55332 Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices 

FDA has determined that the 

applicable regulatory review period for 

SAPHRIS is 4,547 days. Of this time, 

3,833 days occurred during the testing 

phase of the regulatory review period, 

while 714 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: March 4, 1997. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on March 4, 1997. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: August 31, 2007. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

SAPHRIS (NDA 22–117) was submitted 

on August 31, 2007. 

3. The date the application was 

approved: August 13, 2009. FDA has 

verified the applicant’s claim that NDA 

22–117 was approved on August 13, 

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 1,827 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 November 9, 

2010. 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 9, 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. 

Dated: August 13, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–22519 Filed 9–9–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0527] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ULORIC 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ULORIC 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 (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 

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 ULORIC 

(febuxostat). ULORIC is indicated for 

chronic management of hyperuricemia 

in patients with gout. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for ULORIC (U.S. Patent No. 

5,614,520) from Teijin Pharma 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 17, 2010, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 

approval of ULORIC 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 

ULORIC is 3,395 days. Of this time, 

1,873 days occurred during the testing 

phase of the regulatory review period, 

while 1,522 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: October 31, 

1999. The applicant claims April 28, 

1999, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was October 31, 1999, 

which was 30 days after FDA receipt of 

the active IND. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices 55333 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: December 15, 2004. 

The applicant claims December 14, 

2004, as the date the new drug 

application (NDA) for Uloric (NDA 21– 

856) was initially submitted. However, 

FDA records indicate that NDA 21–856 

was submitted on December 15, 2004. 

3. The date the application was 

approved: February 13, 2009. FDA has 

verified the applicant’s claim that NDA 

21–856 was approved on February 13, 

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 November 9, 

2010. 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 9, 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. 

Dated: August 13, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–22521 Filed 9–9–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

National Center for Health Statistics, 

(BSC, NCHS) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC), National 

Center for Health Statistics (NCHS) 

announces the following meeting of the 

aforementioned committee. 

Times and Dates: 

11 a.m.–5:30 p.m., September 23, 

2010. 

8:30 a.m.–2 p.m., September 24, 2010. 

Place: NCHS Headquarters, 3311 

Toledo Road, Hyattsville, Maryland 

20782. 

Status: This meeting is open to the 

public on a first come, first serve basis 

up to the meeting room’s capacity. 

However, visitors must be processed in 

accordance with established Federal 

policies and procedures. For foreign 

nationals or non-US citizens, preapproval is required (please contact 

Althelia Harris, 301–458–4261, 

adw1@cdc.gov or Virginia Cain, 

vcain@cdc.gov at least 10 days in 

advance for requirements). All visitors 

are required to present a valid form of 

picture identification issued by a state, 

Federal or international government. As 

required by the Federal Property 

Management Regulations, Title 41, Code 

of Federal Regulation, Subpart 101– 

20.301, all persons entering in or on 

Federal controlled property and their 

packages, briefcases, and other 

containers in their immediate 

possession are subject to being x-rayed 

and inspected. Federal law prohibits the 

knowing possession or the causing to be 

present of firearms, explosives and other 

dangerous weapons and illegal 

substances. The meeting room 

accommodates approximately 100 

people. 

Purpose: This committee is charged 

with providing advice and making 

recommendations to the Secretary, 

Department of Health and Human 

Services; the Director, CDC; and the 

Director, NCHS, regarding the scientific 

and technical program goals and 

objectives, strategies, and priorities of 

NCHS. 

Matters to be discussed: The agenda 

will include welcome remarks by the 

Director, NCHS; update on the longterm care research program; a 

discussion of the NCHS visitation 

program and an open session for 

comments from the public. 

Requests to make oral presentations 

should be submitted in writing to the 

contact person listed below. All requests 

must contain the name, address, 

telephone number, and organizational 

affiliation of the presenter. 

Written comments should not exceed 

five single-spaced typed pages in length 

and must be received by September 17, 

2010. 

The agenda items are subject to 

change as priorities dictate. 

Contact person for more information: 

Virginia S. Cain, PhD, Director of 

Extramural Research, NCHS/CDC, 3311 

Toledo Road, Room 7211, Hyattsville, 

Maryland 20782, telephone (301) 458– 

4500, fax (301) 458–4020. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both CDC and 

the Agency for Toxic Substances and 

Disease Registry. 

Dated: September 3, 2010. 

Elaine L. Baker, 

Management Analysis and Services Office, 

Centers for Disease Control and Prevention. 

[FR Doc. 2010–22594 Filed 9–9–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Request for Nominations for AHRQ 

Study Section Members 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for nominations for 

public members. 

SUMMARY: In accordance with Title IX of 

the Public Health Service Act, see 42 

U.S.C. 299c–1, and AHRQ’s grant and 

contract regulations, 42 CFR part 67, 

applications submitted to AHRQ will be 

evaluated using the AHRQ peer review 

process to ensure a fair, equitable, and 

unbiased evaluation of their scientific 

and technical merit. The initial peer 

review of grant applications involves an 

assessment conducted by panels of 

experts established to include pertinent 

scientific disciplines and medical 

specialty areas. The confidential part of 

the peer review meetings devoted to 

critical evaluations will be closed 

meetings in accordance with section 

10(d) of the Federal Advisory 


srobinson on DSKHWCL6B1PROD with NOTICES