Notice2026-20065
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
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Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 1, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 individuals on its advisory committees selected without regard to race, color, national origin, religion, age, or sex.
Full Text
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<title>Federal Register, Volume 91 Issue 189 (Thursday, October 1, 2026)</title>
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[Federal Register Volume 91, Number 189 (Thursday, October 1, 2026)]
[Notices]
[Pages 62522-62527]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20065]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0008]
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 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 individuals on its
advisory committees selected without regard to race, color, national
origin, religion, age, or sex.
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 16, 2026 for vacancies listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
(see ADDRESSES) by November 16, 2026. Nominations will be accepted for
current vacancies and for those that will or may occur through December
31, 2026.
ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process should be
submitted electronically to <a href="/cdn-cgi/l/email-protection#6b2a28242638381e0906021818020405182b0d0f0a45030318450c041d"><span class="__cf_email__" data-cfemail="9adbd9d5d7c9c9eff8f7f3e9e9f3f5f4e9dafcfefbb4f2f2e9b4fdf5ec">[email protected]</span></a> or by mail to
Advisory Committee Oversight
[[Page 62523]]
and Management Staff, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg.1, Rm. 3220, Silver Spring, MD 20993-0002.
Consumer representative nominations should be submitted
electronically by logging into the FDA Advisory Committee Membership
Nomination Portal: <a href="https://www.accessdata.fda.gov/scripts/factrsportal/factrs/index.cfm">https://www.accessdata.fda.gov/scripts/factrsportal/factrs/index.cfm</a>, or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 1, Rm. 3220, Silver
Spring, MD 20993-0002. Additional information about becoming a member
of an FDA advisory committee can also be obtained by visiting FDA's
website at <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
FOR FURTHER INFORMATION CONTACT: Kimberly Hamilton, Advisory Committee
Oversight and Management Staff, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 1, Rm. 3220, Silver Spring, MD 20993-0002, 301-
796-8220, <a href="/cdn-cgi/l/email-protection#f09b999d9295829c89de98919d999c849f9eb0969491de989883de979f86"><span class="__cf_email__" data-cfemail="97fcfefaf5f2e5fbeeb9fff6fafefbe3f8f9d7f1f3f6b9ffffe4b9f0f8e1">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
and/or nonvoting consumer representatives for the vacancies listed in
the table below:
------------------------------------------------------------------------
Committee/panel/areas of expertise Approximate date
needed Type of vacancy needed
------------------------------------------------------------------------
FDA Science Board Advisory 1--Voting........ Immediately.
Committee--Knowledgeable in the
fields of food science (safety and
nutrition); clinical research;
veterinary medicine; pharmacology;
toxicology; biostatistics; medical
devices; public health and
epidemiology; product
manufacturing and quality; and
other scientific areas relevant to
FDA regulated products such as
systems biology, informatics,
nanotechnology, and combination
products
Pediatric Advisory Committee-- 1--Voting........ Immediately.
Knowledgeable in pediatric
research, pediatric
subspecialties, statistics, and/or
biomedical ethics
Blood Products Advisory Committee-- 1--Nonvoting..... Immediately.
Knowledgeable in the fields of
clinical and administrative
medicine, hematology, immunology,
blood banking, surgery, internal
medicine, biochemistry,
engineering, biological and
physical sciences, biotechnology,
computer technology, statistics,
epidemiology, sociology/ethics,
and related specialties
Cellular, Tissue and Gene Therapies 1--Voting........ Immediately.
Advisory Committee--Knowledgeable
in the fields of cellular
therapies, tissue transplantation,
gene therapies, and
xenotransplantation. These may
include biostatistics, bioethics,
hematology/oncology, human tissues
and transplantation, reproductive
medicine, general medicine, and
various medical specialties
including surgery and oncology,
immunology, virology, molecular
biology, cell biology,
developmental biology, tumor
biology, biochemistry, rDNA
technology, nuclear medicine, gene
therapy, infectious diseases, and
cellular kinetics
Vaccines and Related Biological 1--Nonvoting..... Immediately.
