Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 36605-36607 [2018-16161]
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Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1095]
Request for Nominations for
Individuals and Consumer
Organizations for Advisory
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Any consumer organization
interested in participating in the
selection of an appropriate voting or
nonvoting member to represent
consumer interests on an FDA advisory
committee or panel may send a letter or
email stating that interest to FDA (see
ADDRESSES) by August 29, 2018, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by August 29,
2018. Nominations will be accepted for
current vacancies and for those that will
or may occur through September 30,
2018.
DATES:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any consumer organizations interested
in participating in the selection of
voting and/or nonvoting consumer
representatives to serve on its advisory
committees or panels notify FDA in
writing. FDA is also requesting
nominations for voting and/or
nonvoting consumer representatives to
serve on advisory committees and/or
panels for which vacancies currently
exist or are expected to occur in the near
future. Nominees recommended to serve
as a voting or nonvoting consumer
representative may be self-nominated or
may be nominated by a consumer
organization.
SUMMARY:
All statements of interest
from consumer organizations interested
in participating in the selection process
and consumer representative
nominations should be submitted
electronically to ACOMSSubmissions@
fda.hhs.gov, by mail to Advisory
Committee Oversight and Management
Staff, 10903 New Hampshire Ave., Bldg.
ADDRESSES:
36605
32, Rm. 5103, Silver Spring, MD 20993–
0002, or by Fax: 301–847–8640.
Consumer representative nominations
should be submitted electronically by
logging into the FDA Advisory
Committee Membership Nomination
Portal: https://www.accessdata.fda.gov/
scripts/FACTRSPortal/FACTRS/
index.cfm, by mail to Advisory
Committee Oversight and Management
Staff, 10903 New Hampshire Ave., Bldg.
32, Rm. 5103, Silver Spring, MD 20993–
0002, or by Fax: 301–847–8640.
Additional information about becoming
a member of an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
For
questions relating to participation in the
selection process: Kimberly Hamilton,
Advisory Committee Oversight and
Management Staff (ACOMS), Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993–0002, 301–
796–8220, kimberly.hamilton@
fda.hhs.gov.
For questions relating to specific
advisory committees or panels, contact
the appropriate contact person listed in
table 1.
FOR FURTHER INFORMATION CONTACT:
TABLE 1—ADVISORY COMMITTEE CONTACTS
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Contact person
Committee/panel
Moon Hee V. Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD
20993–0002, 301–796–2894, MoonHee.Choi@fda.hhs.gov.
Lauren Tesh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2426, Silver Spring, MD 20993–
0002, 301–796–2721, Lauren.Tesh@fda.hhs.gov.
Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2438, Silver Spring, MD 20993–
0002, 301–796–9005, Kalyani.Bhatt@fda.hhs.gov.
Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD
20993–0002, 301–796–4043, Jennifer.Shepherd@fda.hhs.gov.
Cindy Chee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2430, Silver Spring, MD 20993–
0002, 301–796–0889, Cindy.Chee@fda.hhs.gov.
Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD
20993–0002, 301–796–6875, Patricio.Garcia@fda.hhs.gov.
Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD
20993–0002, 301–796–6683, Evella.Washington@fda.hhs.gov.
Pamela Scott, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5572, Silver Spring, MD 20993–
0002, 301–796–5433, Pamela.Scott@fda.hhs.gov.
Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993–
0002, 301–796–0400, Aden.Asefa@fda.hhs.gov.
Sara Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G616, Silver Spring, MD
20993–0002, 301–796–7047, Sara.Anderson@fda.hhs.gov.
Anesthetic and Analgesic Drug Products Advisory Committee.
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Antimicrobial Advisory Committee.
Bone, Reproductive, and Urological Drugs Advisory
Committee.
Cardiovascular and Renal Drugs Advisory Committee;
Medical Imaging Advisory Committee.
Pharmacy Compounding Advisory Committee.
Clinical Chemistry and Clinical Toxicology Devices
Panel; Gastroenterology and Urology Devices Panel.
Ear, Nose, and Throat Devices Panel.
Medical Devices Dispute Resolution Panel.
Microbiology Devices Panel; Radiology Devices Panel.
Orthopaedic and Rehabilitation Devices Panel.
