[Federal Register Volume 89, Number 189 (Monday, September 30, 2024)]
[Notices]
[Pages 79617-79622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22292]


-----------------------------------------------------------------------

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"><span class="__cf_email__" data-cfemail="672624282a343412050a0e14140e08091427010306490f0f1449000811">[email protected]</span></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: 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, <a href="/cdn-cgi/l/email-protection#9dd6f4f0fff8eff1e4b3d5fcf0f4f1e9f2f3ddfbf9fcb3f5f5eeb3faf2eb"><span class="__cf_email__" data-cfemail="a3e8cacec1c6d1cfda8debc2cecacfd7cccde3c5c7c28dcbcbd08dc4ccd5">[email protected]</span></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"><span class="__cf_email__" data-cfemail="fdaf9c96988e95d3af9c9a95888a9c938e9594bd9b999cd395958ed39a928b">[email protected]</span></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"><span class="__cf_email__" data-cfemail="aeedc6dcc7dddac7c0cf80f8cbdcdaeec8cacf80c6c6dd80c9c1d8">[email protected]</span></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"><span class="__cf_email__" data-cfemail="85c8e4f7ece0abc1e0e2f7e0e2eaf7eceac5e3e1e4abededf6abe2eaf3">[email protected]</span></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"><span class="__cf_email__" data-cfemail="ecbf999f9f8d82c2bc8d95888d9eac8a888dc284849fc28b839a">[email protected]</span></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"><span class="__cf_email__" data-cfemail="abe1c4d2c8ce85edd9c2c6dbc4c5ccebcdcfca85c3c3d885ccc4dd">[email protected]</span></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"><span class="__cf_email__" data-cfemail="bce5cad9c8c8d992ebddccd0d9cffcdad8dd92d4d4cf92dbd3ca">[email protected]</span></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"><span class="__cf_email__" data-cfemail="632f02370c1a024d210c0d0d0611230507024d0b0b104d040c15">[email protected]</span></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"><span class="__cf_email__" data-cfemail="cc98ada7b5a5ada4e29fb8a9baa9a2bfa3a28caaa8ade2a4a4bfe2aba3ba">[email protected]</span></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"><span class="__cf_email__" data-cfemail="d69cb3a5a5bfb5b7f885b3b996b0b2b7f8bebea5f8b1b9a0">[email protected]</span></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"><span class="__cf_email__" data-cfemail="6d2e0c03090c0e0843230c01011e2d0b090c4305051e430a021b">[email protected]</span></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"><span class="__cf_email__" data-cfemail="95dff4f8f0e6bbc6e2fcfbfed5f3f1f4bbfdfde6bbf2fae3">[email protected]</span></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"><span class="__cf_email__" data-cfemail="2a6b41434445464b046b5d4540455a4f6a4c4e4b04424259044d455c">[email protected]</span></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


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>