Federal Register / Vol. 74, No. 182 / Tuesday, September 22, 2009 / Notices 48273 

MSC 7854, Bethesda, MD 20892, 301–435– 

2598, firrellj@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Topics on 

Control of Fungal Infections. 

Date: October 16, 2009. 

Time: 8 a.m. to 11 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Baltimore Marriott Waterfront, 700 

Aliceanna Street, Baltimore, MD 21202. 

Contact Person: Tera Bounds, DVM, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3214, 

MSC 7808, Bethesda, MD 20892, 301–435– 

2306, boundst@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel Fellowships: 

Biomedical Imaging and Bioengineering. 

Date: October 16, 2009. 

Time: 12 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting) 

Contact Person: Dharam S. Dhindsa, DVM, 

PhD, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5110, 

MSC 7854, Bethesda, MD 20892, (301) 435– 

1174, dhindsad@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 14, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–22592 Filed 9–21–09; 8:45 am] 

BILLING CODE 4140–01–M 

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: PulmonaryAllergy 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 19, 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 

the efficacy supplement for new drug 

application (sNDA) 21–395, for the 

approved product Spiriva HandiHaler 

(tiotropium inhalation powder), 

manufactured by Boehringer Ingelheim, 

for the reduction in exacerbations 

(worsening of symptoms) in patients 

with chronic obstructive pulmonary 

disease (COPD). 

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 4, 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 27, 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 28, 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 

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. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 17, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–22820 Filed 9–21–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Anesthesiology and Respiratory 

Therapy 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: Anesthesiology 

and Respiratory Therapy Devices Panel 


sroberts on DSKD5P82C1PROD with NOTICES
48274 Federal Register / Vol. 74, No. 182 / Tuesday, September 22, 2009 / Notices 

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 October 28, 2009, from 8 a.m. 

to 5 p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, Salons A, B, & C, 

620 Perry Pkwy., Gaithersburg, MD. 

Contact Person: Neel J. Patel, Center 

for Devices and Radiological Health 

(Bldg. 66, rm. 2532), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–5580, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512624. 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 October 28, 2009, the 

committee will discuss, make 

recommendations, and vote on a 

premarket approval application for the 

Alair Bronchial Thermoplasty System 

sponsored by Asthmatx, Inc. The device 

is indicated for the treatment of severe 

persistent asthma in adults. 

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 on the FDA Internet under the 

appropriate date 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 22, 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 15, 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 16, 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 AnnMarie 

Williams, Conference Management 

Staff, 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: September 17, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–22819 Filed 9–21–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Public Health Service Act, Section 

330A(f) 

AGENCY: Health Resources and Services 

Administration (HRSA), HHS. 

ACTION: Notice of Non-competitive 

Replacement Award to White River 

Rural Health Center, Arkansas. 

SUMMARY: HRSA has issued a noncompetitive replacement award under 

the Rural Health Network Development 

Program to White River Rural Health 

Center, Inc. (WRRHC). The original 

grantee, Siloam Springs Memorial 

Hospital, is no longer eligible to serve as 

the lead entity for this network of rural 

health care providers serving a five 

county area in Arkansas and Oklahoma. 

This replacement award will ensure that 

the medically underserved residents of 

western Benton and Washington 

counties in Arkansas and Adair, 

Cherokee, and Delaware counties in 

Oklahoma continue receiving necessary 

medical care and services without 

disruption. 

SUPPLEMENTARY INFORMATION: Intended 

Recipient of the Award: White River 

Rural Health Center, Inc. in Augusta, 

Arkansas. 

Amount of the Fiscal Year 2009 

Award: $179,995. 

Anticipated Amount of Fiscal Year 

2010 Award: $179,995. 

Original Project Period: May 1, 2008, 

through April 30, 2011. 

Project Period for Replacement 

Award: August 1, 2009; end date April 

30, 2011. 

Authority: The Rural Health Network 

Development Program is authorized under 

the Public Health Service Act, section 

330A(f), 42 U.S.C. 254c(f). The authority for 

the exception to competition is HHS Grants 

Policy Directive 2.04, Awarding Grants. 

Catalogue of Federal Domestic 

Assistance Number: 93.912. 

Justification for Transfer of Funds: 

The network of service providers 

funded under the original grant award 

are currently engaged in activities 

designed to increase access to health 

care and improve the quality of life for 

the poverty-stricken residents in the five 

county service area in Arkansas and 

Oklahoma, while further decreasing 

inefficiencies in the health care system, 

reducing inappropriate emergency room 

use, helping businesses keep insurance 

premiums under control, and improving 

the system for managing patients’ longterm health, especially those with 

conditions like diabetes and heart 

disease. The service area under this 

grant award has a limited number of 

health care providers and a combined 

population of over 111,131. Of this 

population, 23,000 (21 percent) lack 

health insurance, and over 18,000 (16.5 

percent) have incomes less than 100 

percent of the poverty rate. It is critical 

that HRSA funding for this network of 

service providers continues with 

minimal disruption of services. 

Siloam Springs Memorial Hospital is 

no longer able to serve as the lead entity 

for this network of rural health care 

providers in Arkansas and Oklahoma, 

nor were the other network participants 

able to assume the lead fiduciary role. 


sroberts on DSKD5P82C1PROD with NOTICES