Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels and Request for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels, 81618-81622 [2010-32624]
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<![CDATA[
81618
Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices
TRANDATE (labetalol hydrochloride)
tablets, 300 mg and 400 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that TRANDATE (labetalol
hydrochloride) tablets, 300 mg and 400
mg, were withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of
TRANDATE (labetalol hydrochloride)
tablets, 300 mg and 400 mg, from sale.
We have also independently evaluated
relevant literature and data for possible
postmarketing adverse events and have
found no information that would
indicate that this product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list TRANDATE (labetalol
hydrochloride) tablets, 300 mg and 400
mg, in the ‘‘Discontinued Drug Product
List’’ section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to the
TRANDATE products listed in this
document. Additional ANDAs that refer
to these products may also be approved
by the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: December 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–32507 Filed 12–27–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
emcdonald on DSK2BSOYB1PROD with NOTICES
Anesthetic and Life Support Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
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Name of Committee: Anesthetic and Life
Support Drugs Advisory Committee.
General Function of the Committee: To
provide advice and recommendations to the
Agency on FDA’s regulatory issues.
Date and Time: The meeting will be held
on March 10, 2011, from 8 a.m. to 4:30 p.m.
Location: FDA White Oak Campus, 10903
New Hampshire Ave., Building 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability, visitor
parking and transportation may be accessed
at: https://www.fda.gov/AdvisoryCommittees/
default.htm; under the heading ‘‘Resources
for You’’, click on ‘‘White Oak Conference
Center Parking and Transportation
Information for FDA Advisory Committee
Meetings’’. Please note that visitors to the
White Oak Campus must enter through
Building 1.
Contact Person: Kalyani Bhatt, Center for
Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire
Ave., Bldg. 31, rm. 2417, Silver Spring, MD
20993–0002, 301–796–9001, FAX: 301–847–
8533, e-mail: kalyani.bhatt@fda.hhs.gov, or
FDA Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for upto-date information on this meeting. A notice
in the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly enough
to provide timely notice. Therefore, you
should always check the Agency’s Web site
and call the appropriate advisory committee
hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On March 10, 2011, the committee
will: (1) Receive updates regarding
neurodegenerative findings (findings related
to degeneration in the nervous system) in
juvenile animals exposed to anesthetic drugs,
as well as results from human
epidemiological studies using anesthesia in
children (information related to studies of
patterns and causes of disease); (2) discuss
the relevance of these findings to pediatric
patients and provide guidance for future
preclinical and clinical studies; and (3)
discuss the potential implications of these
data upon the practice of pediatric anesthesia
as well as the communication of the risk of
sedative/anesthetic agents to prescribers and
parents.
FDA intends to make background material
available to the public no later than 2
business days before the meeting. 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/AdvisoryCommittees/Calendar/
default.htm. 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
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committee. Written submissions may be
made to the contact person on or before
February 24, 2011. Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those
individuals interested in making 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
February 15, 2011. 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 February 16, 2011.
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 Kalyani
Bhatt 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/
AdvisoryCommittees/
AboutAdvisoryCommittees/ucm111462.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).
Dated: December 21, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–32591 Filed 12–27–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Request for Notification From
Consumer Organizations Interested in
Participating in the Selection Process
for Nominations for Voting and/or
Nonvoting Consumer Representatives
on Public Advisory Committees or
Panels and Request for Nominations
for Voting and/or Nonvoting Consumer
Representatives on Public Advisory
Committees or Panels
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\28DEN1.SGM
Notice.
28DEN1
Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices
The Food and Drug
Administration (FDA) is requesting that
any consumer organizations interested
in participating in the selection of
voting and/or nonvoting consumer
representatives to serve on its advisory
committees or panels notify FDA in
writing. FDA is also requesting
nominations for voting and/or
nonvoting consumer representatives to
serve on advisory committees and/or
panels for which vacancies currently
exist or are expected to occur in the near
future. Nominees recommended to serve
as a voting or nonvoting consumer
representative may either be selfnominated or may be nominated by a
consumer organization. Nominations
will be accepted for current vacancies
and for those that will or may occur
through December 2011.
SUMMARY:
Any consumer organization
interested in participating in the
selection of an appropriate voting or
nonvoting member to represent
consumer interests on an FDA advisory
committee or panel may send a letter or
e-mail stating that interest to FDA (see
ADDRESSES) by January 27, 2011, for
vacancies listed in this document.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by January 27,
2011.
ADDRESSES: All statements of interest
from consumer organizations interested
in participating in the selection process
and consumer representative
nominations should be sent
electronically to CV@OC.FDA.GOV, by
mail to Advisory Committee Oversight
and Management Staff, 10903 New
DATES:
81619
Hampshire Ave., Bldg. 32, rm. 5129,
Silver Spring, MD 20993–0002, or by
FAX to 301–847–8640. Information
about becoming a member of an FDA
advisory committee can be obtained by
visiting FDA’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER GENERAL INFORMATION
CONTACT: Doreen Brandes, Advisory
Committee Oversight and Management
Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
rm. 5122, Silver Spring, MD 20993–
0002, 301–796–8858, e-mail:
Doreen.Brandes@fda.hhs.gov.
