[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

[[Page 36830]]

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

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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