4164-01-P
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.
SUMMARY: The Food and Drug Administration (FDA or 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.
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 [INSERT DATE 45 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL
REGISTER], for vacancies listed in this notice. Concurrently, nomination materials for
prospective candidates should be sent to FDA (see ADDRESSES) by [INSERT DATE 45
DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. Nominations will

be accepted for current vacancies and for those that will or may occur through December 31,
2024.
ADDRESSES: All statements of interest from consumer organizations interested in
participating in the selection process should be submitted electronically to
ACOMSSubmissions@fda.hhs.gov 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, kimberly.hamilton@fda.hhs.gov.
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 Scientist, Food
FDA Science Board Advisory Committee
and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 1, Rm. 3309, Silver Spring, MD 20993-0002, 301-7964769, Rakesh.Raghuwanshi@fda.hhs.gov
Moon Hee Choi, Center for Drug Evaluation and Research,
Anesthetic and Analgesic Drug Products
Food and Drug Administration, 10903 New Hampshire Ave., Advisory Committee; Drug Safety and Risk
Bldg. 31, Rm. 2434, Silver Spring, MD 20993-0002, 301Management Advisory Committee; Non796-2894, MoonHee.Choi@fda.hhs.gov
Prescription Drugs Advisory Committee
Yvette Waples, Center for Drug Evaluation Research, Food
Antimicrobial Drugs Advisory Committee;
and Drug Administration, 10903 New Hampshire Ave.,
Oncologic Drugs Advisory Committee
Bldg. 31, Rm. 2510, Silver Spring, MD 20993-0002, 301796-9034, Yvette.Waples@fda.hhs.gov

Contact Person
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, 301796-2855, LaToya.Bonner@fda.hhs.gov
Takyiah Stevenson, Center for Drug Evaluation Research,
Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2406, Silver Spring, MD 20993-0002, 240402-2507, Takyiah.Stevenson@fda.hhs.gov
Joyce Frimpong, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2426, Silver Spring, MD 20993-0002, 301796-7973, Joyce.Frimpong@fda.hhs.gov
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, 301796-7699, Jessica.Seo@fda.hhs.gov
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, 301636-0510, Candace.Nalls@fda.hhs.gov
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, 301796-6313, James.Swink@fda.hhs.gov
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
Joannie Adams-White, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5561, Silver Spring, MD
20993-0002, 301-796-5421, Joannie.AdamsWhite@fda.hhs.gov

Committee/Panel
Cardiovascular and Renal Drugs Advisory
Committee; Endocrinologic and Metabolic Drugs
Advisory Committee
Medical Imaging Advisory Committee;
Pharmacy Compounding Advisory Committee
Obstetrics, Reproductive and Urologic Drugs
Advisory Committee; Psychopharmacologic
Drugs Advisory Committee
Peripheral and Central Nervous System Drugs
Advisory Committee
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
Circulatory System Devices Panel; General
Hospital and Personal Use Devices Panel;
Hematology and Pathology Devices Panel;
Immunology Devices Panel; Microbiology
Devices Panel; Molecular and Clinical Genetics
Panel; Radiological Devices Panel;
Dental Products Panel; Ophthalmic Devices
Panel; Orthopaedic and Rehabilitation Devices
Panel
Medical Devices Dispute Resolution 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
Approximate Date
Vacancy
Needed
FDA Science Board Advisory Committee--The Science Board
1--Voting
Immediately
provides advice to the Commissioner of Food and Drugs
Administration (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.
Anesthetic and Analgesic Drug Products Advisory Committee-1--Voting
Immediately
Knowledgeable in the fields of anesthesiology, analgesics (such as:

