[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.

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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
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             Contact person                       Committee/panel
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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].
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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 expertise
                needed                            Type of vacancy                  Approximate date needed
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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


