[Federal Register: October 16, 2009 (Volume 74, Number 199)]
[Notices]
[Page 53279-53283]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc09-104]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Request for Nominations for Voting Members on Public Advisory
Panels or Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Device Good
Manufacturing Practice Advisory Committee, certain device panels of the
Medical Devices Advisory Committee, the National Mammography Quality
Assurance Advisory Committee, and the Technical Electronic Products
Radiation Safety Standards Committee in the Center for Devices and
Radiological Health. Nominations will be accepted for current vacancies
and those that will or may occur through August 31, 2010.
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: Because scheduled vacancies occur on various dates throughout
each year, no cutoff date is established for the receipt of
nominations. However, when possible, nominations should be received at
least 6 months before the date of scheduled vacancies for each year, as
indicated in this notice.
ADDRESSES: All nomination for membership should be sent electronically
to CV@OC.FDA.GOV, or by mail to Advisory Committee Oversight &
Management Staff (HF-4), 5600 Fishers Lane, rm. 14C03, Rockville, MD
20857. Information about becoming a member on a FDA advisory committee
can also be obtained by visiting FDA's Web site at http://www.fda.gov/
AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: For specific Committee questions,
contact the following persons listed in table 1 of this document.
[[Page 53280]]
Table 1.--Contact Information for Committees and Panels
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Contact Person Committee/Panel
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Geretta P. Wood, Center for Devices and Radiological Device Panels of the Medical Devices Advisory Committee
Health, Food and Drug Administration, 10903 New
Hampshire Ave., White Oak Bldg. 66, Room 1682, Silver Spring, MD 20993, 301-796-5550, e-mail
Geretta.Wood@fda.hhs.gov
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Normica Facey, Center for Devices and Radiological National Mammography Quality Assurance Advisory
Health, Food and Drug Administration, 10903 New Committee
Hampshire Ave., White Oak Bldg. 66, Room 4652, Silver Spring, MD 20993, e-mail:
Normica.Facey@fda.hhs.gov
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Collin L. Figueroa, Center for Devices and Radiological Device Good Manufacturing Practice Advisory Committee
Health, Food and Drug Administration, 10903 New
Hampshire Ave., White Oak Bldg. 66, Room 3438, Silver Spring, MD 20993, e-mail:
Collin.Figueroa@fda.hhs.gov
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Richard V. Kaczmarek, Center for Devices and Technical Electronic Product Radiation Safety Standards
Radiological Health, Food and Drug Committee
Administration,10903 New Hampshire Ave., White Oak
Bldg. 66, Room 4536, Silver Spring, MD 20993,
e-mail: Richard.Kaczmarek@fda.hhs.gov
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SUPPLEMENTARY INFORMATION:
I. Vacancies
FDA is requesting nominations of voting members for vacancies
listed as follows:
Table 2.--Committee/Panel Expertise Needed and Vacancies
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Current and
Committee/Panel expertise needed Upcoming Approximate
Vacancies Date Needed
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Anesthesiology and Respiratory Therapy 3 December 1,
Devices Panel of the Medical Devices 2009
Advisory Committee--anesthesiologists,
pulmonary medicine specialists, or other
experts who have specialized interests in
ventilator support, pharmacology,
physiology, or the effects and
complications of anesthesia
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Circulatory System Devices Panel of the 1 July 1, 2010
Medical Devices Advisory Committee--
interventional cardiologists,
electrophysiologists, invasive (vascular)
radiologists, vascular and cardiothoracic
surgeons, and cardiologists with special
interest in congestive heart failure
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Clinical Chemistry and Clinical Toxicology 2 March 1, 2010
Devices Panel of the Medical Devices
Advisory Committee--doctors of medicine or
philosophy with experience in clinical
chemistry, clinical toxicology, clinical
pathology, clinical laboratory medicine,
endocrinology, and diabetes
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Dental Products Panel of the Medical Devices 3 Immediately
Advisory Committee--dentists, engineers and 2 November 1,
scientists who have expertise in the areas 2009
of dental implants, dental materials,
periodontology, tissue engineering, and
dental anatomy
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Medical Devices Dispute Resolution Panel of 2 Immediately
the Medical Devices Advisory Committee--
experts with broad, cross-cutting
scientific, clinical, analytical or
mediation skills
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Ear, Nose and Throat Devices Panel of the 1 Immediately
Medical Devices Advisory Committee--
otologists, neurotologists, audiologists
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Gastroenterology and Urology Devices Panel 2 January 1,
of the Medical Devices Advisory Committee-- 2010
transplant specialists,
gastroenterologists, urologists and
nephrologists
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General and Plastic Surgery Devices Panel of 2 Immediately
