Request for Nominations for Voting Members on Public Advisory Panels of the Medical Devices Advisory Committee, 71643-71646 [2021-27376]
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Federal Register / Vol. 86, No. 240 / Friday, December 17, 2021 / Notices
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COVID–19 pandemic and rapidly
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campaign. CDC will carefully consider
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Kalwant Smagh,
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Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2021–27506 Filed 12–15–21; 4:15 pm]
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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.
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 February 15, 2022, will be given
first consideration for membership on
the Panels of the MDAC. Nominations
received after February 15, 2022, 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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Regarding all nomination questions for
membership, contact the following
persons listed in table 1:
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Federal Register / Vol. 86, No. 240 / Friday, December 17, 2021 / Notices
TABLE 1—PRIMARY CONTACT AND COMMITTEE OR PANEL
Primary contact person
Committee or 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, 301–796–6875,
Jarrod.Collier@fda.hhs.gov.
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.
Medical Devices Dispute Resolution Panel.
Circulatory System Devices Panel, Immunology Devices Panel, Microbiology Devices Panel,Ophthalmic 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.
Anesthesiology and Respiratory Therapy Devices Panel, Clinical
Chemistry and Clinical Toxicology 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
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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, 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.
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.
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
cross-cutting scientific, clinical, analytical or mediation skills.
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July 1, 2022.
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January 1, 2022.
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March 1, 2022.
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October 1, 2022.
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Federal Register / Vol. 86, No. 240 / Friday, December 17, 2021 / Notices
TABLE 2— EXPERTISE NEEDED, VACANCIES, AND APPROXIMATE DATE NEEDED—Continued
Expertise needed
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Microbiology Devices Panel of the Medical Devices Advisory Committee—Infectious disease clinicians
(e.g., pulmonary disease specialists, sexually transmitted disease specialists, pediatric ID specialists, tropical diseases specialists) and clinical microbiologists experienced in emerging infectious
diseases; clinical microbiology laboratory directors; molecular biologists with experience in in vitro
diagnostic device testing; virologists; hepatologists; or clinical oncologists experienced with tumor
resistance and susceptibility.
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, and (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.
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—
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 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 Committee
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
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
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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
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March 1, 2022.
2
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June 1, 2022.
2
Immediately.
4
1
Immediately.
February 1, 2022.
4
Immediately.
2
2
Immediately.
September 1, 2022.
3
4
Immediately.
February 1, 2022.
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
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Federal Register / Vol. 86, No. 240 / Friday, December 17, 2021 / Notices
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
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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: December 13, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–27376 Filed 12–16–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1425]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Mitigation
Strategies To Protect Food Against
Intentional Adulteration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on collections of
information describing mitigation
strategies to protect food against
intentional adulteration.
DATES: Submit either electronic or
written comments on the collection of
information by February 15, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 15,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 15, 2022.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
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anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–N–1425 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Mitigation Strategies to Protect Food
Against Intentional Adulteration.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
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]]>Agencies
[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Notices]
[Pages 71643-71646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27376]
-----------------------------------------------------------------------
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 February 15, 2022, will be
given first consideration for membership on the Panels of the MDAC.
Nominations received after February 15, 2022, 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:
[[Page 71644]]
Table 1--Primary Contact and Committee or Panel
------------------------------------------------------------------------
Primary contact person Committee or panel
------------------------------------------------------------------------
Joannie Adams-White, Office of the Medical Devices Dispute
Center Director, Center for Devices Resolution Panel.
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, Circulatory System Devices
Center for Devices and Radiological Panel, Immunology Devices
Health, Food and Drug Administration, Panel, Microbiology Devices
10903 New Hampshire Ave., Bldg. 66 Rm. Panel,Ophthalmic Devices
5211, Silver Spring, MD 20993, 301-796- Panel.
6313, [email protected].
Akinola Awojope, Office of Management, Dental Products Panel,
Center for Devices and Radiological Neurological Devices Panel,
Health, Food and Drug Obstetrics and Gynecology
Administration,10903 New Hampshire Devices Panel Orthopaedic and
Ave., Bldg. 66, Rm. 5216, Silver Rehabilitation Devices Panel.
