[Federal Register: August 24, 2005 (Volume 70, Number 163)]
[Notices]
[Page 49656-49659]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24au05-76]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 certain device panels of the
Medical Devices Advisory Committee, the National Mammography Quality
Assurance Advisory Committee, the Device Good Manufacturing Practice
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, 2006.
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: Send all nominations and curricula vitae to the following
contact persons in table 1 of this document:
Table 1.
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Contact Person Committee/Panel
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Nancy J. Pluhowski, Center for Devices and Certain Device Panels of the
Radiological Health (HFZ-400), Food and Medical Devices Advisory
Drug Administration, 9200 Corporate Committee
Blvd., Rockville, MD 20850, 301-594-2022,
or e-mail: NJP@CDRH.FDA.GOV
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Charles A. Finder, Center for Devices and National Mammography Quality
Radiological Health (HFZ-240), Food and Assurance Advisory
Drug Administration, 1350 Piccard Dr., Committee
Rockville, MD 20850, e-mail:
CAF@CDRH.FDA.GOV
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Collin L. Figueroa, Center for Devices and Device Good Manufacturing
Radiological Health (HFZ-342), Food and Practice Advisory Committee
Drug Administration, 2094 Gaither Rd.,
Rockville, MD 20850, e-mail:
CXF@CDRH.FDA.GOV
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Richard V. Kaczmarek, Center for Devices Technical Electronic Product
and Radiological Health (HFZ-240), Food Radiation Safety Standards
and Drug Administration, 1350 Piccard Committee
Dr., Rockville, MD 20850, e-mail:
RVK@CDRH.FDA.GOV
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FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ-17), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0450, ext. 114, e-mail:
KLW@CDRH.FDA.GOV.
SUPPLEMENTARY INFORMATION:
I. Vacancies
FDA is requesting nominations of voting members for vacancies
listed as follows:
[[Page 49657]]
Table 2.
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Committee/Panel Expertise Needed Current & Upcoming Vacancies Approximate Date Needed
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Anesthesiology and Respiratory Therapy 2 Immediately
Devices Panel of the Medical Devices
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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Clinical Chemistry and Clinical Toxicology 2 March 1, 2006
Devices Panel of the Medical Devices
Advisory Committee--doctors of medicine or
philosophy with experience in clinical
chemistry (e.g., cardiac markers), clinical
toxicology, clinical pathology, clinical
laboratory medicine, and endocrinology
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Dental Products Panel of the Medical Devices 2 November 1, 2005
Advisory Committee--dentists, engineers and
scientists who have expertise in the areas
of dental implants, dental materials,
temporomandibular joint (TMJ) dysfunction,
tissue engineering, and dental anatomy
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Gastroenterology and Urology Devices Panel of 1 Immediately
the Medical Devices Advisory Committee-- 1 January 1, 2006
gastroenterologists, urologists and
nephrologists
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General and Plastic Surgery Devices Panel of 2 September 1, 2005
the Medical Devices Advisory Committee-- 2 September 1, 2006
surgeons (general, plastic, reconstructive,
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 Immediately
Panel of the Medical Devices Advisory 4 January 1, 2006
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 the 3 March 1, 2006
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
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Medical Devices Dispute Resolution Panel of 1 October 1, 2005
the Medical Devices Advisory Committee--
experts with broad, cross-cutting
scientific, clinical, analytical or
mediation skills
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Microbiology Devices Panel of the Medical 3 Immediately
Devices Advisory Committee--infectious 2 March 1, 2006
disease clinicians, e.g., pulmonary disease
specialists, sexually transmitted disease
specialists, pediatric infectious disease
specialists, experts in tropical medicine
and emerging infectious diseases,
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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Neurological Devices Panel of the Medical 3 December 1, 2005
Devices Advisory Committee--neurosurgeons
(cerebrovascular and pediatric),
neurologists (stroke, pediatric, pain
management, and movement disorders),
interventional neuroradiologists,
psychiatrists, and biostatisticians
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[[Page 49658]]
Obstetrics and Gynecology Devices Panel of 1 February 1, 2006
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
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Orthopaedic and Rehabilitation Devices Panel 1 Immediately
of the Medical Devices Advisory Committee-- 1 September 1, 2005
orthopedic surgeons (joint, spine, trauma, 3 September 1, 2006
and pediatric); rheumatologists; engineers
(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, 2006
Devices Advisory Committee--physicians with
experience in general radiology,
mammography, 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 2 February 1, 2006
Advisory Committee--one medical physicist,
one physician, practitioner, or other health
professional whose clinical practice,
research specialization, or professional
expertise includes a significant focus on
mammography
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Device Good Manufacturing Practice Advisory 9 Immediately
Committee: Nine vacancies occurring
immediately; three government
representatives, two industry
representatives, two public representatives
and two health professionals
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Technical Electronic Product Radiation Safety 5 Immediately
Standards Committee--Five vacancies 5 January 1, 2006
occurring immediately, two government
representatives, one industry representative
and two general public representatives; five
vacancies occurring January 1, 2006, one
industry representative, two government
representatives and two 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 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
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.
[[Page 49659]]
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
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.
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 shall 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 government representative or
health professional 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 or industry, 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 must 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 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 shall
include complete curriculum vitae of each nominee, current business
address and telephone number, and shall state that the nominee is aware
of the nomination, is willing to serve as a member, and appears to have
no conflict of interest that would preclude membership. FDA will ask
the potential candidates to provide detailed information concerning
such matters as financial holdings, employment, and research grants
and/or contracts to permit evaluation of possible sources of conflict
of interest.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14 relating to advisory committees.
Dated: August 18, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-16845 Filed 8-23-05; 8:45 am]
BILLING CODE 4160-01-S