48872 Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices 

follow the prompts to the desired center or 

product area. Please call the Information Line 

for up-to-date information on this meeting. A 

notice in the Federal Register about last 

minute modifications that impact a 

previously announced advisory committee 

meeting cannot always be published quickly 

enough to provide timely notice. Therefore, 

you should always check the Agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn about 

possible modifications before coming to the 

meeting. 

Agenda: On October 14, 2011, the 

committee will discuss, make 

recommendations, and vote on a premarket 

approval application for the Progensa PCA3 

assay sponsored by Gen-Probe, Inc. The 

Progensa PCA3 assay is indicated for use in 

conjunction with other patient information to 

aid in the decision for repeat biopsy in men 

50 years of age or older who have had one 

or more previous negative prostate biopsies 

and for whom a repeat biopsy would be 

recommended based on current standard of 

care, before consideration of PCA3 assay 

results. A lower PCA3 score is associated 

with a decreased likelihood of a positive 

biopsy. 

FDA intends to make background material 

available to the public no later than 2 

business days before the meeting. If FDA is 

unable to post the background material on its 

Web site prior to the meeting, the background 

material will be made publicly available at 

the location of the advisory committee 

meeting, and the background material will be 

posted on FDA’s Web site after the meeting. 

Background material is available at http:// 

www.fda.gov/AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the appropriate 

advisory committee link. 

Procedure: Interested persons may present 

data, information, or views, orally or in 

writing, on issues pending before the 

committee. Written submissions may be 

made to the contact person on or before 

September 30, 2011. Oral presentations from 

the public will be scheduled between 

approximately 1 p.m. and 2 p.m., 

immediately following lunch. Those 

individuals interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of the 

general nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and an 

indication of the approximate time requested 

to make their presentation on or before 

September 22, 2011. Time allotted for each 

presentation may be limited. If the number of 

registrants requesting to speak is greater than 

can be reasonably accommodated during the 

scheduled open public hearing session, FDA 

may conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by September 23, 2011. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee meetings 

and will make every effort to accommodate 

persons with physical disabilities or special 

needs. If you require special accommodations 

due to a disability, please contact AnnMarie 

Williams at 301–796–5966 at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly conduct 

of its advisory committee meetings. Please 

visit our Web site at http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ucm111462.htm 

for procedures on public conduct during 

advisory committee meetings. 

Notice of this meeting is given under the 

Federal Advisory Committee Act (5 U.S.C. 

app. 2). 

Dated: August 3, 2011. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2011–20118 Filed 8–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; The Hispanic Community 

Health Study (HCHS)/Study of Latinos 

(SOL) 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Heart, Lung, and Blood 

Institute (NHLBI), the National 

Institutes of Health (NIH) will publish 

periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: Hispanic 

Community Health Study (HCHS)/Study 

of Latinos (SOL). Type of Information 

Collection Request: Revision of 

currently approved collection. (OMB# 

0925–0584). Need and Use of 

Information Collection: A baseline 

examination was conducted from March 

3, 2008 to June 30, 2011. HCHS will 

follow-up new participants enrolled in 

the past year by telephone for dietary 

data, and continue to conduct annual 

follow-up of all participants by 

telephone to ascertain morbidity and 

mortality. Physicians/health care 

providers will be contacted to verify 

reported events for outcomes 

ascertainment. The Hispanic 

Community Health Study (HCHS)/Study 

of Latinos (SOL) will identify risk 

factors for cardiovascular and lung 

disease in Hispanic populations and 

determine the role of acculturation in 

the prevalence and development of 

these diseases. Frequency of Response: 

The participants will be contacted 

annually. Affected Public: Individuals 

or households; Businesses or other for 

profit; Small businesses or 

organizations. Type of Respondents: 

Individuals or households; physicians/ 

health care providers. The annual 

reporting burden is as follows: 

Estimated Number of Respondents: 

17,284; Estimated Number of Responses 

per Respondent: 1; Average Burden 

Hours Per Response: 0.3072; and 

Estimated Total Annual Burden Hours 

Requested: 5,309. The annualized cost 

to respondents is estimated at $104,718, 

assuming respondents time at the rate of 

$15 per hour and physician time at the 

rate of $55 per hour. There are no 

Capital Costs to report. There are no 

Operating or Maintenance Costs to 

report. 

