Request for Nominations for Voting and Nonvoting Consumer Representative Members on Public Advisory Committees and Panels, 46442-46445 [E9-21558]
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46442
Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices
Cosmetic Act (the act) (21 U.S.C.
360j(f)(3)), as amended by the Medical
Device Amendments of 1976, provides
that each medical device panel include
one nonvoting member to represent the
interests of the medical device
manufacturing industry.
FDA is requesting nominations for
nonvoting members representing
industry interests for the following
vacancies listed in table 1 of this
document.
TABLE 1.
Medical Devices Panels
Approximate Date Needed
Dental Products Panel
November 1, 2009
General Hospital and Personal Use Devices Panel
January 1, 2010
Hematology and Pathology Devices Panel
March 1, 2010
Immunology Devices Panel
March 1, 2010
Ophthalmic Devices Panel
November 1, 2009
I. Functions
The functions of the medical device
panels are listed as follows: (1) Review
and evaluate data on the safety and
effectiveness of marketed and
investigational devices and make
recommendations for their regulation,
(2) advise the Commissioner of Food
and Drugs regarding recommended
classification or reclassification of these
devices into one of three regulatory
categories, (3) advise on any possible
risks to health associated with the use
of devices, (4) advise on formulation of
product development protocols, (5)
review premarket approval applications
for medical devices, (6) review
guidelines and guidance documents, (7)
recommend exemption to certain
devices from the application of portions
of the act, (8) advise on the necessity to
ban a device, (9) respond to requests
from the agency to review and make
recommendations on specific issues or
problems concerning the safety and
effectiveness of devices, and (10) make
recommendations on the quality in the
design of clinical studies regarding the
safety and effectiveness of marketed and
investigational devices.
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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
contact person (see FOR FURTHER
INFORMATION CONTACT) within 30 days of
publication of this notice. Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
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
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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 device panel.
The interested organizations are not
bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within the 60
days, the Commissioner of Food and
Drugs will select the nonvoting member
to represent industry interests.
III. Qualifications
Persons nominated for the device
panels should be full time employees of
firms that manufacture products that
would come before the panel, or
consulting firms that represent
manufacturers, or have similar
appropriate ties to industry.
IV. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Within the 30
days, the following information should
be sent to the FDA contact person (see
FOR FURTHER INFORMATION CONTACT): A
current curriculum vitae of each
nominee, current business and/or home
address, telephone number, e-mail
address, and the name of the device
panel of interest. FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process for the device
panel. (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
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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: September 2, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–21555 Filed 9–8–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0412]
Request for Nominations for Voting
and Nonvoting Consumer
Representative Members on Public
Advisory Committees and Panels
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
nominations for voting and nonvoting
consumer representatives to serve on
the National Mammography Quality
Assurance Advisory Committee
(NMQAAC) and certain devices panels
of the Medical Devices Advisory
Committee in the Center for Devices and
Radiological Health (CDRH).
FDA has a special interest in ensuring
that women, minority groups, and
individuals with disabilities are
adequately represented on advisory
committees and, therefore, encourages
nominations of qualified candidates
from these groups.
DATES: Nominations will be accepted for
current vacancies and for those that will
or may occur through October 31, 2010.
Because vacancies occur on various
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Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices
dates throughout the year, there is no
cutoff date for the receipt of
nominations.
ADDRESSES: All nomination for
membership should be sent
electronically to CV@OC.FDA.GOV or
by mail to Advisory Committee
Oversight and Management Staff or by
mail to Advisory Committee Oversight
and Management Staff (HF–4), 5600
Fishers Lane, Rockville, MD 20857.
Information about becoming a member
on an FDA advisory committee can also
be obtained by visiting FDA’s Web site
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/CommitteeMembership/
default.htm.
FOR FURTHER INFORMATION CONTACT:
For general information: Doreen
46443
Brandes, Office of the
Commissioner (HF–4), Food and
Drug Administration, 5600 Fishers
Lane, rm. 14C–3, Rockville, MD
20857, 301–827–8858, email:
doreen.brandes@fda.hhs.gov.
For specific committee questions,
contact the following persons listed
in table 1 of this document.
