Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee, 28661-28664 [2017-13182]
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Federal Register / Vol. 82, No. 120 / Friday, June 23, 2017 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0001]
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.
The Food and Drug
Administration (FDA or Agency) 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
SUMMARY:
the Center for Devices and Radiological
Health. In accordance with the 21st
Century Cures Act, this notice provides
an annual opportunity for patients,
representatives of patients, and sponsors
of medical device submissions 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 August 22, 2017, 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 August 22,
28661
2017, 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: 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 Web site 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—COMMITTEE CONTACT
Primary contact person or designated federal officer
Committee
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.
Shanika Craig, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G644, Silver Spring, MD 20993, 301–796–
6639, email: Shanika.Craig@fda.hhs.gov.
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.
Pamela Scott, Office of the Center Director, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993, 301–
796–5433, email: Pamelad.Scott@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.
Dental Products Panel, Hematology and Pathology Devices Panel,
Orthopaedic and Rehabilitation Devices Panel.
General Hospital and Personal Use Devices Panel, Neurological Devices Panel, Ophthalmic Devices Panel, Immunology Devices Panel,
Device Good Manufacturing Practice Advisory Committee.
Anesthesiology and Respiratory Therapy Devices Panel, Microbiology
Devices Panel, Obstetrics and Gynecology Devices Panel, Radiological Devices Panel.
Clinical Chemistry and Clinical Toxicology Panel, Gastroenterology and
Urology Devices Panel, General and Plastic Surgery Devices Panel.
Medical Devices Dispute Resolution Panel.
Circulatory System Devices Panel, Ear, Nose and Throat Devices
Panel, Molecular and Clinical Genetics Devices Panel.
FDA is
requesting nominations for voting
members for vacancies listed in table 2:
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
TABLE 2—EXPERTISE NEEDED, VACANCIES, AND APPROXIMATE DATE NEEDED
Upcoming
vacancies
Committee expertise needed
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 public representative and a government representative.
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.
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June 1, 2017: Government Representatives (2) and General Public Representative (1).
December 1, 2017.
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TABLE 2—EXPERTISE NEEDED, VACANCIES, AND APPROXIMATE DATE NEEDED—Continued
Upcoming
vacancies
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Committee expertise needed
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, 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 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 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 cross-cutting scientific, clinical, analytical or mediation skills.
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 Devices Panel of the Medical Devices Advisory
Committee—Experts in human genetics and in the clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, neonatologists. Individuals with training in inborn errors of metabolism, biochemical and/or molecular genetics, population genetics, epidemiology and related statistical training,
and clinical molecular genetics testing (e.g., genotyping, array CGH, etc.). Individuals with experience in genetics counseling, medical ethics are also desired,
and individuals with experience in ancillary fields of study will be considered.
Neurological Devices Panel of the Medical Devices Advisory Committee—Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain
management, and movement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians.
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.
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28663
TABLE 2—EXPERTISE NEEDED, VACANCIES, AND APPROXIMATE DATE NEEDED—Continued
Upcoming
vacancies
Committee expertise needed
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—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
asabaliauskas on DSKBBXCHB2PROD with NOTICES
A. Device Good Manufacturing Practice
Advisory Committee
The Committee reviews regulations
proposed for issuance 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 with
regard to 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 (the FD&C Act) envisions
for device advisory panels. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area performs
the following duties: (1) Advises the
Commissioner 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
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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
more of the following areas: Quality
assurance concerning the design,
manufacture, and use of medical
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September 1, 2017.
1
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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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 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 Medical Devices Advisory
Committee. Persons nominated for
membership on the panels should have
adequately diversified experience
appropriate to the work of the panel in
such fields as clinical and
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Federal Register / Vol. 82, No. 120 / Friday, June 23, 2017 / Notices
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
of this document. 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 and/or home address,
telephone number, and email address if
available. 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: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13182 Filed 6–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
asabaliauskas on DSKBBXCHB2PROD with NOTICES
[Docket No. FDA–2017–N–2697]
Submission of Proposed
Recommendations for Industry on
Developing Continuous Manufacturing
of Solid Dosage Drug Products in
Pharmaceutical Manufacturing;
Establishment of a Public Docket
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of docket;
request for comments.