For questions relating to specific
advisory committees or panels, contact
the following persons listed in table 1 of
this document:
TABLE 1
Contact person
Committee/panel
Walter Ellenberg, 10903 New Hampshire Ave., Bldg. 32, rm. 5488, Silver Spring, MD 20993–0002;
phone: 301–796–3873; e-mail: Walter.Ellenberg@fda.hhs.gov.
Martha Monser, 10903 New Hampshire Ave., Bldg. 32, rm. 4286, Silver Spring, MD 20993–0002;
phone: 301–796–4627; e-mail: Martha.Monser@fda.hhs.gov.
Yvette Waples (Acting), 10903 New Hampshire Ave., Bldg. 31, rm. 2410, Silver Spring, MD 20993–
0002; phone: 301–796–9034; e-mail: Yvette.Waples@fda.hhs.gov.
Minh Doan, 10903 New Hampshire Ave., Bldg. 31, rm. 2432, Silver Spring, MD 20993–0002; phone:
301–796–9009; e-mail: Minh.Doan@fda.hhs.gov.
Kalyani Bhatt, 10903 New Hampshire Ave., Bldg. 31, rm. 3438, Silver Spring, MD 20993–0002;
phone: 301–796–9005; e-mail: Kalyani.Bhatt@fda.hhs.gov.
Paul Tran, 10903 New Hampshire Ave., Bldg. 31, rm. 2404, Silver Spring, MD 20993–0002; phone:
301–796–9029; e-mail: Paul.Tran@fda.hhs.gov.
Caleb Briggs, 10903 New Hampshire Ave., Bldg. 31, rm. 2428, Silver Spring, MD 20993–0002;
phone: 301–796–9022; e-mail: Caleb.Briggs@fda.hhs.gov.
Bryan Emery, Rockwall Building (HFM–71), 5515 Security Lane, rm. 1312, Rockville, MD 20852;
phone: 301–827–1277; e-mail: Bryan.Emery@fda.hhs.gov.
Margaret Miller, 10903 New Hampshire Ave., Bldg. 32, rm. 2208, Silver Spring, MD 20993–0002;
phone: 301–796–8890; e-mail: Margaret.Miller@fda.hhs.gov.
Shanika Craig, 10903 New Hampshire Ave., Bldg. 66, rm. 1613, Silver Spring, MD 20993–0002;
phone: 301–796–6639; e-mail: Shanika.Craig@fda.hhs.gov.
Margaret McCabe-Janicki, 10903 New Hampshire Ave., Bldg. 66, rm. 1535, Silver Spring, MD 20993–
0002; phone: 301–796–7029; e-mail: Margaret.Mccabe-Janicki@fda.hhs.gov.
Olga Claudio, 10903 New Hampshire Ave., Bldg. 66, rm. 1611, Silver Spring, MD 20993–0002;
phone: 301–796–7608; e-mail: Olga.Claudio@fda.hhs.gov.
James Swink, 10903 New Hampshire Ave., Bldg. 66, rm. 1609, Silver Spring, MD 20993–0002;
phone: 301–796–6313; e-mail: James.Swink@fda.hhs.gov.
James Engles, 10903 New Hampshire Ave., Bldg. 66, rm. 1566, Silver Spring, MD 20993–0002;
phone: 301–796–7543; e-mail: James.Engles@fda.hhs.gov.
FDA is
requesting nominations for voting and/
or nonvoting consumer representatives
emcdonald on DSK2BSOYB1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Pediatrics Advisory Committee.
Science Board.
Advisory Committee for Pharmaceutical
Science and Clinical Pharmacology
Dermatologic, Ophthalmic Drugs and
Psychopharmacologic Drugs.
Arthritis Drugs.
Anesthetic & Life Support Drugs.
Anti-Viral Drugs
Oncologic Drugs.
Blood Products and Transmissible
Spongiform Encephalopathies
Science Advisory Board to the National
Center of Toxicological Research.
Anesthesiology and Respiratory Therapy
Devices Panel and General Hospital
and Personal Use Devices Panel.
Gastroenterology and Urology General
Plastic Surgery.
Immunology Devices Panel, Dental
Products Devices Panel and National
Mammography Quality Assurance Advisory Committee.
Molecular and Clinical Genetics.
Neurological Devices Panel and Ophthalmic Devices Panel.
for the vacancies listed in table 2 of this
document:
TABLE 2
Committee/panel/areas of expertise needed
Current and upcoming vacancies
Pediatrics Advisory Committee: Knowledgeable in pediatric research,
pediatric subspecialties, statistics, and/or biomedical ethics.
1-Voting .........................................
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immediately.
28DEN1
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Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices
TABLE 2—Continued
Committee/panel/areas of expertise needed
Current and upcoming vacancies
Approximate date needed
Science Board: Knowledgeable in the fields of food safety, nutrition,
chemistry, pharmacology, toxicology, clinical research of systems biology, healthcare devices, nanotechnology, medical imaging, robotics, cell and tissue based products, regenerative medicine and combination products.
