Request for Nominations for Voting Members on Public Advisory Panels or Committees, 61140-61143 [E8-24358]
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Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/oc/advisory/
default.htm for procedures on public
conduct during advisory committee
meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: October 7, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–24356 Filed 10–14–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Request for Nominations for Voting
Members on Public Advisory Panels or
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
date of scheduled vacancies for each
year, as indicated in this notice.
Notice.
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, 2009.
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.
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
DATES:
All nomination for
membership should be sent
electronically to CV@OC.FDA.GOV, or
by mail to Advisory Committee
Oversight & Management Staff (HF–4),
5600 Fishers Lane, rm. 15A–12,
Rockville, MD 20857. Information about
becoming a member on a FDA advisory
committee can also be obtained by
visiting FDA’s Web site at https://
www.fda.gov/oc/advisory/default.htm.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ–17), Food
and Drug Administration, 7520 Standish
Pl., (MPN1), Rockville, MD 20855, 240–
276–8938, e-mail:
Kathleen.Walker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Vacancies
FDA is requesting nominations of
voting members for vacancies listed as
follows:
TABLE 1.
Current &
Upcoming
Vacancies
Committee/Panel and Expertise Needed
Approximate Date
Needed
Dental Products Panel of the 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
3
Immediately
Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee—experts with broad,
cross-cutting scientific, clinical, analytical, or mediation skills
1
Immediately
1
October 1, 2008
Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee—otologists,
neurotologists, audiologists
3
November 1, 2008
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee—transplant specialists, gastroenterologists, urologists, and nephrologists
3
January 1, 2009
General and Plastic Surgery 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
2
September 1, 2009
Hematology and Pathology Devices Panel of 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
2
Immediately
2
March 1, 2009
1
Immediately
2
March 1, 2009
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Immunology Devices Panel of the Medical Devices Advisory Committee—persons with experience in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics,
or clinical laboratory medicine
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Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices
TABLE 1.—Continued
Current &
Upcoming
Vacancies
Committee/Panel and Expertise Needed
Approximate Date
Needed
Microbiology Devices Panel of 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
4
Immediately
Molecular and Clinical 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
3
Immediately
Neurological Devices Panel of the Medical Devices Advisory Committee—neurosurgeons (cerebrovascular
and pediatric), neurologists (stroke, pediatric, pain management, and movement disorders), interventional
neuroradiologists, psychiatrists, and biostatisticians
2
Immediately
2
December 1, 2008
3
Immediately
1
February 1, 2009
Ophthalmic Devices Panel of 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
3
November 1, 2008
Orthopaedic and 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
3
Immediately
2
September 1, 2009
Radiological Devices Panel of the Medical Devices Advisory Committee—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
2
February 1, 2009
National Mammography Quality Assurance Advisory Committee—physicians, practitioners, or other health
professionals whose clinical practice, research specialization, or professional expertise include a significant focus on mammography
1
Immediately
3
February 1, 2009
7
Immediately
15
Immediately
Obstetrics and Gynecology 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
Device Good Manufacturing Practice Advisory Committee—vacancies include three government representatives, two public representatives, and two health professionals
Technical Electronic Product Radiation Safety Standards Committee—vacancies include five government
representatives, five industry representatives, and five general public representatives
II. Functions
jlentini on PROD1PC65 with NOTICES
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) for device
advisory panels. With the exception of
the Medical Devices Dispute Resolution
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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
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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 Devices
Dispute Resolution Panel, each panel,
according to its specialty area, may also
make appropriate recommendations to
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Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices
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-thecounter 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.
jlentini on PROD1PC65 with NOTICES
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 regarding
good manufacturing practices governing
the methods used in, and the facilities
and controls used for, manufacture,
packaging, storage, installation, and
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servicing of devices, and to 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.
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.
D. Technical Electronic Product
Radiation Safety Standards Committee
C. Device Good Manufacturing Practice
Advisory 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
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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.
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.
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Federal Register / Vol. 73, No. 200 / Wednesday, October 15, 2008 / Notices
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 will include complete
curriculum vitae of each nominee,
current business address and telephone
number. Nominations will specify the
advisory panel(s) or advisory
committee(s) for which the nominee is
recommended. Nominations will
include confirmation that the nominee
is aware of the nomination, is willing to
serve as a member of the advisory
committee if selected, and appears to
have no conflict of interest that would
preclude membership. Potential
candidates will be required to provide
detailed information concerning such
matters as 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: October 3, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–24358 Filed 10–14–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jlentini on PROD1PC65 with NOTICES
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Reproduction
Centers Meeting.
Date: November 12–14, 2008.
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18:32 Oct 14, 2008
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Time: 7 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: The Legacy Hotel, 1775 Rockville
Pike, Rockville, MD 20852.
Contact Person: Dennis E. Leszczynski,
PhD, Scientific Review Administrator,
Division of Scientific Review, National
Institute of Child Health and Human
Development, NIH, 6100 Executive Blvd.,
Rm. 5b01, Bethesda, MD 20892, (301) 435–
6884, leszczyd@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: October 7, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–24498 Filed 10–14–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2); notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Tumor
Stem Cells in Cancer Biology, Prevention and
Therapy (P01).
Date: November 19–20, 2008.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott and
Conference Center, 5701 Marinelli Road,
North Bethesda, MD 20852.
Contact Person: Sherwood Githens, PhD,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116
Executive Blvd., Room 8053, Bethesda, MD
20892, 301–435–1822,
githenss@mail.nih.gov.
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Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI SPORE
in Ovarian and Gynecologic Cancers.
