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Notice2024-31270

Request for Nominations for Individuals and Consumer Organizations for Advisory Committees

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Published

December 30, 2024

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or the 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 regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status, and, therefore, encourages nominations of appropriately qualified candidates from all groups.

Full Text

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[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106499-106503]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-31270]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-0008]

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 the 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 regardless of their gender identification,
religious affiliation, racial and ethnic identification, or disability
status, and, therefore, encourages nominations of appropriately
qualified candidates from all 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
February 13, 2025, for vacancies listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
(see ADDRESSES) by February 13, 2025. Nominations will be accepted for
current vacancies and for those that will or may occur through December
31, 2025.

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#efaeaca0a2bcbc9a8d82869c9c8680819caf898b8ec187879cc1888099">[email&#160;protected]</a> or by mail to
Advisory Committee Oversight and Management Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, 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. 32, Rm. 5122, 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:
For questions relating to participation in the selection process:
Kimberly Hamilton, Advisory Committee Oversight and Management Staff,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm.
5122, Silver Spring, MD 20993-0002, 301-796-8220,
<a href="/cdn-cgi/l/email-protection#eea587838c8b9c8297c0a68f8387829a8180ae888a8fc086869dc0898198">[email&#160;protected]</a>.
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
------------------------------------------------------------------------
Rakesh Raghuwanshi, Office of the Chief FDA Science Board Advisory
Scientist, Food and Drug Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3309, Silver
Spring, MD 20993-0002, 301-796-4769,
<a href="/cdn-cgi/l/email-protection#93c1f2f8f6e0fbbdc1f2f4fbe6e4f2fde0fbfad3f5f7f2bdfbfbe0bdf4fce5">[email&#160;protected]</a>.
Christina Vert, Center for Biologics Blood Products Advisory
Evaluation and Research, Food and Drug Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 71, Silver Spring, MD
20993-0002, 240-402-8054,
<a href="/cdn-cgi/l/email-protection#793a110b100a0d101718572f1c0b0d391f1d185711110a571e160f">[email&#160;protected]</a>.
Marie Degregorio, Center for Biologics Cellular, Tissue and Gene
Evaluation and Research, Food and Drug Therapies Advisory Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 71, Silver Spring, MD
20993-0002, 240-402-4207,
<a href="/cdn-cgi/l/email-protection#145975667d713a5071736671737b667d7b547270753a7c7c673a737b62">[email&#160;protected]</a>.
Sussan Paydar, Center for Biologics Vaccines and Related Biological
Evaluation and Research, Food and Drug Products Advisory Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 71, Silver Spring, MD
20993-0002, 202-657-8533,
<a href="/cdn-cgi/l/email-protection#1c4f696f6f7d72324c7d65787d6e5c7a787d3274746f327b736a">[email&#160;protected]</a>.
Joyce Frimpong, Center for Drug Anesthetic and Analgesic Drug
Evaluation and Research, Food and Drug Products Advisory Committee;
Administration, 10903 New Hampshire Obstetrics, Reproductive and
Ave., Bldg. 31, Rm. 2438, Silver Urologic Drugs Advisory
Spring, MD 20993-0002, 301-796-7973, Committee; Psychopharmacologic
<a href="/cdn-cgi/l/email-protection#cb81a4b2a8aee58db9a2a6bba4a5ac8badafb8aae5a3a3b8e5aca4bd">[email&#160;protected]</a>. Drugs Advisory Committee.

[[Page 106500]]