Blood Products: 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.
Transmissible Spongiform Encephalopathies: 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.
Anesthetic and Life Support: Knowledgeable in the fields of anesthesiology, surgery, epidemiology or statistics, and related specialties.
Antiviral Drugs: Knowledgeable in the fields of clinical pharmacology,
internal medicine, infectious diseases, microbiology, virology, psychiatry, statistics, epidemiology, ophthalmology, immunology, pediatrics, hematology, and related specialties.
Arthritis Drugs: Knowledgeable in the fields of arthritis, rheumatology,
orthopedics, epidemiology or statistics, analgesics, and related specialties.
Dermatologic and Ophthalmic Drugs: Knowledgeable in the fields of
dermatology, ophthalmology, internal medicine, pathology, immunology, epidemiology or statistics, and other related professions.
Oncologic Drugs: Knowledgeable in the fields of general oncology, pediatric oncology, hematologic oncology, immunologic oncology, biostatistics, and other related professions.
Pharmaceutical Science and Clinical Pharmacology: Knowledgeable in
the fields of pharmaceutical manufacturing, clinical pharmacology,
pharmacokinetics, bioavailability and bioequivalence research, the
design and evaluation of clinical trials, laboratory analytical techniques, pharmaceutical chemistry, physiochemistry, biochemistry,
biostatistics and related biomedical and pharmacological specialties.
Psychopharmacologic Drugs: Knowledgeable in the fields of
psychopharmacology, psychiatry, epidemiology or statistics, and related specialties.
Veterinary Advisory: Knowledgeable in the fields of companion animal
medicine, food animal medicine, avian medicine, microbiology, biometrics, toxicology, pathology, pharmacology, animal science,
chemistry, public health/epidemiology and minor species/minor use
veterinary medicine.
Science Board to the National Center for Toxicology: Knowledgeable
in the fields related to toxicological research.
National Mammography Quality Assurance Advisory Committee:
Knowledgeable in clinical practice, research specialization, or professional work that has a significant focus on mammography.
1-Voting .........................................
immediately.
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immediately.
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immediately.
1-Voting .........................................
04/01/11.
1-Voting .........................................
11/01/11.
1-Voting .........................................
immediately.
1-Voting .........................................
09/01/11.
1-Voting .........................................
07/01/11.
1-Voting .........................................
11/01/11.
1-Voting .........................................
07/30/11.
1-Voting .........................................
immediately.
1-Voting .........................................
immediately.
2-Voting .........................................
Immediately.
emcdonald on DSK2BSOYB1PROD with NOTICES
Certain Panels of the Medical Devices Advisory Committee
Anesthesiology and Respiratory Therapy Devices: Knowledgeable in
anesthesiology and pulmonary medicine or others who have specialized interests in ventilator support, pharmacology, physiology, or
the effects and complications of anesthesia.
Dental Products Panel: Knowledgeable in the areas of dental implants,
dental materials, periodontology, tissue engineering, and dental
anatomy.
Gastroenterology and Urology Devices: Knowledgeable in the area of
gastroenterology, urology, and nephrology.
General Hospital and Personal Use Devices: Nurses, biomedical engineers, microbiologists/infection control practitioners, or experts
knowledgeable in the area of hospital and personal use devices.
Immunology Devices: Knowledgeable in medical, surgical, or clinical
oncology, internal medicine, clinical immunology, allergy, molecular
diagnostics, or clinical laboratory medicine.
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12/01/10.
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immediately.
1-Nonvoting ...................................
01/01/12.
1-Nonvoting ...................................
01/01/11.
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immediately.
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81621
TABLE 2—Continued
Committee/panel/areas of expertise needed
Current and upcoming vacancies
Molecular and Clinical Genetics Panel: Knowledgeable in human genetics and in the clinical management of patients with genetic disorders, e.g., candidates with training in inborn errors of metabolism,
biochemical and/or molecular genetics, population genetics, epidemiology and related statistical training. Additionally, individuals with
experience in genetic counseling, medical ethics as well as ancillary
fields of study will be considered.
Neurological Devices: Knowledgeable in neurologic diseases and devices used to treat neurologic disorders.
Ophthalmic Devices: Knowledgeable in corneal-external disease,
vitreo-retinal surgery, glaucoma, ocular immunology, ocular pathology; optometrists; vision scientists; ophthalmic professionals quality
of life assessment, electrophysiology, low vision rehabilitation.
1-Nonvoting ...................................
immediately.
1-Nonvoting ...................................
immediately.
1-Nonvoting ...................................
immediately.
I. Functions
A. Pediatric Advisory Committee
Advises and makes recommendations
regarding (1) Pediatric research; (2)
identification of research priorities
related to pediatric therapeutics and the
need for additional treatments of
specific pediatric diseases or conditions;
(3) the ethics, design, and analysis of
clinical trials related to pediatric
therapeutics; (4) pediatric labeling
disputes; (5) pediatric labeling changes;
(6) adverse event reports for drugs
granted pediatric exclusivity and any
safety issues that may occur; (7) any
other pediatric issue or pediatric
labeling dispute involving FDA
regulated products; (8) research
involving children as subjects; and (9)
any other matter involving pediatrics for
which FDA has regulatory
responsibility.
emcdonald on DSK2BSOYB1PROD with NOTICES
B. Science Board
Provides advice primarily to the
Commissioner of Food and Drugs and
other appropriate officials on specific
complex and technical issues as well as
emerging issues in the scientific
community, industry, and academia.
