[Federal Register Volume 65, Number 177 (Tuesday, September 12, 2000)]
[Notices]
[Pages 55028-55030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23325]


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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 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 August 31, 2001.
    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 device panels 
should be sent to Nancy J. Pluhowski, Advisory Panel Coordinator, 
Office of Device Evaluation (HFZ-400), CDRH, Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850.
    All nominations and curricula vitae for the National Mammography 
Quality Assurance Advisory Committee, excluding consumer 
representatives, should be sent to Charles A. Finder, CDRH (HFZ-240), 
Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850.
    All nominations and curricula vitae for consumer representatives 
for the National Mammography Quality Assurance Advisory Committee 
should be sent to Mary C. Wallace, Office of Consumer Affairs (HFE-3), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, CDRH (HFZ-17), 
Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 
301-594-1283, ext. 114, ([email protected]).

SUPPLEMENTARY INFORMATION: FDA is requesting nominations of voting 
members for vacancies listed below.
    1. Anesthesiology and Respiratory Therapy Devices Panel: Three 
vacancies occurring November 30, 2000; 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: Three vacancies immediately, 
two vacancies occurring June 30, 2001; 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, 2000; 
dentists who have expertise in the areas of lasers, temporomandibular 
joint implants and/or endodontics; or experts in tissue engineering 
and/or bone physiology relative to the oral and maxillofacial area.
    4. Ear, Nose, and Throat Devices Panel: One vacancy immediately, 
two vacancies occurring October 31, 2000; audiologists, 
otolaryngologists, neurophysiologists, statisticians, or electrical or 
biomedical engineers.

[[Page 55029]]

    5. Gastroenterology and Urology Devices Panel: One vacancy 
immediately, two vacancies occurring December 31, 2000; nephrologists 
with expertise in diagnostic and therapeutic management of adult and 
pediatric patient populations.
    6. General and Plastic Surgery Devices Panel: One vacancy 
immediately, two vacancies occurring August 31, 2001; general surgeons, 
plastic surgeons, biomaterials experts, laser experts, wound healing 
experts or endoscopic surgery experts.
    7. General Hospital and Personal Use Devices Panel: Two vacancies 
immediately, two vacancies occurring December 31, 2000; internists, 
pediatricians, neonatologists, gerontologists, nurses, biomedical 
engineers or microbiologists/infection control practitioners or 
experts.
    8. Hematology and Pathology Devices Panel: Two vacancies 
immediately, one vacancy occurring February 28, 2001; cytopathologists 
and histopathologists, hematologists (blood banking, coagulation and 
hemostasis), molecular biologists (nucleic acid amplification 
techniques), and hematopathologists (oncology).
    9. Immunology Devices Panel: Two vacancies occurring February 28, 
2001; persons with experience in medical, surgical, or clinical 
oncology, internal medicine, clinical immunology, allergy, molecular 
diagnostics, or clinical laboratory medicine.
    10. Microbiology Devices Panel: Two vacancies occurring February 
28, 2001; infectious disease clinicians, e.g., pulmonary disease 
specialists, sexually transmitted disease specialists, pediatric 
infectious disease specialists; clinical microbiologists; clinical 
microbiology laboratory directors, clinical virologists with expertise 
in clinical diagnosis and in vitro diagnostic assays, e.g., 
hepatologists; molecular biologists; and clinical oncologists 
experienced with antitumor resistance and susceptibility.
    11. Neurological Devices Panel: Two vacancies occurring November 
30, 2000; neurologists with experience in pain management and the 
treatment of movement disorders, neurosurgeons with experience in 
pediatric and stereotactic neurosurgery, interventional 
neuroradiologists, biomedical engineers, or biostatisticians with 
interest in neurological devices.
    12. Obstetrics and Gynecology Devices Panel: Two vacancies 
occurring January 31, 2001; experts in reproductive endocrinology, 
endoscopy, electrosurgery, laser surgery, assisted reproductive 
technologies, and contraception; biostatisticians and engineers with 
experience in obstetrics/gynecology devices; urogynecologists; experts 
in breast care; and experts in gynecology in the older patient.
    13. Ophthalmic Devices Panel: Three vacancies occurring October 31, 
2000; ophthalmologists specializing in refractive surgery, vitreo-
retinal surgery, and the treatment of glaucoma; vision scientists, 
electrophysiologists and optometrists.
    14. Orthopaedic and Rehabilitation Devices Panel: One vacancy 
immediately; one vacancy occurring August 31, 2000; five vacancies 
occurring August 31, 2001; doctors of medicine or philosophy with 
experience in tissue engineering, calcification or biomaterials; 
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.
    15. Radiological Devices Panel: One vacancy occurring January 31, 
2001; physicians and scientists with expertise in nuclear medicine, 
diagnostic or therapeutic radiology, radiation physics, mammography, 
thermography, transillumination, hyperthermia cancer therapy, bone 
densitometry, magnetic resonance, computed tomography, or ultrasound.
    16. National Mammography Quality Assurance Advisory Committee: One 
vacancy immediately; six vacancies occurring January 31, 2001; five 
shall include physicians, practitioners, and other health professionals 
whose clinical practice, research specialization, or professional 
expertise include a significant focus on mammography; and two shall 
include consumer representatives from among national breast cancer or 
consumer health organizations with expertise in mammography.

