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
Federal Register / Vol. 74, No. 182 / Tuesday, September 22, 2009 / Notices 48275 

WRRHC is a successful community 

health center that provides services to 

10 counties within Arkansas and has 

over 22 years of experience in managing 

State and federally funded programs, 

including three previous Rural Health 

Services Outreach grants. The 

comprehensive services that WRRHC 

provides and their ability to expand 

their service area will enable WRRHC to 

maintain the current scope of service 

and activities as originally awarded 

under the grant to Siloam Springs 

Memorial Hospital. This replacement 

award will help ensure the continued 

improvement of health care systems in 

the targeted service area. WRRHC has a 

demonstrated record of sound 

stewardship of Federal funds and can 

effectively serve as the network lead for 

the remainder period of support in a 

manner which minimizes any 

disruption of services provided by the 

network. Consequently, White River 

Rural Health Center has been designated 

the replacement award recipient. 

HRSA is unaware of any other entity 

that both meets the statutory eligibility 

requirements and has the ability to carry 

out these activities. 

FOR FURTHER INFORMATION CONTACT: Tom 

Morris, Associate Administrator, Office 

of Rural Health Policy, Health Resources 

and Services Administration, 5600 

Fishers Lane, Rockville, MD 20857; 

phone 301–443–0835; 

tmorris@hrsa.hhs.gov. 

Dated: September 16, 2009. 

Mary K. Wakefield, 

Administrator. 

[FR Doc. E9–22815 Filed 9–21–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of Biotechnology Activities; 

Recombinant DNA Research: Actions 

Under the NIH Guidelines for Research 

Involving Recombinant DNA Molecules 

(NIH Guidelines) 

AGENCY: National Institutes of Health 

(NIH), Department of Health and Human 

Services (HHS). 

ACTION: Notice of changes to the NIH 

Guidelines. 

SUMMARY: Concerns about the 

emergence of a pandemic influenza 

virus have spurred research on 

influenza viruses that have either 

caused pandemics or are believed to 

have the potential to cause a pandemic. 

These viruses include human H2N2 

virus, which circulated from 1957–1968, 

the 1918–1919 H1N1, which caused the 

deadliest pandemic in the past century, 

and the Highly Pathogenic Avian 

Influenza (HPAI) H5N1 virus that is 

thought to have pandemic potential. 

The public health benefits of this 

research include developing a better 

understanding of the pathogenicity of 

pandemic influenza viruses, their 

virulence mechanisms, mechanisms of 

host adaptation, and ultimately the 

development of vaccines and antiviral 

drugs. These benefits are balanced 

against the potential risks that might 

include the inadvertent release of a 

highly transmissible and potentially 

virulent influenza virus. Consequently, 

explicit and uniform biosafety 

containment practices are critical to the 

safe conduct of research with these 

agents. The NIH Guidelines provide a 

framework for assessing the risks of 

such research. However, after extensive 

consultation with the NIH Recombinant 

DNA Advisory Committee (RAC), 

experts in biosafety and influenza, the 

Centers for Disease Control and 

Prevention (CDC), and the U.S. 

Department of Agriculture (USDA), the 

NIH Office of Biotechnology Activities 

(OBA) concluded that more specific 

guidance in the NIH Guidelines is 

warranted to promote uniform biosafety 

practices for recombinant research with 

these viruses. 

The resulting amendments are ‘‘Minor 

Actions’’ under Section IV–C–1–(b)–2 of 

the NIH Guidelines and, therefore, will 

be implemented immediately upon 

publication in the Federal Register. 

While a Minor Action only requires 

consultation with the RAC chair and 

one or more RAC members, as 

necessary, as noted above, these changes 

were developed after extensive 

consultation with the full RAC and 

other experts and were discussed at 

three public RAC meetings. The RAC 

voted on March 4, 2009 to recommend 

these changes. They are being published 

to inform the scientific and biosafety 

communities, as well as to solicit 

continued scientific input should 

further revisions be needed. 

The NIH Guidelines are being 

changed to provide the following 

biosafety guidance for research with 

potentially pandemic influenza viruses: 

• Designation of human H2N2 viruses 

that circulated from 1957–1968 (human 

H2N2 (1957–1968)), the fully 

reconstructed 1918–1919 H1N1 

influenza virus (1918 H1N1), and 

Highly Pathogenic Avian Influenza 

(HPAI) H5N1 within the Goose/ 

Guangdong/96-like H5 lineage (HPAI 

H5N1) as Risk Group 3 agents. Risk 

Group 3 agents have the potential to 

cause serious or lethal disease in 

humans for which preventative and 

therapeutic measures may be available. 

Up until this revision, all influenza 

viruses (Orthomyxoviruses) were Risk 

Group 2 agents, which are agents that 

are associated with human disease that 

is rarely serious and for which 

preventative and therapeutic agents are 

often available. 

• Requirement for enhanced biosafety 

practices, including the use of powered 

air purifying respirators (PAPRs) and 

other personal protective equipment to 

prevent laboratory worker exposure and 

minimize the risk of spread outside of 

the laboratory. 

• Guidance on the containment for 

research with influenza viruses 

generated by recombinant methods (e.g., 

generation by reverse genetics of 

chimeric viruses with reassorted 

segments, introduction of specific 

mutations) containing one or more 

genes and/or segments from human 

H2N2 (1957–1968), 1918 H1N1 or HPAI 

H5N1. For 1918 H1N1, the NIH 

Guidelines will require Biosafety Level 

3 enhanced containment for all 

influenza viruses that contain one of 

more genes and/or segments from 1918 

H1N1 because of the uncertainty about 

the virulence factors for this agent. 

• Guidance on occupational health 

practices, including policies regarding 

the use of prophylactic antiviral agents 

and isolation of laboratory workers who 

are exposed to one of these viruses. 

DATES: The public is encouraged to 

submit written comments on this action. 

Comments may be submitted to OBA in 

paper or electronic form at the OBA 

mailing, fax, and e-mail addresses 

shown below under the heading FOR

FURTHER INFORMATION CONTACT. All 

comments should be submitted by 

September 22, 2010. All written 

comments received in response to this 

notice will be available for public 

inspection in the NIH OBA office, 6705 

Rockledge Drive, Suite 750, MSC 7985, 

Bethesda, MD 20892–7985, weekdays 

between the hours of 8:30 a.m. and 5 

p.m. and may be posted to OBA’s Web 

site. 

FOR FURTHER INFORMATION: If you have 

questions, or require additional 

information about these changes, please 

contact OBA by e-mail at 

oba@od.nih.gov, or telephone at 301– 

496–9838. Comments may be submitted 

to the same e-mail address or by fax at 

301–496–9839 or by mail to the Office 

of Biotechnology Activities, National 

Institutes of Health, 6705 Rockledge 

Drive, Suite 750, MSC 7985, Bethesda, 

Maryland 20892–7985. Background 

information may be obtained by 


sroberts on DSKD5P82C1PROD with NOTICES