Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee, 42659-42662 [2018-18216]
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Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Number: 93.676]
Announcement of Intent To Solicit and
Issue One OPDIV-Initiated Supplement
to Lutheran Immigration and Refugee
Service, Inc. Under the Standing
Announcement for Residential
(Shelter) Services for Unaccompanied
Children, HHS–2017–ACF–ORR–ZU–
1132
Unaccompanied Alien
Children (UAC) Program, Office of
Refugee Resettlement (ORR),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS).
ACTION: Notice of solicitation and intent
to issue of one OPDIV-Initiated
Supplement to Lutheran Immigration
and Refugee Service, Inc., Baltimore,
MD under the UAC Program.
AGENCY:
ACF, ORR announces the
solicitation and intent to issue one
OPDIV-Initiated Supplement to
Lutheran Immigration and Refugee
Service, Inc., Baltimore, MD in an
amount not to exceed $1,000,000.
ORR has been identifying additional
capacity for fingerprinting services for
an expected increase in the number of
sponsors (parents, guardians, or family
friends to whom the UAC will be
released) who will need to be
fingerprinted. Planning for increased
fingerprinting capacity is a prudent step
to ensure that ORR is able to meet its
responsibility, by law, to ensure that the
sponsor has not engaged in any activity
that would indicate a potential risk to
the UAC.
DATES: Supplemental award funds will
support activities for up to eight months
after award.
FOR FURTHER INFORMATION CONTACT:
Jallyn Sualog, Director, Division of
Unaccompanied Children Operations,
Office of Refugee Resettlement, 330 C
Street SW, Washington, DC 20201.
Telephone: 202–401–4997; email:
jallyn.sualog@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: ORR is
continuously monitoring its capacity to
provide fingerprinting services to the
sponsors of UAC referred to HHS, as
well as the information received from
interagency partners, to inform any
future decisions or actions.
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SUMMARY:
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ORR has specific requirements for the
provision of services. Award recipients
must have the infrastructure, licensing,
experience, and appropriate level of
trained staff to meet those requirements.
The expansion of the existing program
and its services through this
supplemental award is a key strategy for
ORR to be prepared to meet its
responsibility to provide fingerprinting
services to the sponsors of UAC referred
to its care by DHS.
ORR plans to solicit an application
from Lutheran Immigration and Refugee
Service, Inc., Baltimore, MD to meet the
fingerprinting needs. If the application
received a favorable objective review,
ORR intends to issue a supplement in
the amount up to $1,000,000.
Statutory Authority: This program is
authorized by—
(A) Section 462 of the Homeland
Security Act of 2002, which in March
2003, transferred responsibility for the
care and custody of Unaccompanied
Alien Children from the Commissioner
of the former Immigration and
Naturalization Service (INS) to the
Director of ORR of the Department of
Health and Human Services (HHS).
(B) The Flores Settlement Agreement,
Case No. CV85–4544RJK (C.D. Cal.
1996), as well as the William
Wilberforce Trafficking Victims
Protection Reauthorization Act of 2008
(Pub. L. 110–457), which authorizes
post release services under certain
conditions to eligible children. All
programs must comply with the Flores
Settlement Agreement, Case No. CV85–
4544–RJK (C.D. Cal. 1996), pertinent
regulations and ORR policies and
procedures.
ACTION:
42659
Notice.
The Food and Drug
Administration (FDA) is requesting
nominations for voting members to
serve on the Device Good
Manufacturing Practice Advisory
Committee and device panels of the
Medical Devices Advisory Committee 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 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.
SUMMARY:
Nominations received on or
before October 22, 2018 will be given
first consideration for membership on
the Device Good Manufacturing Practice
Advisory Committee and Panels of the
Medical Devices Advisory Committee.
Nominations received after October 22,
2018 will be considered for nomination
to the committee as later vacancies
occur.
DATES:
Food and Drug Administration
All nominations for
membership should be submitted
electronically by logging into the FDA
Advisory Nomination Portal: 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.
[Docket No. FDA–2018–N–3079]
FOR FURTHER INFORMATION CONTACT:
Elizabeth Leo,
Grants Policy Specialist, Division of Grants
Policy, Office of Administration.
[FR Doc. 2018–18230 Filed 8–22–18; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Nominations for Voting
Members on Public Advisory Panels or
Committees; Device Good
Manufacturing Practice Advisory
Committee and the Medical Devices
Advisory Committee
AGENCY:
ADDRESSES:
Regarding all nomination questions for
membership, contact the following
persons listed in table 1:
Food and Drug Administration,
HHS.
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Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
TABLE 1—PANEL AND ADVISORY COMMITTEE CONTACTS
Primary contact person or designated federal officer
Committee/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. 5519, Silver Spring, MD 20993, 301–796–5421, email:
Joannie.Adams-White@fda.hhs.gov.
