[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.

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    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