[Federal Register: June 18, 2002 (Volume 67, Number 117)]
[Notices]
[Page 41429-41432]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jn02-57]
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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:
KLW@CDRH.fda.gov.
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 njp@cdrh.fda.gov
NMQAAC All, excluding Charles A. CDRH (HFZ-240) 1350 Piccard Dr., 301-827-0009
consumer Finder Rockville, MD
representatives 20850, or
caf@cdrh.fda.gov
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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
smk@cdrh.fda.gov
TEPRSSC Industry and Orhan Suleiman CDRH (HFZ-240) 1350 Piccard Dr., 301-594-3533
government Rockville, MD
representatives 20850, or
ohs@cdrh.fda.gov
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 lsherman@oc.fda.
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