[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.
------------------------------------------------------------------------

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