TABLE 1.
Contact Person
Committee/Panel
Geretta P. Wood, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1682, Silver Spring, MD
20993, 301–796–5550, or e-mail Geretta.Wood@fda.hhs.gov
Certain Device Panels of the Medical Devices Advisory
Committee
Normica Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4652, Silver Spring, MD
20993, e-mail: Normica.Facey@fda.hhs.gov
National Mammography Quality Assurance Advisory
Committee
SUPPLEMENTARY INFORMATION:
I. Vacancies
FDA is requesting nominations for
voting and nonvoting consumer
representatives for the vacancies listed
in table 2 of this document:
TABLE 2.
Current & Upcoming Vacancies
Approximate Date Needed
Circulatory System Devices Panel of the Medical Devices Advisory Committee - interventional cardiologists,
electrophysiologists, invasive (vascular) radiologists, vascular and cardiothoracic surgeons, and cardiologists with
special interest in congestive heart failure
1-nonvoting
Immediately
Dental Products Panel of the Medical Devices Advisory Committee - dentists, engineers and scientists who have expertise in the areas of dental implants, dental materials,
periodontology, tissue engineering, and dental anatomy
1-nonvoting
November 1, 2009
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee - surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic and
endoscopic); dermatologists; experts in biomaterials, lasers,
wound healing, and quality of life; and biostatisticians
1-nonvoting
Immediately
Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee - hematologists (benign and/or
malignant hematology), hematopathologists (general and
special hematology, coagulation and homeostasis, and
hematological oncology), gynecologists with special interests
in gynecological oncology, cytopathologists, and molecular
pathologists with special interests in development of predictive and prognostic biomarkers
1-nonvoting
Immediately
Immunology Devices Panel of the Medical Devices Advisory
Committee - persons with experience in medical, surgical, or
clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine
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Committee/Panel Expertise Needed
1-nonvoting
March 1, 2010
Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee - experts with broad, cross-cutting
scientific, clinical, analytical or mediation skills
1-nonvoting
Immediately
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46444
Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices
TABLE 2.—Continued
Committee/Panel Expertise Needed
Current & Upcoming Vacancies
Approximate Date Needed
Microbiology Devices Panel of the Medical Devices Advisory
Committee - infectious disease clinicians, e.g., pulmonary
disease specialists, sexually transmitted disease specialists,
pediatric infectious disease specialists, experts in tropical
medicine and emerging infectious diseases, biofilm development; mycologists; clinical microbiologists and virologists;
clinical virology and microbiology laboratory directors, with
expertise in clinical diagnosis and in vitro diagnostic assays,
e.g., hepatologists; molecular biologists
1-nonvoting
Immediately
Molecular and Clinical Genetics Devices Panel of the Medical
Devices Advisory Committee - experts in human genetics
and in the clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, neonatologists. Individuals with training in inborn errors of metabolism, biochemical and/or molecular genetics, population genetics, epidemiology and related statistical training, and clinical molecular genetics testing (e.g., genotyping, array CGH, etc.) Individuals with experience in genetics counseling, medical ethics are also desired, and individuals with experience in ancillary fields of study will be considered
1-nonvoting
June 1, 2010
Neurological Devices Panel of the Medical Devices Advisory
Committee - neurosurgeons (cerebrovascular and pediatric),
neurologists (stroke, pediatric, pain management, and movement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians
1-nonvoting
December 1, 2009
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee - experts in perinatology, embryology, reproductive endocrinology, pediatric gynecology,
gynecological oncology, operative hysteroscopy, pelviscopy,
electrosurgery, laser surgery, assisted reproductive technologies, contraception, postoperative adhesions, and cervical cancer and colposcopy; biostatisticians and engineers
with experience in obstetrics/gynecology devices;
urogynecologists; experts in breast care; experts in gynecology in the older patient; experts in diagnostic (optical)
spectroscopy; experts in midwifery; labor and delivery nursing
1-nonvoting
February 1, 2010
Ophthalmic Devices Panel of the Medical Devices Advisory
Committee - ophthalmologists specializing in cataract and
refractive surgery and vitreo-retinal surgery, in addition to vision scientists, optometrists, and biostatisticians practiced in
ophthalmic clinical trials
1-nonvoting
November 1, 2009
Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee - orthopedic surgeons (joint,