the Medical Devices Advisory Committee-- 1 September 1,
surgeons (general, plastic, reconstructive, 2010
pediatric, thoracic, abdominal, pelvic and
endoscopic); dermatologists; experts in
biomaterials, lasers, wound healing, and
quality of life; and biostatisticians
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General Hospital and Personal Use Devices 3 January 1,
Panel of the Medical Devices Advisory 2010
Committee--internists, pediatricians,
neonatologists, endocrinologists,
gerontologists, nurses, biomedical
engineers or microbiologists/infection
control practitioners or experts
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Hematology and Pathology Devices Panel of 5 Immediately
the Medical Devices Advisory Committee-- 1 March 1, 2010
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
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[[Page 53281]]
Immunology Devices Panel of the Medical 3 Immediately
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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Microbiology Devices Panel of the Medical 1 Immediately
Devices Advisory Committee--infectious 3 March 1, 2010
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
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Molecular and Clinical Genetics Devices 1 Immediately
Panel of the Medical Devices Advisory 1 June 1, 2010
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; and individuals with
experience in ancillary fields of study
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Neurological Devices Panel of the Medical 5 Immediately
Devices Advisory Committee--neurosurgeons 2 December 1,
(cerebrovascular and pediatric), 2009
neurologists (stroke, pediatric, pain
management, and movement disorders),
interventional neuroradiologists,
psychiatrists, and biostatisticians
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Obstetrics and Gynecology Devices Panel of 1 February 1,
the Medical Devices Advisory Committee-- 2010
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, gynecology in the
older patient, diagnostic (optical)
spectroscopy, midwifery, and labor and
delivery nursing
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Ophthalmic Devices Panel of the Medical 3 November 1,
Devices Advisory Committee-- 2009
ophthalmologists specializing in cataract
and refractive surgery and vitreo-retinal
surgery, in addition to vision scientists,
optometrists, and biostatisticians
practiced in ophthalmic clinical trials
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Orthopaedic and Rehabilitation Devices Panel 3 Immediately
of the Medical Devices Advisory Committee-- 2 Immediately
orthopedic surgeons (joint, spine, trauma, 2 September 1,
and pediatric); rheumatologists; engineers 2010
(biomedical, biomaterials, and
biomechanical); experts in rehabilitation
medicine, sports medicine, and connective
tissue engineering; and biostatisticians
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Radiological Devices Panel of the Medical 2 February 1,
Devices Advisory Committee--physicians with 2010
experience in general radiology,
mammography, ultrasound, magnetic
resonance, computed tomography, other
radiological subspecialties and radiation
oncology; scientists with experience in
diagnostic devices, radiation physics,
statistical analysis, digital imaging and
image analysis
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National Mammography Quality Assurance 6 Immediately
Advisory Committee--physicians,
practitioners, or other health
professionals whose clinical practice,
research specialization, or professional
expertise include a significant focus on
mammography
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Device Good Manufacturing Practice Advisory 7 Immediately
Committee--vacancies include three
government representatives, two public
representatives and two health
professionals
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Technical Electronic Product Radiation 15 Immediately
Safety Standards Committee--vacancies
include five government representatives,
five industry representatives and five
general public representatives
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II. Functions
A. 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 performs the following duties: (1)
Advises the Commissioner of Food and Drugs (the Commissioner) regarding
recommended classification or reclassification of devices into one of
three regulatory categories, (2) advises on any possible risks to
health associated with the use of devices, (3) advises on formulation
of product development protocols; (4) reviews premarket approval
applications for medical devices, (5) reviews guidelines and guidance
documents, (6) recommends exemption of certain devices from the
application of portions of the act, (7) advises on the necessity to ban
a device, and (8) 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
[[Page 53282]]
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.
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.
The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and agency guidance and policies. The panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or agency decisions or actions.
B. National Mammography Quality Assurance Advisory Committee
The functions of the committee are to advise 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 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.
