37716 Federal Register / Vol. 74, No. 144 / Wednesday, July 29, 2009 / Notices 

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 RAPAFLO 

(silodosin). RAPAFLO is indicated for 

treatment of the signs and symptoms of 

benign prostatic hyperplasia. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

RAPAFLO (U.S. Patent No. 5,387,603) 

from Kissei 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 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 RAPAFLO 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 

RAPAFLO is 3,681 days. Of this time, 

3,380 days occurred during the testing 

phase of the regulatory review period, 

while 301 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: September 12, 

1998. The applicant claims September 

17, 1998, as the date the investigational 

new drug application (IND) became 

effective. However, FDA records 

indicate that the IND effective date was 

September 12, 1998, which was 30 days 

after FDA receipt of the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: December 13, 2007. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

RAPAFLO (NDA 22–206) was initially 

submitted on December 13, 2007. 

3. The date the application was 

approved: October 8, 2008. FDA has 

verified the applicant’s claim that NDA 

22–206 was approved on October 8, 

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 1,826 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. E9–18032 Filed 7–28–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0021] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; DUREZOL 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

DUREZOL 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 written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

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 (Public Law 98– 

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 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 

mstockstill on DSKH9S0YB1PROD with NOTICES

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