spine, trauma, and pediatric); rheumatologists; engineers
(biomedical, biomaterials, and biomechanical); experts in rehabilitation medicine, sports medicine, and connective tissue
engineering; and biostatisticians
1-nonvoting
Immediately
2-voting
February 1, 2010
cprice-sewell on DSK2BSOYB1PROD with NOTICES
National Mammography Quality Assurance Advisory Committee - physicians, practitioners, or other health professionals whose clinical practice, research specialization, or
professional expertise include a significant focus on mammography
II. Functions
A. National Mammography Quality
Assurance Advisory Committee
The committee advises FDA on the
following topics: (1) Developing
appropriate quality standards and
regulations for mammography facilities,
(2) developing appropriate standards
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and regulations for bodies accrediting
mammography facilities under this
program, (3) developing regulations
with respect to sanctions, (4) developing
procedures for monitoring compliance
with standards, (5) establishing a
mechanism to investigate consumer
complaints, (6) reporting new
developments concerning breast
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imaging which should be considered in
the oversight of mammography
facilities, (7) determining whether there
exists a shortage of mammography
facilities in rural and health
professional shortage areas and
determining the effects of personnel on
access to the services of such facilities
in such areas, (8) determining whether
E:\FR\FM\09SEN1.SGM
09SEN1
Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices
there will exist a sufficient number of
medical physicists after October 1, 1999,
and (9) determining the costs and
benefits of compliance with these
requirements.
cprice-sewell on DSK2BSOYB1PROD with NOTICES
B. Certain Panels of the Medical Devices
Advisory Committee
The committee reviews and evaluates
data on the safety and effectiveness of
marketed and investigational devices
and makes recommendations for their
regulation. The panels engage in a
number of activities to fulfill the
functions of the Federal Food, Drug, and
Cosmetic Act (the act) envisions for
device advisory panels. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area, advises
the Commissioner of Food and Drugs
(the Commissioner) regarding
recommended 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 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 on issues relating to
the design of clinical studies regarding
the safety and effectiveness of marketed
and investigational devices.
III. Criteria for Members
Persons nominated for membership as
a consumer representatives on the
committee/panels must 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 must 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.
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IV. Selection Procedures
Selection of members representing
consumer interests is conducted
through procedures that include the use
of organizations representing the public
interest and consumer advocacy groups.
The organizations have the
responsibility of recommending
candidates of the agency’s selection.
V. Nomination Procedures
All nominations must include a cover
letter, a curriculum vita or resume (that
includes the nominee’s office address,
telephone number, and e-mail address),
and a list of consumer or communitybased organizations for which the
candidate can demonstrate active
participation.
Nominations will specify the advisory
committee or panel(s) for which the
nominee is recommended. Nominations
will include confirmation that the
nominee is aware of the nomination.
Any interested person or organization
may nominate one or more qualified
persons for membership as consumer
representatives on the advisory
committee/panels. Self-nominations are
also accepted. Potential candidates will
be required to provide detail
information concerning such matters as
financial holdings, employment, and
research grants and/or contracts to
permit evaluation of possible sources of
a conflict of interest. The nomination
should specify the committee/panels of
interest. The term of office is up to 4
years, depending on the appointment
date.
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 2, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–21558 Filed 9–8–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–5281–N–66]
Notice of Submission of Proposed
Information Collection to OMB;
Emergency Comment Request;
Broadband Research Project
AGENCY: Office of Policy Development
and Research, HUD.
ACTION: Notice of proposed information
collection.
SUMMARY: The proposed information
collection requirement described below
has been submitted to the Office of
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46445
Management and Budget (OMB) for
emergency review and approval, as
required by the Paperwork Reduction
Act. The Department is soliciting public
comments on the subject proposal.
DATES: Comments Due Date: September
16, 2009.
