[Federal Register Volume 74, Number 173 (Wednesday, September 9, 2009)]
[Notices]
[Pages 46442-46445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-21558]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0412]


Request for Nominations for Voting and Nonvoting Consumer 
Representative Members on Public Advisory Committees and Panels

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for voting and nonvoting consumer representatives to serve 
on the National Mammography Quality Assurance Advisory Committee 
(NMQAAC) and certain devices panels of the Medical Devices Advisory 
Committee in the Center for Devices and Radiological Health (CDRH).
    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: Nominations will be accepted for current vacancies and for those 
that will or may occur through October 31, 2010. Because vacancies 
occur on various

[[Page 46443]]

dates throughout the year, there is no cutoff date for the receipt of 
nominations.

ADDRESSES: All nomination for membership should be sent electronically 
to <a href="/cdn-cgi/l/email-protection#f5b6a3b5bab6dbb3b1b4dbb2baa3"><span class="__cf_email__" data-cfemail="86c5d0c6c9c5a8c0c2c7a8c1c9d0">[email protected]</span></a> or by mail to Advisory Committee Oversight and 
Management Staff or by mail to Advisory Committee Oversight and 
Management Staff (HF-4), 5600 Fishers Lane, Rockville, MD 20857. 
Information about becoming a member on an FDA advisory committee can 
also be obtained by visiting FDA's Web site http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/CommitteeMembership/default.htm.

FOR FURTHER INFORMATION CONTACT:
    For general information: Doreen Brandes, Office of the Commissioner 
(HF-4), Food and Drug Administration, 5600 Fishers Lane, rm. 14C-3, 
Rockville, MD 20857, 301-827-8858, email: <a href="/cdn-cgi/l/email-protection#e88c879a8d8d86c68a9a89868c8d9ba88e8c89c680809bc68f879e"><span class="__cf_email__" data-cfemail="82e6edf0e7e7ecace0f0e3ece6e7f1c2e4e6e3aceaeaf1ace5edf4">[email protected]</span></a>.
    For specific committee questions, contact the following persons 
listed in table 1 of this document.

                                Table 1.
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             Contact Person                       Committee/Panel
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Geretta P. Wood, Center for Devices and   Certain Device Panels of the
 Radiological Health, Food and Drug        Medical Devices Advisory
 Administration, 10903 New Hampshire       Committee
 Ave., Bldg. 66, rm. 1682, Silver
 Spring, MD 20993, 301-796-5550, or e-
 mail <a href="/cdn-cgi/l/email-protection#3e795b4c5b4a4a5f106951515a7e585a5f1056564d10595148"><span class="__cf_email__" data-cfemail="6b2c0e190e1f1f0a453c04040f2b0d0f0a45030318450c041d">[email protected]</span></a>
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Normica Facey, Center for Devices and     National Mammography Quality
 Radiological Health, Food and Drug        Assurance Advisory Committee
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, rm. 4652, Silver
 Spring, MD 20993, e-mail:
 <a href="/cdn-cgi/l/email-protection#e3ad8c918e8a8082cda58280869aa3858782cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="672908150a0e040649210604021e27010306490f0f1449000811">[email protected]</span></a>
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SUPPLEMENTARY INFORMATION:

I. Vacancies

    FDA is requesting nominations for voting and nonvoting consumer 
representatives for the vacancies listed in table 2 of this document:

                                                    Table 2.
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       Committee/Panel Expertise Needed          Current & Upcoming Vacancies         Approximate Date Needed
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Circulatory System Devices Panel of the        1-nonvoting                       Immediately
 Medical Devices Advisory Committee -
 interventional cardiologists,
 electrophysiologists, invasive (vascular)
 radiologists, vascular and cardiothoracic
 surgeons, and cardiologists with special
 interest in congestive heart failure
----------------------------------------------------------------------------------------------------------------
Dental Products Panel of the Medical Devices   1-nonvoting                       November 1, 2009
 Advisory Committee - dentists, engineers and
 scientists who have expertise in the areas
 of dental implants, dental materials,
 periodontology, tissue engineering, and
 dental anatomy
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General and Plastic Surgery Devices Panel of   1-nonvoting                       Immediately
 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
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Hematology and Pathology Devices Panel of the  1-nonvoting                       Immediately
 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 Medical        1-nonvoting                       March 1, 2010
 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 Panel of    1-nonvoting                       Immediately
 the Medical Devices Advisory Committee -
 experts with broad, cross-cutting
 scientific, clinical, analytical or
 mediation skills
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[[Page 46444]]