Products Advisory Committee--
Knowledgeable in the fields of
immunology, allergy and allergenic
diseases, molecular biology, rDNA,
virology, bacteriology,
parasitology, epidemiology or
biostatistics, vaccine policy,
vaccine safety science, Federal
immunization activities, vaccine
development including
translational and clinical
evaluation programs,
hypersensitivity reactions to
vaccines, preventive medicine,
infectious diseases, pediatrics,
microbiology, and biochemistry
Anesthetic and Analgesic Drug 1--Nonvoting..... Immediately.
Products Advisory Committee--
Knowledgeable in the fields of
anesthesiology, analgesics (e.g.,
abuse deterrent opioids, novel
analgesics, and issues related to
opioid abuse), epidemiology or
statistics, and related
specialties
Antimicrobial Drugs Advisory 1--Voting........ Immediately.
Committee--Knowledgeable in the
fields of infectious disease,
internal medicine, microbiology,
pediatrics, epidemiology or
statistics, and related
specialties
Cardiovascular and Renal Drugs 1--Nonvoting..... Immediately.
Advisory Committee--Knowledgeable
in the fields of cardiology,
nephrology, and related
specialties
Dermatologic and Ophthalmic Drugs 1--Nonvoting..... Immediately.
Advisory Committee--Knowledgeable
in the fields of dermatology,
ophthalmology, dentistry,
immunology, epidemiology or
statistics, and other related
professions
Drug Safety and Risk Management 1--Nonvoting..... Immediately.
Advisory Committee--Knowledgeable
in the fields of risk
communication, risk management,
drug safety, medical, behavioral,
and biological sciences as they
apply to risk management, and drug
abuse
Endocrinologic and Metabolic Drugs 1--Nonvoting..... Immediately.
Advisory Committee--Knowledgeable
in the fields of endocrinology,
metabolism, statistics, and
related specialties
Genetic Metabolic Disease Drugs 1--Nonvoting..... Immediately.
Advisory Committee--Knowledgeable
in the fields of medical genetics,
manifestations of inborn errors of
metabolism, small population trial
design, translational science,
pediatrics, epidemiology, or
statistics and related specialties
Non-Prescription Drugs Advisory 1--Voting........ Immediately.
Committee--Knowledgeable in the
fields of internal medicine,
family practice, clinical
toxicology, clinical pharmacology,
pharmacy, dentistry, and related
specialties
Obstetrics, Reproductive and 1--Nonvoting..... Immediately.
Urologic Drugs Advisory Committee--
Knowledgeable in the fields of
obstetrics, gynecology, urology,
epidemiology, or statistics and
related specialties
Oncologic Drugs Advisory Committee-- 1--Nonvoting..... Immediately.
Knowledgeable in the fields of
general oncology, pediatric
oncology, hematologic oncology,
immunology oncology,
biostatistics, and other related
professions
Peripheral and Central Nervous 1--Nonvoting..... Immediately.
System Advisory Committee--
Knowledgeable in the fields of
neurology, pediatric neurology,
epidemiology, statistics, and
related specialties
Pharmacy Compounding Drugs Advisory 1--Nonvoting..... Immediately.
Committee--Knowledgeable in the
fields of pharmaceutical
compounding, pharmaceutical
manufacturing, pharmacy, medicine,
and related specialties
Psychopharmacologic Drugs Advisory 1--Nonvoting..... Immediately.
Committee--Knowledgeable in
psychopharmacology, psychiatry,
epidemiology, statistics, and
related specialties
[[Page 62524]]
Pulmonary-Allergy Drugs Advisory 1--Nonvoting..... Immediately.
Committee--Knowledgeable in the
fields of pulmonary medicine,
allergy, clinical immunology, and
epidemiology or statistics
Anesthesiology and Respiratory 1--Nonvoting..... Immediately.
Therapy Devices Panel--
Anesthesiologists, pulmonary
medicine specialists, or other
experts who have specialized
interests in ventilator support,
pharmacology, physiology, or the
effects and complications of
anesthesia
Circulatory System Devices Panel-- 1--Nonvoting..... Immediately.
