Center for Scientific Review; Notice of Closed Meetings, 69666-69667 [E8-27257]
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Federal Register / Vol. 73, No. 224 / Wednesday, November 19, 2008 / Notices
Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send one selfaddressed adhesive label to assist that
office in processing your request, or fax
your request to 240–276–3151. See the
SUPPLEMENTARY INFORMATION
section for information on electronic
access to the documents.
Submit written comments concerning
these documents to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Ginette Y. Michaud, Center for Devices
and Radiological Health (HFZ–480),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,
240–276–3700.
SUPPLEMENTARY INFORMATION:
cprice-sewell on PROD1PC64 with NOTICES
I. Background
FDA has participated in a number of
activities to promote the international
harmonization of regulatory
requirements. In September 1992, a
meeting was held in Nice, France by
senior regulatory officials to evaluate
international harmonization. This
meeting led to the development of the
organization now known as GHTF to
facilitate harmonization. Subsequent
meetings have been held in various
locations throughout the world.
The GHTF is a voluntary group of
representatives from national medical
device regulatory authorities and the
regulated industry. Since its inception,
the GHTF has been comprised of
representatives from five founding
members grouped into three
geographical areas: Europe, Asia-Pacific,
and North America, each of which
actively regulates medical devices using
its own unique regulatory framework.
The objective of the GHTF is to
encourage convergence at the global
level of regulatory systems of medical
devices to facilitate trade while
preserving the right of participating
members to address the protection of
public health by regulatory means
considered most suitable. One of the
ways this objective is achieved is by
identifying and developing areas of
international cooperation to facilitate
progressive reduction of technical and
regulatory differences in systems
established to regulate medical devices.
In an effort to accomplish these
objectives, the GHTF formed five study
groups to draft documents and carry on
other activities designed to facilitate
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global harmonization. This notice
relates to documents that have been
developed by one of the Study Groups
(Study Group 1).
Study Group 1 was initially tasked
with the responsibility of identifying
differences between various regulatory
systems. In 1995, the group was asked
to propose areas of potential
harmonization for premarket device
regulations and possible guidelines that
could help lead to harmonization. As a
result of its efforts, this group has
developed SG1(PD)/N055R6:2008 and
SG1/N045:2008.
The proposed document SG1(PD)/
N055R6:2008 entitled ‘‘Definitions of
the Terms Manufacturer, Authorised
Representative, Distributor and
Importer’’ provides a harmonized
definition of the terms ‘‘manufacturer,’’
‘‘authorised representative,’’
‘‘distributor,’’ and ‘‘importer’’.
The final document SG1/N045:2008
entitled ‘‘Principles of In Vitro
Diagnostic (IVD) Medical Devices
Classification’’ assists a manufacturer in
allocating an IVD medical device to the
appropriate risk class by using a set of
harmonized classification principles. It
bases such classification principles on
an IVD medical device’s intended use
and allows regulatory authorities to rule
upon matters of interpretation for a
particular IVD medical device, when
appropriate.
II. Significance of Guidance
These documents represent
recommendations from the GHTF study
group and do not describe regulatory
requirements. FDA is making these
documents available so that industry
and other members of the public may
express their views and opinions. In
particular, FDA seeks comments on the
advantages and disadvantages of the
approaches in the GHTF documents,
particularly where they are not
consistent with current practices for the
manufacture of products in the United
States.
III. Electronic Access
Persons interested in obtaining a copy
of these documents may do so by using
the Internet. The Center for Devices and
Radiological Health (CDRH) maintains
an entry on the Internet for easy access
to information including text, graphics,
and files that may be downloaded to a
personal computer with Internet access.
Updated on a regular basis, the CDRH
home page includes device safety alerts,
Federal Register reprints, information
on premarket submissions (including
lists of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
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on video conferencing and electronic
submissions, Mammography Matters,
and other device-oriented information.
Information on the GHTF may be
accessed at https://www.ghtf.org. The
CDRH Web site may be accessed at
https://www.fda.gov/cdrh.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), written or electronic
comments regarding these documents.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: October 22, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological
Health.