C. Device Good Manufacturing Practice Advisory Committee
The functions of the committee are to review proposed regulations
issuance regarding good manufacturing practices governing the methods
used in, and the facilities and controls used for manufacture,
packaging, storage, installation, and servicing of devices, and make
recommendations regarding the feasibility and reasonableness of those
proposed regulations. The committee also reviews and makes
recommendations on proposed guidelines developed to assist the medical
device industry in meeting the good manufacturing practice
requirements, and provides advice with regard to any petition submitted
by a manufacturer for an exemption or variance from good manufacturing
practice regulations.
Section 520 of the act, (21 U.S.C. 360(j)), as amended, provides
that the Device Good Manufacturing Practice Advisory Committee shall be
composed of nine members as follows: (1) Three of the members shall be
appointed from persons who are officers or employees of any Federal,
State, or local government; (2) two shall be representatives of the
interests of the device manufacturing industry: (3) two shall be
representatives of the interests of physicians and other health
professionals; and (4) two shall be representatives of the interests of
the general public. The agency will publish a separate notice
announcing the vacancies of two representatives of interests of the
device manufacturing industry as they become available.
D. Technical Electronic Product Radiation Safety Standards Committee
The function of the committee is to provide advice and consultation
on the technical feasibility, reasonableness, and practicability of
performance standards for electronic products to control the emission
of radiation from such products. The committee may recommend electronic
product radiation safety standards for consideration.
Section 534(f) of the act (21 U.S.C. 360kk(f)), as amended by the
Safe Medical Devices Act of 1990, provides that the Technical
Electronic Product Radiation Safety Standards Committee include five
members from governmental agencies, including State or Federal
Governments, five members from the affected industries, and five
members from the general public, of which at least one shall be a
representative of organized labor.
III. Qualifications
A. Panels of the Medical Devices Advisory Committee
Persons nominated for membership on the panels should have
adequately diversified experience appropriate to the work of the panel
in such fields as clinical and administrative medicine, engineering,
biological and physical sciences, statistics, and other related
professions. The nature of specialized training and experience
necessary to qualify the nominee as an expert suitable for appointment
may include experience in medical practice, teaching, and/or research
relevant to the field of activity of the panel. The particular needs at
this time for each panel are listed in section I of this document. The
term of office is up to 4 years, depending on the appointment date.
B. National Mammography Quality Assurance Advisory Committee
Persons nominated for membership should be physicians,
practitioners, and other health professionals, whose clinical practice,
research specialization, or professional expertise include a
significant focus on mammography and individuals identified with
consumer interests. Prior experience on Federal public advisory
committees in the same or similar subject areas will also be considered
relevant professional expertise. The particular needs at this time for
this committee are listed in section I of this document. The term of
office is up to 4 years, depending on the appointment date.
C. Device Good Manufacturing Practice Advisory Committee
Persons nominated for membership as a health professional or
officer or employee of any Federal, State, or local government should
have knowledge of or expertise in any one or more of the following
areas: Quality assurance concerning the design, manufacture, and use of
medical devices. To be eligible for selection as a representative of
the general public, nominees should possess appropriate qualifications
to understand and contribute to the committee's work. The particular
needs at this time for this committee are listed in section I of this
document. The term of office is up to 4 years, depending on the
appointment date.
D. Technical Electronic Product Radiation Safety Standards Committee
Persons nominated should be technically qualified by training and
experience in one or more fields of science or engineering applicable
to electronic product radiation safety. The particular needs at this
time for this committee are listed in section I of this document. The
term of office is up to 4
[[Page 53283]]
years, depending on the appointment date.
IV. Nomination Procedures
Any interested person may nominate one or more qualified persons
for membership on one or more of the advisory panels or advisory
committees. Self-nominations are also accepted. Nominations must
include a current, complete resume or curriculum vitae of each nominee,
current business and/or home address, telephone number, and e-mail
address if available. Nominations must specify the advisory panel(s) or
advisory committee(s) for which the nominee is recommended. Nominations
must also acknowledge that the nominee is aware of the nomination,
unless self-nominated. FDA will ask potential candidates to provide
detailed information concerning such matters as financial holdings,
employment, and research grants and/or contracts.
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: October 9, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24896 Filed 10-15-09; 8:45 am]
BILLING CODE 4160-01-S