[Federal Register Volume 77, Number 194 (Friday, October 5, 2012)]
[Notices]
[Pages 61004-61006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-24554]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Request for Nominations for Voting Members 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
nominations for voting members to serve on the Allergenic Products
Advisory Committee, Blood Products Advisory Committee, Cellular, Tissue
and Gene Therapies Advisory Committee, and Transmissible Spongiform and
Encephalopathies Advisory Committee, Center for Biologics Evaluation
and Research. Nominations will be accepted for vacancies that will or
may occur through December 31, 2013.
FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore encourages nominations of
appropriately qualified candidates from these groups.
DATES: Because scheduled vacancies occur on various dates throughout
each year, no cutoff date is established for the receipt of
nominations. However, when possible, nominations should be received at
least 6 months before the date of scheduled vacancies for each year, as
indicated in this notice.
ADDRESSES: All nominations for membership should be sent electronically
to [email protected], or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, rm. 5103, Silver
Spring, MD 20993-0002. Information about becoming a member on a FDA
advisory committee can also be obtained by visiting FDA's Web site at
http://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: For specific Committee questions,
contact the following persons listed in Table 1 of this document:
Table 1
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Contact person Committee
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Donald Jehn, Center for Biologics Evaluation Allergenic Products
and Research, Food and Drug Administration, Advisory Committee.
1401 Rockville Pike, HFM-71, Rockville, MD
20852, 301-827-1293; email:
[email protected].
Bryan Emery, Center for Biologics Evaluation Blood Products Advisory
and Research, Food and Drug Administration, Committee and
1401 Rockville Pike, HFM-71, Rockville, MD Transmissible Spongiform
20852, 301-827-1277, email: Encephalopathies
[email protected]. Advisory Committee.
Gail Dapolito, Center for Biologics Cellular, Tissue and Gene
Evaluation and Research, Food and Drug Therapies Advisory
Administration, 1401 Rockville Pike, HFM-71, Committee.
Rockville, MD 20852, 301-827-1289, email:
[email protected].
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SUPPLEMENTARY INFORMATION:
I. Vacancies
FDA is requesting nominations of voting members for vacancies
listed as follows:
Table 2
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Upcoming
Committee expertise needed vacancies Approximate date needed
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Allergenic Products Advisory 3 September 1, 2013.
Committee--individuals
knowledgeable in clinical
immunology/allergy.
Blood Products Advisory 4 October 1, 2013.
Committee--individuals
knowledgeable in surgery/
trauma, pediatric
hematology/oncology,
hematology, medical
epidemiology.
Cellular, Tissue and Gene 2 April 2, 2013.
Therapies Advisory
Committee--individuals
knowledgeable in tissue
engineering/regenerative
medicine, orthopedic
oncology.
[[Page 61005]]
Transmissible Spongiform 2 February 1, 2013.
Encephalopathies Advisory
Committee--individuals
knowledgeable in veterinary
medicine, prion molecular
biology.
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II. Functions
A. Allergenic Products Advisory Committee
The Committee reviews and evaluates available data concerning the
safety, effectiveness, and adequacy of labeling of marketed and
investigational allergenic biological products or materials that are
administered to humans for the diagnosis, prevention, or treatment of
allergies and allergic disease, and makes appropriate recommendations
to the Commissioner of Food and Drugs of its findings regarding the
affirmation or revocation of biological product licenses, on the
safety, effectiveness, and labeling of the products, on clinical and
laboratory studies of such products, on amendments or revisions to
regulations governing the manufacture, testing and licensing of
allergenic biological products, and on the quality and relevance of
FDA's research programs which provide the scientific support for
regulating these agents.
B. Blood Products Committee
The Committee reviews and evaluates available data concerning the
safety, effectiveness, and appropriate use of blood, products derived
from blood and serum or biotechnology which are intended for use in the
diagnosis, prevention, or treatment of human diseases, and, as
required, any other product for which the Food and Drug Administration
has regulatory responsibility, and advises the Commissioner of Food and
Drugs of its findings regarding the safety, effectiveness, screening
and testing (to determine eligibility) of donors and labeling of the
products, on clinical and laboratory studies involving such products,
on the affirmation or revocation of biological product licenses, and on
the quality and relevance of FDA's research program which provides the
scientific support for regulating these agents. The Committee will
function at times as a medical device panel under the Federal Food,
Drug, and Cosmetic Act Medical Device Amendments of 1976. As such, the
Committee recommends classification of devices subject to its review
into regulatory categories; recommends the assignment of a priority for
the application of regulatory requirements for devices classified in
the standards or premarket approval category; advises on formulation of
product development protocols and reviews premarket approval
applications for those devices to recommend changes in classification
as appropriate; recommends exemption of certain devices from the
application of portions of the Act; advises on the necessity to ban a
device; and responds to requests from the Agency to review and make
recommendations on specific issues or problems concerning the safety
and effectiveness of devices.
C. 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.
D. 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 of Food and Drugs. The Committee will
make recommendations to the Commissioner regarding the regulations of
such products.
III. Qualifications
A. Allergenic Products Advisory Committee
Persons nominated for membership should be authorities
knowledgeable in the fields of allergy, immunology, pediatrics,
internal medicine, biochemistry, and related specialties. The
particular needs at this time for this committee are listed in section
I of this document. The term of office is up to 4 years, depending on
the appointment date.
B. Blood Products Advisory Committee
Persons nominated for membership should be authorities
knowledgeable in the fields of clinical and administrative medicine,
hematology, immunology, blood banking, surgery, internal medicine,
biochemistry, engineering, biological and physical sciences,
biotechnology, computer technology, statistics, epidemiology,
sociology/ethics, and other related professions. The particular needs
at this time for this committee are listed in section I of this
document. The term of office is up to 4 years, depending on the
appointment date.
C. Cellular, Tissue and Gene Therapies Advisory Committee
Persons nominated for membership should be authorities
knowledgeable in the fields of cellular therapies, tissue
transplantation, gene transfer therapies and xenotransplantation
(biostatistics, bioethics, hematology/oncology, human tissues and
transplantation, reproductive medicine, general medicine and various
medical specialties including surgery and oncology, immunology,
virology, molecular biology, cell biology, developmental biology, tumor
biology, biochemistry, rDNA technology, nuclear medicine, gene therapy,
infectious diseases, and cellular kinetics). The particular needs at
this time for this committee are listed in section I of this document.
The term of office is up to 4 years, depending on the appointment date.
D. Transmissible Spongiform Encephalopathies Advisory Committee
Persons nominated for membership should be authorities
knowledgeable in the fields of clinical and administrative medicine,
hematology, virology, neurovirology, neurology, infectious diseases,
immunology, transfusion medicine, surgery, internal medicine,
biochemistry, biostatistics epidemiology, biological and physical
sciences, sociology/ethics, and other related professions.
[[Page 61006]]
IV. Nomination Procedures
Any interested person may nominate one or more qualified persons
for membership on one or more of the advisory panels or advisory
committees. Self-nominations are also accepted. Nominations must
include a current, complete resume or curriculum vitae for each
nominee, and their current business address and/or home address,
telephone number, and email address if available. Nominations must
specify the advisory committee(s) for which the nominee is recommended.
Nominations must also acknowledge that the nominee is aware of the
nomination unless self-nominated. FDA will ask potential candidates to
provide detailed information concerning such matters related to
financial holdings, employment, and research grants and/or contracts to
permit evaluation of possible sources of conflict of interest.
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: September 25, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-24554 Filed 10-4-12; 8:45 am]
BILLING CODE 4160-01-P