7282 Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 

(nevirapine), Valtrex (valacyclovir), 

Zmax (azithromycin), Rotarix (rotavirus 

vaccine, live, oral), Kinrix (Diphtheria 

and Tetanus Toxoids and Acellular 

Pertussis Adsorbed and Inactivated 

Poliovirus Vaccine), Pentacel 

[Diphtheria and Tetanus Toxoids and 

Acellular Pertussis Adsorbed, 

Inactivated Poliovirus and Haemophilus 

b Conjugate (Tetanus Toxoid Conjugate) 

Vaccine], and Daptacel (Diphtheria and 

Tetanus Toxoids and Acellular Pertussis 

Vaccine Adsorbed vaccine). The 

committee will also receive an update 

on Topical Calcineurin Inhibitors: Elidel 

(pimecrolimus) and Protopic 

(tacrolimus). Also, the committee will 

receive a brief followup on the FDA 

Early Communication about reports of 

liver-related adverse events in patients 

taking orlistat (marketed as Alli and 

Xenical). 

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 March 8, 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 February 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 

March 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/Advisory

Committees/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: February 4, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–3024 Filed 2–17–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Breast and Cervical Cancer Early 

Detection and Control Advisory 

Committee (BCCEDCAC) 

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 committee 

meeting: 

Times and Dates: 12 p.m.–5 p.m., March 

15, 2010. 8:30 a.m.–5 p.m., March 16, 2010. 

8:30 a.m.–3 p.m., March 17, 2010. 

Place: Crowne Plaza Atlanta Perimeter at 

Ravinia, 4355 Ashford Dunwoody Road, 

Atlanta, GA 30346, Telephone: 770–395– 

7700. 

Status: Open to the public, limited only by 

the number of seats available. 

Purpose: The committee is charged with 

advising the Secretary, Department of Health 

and Human Services, and the Director, CDC, 

regarding the early detection and control of 

breast and cervical cancer. The committee 

makes recommendations regarding national 

program goals and objectives; 

implementation strategies; and program 

priorities including surveillance, 

epidemiologic investigations, education and 

training, information dissemination, 

professional interactions and collaborations, 

and policy. 

Matters To Be Discussed: The agenda will 

include discussion and review of U.S. 

Preventive Services Task Force guidelines for 

breast and cervical cancer screening; Impact 

of the revised clinical screening 

recommendations for both breast and cervical 

cancer on the National Breast and Cervical 

Cancer Early Detection Program; Discussion 

of what, if any, modifications should be 

made to the NBCCEDP’s current screening 

policies based on revised recommendations. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: Dr. 

Chastity Walker, Designated Federal Officer, 

BCCEDCAC, Division of Cancer Prevention 

and Control, National Center for Chronic 

Disease Prevention and Health Promotion, 

CDC, 4770 Buford Highway, Mailstop K–57, 

Chamblee, Georgia 30316, Telephone: 770– 

488–3013. 

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 the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: February 3, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–3143 Filed 2–17–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Circulatory System Devices Panel of 

the Medical Devices 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: Circulatory 

System Devices Panel of the Medical 

Devices 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 March 18 and 19, 2010, from 8 

a.m. to 6 p.m. 

Location: College Park Holiday Inn, 

Grand Ballroom, 10000 Baltimore Ave., 

College Park, MD. 

Contact Person: James Swink, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES

Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices 7283 

20993, 301–796–6313, e-mail: 

James.Swink@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512625. 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 March 18, 2010, the 

committee will discuss, make 

recommendations, and vote on the 

premarket approval application (PMA) 

for the Cardiac Resynchronization 

Therapy Defibrillators (CRT–Ds) 

sponsored by Boston Scientific. The 

sponsor is seeking expanded indications 

for the their CRT–Ds to include patients 

with low left ventricular ejection 

fraction (≤30%) and wide QRS (≥130 

ms) who are NYHA Class II (ischemic or 

non-ischemic etiology) or NYHA Class I 

(ischemic etiology). 

On March 19, 2010, the committee 

will discuss, make recommendations 

and vote on a PMA for the REVO MRI 

Pacemaker System sponsored by 

Medtronic. The REVO MRI Pacing 

System is a pacemaker (with a standard 

pacing indication) that has been 

specifically designed to be safe for the 

MRI environment under certain MR 

scanning conditions. 

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 March 11, 2010. 

Oral presentations from the public will 

be scheduled immediately following 

lunch. 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 March 3, 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 March 4, 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 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/Advisory

Committees/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: February 4, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–3032 Filed 2–17–10; 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): Strengthening 

Global Human-Animal Interface 

Activities for Avian Influenza and Other 

Zoonotic Diseases, Funding 

Opportunity Announcement (FOA) 

CK10–001, 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., April 7, 

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. 

Matters To Be Discussed: The meeting will 

include the initial review, discussion, and 

evaluation of applications received in 

response to ‘‘Strengthening Global HumanAnimal Interface Activities for Avian 

Influenza and other Zoonotic Diseases, FOA 

CK10–001.’’ 

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: February 11, 2010. 

Andre Tyler, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention. 

[FR Doc. 2010–3141 Filed 2–17–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

Coordinating Center for Infectious 

Diseases, (BSC, CCID) 

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: 

Time and Date: 10 a.m.–11 a.m., March 2, 

2010. 

Place: Teleconference. 

Status: Open to the public, the toll free dial 

in number is 1–866–880–0098 with a pass 

code of 9887280. 

Purpose: The BSC, CCID shall advise the 

Secretary, HHS, and the Director, CDC 

concerning strategies and goals for the 

programs and research within the national 

centers; will administer and oversee peer 

review of scientific programs; and monitor 

the overall strategic direction and focus of 

the national centers. 

Matters To Be Discussed: Agenda items 

will include: 

1. Update from Dr. Khabbaz. 

2. Update on H1N1 response. 

3. Update from National Center for HIV/ 

AIDS, Viral Hepatitis, STD, and TB 

Prevention. 

WReier-Aviles on DSKGBLS3C1PROD with NOTICES