[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