ACTION:
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In connection with promoting
the use of innovative technologies, the
Food and Drug Administration (FDA or
Agency) is establishing a public docket
to invite discussion of issues related to
the adoption of continuous
manufacturing by the pharmaceutical
industry.
SUMMARY:
Submit electronic or written
comments by September 21, 2017.
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 September 21,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of September 21, 2017.
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.
DATES:
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
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
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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–
2017–N–2697 for ‘‘Submission of
Proposed Recommendations for
Industry on Developing Continuous
Manufacturing of Solid Dosage Drug
Products in Pharmaceutical
Manufacturing; Establishment of a
Public Docket.’’ 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.
• 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
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
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Agencies
[Federal Register Volume 82, Number 120 (Friday, June 23, 2017)]
[Notices]
[Pages 28661-28664]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13182]
[[Page 28661]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0001]
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 or Agency) 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. In accordance with the 21st Century Cures Act,
this notice provides an annual opportunity for patients,
representatives of patients, and sponsors of medical device submissions
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 August 22, 2017, 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 August 22, 2017, 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. Information about becoming a member on an
FDA advisory committee can also be obtained by visiting FDA's Web site
at https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for
membership, contact the following persons listed in table 1:
Table 1--Committee Contact
------------------------------------------------------------------------
Primary contact person or designated
federal officer Committee
------------------------------------------------------------------------
Sara Anderson, Office of Device Dental Products Panel,
Evaluation, Center for Devices and Hematology and Pathology
Radiological Health, Food and Drug Devices Panel, Orthopaedic and
Administration, 10903 New Hampshire Rehabilitation Devices Panel.
Ave., Bldg. 66, Rm. G616, Silver
Spring, MD 20993, 301-796-7047, email:
Sara.Anderson@fda.hhs.gov.
Aden S. Asefa, Office of Device General Hospital and Personal
Evaluation, Center for Devices and Use Devices Panel,
Radiological Health, Food and Drug Neurological Devices Panel,
Administration, 10903 New Hampshire Ophthalmic Devices Panel,
Ave., Bldg. 66, Rm. G642, Silver Immunology Devices Panel,
Spring, MD 20993, 301-796-0400, email: Device Good Manufacturing
Aden.Asefa@fda.hhs.gov. Practice Advisory Committee.
Shanika Craig, Office of Device Anesthesiology and Respiratory
Evaluation, Center for Devices and Therapy Devices Panel,
Radiological Health, Food and Drug Microbiology Devices Panel,
Administration, 10903 New Hampshire Obstetrics and Gynecology
Ave., Bldg. 66, Rm. G644, Silver Devices Panel, Radiological
Spring, MD 20993, 301-796-6639, email: Devices Panel.
Shanika.Craig@fda.hhs.gov.
Patricio G. Garcia, Office of Device Clinical Chemistry and Clinical
Evaluation, Center for Devices and Toxicology Panel,
Radiological Health, Food and Drug Gastroenterology and Urology
Administration, 10903 New Hampshire Devices Panel, General and
Ave., Bldg. 66, Rm. G610, Silver Plastic Surgery Devices Panel.
Spring, MD 20993, 301-796-6875, email:
Patricio.Garcia@fda.hhs.gov.
Pamela Scott, Office of the Center Medical Devices Dispute
Director, Center for Devices and Resolution Panel.
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5572, Silver
Spring, MD 20993, 301-796-5433, email:
Pamelad.Scott@fda.hhs.gov.
Evella F. Washington, Office of Device Circulatory System Devices
Evaluation, Center for Devices and Panel, Ear, Nose and Throat
Radiological Health, Food and Drug Devices Panel, Molecular and
Administration, 10903 New Hampshire Clinical Genetics Devices
Ave., Bldg. 66, Rm. G640, Silver Panel.
Spring, MD 20993, 301-796-6683, email:
Evella.Washington@fda.hhs.gov.
