[Federal Register Volume 62, Number 131 (Wednesday, July 9, 1997)]
[Notices]
[Pages 36829-36832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17795]
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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, 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, 1998.
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 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 government and industry
representatives for the Technical Electronic Product Radiation Safety
Standards Committee should be sent to Orhan Suleiman, CDRH (HFZ-240),
(address above).
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 consumer representatives
for the National Mammography Quality Assurance Advisory Committee,
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
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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: Two
vacancies immediately, three vacancies occurring November 30, 1997;
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 immediately;
interventional cardiologists, electrophysiologists, invasive (vascular)
radiologists, vascular and cardiothoracic surgeons, and cardiologists
with special interest in congestive heart failure.
3. Clinical Chemistry and Clinical Toxicology Devices Panel: Three
vacancies occurring February 28, 1998; doctors of medicine or
philosophy with experience in clinical chemistry, clinical toxicology,
clinical pathology, clinical laboratory medicine, or oncology.
4. Dental Products Panel: Two vacancies immediately, one vacancy
occurring October 31, 1997; 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.
5. Ear, Nose, and Throat Devices Panel: Three vacancies occurring
October 31, 1997; audiologists, otolaryngologists, neurophysiologist,
statisticians, or electrical or biomedical engineers.
6. Gastroenterology and Urology Devices Panel: Three vacancies
occurring December 31, 1997; nephrologists with expertise in diagnostic
and therapeutic management of adult and pediatric patient populations.
7. General and Plastic Surgery Devices Panel: Two vacancies
immediately, three vacancies occurring August 31, 1997; general
surgeons, plastic surgeons, biomaterials experts, laser experts, wound
healing experts or endoscopic surgery experts.
8. General Hospital and Personal Use Devices Panel: Five vacancies
immediately, two vacancies occurring December 31, 1997; internists,
pediatricians, neonatologists, gerontologists, nurses, biomedical
engineers or microbiologists/infection control practitioners or
experts.
9. Hematology and Pathology Devices Panel: One vacancy occurring
February 28, 1998; cytopathologists and histopathologists;
hematologists (blood banking, coagulation and hemostasis); molecular
biologists (nucleic acid amplification techniques), and
hematopathologists (oncology).
10. Immunology Devices Panel: Two vacancies immediately, one
vacancy occurring February 28, 1998; persons with experience in
medical, surgical, or clinical oncology, internal medicine, clinical
immunology, allergy, or clinical laboratory medicine.
11. Microbiology Devices Panel: Three vacancies occurring February
28, 1998; 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.
12. Obstetrics and Gynecology Devices Panel: Three vacancies
immediately, two vacancies occurring January 31, 1998; 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,
1997; 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.
14. Orthopedic and Rehabilitation Devices Panel: Three vacancies
immediately, two vacancies occurring August 31, 1997; 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 immediately, two
vacancies occurring January 31, 1998; 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.
16. National Mammography Quality Assurance Advisory Committee:
Seven vacancies occurring January 31, 1998; 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.
17. Device Good Manufacturing Practice Advisory Committee: Four
vacancies occurring May 31, 1998; one government representative, one
health professional, one industry representative, and one general
public representative.
18. Technical Electronic Product Radiation Safety Standards
Committee: Five vacancies occurring December 31, 1997; 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.
[[Page 36831]]
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.
Device Good Manufacturing Practice Advisory Committee
The functions of the committee are to review proposed regulations
for good manufacturing practices governing the methods used in, and the
facilities and controls used for, the manufacturing, packing, storage,
and installation of devices, and make recommendations on the
feasibility and reasonableness of the 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, as amended (21 U.S.C. 360(j)), 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 advise 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, as amended by the Safe Medical Devices
Act of 1990 (21 U.S.C. 360kk(f)), 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.
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.
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
[[Page 36832]]
shall state 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 30, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-17795 Filed 7-8-97; 8:45 am]
BILLING CODE 4160-01-P