Additionally, the Board will provide
advice to the Agency on keeping pace
with technical and scientific evolutions
in the fields of regulatory science, on
formulating an appropriate research
agenda, and on upgrading its scientific
and research facilities to keep pace with
these changes. It will also provide the
means for critical review of Agency
sponsored intramural and extramural
scientific research programs.
C. Blood Products
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 as well as
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the safety, effectiveness, 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 products.
D. Transmissible Spongiform
Encephalopathies
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 well as considers
the quality and relevance of FDA’s
research program which provides
scientific support for the regulation of
these products.
E. Anesthetic and Life Support Drugs
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in anesthesiology
and surgery.
F. Antiviral Drugs
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of infectious diseases and disorders.
G. Arthritis Drugs
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of arthritis, rheumatism, and related
diseases.
H. Oncologic Drugs
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of cancer.
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Approximate date needed
I. Pharmaceutical Science & Clinical
Pharmacology
Provides advice on scientific and
technical issues concerning the safety,
and effectiveness of human generic drug
products for use in the treatment of a
broad spectrum of human diseases, and
as required, any other product for which
the FDA has regulatory responsibility.
The committee may also review Agency
sponsored intramural and extramural
biomedical research programs in
support of FDA’s generic drug
regulatory responsibilities.
J. Psychopharmacologic Drugs
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the practice of
psychiatry and related fields.
K. Veterinary Medicine
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational new
animal drugs, feeds, and devices for use
in the treatment and prevention of
animal diseases and increased animal
production.
L. Technical Electronic Product
Radiation Standards Advisory
Committee
Reviews and evaluates the technical
feasibility, reasonableness, and
practicability of performance standards
for electronic products to control the
emission of radiation from such
products, and may recommend
electronic product radiation safety
standards.
M. Science Advisory Board to the
National Center for Toxicological
Research
Reviews and advises the Agency on
the establishment, implementation, and
evaluation of the research programs that
meet current and future scientific needs
of the Agency. The Board also provides
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Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Notices
an extra-agency review in ensuring that
the research programs at NCTR are
scientifically sound and relevant to the
regulatory needs of the Agency.
emcdonald on DSK2BSOYB1PROD with NOTICES
N. National Mammography Quality
Assurance Advisory Committee
Advises the Agency on development
of appropriate quality standards and
regulations for mammography facilities;
standards and regulations for bodies
accrediting mammography facilities
under this program; regulations with
respect to sanctions; procedures for
monitoring compliance with standards;
and establishing a mechanism to
investigate consumer complaints;
reporting new developments concerning
breast imaging which should be
considered in the oversight of
mammography facilities. Also
determines whether there exists a
shortage of mammography facilities in
rural and health professional shortage
areas and determines the effects of
personnel on access to the services of
such facilities in such areas;
determining whether there will exist a
sufficient number of medical physicists
after October 1, 1999; and determining
the costs and benefits of compliance
with these requirements.
O. Certain Panels of the Medical Devices
Advisory Committee
Reviews and evaluates data on the
safety and effectiveness of marketed and
investigational devices and makes
recommendations for their regulation.
With the exception of the Medical
Devices Dispute Resolution Panel, each
panel, according to its specialty area,
advises on the classification or
reclassification of devices into one of
three regulatory categories; advises on
any possible risks to health associated
with the use of devices; advises on
formulation of product development
protocols; reviews premarket approval
applications for medical devices;
reviews guidelines and guidance
documents; recommends exemption of
certain devices from the application of
portions of the Federal Food, Drug, and
Cosmetic 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. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area, may also
make appropriate recommendations to
the Commissioner of Food and Drugs on
issues relating to the design of clinical
studies regarding the safety and
effectiveness of marketed and
investigational devices. The Dental
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Products Panel also functions at times
as a dental drug panel. The functions of
the dental drug panel are to evaluate
and recommend whether various
prescription drug products should be
changed to over-the-counter status and
to evaluate data and make
recommendations concerning the
approval of new dental drug products
for human use.
II. Criteria for Members
Persons nominated for membership as
consumer representatives on the
committees or panels should meet the
following criteria: (1) Demonstrate ties
to consumer and community-based
organizations, (2) be able to analyze
technical data, (3) understand research
design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy
of products under review. The
consumer representative should be able
to represent the consumer perspective
on issues and actions before the
advisory committee; serve as a liaison
between the committee and interested
consumers, associations, coalitions, and
consumer organizations; and facilitate
dialogue with the advisory committees
on scientific issues that affect
consumers.
III. Selection Procedures
Selection of members representing
consumer interests is conducted
through procedures that include the use
of organizations representing the public
interest and public advocacy groups.
These organizations recommend
nominees for the Agency’s selection.