------------------------------------------------------------------------
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members for vacancies listed in table 2:
Table 2--Expertise Needed, Vacancies, and Approximate Date Needed
------------------------------------------------------------------------
Upcoming Approximate date
Committee expertise needed vacancies needed
------------------------------------------------------------------------
Device Good Manufacturing Practice 5 Immediately: Health
Advisory Committee--Experts Professional (2).
needed to provide cross-cutting June 1, 2017:
scientific or clinical expertise Government
concerning the particular issue Representatives (2)
in dispute. Vacancies include a and General Public
public representative and a Representative (1).
government representative.
Anesthesiology and Respiratory 3 December 1, 2017.
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.
[[Page 28662]]
Circulatory System Devices Panel 1 July 1, 2017.
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 2 Immediately.
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 3 November 1, 2017.
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 1 Immediately.
of the Medical Devices Advisory 3 November 1, 2017.
Committee--Otologists,
neurotologists, and audiologists.
Gastroenterology and Urology, 1 Immediately.
Devices Panel of the Medical 2 January 1, 2018.
Devices Advisory Committee--
Gastroenterologists, urologists,
and nephrologists.
General and Plastic Surgery 1 Immediately.
Devices Panel of the Medical 2 September 1, 2017.
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 1 Immediately.
Devices Panel of the Medical 2 January 1, 2018.
Devices Advisory Committee--
Internists, pediatricians,
neonatologists, endocrinologists,
gerontologists, nurses,
biomedical engineers or
microbiologists/infection control
practitioners or experts.
Hematology and Pathology Devices 1 Immediately.
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 3 Immediately.
Medical Devices Advisory
Committee--Persons with
experience in medical, surgical,
or clinical oncology, internal
medicine, clinical immunology,
allergy, molecular diagnostics,
or clinical laboratory medicine.
Medical Devices Dispute Resolution 1 Immediately.
Panel of the Medical Devices 1 October 1, 2017.
Advisory Committee--Experts with
cross-cutting scientific,
clinical, analytical or mediation
skills.
Microbiology Devices Panel of the 5 Immediately.
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 2 June 1, 2017.
Devices Panel of the Medical
Devices Advisory Committee--
Experts in human genetics and in
the clinical management of
patients with genetic disorders,
e.g., pediatricians,
obstetricians, neonatologists.
Individuals with training in
inborn errors of metabolism,
biochemical and/or molecular
genetics, population genetics,
epidemiology and related
statistical training, and
clinical molecular genetics
testing (e.g., genotyping, array
CGH, etc.). Individuals with
experience in genetics
counseling, medical ethics are
also desired, and individuals
with experience in ancillary
fields of study will be
considered.
Neurological Devices Panel of the 4 Immediately.
Medical Devices Advisory 1 December 1, 2017.
Committee--Neurosurgeons
(cerebrovascular and pediatric),
neurologists (stroke, pediatric,
pain management, and movement
disorders), interventional
neuroradiologists, psychiatrists,
and biostatisticians.
Obstetrics and Gynecology Devices 1 Immediately.
Panel of the Medical Devices 3 February 1, 2018.
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 1 Immediately.
Medical Devices Advisory 2 November 1, 2017.
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.
[[Page 28663]]
Orthopaedic and Rehabilitation 2 September 1, 2017.
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 1 Immediately.
Medical Devices Advisory--
Physicians with experience in
general radiology, mammography,
ultrasound, magnetic resonance,
computed tomography, other
radiological subspecialties and
radiation oncology; scientists
with experience in diagnostic
devices, radiation physics,
statistical analysis, digital
imaging and image analysis.
------------------------------------------------------------------------
I. General Description of the Committees Duties
A. Device Good Manufacturing Practice Advisory Committee
The Committee reviews regulations proposed for issuance 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 with regard to 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 (the FD&C Act) envisions for device advisory panels. With
the exception of the Medical Devices Dispute Resolution Panel, each
panel, according to its specialty area performs the following duties:
(1) Advises the Commissioner 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 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 Medical Devices Advisory Committee. Persons
nominated for membership on the panels should have adequately
diversified experience appropriate to the work of the panel in such
fields as clinical and
[[Page 28664]]
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 of this document. 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 and/or home address,
telephone number, and email address if available. 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: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13182 Filed 6-22-17; 8:45 am]
BILLING CODE 4164-01-P