Request for Nominations for Voting Members on Public Advisory Panels of the Medical Devices Advisory Committee, 73005-73007 [2022-25813]
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Federal Register / Vol. 87, No. 227 / Monday, November 28, 2022 / Notices
case management and service provision,
survivor engagement, and community
training. Interviews with project
participants will be conducted
individually. Participant interviews will
focus on the project services and
assistance received by participants,
including those most helpful to healing
and recovery.
(adults who have received assistance
from the VHT–NC project). Interviews
with project staff and partners will be
conducted individually or, if
appropriate and requested by
respondents, in small groups. Interview
topics will include community context,
project goals and design, organizational
and staff characteristics, partnerships,
outreach and identification approaches,
Respondents: Respondents include
VHT–NC project staff (e.g., project
directors, project coordinators, case
managers/advocates, specialized
services staff), key project partner staff,
and project participants (adults who
have received assistance from the VHT–
NC project).
ANNUAL BURDEN ESTIMATES
Number of
respondents
(total over
request
period)
Instrument
Project leadership interview .............................................................................
Direct services staff interview ..........................................................................
Partner interview ..............................................................................................
Participant interview .........................................................................................
Estimated Total Annual Burden
Hours: 132.
Authority: Section 105(d)(2) of the
Trafficking Victims Protection Act of
2000 (Pub. L. 106–386) [22 U.S.C. 7103].
[FR Doc. 2022–25780 Filed 11–25–22; 8:45 am]
BILLING CODE 4184–47–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3926]
Request for Nominations for Voting
Members on Public Advisory Panels of
the Medical Devices Advisory
Committee
Food and Drug Administration,
HHS.
ACTION:
18
24
36
30
nominations for voting members to
serve on the Medical Devices Advisory
Committee (MDAC) device panels in the
Center for Devices and Radiological
Health. This annual notice is also in
accordance with the 21st Century Cures
Act, which requires the Secretary of
Health and Human Services (the
Secretary) to provide an annual
opportunity for patients, representatives
of patients, and sponsors of medical
devices that may be specifically the
subject of a review by a classification
panel to provide recommendations for
individuals with appropriate expertise
to fill voting member positions on
classification panels. 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.
Mary B. Jones,
ACF/OPRE Certifying Officer.
AGENCY:
Number of
responses per
respondent
(total over
request
period)
Notice.
Nominations received on or
before January 27, 2023, will be given
first consideration for membership on
DATES:
The Food and Drug
Administration (FDA) is requesting
SUMMARY:
Avg. burden
per response
(in hours)
1
1
1
1
Total/annual
burden
(in hours)
1.5
1.25
1.25
1
27
30
45
30
the Panels of the MDAC. Nominations
received after January 27, 2023, will be
considered for nomination to the
committee as later vacancies occur.
All nominations for
membership should be submitted
electronically by logging into the FDA
Advisory Nomination Portal at https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member on an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership, contact the following
persons listed in table 1:
TABLE 1—PRIMARY CONTACT AND PANEL
khammond on DSKJM1Z7X2PROD with NOTICES
Primary contact person
Panel
Joannie Adams-White, Office of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66,
Rm. 5561, Silver Spring, MD 20993, 301–796–5421, Joannie.Adams-White@
fda.hhs.gov.
James P. Swink, Office of Management, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993, 301–796–6313, James.Swink@fda.hhs.gov.
Akinola Awojope, Office of Management, Center for Devices and Radiological Health,
Food and Drug Administration,10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993, 301–636–0512, Akinola.Awojope@fda.hhs.gov.
Jarrod Collier, Office of Management, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver
Spring, MD 20993, 240–672–5763, Jarrod.Collier@fda.hhs.gov.
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Medical Devices Dispute Resolution Panel.
Circulatory System Devices Panel.
Dental Products Panel, Neurological Devices Panel, Obstetrics and Gynecology Devices Panel, Orthopaedic and Rehabilitation Devices Panel.
Ear, Nose and Throat Devices Panel, General Hospital and Personal Use
Devices Panel, Hematology and Pathology Devices Panel, Molecular and
Clinical Genetics Panel, Radiological Devices Panel.
