49384 Federal Register / Vol. 74, No. 186 / Monday, September 28, 2009 / Notices 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6116 

Executive Boulevard, 8041, Rockville, MD 

20852. (Telephone Conference Call). 

Contact Person: Bratin K. Saha, PhD, 

Scientific Review Officer, Program 

Coordination and Referral Branch, Division 

of Extramural Activities, National Cancer 

Institute, NIH, 6116 Executive Boulevard, 

Room 8041, Bethesda, MD 20892. (301) 402– 

0371. sahab@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel. NCI Cancer 

Prevention Research II. 

Date: October 30, 2009. 

Time: 10 a.m. to 12 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6116 

Executive Boulevard, Room # 210, Rockville, 

MD 20852. (Telephone Conference Call). 

Contact Person: Irina Gordienko, PhD, 

Scientific Review Officer, Scientific Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

6116 Executive Blvd., Rm. 7073, Bethesda, 

MD 20892. 301–594–1566. 

gordienkoiv@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel. 

Community Clinical Oncology Programs. 

Date: December 1–2, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Marriott Courtyard Gaithersburg 

Washingtonian Ctr, 204 Boardwalk Place, 

Gaithersburg, MD 20878. 

Contact Person: Gerald G. Lovinger, PhD, 

Scientific Review Administrator, Special 

Review and Logistics Branch, Division of 

Extramural Activities, National Cancer 

Institute, 6116 Executive Blvd., Room 8101, 

Bethesda, MD 20892–8329. 301/496–7987. 

lovingeg@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: September 21, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–23269 Filed 9–25–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Pulmonary-Allergy 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: Pulmonary-Allergy 

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 18, 2009, from 8 a.m. to 5 p.m. 

Location: Hilton Washington DC/Silver 

Spring, The Ballrooms, 8727 Colesville Rd., 

Silver Spring, MD. The hotel phone number 

is 301–589–5200. 

Contact Person: Kristine T. Khuc, Center 

for Drug Evaluation and Research (HFD–21), 

Food and Drug Administration, 5600 Fishers 

Lane (for express delivery, 5630 Fishers 

Lane, rm. 1093), Rockville, MD 20857, 301– 

827–7001, FAX: 301–827–6776, e-mail: 

Kristine.Khuc@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800–741– 

8138 (301–443–0572 in the Washington, DC 

area), code 3014512545. 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: The committee will discuss 

biologics license application (BLA) 103976, 

supplement 5149, for XOLAIR (omalizumab), 

manufactured by Genentech USA, Inc. and 

Novartis Pharmaceuticals Corp. The 

proposed indication for this product is to 

treat moderate to severe persistent asthma in 

patients between 6 and 11 years of age whose 

symptoms are inadequately controlled with 

inhaled steroid medications and have: (1) A 

positive reaction to skin testing with 

common substances that can cause allergies 

and asthma, such as pollen or (2) in vitro 

reactivity, which is measured with a blood 

test that confirms the presence of specific 

proteins consistent with allergies and 

asthma. 

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 3, 2009. 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 October 26, 2009. 

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 27, 2009. 

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/ 

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 22, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23292 Filed 9–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Pulmonary-Allergy Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 74, No. 186 / Monday, September 28, 2009 / Notices 49385 

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: Pulmonary-Allergy 

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 20, 2009, from 8 a.m. to 5 p.m. 

Location: Hilton Washington DC/Silver 

Spring, The Ballrooms, 8727 Colesville Rd., 

Silver Spring, MD. The hotel phone number 

is 301–589–5200. 

Contact Person: Kristine T. Khuc, Center 

for Drug Evaluation and Research (HFD–21), 

Food and Drug Administration, 5600 Fishers 

Lane (for express delivery, 5630 Fishers 

Lane, rm. 1093), Rockville, MD 20857, 301– 

827–7001, FAX: 301–827–6776, e-mail: 

Kristine.Khuc@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800–741– 

8138 (301–443–0572 in the Washington, DC 

area), code 3014512545. 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: The committee will discuss new 

drug application (NDA) 22–368, for ARIDOL 

(mannitol bronchial challenge test), 

manufactured by Pharmaxis Ltd. The 

proposed use of this product is to assess 

bronchial hyperresponsiveness (airway 

irritability in the lungs) to aid in diagnosing 

patients 6 years of age or older who have 

symptoms of asthma or symptoms that are 

suggestive of asthma. 

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 5, 2009. Oral presentations from 

the public will be scheduled between 

approximately 1 p.m. to 2 pm. 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 28, 2009. 

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 29, 2009. 

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/ 

AdvisoryCommittees/ 

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: September 22, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–23270 Filed 9–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

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 Institute on 

Drug Abuse Special Emphasis Panel 

B/START Review. 

Date: October 15, 2009. 

Time: 9 a.m. to 11:30 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6101 

Executive Boulevard, Rockville, MD 20852, 

(Virtual Meeting). 

Contact Person: Gerald L. McLaughlin, 

PhD, Scientific Review Administrator, Office 

of Extramural Affairs, National Institute on 

Drug Abuse, NIH, DHHS, Room 220, MSC 

8401, 6101 Executive Blvd., Bethesda, MD 

20892–8401, 301–402–6626, 

gm145a@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.279, Drug Abuse and 

Addiction Research Programs, National 

Institutes of Health, HHS) 

Dated: September 18, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–23085 Filed 9–25–09; 8:45 am] 

BILLING CODE M 

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. 

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: Center for Scientific 

Review Special Emphasis Panel, Member 

Conflicts: Addiction, Learning, and Feeding. 

Date: October 6–7, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting.) 

Contact Person: Brian Hoshaw, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5181, 

MSC 7844, Bethesda, MD 20892. 301–435– 

1033. hoshawb@csr.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: Center for Scientific 

Review Special Emphasis Panel, Motivated 

Behavior. 

Date: October 7, 2009. 

Time: 1 p.m. to 2 p.m. 


srobinson on DSKHWCL6B1PROD with NOTICES