Representatives from the consumer
health branches of Federal, State, and
local governments also may participate
in the selection process. Any consumer
organization interested in participating
in the selection of an appropriate voting
or nonvoting member to represent
consumer interests should send a letter
stating that interest to FDA (see
ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 30 days, FDA
will compile a list of consumer
organizations that will participate in the
selection process and will forward to
each such organization a ballot listing
three to five qualified nominees selected
by the Agency based on the nominations
received, together with each nominee’s
current curriculum vitae or resume.
Ballots are to be filled out and returned
to FDA within 30 days. The nominee
receiving the highest number of votes
ordinarily will be selected to serve as
the member representing consumer
interests for that particular advisory
committee or panel.
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IV. Nomination Procedures
Any interested person or organization
may nominate one or more qualified
persons to represent consumer interests
on the Agency’s advisory committees or
panels. Self-nominations are also
accepted. Potential candidates will be
required to provide detailed information
concerning such matters as financial
holdings, employment, and research
grants and/or contracts to permit
evaluation of possible sources of
conflicts of interest.
All nominations should include: A
cover letter; a curriculum vitae or
resume that includes the nominee’s
home or office address, telephone
number, and e-mail address; and a list
of consumer or community-based
organizations for which the candidate
can demonstrate active participation.
Nominations also should specify the
advisory committee(s) or panel(s) for
which the nominee is recommended. In
addition, nominations should include
confirmation that the nominee is aware
of the nomination and is willing to serve
as a member of the advisory committee
or panel if selected. The term of office
is up to 4 years.
FDA will review all nominations
received within the specified
timeframes and prepare a ballot
containing the names of three to five
qualified nominees. Names not selected
will remain on a list of eligible
nominees and be reviewed periodically
by FDA to determine continued interest.
Upon selecting qualified nominees for
the ballot, FDA will provide those
consumer organizations that are
participating in the selection process
with the opportunity to vote on the
listed nominees. Only organizations
vote in the selection process. Persons
who nominate themselves to serve as
voting or nonvoting consumer
representatives will not participate in
the selection process.
FDA has a special interest in ensuring
that women, minority groups, and
individuals with physical disabilities
are adequately represented on its
advisory committees and panels and,
therefore, encourages nominations for
appropriately qualified candidates from
these groups.
Dated: December 22, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–32624 Filed 12–27–10; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\28DEN1.SGM
28DEN1
]]>Agencies
[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Pages 81618-81622]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32624]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Request for Notification From Consumer Organizations Interested
in Participating in the Selection Process for Nominations for Voting
and/or Nonvoting Consumer Representatives on Public Advisory Committees
or Panels and Request for Nominations for Voting and/or Nonvoting
Consumer Representatives on Public Advisory Committees or Panels
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 81619]]
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
consumer organizations interested in participating in the selection of
voting and/or nonvoting consumer representatives to serve on its
advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may either be self-nominated or may be nominated by a
consumer organization. Nominations will be accepted for current
vacancies and for those that will or may occur through December 2011.
DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or e-mail stating that interest to FDA (see ADDRESSES) by
January 27, 2011, for vacancies listed in this document. Concurrently,
nomination materials for prospective candidates should be sent to FDA
(see ADDRESSES) by January 27, 2011.
ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should be sent electronically to
CV@OC.FDA.GOV, by mail to Advisory Committee Oversight and Management
Staff, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD
20993-0002, or by FAX to 301-847-8640. Information about becoming a
member of an FDA advisory committee can be obtained by visiting FDA's
Web site at https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER GENERAL INFORMATION CONTACT: Doreen Brandes, Advisory
Committee Oversight and Management Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, rm. 5122, Silver Spring, MD 20993-
0002, 301-796-8858, e-mail: Doreen.Brandes@fda.hhs.gov.
For questions relating to specific advisory committees or panels,
contact the following persons listed in table 1 of this document:
Table 1
------------------------------------------------------------------------
Contact person Committee/panel
------------------------------------------------------------------------
Walter Ellenberg, 10903 New Hampshire Pediatrics Advisory
Ave., Bldg. 32, rm. 5488, Silver Spring, Committee.
MD 20993-0002; phone: 301-796-3873; e-
mail: Walter.Ellenberg@fda.hhs.gov.
Martha Monser, 10903 New Hampshire Ave., Science Board.
Bldg. 32, rm. 4286, Silver Spring, MD
20993-0002; phone: 301-796-4627; e-mail:
Martha.Monser@fda.hhs.gov.
Yvette Waples (Acting), 10903 New Advisory Committee for
Hampshire Ave., Bldg. 31, rm. 2410, Pharmaceutical Science and
Silver Spring, MD 20993-0002; phone: 301- Clinical Pharmacology
796-9034; e-mail: Dermatologic, Ophthalmic
Yvette.Waples@fda.hhs.gov. Drugs and
Psychopharmacologic Drugs.
Minh Doan, 10903 New Hampshire Ave., Bldg. Arthritis Drugs.
31, rm. 2432, Silver Spring, MD 20993-
0002; phone: 301-796-9009; e-mail:
Minh.Doan@fda.hhs.gov.