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Federal Register / Vol. 87, No. 227 / Monday, November 28, 2022 / Notices
TABLE 1—PRIMARY CONTACT AND PANEL—Continued
Primary contact person
Panel
Candace Nalls, Office of Management, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993, 301–636–0510, Candace.Nalls@fda.hhs.gov.
Anesthesiology and Respiratory Therapy Devices Panel, Clinical Chemistry
and Clinical Toxicology Devices Panel, Gastroenterology and Urology
Devices Panel, General and Plastic Surgery Devices Panel.
FDA is
requesting nominations for voting
members for vacancies listed in table 2:
SUPPLEMENTARY INFORMATION:
TABLE 2—EXPERTISE NEEDED, VACANCIES, AND APPROXIMATE DATE NEEDED
khammond on DSKJM1Z7X2PROD with NOTICES
Expertise needed
Vacancies
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, sleep
medicine, pharmacology, physiology, or the effects and complications of anesthesia. FDA is also seeking applicants with pediatric expertise in these areas.
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.
Clinical Chemistry and Clinical Toxicology Panel of the Medical Devices Advisory Committee—Doctors of medicine
or philosophy with experience in clinical chemistry (e.g., cardiac markers), clinical toxicology, clinical pathology,
clinical laboratory medicine, and endocrinology.
Dental Products Panel of the Medical Devices Advisory Committee—Dentists, engineers and scientists who have expertise in the areas of dental implants, dental materials, oral and maxillofacial surgery, endodontics,
periodontology, tissue engineering, snoring/sleep therapy, and dental anatomy.
Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee—Otologists, neurotologists, and
audiologists.
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee—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, human factors experts, or
microbiologists/infection control practitioners or experts.
Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee—Hematologists (benign and/
or malignant hematology), hematopathologists (general and special hematology, coagulation and hemostasis, and
hematological oncology), gynecologists with special interests in gynecological oncology, cytopathologists, and molecular pathologists with special interests in development of predictive and prognostic biomarkers, molecular oncology, cancer screening, cancer risk, digital pathology, whole slide imaging, devices utilizing artificial intelligence/machine learning.
Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee—Experts with cross-cutting
scientific, clinical, analytical, or mediation skills.
Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee—Experts in human genetics, molecular diagnostics, 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, bioinformatics, computational genetics/
genomics, variant classification, cancer genetics/genomics, molecular oncology, radiation biology, and clinical molecular genetics testing, (e.g., sequencing, whole exome sequencing, whole genome sequencing, non-invasive
prenatal testing, cancer screening, circulating cell free/circulating tumor nucleic acid testing, digital PCR,
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.
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.
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee—Orthopaedic surgeons
(joint, spine, trauma, reconstruction, sports medicine, hand, foot and ankle, and pediatric orthopaedic surgeons);
rheumatologists; engineers (biomedical, biomaterials, and biomechanical); experts in rehabilitation medicine, and
musculoskeletal engineering; radiologists specializing in musculoskeletal imaging and analyses and biostatisticians.
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.
I. General Description of the
Committees Duties
The MDAC reviews and evaluates
data on the safety and effectiveness of
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marketed and investigational devices
and makes recommendations for their
regulation. The panels engage in many
activities to fulfill the functions the
Federal Food, Drug, and Cosmetic Act
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November 1, 2023.
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November 1, 2023.
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February 1, 2023.
(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
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Federal Register / Vol. 87, No. 227 / Monday, November 28, 2022 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
duties: (1) advises 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-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.
