Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices 76741 

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 

regulations.gov may be viewed in the 

Division of Dockets Management 

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

through Friday. 

Dated: October 22, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–30991 Filed 12–8–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–E–0021] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; SABRIL 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for SABRIL 

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. 6222, 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 SABRIL 

(vigabatrin). SABRIL is indicated for 

refractory complex partial seizures in 

adults. It should be used as adjunctive 

therapy in patients who have responded 

inadequately to several alternative 

treatments. Subsequent to this approval, 

the Patent and Trademark Office 

received a patent term restoration 

application for SABRIL (U.S. Patent No. 

5,380,936) from Lundbeck, Inc., and the 

Patent and Trademark Office requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated May 10, 

2010, FDA advised the Patent and 

Trademark Office that this human drug 

product had undergone a regulatory 

review period and that the approval of 

SABRIL 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 

SABRIL is 10,205 days. Of this time, 

4,614 days occurred during the testing 

phase of the regulatory review period, 

while 5,591 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 FFD&C act) (21 

U.S.C. 355(i)) became effective: 

September 14, 1981. FDA has verified 

the applicant’s claim that the date the 

investigational new drug application 

became effective was on September 14, 

1981. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FFD&C act: May 2, 1994. 

The applicant claims April 29, 1994, as 

the date the first new drug application 

(NDA) for SABRIL (NDA 20–427) was 

initially submitted. However, FDA 

records indicate that NDA 20–427 was 

submitted on May 2, 1994. 

3. The date the application was 

approved: August 21, 2009. FDA has 

verified the applicant’s claims that NDA 

20–427 (vigabatrin tablets) and NDA 22– 

006 (vigabatrin powder for oral solution) 

were approved on August 21, 2009. 

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 5 years 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 February 7, 

2011. 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 June 7, 2011. 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. It is no longer necessary to 

send three copies of mailed 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 

regulations.gov may be viewed in the 

Division of Dockets Management 

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

through Friday. 


erowe on DSK5CLS3C1PROD with NOTICES
76742 Federal Register / Vol. 75, No. 236 / Thursday, December 9, 2010 / Notices 

Dated: October 22, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–30995 Filed 12–8–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Advisory Mental Health 

Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Mental Health Council. 

Date: January 13–14, 2011. 

Closed: January 13, 2011, 11 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Conference Room C/D/E, 

Rockville, MD 20852. 

Open: January 14, 2011, 8:30 a.m. to 12:30 

p.m. 

Agenda: Presentation of NIMH Director’s 

report and discussion on NIMH program and 

policy issues. 

Place: National Institutes of Health, 

Building 31, C Wing, 31 Center Drive, 6th 

Floor, Conference Room 6, Bethesda, MD 

20892. 

Contact Person: Jane A. Steinberg, Ph.D., 

Director, Division of Extramural Activities, 

National Institute of Mental Health, NIH, 

Neuroscience Center, 6001 Executive Blvd., 

Room 6154, MSC 9609, Bethesda, MD 20892– 

9609, 301–443–5047. 

Any member of the public interested 

in presenting oral comments to the 

committee may notify the Contact 

Person listed on this notice at least 10 

days in advance of the meeting. 

Interested individuals and 

representatives of organizations may 

submit a letter of intent, a brief 

description of the organization 

represented, and a short description of 

the oral presentation. Only one 

representative of an organization may be 

allowed to present oral comments and if 

accepted by the committee, 

presentations may be limited to five 

minutes. Both printed and electronic 

copies are requested for the record. In 

addition, any interested person may file 

written comments with the committee 

by forwarding their statement to the 

Contact Person listed on this notice. The 

statement should include the name, 

address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for 

entrance onto the NIH campus. All 

visitor vehicles, including taxicabs, 

hotel, and airport shuttles will be 

inspected before being allowed on 

campus. Visitors will be asked to show 

one form of identification (for example, 

a government-issued photo ID, driver’s 

license, or passport) and to state the 

purpose of their visit. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nimh.nih.gov/about/advisoryboards-and-groups/namhc/index.shtml, 

where an agenda and any additional 

information for the meeting will be 

posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.242, Mental Health Research 

Grants; 93.281, Scientist Development 

Award, Scientist Development Award for 

Clinicians, and Research Scientist Award; 

93.282, Mental Health National Research 

Service Awards for Research Training, 

National Institutes of Health, HHS) 

Dated: December 3, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–30963 Filed 12–8–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: NIH Exploratory Developmental 

Research Grant Program In Urology. 

Date: December 22, 2010. 

Time: 11 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Mushtaq A. Khan, DVM, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2176, 

MSC 7818, Bethesda, MD 20892, 301–435– 

1778, khanm@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: December 3, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–30961 Filed 12–8–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2010–1085] 

Detecting Oil Leaks From Vessels Into 

the Water 

AGENCY: Coast Guard, DHS. 

ACTION: Notice and request for 

information. 

SUMMARY: In section 707 of the Coast 

Guard Authorization Act of 2010, 

Congress directs the Secretary of the 

Department in which the Coast Guard is 

operating to report on the availability, 

feasibility, and potential cost of 

technology to detect the loss of oil 

carried as cargo or as fuel on tank and 

non-tank vessels greater than 400 gross 


erowe on DSK5CLS3C1PROD with NOTICES