[Federal Register Volume 61, Number 164 (Thursday, August 22, 1996)]
[Notices]
[Pages 43369-43370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21357]
[[Page 43369]]
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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 that will or may occur through June 30, 1997.
-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, Office of Device Evaluation (HFZ-400),
Center for Devices and Radiological Health, 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, 2098
Gaither Rd., Rockville, MD 20850, 301-594-1283, ext. 114.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations of voting
members for vacancies listed below.
-1. Anesthesiology and Respiratory Therapy Devices Panel: One
vacancy occurring November 30, 1996; anesthesiologists, pulmonary
medicine specialists, or other experts who have specialized interests
in ventilatory support, pharmacology, physiology, or the effects and
complications of anesthesia.
-2. Circulatory System Devices Panel: Two vacancies occurring June
30, 1997; interventional cardiologists, electrophysiologists, invasive
(vascular) radiologists, vascular and cardiothoracic surgeons, and
cardiologists with special interest in congestive heart failure.
-3. Dental Products Panel: Two vacancies occurring October 31,
1996; dentists who have experience with lasers, endosseous implants,
and temporomandibular joint implants; or experts in bone physiology
relative to the oral and maxillofacial area.
-4. Gastroenterology and Urology Devices Panel: Three vacancies
immediately; nephrologists, urologists, and gastroenterologists with
expertise in diagnostic and therapeutic management of adult and
pediatric patient populations.
-5. General and Plastic Surgery Devices Panel: One vacancy
immediately, one vacancy occurring August 31, 1996; general surgeons,
plastic surgeons, biomaterials experts, laser experts, wound healing
experts, or endoscopic surgery experts.
-6. General Hospital and Personal Use Devices Panel: One vacancy
immediately, four vacancies occurring December 31, 1996; internists,
pediatricians, neonatologists, gerontologists, nurses, biomedical
engineers, or microbiologists/infection control practitioners or
experts.
-7. Hematology and Pathology Devices Panel: Two vacancies occurring
February 28, 1997; cytopathologists and histopathologists;
hematologists (blood banking, coagulation, and hemostatis); molecular
biologists (nucleic acid amplification techniques), and
hematopathologists (oncology).
-8. Immunology Devices Panel: Three vacancies immediately, two
vacancies occurring February 28, 1997; persons with experience in
medical, surgical, or clinical oncology, internal medicine, clinical
immunology, allergy, or clinical laboratory medicine.
9. Microbiology Devices Panel: Two vacancies occurring February
28, 1997; 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, 1996; neurologists, epileptologists, 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: Two vacancies
immediately, one vacancy occurring January 31, 1997; experts in
reproductive endocrinology, endoscopy, electrosurgery, laser surgery,
assisted reproductive technologies, and contraception.
-12. Ophthalmic Devices Panel: One vacancy immediately, one vacancy
occurring October 31, 1996; ophthalmologists specializing in glaucoma,
surgical pediatric ophthalmology (experienced in correction of
aphakia), retinal diseases or corneal diseases; optometrists with
expertise in contact lenses, or specialists in clinical study design.
-13. Orthopedic and Rehabilitation Devices Panel: Two vacancies
immediately; 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,
1997; physicians and scientists with expertise in nuclear medicine,
diagnostic or therapeutic radiology, mammography, thermography,
transillumination, hyperthermia cancer therapy, bone densitometry,
magnetic resonance, computed tomography, or ultrasound.
[[Page 43370]]
-15. National Mammography Quality Assurance Advisory Committee:
Five vacancies immediately, six vacancies occurring January 31, 1997;
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
advisory 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; (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 or other requirements 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.
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 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 practice,
research specialization, 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: August 13, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-21357 Filed 8-21-96; 8:45 am]
BILLING CODE 4160-01-F