ADDRESSES: Interested persons are
invited to submit comments regarding
this proposal. Comments must be
received within fourteen (14) days from
the date of this Notice. Comments
should refer to the proposal by name
and/or OMB approval number and
should be sent to: Mr. Ross A. Rutledge,
HUD Desk Officer, Office of
Management and Budget, New
Executive Office Building, Washington,
DC 20502; e-mail:
Ross_A._Rutledge@omb.eop.gov; fax:
(202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Lillian Deitzer, Reports Management
Officer, QDAM, Department of Housing
and Urban Development, 451 Seventh
Street, SW., Washington, DC 20410; email: Lillian.L.Deitzer@hud.gov;
telephone (202) 402–8048. This is not a
toll-free number. Copies of available
documents should be submitted to OMB
and may be obtained from Ms. Deitzer.
SUPPLEMENTARY INFORMATION: This
Notice informs the public that the U.S.
Department of Housing and Urban
Development (HUD) has submitted to
OMB, for emergency processing, a
proposed information collection as part
of planning for the National Broadband
Plan ordered under the American
Recovery and Reinvestment Act of 2009.
The information will describe the
availability and usage of broadband
internet services in HUD-assisted
housing and at Neighborhood Networks
Centers. The respondents are Public
Housing Authorities, Tribes and
managers of multi-family and HOME
Investment Partnerships Program
properties as well as managers of
Neighborhood Networks Centers. HUD
will survey all PHAs, Indian Tribes and
managers of Neighborhood Networks
Centers and a 500-respondent sample
for each of Multi-Family managers with
e-mail address, Multi-Family managers
without e-mail addresses and HOME
managers.
For the Residential Broadband
Survey, each respondent will be asked
to voluntarily disclose whether
broadband internet service is available
in their project and approximately how
many residents subscribe to that service.
For the Neighborhood Networks Survey,
each Center manager will be voluntarily
asked to describe the programming
offered at their Center as well as the
number of users who utilize the Center.
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[Federal Register Volume 74, Number 173 (Wednesday, September 9, 2009)]
[Notices]
[Pages 46442-46445]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-21558]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0412]
Request for Nominations for Voting and Nonvoting Consumer
Representative Members on Public Advisory Committees and Panels
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting and nonvoting consumer representatives to serve
on the National Mammography Quality Assurance Advisory Committee
(NMQAAC) and certain devices panels of the Medical Devices Advisory
Committee in the Center for Devices and Radiological Health (CDRH).
FDA has a special interest in ensuring that women, minority groups,
and individuals with disabilities are adequately represented on
advisory committees and, therefore, encourages nominations of qualified
candidates from these groups.
DATES: Nominations will be accepted for current vacancies and for those
that will or may occur through October 31, 2010. Because vacancies
occur on various
[[Page 46443]]
dates throughout the year, there is no cutoff date for the receipt of
nominations.
ADDRESSES: All nomination for membership should be sent electronically
to CV@OC.FDA.GOV or by mail to Advisory Committee Oversight and
Management Staff or by mail to Advisory Committee Oversight and
Management Staff (HF-4), 5600 Fishers Lane, Rockville, MD 20857.
Information about becoming a member on an FDA advisory committee can
also be obtained by visiting FDA's Web site https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/CommitteeMembership/default.htm.
FOR FURTHER INFORMATION CONTACT:
For general information: Doreen Brandes, Office of the Commissioner
(HF-4), Food and Drug Administration, 5600 Fishers Lane, rm. 14C-3,
Rockville, MD 20857, 301-827-8858, email: doreen.brandes@fda.hhs.gov.
For specific committee questions, contact the following persons
listed in table 1 of this document.
Table 1.
------------------------------------------------------------------------
Contact Person Committee/Panel
------------------------------------------------------------------------
Geretta P. Wood, Center for Devices and Certain Device Panels of the
Radiological Health, Food and Drug Medical Devices Advisory
Administration, 10903 New Hampshire Committee
Ave., Bldg. 66, rm. 1682, Silver
Spring, MD 20993, 301-796-5550, or e-
mail Geretta.Wood@fda.hhs.gov
------------------------------------------------------------------------
Normica Facey, Center for Devices and National Mammography Quality
Radiological Health, Food and Drug Assurance Advisory Committee
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4652, Silver
Spring, MD 20993, e-mail:
Normica.Facey@fda.hhs.gov
------------------------------------------------------------------------
SUPPLEMENTARY INFORMATION:
I. Vacancies
FDA is requesting nominations for voting and nonvoting consumer
representatives for the vacancies listed in table 2 of this document:
Table 2.
