[Federal Register Volume 71, Number 196 (Wednesday, October 11, 2006)]
[Notices]
[Pages 59793-59797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16679]


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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 the Device Good 
Manufacturing Practice Advisory Committee, certain device panels of the 
Medical Devices Advisory Committee, the National Mammography Quality 
Assurance Advisory Committee, and the Technical Electronic Products 
Radiation Safety Standards Committee in the Center for Devices and 
Radiological Health. Nominations will be accepted

[[Page 59794]]

for current vacancies and those that will or may occur through August 
31, 2007.
    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: Send all nominations and curricula vitae to the following 
contact persons in table 1 of this document:

                                Table 1.
------------------------------------------------------------------------
           Contact Person                      Committee/Panel
------------------------------------------------------------------------
Geretta P. Wood, Center for Devices  Certain Device Panels of the
 and Radiological Health (HFZ-400),   Medical Devices Advisory Committee
 Food and Drug Administration, 9200
 Corporate Blvd., Rockville, MD
 20850, 301-594-2022, e-mail:
 [email protected]
------------------------------------------------------------------------
Nancy M. Wynne, Center for Devices   National Mammography Quality
 and Radiological Health (HFZ-240),   Assurance Advisory Committee
 Food and Drug Administration, 1350
 Piccard Dr., Rockville, MD 20850,
 e-mail: [email protected]
------------------------------------------------------------------------
Collin L. Figueroa, Center for       Device Good Manufacturing Practice
 Devices and Radiological Health      Advisory Committee
 (HFZ-342), Food and Drug
 Administration, 2094 Gaither Rd.,
 Rockville, MD 20850, e-mail:
 [email protected]
------------------------------------------------------------------------
Richard V. Kaczmarek, Center for     Technical Electronic Product
 Devices and Radiological Health      Radiation Safety Standards
 (HFZ-240), Food and Drug             Committee
 Administration, 1350 Piccard Dr.,
 Rockville, MD 20850, e-mail:
 [email protected]
------------------------------------------------------------------------


FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices 
and Radiological Health (HFZ-17), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 301-827-7293, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Vacancies

    FDA is requesting nominations of voting members for vacancies 
listed as follows:

                                Table 2.
------------------------------------------------------------------------
                                          Current and
   Committee/Panel Expertise Needed         Upcoming        Approximate
                                           Vacancies        Date Needed
------------------------------------------------------------------------
Anesthesiology and Respiratory         2                  Immediately
 Therapy Devices Panel of the Medical  2                  December 1,
 Devices Advisory Committee--                              2006
 anesthesiologists, pulmonary
 medicine specialists, or other
 experts who have specialized
 interests in ventilator support,
 pharmacology, physiology, or the
 effects and complications of
 anesthesia
------------------------------------------------------------------------
Circulatory System Devices Panel of    4                  July 1, 2007
 the Medical Devices Advisory
 Committee--interventional
 cardiologists, electrophysiologists,
 invasive (vascular) radiologists,
 vascular and cardiothoracic
 surgeons, and cardiologists with
 special interest in congestive heart
 failure
------------------------------------------------------------------------
Clinical Chemistry and Clinical        2                  March 1, 2007
 Toxicology Devices Panel of the
 Medical Devices Advisory Committee--
 doctors of medicine or philosophy
 with experience in clinical
 chemistry (e.g., cardiac markers),
 clinical toxicology, clinical
 pathology, clinical laboratory
 medicine, and endocrinology
------------------------------------------------------------------------
Dental Products Panel of the Medical   2                  November 1,
 Devices Advisory Committee--                              2006
 dentists, engineers, and scientists
 who have expertise in the areas of
 dental implants, dental materials,
 periodontology, tissue engineering,
 and dental anatomy
------------------------------------------------------------------------
Ear, Nose, and Throat Devices Panel    1                  November 1,
 of the Medical Devices Advisory                           2006
 Committee--otologists,
 neurotologists, and audiologists
------------------------------------------------------------------------
Gastroenterology and Urology Devices   2                  January 1,
 Panel of the Medical Devices                              2007
 Advisory Committee--
 gastroenterologists, urologists, and
 nephrologists
------------------------------------------------------------------------
General and Plastic Surgery Devices    2                  Immediately
 Panel of the Medical Devices          2                  September 1,
 Advisory Committee--surgeons                              2007
 (general, plastic, reconstructive,
 pediatric, thoracic, abdominal,
 pelvic, and endoscopic);
 dermatologists; experts in
 biomaterials, lasers, wound healing,
 and quality of life; and
 biostatisticians
------------------------------------------------------------------------

