Federal Register / Vol. 74, No. 186 / Monday, September 28, 2009 / Notices 49383 

systems development and on services 

that children and families receive. The 

electronic data reports also will collect 

data about other Project LAUNCHfunded service enhancements, such as 

trainings, Project LAUNCH systems 

change activities, and changes in 

provider settings. Information provided 

in these reports will be aggregated on a 

quarterly basis, and reported semiannually. 

Respondents: State/Tribal Child 

Wellness Coordinator, State/Tribal 

Wellness Council Members, State ECCS 

Project Director, Local Child Wellness 

Coordinator, Local Wellness Council 

Members, Local Evaluator, and Local 

Service Providers. 

ANNUAL BURDEN ESTIMATES’> 

Instrument 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated 

annual burden 

hours 

Site Visit Interview Guide ................................................................................ 216 1 1.25 270 

Electronic Data Reporting: Systems Measures ............................................... 18 2 4 144 

Electronic Data Reporting: Services Measures ............................................... 18 2 8 288 

Estimated Annual Burden Hours: 702 

hours. 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447, Attn: OPRE Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

OPREinfocol1ection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–6974. 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: September 17, 2009. 

Seth F. Chamberlain, 

OPRE Reports Clearance Officer. 

[FR Doc. E9–23242 Filed 9–25–09; 8:45 am] 

BILLING CODE M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

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 of Mental Health Special 

Emphasis Panel. K99. 

Date: October 29, 2009. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852. 

(Telephone Conference Call). 

Contact Person: Megan Libbey, PhD, 

Scientific Review Officer, Division of 

Extramural Activities, National Institute 

of Mental Health, NIH, Neuroscience 

Center, 6001 Executive Blvd., Room 

6148, MSC 9609, Rockville, MD 20852– 

9609. 301–402–6807. 

libbeym@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.242, Mental Health Research 

Grants; 93.281, Scientist Development 

Award, Scientist Development Award for 

Clinicians, and Research Scientist Award; 

93.282, Mental Health National Research 

Service Awards for Research Training, 

National Institutes of Health, HHS) 

Dated: September 21, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–23337 Filed 9–25–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer 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/or contract proposals 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 and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel. 

Pharmacodynamic Assays for Cancer 

Therapeutics. 

Date: October 6, 2009. 

Time: 11 a.m. to 1:30 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, 6116 

Executive Boulevard, Room # 210, Rockville, 

MD 20852. (Telephone Conference Call). 

Contact Person: Thomas M Vollberg, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 

Executive Boulevard, Room 7142, Bethesda, 

MD 20892. 301–594–9582. 

vollbert@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to scheduling 

conflicts. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel. R13 

Conference Grants Review. 

Date: October 29, 2009. 

Time: 1 p.m. to 5 p.m. 


srobinson on DSKHWCL6B1PROD with NOTICES
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