Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representative on Public Advisory Committees and Request for Nominations for Nonvoting Industry Representative on Public Advisory Committees, 67188-67189 [E8-26963]
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Federal Register / Vol. 73, No. 220 / Thursday, November 13, 2008 / Notices
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 https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and 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 November 26, 2008.
Oral presentations from the public will
be scheduled for approximately 30
minutes at the beginning of the
committee deliberations and for
approximately 30 minutes near the end
of committee 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
November 20, 2008. 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 November 24, 2008.
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 visit our Web site at
https://www.fda.gov/oc/advisory/
default.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).
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17:13 Nov 12, 2008
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Dated: November 5, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–26965 Filed 11–12–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0581]
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry Representative
on Public Advisory Committees and
Request for Nominations for
Nonvoting Industry Representative on
Public Advisory Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of
nonvoting industry representatives to
serve on its public advisory committees
for the Center for Biologics Evaluation
and Research (CBER) notify FDA in
writing. FDA is also requesting
nominations for nonvoting industry
representatives to serve on CBER’s
public advisory committees. A nominee
may either be self-nominated or
nominated by an organization to serve
as a nonvoting industry representative.
Nominations will be accepted for
upcoming vacancies effective with this
notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating the interest to
FDA by December 15, 2008, for
vacancies listed in the notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by December 15, 2008.
ADDRESSES: All letters of interest and
nominations should be submitted in
writing to Gail Dapolito (see FOR
FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Gail
Dapolito, Division of Scientific Advisors
and Consultants, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20892,
301–827–1289,
gail.dapolito@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
agency requests nominations for
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nonvoting industry representatives to
the following advisory committees.
I. CBER Advisory Committees
A. The Cellular, Tissue and Gene
Therapies Advisory Committee
The Committee reviews and evaluates
available data relating to the safety,
effectiveness, and appropriate use of
human cells, human tissues, gene
transfer therapies and
xenotransplantation products which are
intended for transplantation,
implantation, infusion and transfer in
the prevention and treatment of a broad
spectrum of human diseases and in the
reconstruction, repair or replacement of
tissues for various conditions. The
Committee also considers the quality
and relevance of FDA’s research
program which provides scientific
support for the regulation of these
products, and makes appropriate
recommendations to the Commissioner
of Food and Drugs (the Commissioner).
B. Vaccines and Related Biological
Products Advisory Committee
The Committee reviews and evaluates
data concerning the safety,
effectiveness, and appropriate use of
vaccines and related biological products
which are intended for use in the
prevention, treatment, or diagnosis of
human diseases, and, as required, any
other product for which FDA has
regulatory responsibility. The
Committee as considers the quality and
relevance of FDA’s research program
which provides scientific support for
the regulation of these products and
makes appropriate recommendations to
the Commissioner.
C. Transmissible Spongiform
Encephalopathies Advisory Committee
The Committee reviews and evaluates
available scientific data concerning the
safety of products which may be at risk
for transmission of spongiform
encephalopathies having an impact on
the public health as determined by the
Commissioner. The Committee will
make recommendations to the
Commissioner regarding the regulation
of such products.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
E:\FR\FM\13NON1.SGM
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Federal Register / Vol. 73, No. 220 / Thursday, November 13, 2008 / Notices
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for a particular committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
III. Application Procedure
Individuals may self nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. A current
curriculum vitae and the name of the
committee of interest should be sent to
the FDA contact person (see FOR
FURTHER INFORMATION CONTACT) within
the 30 days (see DATES). FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the committee. (Persons who nominate
themselves as nonvoting industry
representatives will not participate in
the selection process.)
FDA has a special interest in ensuring
that women, minority groups,
individuals with physical disabilities,
and small businesses are adequately
represented on its advisory committees,
and therefore, encourages nominations
for appropriately qualified candidates
from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: November 5, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–26963 Filed 11–12–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
mstockstill on PROD1PC66 with NOTICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meeting
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
meeting.
VerDate Aug<31>2005
17:13 Nov 12, 2008
Jkt 217001
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel Peptide Facility
Review.
Date: December 8, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Sathasiva B. Kandasamy,
Ph.D., Scientific Review Administrator,
Division of Scientific Review, National
Institute of Child Health, and Human
Development, 6100 Executive Boulevard,
Room 5B01, Bethesda, MD 20892–9304, (301)
435–6680, skandasa@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: November 5, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–26881 Filed 11–12–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Dental and
Craniofacial Research; Notice of
Closed Meeting
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
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
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67189
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; Review T32 Applications,
PAR–07–332.