Michael Gu, Center for Drug Evaluation Antimicrobial Drugs Advisory
and Research, Food and Drug Committee, Drug Safety and
Administration, 10903 New Hampshire Risk Management Advisory
Ave., Bldg. 31, Rm. 2506, Silver Committee; Non-Prescription
Spring, MD 20993-0002, 301-796-2031, Drugs Advisory Committee;
<a href="/cdn-cgi/l/email-protection#bef3d7ddd6dfdbd290f9cbfed8dadf90d6d6cd90d9d1c8">[email&#160;protected]</a>. Oncologic Drugs Advisory
Committee; Pharmaceutical
Science and Clinical
Pharmacology Drugs Advisory
Committee.
LaToya Bonner, Center for Drug Cardiovascular and Renal Drugs
Evaluation and Research, Food and Drug Advisory Committee;
Administration, 10903 New Hampshire Dermatologic and Ophthalmic
Ave., Bldg. 31, Rm. 2428, Silver Drugs Advisory Committee;
Spring, MD 20993-0002, 301-796-2855, Endocrinologic and Metabolic
<a href="/cdn-cgi/l/email-protection#df93be8bb0a6bef19db0b1b1baad9fb9bbbef1b7b7acf1b8b0a9">[email&#160;protected]</a>. Drugs Advisory Committee.
Takyiah Stevenson, Center for Drug Medical Imaging Advisory
Evaluation and Research, Food and Drug Committee;
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2406, Silver
Spring, MD 20993-0002, 240-402-2507,
<a href="/cdn-cgi/l/email-protection#d581b4beacbcb4bdfb86a1b0a3b0bba6babb95b3b1b4fbbdbda6fbb2baa3">[email&#160;protected]</a>.
Jessica Seo, Center for Drug Evaluation Gastrointestinal Drugs Advisory
and Research, Food and Drug Committee; Peripheral and
Administration, 10903 New Hampshire Central Nervous System Drugs
Ave., Bldg. 31, Rm. 2412, Silver Advisory Committee.
Spring, MD 20993-0002, 301-796-7699,
<a href="/cdn-cgi/l/email-protection#3a705f494953595b14695f557a5c5e5b14525249145d554c">[email&#160;protected]</a>.
Candace Nalls, Center for Devices and Anesthesiology and Respiratory
Radiological Health, Food and Drug Therapy Devices Panel;
Administration, 10903 New Hampshire Clinical Chemistry and
Ave., Bldg. 66, Rm. 5211, Silver Clinical Toxicology Devices
Spring, MD 20993-0002, 301-636-0510, Panel; Ear, Nose and Throat
<a href="/cdn-cgi/l/email-protection#76351718121715135838171a1a0536101217581e1e0558111900">[email&#160;protected]</a>. Devices Panel;
Gastroenterology-Urology
Devices Panel; General and
Plastic Surgery Devices Panel.
James Swink, Center for Devices and Circulatory System Devices
Radiological Health, Food and Drug Panel; General Hospital and
Administration, 10903 New Hampshire Personal Use Devices Panel;
Ave., Bldg. 66, Rm. 5211, Silver Hematology and Pathology
Spring, MD 20993-0002, 301-796-6313, Devices Panel; Immunology
<a href="/cdn-cgi/l/email-protection#4208232f27316c11352b2c29022426236c2a2a316c252d34">[email&#160;protected]</a>. Devices Panel; Medical Devices
Dispute Resolution Panel;
Microbiology Devices Panel;
Molecular and Clinical
Genetics Panel; Radiological
Devices Panel.
Akinola Awojope, Center for Devices and Dental Products Panel;
Radiological Health, Food and Drug Ophthalmic Devices Panel;
Administration, 10903 New Hampshire Orthopaedic and Rehabilitation
Ave., Bldg. 66, Rm. 5216, Silver Devices Panel.
Spring, MD 20993-0002, 301-636-0512,
<a href="/cdn-cgi/l/email-protection#99d8f2f0f7f6f5f8b7d8eef6f3f6e9fcd9fffdf8b7f1f1eab7fef6ef">[email&#160;protected]</a>.
------------------------------------------------------------------------

