[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)]
[Notices]
[Pages 15578-15581]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07426]
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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.
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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 May 11,
2018, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by May 11, 2018. Nominations will be accepted for current
vacancies and for those that will or may occur through July 31, 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 or delivery service 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 or delivery service 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:
[email protected].
For questions relating to specific advisory committees or panels,
contact the appropriate contact person listed in table 1.
[[Page 15579]]
Table 1--Advisory Committee Contacts
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Contact person Committee/panel
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Moon Hee V. Choi, Center for Drug Evaluation Anesthetic and Analgesic
and Research, Food and Drug Administration, Drug Products Advisory
10903 New Hampshire Ave., Bldg. 31, Rm. Committee.
2434, Silver Spring, MD 20993-0002, 301-796-
2894, email: [email protected].
Lauren Tesh, Center for Drug Evaluation and Antimicrobial Advisory
Research, Food and Drug Administration, Committee.
10903 New Hampshire Ave., Bldg. 31, Rm.
2426, Silver Spring, MD 20993-0002, 301-796-
2721, email: [email protected].
Kalyani Bhatt, Center for Drug Evaluation and Bone, Reproductive and
Research, Food and Drug Administration, Urological Drugs
10903 New Hampshire Ave., Bldg. 31, Rm. Advisory Committee.
2438, Silver Spring, MD 20993-0002, 301-796-
9005, email: [email protected].
Jennifer Shepherd, Center for Drug Evaluation Cardiovascular and Renal
and Research, Food and Drug Administration, Drugs Advisory
10903 New Hampshire Ave., Bldg. 31, Rm. Committee, Medical
2434, Silver Spring, MD 20993-0002, 301-796- Imaging Advisory
4043, email: [email protected]. Committee.
Cindy Chee, Center for Drug Evaluation and Pulmonary-Allergy Drugs
Research, Food and Drug Administration, Advisory Committee.
10903 New Hampshire Ave., Bldg. 31, Rm.
2430, Silver Spring, MD 20993-0002, 301-796-
0889, email: [email protected].
Patricio Garcia, Center for Devices and Clinical Chemistry and
Radiological Health, Food and Drug Clinical Toxicology
Administration, 10903 New Hampshire Ave., Devices Panel,
Bldg. 66, Rm. G610, Silver Spring, MD 20993- Gastroenterology and
0002, 301-796-6875, email: Urology Devices Panel.
[email protected].
Evella Washington, Center for Devices and Ear, Nose and Throat
Radiological Health, Food and Drug Devices Panel.
Administration, 10903 New Hampshire Ave.,
Bldg. 66, Rm. G640, Silver Spring, MD 20993-
0002, 301-796-6683, email:
[email protected].
Joan Adams-White, 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, 301-796-5421, email: [email protected].
Aden Asefa, Center for Devices and Microbiology Devices
Radiological Health, Food and Drug Panel, Radiology Devices
Administration, 10903 New Hampshire Ave., Panel.
Bldg. 66, Rm. G642, Silver Spring, MD 20993-
0002, 301-796-0400, email:
[email protected].
Sara Anderson, Center for Devices and Orthopaedic and
Radiological Health, Food and Drug Rehabilitation Devices
Administration, 10903 New Hampshire Ave., Panel, Radiological
Bldg. 66, Rm. G616 Silver Spring, MD 20993- Devices Panel.
0002, 301-796-7047, email:
[email protected].
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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
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Committee/panel/areas of Approximate date
expertise needed Type of vacancy needed
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Anesthetic and Analgesic Drug 1--Voting........ Immediately.
Products Advisory Committee--
Knowledgeable in the fields
of anesthesiology, surgery,
epidemiology or statistics,
and related specialties.
Antimicrobial Advisory 1--Voting........ Immediately.
Committee--Knowledgeable in
the fields of infectious
disease, internal medicine,
microbiology, pediatrics,
epidemiology or statistics,
and related specialties.
Bone, Reproductive and 1--Voting........ Immediately.
Urological Drugs Advisory
Committee--Knowledgeable in
the fields of obstetrics,
gynecology, endocrinology,
pediatrics, epidemiology or
statistics and related
specialties.
Cardiovascular and Renal Drugs 1--Voting........ July 1, 2018.
Advisory Committee--
Knowledgeable in the fields
of cardiology, hypertension,
arrhythmia, angina,
congestive heart failure,
diuresis, and biostatistics.
Medical Imaging Advisory 1--Voting........ Immediately.
Committee--Knowledgeable in
the fields of nuclear
medicine, radiology,
epidemiology, statistics and
related specialties.
Pulmonary- Allergy Drugs 1--Voting........ Immediately.
Advisory Committee--
Knowledgeable in the fields
of pulmonary medicine,
allergy, clinical immunology,
and epidemiology or
statistics.
Clinical Chemistry and 1--Non-Voting.... Immediately.
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 1--Non-Voting.... Immediately.
Devices Panel--
Gastroenterologists,
urologists and nephrologists.
Radiology Devices Panel-- 1--Non-Voting.... Immediately.
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 1--Non-Voting.... Immediately.
Panel--Experts in Otologists,
neurologists, audiologists.
[[Page 15580]]
Medical Devices Dispute 1--Non-Voting.... Immediately.
Resolution--Experts with
broad, cross-cutting
scientific, clinical,
analytical or mediation
skills.
Microbiology Devices Panel-- 1--Non-Voting.... Immediately.
Clinicians with an 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 1--Non-Voting.... Immediately.
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.
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I. Functions and General Description of the Committee Duties
A. Anesthetic and Analgesic Drugs 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 & Urologic 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. Pulmonary-Allergy 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 pulmonary disease and diseases with allergic
and/or immunologic mechanisms.
G. Certain Panels of the Medical Devices Advisory Committee
Review and evaluate data on the safety and effectiveness of
marketed and investigational devices and make 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 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
[[Page 15581]]
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 must 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 r[eacute]sum[eacute] 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 section of this document), 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: April 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07426 Filed 4-10-18; 8:45 am]
BILLING CODE 4164-01-P