----------------------------------------------------------------------------------------------------------------
Committee/Panel Expertise Needed Current & Upcoming Vacancies Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
Circulatory System Devices Panel of the 1-nonvoting Immediately
Medical Devices Advisory Committee -
interventional cardiologists,
electrophysiologists, invasive (vascular)
radiologists, vascular and cardiothoracic
surgeons, and cardiologists with special
interest in congestive heart failure
----------------------------------------------------------------------------------------------------------------
Dental Products Panel of the Medical Devices 1-nonvoting November 1, 2009
Advisory Committee - dentists, engineers and
scientists who have expertise in the areas
of dental implants, dental materials,
periodontology, tissue engineering, and
dental anatomy
----------------------------------------------------------------------------------------------------------------
General and Plastic Surgery Devices Panel of 1-nonvoting Immediately
the Medical Devices Advisory Committee -
surgeons (general, plastic, reconstructive,
pediatric, thoracic, abdominal, pelvic and
endoscopic); dermatologists; experts in
biomaterials, lasers, wound healing, and
quality of life; and biostatisticians
----------------------------------------------------------------------------------------------------------------
Hematology and Pathology Devices Panel of the 1-nonvoting Immediately
Medical Devices Advisory Committee -
hematologists (benign and/or malignant
hematology), hematopathologists (general and
special hematology, coagulation and
homeostasis, and hematological oncology),
gynecologists with special interests in
gynecological oncology, cytopathologists,
and molecular pathologists with special
interests in development of predictive and
prognostic biomarkers
----------------------------------------------------------------------------------------------------------------
Immunology Devices Panel of the Medical 1-nonvoting March 1, 2010
Devices Advisory Committee - persons with
experience in medical, surgical, or clinical
oncology, internal medicine, clinical
immunology, allergy, molecular diagnostics,
or clinical laboratory medicine
----------------------------------------------------------------------------------------------------------------
Medical Devices Dispute Resolution Panel of 1-nonvoting Immediately
the Medical Devices Advisory Committee -
experts with broad, cross-cutting
scientific, clinical, analytical or
mediation skills
----------------------------------------------------------------------------------------------------------------
[[Page 46444]]
Microbiology Devices Panel of the Medical 1-nonvoting Immediately
Devices Advisory Committee - infectious
disease clinicians, e.g., pulmonary disease
specialists, sexually transmitted disease
specialists, pediatric infectious disease
specialists, experts in tropical medicine
and emerging infectious diseases, biofilm
development; mycologists; clinical
microbiologists and virologists; clinical
virology and microbiology laboratory
directors, with expertise in clinical
diagnosis and in vitro diagnostic assays,
e.g., hepatologists; molecular biologists
----------------------------------------------------------------------------------------------------------------
Molecular and Clinical Genetics Devices Panel 1-nonvoting June 1, 2010
of the Medical Devices Advisory Committee -
experts in human genetics and in the
clinical management of patients with genetic
disorders, e.g., pediatricians,
obstetricians, neonatologists. Individuals
with training in inborn errors of
metabolism, biochemical and/or molecular
genetics, population genetics, epidemiology
and related statistical training, and
clinical molecular genetics testing (e.g.,
genotyping, array CGH, etc.) Individuals
with experience in genetics counseling,
medical ethics are also desired, and
individuals with experience in ancillary
fields of study will be considered
----------------------------------------------------------------------------------------------------------------
Neurological Devices Panel of the Medical 1-nonvoting December 1, 2009
Devices Advisory Committee - neurosurgeons
(cerebrovascular and pediatric),
neurologists (stroke, pediatric, pain
management, and movement disorders),
interventional neuroradiologists,
psychiatrists, and biostatisticians
----------------------------------------------------------------------------------------------------------------
Obstetrics and Gynecology Devices Panel of 1-nonvoting February 1, 2010
the Medical Devices Advisory Committee -
experts in perinatology, embryology,
reproductive endocrinology, pediatric
gynecology, gynecological oncology,
operative hysteroscopy, pelviscopy,
electrosurgery, laser surgery, assisted
reproductive technologies, contraception,
postoperative adhesions, and cervical cancer
