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
Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices 55335 

TABLE 1.—Continued 

Application 

No. Drug Applicant 

NDA 10–915 Q.E.D. Hairgroom (captan) A.R. Winarick, Inc., 783 Palisade Ave., Cliffside, NJ 07010 

The Director, Center for Drug 

Evaluation and Research, under section 

505(e) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355(e)), and 

under authority delegated by the 

Commissioner, finds that the holders of 

the applications listed in this document 

have repeatedly failed to submit reports 

required by § 314.81. In addition, under 

§ 314.200, we find that the holders of 

the applications have waived any 

contentions concerning the legal status 

of the drug products. Therefore, under 

these findings, approval of the 

applications listed in this document, 

and all amendments and supplements 

thereto, is hereby withdrawn, effective 

September 10, 2010. 

Dated: August 31, 2010. 

Janet Woodcock, 

Director, Center for Drug Evaluation and 

Research. 

[FR Doc. 2010–22603 Filed 9–9–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[Docket No. DHS–2010–0075] 

Privacy Act of 1974; Privacy Act of 

1974: Department of Homeland 

Security/ALL–031 Information Sharing 

Environment Suspicious Activity 

Reporting Initiative System of Records 

AGENCY: Privacy Office, DHS. 

ACTION: Notice of Privacy Act system of 

records. 

SUMMARY: In accordance with the 

Privacy Act of 1974, the Department of 

Homeland Security proposes to 

establish a new Department of 

Homeland Security system of records 

titled, ‘‘Department of Homeland 

Security/ALL—031 Information Sharing 

Environment Suspicious Activity 

Reporting Initiative System of Records.’’ 

This system of records will allow DHS 

to compile suspicious activity report 

data that meet the Information Sharing 

Environment Suspicious Activity 

Reporting Functional Standard and 

share these Suspicious Activity 

Reporting data with authorized 

participants in the Nationwide 

Suspicious Activity Reporting Initiative, 

including other DHS components, 

Federal departments and agencies, 

State, local and Tribal law enforcement 

agencies, and the private sector. 

Additionally, the Department of 

Homeland Security is issuing a Notice 

of Proposed Rulemaking to exempt this 

system from certain provisions of the 

Privacy Act elsewhere in the Federal 

Register. This newly established system 

will be included in the Department of 

Homeland Security’s inventory of 

record systems. 

DATES: Submit comments on or before 

October 12, 2010. This new system will 

be effective October 12, 2010. 

ADDRESSES: You may submit comments, 

identified by docket number DHS– 

2010–0075 by one of the following 

methods: 

• Federal e-Rulemaking Portal: 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 703–483–2999. 

• Mail: Mary Ellen Callahan, Chief 

Privacy Officer, Privacy Office, 

Department of Homeland Security, 

Washington, DC 20528. 

• Instructions: All submissions 

received must include the agency name 

and docket number for this rulemaking. 

All comments received will be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. 

• Docket: For access to the docket to 

read background documents or 

comments received go to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: For 

general questions please contact: Ronald 

Athmann (202–447–4332), Office of 

Intelligence and Analysis, Department 

of Homeland Security, Washington, DC 

20528. For privacy issues please 

contact: Mary Ellen Callahan (703–235– 

0780), Chief Privacy Officer, Privacy 

Office, U.S. Department of Homeland 

Security, Washington, DC 20528. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In accordance with the Privacy Act of 

1974, 5 U.S.C. 552a, the Department of 

Homeland Security (DHS) proposes to 

establish a new DHS system of records 

titled, ‘‘DHS/ALL–031 Information 

Sharing Environment (ISE) Suspicious 

Activity Reporting (SAR) Initiative 

System of Records.’’ 

This system of records will allow DHS 

components that produce, receive, and 

store suspicious activity reports (SARs) 

pursuant to their existing authorities, 

responsibilities, platforms, and 

programs to compile and share report 

data that also meet the ISE–SAR 

Functional Standard with authorized 

participants in the Nationwide SAR 

Initiative (NSI) including, Federal 

departments and agencies, State, local 

and Tribal law enforcement agencies, 

and the private sector. The NSI is one 

of a number of government-wide efforts 

designed to implement guidelines first 

issued by the President on December 16, 

2005, for establishing the ISE pursuant 

to section 1016 of the Intelligence 

Reform and Terrorism Prevention Act of 

2004 (IRTPA), as amended. The NSI 

establishes a nationwide capability to 

gather, document, process, analyze and 

share information about suspicious 

activity, incidents, or behavior 

reasonably indicative of terrorist 

activities (hereafter collectively referred 

to as suspicious activity or activities) to 

enable rapid identification and 

mitigation of potential terrorist threats. 

There is a long history of 

documenting of suspicious activity, 

particularly in the law enforcement 

community; these reports are sometimes 

referred to as suspicious activity reports, 

tips and leads, or other similar terms. 

Federal, State, local and Tribal agencies 

and the private sector currently collect 

and document suspicious activities in 

support of their responsibilities to 

investigate and prevent potential 

crimes, protect citizens, and apprehend 

and prosecute criminals. Since some of 

these documented activities may bear a 

nexus to terrorism, the Program 

Manager for the Information Sharing 

Environment (PM–ISE) has developed a 

standardized process for identifying, 

documenting, and sharing terrorismrelated SAR data (hereinafter referred to 

as an ‘‘ISE–SAR’’), which meet the 

definition and criteria set forth in the 

ISE Functional Standard Suspicious 

Activity Reporting, (Version 1.5, May 

2009) to the maximum extent possible 

consistent with the protection of 

individual privacy, civil rights, and civil 

liberties. The Functional Standard 

defines an ISE–SAR as official 

documentation of observed behavior 

determined to have a potential nexus to 

terrorism (i.e., to be reasonably 


srobinson on DSKHWCL6B1PROD with NOTICES