[FR Doc. E8–27466 Filed 11–18–08; 8:45 am]
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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. Appendix 2), 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.
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Federal Register / Vol. 73, No. 224 / Wednesday, November 19, 2008 / Notices
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Biomaterials
and Tissue Engineering.
Date: December 8–9, 2008.
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: Alexander Gubin, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm. 5144,
MSC 7812, Bethesda, MD 20892, 301–435–
2902, gubina@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, Exploratory
Research Centers of Excellence for Minority,
Health and Health Disparities (P20).
Date: December 9–11, 2008.
Time: 7 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda, 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Ann A. Jerkins, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6154,
MSC 7892, Bethesda, MD 20892, 301–435–
4514, jerkinsa@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, Exploratory
Research Centers of Excellence for Minority
Health and Health Disparities (P20).
Date: December 9–11, 2008.
Time: 7 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Bethesda, 8120
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Stuart B. Moss, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6170,
MSC 7892, Bethesda, MD 20892, 301–435–
1044, mossstua@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, Roadmap
RAID.
Date: January 14–15, 2009.
Time: 8 a.m to 8 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: James J. Li, PhD, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5148, MSC 7849, Bethesda, MD
20892, 301–435–2417, lijames@csr.nih.gov.
Name of Committee: Immunology
Integrated Review Group, Transplantation,
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Tolerance, and Tumor Immunology Study
Section.
Date: January 23–24, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Monterey, 1 Old Golf
Course Road, Monterey, CA 93940.
Contact Person: Cathleen L. Cooper, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4208,
MSC 7812, Bethesda, MD 20892, 301–435–
3566, cooperc@csr.nih.gov.
Name of Committee: Biological Chemistry
and Macromolecular Biophysics, Integrated
Review Group Enabling Bioanalytical and
Biophysical Technologies Study Section.
Date: January 29–30, 2009.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Plaza Hotel, 10 Thomas
Circle, NW., Washington, DC 20005.
Contact Person: Vonda K. Smith, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4148,
MSC 7806, Bethesda, MD 20892, 301–435–
1789, smithvo@csr.nih.gov.
Name of Committee: Cell Biology
Integrated Review Group, Molecular and
Integrative Signal Transduction Study
Section.
Date: January 29–30, 2009.
Time: 8 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sheraton Deflina Santa Monica
Hotel, 530 Pico Boulevard, Santa Monica, CA
90405.
Contact Person: Raya Mandler, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5134,
MSC 7840, Bethesda, MD 20892, (301) 402–
8228, rayam@csr.nih.gov.
Name of Committee: Oncological Sciences
Integrated Review Group, Developmental
Therapeutics Study Section.
Date: January 29–30, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Old Town, 1767 King Street,
Alexandria, VA 22314.
Contact Person: Sharon K. Gubanich, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
MSC 7804, Bethesda, MD 20892, (301) 435–
1767, gubanics@csr.nih.gov.
Name of Committee: Biological Chemistry
and Macromolecular Biophysics, Integrated
Review Group Macromolecular Structure and
Function A Study Section.
Date: January 30, 2009.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sheraton Delfina Santa Monica
Hotel, 530 Pico Boulevard, Santa Monica, CA
90405.
Contact Person: David R. Jollie, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
PO 00000
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69667
Health, 6701 Rockledge Drive, Room 4150,
MSC 7806, Bethesda, MD 20892, (301) 435–
1722, jollieda@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: November 10, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–27257 Filed 11–18–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), 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
Environmental Health Sciences Special
Emphasis Panel, Worker Education and
Hazardous Material Training.
Date: December 3, 2008.
Time: 1 pm to 5 pm.
Agenda: To review and evaluate grant
applications.
Place: NIEHS/National Institutes of Health,
Building 4401, East Campus, 79 T.W.
Alexander Drive, Research Triangle Park, NC
27709 (Telephone Conference Call).
