[Federal Register: May 27, 2004 (Volume 69, Number 103)]
[Notices]
[Page 30317-30320]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my04-69]
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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, 2005.
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 document.
ADDRESSES: Send all nominations and curricula vitae to the following
contact persons:
1. For the device panels: Nancy J. Pluhowski, Center for Devices
and Radiological Health (HFZ-400), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2022, e-mail:
NJP@CDRH.FDA.GOV.
2. For the National Mammography Quality Assurance Advisory
Committee, excluding consumer representatives: Charles A. Finder,
Center for Devices and Radiological Health (HFZ-240), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, e-mail:
CAF@CDRH.FDA.GOV.
3. For health professionals, industry representatives and
government representatives for the Device Good Manufacturing Practice
Advisory Committee: Sharon Kalokerinos, Center for Devices and
Radiological Health (HFZ-300), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, e-mail: SMK@CDRH.FDA.GOV.
4. For government representatives and industry representatives for
the Technical Electronic Product Radiation Safety Standards Committee:
Richard V. Kaczmarek, Center for Devices and Radiological Health (HFZ-
240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD
20850, RVK@CDRH.FDA.GOV.
[[Page 30318]]
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 occurring November 30, 2004; 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: Three vacancies occurring June
30, 2004; interventional cardiologists, electrophysiologists, invasive
(vascular) radiologists, vascular and cardiothoracic surgeons, and
cardiologists with special interest in congestive heart failure.
3. Ear, Nose, and Throat Devices Panel: Three vacancies
occurring October 31, 2004; otologists, neurotologists,
audiologists, hearing scientists and electrophysiologists.
4. Gastroenterology and Urology Devices Panel: Three vacancies
occurring December 31, 2004; urologists and nephrologists.
5. General and Plastic Surgery Devices Panel: One vacancy occurring
August 31, 2004, two vacancies occurring August 31, 2005; 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
occurring December 31, 2004; internists, pediatricians, neonatologists,
endocrinologists, gerontologists, nurses, biomedical engineers or
microbiologists/infection control practitioners or experts.
7. Hematology and Pathology Devices Panel: Three vacancies
immediately, one vacancy occurring February 28, 2005; hematologists
(benign and/or malignant hematology), hematopathologists (general and
special hematology, coagulation and hemostasis, and hematological
oncology), gynecologists with special interests in gynecological
oncology, cytopathologists, and molecular biologists with special
interests in development of predictive and prognostic biomarkers.
8. Immunology Devices Panel: Two vacancies occurring February 28,
2005; persons with experience in medical, surgical, or clinical
oncology, internal medicine, clinical immunology, allergy, molecular
diagnostics, or clinical laboratory medicine.
9. Microbiology Devices Panel: Three vacancies occurring February
28, 2005; infectious disease clinicians, e.g., pulmonary disease
specialists, sexually transmitted disease specialists, pediatric
infectious disease specialists, experts in tropical medicine and
emerging infectious diseases, mycologists; clinical microbiologists and
virologists; clinical virology and microbiology laboratory directors,
with expertise in clinical diagnosis and in vitro diagnostic assays,
e.g., hepatologists; molecular biologists.
10. Neurological Devices Panel: Two vacancies occurring November
30, 2004; neurosurgeons (cerebrovascular and pediatric), neurologists
(stroke, pain management and movement disorders), interventional
neuroradiologists, psychiatrist, biostatisticians.
11. Obstetrics and Gynecology Devices Panel: Two vacancies
occurring January 31, 2005; experts in perinatology, embryology,
reproductive endocrinology, pediatric gynecology, gynecological
oncology, operative hysteroscopy, pelviscopy, electrosurgery, laser
surgery, assisted reproductive technologies, contraception,
postoperative adhesions, and cervical cancer and colposcopy;
biostatisticians and engineers with experience in obstetrics/gynecology
devices; urogynecologists; experts in breast care; experts in
gynecology in the older patient; experts in diagnostic (optical)
spectroscopy; experts in midwifery; labor and delivery nursing.
12. Ophthalmic Devices Panel: Three vacancies occurring October 31,
2004; ophthalmologists specializing in cataract and refractive surgery
and surgical retina, in addition to vision scientists, optometrists,
and biostatisticians practiced in ophthalmic clinical trials.
13. Orthopaedic and Rehabilitation Devices Panel: Two vacancies
occurring August 31, 2005; doctors of medicine or philosophy with
experience in tissue engineering, biomaterials or tribology; orthopedic
surgeons experienced with prosthetic ligament devices, joint implants,
or spinal devices; physical therapists experienced in spinal cord
injuries, neurophysiology, electrotherapy, and joint biomechanics;
rheumatologists; biomedical or biomechanical engineers.
14. Radiological Devices Panel: Two vacancies occurring January 31,
2005; a medical physicist with experience in the calibration, design
and use of diagnostic and therapeutic devices, and an interventional
radiologist with experience in the imaging, evaluation and treatment of
patients with various types of diseases and malignancies.
15. National Mammography Quality Assurance Advisory Committee: Five
vacancies occurring January 31, 2005; one interpreting physician, one
radiological technologist, one medical physicist, and two other health
professionals whose clinical practice, research specialization, or
professional expertise includes a significant focus on mammography.
16. Device Good Manufacturing Practice Advisory Committee: Six
vacancies immediately; three government representatives, two industry
representatives, and one health professional; one vacancy occurring May
31, 2005; one health professional.
17. Technical Electronic Product Radiation Safety Standards
Committee: Three vacancies immediately, two government representatives
and one industry 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 performs the following duties: (1)
Advises the Commissioner of Food and Drugs (the Commissioner) regarding
recommended classification or reclassification of devices into one of
three regulatory categories; (2) advises on any possible risks to
health associated with the use of devices; (3) advises on formulation
of product development protocols; (4) reviews premarket approval
applications for medical devices; (5) reviews guidelines and guidance
documents; (6)recommends exemption of certain devices from the
application of portions of the act; (7) advises on the necessity to ban
a device; and (8) 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
[[Page 30319]]
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 the following
topics: (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 issuance 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: (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.
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 listed 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 at this time for
this committee are listed 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 at this time for this committee
are listed 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 at this
time for this committee are listed 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
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membership on one or more of the advisory panels or advisory
committees. Self-nominations are also accepted. Nominations shall
include 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.
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: May 20, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-11944 Filed 5-26-04; 8:45 am]
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