[Federal Register Volume 73, Number 200 (Wednesday, October 15, 2008)]
[Notices]
[Pages 61140-61143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-24358]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]


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 for current vacancies 
and those that will or may occur through August 31, 2009.
    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: All nomination for membership should be sent electronically 
to [email protected], or by mail to Advisory Committee Oversight & 
Management Staff (HF-4), 5600 Fishers Lane, rm. 15A-12, Rockville, MD 
20857. Information about becoming a member on a FDA advisory committee 
can also be obtained by visiting FDA's Web site at http://www.fda.gov/oc/advisory/default.htm.

FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices 
and Radiological Health (HFZ-17), Food and Drug Administration, 7520 
Standish Pl., (MPN1), Rockville, MD 20855, 240-276-8938, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Vacancies

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

                                Table 1.
------------------------------------------------------------------------
                                         Current &
 Committee/Panel and Expertise Needed     Upcoming     Approximate Date
                                         Vacancies          Needed
------------------------------------------------------------------------
Dental Products Panel of the Medical              3  Immediately
 Devices Advisory Committee--dentists,
 engineers, and scientists who have
 expertise in the areas of dental
 implants, dental materials,
 periodontology, tissue engineering,
 and dental anatomy
------------------------------------------------------------------------
Medical Devices Dispute Resolution                1  Immediately
 Panel of the Medical Devices Advisory
 Committee--experts with broad, cross-
 cutting scientific, clinical,
 analytical, or mediation skills
                                                  1  October 1, 2008
------------------------------------------------------------------------
Ear, Nose, and Throat Devices Panel of            3  November 1, 2008
 the Medical Devices Advisory
 Committee--otologists,
 neurotologists, audiologists
------------------------------------------------------------------------
Gastroenterology and Urology Devices              3  January 1, 2009
 Panel of the Medical Devices Advisory
 Committee--transplant specialists,
 gastroenterologists, urologists, and
 nephrologists
------------------------------------------------------------------------
General and Plastic Surgery Devices               2  September 1, 2009
 Panel of the Medical Devices Advisory
 Committee--surgeons (general,
 plastic, reconstructive, pediatric,
 thoracic, abdominal, pelvic, and
 endoscopic); dermatologists; experts
 in biomaterials, lasers, wound
 healing, and quality of life; and
 biostatisticians
------------------------------------------------------------------------
Hematology and Pathology Devices Panel            2  Immediately
 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
                                                  2  March 1, 2009
------------------------------------------------------------------------
Immunology Devices Panel of the                   1  Immediately
 Medical Devices Advisory Committee--
 persons with experience in medical,
 surgical, or clinical oncology,
 internal medicine, clinical
 immunology, allergy, molecular
 diagnostics, or clinical laboratory
 medicine
                                                  2  March 1, 2009
------------------------------------------------------------------------

[[Page 61141]]

 
Microbiology Devices Panel of the                 4  Immediately
 Medical Devices Advisory Committee--
 infectious disease clinicians, e.g.,
 pulmonary disease specialists,
 sexually transmitted disease
 specialists, pediatric infectious
 disease specialists, experts in
 tropical medicine and emerging
 infectious diseases, biofilm
 development; 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
------------------------------------------------------------------------
Molecular and Clinical Genetics                   3  Immediately
 Devices Panel of the Medical Devices
 Advisory Committee--experts in human
 genetics and in the clinical
 management of patients with genetic
 disorders, e.g., pediatricians,
 obstetricians, neonatologists;
 individuals with training in inborn
 errors of metabolism, biochemical and/
 or molecular genetics, population
 genetics, epidemiology and related
 statistical training, and clinical
 molecular genetics testing (e.g.,
 genotyping, array CGH, etc.);
 individuals with experience in
 genetics counseling, medical ethics
 are also desired, and individuals
 with experience in ancillary fields
 of study will be considered
------------------------------------------------------------------------
Neurological Devices Panel of the                 2  Immediately
 Medical Devices Advisory Committee--
 neurosurgeons (cerebrovascular and
 pediatric), neurologists (stroke,
 pediatric, pain management, and
 movement disorders), interventional
 neuroradiologists, psychiatrists, and
 biostatisticians
                                                  2  December 1, 2008
------------------------------------------------------------------------
Obstetrics and Gynecology Devices                 3  Immediately
 Panel of the Medical Devices 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
                                                  1  February 1, 2009
------------------------------------------------------------------------
Ophthalmic Devices Panel of the                   3  November 1, 2008
 Medical Devices Advisory Committee--
 ophthalmologists specializing in
 cataract and refractive surgery and
 vitreo-retinal surgery, in addition
 to vision scientists, optometrists,
 and biostatisticians practiced in
 ophthalmic clinical trials
------------------------------------------------------------------------
Orthopaedic and Rehabilitation Devices            3  Immediately
 Panel of the Medical Devices Advisory
 Committee--orthopedic surgeons
 (joint, spine, trauma, and
 pediatric); rheumatologists;
 engineers (biomedical, biomaterials,
 and biomechanical); experts in
 rehabilitation medicine, sports
 medicine, and connective tissue
 engineering; and biostatisticians
                                                  2  September 1, 2009
------------------------------------------------------------------------
Radiological Devices Panel of the                 2  February 1, 2009
 Medical Devices Advisory Committee--
 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 Assurance            1  Immediately
 Advisory Committee--physicians,
 practitioners, or other health
 professionals whose clinical
 practice, research specialization, or
 professional expertise include a
 significant focus on mammography
                                                  3  February 1, 2009
------------------------------------------------------------------------
Device Good Manufacturing Practice                7  Immediately
 Advisory Committee--vacancies include
 three government representatives, two
 public representatives, and two
 health professionals
------------------------------------------------------------------------
Technical Electronic Product Radiation           15  Immediately
 Safety Standards Committee--vacancies
 include five government
 representatives, five industry
 representatives, and five general
 public representatives
------------------------------------------------------------------------

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 of the Federal Food, Drug, and 
Cosmetic Act (the act) 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 panel, according to its 
specialty area, may also make appropriate recommendations to

[[Page 61142]]

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 
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 to 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 the 
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. The agency will publish a separate notice 
announcing the vacancies of two representatives of interests of the 
device manufacturing industry.

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, 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 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.

[[Page 61143]]

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, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-24358 Filed 10-14-08; 8:45 am]
BILLING CODE 4160-01-S