 
Microbiology Devices Panel of the Medical      1-nonvoting                        Immediately
 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 Devices Panel  1-nonvoting                       June 1, 2010
 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 Medical      1-nonvoting                       December 1, 2009
 Devices Advisory Committee - neurosurgeons
 (cerebrovascular and pediatric),
 neurologists (stroke, pediatric, pain
 management, and movement disorders),
 interventional neuroradiologists,
 psychiatrists, and biostatisticians
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Obstetrics and Gynecology Devices Panel of     1-nonvoting                       February 1, 2010
 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
----------------------------------------------------------------------------------------------------------------
Ophthalmic Devices Panel of the Medical        1-nonvoting                       November 1, 2009
 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 Panel   1-nonvoting                       Immediately
 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
----------------------------------------------------------------------------------------------------------------
National Mammography Quality Assurance         2-voting                          February 1, 2010
 Advisory Committee - physicians,
 practitioners, or other health professionals
 whose clinical practice, research
 specialization, or professional expertise
 include a significant focus on mammography
----------------------------------------------------------------------------------------------------------------

II. Functions

A. National Mammography Quality Assurance Advisory Committee

    The committee advises 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

[[Page 46445]]

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.

B. Certain Panels of the 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, advises the Commissioner of Food and 
Drugs (the Commissioner) regarding recommended classification or 
reclassification of devices into one of three regulatory categories, 
advises on any possible risks to health associated with the use of 
devices, advises on formulation of product development protocols, 
reviews premarket approval applications for medical devices, reviews 
guidelines and guidance documents, recommends exemption of certain 
devices from the application of portions of the act, advises on the 
necessity to ban a device, and 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.

III. Criteria for Members

    Persons nominated for membership as a consumer representatives on 
the committee/panels must meet the following criteria: (1) Demonstrate 
ties to consumer and community-based organizations, (2) be able to 
analyze technical data, (3) understand research design, (4) discuss 
benefits and risks, and (5) evaluate the safety and efficacy of 
products under review. The consumer representative must be able to 
represent the consumer perspective on issues and actions before the 
advisory committee; serve as a liaison between the committee and 
interested consumers, associations, coalitions, and consumer 
organizations; and facilitate dialogue with the advisory committees on 
scientific issues that affect consumers.

IV. Selection Procedures

    Selection of members representing consumer interests is conducted 
through procedures that include the use of organizations representing 
the public interest and consumer advocacy groups. The organizations 
have the responsibility of recommending candidates of the agency's 
selection.

V. Nomination Procedures

    All nominations must include a cover letter, a curriculum vita or 
resume (that includes the nominee's office address, telephone number, 
and e-mail address), and a list of consumer or community-based 
organizations for which the candidate can demonstrate active 
participation.
    Nominations will specify the advisory committee or panel(s) for 
which the nominee is recommended. Nominations will include confirmation 
that the nominee is aware of the nomination.
    Any interested person or organization may nominate one or more 
qualified persons for membership as consumer representatives on the 
advisory committee/panels. Self-nominations are also accepted. 
Potential candidates will be required to provide detail information 
concerning such matters as financial holdings, employment, and research 
grants and/or contracts to permit evaluation of possible sources of a 
conflict of interest. The nomination should specify the committee/
panels of interest. The term of office is up to 4 years, depending on 
the appointment date.
    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: September 2, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-21558 Filed 9-8-09; 8:45 am]
BILLING CODE 4160-01-S


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