[Federal Register Volume 73, Number 220 (Thursday, November 13, 2008)]
[Notices]
[Pages 67188-67189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26963]
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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.
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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, [email protected].
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]
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