Interventional cardiologists,
electrophysiologists, invasive
(vascular) radiologists, vascular
and cardiothoracic surgeons, and
cardiologists with special
interest in congestive heart
failure
Clinical Chemistry and Clinical 1--Nonvoting..... Immediately.
Toxicology Devices Panel--Doctor
of Medicine or Philosophy with
experience in clinical chemistry
(e.g., cardiac markers), clinical
toxicology, clinical pathology,
clinical laboratory medicine, and
endocrinology
Dental Products Devices Panel-- 1--Nonvoting..... Immediately.
Dentists, engineers and scientists
who have expertise in the areas of
dental implants, dental materials,
periodontology, tissue
engineering, and dental anatomy
Ear, Nose and Throat Devices Panel-- 1--Nonvoting..... Immediately.
Otologists, neurotologists,
audiologists
General and Plastic Surgery Devices 1--Nonvoting..... Immediately.
Panel--Surgeons (general, plastic,
reconstructive, pediatric,
thoracic, abdominal, pelvic and
endoscopic); dermatologists;
experts in biomaterials, lasers,
wound healing, and quality of
life; and biostatisticians
General Hospital and Personal Use 1--Nonvoting..... Immediately.
Devices Panel--Internists,
pediatricians, neonatologists,
endocrinologists, gerontologists,
nurses, biomedical engineers or
microbiologists/infection control
practitioners or experts
Hematology and Pathology Devices 1--Nonvoting..... Immediately.
Panel--Hematologists (benign and/
or malignant hematology),
hematopathologists (general and
special hematology, coagulation
and homeostasis, and hematological
oncology), gynecologists with
special interests in gynecological
oncology, cytopathologists, and
molecular pathologists with
special interests in development
of predictive biomarkers
Immunology Devices Panel--Persons 1--Nonvoting..... Immediately.
with experience in medical,
surgical, or clinical oncology,
internal medicine, clinical
immunology, allergy, molecular
diagnostics, or clinical
laboratory medicine
Microbiology Devices Panel-- 1--Nonvoting..... 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
Molecular and Clinical Genetics 1--Nonvoting..... Immediately.
Devices Panel--Experts in human
genetics and in the clinical
management of patients with
genetic disorders, e.g.,
pediatricians, obstetricians,
neonatologists. The Agency is also
interested in considering
candidates with training in inborn
errors of metabolism, biochemical
and/or molecular genetics,
population genetics, epidemiology,
and related statistical training.
Additionally, individuals with
experience in genetic counseling,
medical ethics, as well as
ancillary fields of study will be
considered
Neurological Devices Panel-- 1--Nonvoting..... Immediately.
Neurosurgeons (cerebrovascular and
pediatric), neurologists (stroke,
pediatric, pain management, and
movement disorders),
interventional neuroradiologists,
psychiatrists, and
biostatisticians
Ophthalmic Devices Panel-- 1--Nonvoting..... Immediately.
Ophthalmologists with expertise in
corneal-external disease, vitreo-
retinal surgery, glaucoma, ocular
immunology, ocular pathology;
optometrists; vision scientists;
and ophthalmic professionals with
expertise in clinical trial
design, quality of life
assessment, electrophysiology, low
vision rehabilitation, and
biostatistics
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
Radiological 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
------------------------------------------------------------------------
I. Functions and General Description of the Committee Duties
A. FDA Science Board Advisory Committee
The Committee reviews and evaluates data concerning specific
complex scientific and technical issues important to FDA and its
mission, including emerging issues within the scientific community.
Additionally, the Committee will provide advice that supports the
Agency in keeping pace with technical and scientific developments,
including regulatory science; and input into the Agency's research
agenda; and on upgrading its scientific and research facilities and
training opportunities. It will also provide, where requested, expert
review of Agency-sponsored intramural and extramural scientific
research programs.
