86338 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 

in FDA. Self-nominations are also 

accepted. Nominations must include a 

cover letter; a current, complete re ́sume ́

or curriculum vitae for each nominee, 

including current business and/or home 

address, telephone number, and email 

address if available, and a signed copy 

of the Acknowledgement and Consent 

form available at the FDA Advisory 

Nomination Portal (see ADDRESSES). 

Nominations must specify the advisory 

committee for which the nominee is 

recommended. 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 

related to financial holdings, 

employment, and research grants and/or 

contracts to permit evaluation of 

possible sources of conflicts of interest. 

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: December 7, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27301 Filed 12–12–23; 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 

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 January 29, 2024, for 

vacancies listed in this notice. 

Concurrently, nomination materials for 

prospective candidates should be sent to 

FDA (see ADDRESSES) by January 29, 

2024. Nominations will be accepted for 

current vacancies and for those that will 

or may occur through December 31, 

2023. 

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. 

Prabhakara Atreya, Center for Biologics Evaluation and Research, Food and Drug 

Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1226, Silver Spring, MD 

20993–0002, 240–402–8006, Prabhakara.Altreya@fda.hhs.gov.

Allergenic Products Advisory Committee. 

Moon Hee Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993– 

0002, 301–796–2894, MoonHee.Choi@fda.hhs.gov.

Anesthetic and Analgesic Drug Products Advisory Committee, Non-Prescription Drugs Advisory Committee. 

She-Chia Jankowski, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6178, Silver Spring, MD 

20993–0002, 240–402–5343, She-Chia.Jankowski@fda.hhs.gov.

Antimicrobial Drugs 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.

Peripheral and Central Nervous System 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.

Cardiovascular and Renal Drugs Advisory Committee, 

Medical Imaging Drugs Advisory Committee. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 86339 

TABLE 1—ADVISORY COMMITTEE CONTACTS—Continued 

Contact person Committee/panel 

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.

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.

Pharmacy Compounding 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.

Psychopharmacologic 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; Microbiology 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; Orthopaedic and Rehabilitation 

Devices Panel. 

Jarrod Collier, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1333, Silver Spring, MD 20993– 

0002, 240–672–5763, Jarrod.Collier@fda.hhs.gov.

General Hospital and Personal Use Devices Panel; Hematology and Pathology Devices Panel; Molecular and 

Clinical Genetics Panel; Ophthalmic Devices Panel; 

Radiological 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.

National Mammography Quality Assurance Advisory 

Committee. 

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 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.

1—Voting ............... Immediately. 

Allergenic Products Advisory Committee—Knowledgeable in the fields of allergy, immunology, pediatrics, internal medicine, biochemistry, and related specialties.1—Voting ............... Immediately. 

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. 

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. 

Antimicrobial Drugs Advisory Committee—Knowledgeable in the fields of infectious disease, internal 

medicine, microbiology, pediatrics, epidemiology or 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. 

Cardiovascular and Renal Drugs Advisory Committee—Knowledgeable in the fields of cardiology, 

hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics.

1—Voting ............... Immediately. 

Medical Imaging Drugs Advisory Committee—Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics, and related specialties.1—Voting ............... Immediately. 

Endocrinologic and Metabolic Drugs Advisory Committee—Knowledgeable in the fields of endocrinology, metabolism, epidemiology or statistics, and related specialties.1—Voting ............... Immediately. 

Pharmacy Compounding Advisory Committee—Knowledgeable in the fields of pharmaceutical 

compounding, pharmaceutical manufacturing, pharmacy, medicine, 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. 


khammond on DSKJM1Z7X2PROD with NOTICES
86340 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 

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 

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, and audiologists ............................ 1—Nonvoting ......... Immediately. 

Gastroenterology-Urology Devices Panel—Gastroenterologists, urologists, and nephrologists ........... 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. 

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. 

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. 

Obstetrics and Gynecology Devices Panel—Experts in perinatology, embryology, reproductive endocrinology, pediatric gynecology, gynecological oncology, operative hysteroscopy, pelviscopy, 

electrosurgery, laser surgery, assisted reproductive technologies, contraception, postoperative adhesions, and cervical cancer and colposcopy; biostatisticians and engineers with experience in 

obstetrics/gynecology devices; urogynecologists; experts in breast care; experts in gynecology in 

the older patient; experts in diagnostic (optical) spectroscopy; experts in midwifery; labor and delivery nursing.

