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Notice2024-22292

Request for Nominations for Individuals and Consumer Organizations for Advisory Committees

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Published

September 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 committee 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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<title>Federal Register, Volume 89 Issue 189 (Monday, September 30, 2024)</title>
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[Federal Register Volume 89, Number 189 (Monday, September 30, 2024)]
[Notices]
[Pages 79617-79622]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-22292]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-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 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

[[Page 79618]]

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 committee
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
November 14, 2024, for vacancies listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
(see ADDRESSES) by November 14, 2024.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#5d1c1e12100e0e283f30342e2e3432332e1d3b393c7335352e733a322b">[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#9dd6f4f0fff8eff1e4b3d5fcf0f4f1e9f2f3ddfbf9fcb3f5f5eeb3faf2eb">[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#f9ab98929c8a91d7ab989e918c8e98978a9190b99f9d98d791918ad79e968f">[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#03406b716a70776a6d622d55667177436567622d6b6b702d646c75">[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, Rm. 1246, Silver
Spring, MD 20993-0002, 240-402-4207,
<a href="/cdn-cgi/l/email-protection#175a76657e723953727065727078657e7857717376397f7f6439707861">[email&#160;protected]</a>.
Sussan Paydar, Center for Biologics Vaccines and Related
Evaluation and Research, Food and Drug Biological Products Advisory
Administration, 10903 New Hampshire Committee.
Ave., Bldg. 71, Silver Spring, MD 20993-
0002, 202-657-8533,
<a href="/cdn-cgi/l/email-protection#c291b7b1b1a3acec92a3bba6a3b082a4a6a3ecaaaab1eca5adb4">[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;
<a href="/cdn-cgi/l/email-protection#e2a88d9b8187cca4908b8f928d8c85a2848683cc8a8a91cc858d94">[email&#160;protected]</a>. Psychopharmacologic Drugs
Advisory Committee.
Yvette Waples, Center for Drug Antimicrobial Drugs Advisory
Evaluation and Research, Food and Drug Committee, Drug Safety and
Administration, 10903 New Hampshire Risk Management Advisory
Ave., Bldg. 31, Rm. 2510, Silver Committee; Non-Prescription
Spring, MD 20993-0002, 301-796-9034, Drugs Advisory Committee;
<a href="/cdn-cgi/l/email-protection#164f6073626273384177667a736556707277387e7e6538717960">[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#703c11241f09115e321f1e1e1502301614115e1818035e171f06">[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#c89ca9a3b1a1a9a0e69bbcadbeada6bba7a688aeaca9e6a0a0bbe6afa7be">[email&#160;protected]</a>.
Jessica Seo, Center for Drug Evaluation Gastrointestinal Drugs
and Research, Food and Drug Advisory Committee;
Administration, 10903 New Hampshire Peripheral and Central
Ave., Bldg. 31, Rm. 2412, Silver Nervous System Drugs Advisory
Spring, MD 20993-0002, 301-796-7699, Committee.
<a href="/cdn-cgi/l/email-protection#713b1402021812105f22141e311715105f1919025f161e07">[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#b4f7d5dad0d5d7d19afad5d8d8c7f4d2d0d59adcdcc79ad3dbc2">[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#d298b3bfb7a1fc81a5bbbcb992b4b6b3fcbabaa1fcb5bda4">[email&#160;protected]</a>. Devices Panel; Medical
Devices Dispute Resolution
Panel; Microbiology Devices
Panel; Molecular and Clinical
Genetics Panel; Radiological
Devices Panel.

