Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices 79617 

rooted in comparisons between new 

devices and predicate devices. However, 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) does not preclude FDA 

from using performance criteria to 

facilitate this comparison. If a legally 

marketed device performs at certain 

levels relevant to its safety and 

effectiveness, and a new device meets 

those levels of performance for the same 

characteristics, FDA could find the new 

device as safe and effective as the 

legally marketed device. Instead of 

reviewing data from direct comparison 

testing between the two devices, FDA 

could support a finding of substantial 

equivalence with data demonstrating 

the new device meets the level of 

performance of an appropriate predicate 

device(s). Under this optional Safety 

and Performance Based Pathway, a 

submitter of air powered dental 

handpieces and air motors, or dental 

cement devices could satisfy the 

requirement to compare its device with 

a legally marketed device by, among 

other things, independently 

demonstrating that the device’s 

performance meets performance criteria 

as established in the relevant abovelisted guidance rather than using direct 

predicate comparison testing for some of 

the performance characteristics. 

These guidances are being 

implemented without prior public 

comment because the Agency has 

determined that prior public 

participation is not feasible or 

appropriate (see section 701(h)(1)(C) of 

the FD&C Act (21 U.S.C. 371(h)(1)(C)) 

and 21 CFR 10.115(g)(2)). FDA has 

determined that these guidance 

documents present less burdensome 

policies that are consistent with public 

health. Although these guidances are 

being implemented immediately, FDA 

will consider all comments received and 

revise the guidance documents as 

appropriate. 

These guidances are being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

These guidances represent the current 

thinking of FDA on ‘‘Air Powered 

Dental Handpieces and Air Motors— 

Performance Criteria for Safety and 

Performance Based Pathway,’’ ‘‘Dental 

Ceramics—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ ‘‘Dental Impression 

Materials—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ and ‘‘Dental Cements— 

Performance Criteria for Safety and 

Performance Based Pathway.’’ They do 

not establish any rights for any person 

and are not binding on FDA or the 

public. You can use an alternative 

approach if it satisfies the requirements 

of the applicable statutes and 

regulations. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the guidances may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. These 

guidance documents are also available 

at https://www.regulations.gov or 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download 

an electronic copy of ‘‘Air Powered 

Dental Handpieces and Air Motors— 

Performance Criteria for Safety and 

Performance Based Pathway,’’ ‘‘Dental 

Ceramics—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ ‘‘Dental Impression 

Materials—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ or ‘‘Dental Cements— 

Performance Criteria for Safety and 

Performance Based Pathway’’ may send 

an email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number GUI00021014 for 

‘‘Air Powered Dental Handpieces and 

Air Motors—Performance Criteria for 

Safety and Performance Based 

Pathway,’’ document number 

GUI00007014 for ‘‘Dental Ceramics— 

Performance Criteria for Safety and 

Performance Based Pathway,’’ 

document number GUI00007013 for 

‘‘Dental Impression Materials— 

Performance Criteria for Safety and 

Performance Based Pathway,’’ or 

document number GUI00021005 for 

‘‘Dental Cements—Performance Criteria 

for Safety and Performance Based 

Pathway’’ to identify the guidance you 

are requesting. 

III. Paperwork Reduction Act of 1995 

While these guidances contain no 

new collection of information, they do 

refer to previously approved FDA 

collections of information. The 

previously approved collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521). The collections of information in 

the following table have been approved 

by OMB: 

21 CFR part; guidance Topic OMB 

control No. 

807, subpart E ................................................................................................................................ Premarket notification .............. 0910–0120 

‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission 

Program’’.

Q-submissions; pre-submissions.0910–0756 

Dated: September 24, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–22309 Filed 9–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
79618 Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices 

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 

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, 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. 


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TABLE 1—ADVISORY COMMITTEE CONTACTS—Continued 

Contact person Committee/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 (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. 


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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 

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. 

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 


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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 


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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 re ́sume ́ 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: 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA), Center for 

Veterinary Medicine’s (CVM), Office of 

Management (OM) and Office of New 

Animal Drug Evaluation (ONADE) have 

modified their organizational structures. 

The new organizational structures were 

approved by the Secretary of Health and 

Human Services on July 22, 2024. 

FOR FURTHER INFORMATION CONTACT: 

Yashika Rahaman, Director, Office of 

Planning, Evaluation, and Risk 

Management, Office of Finance, Budget, 

Acquisitions, and Planning, Food and 

Drug Administration, 4041 Powder Mill 

Rd., Beltsville, MD 20705–4304, 301– 

796–3843. 

I. Introduction 

Part D, Chapter D–B, (Food and Drug 

Administration), the Statement of 

Organization, Functions and 

Delegations of Authority for the 

Department of Health and Human 

Services (35 FR 3685, February 25, 

1970, 60 FR 56606, November 9, 1995, 


ddrumheller on DSK120RN23PROD with NOTICES1