[Federal Register Volume 74, Number 199 (Friday, October 16, 2009)]
[Notices]
[Pages 53279-53283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24896]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


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, 2010.
    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 <a href="/cdn-cgi/l/email-protection#ce8d988e818de0888a8fe0898198"><span class="__cf_email__" data-cfemail="1655405659553850525738515940">[email protected]</span></a>, or by mail to Advisory Committee Oversight & 
Management Staff (HF-4), 5600 Fishers Lane, rm. 14C03, 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/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT:  For specific Committee questions, 
contact the following persons listed in table 1 of this document.

[[Page 53280]]



                             Table 1.--Contact Information for Committees and Panels
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                     Contact Person                                          Committee/Panel
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Geretta P. Wood, Center for Devices and Radiological     Device Panels of the Medical Devices Advisory Committee
 Health, Food and Drug Administration, 10903 New
 Hampshire Ave., White Oak Bldg. 66, Room <greek-
 i>1682, Silver Spring, MD 20993, 301-796-5550, e-mail
 <a href="/cdn-cgi/l/email-protection#2d6a485f4859594c037a4242496d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="4f082a3d2a3b3b2e611820202b0f292b2e6127273c61282039">[email protected]</span></a>
----------------------------------------------------------------------------------------------------------------
Normica Facey, Center for Devices and Radiological       National Mammography Quality Assurance Advisory
 Health, Food and Drug Administration, 10903 New          Committee
 Hampshire Ave., White Oak Bldg. 66, Room <greek-
 i>4652, Silver Spring, MD 20993, e-mail:
 <a href="/cdn-cgi/l/email-protection#82ccedf0efebe1e3acc4e3e1e7fbc2e4e6e3aceaeaf1ace5edf4"><span class="__cf_email__" data-cfemail="fbb594899692989ad5bd9a989e82bb9d9f9ad5939388d59c948d">[email protected]</span></a>
----------------------------------------------------------------------------------------------------------------
Collin L. Figueroa, Center for Devices and Radiological  Device Good Manufacturing Practice Advisory Committee
 Health, Food and Drug Administration, 10903 New
 Hampshire Ave., White Oak Bldg. 66, Room <greek-
 i>3438, Silver Spring, MD 20993, e-mail:
 <a href="/cdn-cgi/l/email-protection#adeec2c1c1c4c383ebc4cad8c8dfc2ccedcbc9cc83c5c5de83cac2db"><span class="__cf_email__" data-cfemail="cf8ca0a3a3a6a1e189a6a8baaabda0ae8fa9abaee1a7a7bce1a8a0b9">[email protected]</span></a>
----------------------------------------------------------------------------------------------------------------
Richard V. Kaczmarek, Center for Devices and             Technical Electronic Product Radiation Safety Standards
 Radiological Health, Food and Drug                       Committee
 Administration,10903 New Hampshire Ave., White Oak
 Bldg. 66, Room <greek-i>4536, Silver Spring, MD 20993,
 e-mail: <a href="/cdn-cgi/l/email-protection#b1e3d8d2d9d0c3d59ffad0d2cbdcd0c3d4daf1d7d5d09fd9d9c29fd6dec7"><span class="__cf_email__" data-cfemail="4b192228232a392f65002a2831262a392e200b2d2f2a65232338652c243d">[email protected]</span></a>
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SUPPLEMENTARY INFORMATION:

