[Federal Register Volume 69, Number 103 (Thursday, May 27, 2004)]
[Notices]
[Pages 30317-30320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11944]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: 
[email protected].
    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: 
[email protected].
    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: [email protected].
    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, [email protected].

[[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: 
[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 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

[[Page 30320]]

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]
BILLING CODE 4160-01-S