[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Notices]
[Pages 36244-36246]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17603]
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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 Device Good Manufacturing
Practice 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 those that will or may occur through June 30, 1999.
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, Office of Device Evaluation (HFZ-
400), CDRH, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850.
All nominations and curricula vitae for health professionals,
industry representatives, and government representatives for the Device
Good Manufacturing Practice Advisory Committee should be sent to Sharon
Kalokerinos, CDRH (HFZ-300), Food and Drug Administration, 2094 Gaither
Rd., 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 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 Device Good Manufacturing Practice Advisory
Committee and 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, 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. Circulatory System Devices Panel: Two vacancies occurring June
30, 1999; interventional cardiologists, electrophysiologists, invasive
(vascular) radiologists, vascular and cardiothoracic surgeons, and
cardiologists with special interest in congestive heart failure.
2. Clinical Chemistry and Clinical Toxicology Devices Panel: One
vacancy occurring February 28, 1999; doctors of medicine or philosophy
with experience in clinical chemistry, clinical toxicology, clinical
pathology, clinical laboratory medicine, or oncology.
3. Dental Products Panel: Three vacancies immediately, one vacancy
occurring October 31, 1998; 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, 1998; audiologists, otolaryngologists, neurophysiologist,
statisticians, or electrical or biomedical engineers.
5. General Hospital and Personal Use Devices Panel: Three vacancies
immediately, one vacancy occurring December 31, 1998; internists,
pediatricians, neonatologists, gerontologists, nurses, biomedical
engineers or microbiologists/infection control practitioners or
experts.
6. Hematology and Pathology Devices Panel: Two vacancies occurring
February 28, 1999; cytopathologists and histopathologists;
hematologists (blood banking, coagulation and hemostasis); molecular
biologists (nucleic acid amplification techniques), and
hematopathologists (oncology).
7. Immunology Devices Panel: One vacancy immediately, one vacancy
occurring February 28, 1999; persons with experience in medical,
surgical, or clinical oncology, internal medicine, clinical immunology,
allergy, molecular diagnostics, human genetics testing or clinical
laboratory medicine.
8. Microbiology Devices Panel: Three vacancies immediately, one
vacancy occurring February 28, 1999; infectious disease clinicians;
clinical microbiologists with expertise in antimicrobial and
antimycobacterial susceptibility testing, chemotherapy and in vitro
diagnostic (IVD) applications; clinical virologists with expertise in
clinical diagnosis and IVD assays; clinical oncologists experienced
with antitumor resistance and susceptibility; and molecular biologists.
9. Obstetrics and Gynecology Devices Panel: Two vacancies occurring
January 31, 1999; 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.
10. Orthopaedic and Rehabilitation Devices Panel: Two vacancies
occurring August 31, 1998; 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.
11. Radiological Devices Panel: Two vacancies occurring January 31,
1999; 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.
12. Device Good Manufacturing Practice Advisory Committee: Four
vacancies immediately, one government representative, one health
professional, one industry representative, and one general public
representative; five
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vacancies occurring May 31, 1999; two government representatives, one
health professional, one industry representative, and one general
public representative.
13. Technical Electronic Product Radiation Safety Standards
Committee: Five vacancies immediately, two government representatives,
one industry representative, and two general public representatives;
five vacancies occurring December 31, 1998, one government
representative, three industry representatives, and one general public
representative.
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.
Device Good Manufacturing Practice Advisory Committee
The functions of the committee are to review proposed regulations
for promulgation regarding good manufacturing practices governing the
methods used in, and the facilities and controls used for manufacture,
packaging, storage, installation, and servicing of devices, and make
recommendations regarding the feasibility and reasonableness of those
proposed regulations. The committee also reviews and makes
recommendations on proposed guidelines developed to assist the medical
device industry in meeting the good manufacturing practice
requirements, and provides advice with regard to any petition submitted
by a manufacturer for an exemption or variance from good manufacturing
practice regulations.
Section 520 of the act (21 U.S.C. 360(j)), as amended, provides
that the Device Good Manufacturing Practice Advisory Committee shall be
composed of nine members as follows: Three of the members shall be
appointed from persons who are officers or employees of any Federal,
State, or local government, two shall be representatives of interests
of the device manufacturing industry, two shall be representatives of
the interests of physicians and other health professionals, and two
shall be representatives of the interests of the general public.
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.
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.
Device Good Manufacturing Practice Advisory Committee
Persons nominated for membership as a government representative or
health professional should have knowledge of or expertise in any one or
more of the following areas: Quality assurance concerning the design,
manufacture, and use of medical devices. To be eligible for selection
as a representative of the general public or industry, nominees should
possess appropriate qualifications to understand and contribute to the
committee's work. 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 or panel 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.
[[Page 36246]]
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 vitae of each
nominee and shall state the 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: June 26, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-17603 Filed 7-1-98; 8:45 am]
BILLING CODE 4160-01-F