[Federal Register Volume 83, Number 222 (Friday, November 16, 2018)]
[Notices]
[Pages 57734-57737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25076]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3789]


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 
December 17, 2018, for vacancies listed in this notice. Concurrently, 
nomination materials for prospective candidates should be sent to FDA 
(see ADDRESSES) by December 17, 2018. Nominations will be accepted for 
current vacancies and for those that will or may occur through December 
30, 2018.

ADDRESSES: All statements of interest from consumer organizations 
interested in participating in the selection process should be 
submitted electronically to [email protected], by mail to 
Advisory Committee Oversight and Management Staff, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993-0002, or by Fax: 301-
847-8640.
    Consumer representative nominations should be submitted 
electronically by

[[Page 57735]]

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. 5122, 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, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993-
0002, Phone: 301-796-6319, [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
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               Contact person                      Committee/panel
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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, Phone:
 301-796-2721, [email protected].
Kalyani Bhatt, Center for Drugs Evaluation   Bone Reproductive and
 and Research, Food and Drug                  Urological Drugs Advisory
 Administration, 10903 New Hampshire Ave.,    Committee.
 Bldg. 31, Rm. 2438, Silver Spring, MD
 20993-0002, Phone: 301-796-9005,
 [email protected].
Jennifer Shepherd, Center for Drugs          Cardiovascular and Renal
 Evaluation and Research, Food and Drug       Drugs Advisory Committee,
 Administration, 10903 New Hampshire Ave.,    Medical Imaging Advisory
 Bldg. 31, Rm. 2434, Silver Spring, MD        Committee.
 20993-0002, Phone: 301-796-4043,
 [email protected].
Cindy Chee, Center for Drug Evaluation and   Pharmacy Compounding
 Research, Food and Drug Administration,      Advisory Committee.
 10903 New Hampshire Ave., Bldg. 31, Rm.
 2430, Silver Spring, MD 20993-0002, Phone:
 301-796-0889, [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        Gastroenterology and
 20993-0002, Phone: 301-796-6875,             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, Phone: 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. 2647, Silver Spring, MD
 20993-0002, Phone: 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, Phone: 301-796-0400,
 [email protected].
Sara Anderson, Center for Devices and        Orthopaedic and
 Radiological Health, Food and Drug           Rehabilitation Devices
 Administration, 10903 New Hampshire Ave.,    Panel.
 Bldg. 66, Rm. G616m Silver Spring, MD
 20993-0002, Phone: 301-796-7047,
 [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
------------------------------------------------------------------------
     Committee/panel/area of                           Approximate date
        expertise needed            Type of vacancy         needed
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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.........  Immediately.
 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.
Pharmacy Compounding Advisory     1--Voting.........  Immediately.
 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.

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Gastroenterology and Urology      1--Nonvoting......  Immediately.
 Devices Panel--
 Gastroenterologists, urologists
 and nephrologists.
Radiology Devices Panel--         1--Nonvoting......  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--Nonvoting......  Immediately.
 Panel--Experts in otology,
 neurology, and audiology.
Medical Devices Dispute           1--Nonvoting......  Immediately.
 Resolution--Experts with broad,
 cross-cutting scientific,
 clinical, analytical, or
 mediation skills.
Microbiology Devices Panel--      1--Nonvoting......  Immediately.
 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    1--Nonvoting......  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.
------------------------------------------------------------------------

I. Functions and General Description of the Committee Duties

A. 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.

B. 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.

C. 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.

D. 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.

E. Pharmacy Compounding Advisory Committee

    Provides advice on scientific, technical, and medical issues 
concerning drug compounding by pharmacists and licensed practitioners.

F. 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 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

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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 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), 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: November 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25076 Filed 11-15-18; 8:45 am]
 BILLING CODE 4164-01-P