B. Pediatrics Advisory Committee
The Committee reviews, evaluates, and makes recommendations to the
Commissioner of Food and Drugs (the Commissioner) regarding (1)
pediatric research conducted under sections 351, 409I, and 499 of the
Public Health Service Act (42 U.S.C. 262, 284m, and 290b) and sections
501,502, 505, 505A, 505B, 510(k), 515, and 520(m) of the Federal Food,
Drug, and Cosmetic Act
[[Page 62525]]
(FD&C Act) (21 U.S.C. 351, 352, 355, 355a, 355c, 360(k), 360e, and
360j(m)); (2) identification of research priorities related to
pediatric therapeutics (including drugs and biological products) and
medical devices for pediatric populations and the need for additional
diagnostics and treatments of specific pediatric diseases or
conditions; (3) the ethics, design, and analysis of clinical trials
related to pediatric therapeutics (including drugs and biological
products) and medical devices; (4) pediatric labeling disputes as
specified in Public Law 107-109, Public Law 110-85, and Public Law 112-
144; (5) pediatric labeling changes as specified in Public Law 107-109,
Public Law 110-85, and Public Law 112-144; (6) adverse event reports
for drugs studied under Public Law 107-109, Public Law 110-85, and
Public Law 112-144; (7) any safety issues that may occur as specified
in Public Law 107-109, Public Law 110-85, and Public Law 112-144; (8)
any other pediatric issue or pediatric labeling dispute involving FDA-
regulated products; (9) pediatric ethical issues including research
involving children as subjects as specified in 21 CFR 50.54; (10)
advise and make recommendations to the Secretary of Health and Human
Services (the Secretary) (HHS) on the development of countermeasures
for pediatric populations in H.R. 307, Pandemic and All-Hazards
Preparedness Reauthorization Act of 2013 (Pub. L. 113-5); and (11) 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 HHS as specified in 45 CFR 46.407.
C. Blood Products Advisory Committee
The Committee reviews and evaluates available data concerning the
safety, effectiveness, and appropriate use of blood, products derived
from blood and serum or biotechnology which are intended for use in the
diagnosis, prevention, or treatment of human diseases, and as required,
any other products for which FDA has regulatory responsibility. The
Committee also advises the Commissioner of its findings regarding
screening and testing (to determine eligibility) of donors and labeling
of the products, on clinical and laboratory studies involving such
products, on the affirmation or revocation of biological products
licenses. The Committee may consider the quality and relevance of FDA's
research program, which provides scientific support for the regulation
of these products, and makes appropriate recommendations to the
Commissioner.
The Committee will function at times as a medical device panel
under the Federal Food, Drug, and Cosmetic Act Medical Device
Amendments of 1976. As such, the Committee recommends classification of
devices subject to its review into regulatory categories; recommends
the assignment of a priority for the application of regulatory
requirements for devices classified in the standards or premarket
approval category; advises on formulation of product development
protocols and reviews premarket approval applications for those devices
to recommend changes in classification as appropriate; recommends
exemption of certain devices from the application of portions of the
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.
D. Cellular, Tissue and Gene Therapies
The Committee reviews and evaluates available data relating to the
safety, effectiveness, and appropriate use of human cells, human
tissues, gene therapies, and xenotransplantation products which are
intended for transplantation, implantation, infusion, and transfer in
the prevention and treatment of a broad spectrum of human diseases and
in the reconstruction, repair, or replacement of tissues for various
conditions. The Committee also considers the quality and relevance of
FDA's research program, which provides scientific support for the
regulation of these products, and makes appropriate recommendations to
the Commissioner.
E. Vaccines and Related Biological Products
The Committee reviews and evaluates data concerning the safety,
effectiveness, and appropriate use of vaccines, allergenics, and
related biological products which are intended for use in the
prevention, treatment, or diagnosis of human diseases, and as required,
any other products for which FDA has regulatory responsibility. The
Committee may consider the quality and relevance of FDA's research
program, which provides scientific support for the regulation of these
products, and makes appropriate recommendations to the Commissioner.
F. Anesthetic and Analgesic Drug Products Advisory Committee
The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products including analgesics, e.g., abuse-deterrent opioids, novel
analgesics, and issues related to opioid abuse, and those for use in
anesthesiology and makes appropriate recommendations to the
Commissioner.
G. Antimicrobial Drugs Advisory Committee
The 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
and makes appropriate recommendations to the Commissioner.
