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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 [www.gpo.gov]
[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 [email protected] 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: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, 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 https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: 
    For questions relating to participation in the selection process: 
Kimberly Hamilton, Advisory Committee Oversight and Management Staff, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 
5122, Silver Spring, MD 20993-0002, 301-796-8220, 
[email protected].
    For questions relating to specific advisory committees or panels, 
contact the appropriate contact person listed in table 1.

                  Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
             Contact person                      Committee/panel
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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,
 [email protected].
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,
 [email protected].
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,
 [email protected].
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,
 [email protected].
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
 [email protected].             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;
 [email protected].                  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
 [email protected].               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,
 [email protected].
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,
 [email protected].
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
 [email protected].               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
 [email protected].                 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,
 [email protected].
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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
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     Committee/panel/areas of                           Approximate date
         expertise needed           Type of  vacancy         needed
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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.
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[[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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