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
55334 Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices 

Committee Act, as amended (5 U.S.C. 

Appendix 2). 

AHRQ is seeking nominations to fill 

approximately 20 to 30 percent of its 

study section membership, across the 

following study sections: 

(1) Health System Research (HSR), 

(2) Health Care Technology and 

Decision Sciences (HCTDS), 

(3) Health Care Quality and 

Effectiveness Research (HCQER), and 

(4) Health Care Research Training 

(HCRT). 

The primary research foci and 

functions of these four study sections 

are described on the AHRQ Web site: 

(http:Ilwww.AHRQ 

.qovlfundlpeerrevlpeerdesc. htm). 

Individuals from the health services 

research and health care community 

who could serve as peer reviewers on 

these study sections are sought to 

replace study section members whose 

terms have expired. In sending your 

nomination, please specify the 

nominee’s professional/scientific/ 

technical expertise, affiliations and full 

contact information, if this information 

is available. 

Factors that will be considered in the 

selection of individuals to serve on 

study sections include: competence in a 

scientific, technical or clinical 

discipline or research specialty, 

particularly in health services research; 

fairness and evenhandedness in 

judgment and review; ability to work 

effectively in a group context; and 

commitment to complete work 

assignments. 

A diversity of perspectives is valuable 

to AHRQ’s work. To help obtain a 

diversity of perspectives among 

nominees, AHRQ encourages 

nominations of women and members of 

minority populations. AHRQ also seeks 

broad geographic representation. 

DATES: AHRQ would like to receive your 

recommendations no later than Friday, 

October 1,2010. 

ADDRESSES: Please direct your 

correspondence to: Kishena C. 

Wadhwani, PhD., M.P.H., Director, 

Division of Scientific Review (DSR), 

Office of Extramural Research, 

Education and Priority Populations 

(OEREP), Agency for Healthcare 

Research and Quality (AHRQ), 

Department of Health and Human 

Services (DHHS), 540 Gaither Road, 

Room 2032, Rockville, MD 20850, 

Phone: (301) 427–1556, Fax: (301) 427– 

1562, e-mail: Kishena.WadhwanjAHRQ 

hhs.gov. 

FOR FURTHER INFORMATION CONTACT: 

Kishena C. Wadhwani, PhD., M.P.H. 

(See ADDRESSES section.) 

SUPPLEMENTARY INFORMATION: 

Background 

Currently, AHRQ has one chartered 

Health Services Research Initial Review 

Group (IRG) responsible for the peer 

review of research and training grant 

applications submiffed for funding 

consideration. The IRG is to advise the 

Director of the Agency on matters 

related to scientific and technical merit 

of research grant proposals to improve 

the quality, safety, efficiency, and 

effectiveness of health care for all 

Americans. 

This IRG is currently comprised of 

four subcommittees or study sections, 

each with a particular research focus 

around which peer reviewers’ expertise 

is assembled. These study sections 

convene three times per year to review 

the grant applications submitted to the 

three different submission cycles. Study 

section members are appointed for up to 

a maximum of four years. 

Dated: September 1, 2010. 

Carolyn M. Clancy, 

Director, AHRQ. 

[FR Doc. 2010–22544 Filed 9–9–10; 8:45 am] 

BILLING CODE 416Q–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0444] 

Schmid Laboratories, Inc. et al.; 

Withdrawal of Approval of Five New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of five new drug applications 

(NDAs) from multiple holders of these 

applications. The basis for the 

withdrawals is that the holders of the 

applications have repeatedly failed to 

file required annual reports for the 

applications. 

DATES: Effective September 10, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Florine P. Purdie, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6366, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: The 

holders of approved applications to 

market new drugs for human use are 

required to submit annual reports to 

FDA concerning each of their approved 

applications in accordance with 

§ 314.81 (21 CFR 314.81). 

In the Federal Register of September 

24, 2009 (74 FR 49760), FDA published 

a notice offering an opportunity for a 

hearing (NOOH) on a proposal to 

withdraw approval of five NDAs 

because the firms had failed to submit 

the required annual reports for these 

applications. The holders of these 

applications did not respond to the 

NOOH. Failure to file a written notice 

of participation and request for hearing 

as required by § 314.200 (21 CFR 

314.200) constitutes an election by the 

applicant not to make use of the 

opportunity for a hearing concerning the 

proposal to withdraw approval of the 

applications and a waiver of any 

contentions concerning the legal status 

of the drug products. Therefore, the 

Director, Center for Drug Evaluation and 

Research, is withdrawing approval of 

the five applications listed in table 1 of 

this document. 

TABLE 1. 

Application 

No. Drug Applicant 

NDA 5–766 Ramses Vaginal Jelly Schmid Laboratories, Inc., Route 46 West, Little Falls, NJ 07424 

NDA 7–220 Synthetic Vitamin A (vitamin A palmitate) Merck & Co., Inc., 770 Sumneytown Pike, P.O. Box 4, West Point, PA 19486 

NDA 8–595 Immolin Vaginal Cream Jel Schmid Laboratories, Inc. 

NDA 8–612 Silicote (simethicone) Ointment Arnar-Stone Laboratories, Inc., 601 East Kensington Rd., Mount Prospect, IL 60056 


srobinson on DSKHWCL6B1PROD with NOTICES