and colposcopy; biostatisticians and
engineers with experience in obstetrics/
gynecology devices; urogynecologists;
experts in breast care; experts in
gynecology in the older patient; experts in
diagnostic (optical) spectroscopy; experts
in midwifery; labor and delivery nursing
----------------------------------------------------------------------------------------------------------------
Ophthalmic Devices Panel of the Medical 1-nonvoting November 1, 2009
Devices Advisory Committee -
ophthalmologists specializing in cataract
and refractive surgery and vitreo-retinal
surgery, in addition to vision scientists,
optometrists, and biostatisticians practiced
in ophthalmic clinical trials
----------------------------------------------------------------------------------------------------------------
Orthopaedic and Rehabilitation Devices Panel 1-nonvoting Immediately
of the Medical Devices Advisory Committee -
orthopedic surgeons (joint, spine, trauma,
and pediatric); rheumatologists; engineers
(biomedical, biomaterials, and
biomechanical); experts in rehabilitation
medicine, sports medicine, and connective
tissue engineering; and biostatisticians
----------------------------------------------------------------------------------------------------------------
National Mammography Quality Assurance 2-voting February 1, 2010
Advisory Committee - physicians,
practitioners, or other health professionals
whose clinical practice, research
specialization, or professional expertise
include a significant focus on mammography
----------------------------------------------------------------------------------------------------------------
II. Functions
A. National Mammography Quality Assurance Advisory Committee
The committee advises FDA on the following topics: (1) Developing
appropriate quality standards and regulations for mammography
facilities, (2) developing appropriate standards and regulations for
bodies accrediting mammography facilities under this program, (3)
developing regulations with respect to sanctions, (4) developing
procedures for monitoring compliance with standards, (5) establishing a
mechanism to investigate consumer complaints, (6) reporting new
developments concerning breast imaging which should be considered in
the oversight of mammography facilities, (7) determining whether there
exists a shortage of mammography facilities in rural and health
professional shortage areas and determining the effects of personnel on
access to the services of such facilities in such areas, (8)
determining whether
[[Page 46445]]
there will exist a sufficient number of medical physicists after
October 1, 1999, and (9) determining the costs and benefits of
compliance with these requirements.
B. Certain Panels of the Medical Devices Advisory Committee
The committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational devices and makes
recommendations for their regulation. The panels engage in a number of
activities to fulfill the functions of the Federal Food, Drug, and
Cosmetic Act (the act) envisions for device advisory panels. With the
exception of the Medical Devices Dispute Resolution Panel, each panel,
according to its specialty area, advises the Commissioner of Food and
Drugs (the Commissioner) regarding recommended 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 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 on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
III. Criteria for Members
Persons nominated for membership as a consumer representatives on
the committee/panels must 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 must 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.
IV. Selection Procedures
Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and consumer advocacy groups. The organizations
have the responsibility of recommending candidates of the agency's
selection.
V. Nomination Procedures
All nominations must include a cover letter, a curriculum vita or
resume (that includes the nominee's 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 will specify the advisory committee or panel(s) for
which the nominee is recommended. Nominations will include confirmation
that the nominee is aware of the nomination.
Any interested person or organization may nominate one or more
qualified persons for membership as consumer representatives on the
advisory committee/panels. Self-nominations are also accepted.
Potential candidates will be required to provide detail information
concerning such matters as financial holdings, employment, and research
grants and/or contracts to permit evaluation of possible sources of a
conflict of interest. The nomination should specify the committee/
panels of interest. The term of office is up to 4 years, depending on
the appointment date.
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 2, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21558 Filed 9-8-09; 8:45 am]
BILLING CODE 4160-01-S