II. Criteria for Voting Members
The MDAC with its 18 panels shall
consist of a maximum of 159 standing
members. Members are selected by the
Commissioner or designee from among
authorities in clinical and
administrative medicine, engineering,
biological and physical sciences, and
other related professions. Almost all
non-Federal members of this committee
serve as Special Government
Employees. A maximum of 122
members shall be standing voting
members and 37 shall be nonvoting
members who serve as representatives
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of consumer interests and of industry
interests. FDA is publishing separate
documents announcing the Request for
Nominations Notification for Nonvoting
Representatives on certain panels of the
MDAC. 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 current needs for each
panel are listed in table 2. Members will
be invited to serve for terms of up to 4
years.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on one or more of the
advisory panels. Self-nominations are
also accepted. Nominations must
include a current, complete re´sume´ or
curriculum vitae for each nominee,
including current business address,
telephone number, and email address if
available and a signed copy of the
Acknowledgement and Consent form
available at the FDA Advisory
Nomination Portal (see ADDRESSES).
Nominations must also specify the
advisory panel(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: November 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–25813 Filed 11–25–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
AGENCY:
PO 00000
Office of the Secretary, HHS;
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ACTION:
73007
Notice.
Findings of research
misconduct have been made against
Douglas D. Taylor, Ph.D. (Respondent),
former Professor and Vice Chair for
Research, Department of Obstetrics &
Gynecology, University of Louisville
School of Medicine (UL). Respondent
engaged in research misconduct in
research supported by U.S. Public
Health Service (PHS) funds, specifically
National Cancer Institute (NCI),
National Institutes of Health (NIH),
grants R41 CA139802 and R21
CA098166. The administrative actions,
including debarment for a period of
three (3) years, were implemented
beginning on October 17, 2022, and are
detailed below.
FOR FURTHER INFORMATION CONTACT:
Wanda K. Jones, Dr.P.H., Acting
Director, Office of Research Integrity,
1101 Wootton Parkway, Suite 240,
Rockville, MD 20852, (240) 453–8200.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that the Office of Research
Integrity (ORI) has taken final action in
the following case:
Douglas D. Taylor, Ph.D., University
of Louisville School of Medicine: Based
on the evidence and findings of
investigations conducted by UL, ORI’s
oversight review of UL’s investigation,
and additional evidence obtained and
analysis conducted by ORI during its
oversight review, ORI found that Dr.
Douglas D. Taylor, former Professor and
Vice Chair for Research, Department of
Obstetrics & Gynecology, UL, engaged in
research misconduct under 42 CFR part
93 in research supported by PHS funds,
specifically NCI, NIH, grants R41
CA139802 and R21 CA098166.
ORI found based on a preponderance
of the evidence that Respondent
intentionally, knowingly, or recklessly
used falsely labeled images to falsely
report data in figures, and in one
finding, intentionally, knowingly, or
recklessly plagiarized, reused, and
falsely labeled an image to falsely report
data in a figure. Respondent’s research
misconduct occurred in one (1) funded
PHS grant application, twelve (12)
unfunded PHS grant applications, and
two (2) PHS-supported published
papers. ORI found that these acts
constitute a significant departure from
accepted practices of the relevant
research community. The affected
papers and grant applications are:
• Patient-derived tumor-reactive
antibodies as diagnostic markers for
ovarian cancer. Gynecol. Oncol. 2009
Oct;115(1):112–20; doi: 10.1016/
j.ygyno.2009.06.031 (hereafter referred
to as ‘‘Gynecol. Oncol. 2009’’).
SUMMARY:
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]]>Agencies
[Federal Register Volume 87, Number 227 (Monday, November 28, 2022)]
[Notices]
[Pages 73005-73007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25813]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3926]
Request for Nominations for Voting Members on Public Advisory
Panels of the Medical Devices Advisory Committee
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 Medical Devices Advisory
Committee (MDAC) device panels in the Center for Devices and
Radiological Health. This annual notice is also in accordance with the
21st Century Cures Act, which requires the Secretary of Health and
Human Services (the Secretary) to provide an annual opportunity for
patients, representatives of patients, and sponsors of medical devices
that may be specifically the subject of a review by a classification
panel to provide recommendations for individuals with appropriate
expertise to fill voting member positions on classification panels. 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: Nominations received on or before January 27, 2023, will be
given first consideration for membership on the Panels of the MDAC.
Nominations received after January 27, 2023, will be considered for
nomination to the committee as later vacancies occur.