Kalyani Bhatt, 10903 New Hampshire Ave., Anesthetic & Life Support
Bldg. 31, rm. 3438, Silver Spring, MD Drugs.
20993-0002; phone: 301-796-9005; e-mail:
Kalyani.Bhatt@fda.hhs.gov.
Paul Tran, 10903 New Hampshire Ave., Bldg. Anti-Viral Drugs
31, rm. 2404, Silver Spring, MD 20993-
0002; phone: 301-796-9029; e-mail:
Paul.Tran@fda.hhs.gov.
Caleb Briggs, 10903 New Hampshire Ave., Oncologic Drugs.
Bldg. 31, rm. 2428, Silver Spring, MD
20993-0002; phone: 301-796-9022; e-mail:
Caleb.Briggs@fda.hhs.gov.
Bryan Emery, Rockwall Building (HFM-71), Blood Products and
5515 Security Lane, rm. 1312, Rockville, Transmissible Spongiform
MD 20852; phone: 301-827-1277; e-mail: Encephalopathies
Bryan.Emery@fda.hhs.gov.
Margaret Miller, 10903 New Hampshire Ave., Science Advisory Board to
Bldg. 32, rm. 2208, Silver Spring, MD the National Center of
20993-0002; phone: 301-796-8890; e-mail: Toxicological Research.
Margaret.Miller@fda.hhs.gov.
Shanika Craig, 10903 New Hampshire Ave., Anesthesiology and
Bldg. 66, rm. 1613, Silver Spring, MD Respiratory Therapy Devices
20993-0002; phone: 301-796-6639; e-mail: Panel and General Hospital
Shanika.Craig@fda.hhs.gov. and Personal Use Devices
Panel.
Margaret McCabe-Janicki, 10903 New Gastroenterology and Urology
Hampshire Ave., Bldg. 66, rm. 1535, General Plastic Surgery.
Silver Spring, MD 20993-0002; phone: 301-
796-7029; e-mail: Margaret.Mccabe-Janicki@fda.hhs.gov.
Olga Claudio, 10903 New Hampshire Ave., Immunology Devices Panel,
Bldg. 66, rm. 1611, Silver Spring, MD Dental Products Devices
20993-0002; phone: 301-796-7608; e-mail: Panel and National
Olga.Claudio@fda.hhs.gov. Mammography Quality
Assurance Advisory
Committee.
James Swink, 10903 New Hampshire Ave., Molecular and Clinical
Bldg. 66, rm. 1609, Silver Spring, MD Genetics.
20993-0002; phone: 301-796-6313; e-mail:
James.Swink@fda.hhs.gov.
James Engles, 10903 New Hampshire Ave., Neurological Devices Panel
Bldg. 66, rm. 1566, Silver Spring, MD and Ophthalmic Devices
20993-0002; phone: 301-796-7543; e-mail: Panel.
James.Engles@fda.hhs.gov.
------------------------------------------------------------------------
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
and/or nonvoting consumer representatives for the vacancies listed in
table 2 of this document:
Table 2
------------------------------------------------------------------------
Committee/panel/areas of Current and Approximate date
expertise needed upcoming vacancies needed
------------------------------------------------------------------------
Pediatrics Advisory Committee: 1-Voting.......... immediately.
Knowledgeable in pediatric
research, pediatric
subspecialties, statistics, and/
or biomedical ethics.
[[Page 81620]]
Science Board: Knowledgeable in 1-Voting.......... immediately.
the fields of food safety,
nutrition, chemistry,
pharmacology, toxicology,
clinical research of systems
biology, healthcare devices,
nanotechnology, medical
imaging, robotics, cell and
tissue based products,
regenerative medicine and
combination products.
Blood Products: Knowledgeable in 1-Voting.......... immediately.
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.
Transmissible Spongiform 1-Voting.......... immediately.
Encephalopathies: 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.
Anesthetic and Life Support: 1-Voting.......... 04/01/11.
Knowledgeable in the fields of
anesthesiology, surgery,
epidemiology or statistics, and
related specialties.
Antiviral Drugs: Knowledgeable 1-Voting.......... 11/01/11.
in the fields of clinical
pharmacology, internal
medicine, infectious diseases,
microbiology, virology,
psychiatry, statistics,
epidemiology, ophthalmology,
immunology, pediatrics,
hematology, and related
specialties.
Arthritis Drugs: Knowledgeable 1-Voting.......... immediately.
in the fields of arthritis,
rheumatology, orthopedics,
epidemiology or statistics,
analgesics, and related
specialties.
Dermatologic and Ophthalmic 1-Voting.......... 09/01/11.
Drugs: Knowledgeable in the
fields of dermatology,
ophthalmology, internal
medicine, pathology,
immunology, epidemiology or
statistics, and other related
professions.
Oncologic Drugs: Knowledgeable 1-Voting.......... 07/01/11.
in the fields of general
oncology, pediatric oncology,
hematologic oncology,
immunologic oncology,
biostatistics, and other
related professions.
Pharmaceutical Science and 1-Voting.......... 11/01/11.
