[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Notices]
[Pages 48098-48102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22344]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Request for Nominations for Individuals and Consumer 
Organizations for Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 48099]]

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 
November 15, 2017, for vacancies listed in this notice. Concurrently, 
nomination materials for prospective candidates should be sent to FDA 
(see ADDRESSES) by November 15, 2017. Nominations will be accepted for 
current vacancies and for those that will or may occur through November 
30, 2017.

ADDRESSES: All statements of interest from consumer organizations 
interested in participating in the selection process and consumer 
representative nominations should be submitted electronically to 
<a href="/cdn-cgi/l/email-protection#93d2d0dcdec0c0e6f1fefae0e0fafcfde0d3f5f7f2bdfbfbe0bdf4fce5"><span class="__cf_email__" data-cfemail="f2b3b1bdbfa1a187909f9b81819b9d9c81b2949693dc9a9a81dc959d84">[email protected]</span></a>; 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 on an FDA advisory committee can also be 
obtained by visiting FDA's Web site at http://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: 
<a href="/cdn-cgi/l/email-protection#fa919397989f889683d4929b9793968e9594ba9c9e9bd4929289d49d958c"><span class="__cf_email__" data-cfemail="a3c8cacec1c6d1cfda8dcbc2cecacfd7cccde3c5c7c28dcbcbd08dc4ccd5">[email protected]</span></a>.
    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:
 <a href="/cdn-cgi/l/email-protection#3d715c484f58531369584e557d5b595c1355554e135a524b"><span class="__cf_email__" data-cfemail="206c415552454e0e74455348604644410e4848530e474f56">[email protected]</span></a>.
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
 20993-0002, phone: 301-796-6875, email:
 <a href="/cdn-cgi/l/email-protection#f1a19085839892989edfb6908392989eb1979590df999982df969e87"><span class="__cf_email__" data-cfemail="f1a19085839892989edfb6908392989eb1979590df999982df969e87">[email protected]</span></a>.
Evella Washington, Center for Devices and    Ear, Nose and Throat
 Radiological Health, Food and Drug           Devices Panel, Immunology
 Administration, 10903 New Hampshire Ave.,    Devices Panel.
 Bldg. 66, Rm. G640, Silver Spring, MD
 20993-0002, phone: 301-796-6683, email:
 <a href="/cdn-cgi/l/email-protection#afead9cac3c3ce81f8cedcc7c6c1c8dbc0c1efc9cbce81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="276251424b4b46097046544f4e494053484967414346094f4f5409404851">[email protected]</span></a>.
Pamela Scott, Center for Devices and         Medical Devices Dispute
 Radiological Health, Food and Drug           Resolution.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 66, Rm. 5572, Silver Spring, MD
 20993-0002, phone: 301-796-5433, email:
 <a href="/cdn-cgi/l/email-protection#b2e2d3dfd7ded39ce1d1ddc6c6f2d4d6d39cdadac19cd5ddc4"><span class="__cf_email__" data-cfemail="e0b0818d858c81ceb3838f9494a0868481ce888893ce878f96">[email protected]</span></a>.
Aden Asefa, Center for Devices and           Neurological Devices Panel.
 Radiological Health, Food and Drug
 Administration, 10903 New Hampshire Ave.,
 Bldg. 66, Rm. G642, Silver Spring, MD
 20993-0002, phone: 301-796-0400, email:
 <a href="/cdn-cgi/l/email-protection#59183d3c3777182a3c3f38193f3d387731312a773e362f"><span class="__cf_email__" data-cfemail="034267666d2d4270666562436567622d6b6b702d646c75">[email protected]</span></a>.
LaToya Bonner, Center for Drug Evaluation    Endocrinologic and
 and Research, Food and Drug                  Metabolic Drugs Advisory
 Administration, 10903 New Hampshire Ave.,    Committee.
 Bldg. 31, Rm. 2428, Silver Spring, MD
 20993-0002, phone: 301-796-2855, email:
 <a href="/cdn-cgi/l/email-protection#773b1623180e165935181919120537111316591f1f0459101801"><span class="__cf_email__" data-cfemail="de92bf8ab1a7bff09cb1b0b0bbac9eb8babff0b6b6adf0b9b1a8">[email protected]</span></a>.
Karen Strambler, Center for Food Safety and  Food Advisory Committee.
 Nutrition, Food and Drug Administration,
 FDA College Park, CPK1, Rm. 1C008, College
 Park, MD 20740, phone: 240-402-2589,
 email: <a href="/cdn-cgi/l/email-protection#5813392a3d36760b2c2a39353a343d2a183e3c397630302b763f372e"><span class="__cf_email__" data-cfemail="9dd6fceff8f3b3cee9effcf0fff1f8efddfbf9fcb3f5f5eeb3faf2eb">[email protected]</span></a>.
Cindy Chee, Center for Drug Evaluation and   Gastrointestinal Drugs
 Research, Food and Drug Administration,      Advisory Committee,
 10903 New Hampshire Ave., Bldg. 31, Rm.      Pulmonary-Allergy Drugs
 2430, Silver Spring, MD 20993-0002, phone:   Advisory Committee.
 301-796-0889, email:
 <a href="/cdn-cgi/l/email-protection#1c5f75727865325f7479795c7a787d3274746f327b736a"><span class="__cf_email__" data-cfemail="1b5872757f623558737e7e5b7d7f7a35737368357c746d">[email protected]</span></a>.
Jennifer Shepherd, Center for Drug           Medical Imaging Advisory
 Evaluation and Research, Food and Drug       Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 31, Rm. 2434, Silver Spring, MD
 20993-0002, phone: 301-796-4043, email:
 <a href="/cdn-cgi/l/email-protection#eea48b808087888b9cc0bd868b9e868b9c8aae888a8fc086869dc0898198"><span class="__cf_email__" data-cfemail="652f000b0b0c0300174b360d00150d001701250301044b0d0d164b020a13">[email protected]</span></a>.
Moon Hee Choi, Center for Drug Evaluation    Non-Prescription Drugs
 and Research, Food and Drug                  Advisory Committee,
 Administration, 10903 New Hampshire Ave.,    Peripheral & Central
 Bldg. 31, Rm. 2434, Silver Spring, MD        Nervous Systems Advisory
 20993-0002, phone: 301-796-2894, email:      Committee.
 <a href="/cdn-cgi/l/email-protection#4e03212120062b2b600d2621270e282a2f6026263d60292138"><span class="__cf_email__" data-cfemail="064b6969684e636328456e696f46606267286e6e7528616970">[email protected]</span></a>.
Marieann Brill, Office of the Commissioner,  Pediatrics Advisory
 Office of Medical Products and Tobacco,      Committee.
 Food and Drug Administration, 10903 New
 Hampshire Ave., Bldg. 32, Rm. 5154, Silver
 Spring, MD 20993-0002, phone: 240-402-
 3838, email: <a href="/cdn-cgi/l/email-protection#fcb19d8e959d9292d2be8e959090bc9a989dd294948fd29b938a"><span class="__cf_email__" data-cfemail="4f022e3d262e2121610d3d2623230f292b2e6127273c61282039">[email protected]</span></a>.
------------------------------------------------------------------------


SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
and/or nonvoting consumer representatives for the vacancies listed in 
table 2.

[[Page 48100]]



      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
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Antimicrobial Advisory Committee--           1--Voting..................  November 30, 2017.
 Knowledgeable in the fields of infectious
 disease, internal medicine, microbiology,
 pediatrics, epidemiology or statistics,
 and related specialties.
Clinical Chemistry and Clinical Toxicology   1--Nonvoting...............  Immediately.
 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.
Ear, Nose and Throat Devices Panel--         1--Nonvoting...............  Immediately.
 Otologists, neurologists, and audiologists.
Immunology Devices--Persons with experience  1--Nonvoting...............  Immediately.
 in medical, surgical, or clinical
 oncology, internal medicine, clinical
 immunology, allergy, molecular
 diagnostics, or clinical laboratory
 medicine.
Medical Devices Dispute Resolution--Experts  1--Nonvoting...............  Immediately.
 with broad, cross-cutting scientific,
 clinical, analytical, or mediation skills.
Neurological Devices Panel--Neurosurgeons    1--Nonvoting...............  Immediately.
 (cerebrovascular and pediatric),
 neurologists (stroke, pediatric, pain
 management, and movement disorders),
 interventional neuroradiologists,
 psychiatrists, and biostatisticians.
Endocrinologic and Metabolic Drugs Advisory  1--Voting..................  Immediately.
 Committee--Knowledgeable in the fields of
 endocrinology, metabolism, epidemiology or
 statistics, and related specialties.
Food Advisory Committee--Knowledgeable in    1--Voting..................  Immediately.
 the fields of physical sciences,
 biological and life sciences, food
 science, risk assessment, nutrition, food
 technology, molecular biology, and other
 relevant scientific and technical
 disciplines.
Gastrointestinal Drugs Advisory Committee--  1--Voting..................  Immediately.
 Knowledgeable in the fields of
 gastroenterology, endocrinology, surgery,
 clinical pharmacology, physiology,
 pathology, liver function, motility,
 esophagitis, and statistics.
Pulmonary-Allergy Drugs Advisory Committee-- 1--Voting..................  Immediately.
 Knowledgeable in the fields of pulmonary
 medicine, allergy, clinical immunology,
 and epidemiology or statistics.
Medical Imaging Advisory Committee--         1--Voting..................  Immediately.
 Knowledgeable in the fields of nuclear
 medicine, radiology, epidemiology,
 statistics, and related specialties.
Non-Prescription Drugs Advisory Committee--  1--Voting..................  Immediately.
 Knowledgeable in the fields of internal
 medicine, family practice, clinical
 toxicology, clinical pharmacology,
 pharmacy, dentistry, and related
 specialties.
Peripheral and Central Nervous System Drugs  1--Voting..................  Immediately.
 Advisory Committee--Knowledgeable in the
 fields of neurology, neuropharmacology,
 neuropathology, otolaryngology,
 epidemiology or statistics, and related
 specialties.
Pediatrics Advisory Committee--              1--Voting..................  Immediately.
 Knowledgeable in pediatric research,
 pediatric subspecialties, statistics, and/
 or biomedical ethics. The core of voting
 members shall also include one
 representative from a pediatric health
 organization and one representative from a
 relevant patient or patient-family
 organization and may include one
 technically qualified member, selected by
 the Commissioner or designee, who is
 identified with consumer interests and is
 recommended by either a consortium of
 consumer-oriented organizations or other
 interested persons. In addition to the
 voting members, the Committee may include
 one nonvoting member who is identified
 with industry interests.
----------------------------------------------------------------------------------------------------------------

