[Federal Register Volume 60, Number 40 (Wednesday, March 1, 1995)]
[Notices]
[Pages 11099-11101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-4910]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Request for Nominations for Voting Members on Public Advisory
Panels or Committees in the Center for Devices and Radiological Health
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 and on the National Mammography
Quality Assurance Advisory Committee in the Center for Devices and
Radiological Health (CDRH). Nominations will be accepted for current
vacancies and those vacancies that will or may occur through February
28, 1996.
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 nominations and curricula vitae for the panels should be
sent to Nancy J. Pluhowski, Center for Devices and Radiological Health
(HFZ-400), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850.
All nominations and curricula vitae for the National Mammography
Quality Assurance Advisory Committee should be sent to Charles K.
Showalter, Center for Devices and Radiological Health (HFZ-240), Food
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850.
FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for
Devices and Radiological Health (HFZ-17), Food and Drug Administration,
1350 Piccard Dr., Rockville, MD 20850, 301-443-6932.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations of voting
members for the vacancies listed below.
1. Anesthesiology and Respiratory Therapy Devices Panel: One
vacancy occurring November 30, 1995; general anesthesiologists,
anesthesiologists specializing in regional anesthesia, physicians with
expertise in ventilatory support, or nurse
anesthetists. [[Page 11100]]
2. Circulatory System Devices Panel: Three vacancies occurring June
30, 1995; interventional cardiologists, electrophysiologists, invasive
(vascular) radiologists, vascular and cardiothoracic surgeons, and
cardiologists with special interest in congestive heart failure.
3. Clinical Chemistry and Clinical Toxicology Devices Panel: Three
vacancies occurring February 28, 1996; doctors of medicine or
philosophy with experience in clinical chemistry, clinical toxicology,
clinical pathology, clinical laboratory medicine, or oncology.
4. Dental Products Panel: Two vacancies occurring October 31, 1995;
dentists who have experience with lasers, endosseous implants, and
temporomandibular joint implants; or experts in bone physiology
relative to the oral and maxillofacial area.
5. Ear, Nose, and Throat Devices Panel: One vacancy occurring
October 31, 1995; audiologists, otolaryngologists, neurophysiologists,
statisticians, or electrical or biomedical engineers.
6. Gastroenterology and Urology Devices Panel: Three vacancies
occurring December 31, 1995; nephrologists, urologists, and
gastroenterologists with expertise in diagnostic and therapeutic
management of adult and pediatric patient populations.
7. Hematology and Pathology Devices Panel: One vacancy occurring
February 28, 1996; cytopathologists and histopathologists;
hematologists (blood banking, coagulation, and hemostatis); molecular
biologists (nucleic acid amplification techniques), and
hematopathologists (oncology).
8. Immunology Devices Panel: Two vacancies occurring February 28,
1996; medical or surgical oncologists experienced with tumor markers,
or clinical immunologists.
9. Microbiology Devices Panel: One vacancy occurring February 28,
1996; infectious disease clinicians; clinical microbiologists with
expertise in antimicrobial and antimycobacterial susceptibility testing
and chemotherapy; clinical virologists with expertise in diagnosis and
assays; clinical oncologists experienced with antitumor resistance and
susceptibility; and molecular biologists.
10. Neurological Devices Panel: Two vacancies occurring November
30, 1995; neurologists, biomedical engineers, interventional
neuroradiologists, neurosurgeons with interest in medical devices, or
persons experienced with neurological devices with a strong background
in biostatistics.
11. Obstetrics and Gynecology Devices Panel: One vacancy occurring
January 31, 1996; experts in reproductive endocrinology, endoscopy,
electrosurgery, laser surgery, assisted reproductive technologies, and
contraception.
12. Ophthalmic Devices Panel: Two vacancies occurring October 31,
1995; ophthalmologists specializing in glaucoma, surgical pediatric
ophthalmology (experienced in correction of aphakia), retinal diseases
or corneal diseases; and optometrists with expertise in contact lenses.
13. Orthopedic and Rehabilitation Devices Panel: One vacancy
occurring August 31, 1995; orthopedic surgeons experienced with
prosthetic ligament devices, joint implants, or spinal instrumentation;
physical therapists experienced in spinal cord injuries,
neurophysiology, electrotherapy, and joint biomechanics;
rheumatologists; or biomedical engineers.
14. Radiological Devices Panel: One vacancy occurring January 31,
1996; physicians and scientists with expertise in nuclear medicine,
diagnostic or therapeutic radiology, mammography, thermography,
transillumination, hyperthermia, bone densitometry, magnetic resonance,
computed tomography, or ultrasound.
15. National Mammography Quality Assurance Advisory Committee: Four
vacancies occurring January 31, 1996; physicians, practitioners, and
other health professionals, whose clinical practice, research
specialization, or professional expertise include a significant focus
on mammography.
Functions
Medical Device Panels
The functions of the panels are to: (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
Federal Food, Drug, and Cosmetic 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.
The Dental Products Panel also functions at times as a dental drug
panel. The functions of the drug panel are to: (1) Evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status; (2) evaluate data and make recommendations
concerning the approval of new dental drug products for human use; (3)
evaluate data and make recommendations concerning drug products that
may also be cosmetics; and (4) using a Plaque Subcommittee, review and
evaluate data concerning the safety and effectiveness of active
ingredients, and combinations thereof, of various currently marketed
dental drug products for human use, and the adequacy of their labeling.
The subcommittee will advise on the promulgation of monographs
establishing conditions under which these drugs are generally
recognized as safe and effective and not misbranded.
National Mammography Quality Assurance Advisory Committee
The functions of the committee are to advise FDA on: (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; and (6) reporting new
developments concerning breast imaging which should be considered in
the oversight of mammography facilities.
The committee will also determine whether there exists a shortage
of mammography facilities in rural and health professional shortage
areas and the effects of personnel or other requirements on access to
the services of such facilities in such areas; whether there will exist
a sufficient number of medical physicists after October 1, 1999, and
the costs and benefits of compliance with these requirements.
Qualifications
Medical Device Panels
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 [[Page 11101]] 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 shown above. The term of office is up to 4
years, depending on the appointment date.
National Mammography Quality Assurance Advisory Committee
Persons nominated for membership should be physicians,
practitioners, and other health professionals, whose clinical
practices, research specializations, or professional expertise include
a significant focus on mammography. Prior experience on Federal public
advisory committees in the same or similar subject areas will also be
considered relevant professional expertise. The particular needs for
this committee are shown above. The term of office is up to 4 years,
depending on the appointment date.
Nomination Procedures
Any interested person may nominate one or more qualified persons
for membership on one or more of the advisory panels or the National
Mammography Quality Assurance Advisory Committee. Self-nominations are
also accepted. Nominations shall include a 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: February 21, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-4910 Filed 2-28-95; 8:45 am]
BILLING CODE 4160-01-F