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Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices
FDA is
requesting nominations for voting and/
SUPPLEMENTARY INFORMATION:
or nonvoting consumer representatives
for the vacancies listed in table 2:
TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED
Approximate date
needed
Committee/panel/areas of expertise needed
Type of vacancy
Anesthetic and Analgesic Drug Products Advisory Committee—Knowledgeable in the fields of
anesthesiology, surgery, epidemiology or statistics, and related specialties..
Antimicrobial Advisory Committee—Knowledgeable in the fields of infectious disease, internal
medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties.
Bone, Reproductive, and Urological Drugs Advisory Committee—Knowledgeable in the fields of
obstetrics, gynecology, endocrinology, pediatrics, epidemiology or statistics, and related specialties.
Cardiovascular and Renal Drugs Advisory Committee—Knowledgeable in the fields of cardiology, hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics.
Medical Imaging Advisory Committee—Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics, and related specialties.
Pharmacy Compounding Advisory Committee—Knowledgeable in the fields of pharmaceutical
compounding, pharmaceutical manufacturing pharmacy, medicine, and other related specialties.
Clinical Chemistry and Clinical Toxicology Devices Panel—Doctors of medicine or philosophy
with experience in clinical chemistry (e.g., cardiac markers), clinical toxicology, clinical pathology, clinical laboratory medicine, and endocrinology.
Gastroenterology and Urology Devices Panel—Gastroenterologists, urologists, and
nephrologists.
Radiology Devices Panel—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.
Ear, Nose and Throat Devices Panel—Experts in otology, neurology, and audiology ..................
Medical Devices Dispute Resolution—Experts with broad, cross-cutting scientific, clinical, analytical, or mediation skills.
Microbiology Devices Panel—Clinicians with expertise in infectious disease, e.g., pulmonary
disease specialists, sexually transmitted disease specialists, pediatric infectious disease specialists, experts in tropical medicine and emerging infectious diseases, mycologists; clinical
microbiologists and virologists; clinical virology and microbiology laboratory directors, with expertise in clinical diagnosis and in vitro diagnostic assays, e.g., hepatologists; molecular biologists.
Orthopaedic and Rehabilitation Devices Panel—Orthopedic surgeons (joint spine, trauma, and
pediatric); rheumatologists; engineers (biomedical, biomaterials, and biomechanical); experts
in rehabilitation medicine, sports medicine, and connective tissue engineering; and biostatisticians..
1—Voting ...................
Immediately.
1—Voting ...................
Immediately.
1—Voting ...................
Immediately.
1—Voting ...................
Immediately.
1—Voting ...................
Immediately.
1—Voting ...................
September 30, 2018.
1—Nonvoting .............
Immediately.
1—Nonvoting .............
Immediately.
1—Nonvoting .............
Immediately.
1—Nonvoting .............
1—Nonvoting .............
Immediately.
Immediately.
1—Nonvoting .............
Immediately.
1—Nonvoting .............
Immediately.
I. Functions and General Description of
the Committee Duties
D. Cardiovascular and Renal Drugs
Advisory Committee
G. Certain Panels of the Medical Devices
Advisory Committee
A. Anesthetic and Analgesic Drug
Products Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of cardiovascular and renal disorders.
Reviews and evaluates data on the
safety and effectiveness of marketed and
investigational devices and makes
recommendations for their regulation.
With the exception of the Medical
Devices Dispute Resolution Panel, each
panel, according to its specialty area,
advises on the classification or
reclassification of devices into one of
three regulatory categories; advises on
any possible risks to health associated
with the use of devices; advises on
formulation of product development
protocols; reviews premarket approval
applications for medical devices;
reviews guidelines and guidance
documents; recommends exemption of
certain devices from the application of
portions of the Federal Food, Drug, and
Cosmetic Act; advises on the necessity
to ban a device; and responds to
requests from the Agency to review and
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in anesthesiology
and surgery.
B. Antimicrobial Advisory Committee
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Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of infectious diseases and disorders.
C. Bone, Reproductive, and Urological
Drugs Advisory Committee
Reviews and evaluates data on the
safety and effectiveness of marketed and
investigational human drugs for use in
the practice of obstetrics, gynecology,
and related specialties.
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E. Medical Imaging Advisory Committee
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in diagnostic and
therapeutic procedures using
radioactive pharmaceuticals and
contrast media used in diagnostic
radiology.
F. Pharmacy Compounding Advisory
Committee
Provides advice on scientific,
technical, and medical issues
concerning drug compounding by
pharmacists and licensed practitioners.
