[Federal Register Volume 59, Number 115 (Thursday, June 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14647]
[[Page Unknown]]
[Federal Register: June 16, 1994]
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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 and on the Technical Electronic
Product Radiation Safety Standards Committee in the Center for Devices
and Radiological Health. Nominations will be accepted for current
vacancies and for those that will or may occur through February 28,
1995.
FDA has a special interest in ensuring that women, minority groups,
and individuals with disabilities are adequately represented on
advisory committees and, therefore, extends particular encouragement to
nominations for appropriately qualified female, minority, and
physically disabled candidates.
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, 1390 Piccard Dr., Rockville,
MD 20850.
All nominations and curricula vitae for the Technical Electronic
Product Radiation Safety Standards Committee should be sent to Kay A.
Levin (address below).
FOR FURTHER INFORMATION CONTACT: Kay A. Levin, Center for Devices and
Radiological Health (HFZ-10), Food and Drug Administration, 12720
Twinbrook Pkwy., Rockville, MD 20857, 301-443-9422.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations of voting
members for vacancies listed below.
1. Anesthesiology and Respiratory Therapy Devices Panel: Six
vacancies immediately, one vacancy occurring November 30, 1994; general
anesthesiologists, anesthesiologists with a specialty in regional
anesthesia, physicians having expertise in ventilatory support, or
nurse anesthetist.
2. Clinical Chemistry and Clinical Toxicology Devices Panel: Three
vacancies immediately, one vacancy occurring February 28, 1995; doctors
of medicine or philosophy with experience in clinical chemistry,
clinical toxicology, clinical pathology, clinical laboratory medicine,
or oncology.
3. Dental Products Panel: One vacancy immediately, two vacancies
occurring October 31, 1994; individuals with expertise in lasers for
dental use, dental endosseous implants, temporomandibular joint
implants, or bone physiology as it applies to the oral and
maxillofacial area.
4. Ear, Nose, and Throat Devices Panel: One vacancy occurring
October 31, 1994; audiologist, otolaryngologist, neurophysiologist,
statistician, or electrical or biomedical engineer.
5. Gastroenterology and Urology Devices Panel: Three vacancies
immediately, one vacancy occurring December 31, 1994;
gastroenterologists, nephrologists, or urologists with expertise in
pediatrics or lithotripsy, or experience in diagnosis and treatment of
impotence, incontinence, and prostatism.
6. General and Plastic Surgery Devices Panel: Two vacancies
occurring August 31, 1994; general surgeons.
7. General Hospital and Personal Use Devices Panel: One vacancy
immediately; experts in pediatrics, internal medicine, neonatology,
gerontology, infection control, or biomedical engineering.
8. Hematology and Pathology Devices Panel: One vacancy immediately,
three vacancies occurring February 28, 1995; cytopathologists.
9. Immunology Devices Panel: One vacancy immediately, two vacancies
occurring February 28, 1995; oncologists, medical or surgical
oncologists with experience with tumor markers, or clinical
immunologists.
10. Microbiology Devices Panel: One vacancy occurring February 28,
1995; an infectious disease clinician or expert in antimicrobial
susceptibility testing devices, and/or virology testing devices, and/or
biotechnology; or clinical oncologist with experience with tumor
markers.
11. Neurological Devices Panel: Seven vacancies immediately;
neurologists, biomedical engineers, interventional neuroradiologists,
neurosurgeons with interest in medical devices, or persons experienced
with neurological devices with a strong background in biostatistics.
12. Obstetrics and Gynecology Devices Panel: Four vacancies
immediately, two vacancies occurring January 31, 1995; experts in
endoscopy, electrosurgery, laser surgery, and assisted reproductive
technologies, contraception, and/or instrumentation used during these
procedures, or reproductive endocrinology.
13. Orthopedic and Rehabilitation Devices Panel: One vacancy
occurring August 31, 1994; orthopedic surgeon with expertise in joint
structure and function, prosthetic ligament devices, joint biomechanics
and implants, or spinal instrumentation; physical therapist with
expertise in spinal cord injuries, neurophysiology, electrotherapy, and
joint biomechanics; rheumatologist; or biomedical engineer.
14. Radiological Devices Panel: Four vacancies immediately, two
vacancies occurring January 31, 1995; 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. Technical Electronic Product Radiation Safety Standards
Committee: One vacancy immediately, three vacancies occurring December
31, 1994; employees of governmental agencies, including State or
Federal Government.
Functions
Medical Device and Dental Products Panels
The functions of the panels are to: (1) Review and evaluate
available data concerning the safety and effectiveness of marketed and
investigational devices; (2) advise the Commissioner of Food and Drugs
regarding recommended classification of these devices into one of three
regulatory categories; (3) recommend the assignment of a priority for
the application of regulatory requirements for devices classified in
the standards or premarket approval category; (4) advise on any
possible risks to health associated with the use of devices; (5) advise
on formulation of product development protocols and review premarket
approval applications for those devices classified in the premarket
approval category; (6) review classification of devices to recommend
changes in classification as appropriate; (7) recommend exemption of
certain devices from the application of portions of the Federal Food,
Drug, and Cosmetic Act; (8) advise on the necessity to ban a device;
and (9) respond to requests from the agency to review and make
recommendations on specific issues or problems concerning the safety
and effectiveness of devices.
The Dental Products Panel will also function at times as a drug
advisory panel. As such, the panel reviews and evaluates available data
concerning the safety and effectiveness of active ingredients, and
combinations thereof, of various currently marketed dental drug
products for human use, the adequacy of their labeling, and advises the
Commissioner of Food and Drugs on the promulgation of monographs
establishing conditions under which these drugs are generally
recognized as safe and effective and not misbranded. The panel also
evaluates and recommends whether various prescription drug products
should be changed to over-the-counter status. The panel also evaluates
data and makes recommendations concerning the approval of new dental
drug products for human use.
Technical Electronic Product Radiation Safety Standards Committee
The function of the Technical Electronic Product Radiation Safety
Standards 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.
Qualifications
Medical Device and Dental Products 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.
Technical Electronic Product Radiation Safety Standards Committee
Persons nominated for the Technical Electronic Product Radiation
Safety Standards Committee 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
for this committee are identified 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 committees.
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: June 10, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-14647 Filed 6-15-94; 8:45 am]
BILLING CODE 4160-01-F
