61506 Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee on Immunization 

Practices (ACIP) 

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.–6 p.m., 

October 27, 2010; 8 a.m.–5 p.m., October 

28, 2010. 

Place: CDC, Tom Harkin Global 

Communications Center, 1600 Clifton 

Road, NE., Building 19, Kent ‘‘Oz’’ 

Nelson Auditorium, Atlanta, Georgia 

30333. 

Status: Open to the public, limited 

only by the space available. 

Purpose: The committee is charged 

with advising the Director, CDC, on the 

appropriate uses of immunizing agents. 

In addition, under 42 U.S.C. 1396s, the 

committee is mandated to establish and 

periodically review and, as appropriate, 

revise the list of vaccines for 

administration to vaccine-eligible 

children through the Vaccines for 

Children (VFC) program, along with 

schedules regarding the appropriate 

periodicity, dosage, and 

contraindications applicable to the 

vaccines. 

Matters To Be Discussed: The agenda 

will include discussions on: Evidence 

based recommendations; Human 

Papillomavirus (HPV) vaccines; 

Meningococcal vaccine; Hepatitis 

vaccines; vaccine supply update; RSV 

Immunoprophylaxis; Rotavirus 

vaccines; Pertussis vaccine; Influenza 

vaccines; the 2011 Immunization 

Schedule for adults, children & 

adolescents; and the Herpes Zoster 

vaccine. Agenda items are subject to 

change as priorities dictate. 

Contact Person for More Information: 

Leola Mitchell, National Center for 

Immunization and Respiratory Diseases, 

CDC, 1600 Clifton Road, NE., Mailstop 

E–05, Atlanta, Georgia 30333, 

Telephone (404) 639–8836, Fax (404) 

639–8905. 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 CDC and Agency for Toxic 

Substances and Disease Registry. 

Dated: September 27, 2010. 

Elaine Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–25012 Filed 10–4–10; 8:45 am] 

BILLING CODE 4160–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Gastrointestinal Drugs 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: Gastrointestinal 

Drugs 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 November 4, 2010, from 8 a.m. 

to 5 p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, The Ballroom, 620 

Perry Pkwy., Gaithersburg, MD. The 

hotel telephone number is 301–977– 

8900. 

Contact Person: Kristine T. Khuc, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, FAX: 

301–847–8533, email: 

kristine.khuc@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512538. 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 November 4, 2010, the 

committee will discuss the adequacy of 

endoscopically documented gastric 

ulcers as an outcome measure to 

evaluate drugs intended to prevent 

gastrointestinal complications of 

nonsteroidal anti-inflammatory drugs 

including aspirin. 

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 October 21, 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 13, 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 14, 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 Kristine T. 

Khuc 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. 

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Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 61507 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 30, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–24984 Filed 10–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

General and Plastic Surgery Devices 

Panel of the Medical Devices Advisory 

Committee; Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing an amendment to 

the notice of meeting of the General and 

Plastic Surgery Devices Panel of the 

Medical Devices Advisory Committee. 

This meeting was announced in the 

Federal Register of August 16, 2010 (75 

FR 49940). The amendment is being 

made to reflect a change in the Agenda 

portion of the document. There are no 

other changes. 

FOR FURTHER INFORMATION CONTACT: 

Margaret McCabe-Janicki, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 1535, 

Silver Spring, MD 20993–0002, 301– 

796–7029, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 3014512519. Please call the 

Information Line for up-to-date 

information on this meeting. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 16, 2010, 

FDA announced that a meeting of the 

General and Plastic Surgery Devices 

Panel of the Medical Devices Advisory 

Committee would be held on November 

18, 2010. On page 49940, in the second 

column, in the Agenda portion of the 

document, the first full paragraph is 

changed to read as follows: 

Agenda: On November 18, 2010, the 

committee will discuss, make 

recommendations, and vote on 

information related to the premarket 

approval application for MelaFind, 

sponsored by MELA Sciences. 

MelaFind(R) is a non-invasive and 

objective multi-spectral computer vision 

system designed to aid physicians in the 

detection of early melanoma from 

among clinically atypical (those having 

one or more clinical or historical 

characteristics of melanoma, such as 

asymmetry, border irregularity, color 

variegation, diameter greater than 6 

millimeters, evolving, patient concern, 

regression, and ‘‘ugly duckling’’) 

cutaneous pigmented lesions that are 

non-ulcerated, not bleeding, and less 

than 2.2 centimeters in diameter, when 

a physician chooses to obtain additional 

information before making a final 

decision to biopsy to rule out 

melanoma. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: September 30, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–24983 Filed 10–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; 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 Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

NHLBI Research Centers at Minority-Serving 

Institutions. 

Date: October 20, 2010. 

Time: 8 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Chang Sook Kim, PhD, 

Scientific Review Officer, Review Branch, 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7190, 

Bethesda, MD 20892, 301–435–0287, 

carolko@mail.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Mentored Patient Oriented Research Career 

Development Awards. 

Date: October 21, 2010. 

Time: 8 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 8120 Military Road, NW., 

Washington, DC 20015. 

Contact Person: Stephanie J. Webb, PhD, 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7196, 

Bethesda, MD 20892, 301–435–0291, 

stephanie.webb@nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Programs of Excellence in Glycosciences. 

Date: October 25–26, 2010. 

Time: 8 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Residence Inn Bethesda, 7335 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: YingYing Li-Smerin, MD, 

PhD, Scientific Review Officer, Office of 

Scientific Review, National Heart, Lung, and 

Blood Institute, National Institutes of Health, 

6701 Rockledge Drive, Room 7184, Bethesda, 

MD 20892–7924, 301–435–0277, 

lismerin@nhlbi.nih.gov. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Program Project in Cardiac Fibrillation. 

Date: October 28, 2010. 

Time: 10 a.m. to 2 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: William J Johnson, PhD, 

Scientific Review Officer, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7178, 

Bethesda, MD 20892–7924, 301–435–0725, 

johnsonwj@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: September 28, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–24932 Filed 10–4–10; 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. 

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