Date: February 11–13, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Caron Lyman, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Cancer
Institute, National Institutes of Health, 6116
Executive Blvd. Room 8119, Bethesda, MD
20892–8328, 301–451–4761,
lymanc@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: October 8, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–24471 Filed 10–14–08; 8:45 am]
BILLING CODE 4140–01–P
National Cancer Institute; Notice of
Closed Meetings
PO 00000
61143
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Federal Emergency
Management Agency, DHS.
ACTION: Notice; 60-day notice and
request for comments; Extension,
without change, of a currently approved
collection, OMB Number 1660–0038,
FEMA Form—None.
AGENCY:
SUMMARY: The Federal Emergency
Management Agency, as part of its
continuing effort to reduce paperwork
and respondent burden, invites the
general public and other Federal
agencies to take this opportunity to
comment on a continuing information
collection. In accordance with the
Paperwork Reduction Act of 1995, this
notice seeks comments concerning
information collected from new
applicants to the National Flood
Insurance Program (NFIP), Write-YourOwn (WYO) Program.
SUPPLEMENTARY INFORMATION: Under the
WYO Program, the Federal Emergency
Management Agency may enter into
arrangements authorized by the
National Flood Insurance Act of 1968,
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]]>Agencies
[Federal Register Volume 73, Number 200 (Wednesday, October 15, 2008)]
[Notices]
[Pages 61140-61143]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24358]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0038]
Request for Nominations for Voting Members on Public Advisory
Panels or Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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, 2009.
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 CV@OC.FDA.GOV, or by mail to Advisory Committee Oversight &
Management Staff (HF-4), 5600 Fishers Lane, rm. 15A-12, Rockville, MD
20857. Information about becoming a member on a FDA advisory committee
can also be obtained by visiting FDA's Web site at https://www.fda.gov/
oc/advisory/default.htm.
FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ-17), Food and Drug Administration, 7520
Standish Pl., (MPN1), Rockville, MD 20855, 240-276-8938, e-mail:
Kathleen.Walker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Vacancies
FDA is requesting nominations of voting members for vacancies
listed as follows:
Table 1.
------------------------------------------------------------------------
Current &
Committee/Panel and Expertise Needed Upcoming Approximate Date
Vacancies Needed
------------------------------------------------------------------------
Dental Products Panel of the Medical 3 Immediately
Devices Advisory Committee--dentists,
engineers, and scientists who have
expertise in the areas of dental
implants, dental materials,
periodontology, tissue engineering,
and dental anatomy
------------------------------------------------------------------------
Medical Devices Dispute Resolution 1 Immediately
Panel of the Medical Devices Advisory
Committee--experts with broad, cross-
cutting scientific, clinical,
analytical, or mediation skills
1 October 1, 2008
------------------------------------------------------------------------
Ear, Nose, and Throat Devices Panel of 3 November 1, 2008
the Medical Devices Advisory
Committee--otologists,
neurotologists, audiologists
------------------------------------------------------------------------
Gastroenterology and Urology Devices 3 January 1, 2009
Panel of the Medical Devices Advisory
Committee--transplant specialists,
gastroenterologists, urologists, and
nephrologists
------------------------------------------------------------------------
General and Plastic Surgery Devices 2 September 1, 2009
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
------------------------------------------------------------------------
Hematology and Pathology Devices Panel 2 Immediately
of 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
2 March 1, 2009
------------------------------------------------------------------------
Immunology Devices Panel of the 1 Immediately
Medical Devices Advisory Committee--
persons with experience in medical,
surgical, or clinical oncology,
internal medicine, clinical
immunology, allergy, molecular
diagnostics, or clinical laboratory
medicine
2 March 1, 2009
------------------------------------------------------------------------
[[Page 61141]]
Microbiology Devices Panel of the 4 Immediately
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
------------------------------------------------------------------------
Molecular and Clinical Genetics 3 Immediately
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 of the 2 Immediately
Medical Devices Advisory Committee--
neurosurgeons (cerebrovascular and
pediatric), neurologists (stroke,
pediatric, pain management, and
movement disorders), interventional
neuroradiologists, psychiatrists, and
biostatisticians
2 December 1, 2008
------------------------------------------------------------------------
Obstetrics and Gynecology Devices 3 Immediately
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
1 February 1, 2009
------------------------------------------------------------------------
Ophthalmic Devices Panel of the 3 November 1, 2008
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 Devices 3 Immediately
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
2 September 1, 2009
------------------------------------------------------------------------
Radiological Devices Panel of the 2 February 1, 2009
Medical Devices Advisory Committee--
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
------------------------------------------------------------------------
National Mammography Quality Assurance 1 Immediately
Advisory Committee--physicians,
practitioners, or other health
professionals whose clinical
practice, research specialization, or
professional expertise include a
significant focus on mammography
3 February 1, 2009
------------------------------------------------------------------------
Device Good Manufacturing Practice 7 Immediately
Advisory 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) 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
Devices Dispute Resolution Panel, each panel, according to its
specialty area, may also make appropriate recommendations to
[[Page 61142]]
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
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 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.
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 years, depending on the appointment date.
[[Page 61143]]
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 will
include complete curriculum vitae of each nominee, current business
address and telephone number. Nominations will specify the advisory
panel(s) or advisory committee(s) for which the nominee is recommended.
Nominations will include confirmation that the nominee is aware of the
nomination, is willing to serve as a member of the advisory committee
if selected, and appears to have no conflict of interest that would
preclude membership. Potential candidates will be required to provide
detailed information concerning such matters as 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: October 3, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-24358 Filed 10-14-08; 8:45 am]
BILLING CODE 4160-01-S
