2024-22292. Request for Nominations for Individuals and Consumer Organizations for Advisory Committees  

  • Table 1—Advisory Committee Contacts

    Contact person Committee/panel
    Rakesh Raghuwanshi, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver Spring, MD 20993-0002, 301-796-4769, Rakesh.Raghuwanshi@fda.hhs.gov FDA Science Board Advisory Committee.
    Christina Vert, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 240-402-8054, Christina.Vert@fda.hhs.gov Blood Products Advisory Committee.
    Marie DeGregorio, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1246, Silver Spring, MD 20993-0002, 240-402-4207, Marie.Degregorio@fda.hhs.gov Cellular, Tissue and Gene Therapies Advisory Committee.
    Sussan Paydar, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 202-657-8533, Sussan.Paydar@fda.hhs.gov Vaccines and Related Biological Products Advisory Committee.
    Joyce Frimpong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2438, Silver Spring, MD 20993-0002, 301-796-7973, Joyce.Frimpong@fda.hhs.gov Anesthetic and Analgesic Drug Products Advisory Committee; Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Psychopharmacologic Drugs Advisory Committee.
    Yvette Waples, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2510, Silver Spring, MD 20993-0002, 301-796-9034, Yvette.Waples@fda.hhs.gov Antimicrobial Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee; Non-Prescription Drugs Advisory Committee; Oncologic Drugs Advisory Committee; Pharmaceutical Science and Clinical Pharmacology Drugs Advisory Committee.
    LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2428, Silver Spring, MD 20993-0002, 301-796-2855, LaToya.Bonner@fda.hhs.gov Cardiovascular and Renal Drugs Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee.
    Takyiah Stevenson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2406, Silver Spring, MD 20993-0002, 240-402-2507, Takyiah.Stevenson@fda.hhs.gov Medical Imaging Advisory Committee.
    Jessica Seo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2412, Silver Spring, MD 20993-0002, 301-796-7699, Jessica.Seo@fda.hhs.gov Gastrointestinal Drugs Advisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee.
    Candace Nalls, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993-0002, 301-636-0510, Candace.Nalls@fda.hhs.gov Anesthesiology and Respiratory Therapy Devices Panel; Clinical Chemistry and Clinical Toxicology Devices Panel; Ear, Nose and Throat Devices Panel; Gastroenterology-Urology Devices Panel; General and Plastic Surgery Devices Panel.
    James Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993-0002, 301-796-6313, James.Swink@fda.hhs.gov Circulatory System Devices Panel; General Hospital and Personal Use Devices Panel; Hematology and Pathology Devices Panel; Immunology Devices Panel; Medical Devices Dispute Resolution Panel; Microbiology Devices Panel; Molecular and Clinical Genetics Panel; Radiological Devices Panel.
    ( print page 79619)
    Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002, 301-636-0512, Akinola.Awojope@fda.hhs.gov Dental Products Panel; Ophthalmic Devices Panel; Orthopaedic and Rehabilitation Devices Panel.

    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—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 1—Voting Immediately.
    Blood Products Advisory 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 1—Voting October 1, 2025.
    Cellular, Tissue and Gene 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) 1—Voting April 1, 2025.
    Vaccines and Related Biological 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 1—Voting February 1, 2025.
    Anesthetic and Analgesic Drug 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 1—Voting Immediately.
    Obstetrics, Reproductive and Urologic Drugs Advisory Committee—Knowledgeable in the fields of obstetrics, gynecology, urology, pediatrics, epidemiology, or statistics and related specialties 1—Voting Immediately.
    Psychopharmacologic Drugs Advisory Committee—Knowledgeable in the fields of psychopharmacology, psychiatry, epidemiology or statistics, and related specialties 1—Voting Immediately.
    Antimicrobial Drugs Advisory Committee—Knowledgeable in the fields of infectious disease, internal medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties 1—Voting Immediately.
    Drug Safety and Risk Management Advisory Committee—Knowledgeable in risk communication, risk management, drug safety, medical, behavioral, and biological sciences as they apply to risk management, and drug abuse 1—Voting Immediately.
    Non-Prescription Drugs Advisory Committee—Knowledgeable in the fields of internal medicine, family practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and related specialties 1—Voting Immediately.
    Oncologic Drugs Advisory Committee—Knowledgeable in the fields of general oncology, pediatric oncology, hematologic oncology, immunologic oncology, biostatistics, and other related professions 1—Voting November 1, 2024.
    Pharmaceutical Science and 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 1—Voting December 1, 2025.
    Cardiovascular and Renal Drugs Advisory Committee—Knowledgeable in the fields of cardiology, hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics 1—Voting Immediately.
    Dermatologic and Ophthalmic Drugs Advisory Committee—Knowledgeable in the fields of dermatology, ophthalmology, internal medicine, pathology, immunology, epidemiology or statistics, and other related professions 1—Voting September 1, 2025.
    Endocrinologic and Metabolic Drugs Advisory Committee—Knowledgeable in the fields of endocrinology, metabolism, epidemiology or statistics, and related specialties 1—Voting Immediately.
    Medical Imaging Drugs Advisory Committee—Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics, and related specialties 1—Voting Immediately.
    ( print page 79620)
    Peripheral and Central Nervous Systems Drugs Advisory Committee—Knowledgeable in the fields of neurology, pediatric neurology, epidemiology, statistics, and related specialties 1—Voting Immediately.
    Anesthesiology and Respiratory 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 1—Nonvoting Immediately.
    Clinical Chemistry and Clinical 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 1—Nonvoting Immediately.
    Ear, Nose and Throat Devices Panel—Otologists, neurotologists, audiologists 1—Nonvoting Immediately.
    General and Plastic Surgery 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 1—Nonvoting Immediately.
    Circulatory System Devices Panel—Interventional cardiologists, electrophysiologists, invasive (vascular) radiologists, vascular and cardiothoracic surgeons, and cardiologists with special interest in congestive heart failure 1—Nonvoting Immediately.
    General Hospital and Personal Use Devices Panel—Internists, pediatricians, neonatologists, endocrinologists, nurses, biomedical engineers or microbiologists/infection control practitioners or experts 1—Nonvoting Immediately.
    Hematology and Pathology Devices 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 1—Nonvoting Immediately.
    Immunology Devices Panel—Persons with experience in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine 1—Nonvoting Immediately.
    Medical Devices Dispute Resolution Panel—Experts with broad, cross-cutting scientific, clinical, analytical or mediation skills 1—Nonvoting October 1, 2024.
    Microbiology Devices Panel—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 1—Nonvoting Immediately.
    Molecular and Clinical Genetics Devices Panel—Experts in human genetics and in the clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, neonatologists. The Agency is also interested in considering candidates with training in inborn errors of metabolism, biochemical and/or molecular genetics, population genetics, epidemiology, and related statistical training. Additionally, individuals with experience in genetic counseling, medical ethics, as well as ancillary fields of study will be considered 1—Nonvoting Immediately.
    Radiological Devices Panel—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 1—Nonvoting Immediately.
    Dental Products Panel—Dentists, engineers and scientists who have expertise in the areas of dental implants, dental materials, periodontology, tissue engineering, and dental anatomy 1—Nonvoting Immediately.
    Ophthalmic Devices Panel—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 1—Nonvoting Immediately.
    Orthopaedic and Rehabilitation 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 1—Nonvoting Immediately.