Clinical Pharmacology:
Knowledgeable in the fields of
pharmaceutical manufacturing,
clinical pharmacology,
pharmacokinetics,
bioavailability and
bioequivalence research, the
design and evaluation of
clinical trials, laboratory
analytical techniques,
pharmaceutical chemistry,
physiochemistry, biochemistry,
biostatistics and related
biomedical and pharmacological
specialties.
Psychopharmacologic Drugs: 1-Voting.......... 07/30/11.
Knowledgeable in the fields of
psychopharmacology, psychiatry,
epidemiology or statistics, and
related specialties.
Veterinary Advisory: 1-Voting.......... immediately.
Knowledgeable in the fields of
companion animal medicine, food
animal medicine, avian
medicine, microbiology,
biometrics, toxicology,
pathology, pharmacology, animal
science, chemistry, public
health/epidemiology and minor
species/minor use veterinary
medicine.
Science Board to the National 1-Voting.......... immediately.
Center for Toxicology:
Knowledgeable in the fields
related to toxicological
research.
National Mammography Quality 2-Voting.......... Immediately.
Assurance Advisory Committee:
Knowledgeable in clinical
practice, research
specialization, or professional
work that has a significant
focus on mammography.
------------------------------------------------------------------------
Certain Panels of the Medical Devices Advisory Committee
------------------------------------------------------------------------
Anesthesiology and Respiratory 1-Nonvoting....... 12/01/10.
Therapy Devices: Knowledgeable
in anesthesiology and pulmonary
medicine or others who have
specialized interests in
ventilator support,
pharmacology, physiology, or
the effects and complications
of anesthesia.
Dental Products Panel: 1-Nonvoting....... immediately.
Knowledgeable in the areas of
dental implants, dental
materials, periodontology,
tissue engineering, and dental
anatomy.
Gastroenterology and Urology 1-Nonvoting....... 01/01/12.
Devices: Knowledgeable in the
area of gastroenterology,
urology, and nephrology.
General Hospital and Personal 1-Nonvoting....... 01/01/11.
Use Devices: Nurses, biomedical
engineers, microbiologists/
infection control
practitioners, or experts
knowledgeable in the area of
hospital and personal use
devices.
Immunology Devices: 1-Nonvoting....... immediately.
Knowledgeable in medical,
surgical, or clinical oncology,
internal medicine, clinical
immunology, allergy, molecular
diagnostics, or clinical
laboratory medicine.
[[Page 81621]]
Molecular and Clinical Genetics 1-Nonvoting....... immediately.
Panel: Knowledgeable in human
genetics and in the clinical
management of patients with
genetic disorders, e.g.,
candidates with training in
inborn errors of metabolism,
biochemical and/or molecular
genetics, population genetics,
epidemiology and related
statistical training.
Additionally, individuals with
experience in genetic
counseling, medical ethics as
well as ancillary fields of
study will be considered.
Neurological Devices: 1-Nonvoting....... immediately.
Knowledgeable in neurologic
diseases and devices used to
treat neurologic disorders.
Ophthalmic Devices: 1-Nonvoting....... immediately.
Knowledgeable in corneal-
external disease, vitreo-
retinal surgery, glaucoma,
ocular immunology, ocular
pathology; optometrists; vision
scientists; ophthalmic
professionals quality of life
assessment, electrophysiology,
low vision rehabilitation.
------------------------------------------------------------------------
I. Functions
A. Pediatric Advisory Committee
Advises and makes recommendations regarding (1) Pediatric research;
(2) identification of research priorities related to pediatric
therapeutics and the need for additional treatments of specific
pediatric diseases or conditions; (3) the ethics, design, and analysis
of clinical trials related to pediatric therapeutics; (4) pediatric
labeling disputes; (5) pediatric labeling changes; (6) adverse event
reports for drugs granted pediatric exclusivity and any safety issues
that may occur; (7) any other pediatric issue or pediatric labeling
dispute involving FDA regulated products; (8) research involving
children as subjects; and (9) any other matter involving pediatrics for
which FDA has regulatory responsibility.
B. Science Board
Provides advice primarily to the Commissioner of Food and Drugs and
other appropriate officials on specific complex and technical issues as
well as emerging issues in the scientific community, industry, and
academia. Additionally, the Board will provide advice to the Agency on
keeping pace with technical and scientific evolutions in the fields of
regulatory science, on formulating an appropriate research agenda, and
on upgrading its scientific and research facilities to keep pace with
these changes. It will also provide the means for critical review of
Agency sponsored intramural and extramural scientific research
programs.
C. Blood Products
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 as well as the safety,
effectiveness, 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 products.
D. Transmissible Spongiform Encephalopathies
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 well as
considers the quality and relevance of FDA's research program which
provides scientific support for the regulation of these products.
E. Anesthetic and Life Support Drugs
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in anesthesiology and surgery.
F. Antiviral Drugs
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of infectious diseases and disorders.
G. Arthritis Drugs
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
treatment of arthritis, rheumatism, and related diseases.
H. Oncologic Drugs
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
treatment of cancer.