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Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices
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 of Food and Drugs 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 Members
Persons nominated for membership as
consumer representatives on
committees or panels should meet the
following criteria: (1) Demonstrate an
affiliation with and/or active
participation in consumer or
community-based organizations, (2) be
able to analyze technical data, (3)
understand research design, (4) discuss
benefits and risks, and (5) evaluate the
safety and efficacy of products under
review. The consumer representative
should be able to represent the
consumer perspective on issues and
actions before the advisory committee;
serve as a liaison between the
committee and interested consumers,
associations, coalitions, and consumer
organizations; and facilitate dialogue
with the advisory committees on
scientific issues that affect consumers.
III. Selection Procedures
Selection of members representing
consumer interests is conducted
through procedures that include the use
of organizations representing the public
interest and public advocacy groups.
These organizations recommend
nominees for the Agency’s selection.
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Representatives from the consumer
health branches of Federal, State, and
local governments also may participate
in the selection process. Any consumer
organization interested in participating
in the selection of an appropriate voting
or nonvoting member to represent
consumer interests should send a letter
stating that interest to FDA (see
ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 30 days, FDA
will compile a list of consumer
organizations that will participate in the
selection process and will forward to
each such organization a ballot listing at
least two qualified nominees selected by
the Agency based on the nominations
received, together with each nominee’s
current curriculum vitae or resume.
Ballots are to be filled out and returned
to FDA within 30 days. The nominee
receiving the highest number of votes
ordinarily will be selected to serve as
the member representing consumer
interests for that particular advisory
committee or panel.
IV. Nomination Procedures
Any interested person or organization
may nominate one or more qualified
persons to represent consumer interests
on the Agency’s advisory committees or
panels. Self-nominations are also
accepted. Nominations must include a
current, complete resume or curriculum
vitae for each nominee and a signed
copy of the Acknowledgement and
Consent form available at the FDA
Advisory Nomination Portal (see
ADDRESSES), and a list of consumer or
community-based organizations for
which the candidate can demonstrate
active participation.
Nominations must also specify the
advisory committee(s) or panel(s) for
which the nominee is recommended. In
addition, 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 as
financial holdings, employment, and
research grants and/or contracts to
permit evaluation of possible sources of
conflicts of interest. Members will be
invited to serve for terms up to 4 years.
FDA will review all nominations
received within the specified
timeframes and prepare a ballot
containing the names of qualified
nominees. Names not selected will
remain on a list of eligible nominees
and be reviewed periodically by FDA to
determine continued interest. Upon
selecting qualified nominees for the
ballot, FDA will provide those
consumer organizations that are
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36607
participating in the selection process
with the opportunity to vote on the
listed nominees. Only organizations
vote in the selection process. Persons
who nominate themselves to serve as
voting or nonvoting consumer
representatives will not participate in
the selection process.
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: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16161 Filed 7–27–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2014–N–1069; FDA–
2017–N–6931; FDA–2011–N–0362; FDA–
2011–N–0279; FDA–2011–N–0672; FDA–
2014–N–0913; FDA–2017–N–0493; and
FDA–2011–N–0781]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUMMARY:
The
following is a list of FDA information
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under section 3507 of the Paperwork
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The OMB control number and
expiration date of OMB approval for
each information collection are shown
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or sponsor, and a person is not required
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information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)]
[Notices]
[Pages 36605-36607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16161]
[[Page 36605]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1095]
Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
consumer organizations interested in participating in the selection of
voting and/or nonvoting consumer representatives to serve on its
advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may be self-nominated or may be nominated by a consumer
organization.
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: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to FDA (see ADDRESSES) by August
29, 2018, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by August 29, 2018. Nominations will be accepted for current
vacancies and for those that will or may occur through September 30,
2018.
ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should be submitted electronically to
[email protected], by mail to Advisory Committee Oversight
and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002, or by Fax: 301-847-8640.
Consumer representative nominations should be submitted
electronically by logging into the FDA Advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002, or by Fax: 301-847-8640. Additional information
about becoming a member of 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: For questions relating to
participation in the selection process: Kimberly Hamilton, Advisory
Committee Oversight and Management Staff (ACOMS), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002, 301-796-8220, [email protected].
For questions relating to specific advisory committees or panels,
contact the appropriate contact person listed in table 1.
Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
Contact person Committee/panel
------------------------------------------------------------------------
Moon Hee V. Choi, Center for Drug Anesthetic and Analgesic Drug
Evaluation and Research, Food and Drug Products Advisory Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2434, Silver
Spring, MD 20993-0002, 301-796-2894,
[email protected].
Lauren Tesh, Center for Drug Evaluation Antimicrobial Advisory
and Research, Food and Drug Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2426, Silver
Spring, MD 20993-0002, 301-796-2721,
[email protected].
Kalyani Bhatt, Center for Drug Bone, Reproductive, and
Evaluation and Research, Food and Drug Urological Drugs Advisory
Administration, 10903 New Hampshire Committee.
Ave., Bldg. 31, Rm. 2438, Silver
Spring, MD 20993-0002, 301-796-9005,
[email protected].
Jennifer Shepherd, Center for Drug Cardiovascular and Renal Drugs
Evaluation and Research, Food and Drug Advisory Committee; Medical
Administration, 10903 New Hampshire Imaging Advisory Committee.
Ave., Bldg. 31, Rm. 2434, Silver
Spring, MD 20993-0002, 301-796-4043,
[email protected].
Cindy Chee, Center for Drug Evaluation Pharmacy Compounding Advisory
and Research, Food and Drug Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2430, Silver
Spring, MD 20993-0002, 301-796-0889,
[email protected].
Patricio Garcia, Center for Devices and Clinical Chemistry and
Radiological Health, Food and Drug Clinical Toxicology Devices
Administration, 10903 New Hampshire Panel; Gastroenterology and
Ave., Bldg. 66, Rm. G610, Silver Urology Devices Panel.
Spring, MD 20993-0002, 301-796-6875,
[email protected].
Evella Washington, Center for Devices Ear, Nose, and Throat Devices
and Radiological Health, Food and Drug Panel.
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G640, Silver
Spring, MD 20993-0002, 301-796-6683,
[email protected].
Pamela Scott, Center for Devices and Medical Devices Dispute
Radiological Health, Food and Drug Resolution Panel.
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5572, Silver
Spring, MD 20993-0002, 301-796-5433,
[email protected].
Aden Asefa, Center for Devices and Microbiology Devices Panel;
Radiological Health, Food and Drug Radiology Devices Panel.
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G642, Silver
Spring, MD 20993-0002, 301-796-0400,
[email protected].
Sara Anderson, Center for Devices and Orthopaedic and Rehabilitation
Radiological Health, Food and Drug Devices Panel.
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G616, Silver
Spring, MD 20993-0002, 301-796-7047,
[email protected].
------------------------------------------------------------------------
[[Page 36606]]
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
and/or nonvoting consumer representatives for the vacancies listed in
table 2:
Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
Committee/panel/areas of expertise
needed Type of vacancy Approximate date needed
----------------------------------------------------------------------------------------------------------------
Anesthetic and Analgesic Drug Products 1--Voting.......................... Immediately.
Advisory Committee--Knowledgeable in
the fields of anesthesiology,
surgery, epidemiology or statistics,
and related specialties..
Antimicrobial Advisory Committee-- 1--Voting.......................... Immediately.
Knowledgeable in the fields of
infectious disease, internal
medicine, microbiology, pediatrics,
epidemiology or statistics, and
related specialties.
Bone, Reproductive, and Urological 1--Voting.......................... Immediately.
Drugs Advisory Committee--
Knowledgeable in the fields of
obstetrics, gynecology,
endocrinology, pediatrics,
epidemiology or statistics, and
related specialties.
Cardiovascular and Renal Drugs 1--Voting.......................... Immediately.
Advisory Committee--Knowledgeable in
the fields of cardiology,
hypertension, arrhythmia, angina,
congestive heart failure, diuresis,
and biostatistics.
Medical Imaging Advisory Committee-- 1--Voting.......................... Immediately.
Knowledgeable in the fields of
nuclear medicine, radiology,
epidemiology, statistics, and related
specialties.
Pharmacy Compounding Advisory 1--Voting.......................... September 30, 2018.
Committee--Knowledgeable in the
fields of pharmaceutical compounding,
pharmaceutical manufacturing
pharmacy, medicine, and other related
specialties.
Clinical Chemistry and Clinical 1--Nonvoting....................... Immediately.
Toxicology Devices Panel--Doctors of
medicine or philosophy with
experience in clinical chemistry
(e.g., cardiac markers), clinical
toxicology, clinical pathology,
clinical laboratory medicine, and
endocrinology.