ESTIMATE OF ANNUAL HOUR BURDEN

Type of response Number of respondents 

Frequency of 

responses 

Average hours 

per response 

Annual hour 

burden 

Participant telephone Interviews: 

a. Follow-up call, Year 1 ........................................................................... 1,333 1 0.75 1,000 

b. Follow-up call, Year 2 ........................................................................... 5,333 1 0.25 1,333 

c. Follow-up call, Year 3,4,5,6 .................................................................. 9,334 1 0.25 2,334 

Non Participant Components: 

Physician, medical examiner, next of kin or other contact follow-up 1 ..... 1,284 1 0.50 642 

Total unique respondents .................................................................. 17,284 ........................ ........................ 5,309 

1Annual burden is placed on doctors and respondent relatives/informants through requests for information which will help in the compilation of 

the number and nature of new fatal and nonfatal events. 


sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Notices 48873 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) Ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

Ways to minimize the burden of the 

collection of information on those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Dr. Larissa AvilesSanta, Project Officer, NIH, NHLBI, 6701 

Rockledge Drive, MSC 7936, Bethesda, 

MD 20892–7936, or call non-toll-free 

number 301–435–0450 or e-mail your 

request, including your address to: 

AvilessantaL@NHLBI.NIH.GOV. 

DATES: Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60-days of the date of 

this publication. 

Dated: August 1, 2011. 

Michael S. Lauer, 

Director, Division of Cardiovascular Sciences, 

National Heart, Lung, and Blood Institute, 

NIH. 

Lynn Susulske, 

NHLBI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2011–20174 Filed 8–8–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Library of Medicine Notice of 

Meetings 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App), notice is 

hereby given of a meeting of the Board 

of Scientific Counselors, Lister Hill 

Center for Biomedical Communications. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in section 

552b(c)(6), Title 5 U.S.C., as amended 

for review, discussion, and evaluation of 

individual intramural programs and 

projects conducted by the NATIONAL 

LIBRARY OF MEDICINE, including 

consideration of personnel 

qualifications and performance, and the 

competence of individual investigators, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Board of Scientific 

Counselors, Lister Hill Center for Biomedical 

Communications. 

Date: September 26–27, 2011. 

Open: September 26, 2011, 9 a.m. to 11:30 

a.m. 

Agenda: Review of research and 

development programs and preparation of 

reports of the Lister Hill Center for 

Biomedical Communications. 

Place: National Library of Medicine, 

Building 38, 2nd Floor, Board Room, 8600 

Rockville Pike, Bethesda, MD 20892. 

Closed: September 26, 2011, 11:30 p.m. to 

4:30 p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Library of Medicine, 

Building 38, 2nd Floor, Board Room, 8600 

Rockville Pike, Bethesda, MD 20892. 

Open: September 27, 2011, 10 a.m. to 11:15 

a.m. 

Agenda: Review of research and 

development programs and preparation of 

reports of the Lister Hill Center for 

Biomedical Communications. 

Place: National Library of Medicine, 

Building 38, 2nd Floor, Board Room, 8600 

Rockville Pike, Bethesda, MD 20892. 

Contact Person: Karen Steely, Program 

Assistant, Lister Hill Center for Biomedical 

Communications, National Library of 

Medicine, Building 38A, Room 7S709, 

Bethesda, MD 20892, 301–435–3137, 

ksteely@mail.nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.879, Medical Library 

Assistance, National Institutes of Health, 

HHS) 

Dated: August 3, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–20178 Filed 8–8–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging 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 on Aging Special Emphasis 

Panel, AD Mutation. 

Date: August 30, 2011. 

Time: 1 p.m. to 1:45 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin 

Avenue, Suite 2C212, Bethesda, MD 

20892, (Telephone Conference Call). 

Contact Person: Alicja L. Markowska, 

PhD, DSC, Scientific Review Branch, 

National Institute On Aging, 7201 

Wisconsin Avenue, Suite 2C212, 

Bethesda, MD 20892, 301–496–9666, 

markowsa@nia.nih.gov. 

Name of Committee: National 

Institute on Aging Special Emphasis 

Panel, Registry For AD. 

Date: August 30, 2011. 

Time: 1:45 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin 

Avenue, Suite 2C212, Bethesda, MD 

20892, (Telephone Conference Call). 

Contact Person: Alicja L. Markowska, 

PHD, DSC, Scientific Review Branch, 

National Institute On Aging, 7201 

Wisconsin Avenue, Suite 2C212, 


sroberts on DSK5SPTVN1PROD with NOTICES