Federal Register / Vol. 74, No. 159 / Wednesday, August 19, 2009 / Notices 41915 

Bethesda, MD 20892–7985. 301–496–9838. 

lewallla@od.nih.gov. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

oba.od.nih.gov/rdna/rdna.html, where an 

agenda and any additional information for 

the meeting will be posted when available. 

OMB’s ‘‘Mandatory Information 

Requirements for Federal Assistance Program 

Announcements’’ (45 FR 39592, June 11, 

1980) requires a statement concerning the 

official government programs contained in 

the Catalog of Federal Domestic Assistance. 

Normally NIH lists in its announcements the 

number and title of affected individual 

programs for the guidance of the public. 

Because the guidance in this notice covers 

virtually every NIH and Federal research 

program in which DNA recombinant 

molecule techniques could be used, it has 

been determined not to be cost effective or 

in the public interest to attempt to list these 

programs. Such a list would likely require 

several additional pages. In addition, NIH 

could not be certain that every Federal 

program would be included as many Federal 

agencies, as well as private organizations, 

both national and international, have elected 

to follow the NIH Guidelines. In lieu of the 

individual program listing, NIH invites 

readers to direct questions to the information 

address above about whether individual 

programs listed in the Catalog of Federal 

Domestic Assistance are affected. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.14, Intramural Research 

Training Award; 93.22, Clinical Research 

Loan Repayment Program for Individuals 

from Disadvantaged Backgrounds; 93.232, 

Loan Repayment Program for Research 

Generally; 93.39, Academic Research 

Enhancement Award; 93.936, NIH Acquired 

Immunodeficiency Syndrome Research Loan 

Repayment Program; 93.187, Undergraduate 

Scholarship Program for Individuals from 

Disadvantaged Backgrounds, National 

Institutes of Health, HHS) 

Dated: August 11, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–19906 Filed 8–18–09; 8:45 am] 

BILLING CODE 4140–01–P 

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. RFA–OD– 

09–003 Challenge Grants Panel 30. 

Date: July 28, 2009. 

Time: 11 a.m. to 2 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Cathy Wedeen, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3213, 

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

1191. wedeenc@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. RFA–OD– 

09–003 Challenge Grants Panel 31. 

Date: August 3, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: George W. Chacko, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5170, 

MSC 7849, Bethesda, MD 20892. 301–435– 

1245. chackoge@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. RFA–OD– 

09–003 Challenge Grants Panel 32. 

Date: August 7, 2009. 

Time: 2:45 p.m. to 3:15 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Maribeth Champoux, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3170, 

MSC 7848, Bethesda, MD 20892. 301–594– 

3163. champoum@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. RFA–OD– 

09–003 Challenge Grant Panel 33. 

Date: August 11, 2009. 

Time: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

Bethesda, MD 20892 (Telephone Conference 

Call). 

Contact Person: John Firrell, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5213, 

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

2598. firrellj@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. RFA–OD– 

09–003 Challenge Grants Panel 34. 

Date: August 12, 2009. 

Time: 3 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Bob Weller, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3160, 

MSC 7770, Bethesda, MD 20892. (301) 435– 

0694. wellerr@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. RFA–OD– 

09–003 Challenge Grants Panel 35. 

Date: August 13, 2009. 

Time: 3 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Noni Byrnes, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5130, 

MSC 7840, Bethesda, MD 20892. (301) 435– 

1023. byrnesn@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. RFA OD– 

09–003 Challenge Grants Panel 36. 

Date: August 14, 2009. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Carole L. Jelsema, PhD, 

Chief and Scientific Review Officer, Center 

for Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4176, 

MSC 7850, Bethesda, MD 20892. (301) 435– 

1248. jelsemac@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. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 


jlentini on DSKJ8SOYB1PROD with NOTICES
41916 Federal Register / Vol. 74, No. 159 / Wednesday, August 19, 2009 / Notices 

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: August 12, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–19879 Filed 8–18–09; 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 

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 

Allergy and Infectious Diseases Special 

Emphasis Panel, Clinical Trials and Planning 

Grants. 

Date: September 9, 2009. 