I. Vacancies

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

        Table 2.--Committee/Panel Expertise Needed and Vacancies
------------------------------------------------------------------------
                                              Current and
      Committee/Panel expertise needed          Upcoming    Approximate
                                               Vacancies    Date Needed
------------------------------------------------------------------------
Anesthesiology and Respiratory Therapy        3            December 1,
 Devices Panel of the Medical Devices                       2009
 Advisory Committee--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 the       1            July 1, 2010
 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 Toxicology    2            March 1, 2010
 Devices Panel of the Medical Devices
 Advisory Committee--doctors of medicine or
 philosophy with experience in clinical
 chemistry, clinical toxicology, clinical
 pathology, clinical laboratory medicine,
 endocrinology, and diabetes
------------------------------------------------------------------------
Dental Products Panel of the Medical Devices  3            Immediately
 Advisory Committee--dentists, engineers and  2            November 1,
 scientists who have expertise in the areas                 2009
 of dental implants, dental materials,
 periodontology, tissue engineering, and
 dental anatomy
------------------------------------------------------------------------
Medical Devices Dispute Resolution Panel of   2            Immediately
 the Medical Devices Advisory Committee--
 experts with broad, cross-cutting
 scientific, clinical, analytical or
 mediation skills
------------------------------------------------------------------------
Ear, Nose and Throat Devices Panel of the     1            Immediately
 Medical Devices Advisory Committee--
 otologists, neurotologists, audiologists
------------------------------------------------------------------------
Gastroenterology and Urology Devices Panel    2            January 1,
 of the Medical Devices Advisory Committee--                2010
 transplant specialists,
 gastroenterologists, urologists and
 nephrologists
------------------------------------------------------------------------
General and Plastic Surgery Devices Panel of  2            Immediately
 the Medical Devices Advisory Committee--     1            September 1,
 surgeons (general, plastic, reconstructive,                2010
 pediatric, thoracic, abdominal, pelvic and
 endoscopic); dermatologists; experts in
 biomaterials, lasers, wound healing, and
 quality of life; and biostatisticians
------------------------------------------------------------------------
General Hospital and Personal Use Devices     3            January 1,
 Panel of the Medical Devices Advisory                      2010
 Committee--internists, pediatricians,
 neonatologists, endocrinologists,
 gerontologists, nurses, biomedical
 engineers or microbiologists/infection
 control practitioners or experts
------------------------------------------------------------------------
Hematology and Pathology Devices Panel of     5            Immediately
 the Medical Devices Advisory Committee--     1            March 1, 2010
 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
------------------------------------------------------------------------

[[Page 53281]]

 
Immunology Devices Panel of the Medical       3            Immediately
 Devices Advisory Committee--persons with
 experience in medical, surgical, or
 clinical oncology, internal medicine,
 clinical immunology, allergy, molecular
 diagnostics, or clinical laboratory
 medicine
------------------------------------------------------------------------
Microbiology Devices Panel of the Medical     1            Immediately
 Devices Advisory Committee--infectious       3            March 1, 2010
 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 Devices       1            Immediately
 Panel of the Medical Devices Advisory        1            June 1, 2010
 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; and individuals with
 experience in ancillary fields of study
------------------------------------------------------------------------
Neurological Devices Panel of the Medical     5            Immediately
 Devices Advisory Committee--neurosurgeons    2            December 1,
 (cerebrovascular and pediatric),                           2009
 neurologists (stroke, pediatric, pain
 management, and movement disorders),
 interventional neuroradiologists,
 psychiatrists, and biostatisticians
------------------------------------------------------------------------
Obstetrics and Gynecology Devices Panel of    1            February 1,
 the Medical Devices Advisory Committee--                   2010
 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, gynecology in the
 older patient, diagnostic (optical)
 spectroscopy, midwifery, and labor and
 delivery nursing
------------------------------------------------------------------------
Ophthalmic Devices Panel of the Medical       3            November 1,
 Devices Advisory Committee--                               2009
 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 Panel  3            Immediately
 of the Medical Devices Advisory Committee--  2            Immediately
 orthopedic surgeons (joint, spine, trauma,   2            September 1,
 and pediatric); rheumatologists; engineers                 2010
 (biomedical, biomaterials, and
 biomechanical); experts in rehabilitation
 medicine, sports medicine, and connective
 tissue engineering; and biostatisticians
------------------------------------------------------------------------
Radiological Devices Panel of the Medical     2            February 1,
 Devices Advisory Committee--physicians with                2010
 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        6            Immediately
 Advisory Committee--physicians,
 practitioners, or other health
 professionals whose clinical practice,
 research specialization, or professional
 expertise include a significant focus on
 mammography
------------------------------------------------------------------------
Device Good Manufacturing Practice Advisory   7            Immediately
 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) 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

[[Page 53282]]

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 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 as they become available.

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

[[Page 53283]]

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 must 
include a current, complete resume or curriculum vitae of each nominee, 
current business and/or home address, telephone number, and e-mail 
address if available. Nominations must specify the advisory panel(s) or 
advisory committee(s) for which the nominee is recommended. Nominations 
must also acknowledge that the nominee is aware of the nomination, 
unless self-nominated. FDA will ask potential candidates to provide 
detailed information concerning such matters as financial holdings, 
employment, and research grants and/or contracts.
    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 9, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24896 Filed 10-15-09; 8:45 am]
BILLING CODE 4160-01-S


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