Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Notices 31743 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Developmental Pharmacology. 

Date: August 4–5, 2009. 

Time: 9 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: Janet M. Larkin, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1102, 

MSC 7840, Bethesda, MD 20892, 310–435– 

1026, larkinja@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: June 26, 2009. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–15687 Filed 7–1–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Circulatory System 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). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Circulatory 

System Devices Panel 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 July 22 and 23, 2009, from 8 

a.m. to 6 p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, Salons A, B and C, 

620 Perry Pkwy., Gaithersburg, MD. 

Contact Person: James Swink, Center 

for Devices and Radiological Health 

(HFZ–450), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 240–276–4050, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512625. 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 July 22, 2009, the 

committee will discuss, make 

recommendations, and vote on a 

Humanitarian Device Exemption (HDE) 

application, sponsored by Medtronic, 

Inc., for the MEDTRONIC MELODY 

Transcatheter Pulmonary Valve (Model 

PB10) and MEDTRONIC ENSEMBLE 

Transcatheter Valve Delivery System 

(NU10). The MEDTRONIC MELODY 

Transcatheter Pulmonary Valve (Model 

PB10) and MEDTRONIC ENSEMBLE 

Transcatheter Valve Delivery System 

(NU10) is indicated for use in patients 

with the following clinical conditions: 

Regurgitant (insufficient or leaky) 

Right Ventricular Outflow Tract 

(RVOT)—The right ventricular 

outflow tract is that portion of the 

right ventricle leading up to the 

pulmonary valve and pulmonary 

artery. When the ventricles 

contract, blood moves along the 

outflow tract and through the 

pulmonary valve; blood then flows 

to the lungs where gas exchange 

takes place. 

Conduits—In the context of this 

device, a surgically implanted tube 

that allows blood to pass from the 

heart to the pulmonary arteries. 

• Stenotic (stiff valve leaflets that 

cannot open or close properly) 

RVOT conduits where the risk of 

worsening regurgitation is a relative 

contraindication to balloon 

dilatation or stenting. 

• Existence of a full 

(circumferential) RVOT conduit 

that was equal to or greater than 16 

millimeters (mm) in diameter when 

originally implanted. 

On July 23, 2009, from 8 a.m. to 10 

a.m., and from 1 p.m. to 6 p.m., the 

committee will discuss general 

questions about adhesion barriers for 

cardiovascular use. Some of these 

questions will focus on understanding 

the target population (pediatric and/or 

adult) that would benefit from these 

devices and the development of 

appropriate endpoints for a clinical 

trial. 

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, click on the year 2009, 

scroll down to the appropriate advisory 

committee link. 

Procedure: On July 22, 2009, from 8 

a.m. to 6 p.m., and on July 23, 2009, 

from 8 a.m. to 10 a.m. and from 1 p.m. 

to 6 p.m., the meeting is open to the 

public. 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 

July 15, 2009. Oral presentations from 

the public will be scheduled 

approximately 30 minutes at the 

beginning of committee deliberations 

and approximately 30 minutes near the 

end of the deliberations. 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 July 7, 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 July 8, 2009. 

Closed Presentation of Data: On July 

23, 2009, from 10 a.m. to 12 noon, the 

meeting will be closed to permit 

discussion and review of trade secret 

and confidential commercial 

information (5 U.S.C. 552b(c)(4)) related 

to the design of a potential clinical trial. 

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 240–276–8932, at least 7 days 

in advance of the meeting.FDA is 

committed to the orderly conduct of its 

advisory committee meetings. Please 

31744 Federal Register / Vol. 74, No. 126 / Thursday, July 2, 2009 / Notices 

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: June 26, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–15680 Filed 7–1–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; Amended Notice of 

Meeting 

Notice is hereby given of a change in 

the meeting of the National Institute of 

Child Health and Human Development 

Special Emphasis Panel, July 14, 2009, 

1 p.m. to July 14, 2009, 4:30 p.m., 

National Institutes of Health, 6100 

Executive Boulevard, Rockville, MD 

20852 which was published in the 

Federal Register on July 22, 2009, 74 FR 

29499. 

