69094 Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices 

II. Additional Information on PDUFA 

There are several sources of 

information on FDA’s Web site that may 

be useful for interested stakeholders to 

better understand the history and 

evolution of the PDUFA program and its 

current status: 

• Information on the April 2010 

public meeting on PDUFA 

Reauthorization, the Federal Register 

notice announcing the meeting, and the 

transcript of the meeting are available at 

http://www.fda.gov/ForIndustry/

UserFees/PrescriptionDrugUserFee/

ucm117890.htm. The slide 

presentations from the meeting can be 

found at http://www.regulations.gov 

using Docket No. FDA–2010–N–0128. 

• FDA created a webinar on the 

PDUFA program, drug development, 

and FDA’s drug review in PDUFA IV. 

These presentations are available at 

http://www.fda.gov/ForIndustry/

UserFees/PrescriptionDrugUserFee/ 

ucm207597.htm. 

• Key Federal Register documents, 

PDUFA-related guidances, legislation, 

performance reports, and financial 

reports and plans are posted at http:// 

www.fda.gov/ForIndustry/UserFees/

PrescriptionDrugUserFee/default.htm. 

• Specific information on the FDA 

Amendments Act of 2007 is available at: 

http://www.fda.gov/

RegulatoryInformation/Legislation/

FederalFoodDrugand

CosmeticActFDCAct/Significant

AmendmentstotheFDCAct/Foodand

DrugAdministration

AmendmentsActof2007/default.htm. 

III. How To Submit Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: November 3, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–28357 Filed 11–9–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Solicitation for Nominations for 

Members of the U.S. Preventive 

Services Task Force (USPSTF) 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Solicits nominations for new 

members of USPSTF. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) invites 

nominations of individuals qualified to 

serve as members of the U.S. Preventive 

Services Task Force (USPSTF). 

The USPSTF, a standing, independent 

panel of non-Federal experts that makes 

evidence-based recommendations to the 

health care community and the public 

regarding the provision of clinical 

preventive services, see 42 U.S.C. 299b– 

4(a), is composed of members appointed 

to serve for four-year terms with an 

option for a one-year or two-year 

extension. New members are selected 

each year to replace those members who 

are completing their appointments. 

Individuals nominated but not 

appointed in previous years, as well as 

those newly nominated, are considered 

in the annual selection process. 

USPSTF members meet three times a 

year for two days in the Washington, DC 

area. Between meetings, member duties 

include reviewing and preparing 

comments (off site) on systematic 

evidence reviews prior to discussing 

and making recommendations on 

preventive services, drafting final 

recommendation documents, and 

participating in workgroups on specific 

topics or methods. 

A diversity of perspectives is valuable 

to the work of the USPSTF. To help 

obtain a diversity of perspectives among 

nominees, AHRQ particularly 

encourages nominations of women, 

members of minority populations, and 

persons with disabilities. Interested 

individuals can self nominate. 

Organizations and individuals may 

nominate one or more persons qualified 

for membership on the USPSTF. 

Qualification Requirements: The 

mission of the USPSTF is to review the 

scientific evidence related to the 

effectiveness and appropriateness of 

clinical preventive services for the 

purpose of developing 

recommendations for the health care 

community. Therefore, in order to 

qualify for the USPSTF, an applicant or 

nominee MUST demonstrate the 

following: 

1. Knowledge and experience in the 

critical evaluation of research published 

in peer reviewed literature and in the 

methods of evidence review; 

2. Understanding and experience in 

the application of synthesized evidence 

to clinical decisionmaking and/or 

policy; 

3. Expertise in disease prevention and 

health promotion; 

4. Ability to work collaboratively with 

peers; and, 

5. Clinical expertise in the primary 

health care of children and/or adults, 

and/or expertise in counseling and 

behavioral interventions for primary 

care patients. 

Some USPSTF members without 

primary health care clinical experience 

may be selected based on their expertise 

in methodological issues such as 

medical decisionmaking, clinical 

epidemiology, behavioral medicine, 

health equity, and health economics. 

For individuals with clinical expertise 

in primary health care, additional 

qualifications in one or more of these 

areas would enhance their candidacy. 

Consideration will be given to 

individuals who are recognized 

nationally for scientific leadership 

within their field of expertise. 

Applicants must have no substantial 

conflicts of interest, whether financial, 

professional, or other conflicts, that 

would impair the scientific integrity of 

the work of the USPSTF. 

DATES: Nominations are welcome at any 

time. To be considered for appointment 

in 2011, complete nominations must be 

received by November 29, 2010. 

Nominated individuals will be 

selected for the USPSTF on the basis of 

their qualifications (in particular, those 

that address the required qualifications, 

outlined above) and the current 

expertise needs of the USPSTF. All 

individuals with complete nominations 

will be considered. AHRQ will retain 

and consider for future vacancies the 

nominations of those not selected 

during this cycle. 

ADDRESSES: Submit your responses 

either in writing or electronically to: 

Gloria Washington, ATTN: USPSTF 

Nominations, Center for Primary Care, 

Prevention, and Clinical Partnerships, 

Agency for Healthcare Research and 

Quality, 540 Gaither Road, Rockville, 

Maryland 20850, 

USPSTFnominations@AHRQ.hhs.gov. 

