[Federal Register Volume 66, Number 140 (Friday, July 20, 2001)]
[Notices]
[Pages 37978-37980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-18161]


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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 Products Radiation 
Safety Standards Committee in the Center for Devices and Radiological 
Health. Nominations will be accepted for current vacancies and those 
that will or may occur through August 31, 2002.
    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), Center for Devices and 
Radiological Health, Food and Drug Administration, 9200 Corporate 
Blvd., Rockville, MD 20850, e-mail: [email protected].
    All nominations and curricula vitae for the National Mammography 
Quality Assurance Advisory Committee, excluding consumer 
representatives, should be sent to Charles A. Finder, Center for 
Devices and Radiological Health (HFZ-240), Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850.
    All nominations and curricula vitae for industry representatives 
and government representatives for the Device Good Manufacturing 
Practice Advisory Committee should be sent to Sharon Kalokerinos, 
Center for Devices and Radiological Health (HFZ-300), Food and Drug 
Administration, 2094 Gaither Rd., Rockville, MD 20850.
    All nominations and curricula vitae for government representatives 
and industry representatives for the Technical Electronic Product 
Radiation Safety Standards Committee should be sent to Orhan Suleiman, 
Center for Devices and Radiological Health (HFZ-240), Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850.
    All nominations and curricula vitae for consumer representatives 
for the National Mammography Quality Assurance Advisory Committee, and 
general public representatives for the Device Good Manufacturing 
Practice Advisory Committee and the Technical Electronic Product 
Radiation Safety Standards Committee should be sent to Maureen Hess, 
Office of Consumer Affairs (HFE-50), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, e-mail: [email protected].

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, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting nominations of voting 
members for vacancies listed below.
    1. Anesthesiology and Respiratory Therapy Devices Panel: Two 
vacancies occurring November 30, 2001; 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. Dental Products Panel: Two vacancies immediately; dentists who 
have expertise in the areas of lasers, temporomandibular joint implants 
and/or endodontics; or experts in tissue engineering and/or bone 
physiology relative to the oral and maxillofacial area.
    4. Ear, Nose, and Throat Devices Panel: Three vacancies occurring 
October 31, 2001; otologists, neurotologists, audiologists, hearing 
scientists, and electrophysiologists.
    5. Gastroenterology and Urology Devices Panel: Three vacancies 
occurring December 31, 2001; urologists, gastroenterologists, and 
biostatisticians.
    6. General and Plastic Surgery Devices Panel: Three vacancies 
immediately, three vacancies occurring August 31, 2002; general 
surgeons, plastic surgeons, biomaterials experts, laser experts, wound 
healing experts or endoscopic surgery experts.
    7. General Hospital and Personal Use Devices Panel: Four vacancies 
immediately, three vacancies occurring December 31, 2001; internists, 
pediatricians, neonatologists, endocrinologists, gerontologists, 
nurses, biomedical engineers or microbiologists/infection control 
practitioners or experts.
    8. Immunology Devices Panel: One vacancy occurring February 28, 
2002; persons with experience in medical, surgical, or clinical 
oncology, internal medicine, clinical immunology, allergy, molecular 
diagnostics, or clinical laboratory medicine.
    9. Medical Devices Dispute Resolution Panel: One vacancy 
immediately;

[[Page 37979]]

experts with broad, cross-cutting scientific, clinical, analytical or 
mediation skills.
    10. Microbiology Devices Panel: Two vacancies occurring February 
28, 2002; infectious disease clinicians, e.g., pulmonary disease 
specialists, sexually transmitted disease specialists, pediatric 
infectious disease specialists, mycologists; clinical microbiologists; 
clinical microbiology laboratory directors, and clinical virologists 
with expertise in clinical diagnosis and in vitro diagnostic assays, 
e.g., hepatologists; molecular biologists.
    11. Neurological Devices Panel: Three vacancies occurring November 
30, 2001; neurosurgeons (cerebrovascular and pediatric), neurologists 
(pain management and movement disorders), interventional 
neuroradiologists, or biostatisticians.
    12. Obstetrics and Gynecology Devices Panel: Two vacancies 
occurring January 31, 2002; experts in perinatology, embryology, 
reproductive endocrinology, operative hysteroscopy, pelviscopy, 
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. Orthopaedic and Rehabilitation Devices Panel: Five vacancies 
immediately; 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.
    14. Radiological Devices Panel: One vacancy immediately, two 
vacancies occurring January 31, 2002; physicians and scientists with 
expertise in nuclear medicine, diagnostic or therapeutic radiology, 
radiation physics, mammography, thermography, transillumination, 
hyperthermia cancer therapy, bone densitometry, magnetic resonance 
imaging, computed tomography, ultrasound imaging, statistical analysis, 
digital imaging and image processing, or computer-aided detection and 
diagnosis.
    15. National Mammography Quality Assurance Advisory Committee: Four 
vacancies occurring January 31, 2002; two 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.
    16. Device Good Manufacturing Practice Advisory Committee: Three 
vacancies occurring May 31, 2002; one government representative, one 
industry representative, and one general public representative.
    17. Technical Electronic Product Radiation Safety Standards 
Committee: Five vacancies occurring December 31, 2001, two government 
representatives, one industry representative, and two general public 
representatives.

Functions

Medical Devices Advisory Committee

    The committee reviews and evaluates data on the safety and 
effectiveness of marketed and investigational devices and makes 
recommendations for their regulation. The panels engage in a number of 
activities to fulfill the functions the Federal Food, Drug, and 
Cosmetic Act (the act) envisions for device advisory panels. With the 
exception of the Medical Devices Dispute Resolution Panel, each panel, 
according to its specialty area, advises the Commissioner of Food and 
Drugs (the Commissioner) regarding recommended classification or 
reclassification of devices into one of three regulatory categories; 
advises on any possible risks to health associated with the use of 
devices; advises on formulation of product development protocols; 
reviews premarket approval applications for medical devices; reviews 
guidelines and guidance documents; recommends exemption of certain 
devices from the application of portions of the act; advises on the 
necessity to ban a device; and responds to requests from the agency to 
review and make recommendations on specific issues or problems 
concerning the safety and effectiveness of devices. With the exception 
of the Medical Devices Dispute Resolution Panel, each panel, according 
to its specialty area, may also make appropriate recommendations to the 
Commissioner on issues relating to 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 dental drug panel are to evaluate and 
recommend whether various prescription drug products should be changed 
to over-the-counter status and to evaluate data and make 
recommendations concerning the approval of new dental drug products for 
human use.
    The Medical Devices Dispute Resolution Panel provides advice to the 
Commissioner on complex or contested scientific issues between the FDA 
and medical device sponsors, applicants, or manufacturers relating to 
specific products, marketing applications, regulatory decisions and 
actions by FDA, and agency guidance and policies. The panel makes 
recommendations on issues that are lacking resolution, are highly 
complex in nature, or result from challenges to regular advisory panel 
proceedings or agency decisions or actions.

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 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

[[Page 37980]]

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: (1) Three of the members shall be 
appointed from persons who are officers or employees of any Federal, 
State, or local government; (2) two shall be representatives of 
interests of the device manufacturing industry; (3) two shall be 
representatives of the interests of physicians and other health 
professionals; and (4) 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

Panels of the Medical Devices Advisory Committee

    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 that include use of a consortium of consumer 
organizations that 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: July 16, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-18161 Filed 7-19-01; 8:45 am]
BILLING CODE 4160-01-S