LCDR Sara Anderson, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 66, Rm. G616, Silver Spring, MD 20993, 301–796–7047, email:
Sara.Anderson@fda.hhs.gov.
Aden S. Asefa, Office of Device Evaluation, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66,
Rm. G642, Silver Spring, MD 20993, 301–796–0400, email: Aden.Asefa@
fda.hhs.gov.
LCDR Patricio G. Garcia, Office of Device Evaluation, Center for Devices and
Radiological Health, Food and Drug Administration,10903 New Hampshire
Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993, 301–796–6875, email:
Patricio.Garcia@fda.hhs.gov.
Evella F. Washington, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 66, Rm. G640, Silver Spring, MD 20993, 301–796–6683, email:
Evella.Washington@fda.hhs.gov.
Information about becoming a
member on an FDA advisory committee
can also be obtained by visiting FDA’s
Medical Devices Dispute Resolution Panel.
Dental Products Panel.
Hematology and Pathology Devices Panel.
Orthopaedic and Rehabilitation Devices Panel.
Radiological Devices Panel.
Immunology Devices Panel.
Microbiology Devices Panel.
Neurological Devices Panel.
Ophthalmic Devices Panel.
Device Good Manufacturing Practice Advisory Committee.
Clinical Chemistry and Clinical Toxicology Devices Panel.
Gastroenterology and Urology Devices Panel.
General and Plastic Surgery Devices Panel.
Obstetrics and Gynecology Devices Panel.
Anesthesiology and Respiratory Therapy Devices Panel.
Circulatory System Devices Panel.
Ear, Nose and Throat Devices Panel.
General Hospital and Personal Use Devices Panel.
Molecular and Clinical Genetics Devices Panel.
website at https://www.fda.gov/
AdvisoryCommittees/default.htm.
FDA is
requesting nominations for voting
members for vacancies listed in table 2:
SUPPLEMENTARY INFORMATION:
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TABLE 2—EXPERTISE NEEDED, VACANCIES, AND APPROXIMATE DATE NEEDED
Approximate
date needed
Committee/panel expertise needed
Vacancies
Device Good Manufacturing Practice Advisory Committee—Experts needed to provide cross-cutting scientific or clinical expertise concerning the particular issue in
dispute. Vacancies include a representative of the interests of the general public
and government and representatives of the interests of physicians and other
health professionals.
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.
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, 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—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.
1 General Public Representative ............
2 Health Professional Representatives.
1 Government Representative ................
Immediately.
1 ..............................................................
3 ..............................................................
Immediately.
11/30/2018.
3 ..............................................................
Immediately.
1 ..............................................................
2/28/2019.
2 ..............................................................
10/31/2018.
3 ..............................................................
10/31/2018.
0 ..............................................................
N/A.
1 ..............................................................
1 ..............................................................
Immediately.
8/31/2018.
3 ..............................................................
3 ..............................................................
Immediately.
12/31/2018.
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Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
42661
TABLE 2—EXPERTISE NEEDED, VACANCIES, AND APPROXIMATE DATE NEEDED—Continued
Vacancies
Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee—Hematologists
(benign
and/or
malignant
hematology),
hematopathologists (general and special hematology, coagulation and homeostasis, and hematological oncology), gynecologists with special interests in gynecological oncology, cytopathologists, and molecular pathologists with special interests in development of predictive and prognostic biomarkers.
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, clinical, analytical, or mediation skills.
Microbiology Devices Panel of the Medical Devices Advisory Committee—Infectious disease (ID) 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 Devices Panel of the Medical Devices Advisory
Committee—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 comparative genomic hybridization (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—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, 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 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.
1 ..............................................................
2/28/2019.
1 ..............................................................
2 ..............................................................
Immediately.
2/28/19.
1 ..............................................................
9/30/2018.
2 ..............................................................
Immediately.
3 ..............................................................
2 ..............................................................
Immediately.
5/31/2019.
1 ..............................................................
Immediately.
1 ..............................................................
2 ..............................................................
Immediately.
1/31/2019.
2 ..............................................................
3 ..............................................................
Immediately.
10/31/2018.
2 ..............................................................
1 ..............................................................
8/31/2018.
8/31/2019.
3 ..............................................................
3 ..............................................................
Immediately.
1/31/2019.
