Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 20691 

purpose of the public workshop is to 

facilitate discussion among FDA and 

worldwide orthopedic registries that 

have orthopedic implant information 

and create a research network to 

advance the methodology and conduct 

of research related to orthopedic device 

performance. 

Date and Time: The public workshop 

will be held on May 9, 2011, from 8 a.m. 

to 5:30 p.m. 

Location: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

rm. 1503 (the Great Room), Silver 

Spring, MD 20993. Participants are 

encouraged to arrive early to ensure 

time for parking and security screening 

before the meeting. 

Contacts: 

For information regarding the public 

workshop and registration: Betty Jo 

Alfstad, Surgical Outcomes and 

Analysis, Kaiser Permanente, 3033 

Bunker Hill Street, B30, San Diego, CA 

92109, 858–581–8272, e-mail: 

Betty.Jo.Alfstad@kp.org; 

For information regarding this notice: 

Tamia Woodruff, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 307– 

796–6091, e-mail: 

Tamia.Woodruff@fda.hhs.gov. 

Registration: There is no fee to attend 

the public workshop, but attendees 

must register in advance. Registration 

will be on a first-come, first-served 

basis. Non-U.S. citizens are subject to 

additional security screening, and they 

should register as soon as possible. 

Registration ends April 25, 2011. Onsite 

registration is not available. If 

registration reaches maximum capacity 

prior to April 25, 2011, FDA will post 

a notice closing workshop registration 

on FDA’s Web site at http:// 

www.fda.gov/cdrh/meetings.html. 

To register for the public workshop, 

mail or e-mail your name, title, 

organization affiliation, address, phone 

number, and email address to Betty Jo 

Alfstad (see Contacts). Registrants will 

receive e-mail confirmation upon 

acceptance for their participation in the 

public workshop. If you need special 

accommodations due to a disability, 

please contact Tamia Woodruff (see 

Contacts) at least 7 days in advance of 

the public workshop. 

SUPPLEMENTARY INFORMATION: 

I. Why are we holding this public 

workshop? 

The purpose of the public workshop 

is to facilitate discussion among FDA 

and international orthopedic registries 

and develop a research consortium 

(ICOR) that will advance the 

methodology and conduct of studies for 

orthopedic medical devices. We are 

reaching out to registries that have 

relevant data and are interested in 

collaboration to establish a network that 

will work with FDA to determine the 

evidence gaps and questions, datasets 

and approaches for conducting robust 

analytic studies and improve our 

understanding of the performance of 

orthopedic devices. 

II. Who is the target audience for this 

public workshop? Who should attend 

this public workshop? 

This workshop is open to all 

interested parties. The target audience is 

comprised of data holders, researchers, 

and industry interested in advancing the 

infrastructure and methods for studying 

orthopedic medical devices. 

III. What are the topics we intend to 

address at the public workshop? 

We intend to discuss a large number 

of issues at the workshop, including, but 

not limited to the following: 

• Regulatory science, clinical 

community, payers’ and patients’ needs 

that led to creation of ICOR. 

• New methods for distributed 

network based collaborative studies. 

• The opportunities for medical 

device outcomes research. 

IV. Where can I find out more about 

this public workshop? 

Background information on the public 

workshop, registration information, the 

agenda, information about lodging, and 

other relevant information will be 

posted, as it becomes available, on the 

Internet at http://www.fda.gov/cdrh/ 

meetings.html. 

Dated: April 7, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8894 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; 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 materials, 

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 of 

Neurological Disorders and Stroke Initial 

Review Group; Neurological Sciences and 

Disorders C. 

Date: June 9–10, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Lorien Hotel and Spa, 1600 King 

Street, Washington, DC 22314. 

Contact Person: William C. Benzing, PhD, 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research, 

NINDS/NIH/DHHS/Neuroscience Center, 

6001 Executive Blvd., Suite 3208, MSC 9529, 

Bethesda, MD 20892, 301–496–0660, 

benzingw@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: April 6, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–8965 Filed 4–12–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of the National Advisory 

Neurological Disorders and Stroke 

Council. 

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 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 materials, 

mstockstill on DSKH9S0YB1PROD with NOTICES

20692 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 

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 Advisory 

Neurological Disorders and Stroke Council. 

Date: May 26–27, 2011. 

Open: May 26, 2011, 10:45 a.m. to 4:45 

p.m. 

Agenda: Report by the Director, NINDS; 

Report by the Associate Director for 

Extramural Research, NINDS; Other 

Administrative and Program Developments; 

and an Overview of the NINDS Intramural 

Program. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, C Wing, 

Conference Room 10, Bethesda, MD 20892. 

Closed: May 26, 2011, 4:45 p.m. to 5:15 

p.m. 

Agenda: To review and evaluate the 

Division of Intramural Research Board of 

Scientific Counselors Reports. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, C Wing, 

Conference Room 10, Bethesda, MD 20892. 

Closed: May 27, 2011, 8 a.m. to 11 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, C Wing, 

Conference Room 10, Bethesda, MD 20892. 

Contact Person: Robert Finkelstein, PhD, 

Associate Director for Extramural Research, 

National Institute of Neurological Disorders 

and Stroke, NIH, 6001 Executive Blvd., Suite 

3309, MSC 9531, Bethesda, MD 20892, (301) 

496–9248. 

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. 

Information is also available on the 

Institute’s/Center’s home page: http:/// 

www.ninds.nih.gov, where an agenda and 

any additional information for the meeting 

will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS). 

Dated: April 7, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–8935 Filed 4–12–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; 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: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Cardiac Electrophysiology. 

Date: May 19, 2011. 

Time: 2:30 p.m. to 5 p.m. 

Agenda:To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Maqsood A. Wani, DVM, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2114, 

MSC 7814, Bethesda, MD 20892, 301–435– 

2270, wanimaqs@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PA–11– 

011—Getting from Genes to Function in Lung 

Disease. 

Date: May 25–26, 2011. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Ghenima Dirami, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4122, 

MSC 7814, Bethesda, MD 20892, 301–594– 

1321, diramig@csr.nih.gov. 

Name of Committee: Oncology 1-Basic 

Translational Integrated Review Group; 

Tumor Progression and Metastasis Study 

Section. 

Date: May 26–27, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Alexandria Old Town, 1767 

King Street, Alexandria, VA 22314. 

Contact Person: Rolf Jakobi, PhD, Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 6187, MSC 7806, Bethesda, MD 

20892, 301–495–1718, jakobir@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; RFA Panel: 

Investigations on Primary Immunodeficiency 

Diseases. 

Date: May 26, 2011. 

Time: 12 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Scott Jakes, PhD, Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Room 4198, MSC 7812, Bethesda, MD 

20892, 301–495–1506, jakesse@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: April 7, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–8933 Filed 4–12–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Meeting 

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 meeting. 

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 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 of 

Diabetes and Digestive and Kidney Diseases 

Initial Review Group; Diabetes, 

Endocrinology and Metabolic Diseases B 

Subcommittee. 

Date: May 31–June 2, 2011. 

mstockstill on DSKH9S0YB1PROD with NOTICES