[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