[[Page 59795]]

 
Hematology and Pathology Devices       3                  Immediately
 Panel of the Medical Devices
 Advisory Committee--hematologists
 (benign and/or malignant
 hematology), hematopathologists
 (general and special hematology,
 coagulation and homeostasis, and
 hematological oncology),
 gynecologists with special interests
 in gynecological oncology,
 cytopathologists, and molecular
 pathologists with special interests
 in development of predictive and
 prognostic biomarkers
------------------------------------------------------------------------
Immunology Devices Panel of the        2                  March 1, 2007
 Medical Devices Advisory Committee--
 persons with experience in medical,
 surgical, or clinical oncology,
 internal medicine, clinical
 immunology, allergy, molecular
 diagnostics, or clinical laboratory
 medicine
------------------------------------------------------------------------
Medical Devices Dispute Resolution     1                  Immediately
 Panel of the Medical Devices
 Advisory Committee--experts with
 broad, cross-cutting scientific,
 clinical, analytical, or mediation
 skills
------------------------------------------------------------------------
Microbiology Devices Panel of the      3                  Immediately
 Medical Devices Advisory Committee--  2                  March 1, 2007
 infectious disease clinicians (e.g.,
 pulmonary disease specialists,
 sexually transmitted disease
 specialists, pediatric infectious
 disease specialists, experts in
 tropical medicine and emerging
 infectious diseases, and
 mycologists); clinical
 microbiologists and virologists;
 clinical virology and microbiology
 laboratory directors, with expertise
 in clinical diagnosis and in vitro
 diagnostic assays (e.g.,
 hepatologists and molecular
 biologists)
------------------------------------------------------------------------
Molecular and Clinical Genetics        1                  Immediately
 Devices Panel of the Medical Devices  3                  June 1, 2007
 Advisory Committee--experts in human
 genetics and in the clinical
 management of patients with genetic
 disorders (e.g., pediatricians,
 obstetricians, and neonatologists);
 individuals with training in inborn
 errors of metabolism, biochemical
 and/or molecular genetics,
 population genetics, epidemiology,
 and related statistical training;
 individuals with experience in
 genetic counseling or medical
 ethics; ancillary fields of study
 will be considered as well
------------------------------------------------------------------------
Obstetrics and Gynecology Devices      2                  February 1,
 Panel of the Medical Devices                              2007
 Advisory Committee--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
------------------------------------------------------------------------
Radiological Devices Panel of the      1                  February 1,
 Medical Devices Advisory Committee--                      2007
 physicians with experience in
 general radiology, mammography,
 ultrasound, magnetic resonance,
 computed tomography, other
 radiological subspecialties, and
 radiation oncology; scientists with
 experience in diagnostic devices,
 radiation physics, statistical
 analysis, digital imaging, and image
 analysis
------------------------------------------------------------------------
National Mammography Quality           1                  February 1,
 Assurance Advisory Committee--                            2007
 physician, practitioner, or other
 health professional whose clinical
 practice, research specialization,
 or professional expertise includes a
 significant focus on mammography
------------------------------------------------------------------------
Device Good Manufacturing Practice     9                  Immediately
 Advisory Committee--Nine vacancies
 occurring immediately; three
 government representatives, two
 industry representatives, two public
 representatives, and two health
 professionals
------------------------------------------------------------------------
Technical Electronic Product           10                 Immediately
 Radiation Safety Standards            5                  January 1,
 Committee--10 vacancies occurring                         2007
 immediately, 4 government
 representatives, 2 industry
 representatives, and 4 general
 public representatives; 5 vacancies
 occurring January 1, 2007, 3
 industry representatives, 1
 government representative, and 1
 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, 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)

[[Page 59796]]

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 
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 
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 should 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 health professional or 
officer or employee of any Federal, State, or local government 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.

[[Page 59797]]

D. Technical Electronic Product Radiation Safety Standards Committee

    Persons nominated should 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 membership on one or more of the advisory panels or advisory 
committees. Self-nominations are also accepted. Nominations will 
include complete curriculum vitae of each nominee, current business 
address and telephone number. Nominations will specify the advisory 
panel(s) or advisory committee(s) for which the nominee is recommended. 
Nominations will include confirmation that the nominee is aware of the 
nomination, is willing to serve as a member of the advisory committee 
if selected, and appears to have no conflict of interest that would 
preclude membership. Potential candidates will be required 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: October 3, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-16679 Filed 10-10-06; 8:45 am]
BILLING CODE 4160-01-S