Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 106499 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

January 22, 2025. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Artair Mallett 

at Artair.Mallett@fda.hh.gov or 301– 

796–9638, at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

The conditions for issuance of a waiver 

under 21 CFR 10.19 are met. 

Dated: December 19, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31260 Filed 12–27–24; 8:45 am] 

BILLING CODE 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 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 

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 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, 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@fdsa.hhs.gov.

Anesthetic and Analgesic Drug Products Advisory Committee; Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Psychopharmacologic Drugs 

Advisory Committee. 


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TABLE 1—ADVISORY COMMITTEE CONTACTS—Continued 

Contact person Committee/panel 

Michael Gu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2506, Silver Spring, MD 

20993–0002, 301–796–2031, Michael.Gu@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. 

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 (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.

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 ..... Immediately. 


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TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE

NEEDED—Continued 

Committee/panel/areas of expertise needed Type of 

vacancy 

Approximate date 

needed 

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. 

Peripheral and Central Nervous Systems Drugs Advisory Committee—Knowledgeable in the fields of 

neurology, neuropharmacology, neuropathology, otolaryngology, epidemiology or 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, and 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. 


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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 


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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 selfnominated. 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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