H. Cardiovascular and Renal Drugs Advisory Committee
The 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 kidney diseases
and makes appropriate recommendations to the Commissioner.
I. Dermatologic and Ophthalmic Drugs Advisory Committee
The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of dermatologic and ophthalmic
disorders and makes appropriate recommendations to the Commissioner.
J. Drug Safety and Risk Management Advisory Committee
The Committee reviews and evaluates information on risk management,
risk communication, and quantitative evaluation of spontaneous reports
for drugs for human use and for any other product for which FDA has
regulatory responsibility. The Committee also advises the Commissioner
regarding the scientific and medical evaluation of information gathered
by HHS and the Department of Justice with regard to safety, efficacy,
and abuse potential of drugs or other substances, and makes
recommendations as appropriate to be taken by HHS with regard to the
marketing, investigation, and control of such drugs or other
substances. The Committee may consider the quality and relevance of
FDA's research program, which provides scientific support for the
regulation of these products, and
[[Page 62526]]
makes appropriate recommendations to the Commissioner.
K. Endocrinologic and Metabolic Drugs Advisory Committee
The 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 and makes
appropriate recommendations to the Commissioner.
L. Genetic Metabolic Disease Advisory Committee
The Committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational human drug and biologic
products for use in the treatment of genetic metabolic diseases and
makes appropriate recommendations to the Commissioner. The Committee
may consider the quality and relevance of FDA's research program, which
provides scientific support for the regulation of these products, and
makes appropriate recommendations to the Commissioner.
M. Nonprescription Drugs Advisory Committee
The Committee reviews and evaluates 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 broad spectrum of human symptoms and diseases and advises
the Commissioner either on 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 serves 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.
N. Obstetrics, Reproductive and Urologic Products Advisory Committee
The Committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational human drug products for
use in the practice of obstetrics, gynecology, urology and related
specialties, and makes appropriate recommendations to the Commissioner.
The Committee may consider the quality and relevance of FDA's research
program, which provides scientific support for the regulation of these
products and makes appropriate recommendations to the Commissioner.
O. Oncologic Drugs Advisory Committee
The Committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of cancer and makes appropriate recommendations to
the Commissioner.
P. Peripheral and Central Nervous Systems Drugs Advisory Committee
The 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 and makes appropriate
recommendations to the Commissioner.
Q. Pharmacy Compounding Advisory Committee
The Committee reviews and evaluates scientific, technical, and
medical issues concerning drug compounding under sections 503A and 503B
of the FD&C Act (21 U.S.C. 353a and 353b) and, as required, any other
product for which FDA has regulatory responsibility, and makes
appropriate recommendations to the Commissioner. The Committee may
consider the quality and relevance of FDA's research program, which
provides scientific support for the regulation of these products and
makes appropriate recommendations to the Commissioner.
R. Psychopharmacologic Drugs Advisory Committee
The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the practice of psychiatry and related specialties.
The Committee may consider the quality and relevance of FDA's research
program, which provides scientific support for the regulation of these
products, and makes appropriate recommendations to the Commissioner.
S. Pulmonary-Allergy Drugs Advisory Committee
The 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. The Committee may consider
the quality and relevance of FDA's research program, which provides
scientific support for the regulation of these products, and makes
appropriate recommendations to the Commissioner.
T. Medical Devices Advisory Committee Panels
The Medical Devices Advisory Committee has established certain
panels to 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: (1)
advises on the classification or reclassification of devices into one
of three regulatory categories and advises on any possible risks to
health associated with the use of devices; (2) advises on formulation
of product development protocols; (3) reviews premarket approval
applications for medical devices; (4) reviews guidelines and guidance
documents; (5) recommends exemption of certain devices from the
application of portions of the FD&C Act; (6) advises on the necessity
to ban a device; and (7) 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 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.
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
[[Page 62527]]
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 interest should send a letter
stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 45 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 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 of up to 4 years, or for less time at the discretion of the
Commissioner or designee.
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.
After 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. 1001 et seq.) and 21 CFR part 14, relating to advisory
committees.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20065 Filed 9-30-26; 8:45 am]
BILLING CODE 4164-01-P
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