[Federal Register Volume 64, Number 197 (Wednesday, October 13, 1999)]
[Notices]
[Pages 55481-55483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26640]


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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, the National Mammography Quality 
Assurance Advisory Committee, and the Technical Electronic Product 
Radiation Safety Standards Committee in the Center for Devices and 
Radiological Health (CDRH). Nominations will be accepted for current 
vacancies and for those that will or may occur through August 31, 2000.
     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 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 government and industry 
representatives for the Technical Electronic Product Radiation Safety 
Standards Committee should be sent to Orhan H. Suleiman, CDRH (HFZ-
240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850.
     All nominations and curricula vitae for general public 
representatives for the Technical Electronic Product Radiation Safety 
Standards Committee should be sent to Annette Funn, Office of Consumer 
Affairs (HFE-88), 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.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations of voting 
members for vacancies listed below.
     1. Circulatory System Devices Panel: Three vacancies occurring 
June 30, 2000; interventional cardiologists, electrophysiologists, 
invasive (vascular) radiologists, vascular and cardiothoracic

[[Page 55482]]

surgeons, and cardiologists with special interest in congestive heart 
failure.
     2. Clinical Chemistry and Clinical Toxicology Devices Panel: Three 
vacancies occurring February 28, 2000; doctors of medicine or 
philosophy with experience in clinical chemistry, clinical toxicology, 
clinical pathology, clinical laboratory medicine, endocrinology or 
oncology.
     3. Dental Products Panel: One vacancy immediately, one vacancy 
occurring October 31, 1999; dentists who have expertise in the areas of 
lasers, endosseous implants, temporomandibular joint implants, dental 
materials and/or endodontics; or experts in bone physiology relative to 
the oral and maxillofacial area.
     4. Ear, Nose, and Throat Devices Panel: One vacancy occurring 
October 31, 1999; audiologists, otolaryngologists, neurophysiologist, 
statisticians, or electrical or biomedical engineers.
     5. General and Plastic Surgery Devices Panel: One vacancy 
immediately; 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, one vacancy occurring December 31, 1999; 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, 2000; cytopathologists and histopathologists; 
hematologists (blood banking, coagulation and hemostasis); molecular 
biologists (nucleic acid amplification techniques), and 
hematopathologists (oncology).
     8. Immunology Devices Panel: Three vacancies occurring February 
28, 2000; persons with experience in medical, surgical, or clinical 
oncology, internal medicine, clinical immunology, allergy, molecular 
diagnostics, or clinical laboratory medicine.
     9. Microbiology Devices Panel: One vacancy occurring February 28, 
2000; infectious disease clinicians, e.g., pulmonary disease 
specialists, sexually transmitted disease (STD) specialists, pediatric 
infectious disease specialists; clinical microbiologists; clinical 
microbiology laboratory directors, clinical virologists with expertise 
in clinical diagnosis and in vitro diagnostic (IVD) assays, e.g., 
hepatologists; molecular biologists; and clinical oncologists 
experienced with antitumor resistance and susceptibility.
     10. Obstetrics and Gynecology Devices Panel: One vacancy occurring 
January 31, 2000; 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.
     11. Ophthalmic Devices Panel: One vacancy occurring October 31, 
1999; ophthalmologists specializing in refractive surgery, vitreo-
retinal surgery, and the treatment of glaucoma; vision scientists and 
electrophysiologists.
     12. Orthopaedic and Rehabilitation Devices Panel: One vacancy 
immediately; one vacancy occurring August 31, 2000; 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.
     13. Radiological Devices Panel: Two vacancies occurring January 
31, 2000; 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.
     14. National Mammography Quality Assurance Advisory Committee: 
Three vacancies occurring January 31, 2000; physicians, practitioners, 
and other health professionals whose clinical practice, research 
specialization, or professional expertise include a significant focus 
on mammography.
     15. Technical Electronic Product Radiation Safety Standards 
Committee: Five vacancies occurring December 31, 1999; two government 
representatives, one industry representative, and two general public 
representatives.

 Functions

 Medical Devices 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 (the 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 
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; and (2) evaluate data and make 
recommendations concerning the approval of new dental drug products for 
human use.

 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 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.

 Technical Electronic Product Radiation Safety Standards Committee

     The function of the 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.

[[Page 55483]]

     Section 534(f) of the act (21 U.S.C. 360kk(f)), as amended by the 
Safe Medical Devices Act of 1990, provides that the Technical 
Electronic Product Radiation Safety Standards Committee include five 
members from governmental agencies, including State or Federal 
Governments, five members from the affected industries, and five 
members from the general public, of which at least one shall be a 
representative of organized labor.

 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 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.

 Technical Electronic Product Radiation Safety Standards Committee

     Persons nominated 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 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/General Public 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 which include use of a consortium of consumer 
organizations which 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 30, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-26640 Filed 10-12-99; 8:45 am]
BILLING CODE 4160-01-F