ADDRESSES: All nominations for membership should be submitted
electronically by logging into the FDA Advisory Nomination Portal at
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or
by mail to Advisory Committee Oversight and Management Staff, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002. Information about becoming a member on an
FDA advisory committee can also be obtained by visiting FDA's website
at https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for
membership, contact the following persons listed in table 1:
Table 1--Primary Contact and Panel
----------------------------------------------------------------------------------------------------------------
Primary contact person Panel
----------------------------------------------------------------------------------------------------------------
Joannie Adams-White, Office of the Center Director, Center Medical Devices Dispute Resolution Panel.
for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5561, Silver Spring, MD 20993, 301-796-5421,
[email protected].
James P. Swink, Office of Management, Center for Devices Circulatory System Devices Panel.
and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver
Spring, MD 20993, 301-796-6313, [email protected].
Akinola Awojope, Office of Management, Center for Devices Dental Products Panel, Neurological Devices Panel,
and Radiological Health, Food and Drug Obstetrics and Gynecology Devices Panel,
Administration,10903 New Hampshire Ave., Bldg. 66, Rm. Orthopaedic and Rehabilitation Devices Panel.
5216, Silver Spring, MD 20993, 301-636-0512,
[email protected].
Jarrod Collier, Office of Management, Center for Devices Ear, Nose and Throat Devices Panel, General Hospital
and Radiological Health, Food and Drug Administration, and Personal Use Devices Panel, Hematology and
10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Pathology Devices Panel, Molecular and Clinical
Spring, MD 20993, 240-672-5763, Genetics Panel, Radiological Devices Panel.
[email protected].
[[Page 73006]]
Candace Nalls, Office of Management, Center for Devices Anesthesiology and Respiratory Therapy Devices
and Radiological Health, Food and Drug Administration, Panel, Clinical Chemistry and Clinical Toxicology
10903 New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Devices Panel, Gastroenterology and Urology Devices
Spring, MD 20993, 301-636-0510, [email protected]. Panel, General and Plastic Surgery Devices Panel.
----------------------------------------------------------------------------------------------------------------
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members for vacancies listed in table 2:
Table 2--Expertise Needed, Vacancies, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
Expertise needed Vacancies Approximate date needed
----------------------------------------------------------------------------------------------------------------
Anesthesiology and Respiratory Therapy Devices 4 Immediately.
Panel of the Medical Devices Advisory 2 December 1, 2023.
Committee--Anesthesiologists, pulmonary
medicine specialists, or other experts who
have specialized interests in ventilator
support, sleep medicine, pharmacology,
physiology, or the effects and complications
of anesthesia. FDA is also seeking applicants
with pediatric expertise in these areas.
Circulatory System Devices Panel of the 3 July 1, 2023.
Medical Devices Advisory Committee--
Interventional cardiologists,
electrophysiologists, invasive (vascular)
radiologists, vascular and cardiothoracic
surgeons, and cardiologists with special
interest in congestive heart failure.
Clinical Chemistry and Clinical Toxicology 2 Immediately.
Panel of the Medical Devices Advisory
Committee--Doctors of medicine or philosophy
with experience in clinical chemistry (e.g.,
cardiac markers), clinical toxicology,
clinical pathology, clinical laboratory
medicine, and endocrinology.
Dental Products Panel of the Medical Devices 6 Immediately.
Advisory Committee--Dentists, engineers and 2 November 1, 2023.
scientists who have expertise in the areas of
dental implants, dental materials, oral and
maxillofacial surgery, endodontics,
periodontology, tissue engineering, snoring/
sleep therapy, and dental anatomy.
Ear, Nose, and Throat Devices Panel of the 4 Immediately.
Medical Devices Advisory Committee-- 4 November 1, 2023.
Otologists, neurotologists, and audiologists.
Gastroenterology and Urology Devices Panel of 1 Immediately.
the Medical Devices Advisory Committee--
Gastroenterologists, urologists, and
nephrologists.
General and Plastic Surgery Devices Panel of 3 September 1, 2023.
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 1 Immediately.
