegetable oils for 

customs purposes for the next three 

years as of August 20, 2012. 

DATES: Effective Dates: The 

accreditation and approval of AmSpec 

Services, LLC, as commercial gauger 

and laboratory became effective on 

August 20, 2012. The next triennial 

inspection date will be scheduled for 

August 2015. 

FOR FURTHER INFORMATION CONTACT: 

Approved Gauger and Accredited 

Laboratories Manager, Laboratories and 

Scientific Services, U.S. Customs and 

Border Protection, 1300 Pennsylvania 

Avenue NW, Suite 1500N, Washington, 

DC 20229, tel. 202–344–1060. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given pursuant to 19 CFR 151.12 

and 19 CFR 151.13, AmSpec Services, 

LLC, 1950 East 220th St, Suite #304, 

Long Beach, CA 90745, 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/

linkhandler/cgov/trade/basic_trade/

labs_scientific_svcs/commercial_

gaugers/gaulist.ctt/gaulist.pdf. 

Dated: January 23, 2013. 

Ira S. Reese, 

Executive Director, Laboratories and 

Scientific Services. 

[FR Doc. 2013–02122 Filed 1–30–13; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Accreditation and Approval of King 

Laboratories, Inc., as a Commercial 

Gauger and Laboratory 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: Notice of accreditation and 

approval of King Laboratories, Inc., as a 

commercial gauger and laboratory. 

SUMMARY: Notice is hereby given, 

pursuant to CBP regulation, that King 

Laboratories, Inc., has been approved to 

gauge and accredited to test petroleum 

and petroleum products, organic 

chemicals and vegetable oils for 

customs purposes for the next three 

years as of June 13, 2012. 

DATES: Effective Dates: The 

accreditation and approval of King 

Laboratories, Inc., as commercial gauger 

and laboratory became effective on June 

13, 2012. The next triennial inspection 

date will be scheduled for June 2015. 

FOR FURTHER INFORMATION CONTACT: 

Approved Gauger and Accredited 

Laboratories Manager, Laboratories and 

Scientific Services, U.S. Customs and 

Border Protection, 1300 Pennsylvania 

Avenue NW., Suite 1500N, Washington, 

DC 20229, tel. 202–344–1060. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given pursuant to 19 CFR 151.12 

and 19 CFR 151.13, King Laboratories, 

Inc., 1300 E. 223rd St. #401, Carson, CA 

90745, 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/

linkhandler/cgov/trade/basic_trade/

labs_scientific_svcs/commercial_

gaugers/gaulist.ctt/gaulist.pdf. 

Dated: January 23, 2013. 

Ira S. Reese, 

Executive Director, Laboratories and 

Scientific Services. 

[FR Doc. 2013–02130 Filed 1–30–13; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Accreditation and Approval of Saybolt 

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 Saybolt LP, as a commercial 

gauger and laboratory. 

SUMMARY: Notice is hereby given, 

pursuant to CBP regulations, that 

Saybolt LP, has been approved to gauge 

and accredited to test petroleum and 

petroleum products, organic chemicals 

and vegetable oils for customs purposes 

for the next three years as of September 

12, 2012. 

DATES: Effective Dates: The 

accreditation and approval of Saybolt 

LP, as commercial gauger and laboratory 

became effective on September 12, 2012. 


srobinson on DSK4SPTVN1PROD with