Contact Person: Sally Eckert-Tilotta, PhD,
Scientific Review Administrator, National
Inst. of Environmental Health Sciences,
Office of Program Operations, Scientific
Review Branch, P.O. Box 12233, Research
Triangle Park, NC 27709, (919) 541–1446,
eckertt1@niehs.nih.gov.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel, Beryllium: Exposure,
Immune and Genetic Mechanisms.
Date: December 9, 2008.
Time: 1 pm to 4 pm.
Agenda: To review and evaluate grant
applications.
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]]>Agencies
[Federal Register Volume 73, Number 224 (Wednesday, November 19, 2008)]
[Notices]
[Pages 69666-69667]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27257]
-----------------------------------------------------------------------
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. Appendix 2), 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.
[[Page 69667]]
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Biomaterials and Tissue Engineering.
Date: December 8-9, 2008.
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: Alexander Gubin, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Rm. 5144, MSC 7812, Bethesda, MD 20892, 301-435-
2902, gubina@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, Exploratory Research Centers of Excellence for Minority,
Health and Health Disparities (P20).
Date: December 9-11, 2008.
Time: 7 p.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Doubletree Hotel Bethesda, 8120 Wisconsin Avenue,
Bethesda, MD 20814.
Contact Person: Ann A. Jerkins, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6154, MSC 7892, Bethesda, MD 20892, 301-435-
4514, jerkinsa@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, Exploratory Research Centers of Excellence for Minority
Health and Health Disparities (P20).
Date: December 9-11, 2008.
Time: 7 p.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Doubletree Hotel Bethesda, 8120 Wisconsin Avenue,
Bethesda, MD 20814.
Contact Person: Stuart B. Moss, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6170, MSC 7892, Bethesda, MD 20892, 301-435-
1044, mossstua@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, Roadmap RAID.
Date: January 14-15, 2009.
Time: 8 a.m to 8 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: James J. Li, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5148, MSC 7849, Bethesda, MD 20892, 301-435-
2417, lijames@csr.nih.gov.
Name of Committee: Immunology Integrated Review Group,
Transplantation, Tolerance, and Tumor Immunology Study Section.
Date: January 23-24, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Monterey, 1 Old Golf Course Road, Monterey,
CA 93940.
Contact Person: Cathleen L. Cooper, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4208, MSC 7812, Bethesda, MD
20892, 301-435-3566, cooperc@csr.nih.gov.
Name of Committee: Biological Chemistry and Macromolecular
Biophysics, Integrated Review Group Enabling Bioanalytical and
Biophysical Technologies Study Section.
Date: January 29-30, 2009.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant applications.
Place: Washington Plaza Hotel, 10 Thomas Circle, NW.,
Washington, DC 20005.
Contact Person: Vonda K. Smith, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4148, MSC 7806, Bethesda, MD 20892, 301-435-
1789, smithvo@csr.nih.gov.
Name of Committee: Cell Biology Integrated Review Group,
Molecular and Integrative Signal Transduction Study Section.
Date: January 29-30, 2009.
Time: 8 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Sheraton Deflina Santa Monica Hotel, 530 Pico Boulevard,
Santa Monica, CA 90405.
Contact Person: Raya Mandler, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5134, MSC 7840, Bethesda, MD 20892, (301) 402-
8228, rayam@csr.nih.gov.
Name of Committee: Oncological Sciences Integrated Review Group,
Developmental Therapeutics Study Section.
Date: January 29-30, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Old Town, 1767 King Street, Alexandria, VA 22314.
Contact Person: Sharon K. Gubanich, PhD, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214, MSC 7804, Bethesda, MD
20892, (301) 435-1767, gubanics@csr.nih.gov.
Name of Committee: Biological Chemistry and Macromolecular
Biophysics, Integrated Review Group Macromolecular Structure and
Function A Study Section.
Date: January 30, 2009.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant applications.
Place: Sheraton Delfina Santa Monica Hotel, 530 Pico Boulevard,
Santa Monica, CA 90405.
Contact Person: David R. Jollie, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4150, MSC 7806, Bethesda, MD 20892, (301) 435-
1722, jollieda@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: November 10, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E8-27257 Filed 11-18-08; 8:45 am]
BILLING CODE 4140-01-P
