55806 Federal Register / Vol. 75, No. 177 / Tuesday, September 14, 2010 / Notices 

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 November 16, 2010, the 

committee will discuss biologic license 

application 125370, belimumab, 

proposed trade name BENLYSTA, 

sponsored by Human Genome Sciences, 

for the proposed indication of reducing 

disease activity in adult patients with 

active, autoantibody-positive systemic 

lupus erythematosus. 

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 November 1, 2010. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. to 2 p.m. Those desiring to make 

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 October 22, 2010. 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 

October 25, 2010. 

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 Anuja Patel 

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/AboutAdvisory

Committees/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: September 9, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–22867 Filed 9–13–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Patient 

Protection and Affordable Care Act 

(PPACA), Emerging Infections 

Program (EIP), Enhancing 

Epidemiology and Laboratory 

Capacity, Funding Opportunity 

Announcement (FOA) CI10–003, Initial 

Review 

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) 

announces the aforementioned meeting: 

Time and Date: 12 p.m.–2 p.m., September 

21, 2010 (Closed). 

Place: Teleconference. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c) (4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

This notice is being published on less than 

15 days notice to the public in order for the 

Agency to fulfill its obligations under Section 

4002(b) of the PPACA prior to 2010 Fiscal 

Year-End and in order to meet the objectives 

of the funding opportunity announcement. 

Matters To Be Discussed: The meeting will 

include the initial review, discussion, and 

evaluation of applications received in 

response to ‘‘Patient Protection and 

Affordable Care Act (PPACA), Emerging 

Infections Program (EIP), Enhancing 

Epidemiology and Laboratory Capacity, 

Funding Opportunity Announcement FOA 

CI10–003.’’ 

Contact Person for More Information: 

Gregory Anderson, M.S., M.P.H., Scientific 

Review Officer, CDC, 1600 Clifton Road, NE., 

Mailstop E60, Atlanta, GA 30333, Telephone: 

(404) 498–2293. 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 8, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–22815 Filed 9–13–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of Closed 

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 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 Eye Institute 

Special Emphasis Panel, RO1 Epidemiology 

Applications. 

Date: September 29, 2010. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, NEI, 

5635 Fishers Lane, Rockville, MD 20892. 

(Telephone Conference Call) 

Contact Person: Samuel Rawlings, PhD, 

Chief, Scientific Review Officer, Division of 

Extramural Research, National Eye Institute, 

National Institutes of Health, 5635 Fishers 

Lane, Suite 1300, MSC 9300, 301–451–2020, 

rawlings@nei.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: September 8, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–22841 Filed 9–13–10; 8:45 am] 

BILLING CODE 4140–01–P 


jlentini on DSKJ8SOYB1PROD with NOTICES