[Federal Register Volume 67, Number 117 (Tuesday, June 18, 2002)]
[Notices]
[Pages 41429-41432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15210]


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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 (MDAC), the National Mammography 
Quality Assurance Advisory Committee (NMQAAC), the Device Good 
Manufacturing Practice Advisory Committee (DGMPAC), and the Technical 
Electronic Products Radiation Safety Standards Committee (TEPRSSC) in 
the Center for Devices and Radiological Health (CDRH). Nominations will 
be accepted for current vacancies and those that will or may occur 
through August 31, 2003.
    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:  See table 1, in section IV.B of SUPPLEMENTARY INFORMATION.

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:

I. Vacancies

     FDA is requesting nominations of voting members for vacancies 
listed as follows:
    1. Anesthesiology and Respiratory Therapy Devices Panel: Two 
vacancies immediately, two vacancies occurring November 30, 2002; 
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, two 
vacancies occurring June 30, 2003; 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 occurring October 31, 2002; 
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. Gastroenterology and Urology Devices Panel: One vacancy 
occurring December 31, 2002; urologists and gastroenterologists.
    5. General and Plastic Surgery Devices Panel: Four vacancies 
occurring August 31, 2002, and one vacancy occurring August 31, 2003; 
general surgeons, plastic surgeons, thoracic surgeons, abdominal 
surgeons, pelvic surgeons and reconstructive surgeons, biomaterials 
experts, laser experts, wound healing experts or endoscopic surgery 
experts.
    6. General Hospital and Personal Use Devices Panel: Three vacancies 
immediately; internists, pediatricians, neonatologists, 
endocrinologists, gerontologists, nurses, biomedical engineers or 
microbiologists/infection control practitioners or experts.
    7. Hematology and Pathology Devices Panel: Three vacancies 
occurring February 28, 2003; gynecologists, cytopathologists, 
histopathologists, hematologists (blood banking, coagulation and 
hemostasis), molecular biologists (nucleic acid amplification 
techniques), and hematopathologists (oncology).
    8. Immunology Devices Panel: One vacancy occurring February 28, 
2003; persons with experience in medical, surgical, or clinical 
oncology, internal medicine, clinical immunology, allergy,

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molecular diagnostics, or clinical laboratory medicine.
    9. Molecular and Clinical Genetics Devices Panel: Three vacancies 
occurring May 31, 2003; experts in human genetics and in the clinical 
management of patients with genetic disorders, e.g., pediatricians, 
obstetricians, and neonatologists. The agency is also interested in 
considering candidates with training in inborn errors of metabolism, 
biochemical and/or molecular genetics, population genetics, 
epidemiology and related statistical training. Additionally, 
individuals with experience in genetic counseling, medical ethics as 
well as ancillary fields of study will be considered.
    10. Obstetrics and Gynecology Devices Panel: Two vacancies 
occurring January 31, 2003; experts in perinatology, embryology, 
reproductive endocrinology, operative hysteroscopy, pelviscopy, 
electrosurgery, laser surgery, assisted reproductive technologies, 
contraception, post-operative adhesions, and cervical cancer and 
colposcopy; biostatisticians and engineers with experience in 
obstetrics/gynecology devices; urogynecologists; experts in breast 
care; expert in gynecology in the older patient; experts in diagnostic 
(optical) spectroscopy.
    11. Radiological Devices Panel: One vacancy occurring January 31, 
2003; statistician with biomedical expertise including the design of 
clinical trials, ROC (receiver operating characteristic) analysis, 
diagnostic test evaluation, and data testing.
    12. National Mammography Quality Assurance Advisory Committee: One 
vacancy occurring January 31, 2003; physician, practitioner, or other 
health professional whose clinical practice, research specialization, 
or professional expertise includes a significant focus on mammography.
    13. Device Good Manufacturing Practice Advisory Committee: three 
vacancies occurring immediately; one government representative, one 
industry representative, and one general public representative; four 
vacancies occurring May 31, 2003; two government representatives, one 
industry representative, and one health professional.
    14. Technical Electronic Product Radiation Safety Standards 
Committee: Five vacancies occurring December 31, 2002, one government 
representative, three industry representatives, and one general public 
representative.

II. Functions

A. 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 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.

B. 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.

C. 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. 360j), 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

[[Page 41431]]

representatives of the interests of the general public.

D. 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.

III. Qualifications

A. 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 in section I of this document. The 
term of office is up to 4 years, depending on the appointment date.

B. 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 in 
section I of this document. The term of office is up to 4 years, 
depending on the appointment date.

C. 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 in section I of this 
document. The term of office is up to 4 years, depending on the 
appointment date.

D. 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 
in section I of this document. The term of office is up to 4 years, 
depending on the appointment date.

IV. 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.

A. 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.

                           B. Table 1.--Addresses for Curriculum Vitae and Nominations
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                             Type of                        Office/Center/                                     E-
  Advisory Committee      Representative    Contact Person     Mail Code    Addresses/ E-mail    Telephone    Mail
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For device panels of   All types            Nancy J.        Office of       9200 Corporate     301-594-2022
 the MDAC                                    Pluhowski       Device          Blvd.,            ext. 133
                                                             Evaluation      Rockville, MD
                                                             (HFZ-400),      20850, or
                                                             CDRH            [email protected]
NMQAAC                 All, excluding       Charles A.      CDRH (HFZ-240)  1350 Piccard Dr.,  301-827-0009
                        consumer             Finder                          Rockville, MD
                        representatives                                      20850, or
                                                                             [email protected]

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DGMPAC                 Industry and         Sharon          CDRH (HFZ-300)  2094 Gaither Rd.,  301-594-4613
                        government           Kalokerinos                     Rockville, MD     ext. 139
                        representatives                                      20850, or
                                                                             [email protected]
TEPRSSC                Industry and         Orhan Suleiman  CDRH (HFZ-240)  1350 Piccard Dr.,  301-594-3533
                        government                                           Rockville, MD
                        representatives                                      20850, or
                                                                             [email protected]
NMQAAC, DGMPAC,        Consumer and         Linda A.        Office of the   5600 Fishers       301-827-1220
 TEPRSSC                general public       Sherman         Senior          Lane, Rockville,
                        representatives                      Associate       MD 20857, or
                                                             Commissioner    [email protected].
                                                             for Office of   gov
                                                             External
                                                             Relations (HF-
                                                             4)
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    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 10, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-15210 Filed 6-17-02; 8:45 am]
BILLING CODE 4160-01-S