Panel of the Medical Devices Advisory 1 January 1, 2023.
Committee--Internists, pediatricians,
neonatologists, endocrinologists,
gerontologists, nurses, biomedical engineers,
human factors experts, or microbiologists/
infection control practitioners or experts.
Hematology and Pathology Devices Panel of the 4 Immediately.
Medical Devices Advisory Committee-- 3 March 1, 2023.
Hematologists (benign and/or malignant
hematology), hematopathologists (general and
special hematology, coagulation and
hemostasis, and hematological oncology),
gynecologists with special interests in
gynecological oncology, cytopathologists, and
molecular pathologists with special interests
in development of predictive and prognostic
biomarkers, molecular oncology, cancer
screening, cancer risk, digital pathology,
whole slide imaging, devices utilizing
artificial intelligence/machine learning.
Medical Devices Dispute Resolution Panel of 1 October 1, 2023.
the Medical Devices Advisory Committee--
Experts with cross-cutting scientific,
clinical, analytical, or mediation skills.
Molecular and Clinical Genetics Panel of the 3 Immediately.
Medical Devices Advisory Committee--Experts 3 June 1, 2023.
in human genetics, molecular diagnostics, 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, bioinformatics,
computational genetics/genomics, variant
classification, cancer genetics/genomics,
molecular oncology, radiation biology, and
clinical molecular genetics testing, (e.g.,
sequencing, whole exome sequencing, whole
genome sequencing, non-invasive prenatal
testing, cancer screening, circulating cell
free/circulating tumor nucleic acid testing,
digital PCR, 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 2 Immediately.
Devices Advisory Committee--Neurosurgeons 1 December 1, 2023.
(cerebrovascular and pediatric), neurologists
(stroke, pediatric, pain management, and
movement disorders), interventional
neuroradiologists, psychiatrists, and
biostatisticians.
Obstetrics and Gynecology Devices Panel of the 3 Immediately.
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.
Orthopaedic and Rehabilitation Devices Panel 6 Immediately.
of the Medical Devices Advisory Committee--
Orthopaedic surgeons (joint, spine, trauma,
reconstruction, sports medicine, hand, foot
and ankle, and pediatric orthopaedic
surgeons); rheumatologists; engineers
(biomedical, biomaterials, and
biomechanical); experts in rehabilitation
medicine, and musculoskeletal engineering;
radiologists specializing in musculoskeletal
imaging and analyses and biostatisticians.
Radiological Devices Panel of the Medical 1 Immediately.
Devices Advisory Committee--Physicians with 1 February 1, 2023.
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.
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I. General Description of the Committees Duties
The MDAC reviews and evaluates data on the safety and effectiveness
of marketed and investigational devices and makes recommendations for
their regulation. The panels engage in many activities to fulfill the
functions the Federal Food, Drug, and Cosmetic Act (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
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duties: (1) advises 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.
II. Criteria for Voting Members
The MDAC with its 18 panels shall consist of a maximum of 159
standing members. Members are selected by the Commissioner or designee
from among authorities in clinical and administrative medicine,
engineering, biological and physical sciences, and other related
professions. Almost all non-Federal members of this committee serve as
Special Government Employees. A maximum of 122 members shall be
standing voting members and 37 shall be nonvoting members who serve as
representatives of consumer interests and of industry interests. FDA is
publishing separate documents announcing the Request for Nominations
Notification for Nonvoting Representatives on certain panels of the
MDAC. 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 current needs for
each panel are listed in table 2. Members will be invited to serve for
terms of up to 4 years.
III. Nomination Procedures
Any interested person may nominate one or more qualified
individuals for membership on one or more of the advisory panels. Self-
nominations are also accepted. Nominations must include a current,
complete r[eacute]sum[eacute] or curriculum vitae for each nominee,
including current business address, telephone number, and email address
if available and a signed copy of the Acknowledgement and Consent form
available at the FDA Advisory Nomination Portal (see ADDRESSES).
Nominations must also specify the advisory panel(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: November 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25813 Filed 11-25-22; 8:45 am]
BILLING CODE 4164-01-P