I. General Description of the
Committees Duties
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Approximate
date needed
Committee/panel expertise needed
A. Device Good Manufacturing Practice
Advisory Committee
The Committee reviews regulations
proposed for promulgation regarding
good manufacturing practices governing
the methods used in, and the facilities
and controls used for, the manufacture,
packing, storage, and installation of
devices, and makes recommendations to
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the Commissioner of Food and Drugs
(the Commissioner) regarding the
feasibility and reasonableness of those
proposed regulations. The Committee
also advises the Commissioner on any
petition submitted by a manufacturer for
an exemption or variance from good
manufacturing practice regulations that
is referred to the committee.
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B. 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 the Federal Food, Drug, and
Cosmetic Act (FD&C Act) envisions for
device advisory panels. With the
exception of the Medical Devices
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Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
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-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.
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II. Criteria for Voting Members
A. Device Good Manufacturing Practice
Advisory Committee
The Committee consists of a core of
nine members including the Chair.
Members and the Chair are selected by
the Secretary of Health and Human
Services. 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
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Jkt 244001
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.
Three of the members shall be officers
or employees of any State or local
government or of the Federal
Government; two shall be representative
of the interests of the device
manufacturing industry; two shall be
representatives of the interests of
physicians and other health
professionals; and two shall be
representatives of the interests of the
general public. Almost all non-Federal
members of this committee serves as
Special Government Employees.
Members are invited to serve for
overlapping terms of 4 years. The
particular needs at this time for this
committee are listed in table 2 of this
document.
B. Panels of the Medical Devices
Advisory Committee
The Medical Devices Advisory
Committee (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 particular needs at this
time for each panel are listed in table 2.
Members will be invited to serve for
terms of up to 4 years.
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III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals 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, 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 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: August 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–18216 Filed 8–22–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–2896]
Osteoarthritis: Structural Endpoints for
the Development of Drugs, Devices,
and Biological Products for Treatment;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Osteoarthritis: Structural Endpoints for
the Development of Drugs, Devices, and
Biological Products for Treatment.’’ The
purpose of this draft guidance is to
assist sponsors who are developing
drugs, devices, or biological products to
treat the underlying pathophysiology
and structural progression of
osteoarthritis (OA). This draft guidance
does not address improvement of
symptoms of OA, such as pain or
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Notices]
[Pages 42659-42662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18216]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3079]
Request for Nominations for Voting Members on Public Advisory
Panels or Committees; Device Good Manufacturing Practice Advisory
Committee and 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 Device Good
Manufacturing Practice Advisory Committee and device panels of the
Medical Devices Advisory Committee 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 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 October 22, 2018 will be given
first consideration for membership on the Device Good Manufacturing
Practice Advisory Committee and Panels of the Medical Devices Advisory
Committee. Nominations received after October 22, 2018 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:
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.
FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for
membership, contact the following persons listed in table 1:
[[Page 42660]]
Table 1--Panel and Advisory Committee Contacts
------------------------------------------------------------------------
Primary contact person or designated
federal officer Committee/panel
------------------------------------------------------------------------
Joannie Adams-White, Office of the Medical Devices Dispute
Center Director, Center for Devices and Resolution Panel.
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5519, Silver
Spring, MD 20993, 301-796-5421, email:
[email protected].
LCDR Sara Anderson, Office of Device Dental Products Panel.
Evaluation, Center for Devices and Hematology and Pathology
Radiological Health, Food and Drug Devices Panel.
Administration, 10903 New Hampshire Orthopaedic and Rehabilitation
Ave., Bldg. 66, Rm. G616, Silver Devices Panel.
Spring, MD 20993, 301-796-7047, email: Radiological Devices Panel.
[email protected].
Aden S. Asefa, Office of Device Immunology Devices Panel.
Evaluation, Center for Devices and Microbiology Devices Panel.
Radiological Health, Food and Drug Neurological Devices Panel.
Administration, 10903 New Hampshire Ophthalmic Devices Panel.
Ave., Bldg. 66, Rm. G642, Silver Device Good Manufacturing
Spring, MD 20993, 301-796-0400, email: Practice Advisory Committee.
[email protected].
LCDR Patricio G. Garcia, Office of Clinical Chemistry and
Device Evaluation, Center for Devices Clinical Toxicology Devices
and Radiological Health, Food and Drug Panel.
Administration,10903 New Hampshire Gastroenterology and Urology
Ave., Bldg. 66, Rm. G610, Silver Devices Panel.
Spring, MD 20993, 301-796-6875, email: General and Plastic Surgery
[email protected]. Devices Panel.
Obstetrics and Gynecology
Devices Panel.
Evella F. Washington, Office of Device Anesthesiology and Respiratory
Evaluation, Center for Devices and Therapy Devices Panel.
Radiological Health, Food and Drug Circulatory System Devices
Administration, 10903 New Hampshire Panel.
Ave., Bldg. 66, Rm. G640, Silver Ear, Nose and Throat Devices
Spring, MD 20993, 301-796-6683, email: Panel.