Spring, MD 20993, 301-636-0512,
[email protected].
Jarrod Collier, Office of Management, Ear, Nose and Throat Devices
Center for Devices and Radiological Panel, General Hospital and
Health, Food and Drug Personal Use Devices Panel,
Administration,10903 New Hampshire Hematology and Pathology
Ave., Bldg. 66, Rm. 5216, Silver Devices Panel, Molecular and
Spring, MD 20993, 301-796-6875, Clinical Genetics Panel,
[email protected]. Radiological Devices Panel.
Candace Nalls, Office of Management, Anesthesiology and Respiratory
Center for Devices and Radiological Therapy Devices Panel,
Health, Food and Drug Clinical Chemistry and
Administration,10903 New Hampshire Clinical Toxicology Devices
Ave., Bldg. 66, Rm. 5214, Silver Panel, General and Plastic
Spring, MD 20993, 301-636-0510, Surgery Devices Panel.
[email protected].
------------------------------------------------------------------------
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 3 Immediately.
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 1 Immediately.
Devices Advisory Committee--Interventional 1 July 1, 2022.
cardiologists, electrophysiologists, invasive
(vascular) radiologists, vascular and
cardiothoracic surgeons, and cardiologists
with special interest in congestive heart
failure.
Clinical Chemistry and Clinical Toxicology 1 March 1, 2022.
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 3 Immediately.
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 4 Immediately.
Medical Devices Advisory Committee--
Otologists, neurotologists, and audiologists.
General and Plastic Surgery Devices Panel of 4 Immediately.
the Medical Devices Advisory Committee--
Surgeons (general, plastic, reconstructive,
pediatric, thoracic, abdominal, pelvic, and
endoscopic); dermatologists; experts in
biomaterials, lasers, wound healing, and
quality of life; and biostatisticians.
General Hospital and Personal Use Devices Panel 2 Immediately.
of the Medical Devices Advisory Committee-- 1 January 1, 2022.
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 3 Immediately.
Medical Devices Advisory Committee-- 1 March 1, 2022.
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.
Immunology Devices Panel of the Medical Devices 7 Immediately.
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 1 October 1, 2022.
Medical Devices Advisory Committee--Experts
with cross-cutting scientific, clinical,
analytical or mediation skills.
[[Page 71645]]
Microbiology Devices Panel of the Medical 5 Immediately.
Devices Advisory Committee--Infectious disease 2 March 1, 2022.
clinicians (e.g., pulmonary disease
specialists, sexually transmitted disease
specialists, pediatric ID specialists,
tropical diseases specialists) and clinical
microbiologists experienced in emerging
infectious diseases; clinical microbiology
laboratory directors; molecular biologists
with experience in in vitro diagnostic device
testing; virologists; hepatologists; or
clinical oncologists experienced with tumor
resistance and susceptibility.
Molecular and Clinical Genetics Panel of the 2 Immediately.
Medical Devices Advisory Committee--Experts in 2 June 1, 2022.
human genetics, molecular diagnostics, and in
the clinical management of patients with
genetic disorders, and (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
(cerebrovascular and pediatric), neurologists
(stroke, pediatric, pain management, and
movement disorders), interventional
neuroradiologists, psychiatrists, and
biostatisticians.
Obstetrics and Gynecology Devices Panel of the 4 Immediately.
Medical Devices Advisory Committee--Experts in 1 February 1, 2022.
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 4 Immediately.
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 2 Immediately.
the Medical Devices Advisory Committee-- 2 September 1, 2022.
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 musculoskeletal imaging and
analyses and biostatisticians.
Radiological Devices Panel of the Medical 3 Immediately.
Devices Advisory Committee--Physicians with 4 February 1, 2022.
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 Committee 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 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
[[Page 71646]]
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: December 13, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27376 Filed 12-16-21; 8:45 am]
BILLING CODE 4164-01-P
