[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]]

-----------------------------------------------------------------------


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.

-----------------------------------------------------------------------

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