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. 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: (1) 
Advises on the classification or reclassification of devices into one 
of three regulatory categories; (2) advises on any possible risks to 
health associated with the use of devices; (3) advises on formulation 
of product development protocols; (4) reviews premarket approval 
applications for medical devices; (5) reviews guidelines and guidance 
documents; (6) recommends exemption of certain devices from the 
application of portions of the Federal Food, Drug, and Cosmetic Act; 
(7) advises on the necessity to ban a device; and (8) 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 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.

C. Endocrinologic and Metabolic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational human

[[Page 48101]]

drug products for use in the treatment of endocrine and metabolic 
disorders.

D. Food Advisory Committee

    Make recommendations on emerging food safety, food science, 
nutrition, and other food-related health issues that FDA considers of 
primary importance for its food and cosmetics programs. Reviewing and 
evaluating available data and making recommendations on matters such as 
those relating to: (1) Broad scientific and technical food or cosmetic 
related issues; (2) the safety of new foods and food ingredients; (3) 
labeling of foods and cosmetics; (4) nutrient needs and nutritional 
adequacy; and (5) safe exposure limits for food contaminants. The 
Committee may also be asked to provide advice and make recommendations 
on ways of communicating to the public the potential risks associated 
with these issues and on approaches that might be considered for 
addressing the issues.

E. Gastrointestinal 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 gastrointestinal diseases.

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. Medical Imaging Drugs 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.

H. Non-Prescription Drugs Advisory Committee

    Review and evaluate available data concerning the safety and 
effectiveness of over-the-counter (nonprescription) human drug 
products, or any other FDA-regulated product, for use in the treatment 
of a broad spectrum of human symptoms and diseases and advise the 
Commissioner either on the promulgation of monographs establishing 
conditions under which these drugs are generally recognized as safe and 
effective and not misbranded or on the approval of new drug 
applications for such drugs. The Committee will serve as a forum for 
the exchange of views regarding the prescription and nonprescription 
status, including switches from one status to another, of these various 
drug products and combinations thereof. The Committee may also conduct 
peer review of Agency sponsored intramural and extramural scientific 
biomedical programs in support of FDA's mission and regulatory 
responsibilities.

I. Peripheral and Central Nervous System Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational human drug products for use in the 
treatment of neurologic diseases.

J. Pediatrics Advisory Committee

    The Committee advises and makes recommendations to the Commissioner 
of Food and Drugs regarding: (1) Pediatric research; (2) identification 
of research priorities related to pediatric therapeutics and the need 
for additional treatments of specific pediatric diseases or conditions; 
(3) the ethics, design, and analysis of clinical trials related to 
pediatric therapeutics; (4) pediatric labeling disputes; (5) pediatric 
labeling changes; (6) adverse event reports for drugs granted pediatric 
exclusivity and any safety issues that may occur; (7) any other 
pediatric issue or pediatric labeling dispute involving FDA regulated 
products; (8) research involving children as subjects; and (9) any 
other matter involving pediatrics for which FDA has regulatory 
responsibility. The Committee also advises and makes recommendations to 
the Secretary of Health and Human Services (Secretary) directly or to 
the Secretary through the Commissioner on research involving children 
as subjects that is conducted or supported by the Department of Health 
and Human Services.

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 
r[eacute]sum[eacute]. 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, 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

[[Page 48102]]

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: October 11, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22344 Filed 10-13-17; 8:45 am]
 BILLING CODE 4164-01-P


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