Functions

Medical Devices Advisory Committee

    The committee reviews and evaluates data on the safety and 
effectiveness of marketed and investigational devices and makes 
recommendations for their regulation. The panels engage in a number of 
activities to fulfill the functions the Federal Food, Drug, and 
Cosmetic Act (the act) envisions for device advisory panels. With the 
exception of the Medical Devices Dispute Resolution Panel, each panel, 
according to its specialty area, advises the Commissioner of Food and 
Drugs (the Commissioner) regarding recommended classification or 
reclassification of devices into one of three regulatory categories; 
advises on any possible risks to health associated with the use of 
devices; advises on formulation of product development protocols; 
reviews premarket approval applications for medical devices; reviews 
guidelines and guidance documents; recommends exemption of certain 
devices from the application of portions of the act; advises on the 
necessity to ban a device; and responds to requests from the agency to 
review and make recommendations on specific issues or problems 
concerning the safety and effectiveness of devices. With the exception 
of the Medical Devices Dispute Resolution Panel, each panel, according 
to its specialty area, may also make appropriate recommendations to the 
Commissioner on issues relating to 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 dental drug panel are to evaluate and 
recommend whether various prescription drug products should be changed 
to over-the-counter status and to evaluate data and make 
recommendations concerning the approval of new dental drug products for 
human use.
    The Medical Devices Dispute Resolution Panel provides advice to the 
Commissioner on complex or contested scientific issues between the FDA 
and medical device sponsors, applicants, or manufacturers relating to 
specific products, marketing applications, regulatory decisions and 
actions by FDA, and agency guidance and policies. The panel makes 
recommendations on issues that are lacking resolution, are highly 
complex in nature, or result from challenges to regular advisory panel 
proceedings or agency decisions or actions.

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

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facilities in rural and health professional shortage areas and 
determining the effects of personnel 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

Panels of the Medical Devices Advisory Committee

    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 and individuals identified with 
consumer interests. Prior experience on Federal public advisory 
committees in the same or similar subject areas will also be considered 
relevant professional expertise. The particular needs 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 advisory 
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.

Consumer Representatives

    Any interested person may nominate one or more qualified persons as 
a member of a particular advisory committee to represent consumer 
interests as identified in this notice. To be eligible for selection, 
the applicant's experience and/or education will be evaluated against 
Federal civil service criteria for the position to which the person 
will be appointed.
    Selection of members representing consumer interests is conducted 
through procedures that include use of a consortium of consumer 
organizations that has the responsibility for recommending candidates 
for the agency's selection. Candidates should possess appropriate 
qualifications to understand and contribute to the committee's work.
    Nominations shall include a complete curriculum vita of each 
nominee 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. The 
nomination should state whether the nominee is interested only in a 
particular advisory committee or in any advisory committee. The term of 
office is up to 4 years, depending on the appointment date.
    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: September 1, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-23325 Filed 9-11-00; 8:45 am]
BILLING CODE 4160-01-F