The meeting date has been changed to 

July 23, 2009, 1 p.m. to July 23, 2009, 

4:30 p.m. The meeting is closed to the 

public. 

Dated: June 26, 2009. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–15672 Filed 7–1–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; 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: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Recovery Act Limited 

Competition for NIH Grants: Research and 

Research Infrastructure ‘‘Grand 

Opportunities’’ (RC2)–2. 

Date: July 30, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817 

(Telephone Conference Call). 

Contact Person: B. Duane Price, PhD, 

Scientific Review Officer, Scientific Review 

Program, DHHS/NIH/NIAID/DEA, Room 

3139, 6700B Rockledge Drive, MSC 7616, 

Bethesda, MD 20892–7616, 301–496–2550, 

pricebd@niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Recovery Act Limited 

Competition for NIH Grants: Research and 

Research Infrastructure ‘‘Grand 

Opportunities’’ (RC2)–1. 

Date: July 31, 2009. 

Time: 12 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6700B 

Rockledge Drive, Bethesda, MD 20817 

(Telephone Conference Call). 

Contact Person: B. Duane Price, PhD, 

Scientific Review Officer, Scientific Review 

Program, DHHS/NIH/NIAID/DEA, Room 

3139, 6700B Rockledge Drive, MSC 7616, 

Bethesda, MD 20892–7616, 301–496–2550, 

pricebd@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: June 26, 2009. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–15671 Filed 7–1–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–3305– 

EM; Docket ID FEMA–2008–0018] 

Oklahoma; Amendment No. 1 to Notice 

of an Emergency Declaration 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This notice amends the notice 

of an emergency declaration for the 

State of Oklahoma (FEMA–3305–EM), 

dated June 23, 2009, and related 

determinations. 

DATES: Effective Date: June 23, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Miller, Disaster Assistance 

Directorate, Federal Emergency 

Management Agency, 500 C Street, SW., 

Washington, DC 20472, (202) 646–3886. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) hereby gives notice that 

pursuant to the authority vested in the 

Administrator, under Executive Order 

12148, as amended, Kenneth R. 

Tingman, of FEMA is appointed to act 

as the Federal Coordinating Officer for 

this emergency. 

This action terminates the 

appointment of Douglas G. Mayne as 

Federal Coordinating Officer for this 

emergency. 

The following Catalog of Federal Domestic 

Assistance Numbers (CFDA) are to be used 

for reporting and drawing funds: 97.030, 

Community Disaster Loans; 97.031, Cora 

Brown Fund; 97.032, Crisis Counseling; 

97.033, Disaster Legal Services; 97.034, 

Disaster Unemployment Assistance (DUA); 

97.046, Fire Management Assistance Grant; 

97.048, Disaster Housing Assistance to 

Individuals and Households In Presidentially 

Declared Disaster Areas; 97.049, 

Presidentially Declared Disaster Assistance— 

Disaster Housing Operations for Individuals 

and Households; 97.050, Presidentially 

Declared Disaster Assistance to Individuals 

and Households—Other Needs; 97.036, 

Disaster Grants—Public Assistance 

(Presidentially Declared Disasters); 97.039, 

Hazard Mitigation Grant. 

W. Craig Fugate, 

Administrator, Federal Emergency 

Management Agency. 

[FR Doc. E9–15675 Filed 7–1–09; 8:45 am] 

BILLING CODE 9111–23–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–1841– 

DR; Docket ID FEMA–2008–0018] 

Kentucky; Amendment No. 2 to Notice 

of a Major Disaster Declaration 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This notice amends the notice 

of a major disaster declaration for the 

Commonwealth of Kentucky (FEMA– 

1841–DR), dated May 29, 2009, and 

related determinations.