[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27497-27501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12352]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 July
17, 2017, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by July 17, 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
[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 at: 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
[[Page 27498]]
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.
Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
Contact person Committee/panel
------------------------------------------------------------------------
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:
[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-
0002, phone: 301-796-6875, email:
[email protected]..
Evella Washington, Center for Devices and Ear, Nose and Throat
Radiological Health, Food and Drug Devices Panel,
Administration, 10903 New Hampshire Ave., Immunology Devices
Bldg. 66, Rm. 1535, Silver Spring, MD 20993- Panel.
0002, phone: 301-796-6683, email:
[email protected]..
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:
[email protected]..
Aden Asefa, Center for Devices and Neurological Devices
Radiological Health, Food and Drug Panel.
Administration, 10903 New Hampshire Ave.,
Bldg. 66, Rm. 2648, Silver Spring, MD 20993-
0002, phone: 301-796-0400, email:
[email protected]..
LaToya Bonner, Center for Drug Evaluation and Endocrinologic and
Research, Food and Drug Administration, Metabolic Drugs Advisory
10903 New Hampshire Ave., Bldg. 31, Rm. Committee.
2428, Silver Spring, MD 20993-0002, phone:
301-796-2855, email:
[email protected]..
Karen Strambler, Center for Food Safety and Foods Advisory Committee.
Nutrition, Food and Drug Administration, FDA
College Park, CPK1, Rm. 1C008, College Park,
MD 20740, phone: 240-402-2589, email:
[email protected]..
Cindy Hong, 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: [email protected]..
Jennifer Shepherd, Center for Drug Evaluation Medical Imaging Advisory
and Research, Food and Drug Administration, Committee,
10903 New Hampshire Ave., Bldg. 31, Rm. Pharmaceutical Science
2434, Silver Spring, MD 20993-0002, phone: and Clinical
301-796-4043, email: Pharmacology.
[email protected]..
Sara Anderson, Center for Devices and National Mammography
Radiological Health, Food and Drug Quality Assurance
Administration, 10903 New Hampshire Ave., Advisory Committee.
Bldg. 66, Rm. 1643, Silver Spring, MD 20993-
0002, phone: 301-796-0889, email:
[email protected]..
Moon Hee Choi, Center for Drug Evaluation and Non-Prescription Drugs
Research, Food and Drug Administration, Advisory Committee,
10903 New Hampshire Ave., Bldg. 31, Rm. Peripheral & Central
2434, Silver Spring, MD 20993-0002, phone: Nervous Systems Advisory
301-796-2894, email: Committee.
[email protected]..
Marie ann Brill, Office of the Commissioner, Pediatrics Advisory
Office of Medical Products and Tobacco, Food Committee.
and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5154, Silver Spring, MD
20993-0002, phone: 240-402-3838, email:
[email protected]..
------------------------------------------------------------------------
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/areas of expertise needed Type of vacancy Approximate date needed
----------------------------------------------------------------------------------------------------------------
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 1--Non-Voting................... February 28, 2017.
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.
Ear, Nose and Throat Devices Panel-- 1--Non-Voting................... Immediately.
Otologists, neurologists, audiologists.
Immunology Devices--Persons with 1--Non-Voting................... Immediately.
experience in medical, surgical, or
clinical oncology, internal medicine,
clinical immunology, allergy, molecular
diagnostics, or clinical laboratory
medicine.
Medical Devices Dispute Resolution-- 1--Non-Voting................... Immediately.
Experts with broad, cross-cutting
scientific, clinical, analytical, or
mediation skills.
Neurological Devices Panel--Neurosurgeons 1--Non-Voting................... Immediately.
(cerebrovascular and pediatric),
neurologists (stroke, pediatric, pain
management, and movement disorders),
interventional neuroradiologists,
psychiatrists, and biostatisticians.
Endocrinologic and Metabolic Drugs 1--Voting....................... June 30, 2017.
Advisory Committee--Knowledgeable in the
fields of endocrinology, metabolism,
epidemiology or statistics, and related
specialties.
Foods Advisory Committee--Knowledgeable 1--Voting....................... June 30, 2017.
in 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 1--Voting....................... Immediately.
Committee--Knowledgeable in the fields
of gastroenterology, endocrinology,
surgery, clinical pharmacology,
physiology, pathology, liver function,
motility, esophagitis, and statistics.
Pulmonary-Allergy Drugs Advisory 1--Voting....................... May 31, 2017.
Committee--Knowledgeable in the fields
of pulmonary medicine, allergy, clinical
immunology, and epidemiology or
statistics.
[[Page 27499]]
Medical Imaging Advisory Committee-- 1--Voting....................... Immediately.
Knowledgeable in the fields of nuclear
medicine, radiology, epidemiology,
statistics, and related specialties.
Pharmaceutical Science and Clinical 1--Voting....................... Immediately.
Pharmacology--Knowledgeable in the
fields of pharmaceutical manufacturing,
clinical pharmacology, pharmacokinetics,
bioavailability and bioequivalence
research, the design and evaluation of
clinical trials, laboratory analytical
techniques, pharmaceutical chemistry,
physiochemistry, biochemistry,
biostatistics, and related biomedical
and pharmacological specialties.
National Mammography Quality Assurance 1--Non-Voting................... Immediately.
Advisory Committee--Physician,
practitioner, or other health
professional whose clinical practice,
research specialization, or professional
expertise includes a significant focus
on mammography.
Non-Prescription Drugs Advisory 1--Voting....................... May 31, 2017.
Committee--Knowledgeable in the fields
of internal medicine, family practice,
clinical toxicology, clinical
pharmacology, pharmacy, dentistry, and
related specialties.
Peripheral and Central Nervous System 1--Voting....................... Immediately.
Drugs 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 non-voting 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 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.
C. Endocrinologic and Metabolic Drugs Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human 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. Pharmaceutical Science and Clinical Pharmacology Advisory Committee
Provide advice on scientific and technical issues concerning the
safety,
[[Page 27500]]
and effectiveness of human generic drug products for use in the
treatment of a broad spectrum of human diseases, and as required, any
other product for which FDA has regulatory responsibility. The
committee may also review Agency sponsored intramural and extramural
biomedical research programs in support of FDA's generic drug
regulatory responsibilities.
I. National Mammography Quality Assurance Advisory Committee
Advise the Agency on the following development of appropriate
quality standards and regulations for mammography facilities; standards
and regulations for bodies accrediting mammography facilities under
this program; regulations with respect to sanctions; procedures for
monitoring compliance with standards; establishing a mechanism to
investigate consumer complaints; reporting new developments concerning
breast imaging which should be considered in the oversight of
mammography facilities. As well as determining whether there exists a
shortage of mammography facilities in rural and health professional
shortage areas and determining the effects of personnel on access to
the services of such facilities in such areas; determining whether
there will exist a sufficient number of medical physicists after
October 1, 1999; and determining the costs and benefits of compliance
with these requirements.
J. 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.
K. 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.
L. 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 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 should include a cover letter and current curriculum vitae
or r[eacute]sum[eacute] for each nominee, including a current business
and/or home address, telephone number, and email address if available,
and a list of consumer or community-based organizations for which the
candidate can demonstrate active participation.
Nominations should also specify the advisory committee(s) or
panel(s) for which the nominee is recommended. In addition, nominations
should include confirmation 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
[[Page 27501]]
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: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation and Analysis.
[FR Doc. 2017-12352 Filed 6-14-17; 8:45 am]
BILLING CODE 4164-01-P