I. Pharmaceutical Science & Clinical Pharmacology
Provides advice on scientific and technical issues concerning the
safety, and effectiveness of human generic drug products for use in the
treatment of a broad spectrum of human diseases, and as required, any
other product for which the FDA has regulatory responsibility. The
committee may also review Agency sponsored intramural and extramural
biomedical research programs in support of FDA's generic drug
regulatory responsibilities.
J. Psychopharmacologic Drugs
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
practice of psychiatry and related fields.
K. Veterinary Medicine
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational new animal drugs, feeds,
and devices for use in the treatment and prevention of animal diseases
and increased animal production.
L. Technical Electronic Product Radiation Standards Advisory Committee
Reviews and evaluates the technical feasibility, reasonableness,
and practicability of performance standards for electronic products to
control the emission of radiation from such products, and may recommend
electronic product radiation safety standards.
M. Science Advisory Board to the National Center for Toxicological
Research
Reviews and advises the Agency on the establishment,
implementation, and evaluation of the research programs that meet
current and future scientific needs of the Agency. The Board also
provides
[[Page 81622]]
an extra-agency review in ensuring that the research programs at NCTR
are scientifically sound and relevant to the regulatory needs of the
Agency.
N. National Mammography Quality Assurance Advisory Committee
Advises the Agency on development of appropriate quality standards
and regulations for mammography facilities; standards and regulations
for bodies accrediting mammography facilities under this program;
regulations with respect to sanctions; procedures for monitoring
compliance with standards; and establishing a mechanism to investigate
consumer complaints; reporting new developments concerning breast
imaging which should be considered in the oversight of mammography
facilities. Also determines whether there exists a shortage of
mammography facilities in rural and health professional shortage areas
and determines the effects of personnel on access to the services of
such facilities in such areas; determining whether there will exist a
sufficient number of medical physicists after October 1, 1999; and
determining the costs and benefits of compliance with these
requirements.
O. Certain Panels of the Medical Devices Advisory Committee
Reviews and evaluates data on the safety and effectiveness of
marketed and investigational devices and makes recommendations for
their regulation. With the exception of the Medical Devices Dispute
Resolution Panel, each panel, according to its specialty area, advises
on the classification or reclassification of devices into one of three
regulatory categories; advises on any possible risks to health
associated with the use of devices; advises on formulation of product
development protocols; reviews premarket approval applications for
medical devices; reviews guidelines and guidance documents; recommends
exemption of certain devices from the application of portions of the
Federal Food, Drug, and Cosmetic 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. With the exception of the Medical Devices
Dispute Resolution Panel, each panel, according to its specialty area,
may also make appropriate recommendations to the Commissioner of Food
and Drugs on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices. The Dental Products Panel also functions at times as a dental
drug panel. The functions of the dental drug panel are to evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status and to evaluate data and make
recommendations concerning the approval of new dental drug products for
human use.
II. Criteria for Members
Persons nominated for membership as consumer representatives on the
committees or panels should meet the following criteria: (1)
Demonstrate ties to consumer and community-based organizations, (2) be
able to analyze technical data, (3) understand research design, (4)
discuss benefits and risks, and (5) evaluate the safety and efficacy of
products under review. The consumer representative should be able to
represent the consumer perspective on issues and actions before the
advisory committee; serve as a liaison between the committee and
interested consumers, associations, coalitions, and consumer
organizations; and facilitate dialogue with the advisory committees on
scientific issues that affect consumers.
III. Selection Procedures
Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing three to five
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
resume. Ballots are to be filled out and returned to FDA within 30
days. The nominee receiving the highest number of votes ordinarily will
be selected to serve as the member representing consumer interests for
that particular advisory committee or panel.
IV. Nomination Procedures
Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Potential candidates will be required to provide detailed information
concerning such matters as financial holdings, employment, and research
grants and/or contracts to permit evaluation of possible sources of
conflicts of interest.
All nominations should include: A cover letter; a curriculum vitae
or resume that includes the nominee's home or office address, telephone
number, and e-mail address; and a list of consumer or community-based
organizations for which the candidate can demonstrate active
participation.
Nominations also should specify the advisory committee(s) or
panel(s) for which the nominee is recommended. In addition, nominations
should include confirmation that the nominee is aware of the nomination
and is willing to serve as a member of the advisory committee or panel
if selected. The term of office is up to 4 years.
FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of three to five
qualified nominees. Names not selected will remain on a list of
eligible nominees and be reviewed periodically by FDA to determine
continued interest. Upon selecting qualified nominees for the ballot,
FDA will provide those consumer organizations that are participating in
the selection process with the opportunity to vote on the listed
nominees. Only organizations vote in the selection process. Persons who
nominate themselves to serve as voting or nonvoting consumer
representatives will not participate in the selection process.
FDA has a special interest in ensuring that women, minority groups,
and individuals with physical disabilities are adequately represented
on its advisory committees and panels and, therefore, encourages
nominations for appropriately qualified candidates from these groups.
Dated: December 22, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-32624 Filed 12-27-10; 8:45 am]
BILLING CODE 4160-01-P
