Center for Scientific Review; Notice of Closed Meetings, 41915-41916 [E9-19879]

Download as PDF Federal Register / Vol. 74, No. 159 / Wednesday, August 19, 2009 / Notices Bethesda, MD 20892–7985. 301–496–9838. lewallla@od.nih.gov. Information is also available on the Institute’s/Center’s home page: https:// 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 jlentini on DSKJ8SOYB1PROD with NOTICES 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 VerDate Nov<24>2008 16:53 Aug 18, 2009 Jkt 217001 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. PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 41915 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; E:\FR\FM\19AUN1.SGM 19AUN1 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) DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: August 12, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–19879 Filed 8–18–09; 8:45 am] [Docket No. FDA–2009–N–0664] Food and Drug Administration Methodologies for Post-Approval Studies of Medical Devices; Public Workshop AGENCY: BILLING CODE 4140–01–P Food and Drug Administration, HHS. ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting jlentini on DSKJ8SOYB1PROD with NOTICES 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 VerDate Nov<24>2008 16:53 Aug 18, 2009 Jkt 217001 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 Canos, 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 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 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 Canos (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 https://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 E:\FR\FM\19AUN1.SGM 19AUN1

Agencies

[Federal Register Volume 74, Number 159 (Wednesday, August 19, 2009)]
[Notices]
[Pages 41915-41916]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19879]


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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;

[[Page 41916]]

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

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