Nomination Submissions 

Nominations may be submitted in 

writing or electronically, but must 

include: 

(1) The applicant’s current curriculum 

vitae and contact information, including 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 217 / Wednesday, November 10, 2010 / Notices 69095 

mailing address, e-mail address, and 

telephone number and 

(2) A letter explaining how this 

individual meets the qualification 

requirements and how he/she would 

contribute to the USPSTF. The letter 

should also attest to the nominee’s 

willingness to serve as a member of the 

USPSTF. 

AHRQ will later ask persons under 

serious consideration for membership to 

provide detailed information that will 

permit evaluation of possible significant 

conflicts of interest. Such information 

will concern matters such as financial 

holdings, consultancies, and research 

grants or contracts. 

Nominee Selection 

Appointments to the USPSTF will be 

made on the basis of qualifications as 

outlined above (see Qualification 

Requirements) and the current expertise 

needs of the USPSTF. 

Arrangement for Public Inspection 

Nominations and applications are 

kept on file at the Center for Primary 

care, Prevention, and Clinical 

Partnerships, AHRQ and are available 

for review during business hours. AHRQ 

does not reply to individual 

nominations, but considers all 

nominations in selecting members. 

Information regarded as private and 

personal, such as a nominee’s Social 

Security number, home and e-mail 

addresses, home telephone and fax 

numbers, or names of family members 

will not be disclosed to the public. This 

is in accord with AHRQ confidentiality 

policies and Department of Health and 

Human Services regulations (45 CFR 

5.67). 

FOR FURTHER INFORMATION CONTACT: 

Gloria Washington at 

USPSTFnominations@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

Under Title IX of the Public Health 

Service Act, AHRQ is charged with 

enhancing the quality, appropriateness, 

and effectiveness of health care services 

and access to such services. 42 U.S.C. 

299(b). AHRQ accomplishes these goals 

through scientific research and 

promotion of improvements in clinical 

practice, including clinical prevention 

of diseases and other health conditions, 

and improvements in the organization, 

financing, and delivery of health care 

services. See 42 U.S.C. 299(b). 

The USPSTF is a panel of non-Federal 

experts that makes independent 

evidence-based recommendations 

regarding the provision of clinical 

preventive services. See 42 U.S.C. 299b– 

4(a). The USPSTF was first established 

in 1984 under the auspices of the U.S. 

Public Health Service. Currently, the 

USPSTF is convened by the Director of 

AHRQ, and AHRQ provides ongoing 

administrative, research and technical 

support for the USPSTF’s operation. 

The USPSTF is charged with rigorously 

evaluating the effectiveness and 

appropriateness of clinical preventive 

services and formulating or updating 

recommendations for primary care 

clinicians regarding the appropriate 

provision of preventive services. See 42 

U.S.C. 299b–4(a)(1). Current USPSTF 

recommendations and associated 

evidence reviews are available on the 

Internet (http:// 

USPreventiveServicesTaskForce.org). 

Dated: November 1, 2010. 

Carolyn M. Clancy, 

AHRQ Director. 

[FR Doc. 2010–28041 Filed 11–8–10; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HOMELAND 

SECURITY 

United States Immigration and 

Customs Enforcement 

Agency Information Collection 

Activities: Revision of an Existing 

Information Collection; Comment 

Request 

ACTION: 60-Day Notice of Information 

Collection for Review; Student and 

Exchange Visitor Information System 

(SEVIS); OMB Control No. 1653–0038. 

The Department of Homeland 

Security, U.S. Immigration and Customs 

Enforcement (ICE), will be submitting 

the following information collection 

request for review and clearance in 

accordance with the Paperwork 

Reduction Act of 1995. The information 

collection is published to obtain 

comments from the public and affected 

agencies. Comments are encouraged and 

will be accepted for sixty days until 

January 10, 2011. 

Written comments and suggestions 

regarding items contained in this notice, 

and especially with regard to the 

estimated public burden and associated 

response time should be directed to the 

Department of Homeland Security 

(DHS), Joseph M. Gerhart, Chief, 

Records Management Branch, U.S. 

Immigration and Customs Enforcement, 

500 12th Street, SW., STOP 5705, 

Washington, DC 20536–5705. 

Comments are encouraged and will be 

accepted for sixty days until January 10, 

2011. Written comments and 

suggestions from the public and affected 

agencies concerning the proposed 

collection of information should address 

one or more of the following four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency’s, including 

whether the information will have 

practical utility; 

(2) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of this information 

collection: 

(1) Type of Information Collection: 

Revision of a currently approved 

information collection. 

(2) Title of the Form/Collection: 

Student and Exchange Visitor 

Information System (SEVIS). 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Homeland Security 

sponsoring the collection: Forms I–17 

and I–20; U.S. Immigration and Customs 

Enforcement. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Not-for-profit 

institutions and individuals or 

households. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 


emcdonald on DSK2BSOYB1PROD with NOTICES