Date: February 12, 2009.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Mary Kelly, Scientific
Review Officer, Scientific Review Branch,
National Inst of Dental & Craniofacial
Research, NIH, 6701 Democracy Blvd, room
672, MSC 4878, Bethesda, MD 20892–4878,
301–594–4809, mary_kelly@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
Dated: November 6, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–27001 Filed 11–12–08; 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. Appendix 2), 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, Integrated Pre-Clinical/
Clinical Program For HIV Topical
Microbicides.
Date: December 8–9, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crowne Plaza—Silver Spring, 8777
Georgia Avenue, Silver Spring, MD 20910.
Contact Person: Betty Poon, Ph.D.,
Scientific Review Officer, Scientific Review
E:\FR\FM\13NON1.SGM
13NON1
]]>Agencies
[Federal Register Volume 73, Number 220 (Thursday, November 13, 2008)]
[Notices]
[Pages 67188-67189]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26963]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0581]
Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for Nonvoting Industry
Representative on Public Advisory Committees and Request for
Nominations for Nonvoting Industry Representative on Public Advisory
Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
nonvoting industry representatives to serve on its public advisory
committees for the Center for Biologics Evaluation and Research (CBER)
notify FDA in writing. FDA is also requesting nominations for nonvoting
industry representatives to serve on CBER's public advisory committees.
A nominee may either be self-nominated or nominated by an organization
to serve as a nonvoting industry representative. Nominations will be
accepted for upcoming vacancies effective with this notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating the interest to FDA by December
15, 2008, for vacancies listed in the notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA by December
15, 2008.
ADDRESSES: All letters of interest and nominations should be submitted
in writing to Gail Dapolito (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Gail Dapolito, Division of Scientific
Advisors and Consultants, Center for Biologics Evaluation and Research
(HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville,
MD 20892, 301-827-1289, gail.dapolito@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The agency requests nominations for
nonvoting industry representatives to the following advisory
committees.
I. CBER Advisory Committees
A. The Cellular, Tissue and Gene Therapies Advisory Committee
The Committee reviews and evaluates available data relating to the
safety, effectiveness, and appropriate use of human cells, human
tissues, gene transfer therapies and xenotransplantation products which
are intended for transplantation, implantation, infusion and transfer
in the prevention and treatment of a broad spectrum of human diseases
and in the reconstruction, repair or replacement of tissues for various
conditions. The Committee also considers the quality and relevance of
FDA's research program which provides scientific support for the
regulation of these products, and makes appropriate recommendations to
the Commissioner of Food and Drugs (the Commissioner).
B. Vaccines and Related Biological Products Advisory Committee
The Committee reviews and evaluates data concerning the safety,
effectiveness, and appropriate use of vaccines and related biological
products which are intended for use in the prevention, treatment, or
diagnosis of human diseases, and, as required, any other product for
which FDA has regulatory responsibility. The Committee as considers the
quality and relevance of FDA's research program which provides
scientific support for the regulation of these products and makes
appropriate recommendations to the Commissioner.
C. Transmissible Spongiform Encephalopathies Advisory Committee
The Committee reviews and evaluates available scientific data
concerning the safety of products which may be at risk for transmission
of spongiform encephalopathies having an impact on the public health as
determined by the Commissioner. The Committee will make recommendations
to the Commissioner regarding the regulation of such products.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a
[[Page 67189]]
complete list of all such organizations; and a list of all nominees
along with their current resumes. The letter will also state that it is
the responsibility of the interested organizations to confer with one
another and to select a candidate, within 60 days after the receipt of
the FDA letter, to serve as the nonvoting member to represent industry
interests for a particular committee. The interested organizations are
not bound by the list of nominees in selecting a candidate. However, if
no individual is selected within 60 days, the Commissioner will select
the nonvoting member to represent industry interests.
III. Application Procedure
Individuals may self nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. A current curriculum vitae and the name of the
committee of interest should be sent to the FDA contact person (see FOR
FURTHER INFORMATION CONTACT) within the 30 days (see DATES). FDA will
forward all nominations to the organizations expressing interest in
participating in the selection process for the committee. (Persons who
nominate themselves as nonvoting industry representatives will not
participate in the selection process.)
FDA has a special interest in ensuring that women, minority groups,
individuals with physical disabilities, and small businesses are
adequately represented on its advisory committees, and therefore,
encourages nominations for appropriately qualified candidates from
these groups.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: November 5, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-26963 Filed 11-12-08; 8:45 am]
BILLING CODE 4160-01-S
