
[Federal Register: February 11, 2009 (Volume 74, Number 27)]
[Notices]
[Page 6904-6906]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11fe09-64]

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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 and Nonvoting Consumer
Representative Members on Public Advisory Committee 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, 2009. Because vacancies
occur on various dates throughout the year, there is no cutoff date for
the receipt of nominations.

ADDRESSES: All nominations for membership should be sent electronically
to CV@OC.FDA.GOV 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 at http://www.fda.gov/oc/
advisory/default.htm.

FOR FURTHER INFORMATION CONTACT: 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  Certain Device Panels of the
 and Radiological Health (HFZ-400),   Medical Devices Advisory Committee
 Food and Drug Administration, 9200
 Corporate Blvd., Rockville, MD
 20850, 240-276-3993, e-mail:
 Geretta.Wood@fda.hhs.gov
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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: Nancy.Wynne@fda.hhs.gov
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[[Page 6905]]


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     Current & Upcoming    Approximate Date
            Needed                   Vacancies              Needed
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Circulatory System Devices             1--nonvoting          Immediately
 Panel of the Medical Devices
 Advisory Committee--
 interventional cardiologists,
 electrophysiologists,
 invasive (vascular)
 radiologists, vascular and
 cardiothoracic surgeons, and
 cardiologists with special
 interest in congestive heart
 failure
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Clinical Chemistry and                 1--nonvoting        March 1, 2009
 Clinical Toxicology 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           1--nonvoting     November 1, 2009
 Medical Devices Advisory
 Committee--dentists,
 engineers and scientists who
 have expertise in the areas
 of dental implants, dental
 materials, periodontology,
 tissue engineering, and
 dental anatomy
------------------------------------------------------------------------
General and Plastic Surgery             1-nonvoting          Immediately
 Devices 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
------------------------------------------------------------------------
Medical Devices Dispute                 1-nonvoting          Immediately
 Resolution Panel of the
 Medical Devices Advisory
 Committee--experts with
 broad, cross-cutting
 scientific, clinical,
 analytical or mediation
 skills
------------------------------------------------------------------------
Microbiology Devices Panel of           1-nonvoting        March 1, 2009
 the 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
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Ophthalmic Devices Panel of             1-nonvoting     November 1, 2009
 the 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                    1     January 31, 2009
 Devices 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
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National Mammography Quality            2-nonvoting     February 1, 2009
 Assurance 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. NMQAAC

    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 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's (the act) envisions for device advisory panels. With the
exception of the Medical Devices Dispute Resolution Panel, each panel,
according to its specialty area, does the following: (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.

[[Page 6906]]

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: February 4, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-2845 Filed 2-10-09; 8:45 am]

BILLING CODE 4160-01-S
