Request for Nominations for Voting Members on Public Advisory Panels or Committees, 9060-9063 [2013-02793]
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9060
Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices
registries are required to submit quality
measures data once, within 2 months
following the reporting period. How
much time are reporting entities outside
of PQRS afforded to submit quality
measures data? What challenges do
reporting entities face in reporting data
according to current timeframes?
++ What oversight (for example,
checks or audits) should be in place to
ensure that data is submitted and
calculated properly by entities?
• Questions regarding selection of
measures related to registry reporting
under PQRS for 2014 and subsequent
years and for the EHR Incentive Program
if registry reporting is established as a
reporting method for that program in
future years:
++ Should we require that a certain
proportion of submitted measures have
particular characteristics such as being
NQF-endorsed or outcome-based?
++ Should we require that the quality
measures data submitted cover a certain
number of the six national quality
strategy domains?
++ To what extent would third-party
entities struggle to meet reporting for
measures currently available under
PQRS and EHR Incentive Program?
• Questions regarding registry
measures reporting criteria:
++ If we propose revised criteria for
satisfactory reporting under PQRS and
for meeting the CQM component of
meaningful use under the EHR Incentive
Program, how many measures should an
eligible professional be required to
report to collect meaningful quality
data? For example, for reporting periods
occurring in 2014, eligible professionals
using CEHRT must report 9 measures
covering at least 3 domains to meet the
criteria for satisfactory reporting for the
2014 PQRS incentive and meet the CQM
component of achieving meaningful use
for the EHR Incentive Program. (For
more information see the EHR Incentive
Program Stage 2 final rule (77 FR 54058)
and the CY 2013 Medicare PFS final
rule with comment period (77 FR
69192).) If we were to align reporting
criteria with reporting requirements for
other non-federal reporting programs, in
future years, should we propose to
require reporting on a different number
of measures than what is currently
required for the PQRS in 2013 and the
EHR Incentive Program under the Stage
2 final rule or should the non-federal
reporting programs align with CMS
criteria?
++ For PQRS, should eligible
professionals still be required to report
quality measures data on a certain
percentage of their applicable patients,
such as 80 percent, for 2014 and
subsequent years? Or, should we require
that eligible professionals report on a
certain minimum number of patients,
such as 20, rather than a percentage?
(Catalog of Federal Domestic Assistance
Program No. 93.773 Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: January 9, 2013.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2013–02703 Filed 2–4–13; 11:15 am]
BILLING CODE 4120–01–P
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.
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.
SUMMARY:
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.
DATES:
All nominations for
membership should be sent
electronically to cv@oc.fda.gov, 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 https://www.fda.gov/
AdvisoryCommittees/default.htm.
ADDRESSES:
For
specific Committee/Panel questions,
contact the following persons listed in
table 1 of this document.
FOR FURTHER INFORMATION CONTACT:
TABLE 1
Committee/certain device panels of the medical devices advisory committee
mstockstill on DSK4VPTVN1PROD with NOTICES
Contact person
LCDR Sara Anderson, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 1544, Silver Spring, MD 20993, 301–796–7046, email:
Sara.Anderson@fda.hhs.gov.
Shanika Craig, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm.
1613, Silver Spring, MD 20993, 301–796–6639, email:
Shanika.Craig@fda.hhs.gov.
Natasha Facey, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm.
1544, Silver Spring, MD 20993, 301–796–5290, email:
Natasha.Facey@fda.hhs.gov.
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National Mammography Quality Assurance Advisory Committee.
Dental Products Panel.
Hematology and Pathology Devices Panel.
Orthopaedic and Rehabilitation Devices Panel.
Technical Electronic Product Radiation Safety Standards Committee.
Anesthesiology and Respiratory Therapy Devices Panel.
Gastroenterology and Urology Devices Panel.
Microbiology Devices Panel.
Obstetrics and Gynecology Devices Panel.
Radiological Devices Panel.
Device Good Manufacturing Practice Advisory Committee.
General Hospital and Personal Use Devices Panel.
Immunology Devices Panel.
Ophthalmic Devices Panel.
Neurological Devices Panel.