[email protected]. General Hospital and Personal
Use Devices Panel.
Molecular and Clinical
Genetics Devices Panel.
------------------------------------------------------------------------
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.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members for vacancies listed in table 2:
Table 2--Expertise Needed, Vacancies, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
Committee/panel expertise needed Vacancies Approximate date needed
----------------------------------------------------------------------------------------------------------------
Device Good Manufacturing Practice Advisory 1 General Public Immediately.
Committee--Experts needed to provide cross- Representative. .............................
cutting scientific or clinical expertise 2 Health Professional 6/1/2019.
concerning the particular issue in dispute. Representatives..
Vacancies include a representative of the 1 Government Representative..
interests of the general public and government
and representatives of the interests of
physicians and other health professionals.
Anesthesiology and Respiratory Therapy Devices 1............................ Immediately.
Panel of the Medical Devices Advisory Committee-- 3............................ 11/30/2018.
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 3............................ Immediately.
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 1............................ 2/28/2019.
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 2............................ 10/31/2018.
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 3............................ 10/31/2018.
Devices Advisory Committee--Otologists,
neurotologists, audiologists.
Gastroenterology and Urology Devices Panel of the 0............................ N/A.
Medical Devices Advisory Committee--
Gastroenterologists, urologists, and
nephrologists.
General and Plastic Surgery Devices Panel of the 1............................ Immediately.
Medical Devices Advisory Committee--Surgeons 1............................ 8/31/2018.
(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 3............................ Immediately.
the Medical Devices Advisory Committee-- 3............................ 12/31/2018.
Internists, pediatricians, neonatologists,
endocrinologists, gerontologists, nurses,
biomedical engineers or microbiologists/infection
control practitioners or experts.
[[Page 42661]]
Hematology and Pathology Devices Panel of the 1............................ 2/28/2019.
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 1............................ Immediately.
Advisory Committee--Persons with experience in 2............................ 2/28/19.
medical, surgical, or clinical oncology, internal
medicine, clinical immunology, allergy, molecular
diagnostics, or clinical laboratory medicine.
Medical Devices Dispute Resolution Panel of the 1............................ 9/30/2018.
Medical Devices Advisory Committee--Experts with
broad, cross-cutting scientific, clinical,
analytical, or mediation skills.
Microbiology Devices Panel of the Medical Devices 2............................ Immediately.
Advisory Committee--Infectious disease (ID)
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 Devices Panel of 3............................ Immediately.
the Medical Devices Advisory Committee--Human 2............................ 5/31/2019.
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 comparative genomic hybridization (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 1............................ Immediately.
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 1............................ Immediately.
Medical Devices Advisory Committee--Perinatology, 2............................ 1/31/2019.
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 2............................ Immediately.
Advisory Committee--Ophthalmologists specializing 3............................ 10/31/2018.
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............................ 8/31/2018.
the Medical Devices Advisory Committee-- 1............................ 8/31/2019.
Orthopaedic 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 3............................ Immediately.
Advisory Committee--Physicians with experience in 3............................ 1/31/2019.
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
A. Device Good Manufacturing Practice Advisory Committee
The Committee reviews regulations proposed for promulgation
regarding good manufacturing practices governing the methods used in,
and the facilities and controls used for, the manufacture, packing,
storage, and installation of devices, and makes recommendations to the
Commissioner of Food and Drugs (the Commissioner) regarding the
feasibility and reasonableness of those proposed regulations. The
Committee also advises the Commissioner on any petition submitted by a
manufacturer for an exemption or variance from good manufacturing
practice regulations that is referred to the committee.
B. 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 the Federal Food, Drug, and
Cosmetic Act (FD&C Act) envisions for device advisory panels. With the
exception of the Medical Devices
[[Page 42662]]
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
A. Device Good Manufacturing Practice Advisory Committee
The Committee consists of a core of nine members including the
Chair. Members and the Chair are selected by the Secretary of Health
and Human Services. 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. Three of the members shall be officers or employees
of any State or local government or of the Federal Government; two
shall be representative of the interests of the device manufacturing
industry; two shall be representatives of the interests of physicians
and other health professionals; and two shall be representatives of the
interests of the general public. Almost all non-Federal members of this
committee serves as Special Government Employees. Members are invited
to serve for overlapping terms of 4 years. The particular needs at this
time for this committee are listed in table 2 of this document.
B. Panels of the Medical Devices Advisory Committee
The Medical Devices Advisory Committee (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 Non-Voting 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 particular needs at this time 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 or
advisory committees. Self-nominations are also accepted. Nominations
must include a current, complete resume 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 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: August 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18216 Filed 8-22-18; 8:45 am]
BILLING CODE 4164-01-P