Gastroenterology and Urology Devices 1--Nonvoting....................... Immediately.
Panel--Gastroenterologists,
urologists, and nephrologists.
Radiology Devices Panel--Physicians 1--Nonvoting....................... Immediately.
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.
Ear, Nose and Throat Devices Panel-- 1--Nonvoting....................... Immediately.
Experts in otology, neurology, and
audiology.
Medical Devices Dispute Resolution-- 1--Nonvoting....................... Immediately.
Experts with broad, cross-cutting
scientific, clinical, analytical, or
mediation skills.
Microbiology Devices Panel--Clinicians 1--Nonvoting....................... Immediately.
with expertise in infectious disease,
e.g., pulmonary disease specialists,
sexually transmitted disease
specialists, pediatric infectious
disease specialists, experts in
tropical medicine and emerging
infectious diseases, mycologists;
clinical microbiologists and
virologists; clinical virology and
microbiology laboratory directors,
with expertise in clinical diagnosis
and in vitro diagnostic assays, e.g.,
hepatologists; molecular biologists.
Orthopaedic and Rehabilitation Devices 1--Nonvoting....................... Immediately.
Panel--Orthopedic surgeons (joint
spine, trauma, and pediatric);
rheumatologists; engineers
(biomedical, biomaterials, and
biomechanical); experts in
rehabilitation medicine, sports
medicine, and connective tissue
engineering; and biostatisticians..
----------------------------------------------------------------------------------------------------------------
I. Functions and General Description of the Committee Duties
A. Anesthetic and Analgesic Drug Products Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in anesthesiology and surgery.
B. Antimicrobial Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of infectious diseases and disorders.
C. Bone, Reproductive, and Urological Drugs Advisory Committee
Reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in the practice of
obstetrics, gynecology, and related specialties.
D. Cardiovascular and Renal Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of cardiovascular and renal disorders.
E. Medical Imaging Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in
diagnostic and therapeutic procedures using radioactive pharmaceuticals
and contrast media used in diagnostic radiology.
F. Pharmacy Compounding Advisory Committee
Provides advice on scientific, technical, and medical issues
concerning drug compounding by pharmacists and licensed practitioners.
G. Certain Panels of the Medical Devices Advisory Committee
Reviews and evaluates data on the safety and effectiveness of
marketed and investigational devices and makes recommendations for
their regulation. With the exception of the Medical Devices Dispute
Resolution Panel, each panel, according to its specialty area, advises
on the classification or reclassification of devices into one of three
regulatory categories; advises on any possible risks to health
associated with the use of devices; advises on formulation of product
development protocols; reviews premarket approval applications for
medical devices; reviews guidelines and guidance documents; recommends
exemption of certain devices from the application of portions of the
Federal Food, Drug, and Cosmetic Act; advises on the necessity to ban a
device; and responds to requests from the Agency to review and
[[Page 36607]]
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 of Food and Drugs 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 Members
Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
Demonstrate an affiliation with and/or active participation in consumer
or community-based organizations, (2) be able to analyze technical
data, (3) understand research design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy of products under review. The
consumer representative should be able to represent the consumer
perspective on issues and actions before the advisory committee; serve
as a liaison between the committee and interested consumers,
associations, coalitions, and consumer organizations; and facilitate
dialogue with the advisory committees on scientific issues that affect
consumers.
III. Selection Procedures
Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
resume. Ballots are to be filled out and returned to FDA within 30
days. The nominee receiving the highest number of votes ordinarily will
be selected to serve as the member representing consumer interests for
that particular advisory committee or panel.
IV. Nomination Procedures
Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Nominations must include a current, complete resume or curriculum vitae
for each nominee and a signed copy of the Acknowledgement and Consent
form available at the FDA Advisory Nomination Portal (see ADDRESSES),
and a list of consumer or community-based organizations for which the
candidate can demonstrate active participation.
Nominations must also specify the advisory committee(s) or panel(s)
for which the nominee is recommended. In addition, 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 as financial holdings, employment,
and research grants and/or contracts to permit evaluation of possible
sources of conflicts of interest. Members will be invited to serve for
terms up to 4 years.
FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
Upon selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting or nonvoting consumer representatives
will not participate in the selection process.
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: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16161 Filed 7-27-18; 8:45 am]
BILLING CODE 4164-01-P
