[Federal Register: October 11, 2006 (Volume 71, Number 196)]
[Notices]
[Page 59793-59797]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11oc06-104]
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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 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
[[Page 59794]]
for current vacancies and those that will or may occur through August
31, 2007.
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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Geretta P. Wood, Center for Devices Certain Device Panels of the
and Radiological Health (HFZ-400), Medical Devices Advisory Committee
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD
20850, 301-594-2022, e-mail:
geretta.wood@fda.hhs.gov
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Nancy M. Wynne, Center for Devices National Mammography Quality
and Radiological Health (HFZ-240), Assurance Advisory Committee
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850,
e-mail: nancy.wynne@fda.hhs.gov
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Collin L. Figueroa, Center for Device Good Manufacturing Practice
Devices and Radiological Health Advisory Committee
(HFZ-342), Food and Drug
Administration, 2094 Gaither Rd.,
Rockville, MD 20850, e-mail:
collin.figueroa@fda.hhs.gov
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Richard V. Kaczmarek, Center for Technical Electronic Product
Devices and Radiological Health Radiation Safety Standards
(HFZ-240), Food and Drug Committee
Administration, 1350 Piccard Dr.,
Rockville, MD 20850, e-mail:
richard.kaczmarek@fda.hhs.gov
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FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ-17), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 301-827-7293, e-mail:
kathleen.walker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Vacancies
FDA is requesting nominations of voting members for vacancies
listed as follows:
Table 2.
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Current and
Committee/Panel Expertise Needed Upcoming Approximate
Vacancies Date Needed
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Anesthesiology and Respiratory 2 Immediately
Therapy Devices Panel of the Medical 2 December 1,
Devices Advisory Committee-- 2006
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 4 July 1, 2007
the 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 2 March 1, 2007
Toxicology 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 2 November 1,
Devices Advisory Committee-- 2006
dentists, engineers, and scientists
who have expertise in the areas of
dental implants, dental materials,
periodontology, tissue engineering,
and dental anatomy
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Ear, Nose, and Throat Devices Panel 1 November 1,
of the Medical Devices Advisory 2006
Committee--otologists,
neurotologists, and audiologists
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Gastroenterology and Urology Devices 2 January 1,
Panel of the Medical Devices 2007
Advisory Committee--
gastroenterologists, urologists, and
nephrologists
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General and Plastic Surgery Devices 2 Immediately
Panel of the Medical Devices 2 September 1,
Advisory Committee--surgeons 2007
(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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[[Page 59795]]
Hematology and Pathology Devices 3 Immediately
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
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Immunology Devices Panel of the 2 March 1, 2007
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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Medical Devices Dispute Resolution 1 Immediately
Panel of 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 3 Immediately
Medical Devices Advisory Committee-- 2 March 1, 2007
infectious disease clinicians (e.g.,
pulmonary disease specialists,
sexually transmitted disease
specialists, pediatric infectious
disease specialists, experts in
tropical medicine and emerging
infectious diseases, and
mycologists); clinical
microbiologists and virologists;
clinical virology and microbiology
laboratory directors, with expertise
in clinical diagnosis and in vitro
diagnostic assays (e.g.,
hepatologists and molecular
biologists)
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Molecular and Clinical Genetics 1 Immediately
Devices Panel of the Medical Devices 3 June 1, 2007
Advisory Committee--experts in human
genetics and in the clinical
management of patients with genetic
disorders (e.g., pediatricians,
obstetricians, and neonatologists);
individuals with training in inborn
errors of metabolism, biochemical
and/or molecular genetics,
population genetics, epidemiology,
and related statistical training;
individuals with experience in
genetic counseling or medical
ethics; ancillary fields of study
will be considered as well
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Obstetrics and Gynecology Devices 2 February 1,
Panel of the Medical Devices 2007
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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Radiological Devices Panel of the 1 February 1,
Medical Devices Advisory Committee-- 2007
physicians with 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 1 February 1,
Assurance Advisory Committee-- 2007
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 9 Immediately
Advisory 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 10 Immediately
Radiation Safety Standards 5 January 1,
Committee--10 vacancies occurring 2007
immediately, 4 government
representatives, 2 industry
representatives, and 4 general
public representatives; 5 vacancies
occurring January 1, 2007, 3
industry representatives, 1
government representative, and 1
general public representative
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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)
[[Page 59796]]
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.
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 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 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.
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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 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 will
include complete curriculum vitae of each nominee, current business
address and telephone number. Nominations will specify the advisory
panel(s) or advisory committee(s) for which the nominee is recommended.
Nominations will include confirmation that the nominee is aware of the
nomination, is willing to serve as a member of the advisory committee
if selected, and appears to have no conflict of interest that would
preclude membership. 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 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: October 3, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-16679 Filed 10-10-06; 8:45 am]
BILLING CODE 4160-01-S