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Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices
TABLE 1—Continued
Committee/certain device panels of the medical devices advisory committee
Contact person
Pamela D. Scott, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm.
5406, Silver Spring, MD 20993, 301–796–5433, email:
PamelaD.Scott@fda.hhs.gov.
Jamie Waterhouse, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm.
1544, Silver Spring, MD 20993, 301–796–3036, email:
Jamie.Waterhouse@fda.hhs.gov.
Medical Devices Dispute Resolution Panel.
Circulatory System Devices Panel.
Ear, Nose and Throat Devices Panel.
General and Plastic Surgery Devices Panel.
Molecular and Clinical Genetics Devices Panel.
I. Vacancies
FDA is requesting nominations of
voting members for vacancies listed as
follows:
SUPPLEMENTARY INFORMATION:
TABLE 2
Current and
upcoming
vacancies
mstockstill on DSK4VPTVN1PROD with NOTICES
Committee/panel expertise needed
Anesthesiology and 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 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 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 Panel of the Medical Devices Advisory Committee—Otologists,
neurotologists, audiologists.
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee—Transplant
specialists, gastroenterologists, urologists and nephrologists.
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.
General Hospital and Personal Use Devices Panel 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 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 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.
Medical Devices Dispute 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 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.
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.
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.
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needed
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July 1, 2013.
3
November 1, 2013.
3
November 1, 2013.
3
2
2
Immediately.
January 1, 2014.
September 1, 2013.
1
3
Immediately.
January 1, 2014.
4
March 1, 2013.
1
1
Immediately.
March 1, 2013.
1
October 1, 2013.
1
3
Immediately.
March 1, 2013.
2
June 1, 2013.
1
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December 1, 2013.
December 1, 2013.
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Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices
TABLE 2—Continued
Current and
upcoming
vacancies
Committee/panel expertise needed
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.
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.
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.
Radiological Devices Panel 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 Practice Advisory Committee—Vacancies include a public representative
and a government representative.
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.
Technical Electronic Product Radiation Safety Standards Advisory Committee—Vacancies include general public representative and a government representative.
II. Functions
mstockstill on DSK4VPTVN1PROD 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 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
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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-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.
B. National Mammography Quality
Assurance Advisory Committee
The functions of the committee are to
advise FDA on the following topics: (1)
Developing appropriate quality
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needed
2
February 1, 2013.
2
November 1, 2013.
3
September 1, 2013.
2
February 1, 2013.
2
June 1, 2013.
1
February 1, 2013.
2
January 1, 2014.
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
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Federal Register / Vol. 78, No. 26 / Thursday, February 7, 2013 / Notices
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
mstockstill on DSK4VPTVN1PROD with NOTICES
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
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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,
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9063
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 selfnominated. 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]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
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 Institute of
Diabetes and Digestive and Kidney Diseases
Initial Review Group; Kidney, Urologic and
Hematologic Diseases D Subcommittee.
Date: March 5–7, 2013.
Open: March 5, 2013, 4:00 p.m. to 4:30
p.m.
Agenda: To review procedures and discuss
policy.
E:\FR\FM\07FEN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 26 (Thursday, February 7, 2013)]
[Notices]
[Pages 9060-9063]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-02793]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 cv@oc.fda.gov, 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
https://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
------------------------------------------------------------------------
Committee/certain device panels
Contact person of the medical devices advisory
committee
------------------------------------------------------------------------
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.
Sara.Anderson@fda.hhs.gov. 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.
Shanika.Craig@fda.hhs.gov. 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.
Natasha.Facey@fda.hhs.gov. 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:
PamelaD.Scott@fda.hhs.gov.
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
Jamie.Waterhouse@fda.hhs.gov. Devices Panel.
Molecular and Clinical Genetics
Devices Panel.
------------------------------------------------------------------------
SUPPLEMENTARY INFORMATION:
I. Vacancies
FDA is requesting nominations of voting members for vacancies
listed as follows:
Table 2
------------------------------------------------------------------------
Current and
Committee/panel expertise upcoming Approximate date needed
needed vacancies
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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]
BILLING CODE 4160-01-P
