[Federal Register Volume 78, Number 26 (Thursday, February 7, 2013)]
[Notices]
[Pages 9060-9063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02793]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
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 December 31, 2013.
FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees, and therefore encourages nominations of
appropriately 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 nominations for membership should be sent electronically
to [email protected], or by mail to Advisory Committee Oversight &
Management Staff, 10903 New Hampshire Ave., Bldg. 32, rm. 5103, Silver
Spring, MD 20993-0002. 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/Panel
questions, contact the following persons listed in table 1 of this
document.
Table 1
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Committee/certain device panels
Contact person of the medical devices advisory
committee
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LCDR Sara Anderson, Center for Devices National Mammography Quality
and Radiological Health, Food and Drug Assurance Advisory Committee.
Administration, 10903 New Hampshire Dental Products Panel.
Ave., Bldg. 66, rm. 1544, Silver Hematology and Pathology
Spring, MD 20993, 301-796-7046, email: Devices Panel.
[email protected]. Orthopaedic and Rehabilitation
Devices Panel.
Shanika Craig, Center for Devices and Technical Electronic Product
Radiological Health, Food and Drug Radiation Safety Standards
Administration, 10903 New Hampshire Committee.
Ave., Bldg. 66, rm. 1613, Silver Anesthesiology and Respiratory
Spring, MD 20993, 301-796-6639, email: Therapy Devices Panel.
[email protected]. Gastroenterology and Urology
Devices Panel.
Microbiology Devices Panel.
Obstetrics and Gynecology
Devices Panel.
Radiological Devices Panel.
Natasha Facey, Center for Devices and Device Good Manufacturing
Radiological Health, Food and Drug Practice Advisory Committee.
Administration, 10903 New Hampshire General Hospital and Personal
Ave., Bldg. 66, rm. 1544, Silver Use Devices Panel.
Spring, MD 20993, 301-796-5290, email: Immunology Devices Panel.
[email protected]. Ophthalmic Devices Panel.
Neurological Devices Panel.
[[Page 9061]]
Pamela D. Scott, Center for Devices and Medical Devices Dispute
Radiological Health, Food and Drug Resolution Panel.
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5406, Silver
Spring, MD 20993, 301-796-5433, email:
[email protected].
Jamie Waterhouse, Center for Devices Circulatory System Devices
and Radiological Health, Food and Drug Panel.
Administration, 10903 New Hampshire Ear, Nose and Throat Devices
Ave., Bldg. 66, rm. 1544, Silver Panel.
Spring, MD 20993, 301-796-3036, email: General and Plastic Surgery
[email protected]. Devices Panel.
Molecular and Clinical Genetics
Devices Panel.
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SUPPLEMENTARY INFORMATION:
I. Vacancies
FDA is requesting nominations of voting members for vacancies
listed as follows:
Table 2
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Current and
Committee/panel expertise upcoming Approximate date needed
needed vacancies
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Anesthesiology and 3 December 1, 2013.
Respiratory Therapy Devices
Panel of the Medical
Devices 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 1 July 1, 2013.
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.
Dental Products Panel of the 3 November 1, 2013.
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.
Ear, Nose and Throat Devices 3 November 1, 2013.
Panel of the Medical
Devices Advisory Committee--
Otologists, neurotologists,
audiologists.
Gastroenterology and Urology 3 Immediately.
Devices Panel of the 2 January 1, 2014.
Medical Devices Advisory
Committee--Transplant
specialists,
gastroenterologists,
urologists and
nephrologists.
General and Plastic Surgery 2 September 1, 2013.
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.
General Hospital and 1 Immediately.
Personal Use Devices Panel 3 January 1, 2014.
of the Medical Devices
Advisory Committee--
Internists, pediatricians,
neonatologists,
endocrinologists,
gerontologists, nurses,
biomedical engineers or
microbiologists/infection
control practitioners or
experts.
Hematology and Pathology of 4 March 1, 2013.
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.
Immunology Devices Panel of 1 Immediately.
the Medical Devices 1 March 1, 2013.
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 1 October 1, 2013.
Resolution Panel of the
Medical Devices Advisory
Committee--Experts with
broad, cross-cutting
scientific, engineering,
clinical, analytical or
mediation skills who are
familiar with the materials
and/or operating mechanisms
related to addressing
complex or contested
scientific issues.
Microbiology Devices Panel 1 Immediately.
of the Medical Devices 3 March 1, 2013.
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 2 June 1, 2013.
Genetics 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 1 December 1, 2013.
of the Medical Devices
Advisory Committee--
Neurosurgeons
(cerebrovascular and
pediatric), neurologists
(stroke, pediatric, pain
management, and movement
disorders), interventional
neuroradiologists,
psychiatrists, and
biostatisticians.
[[Page 9062]]
Obstetrics and Gynecology 2 February 1, 2013.
Devices 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.
Ophthalmic Devices Panel of 2 November 1, 2013.
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 3 September 1, 2013.
Rehabilitation 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.
Radiological Devices Panel 2 February 1, 2013.
of the Medical Devices
Advisory--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.
Device Good Manufacturing 2 June 1, 2013.
Practice Advisory
Committee--Vacancies
include a public
representative and a
government representative.
National Mammography Quality 1 February 1, 2013.
Assurance Advisory
Committee--Physicians,
practitioners, or other
health professionals whose
clinical practice, research
specialization, or
professional expertise
include a significant focus
on mammography.
Technical Electronic Product 2 January 1, 2014.
Radiation Safety Standards
Advisory Committee--
Vacancies include general
public representative and a
government representative.
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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 what the Federal Food, Drug, and
Cosmetic Act (the FD&C 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 FD&C 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 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 that 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 to make
recommendations regarding the feasibility and reasonableness of those
proposed
[[Page 9063]]
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 FD&C Act, (21 U.S.C. 360j), 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.
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 FD&C 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.
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 for each
nominee, and their current business address and/or home address,
telephone number, and email 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 related to 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: February 1, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-02793 Filed 2-6-13; 8:45 am]
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