Time: 10 a.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge 6700, 6700B Rockledge Drive, 

Bethesda, MD 20817 (Telephone Conference 

Call). 

Contact Person: Brenda Lange-Gustafson, 

PhD, Scientific Review Officer, NIAID/NIH/ 

DHHS, Scientific Review Program, Room 

3122, 6700–B Rockledge Drive, MSC–7616, 

Bethesda, MD 20892–7616, 301–451–3684, 

bgustafson@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: August 12, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–19877 Filed 8–18–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Methodologies for Post-Approval 

Studies of Medical Devices; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public workshop entitled 

‘‘Methodologies for Post-Approval 

Studies of Medical Devices.’’ The 

purpose of the workshop is to facilitate 

discussion among FDA, industry, 

academia, professional societies, 

clinical investigators and other 

interested parties on issues related to 

methodologies for post-approval studies 

of medical devices. The target audiences 

for this workshop are Epidemiologists, 

Statisticians, Clinicians and Regulatory 

Affairs Specialists. 

Dates and Times: The workshop will 

be held on September 9, 2009, from 9 

a.m. to 5 p.m. and September 10, 2009, 

from 9 a.m. to 5 p.m. Participants are 

encouraged to arrive early to ensure 

time for parking and security screening 

before the meeting. Security screening 

will begin at 8 a.m., and registration will 

begin at 8:30 a.m. Please pre-register for 

the workshop by following the 

instructions in this document. 

Location: The workshop will be held 

at the FDA White Oak Campus, 10903 

New Hampshire Ave., Silver Spring, MD 

20993. 

Contact Persons: Daniel Can ̃os, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., WO66/Room 

4120, Silver Spring, MD 20993, 240– 

796–6057, daniel.canos@fda.hhs.gov ; or 

Ellen Pinnow, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., WO66/Room 4106, Silver Spring, 

MD 20993, 301–796–6066, 

ellen.pinnow@fda.hhs.gov 

Registration: To register for the 

conference please visit the following 

Web site: https://medsun2.S-3.net/ 

FDAPASWkshpSep09. There is no fee to 

attend the workshop, but attendees must 

register in advance. The registration 

process will be handled by Social and 

Scientific Systems, which has extensive 

experience in planning, executing, and 

organizing educational meetings. 

Although the facility is spacious, 

registration will be on a first-come, firstserved basis. In-person attendance is 

limited to 120 participants. You may 

also register to attend the meeting via 

webcast. Non-U.S. citizens are subject to 

additional security screening, and they 

should register as soon as possible. If 

you need special accommodations 

because of a disability, please contact 

Daniel Can ̃ os (see Contact Persons) at 

least 7 days before the public workshop. 

SUPPLEMENTARY INFORMATION: 

I. Why Are We Holding This Public 

Workshop? 

The purpose of the public workshop 

is to facilitate discussion among FDA 

and other interested parties on 

methodological issues related to PostApproval Studies for medical devices. 

II. What Are the Topics We Intend To 

Address at the Public Workshop? 

We hope to discuss a large number of 

issues at the workshop, including, but 

not limited to: 

• Regulatory requirements for 

conducting Post-Approval Studies for 

medical devices; 

• Using existing infrastructure (e.g., 

registries) to facilitate Post-Approval 

Studies; 

• Using innovative study design 

strategies and advanced epidemiologic 

methods to enhance and facilitate PostApproval Studies; 

• Review important measurement 

considerations inherent to PostApproval Studies; 

• Clinical research organizations, 

industry, academia, and other clinical 

trial consultant’s perspectives on all of 

the previous issues related to PostApproval Study methodologies for 

medical devices. 

III. Where Can I Find Out More About 

This Public Workshop? 

Background information on the public 

workshop, registration information, the 

agenda, information about lodging, and 

other relevant information will be 

posted, as it becomes available, on the 

Internet at http://www.fda.gov/cdrh/ 

meetings.html. 

Dated: August 12, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. 09–19904 Filed 8–18–09; 8:45 am] 

BILLING CODE 4160–01–S 


jlentini on DSKJ8SOYB1PROD with NOTICES