[Federal Register: September 9, 2009 (Volume 74, Number 173)]
[Notices]
[Page 46442-46445]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09se09-71]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 CV@OC.FDA.GOV 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: doreen.brandes@fda.hhs.gov.
For specific committee questions, contact the following persons
listed in table 1 of this document.
Table 1.
------------------------------------------------------------------------
Contact Person Committee/Panel
------------------------------------------------------------------------
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 Geretta.Wood@fda.hhs.gov
------------------------------------------------------------------------
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:
Normica.Facey@fda.hhs.gov
------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
Committee/Panel Expertise Needed Current & Upcoming Vacancies Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
[[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
----------------------------------------------------------------------------------------------------------------
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