[[Page 79619]]

Akinola Awojope, Center for Devices and Dental Products Panel;
Radiological Health, Food and Drug Ophthalmic Devices Panel;
Administration, 10903 New Hampshire Orthopaedic and
Ave., Bldg. 66, Rm. 5216, Silver Rehabilitation Devices Panel.
Spring, MD 20993-0002, 301-636-0512,
<a href="/cdn-cgi/l/email-protection#a3e2c8cacdcccfc28de2d4ccc9ccd3c6e3c5c7c28dcbcbd08dc4ccd5">[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 expertise
needed Type of vacancy Approximate date needed
----------------------------------------------------------------------------------------------------------------
FDA Science Board Advisory Committee-- 1--Voting......................... Immediately.
The Science Board provides advice to
the Commissioner of Food and Drugs
(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 Committee-- 1--Voting......................... October 1, 2025.
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 Therapies-- 1--Voting......................... April 1, 2025.
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 Products 1--Voting......................... February 1, 2025.
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 Products 1--Voting......................... Immediately.
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 Urologic 1--Voting......................... Immediately.
Drugs Advisory Committee--Knowledgeable
in the fields of obstetrics,
gynecology, urology, pediatrics,
epidemiology, or statistics and related
specialties.
Psychopharmacologic Drugs Advisory 1--Voting......................... Immediately.
Committee--Knowledgeable in the fields
of psychopharmacology, psychiatry,
epidemiology or statistics, and related
specialties.
Antimicrobial Drugs Advisory Committee-- 1--Voting......................... Immediately.
Knowledgeable in the fields of
infectious disease, internal medicine,
microbiology, pediatrics, epidemiology
or statistics, and related specialties.
Drug Safety and Risk Management Advisory 1--Voting......................... Immediately.
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 Committee-- 1--Voting......................... November 1, 2024.
Knowledgeable in the fields of general
oncology, pediatric oncology,
hematologic oncology, immunologic
oncology, biostatistics, and other
related professions.
Pharmaceutical Science and Clinical 1--Voting......................... December 1, 2025.
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 Advisory 1--Voting......................... Immediately.
Committee--Knowledgeable in the fields
of cardiology, hypertension,
arrhythmia, angina, congestive heart
failure, diuresis, and biostatistics.
Dermatologic and Ophthalmic Drugs 1--Voting......................... September 1, 2025.
Advisory Committee--Knowledgeable in
the fields of dermatology,
ophthalmology, internal medicine,
pathology, immunology, epidemiology or
statistics, and other related
professions.
Endocrinologic and Metabolic Drugs 1--Voting......................... Immediately.
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.

[[Page 79620]]

Peripheral and Central Nervous Systems 1--Voting......................... Immediately.
Drugs Advisory Committee--Knowledgeable
in the fields of neurology, pediatric
neurology, epidemiology, statistics,
and related specialties.
Anesthesiology and Respiratory Therapy 1--Nonvoting...................... Immediately.
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 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.
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 Panel-- 1--Nonvoting...................... Immediately.
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 with 1--Nonvoting...................... Immediately.
experience in medical, surgical, or
clinical oncology, internal medicine,
clinical immunology, allergy, molecular
diagnostics, or clinical laboratory
medicine.
Medical Devices Dispute Resolution 1--Nonvoting...................... October 1, 2024.
Panel--Experts with broad, cross-
cutting scientific, clinical,
analytical or mediation skills.
Microbiology Devices Panel--Clinicians 1--Nonvoting...................... Immediately.
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 Devices 1--Nonvoting...................... Immediately.
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.
Radiological Devices Panel--Physicians 1--Nonvoting...................... Immediately.
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 Devices 1--Nonvoting...................... Immediately.
Panel--Orthopedic surgeons (joint
spine, trauma, and pediatric);
rheumatologists; engineers (biomedical,
biomaterials, and biomechanical);
experts in rehabilitation medicine,
sports medicine, and connective tissue
engineering; and biostatisticians.
----------------------------------------------------------------------------------------------------------------

I. Functions and General Description of the Committee Duties

A. FDA Science Board Advisory Committee

The Science Board Advisory Committee (Science Board) provides
advice to the Commissioner of Food and Drugs (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

[[Page 79621]]

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 make 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 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

[[Page 79622]]

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) 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 45 days of the end of this 30-day period, 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 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.
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: September 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-22292 Filed 9-27-24; 8:45 am]
BILLING CODE 4164-01-P

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