55406 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Notices 

www.fda.gov/ohrms/dockets/ac/ 

acmenu.htm under the heading 

‘‘Psychopharmacologic Drugs Advisory 

Committee (PDAC)’’ (click on the year 

2005 and scroll down to PDAC 

meetings). 

Agenda: On October 25, 2005, the 

committee will discuss issues and 

questions pertinent to the need for 

longer-term efficacy data for proposed 

drug treatments for chronic psychiatric 

disorders, and issues and questions 

pertinent to optimal study designs for 

obtaining valid information about 

longer-term benefits of drug treatment. 

On October 26, 2005, the committee will 

discuss the question of whether or not 

dietary restrictions would be needed for 

the 20 milligrams (mg) dose for 

proposed trade name EMSAM 

(selegiline transdermal system) (new 

drug applications (NDAs): NDA 21–336, 

short-term claim, and NDA 21–708, 

longer-term claim, Somerset 

Pharmaceuticals), for the treatment of 

major depressive disorder. 

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 by October 12, 2005. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. on October 25, 2005, 

and between approximately 11 a.m. and 

11:30 a.m. on October 26, 2005. Time 

allotted for each presentation may be 

limited. Those desiring to make formal 

oral presentations should notify the 

contact person before October 12, 2005, 

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. 

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 Karen 

Templeton-Somers at least 7 days in 

advance of the meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 8, 2005. 

Scott Gottlieb, 

Deputy Commissioner for Policy. 

[FR Doc. 05–18872 Filed 9–20–05; 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 Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of the 

National Heart, Lung, and Blood 

Advisory 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 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 Advisory Council. 

Date: October 26, 2005. 

Open: 8:30 a.m. to 12 p.m. 

Agenda: Discussion of program policies 

and issues. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Bethesda, MD 

20892. 

Closed: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Bethesda, MD 

20892. 

Contact Person: Deborah P. Beebe, PhD, 

Director, Division of Extramural Affairs, 

National Heart, Lung, and Blood Institute, 

National Institutes of Health, Two Rockledge 

Center, Room 7100, 6701 Rockledge Drive, 

Bethesda, MD 20892, (301) 435–0260. 

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 

into the building by non-government 

employees. Persons without a government 

I.D. will need to show a photo I.D. and signin at the security desk upon entering the 

building. 

Information is also available on the 

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

nhlbi.gov/meetings/index.htm, where an 

agenda and any additional information for 

the meeting will be posted when available. 

(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 13, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–18864 Filed 9–20–05; 8:45 am] 

BILLING CODE 4140–01–M 

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. Appendix 2), 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 Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel, Preclinical Studies of Gene 

Therapy for Parkinson’s Disease. 

Date: October 4, 2005. 

Time: 2 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Suite 3208, Rockville, MD 20852, 

(Telephone Conference Call). 

Contact Person: Shantadurga Rajaram, 

PhD, Scientific Review Administrator, 

Scientific Review Branch, NIH/NINDS/ 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3208, Msc 9529, Bethesda, MD 20852, 

(301) 435–6033, rajarams@mail.nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel, UDALL Center Review. 

Date: October 27, 2005. 

Time: 1:30 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Notices 55407 

Boulevard, Rockville, MD 20852, (Telephone 

Conference Call). 

Contact Person: Joann McConnel, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, NIH/NINDS/Neuroscience 

Center, 6001 Executive Blvd., Suite 3208, 

Msc 9529, Bethesda, MD 20892–9529, (301) 

496–5324, mcconnej@ninds.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: September 13, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–18859 Filed 9–20–05; 8:45 am] 

BILLING CODE 4140–01–M 

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. Appendix 2), 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: Training Grant and 

Career Development Review Committee. 

Date: September 22–23, 2005. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Wyndham City Center Hotel, 1143 

New Hampshire Ave., NW., Washington, DC 

20037. 

Contact Person: Raul A. Saavedra, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, Division of Extramural 

Research, NINDS/NIH/DHHS, NSC; 6001 

Executive Blvd., Ste. 3208, Bethesda, MD 

20892–9529, (301) 496–9223, 

saavedrr@ninds.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Initial 

Review Group, Neurological Sciences and 

Disorders C. 

Date: October 20–21, 2005. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Wyndham Washington, DC, 1400 M 

Street NW Washington, DC 20005. 

Contact Person: Andrea Sawczuk, DDS, 

PhD, Scientific Review Administrator, 

Scientific Review Branch, Division of 

Extramural Research, NINDS/NIH/DHHS, 

6001 Executive Blvd., Room #3208, Bethesda, 

MD 20892, (301) 496–0660, 

sawczuka@ninds.nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Initial 

Review Group, Neurological Sciences and 

Disorders B. 

Date: October 24–25, 2005. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Holiday Inn Select Bethesda, 8120 

Wisconsin Ave, Bethesda, MD 20814. 

Contact Person: W. Ernest Lyons, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, NINDS/NIH/DHHS, 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3208, MSC 9529, Bethesda, MD 20892–

9529, (301) 496–4056. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Initial 

Review Group, Neurological Sciences and 

Disorders A. 

Date: October 27, 2005. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Wyndham City Center Hotel, 1143 

New Hampshire Ave., NW, DC 20037. 

Contact Person: Richard D. Crosland, Phd, 

Scientific Review Administrator, Scientific 

Review Branch, Division of Extramural 

Research, NINDS/NIH/DHHS, Neuroscience 

Center, 6001 Executive Blvd, Suite 3208, 

MSC 9529, Bethesda, MD 20892–9529, (301) 

496–9223. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Initial 

Review Group, Neurological Sciences and 

Disorders K. 

Date: October 27–28, 2005. 

Time: 7:30 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Holiday Inn Select—Bethesda, 8120 

Wisconsin Avenue, Bethesda, MD 20814. 

Contact Person: Katherine M. Woodbury, 

PhD, Scientific Review Administrator, 

Scientific Review Branch, NINDS/NIH/ 

DHHS, Neuroscience Center, 6001 Executive 

Blvd, Suite 3208, MSC 9529, Bethesda, MD 

20892–9529, (301) 496–9223. 

(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: September 13, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–18861 Filed 9–20–05; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), 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 Institute of 

Child Health and Human Development Initial 

Review Group, Development Biology 

Subcommittee. 

Date: October 10–11, 2005. 

Time: October 10, 2005, 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Latham Hotel, 3000 M Street, NW., 

Washington, DC 20007. 

Time:October 11, 2005, 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Latham Hotel, 3000 M Street, NW., 

Washington, DC 20007. 

Contact Person: Norman Chang, PhD, 

Scientific Review Administrator, Division of 

Scientific Review, National Institute of Child 

Health and Human Development, NIH, 6100 

Executive Blvd., Room 5B01, Bethesda, MD 

20892, (301) 496–1485, 

changn@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: September 13, 2005. 

Anthony M. Coelho, Jr., 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 05–18862 Filed 9–20–05; 8:45 am] 

BILLING CODE 4140–01–M