Federal Register / Vol. 75, No. 90 / Tuesday, May 11, 2010 / Notices 26265 

301–796–9001, yvette.waples@ 

fda.hhs.gov) or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512534. 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 June 28, 2010, the 

committee will discuss new drug 

application (NDA) 22–340, voclosporin 

10-milligram capsules, by Lux 

Biosciences, Inc. The proposed 

indication for this new drug product is 

treatment of noninfectious uveitis 

involving the posterior or intermediate 

segments of the eye. 

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 June 14, 2010. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 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 June 4, 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 June 7, 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 Yvette 

Waples 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: May 5, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–11039 Filed 5–10–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Pediatric Advisory Committee; Notice 

of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Pediatric 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on Monday, June 21, 2010, from 9 

a.m. to 5 p.m. 

Location: Bethesda Marriott Hotel, 

Congressional Ballroom, 5151 Pooks 

Hill Rd., Bethesda, MD. 20814. 

Contact Person: Doreen Kezer, Office 

of Science and Health Coordination, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, rm. 

4254, Silver Spring, MD 20993–0002, 

301–796–8524, e-mail: 

Doreen.Kezer@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

8732310001. 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 Monday, June 21, the 

Pediatric Advisory Committee will meet 

to discuss pediatric-focused safety 

reviews, as mandated by the Best 

Pharmaceuticals for Children Act and 

the Pediatric Research Equity Act, for 

Kogenate FS (antihemophilic factor 

(recombinant)), Casodex (bicalutamide), 

Apidra (insulin glulisine [rDNA]), 

NovoLog (insulin aspart [rDNA]), 

Arimidex (anastrozole), Desmopressin 

Acetate, Prevacid (lansoprazole), 

Nexium (esomeprazole magnesium), 

Aciphex (rabeprazole sodium), Prilosec 

(omeprazole), OraVerse (phentolamine 

mesylate), Zemuron (rocuronium 

bromide). The committee will also 

receive a followup presentation on 

Suprane (desflurane). 

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 June 7, 2010. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 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 


emcdonald on DSK2BSOYB1PROD with NOTICES
26266 Federal Register / Vol. 75, No. 90 / Tuesday, May 11, 2010 / Notices 

or before May 28, 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 June 1, 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 Doreen Kezer 

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: May 5, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–11038 Filed 5–10–10; 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: Developing Novel 

Diagnostic Tests To Improve 

Surveillance for Antimicrobial 

Resistant Pathogens, Funding 

Opportunity Announcement CI10–002; 

Initial Review 

Correction: This notice was published 

in the Federal Register on April 23, 

2010, Volume 75, Number 78, page 

21339. The time and date, and place 

should read as follows: 

Time and Date: 

12 p.m.–3 p.m., May 18, 2010 

(Closed). 

Place: Teleconference. 

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: April 29, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–11189 Filed 5–10–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Safety and Occupational Health Study 

Section (SOHSS), National Institute for 

Occupational Safety and Health 

(NIOSH) 

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 following meeting of the 

aforementioned committee: 

Times And Dates: 

8 a.m.–5 p.m., June 22, 2010. (Closed). 

8 a.m.–5 p.m., June 23, 2010. (Closed). 

Place: Omni Hotel, 500 California 

Street, San Francisco, California 94104, 

Telephone (415) 677–9494, Fax (415) 

273–3038. 

Status: These portions of 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, Centers for Disease 

Control and Prevention, pursuant to 

Section 10(d) Public Law 92–463. 

Purpose: The Safety and Occupational 

Health Study Section will review, 

discuss, and evaluate grant 

application(s) received in response to 

the Institute’s standard grants review 

and funding cycles pertaining to 

research issues in occupational safety 

and health, and allied areas. 

It is the intent of NIOSH to support 

broad-based research endeavors in 

keeping with the Institute’s program 

goals. This will lead to improved 

understanding and appreciation for the 

magnitude of the aggregate health 

burden associated with occupational 

injuries and illnesses, as well as to 

support more focused research projects, 

which will lead to improvements in the 

delivery of occupational safety and 

health services, and the prevention of 

work-related injury and illness. It is 

anticipated that research funded will 

promote these program goals. 

Matters to be Discussed: The meeting 

will convene to address matters related 

to the conduct of Study Section 

business and for the study section to 

consider safety and occupational healthrelated grant applications. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: 

Price Connor, PhD., NIOSH Health 

Scientist, 1600 Clifton Road, NE., 

Mailstop E–20, Atlanta, Georgia 30333, 

Telephone (404) 498–2511, Fax (404) 

498–2571. 

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: April 29, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–11186 Filed 5–10–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute (NCI); 

National Institute of Allergy and 

Infectious Diseases (NIAID); National 

Institute of Arthritis and 

Musculoskeletal and Skin Diseases 

(NIAMS); and Office of Research on 

Women’s Health (ORWH), Office of the 

Director (OD), NIH 

AGENCY: National Institutes of Health 

(NIH). 

ACTION: Notice of Open Conference. 

Notice is hereby given that the NIH, 

an agency of the Department of Health 

and Human Services, in collaboration 

with the Lupus Foundation of America, 

Washington, DC, will hold a scientific 

conference. 

Title: ‘‘Systemic Lupus 

Erythematosus: From Mouse Models to 

Human Disease and Treatment.’’ 

Dates: September 2–3, 2010. 

Location: Lister Hill Auditorium, 

Building 38A, NIH, Bethesda, Maryland. 


emcdonald on DSK2BSOYB1PROD with NOTICES