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 Approximate date
expertise needed Type of vacancy needed
------------------------------------------------------------------------
FDA Science Board Advisory 1--Voting......... Immediately.
Committee--The Science Board
provides advice to the
Commissioner of Food and Drugs
(the Commissioner) and other
appropriate officials on
specific complex scientific and
technical issues important to
FDA and its mission, including
emerging issues within the
scientific community.
Additionally, the Science Board
provides advice that supports
the Agency in keeping pace with
technical and scientific
developments, including in
regulatory science; and input
into the Agency's research
agenda, and on upgrading its
scientific and research
facilities and training
opportunities. It also provides,
where requested, expert review
of Agency-sponsored intramural
and extramural scientific
research programs.
Blood Products Advisory 1--Voting......... October 1, 2025.
Committee--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 other related professions.
Cellular, Tissue and Gene 1--Voting......... April 1, 2025.
Therapies--Knowledgeable in the
fields of cellular therapies,
tissue transplantation, gene
transfer therapies and
xenotransplantation
(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--Voting......... February 1, 2025.
Products Advisory Committee--
Knowledgeable in the fields of
immunology, molecular biology,
rDNA, virology, bacteriology,
epidemiology or biostatistics,
allergy, preventive medicine,
infectious diseases, pediatrics,
microbiology, and biochemistry.
Anesthetic and Analgesic Drug 1--Voting......... Immediately.
Products Advisory Committee--
Knowledgeable in the fields of
anesthesiology, analgesics (such
as: abuse deterrent opioids,
novel analgesics, and issues
related to opioid abuse),
epidemiology or statistics, and
related specialties.
Obstetrics, Reproductive and 1--Voting......... Immediately.
Urologic Drugs Advisory
Committee--Knowledgeable in the
fields of obstetrics,
gynecology, urology, pediatrics,
epidemiology or statistics, and
related specialties.
Psychopharmacologic Drugs 1--Voting......... Immediately.
Advisory Committee--
Knowledgeable in the fields of
psychopharmacology, psychiatry,
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.
Drug Safety and Risk Management 1--Voting......... Immediately.
Advisory Committee--
Knowledgeable in risk
communication, risk management,
drug safety, medical,
behavioral, and biological
sciences as they apply to risk
management, and drug abuse.
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.
Oncologic Drugs Advisory 1--Voting......... Immediately.
Committee--Knowledgeable in the
fields of general oncology,
pediatric oncology, hematologic
oncology, immunologic oncology,
biostatistics, and other related
professions.

[[Page 106501]]

Pharmaceutical Science and 1--Voting......... December 1, 2025.
Clinical Pharmacology--
Knowledgeable in the fields of
pharmaceutical sciences
(pharmaceutical manufacturing,
bioequivalence research,
laboratory analytical
techniques, pharmaceutical
chemistry, physiochemistry,
biochemistry, molecular biology,
immunology, microbiology) and
clinical pharmacology (dose-
response, pharmacokinetics-
pharmacodynamics, modeling and
simulation, pharmacogenomics,
clinical trial design,
pediatrics and special
populations and innovative
methods in drug development),
biostatistics, related
biomedical and pharmacological
specialties, current good
manufacturing practices, and
quality systems implementation.
Cardiovascular and Renal Drugs 1--Voting......... Immediately.
Advisory Committee--
Knowledgeable in the fields of
cardiology, hypertension,
arrhythmia, angina, congestive
heart failure, diuresis, and
biostatistics.
Dermatologic and Ophthalmic Drugs 1--Voting......... September 1,
Advisory Committee-- 2025.
Knowledgeable in the fields of
dermatology, ophthalmology,
internal medicine, pathology,
immunology, epidemiology or
statistics, and other related
professions.
Endocrinologic and Metabolic 1--Voting......... Immediately.
Drugs Advisory Committee--
Knowledgeable in the fields of
endocrinology, metabolism,
epidemiology or statistics, and
related specialties.
Medical Imaging Drugs Advisory 1--Voting......... Immediately.
Committee--Knowledgeable in the
fields of nuclear medicine,
radiology, epidemiology,
statistics, and related
specialties.
Peripheral and Central Nervous 1--Voting......... Immediately.
Systems Drugs Advisory
Committee--Knowledgeable in the
fields of neurology,
neuropharmacology,
neuropathology, otolaryngology,
epidemiology or statistics, and
related specialties.
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.
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.
Ear, Nose and Throat Devices 1--Nonvoting...... Immediately.
Panel--Otologists,
neurotologists, audiologists.
General and Plastic Surgery 1--Nonvoting...... Immediately.
Devices Panel--Surgeons
(general, plastic,
reconstructive, pediatric,
thoracic, abdominal, pelvic, and
endoscopic); dermatologists;
experts in biomaterials, lasers,
wound healing, and quality of
life; and biostatisticians.
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.
General Hospital and Personal Use 1--Nonvoting...... Immediately.
Devices Panel--Internists,
pediatricians, neonatologists,
endocrinologists, 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.
Medical Devices Dispute 1--Nonvoting...... October 1, 2024.
Resolution Panel--Experts with
broad, cross-cutting scientific,
clinical, analytical, or
mediation skills.
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, and
ancillary fields of study will
be considered.
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.
Dental Products Panel--Dentists, 1--Nonvoting...... Immediately.
engineers and scientists who
have expertise in the areas of
dental implants, dental
materials, periodontology,
tissue engineering, and dental
anatomy.
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.
------------------------------------------------------------------------

[[Page 106502]]

I. Functions and General Description of the Committee Duties

A. FDA Science Board Advisory Committee

The Science Board Advisory Committee (Science Board) provides
advice to the Commissioner and other appropriate officials on specific
complex scientific and technical issues important to FDA and its
mission, including emerging issues within the scientific community.
Additionally, the Science Board provides advice that supports the
Agency in keeping pace with technical and scientific developments,
including in regulatory science, and input into the Agency's research
agenda and on upgrading its scientific and research facilities and
training opportunities. It also provides, where requested, expert
review of Agency-sponsored intramural and extramural scientific
research programs.