Committee/Panel/Areas of Expertise Needed
abuse deterrent opioids, novel analgesics, and issues related to
opioid abuse) epidemiology or statistics, and related specialties.
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.
Non-Prescription Drugs Advisory Committee--Knowledgeable in the
fields of internal medicine, family practice, clinical toxicology,
clinical pharmacology, pharmacy, dentistry, and related specialties.
Antimicrobial Drugs Advisory Committee--Knowledgeable in the
fields of infectious disease, internal medicine, microbiology,
pediatrics, epidemiology or statistics, and related specialties.
Oncologic Drugs Advisory Committee--Knowledgeable in the fields
of general oncology, pediatric oncology, hematologic oncology,
immunologic oncology, biostatistics, and other related professions.
Cardiovascular and Renal Drugs Advisory Committee-Knowledgeable in the fields of cardiology, hypertension, arrhythmia,
angina, congestive heart failure, diuresis, and biostatistics.
Endocrinologic and Metabolic Drugs Advisory Committee-Knowledgeable in the fields of endocrinology, metabolism,
epidemiology or statistics, and related specialties.
Medical Imaging Drugs Advisory Committee--Knowledgeable in the
fields of nuclear medicine, radiology, epidemiology, statistics, and
related specialties.
Pharmacy Compounding Advisory Committee--Knowledgeable in the
fields of pharmaceutical compounding, pharmaceutical
manufacturing, pharmacy, medicine, and related specialties.
Obstetrics, Reproductive and Urologic Drugs Advisory Committee-Knowledgeable in the fields of obstetrics, gynecology, urology,
pediatrics, epidemiology, or statistics and related specialties.
Psychopharmacologic Drugs Advisory Committee--Knowledgeable in
the fields of psychopharmacology, psychiatry, epidemiology or
statistics, and related specialties.
Peripheral and Central Nervous Systems Drugs Advisory Committee-Knowledgeable in the fields of neurology, neuropharmacology,
neuropathology, otolaryngology, epidemiology or statistics, and
related specialties.
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.
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.
Ear, Nose and Throat Devices Panel--Otologists, neurotologists,
audiologists
Gastroenterology-Urology Devices Panel--Gastroenterologists,
urologists, and nephrologists.
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.
Circulatory System Devices Panel--Interventional cardiologists,
electrophysiologists, invasive (vascular) radiologists, vascular and
cardiothoracic surgeons, and cardiologists with special interest in
congestive heart failure.
General Hospital and Personal Use Devices Panel--Internists,
pediatricians, neonatologists, endocrinologists, nurses, biomedical

Type of
Vacancy

Approximate Date
Needed

1--Voting

Immediately

1--Voting

Immediately

1--Voting

Immediately

1--Voting

November 1, 2024

1--Voting

Immediately

1--Voting

Immediately

1--Voting

Immediately

1--Voting

Immediately

1--Voting

July 2024

1--Voting

Immediately

1--Voting

Immediately

1--Nonvoting

Immediately

1--Nonvoting

Immediately

1--Nonvoting

Immediately

1--Nonvoting

Immediately

1--Nonvoting

Immediately

1--Nonvoting

Immediately

1--Nonvoting

Immediately

Committee/Panel/Areas of Expertise Needed
engineers or microbiologists/infection control practitioners or
experts.
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.
Immunology Devices Panel--Persons with experience in medical,
surgical, or clinical oncology, internal medicine, clinical
immunology, allergy, molecular diagnostics, or clinical laboratory
medicine.
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.
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.
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.
Dental Products Panel--Dentists, engineers and scientists who have
expertise in the areas of dental implants, dental materials,
periodontology, tissue engineering, and dental anatomy.
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.
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.
Medical Devices Dispute Resolution Panel--Experts with broad, crosscutting scientific, clinical, analytical or mediation skills.

Type of
Vacancy

Approximate Date
Needed

1--Nonvoting

Immediately

1--Nonvoting

Immediately

1--Nonvoting

Immediately

1--Nonvoting

Immediately

1--Nonvoting

Immediately

1--Nonvoting

Immediately

1--Nonvoting

Immediately

1--Nonvoting

Immediately

1--Nonvoting

October 1, 2024

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. 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 of Food and Drugs Administration.
C. 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 regarding safety, efficacy, and abuse potential of drugs or other
substances, and recommends actions to be taken by HHS regarding the marketing, investigation,
and control of such drugs or other substances.
D. Nonprescription Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and effectiveness of over-thecounter (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.
E. 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.
F. 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.
G. 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.
H. 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.
I. 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.
J. Pharmacy Compounding Drugs Advisory Committee

Provides advice on scientific, technical, and medical issues concerning drug
compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, and,
as required, any other product for which FDA has regulatory responsibility.
K. Obstetrics, Reproductive, and Urologic Drugs 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.
L. 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.
M. 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.
N. 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) 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 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 résumé. 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 résumé 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 communitybased 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 of qualified nominees not selected
will remain on a list of eligible nominees and be reviewed periodically by FDA to determine
continued interest. After preparing 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. 1001 et seq.)
and 21 CFR part 14, relating to advisory committees.
Dated: June 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12999 Filed: 6/12/2024 8:45 am; Publication Date: 6/13/2024]