Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Notices 37717 

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 DUREZOL 

(difluprednate ophthalmic emulsion). 

DUREZOL is indicated for the treatment 

of inflammation and pain associated 

with ocular surgery. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for DUREZOL (U.S. Patent 

No. 6,114,319) from Senju 

Pharmaceutical Co. Ltd., 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 18, 2009, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of DUREZOL 

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 

DUREZOL is 560 days. Of this time, 369 

days occurred during the testing phase 

of the regulatory review period, while 

181 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: December 13, 

2006. FDA has verified the applicant’s 

claim that the investigational new drug 

application became effective on 

December 13, 2006. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: December 26, 2007. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

DUREZOL (NDA 22–212) was initially 

submitted on December 26, 2007. 

3. The date the application was 

approved: June 23, 2008. FDA has 

verified the applicant’s claim that NDA 

22–212 was approved on June 23, 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 369 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 September 28, 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 

January 25, 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 23, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–18034 Filed 7–28–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, July 27, 

2009, 9 a.m. to July 28, 2009, 6 p.m., 

National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

which was published in the Federal 

Register on July 1, 2009, 74 FR 31453– 

31454. 

The meeting will be held August 3, 

2009 to August 4, 2009. The meeting 

time and location remain the same. The 

meeting is closed to the public. 

Dated: July 23, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–18023 Filed 7–28–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meetings 

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 meetings. 

The meetings 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 Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; Go Applications. 

Date: August 5, 2009. 

Time: 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call) 

Contact Person: Raul A Saavedra, Ph.D., 

Scientific Review Administrator, Scientific 

Review Branch, Division of Extramural 

Research, NINDS/NIH/DHHS, NSC; 6001 

Executive Blvd., Ste. 3208, Bethesda, MD 

20892–9529, 301–496–9223, 

saavedrr@ninds.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. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel; Go Applications. 

Date: August 6, 2009. 

Time: 10 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call) 

Contact Person: Ernest W Lyons, Ph.D. 

Scientific Review Administrator, Scientific 

Review Branch, NINDS/NIH/DHHS, 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3208, MSC 952, Bethesda, MD 20892– 

9529, 301–496–4056, lyonse@ninds.nih.gov. 

mstockstill on DSKH9S0YB1PROD with NOTICES