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. 

General Hospital and Personal Use Devices Panel—Internists, pediatricians, neonatologists, 

endocrinologists, gerontologists, 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 hemostasis, 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. 

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. 

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. 

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. 

National Mammography Quality Assurance Advisory Committee—Physician, practitioner, or other 

health professional whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography.

3—Voting ............... 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. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 86341 

B. Allergenic Products Advisory 

Committee 

Reviews and evaluates available data 

concerning the safety, effectiveness, and 

adequacy of labeling of marketed and 

investigational allergenic biological 

products or materials that are 

administered to humans for the 

diagnosis, prevention, or treatment of 

allergies and allergic disease and makes 

appropriate recommendations to the 

Commissioner regarding the affirmation 

or revocation of biological product 

licenses; on the safety, effectiveness, 

and labeling of the products; on clinical 

and laboratory studies of such products; 

on amendments or revisions to 

regulations governing the manufacture, 

testing, and licensing of allergenic 

biological products; and on the quality 

and relevance of FDA’s research 

programs. 

C. 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 drug products for use in 

anesthesiology, and makes appropriate 

recommendations to the Commissioner. 

D. 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. 

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. Arthritis Advisory Committee 

Reviews and evaluates data 

concerning the safety and effectiveness 

of marketed and investigational human 

drug products for use in the treatment 

of arthritis, rheumatism, and related 

diseases. 

G. 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. 

H. 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. 

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. 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. 

K. Pharmacy Compounding 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 (FD&C 

Act), and, as required, any other product 

for which FDA has regulatory 

responsibility. 

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. 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 FD&C 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. 

N. National Mammography Quality 

Assurance Advisory Committee 

Advises the Agency on the 

development of appropriate quality 

standards and regulations for 

mammography facilities; standards and 

regulations for bodies accrediting 

mammography facilities under this 

program; regulations with respect to 

sanctions; procedures for monitoring 

compliance with standards; establishing 

a mechanism to investigate consumer 

complaints; and reporting new 

developments concerning breast 

imaging that should be considered in 

the oversight of mammography 

facilities. The Committee also advises 

on determining whether there exists a 

shortage of mammography facilities in 


khammond on DSKJM1Z7X2PROD with NOTICES
86342 Federal Register / Vol. 88, No. 238 / Wednesday, December 13, 2023 / Notices 

rural and health professional shortage 

areas and determining the effects of 

personnel on access to the services of 

such facilities in such areas; 

determining whether there will be a 

sufficient number of medical physicists 

after October 1, 1999; and determining 

the costs and benefits of compliance 

with these requirements. 

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 re ́sume ́. 

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: December 8, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27308 Filed 12–12–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0008] 

Request for Nominations of Individuals 

and Consumer Organizations for the 

Genetic Metabolic Diseases Advisory 

Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

requesting nominations for a voting 

consumer representative to serve on the 

Genetic Metabolic Diseases Advisory 

Committee. FDA is also requesting that 

any consumer organizations interested 

in participating in the selection of a 

voting consumer representative to serve 

on the Genetic Metabolic Diseases 

Advisory Committee notify FDA in 

writing. Nominees recommended to 

serve as a voting consumer 

representative may either be selfnominated or may be nominated by a 

consumer organization. Nominations 

will be accepted for the current vacancy 

effective with this notice. FDA seeks to 

include the views of members of all 

gender groups, members of all racial and 

ethnic groups, and individuals with and 

without disabilities on its advisory 

committees and, therefore, encourages 

nominations of appropriately qualified 

candidates from these groups. 

DATES: Any consumer organization 

interested in participating in the 

selection of an appropriate voting 

member to represent consumer interests 

on the Genetic Metabolic Diseases 

Advisory Committee may send a letter 

or email stating that interest to FDA (see 

ADDRESSES) by February 12, 2024 for 

vacancy listed in this notice. 

Concurrently, nomination materials for 

prospective candidates should be sent to 

FDA (see ADDRESSES) by February 12, 

2024. Nominations will be accepted for 

current vacancy. 

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 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 


khammond on DSKJM1Z7X2PROD with NOTICES