B. Blood Products Advisory 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 as well as the safety,
effectiveness, and labeling of the products, on clinical and laboratory
studies involving such products, on the affirmation or revocation of
biological product licenses, and on the quality and relevance of FDA's
research program which provides the scientific support for regulating
these products.

C. Cellular, Tissue, and Gene Therapies

Reviews and evaluates available data relating to the safety,
effectiveness, and appropriate use of human cells, human tissues, gene
transfer 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, as well as considers the quality and relevance of FDA's
research program which provides scientific support for the regulation
of these products.

D. Vaccines and Related Biological Products

Reviews and evaluates data concerning the safety, effectiveness,
and appropriate use of vaccines and related biological products which
are intended for use in the prevention, treatment, or diagnosis of
human diseases, as well as considers the quality and relevance of FDA's
research program which provides scientific support for the regulation
of these products.

E. Anesthetic and Analgesic Drug Products Advisory 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.

F. Obstetrics, Reproductive and Urologic Products Advisory 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.

G. Psychopharmacologic Drugs Advisory Committee

Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
practice of psychiatry and related fields.

H. Antimicrobial 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 infectious diseases and disorders.

I. Drug Safety and Risk Management Advisory 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. Advises on the scientific and medical
evaluation of all information gathered by the Department of Health and
Human Services (HHS) and the Department of Justice with regard to
safety, efficacy, and abuse potential of drugs or other substances, and
recommends actions to be taken by HHS with regard to the marketing,
investigation, and control of such drugs or other substances.

J. Nonprescription Drugs Advisory 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 a broad spectrum of human symptoms and diseases, and advises 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 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.

K. Oncologic 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 cancer.

L. Pharmaceutical Science and Clinical Pharmacology

Reviews and evaluates scientific, clinical, and technical issues
related to the safety and effectiveness of drug products for use in the
treatment of a broad spectrum of human diseases, the quality
characteristics which such drugs purport or are represented to have,
and as required, any other product for which FDA has regulatory
responsibility, and makes appropriate recommendations to the
Commissioner. The Committee may also review Agency-sponsored intramural
and extramural biomedical research programs in support of FDA's drug
regulatory responsibilities and its critical path initiatives related
to improving the efficacy and safety of drugs and improving the
efficiency of drug development.

M. 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.

N. Dermatologic and Ophthalmic Drugs

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.

O. Endocrinologic and Metabolic Drugs Advisory Committee

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

[[Page 106503]]

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

P. 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.

Q. 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.

R. Peripheral and Central Nervous System 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 neurologic diseases.

S. 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 Federal Food, Drug, and Cosmetic 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) be able to discuss benefits
and risks, and (5) be able to 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 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
resume. Ballots are to be filled out and returned to FDA within 30
days. The nominee receiving the highest number of votes ordinarily will
be selected to serve as the member representing consumer interests for
that particular advisory committee or panel.

IV. Nomination Procedures

Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Nominations must include a current, complete resume or curriculum vitae
for each nominee and a signed copy of the Acknowledgement and Consent
form available at the FDA Advisory Nomination Portal (see ADDRESSES),
and a list of consumer or community-based organizations for which the
candidate can demonstrate active participation.
Nominations must also specify the advisory committee(s) or panel(s)
for which the nominee is recommended. In addition, nominations must
also acknowledge that the nominee is aware of the nomination unless
self-nominated. FDA will ask potential candidates to provide detailed
information concerning such matters as financial holdings, employment,
and research grants and/or contracts to permit evaluation of possible
sources of conflicts of interest. Members will be invited to serve for
terms of 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.
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. app. 2) and 21 CFR part 14, relating to advisory committees.

Dated: December 16, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31270 Filed 12-27-24; 8:45 am]
BILLING CODE 4164-01-P

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