[Federal Register Volume 87, Number 126 (Friday, July 1, 2022)]
[Notices]
[Pages 39526-39531]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14135]


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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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting 
that any consumer organizations interested in participating in the 
selection of voting and/or nonvoting consumer representatives to serve 
on its advisory committees or panels notify FDA in writing. FDA is also 
requesting nominations for voting and/or nonvoting consumer 
representatives to serve on advisory

[[Page 39527]]

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 August 
15, 2022, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA (see 
ADDRESSES) by August 15, 2022. 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 [email protected] 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, [email protected].
    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      FDA Science Board Advisory
 Scientist, Food and Drug Administration,     Committee.
 10903 New Hampshire Ave., Bldg. 1, Rm.
 3309, Silver Spring, MD 20993-0002, 301-
 796-4769, [email protected].
Prabhakara Atreya, Center for Biologics      Allergenics Products
 Evaluation and Research, Food and Drug       Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 71, Rm. 1226, Silver Spring, MD
 20993-0002, 240-402-8006,
 [email protected].
Moon Hee Choi, Center for Drugs Evaluation   Anesthetic and Analgesic
 and Research, Food and Drug                  Drug Advisory Committee,
 Administration, 10903 New Hampshire Ave.,    Non-Prescription Drugs
 Bldg. 31, Rm. 2434, Silver Spring, MD        Advisory Committee.
 20993-0002, 301-796-2894,
 [email protected].
She-Chia Chen, Center for Dugs Evaluation    Antimicrobial Drugs
 and Research, Food and Drug                  Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 31 Rm. 2438, Silver Spring, MD 20993-
 0002, 240-402-5343, [email protected].
Jessica Seo, Center for Drugs Evaluation     Arthritis Drugs Advisory
 and Research, Food and Drug                  Committee, Peripheral and
 Administration, 10903 New Hampshire Ave.,    Central Nervous System
 Bldg. 31, Rm. 2412, Silver Spring, MD        Drugs Advisory Committee.
 20993-0002, 301-796-7699,
 [email protected].
Joyce Yu, Center for Drugs Evaluation        Cardiovascular Drugs
 Research, Food and Drug Administration,      Advisory Committee,
 10903 New Hampshire Ave., Bldg. 31, Rm.      Medical Imaging Drugs
 2438, Silver Spring, MD 20993-0002, 301-     Advisory Committee.
 837-7126, [email protected].
LaToya Bonner, Center for Drugs Evaluation   Endocrinologic and
 and Research, Food and Drug                  Metabolic Drugs Advisory
 Administration, 10903 New Hampshire Ave.,    Committee.
 Bldg. 31, Rm. 2428, Silver Spring, MD
 20993-0002, 301-796-2855,
 [email protected].
Takyiah Stevenson, Center for Drugs          Pharmacy Compounding Drugs
 Evaluation Research, Food and Drug           Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 31, Rm. 2406, Silver Spring, MD
 20993-0002, 240-402-2507,
 [email protected].
Joyce Frimpong, Center for Drugs Evaluation  Psychopharmacologic Drugs
 and Research, Food and Drug                  Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 31, Rm. 2462, Silver Spring, MD
 20993-0002, 301-796-7973,
 [email protected].
Candace Nalls, Center for Devices and        Anesthesiology and
 Radiological Health, Food and Drug           Respiratory Therapy
 Administration, 10903 New Hampshire Ave.,    Devices Panel, Clinical
 Bldg. 66, Rm. 5211, Silver Spring, MD        Chemistry and Clinical
 20993-0002, 301-636-0510,                    Toxicology Devices Panel,
 [email protected].                   Ear, Nose and Throat
                                              Devices Panel,
                                              Gastroenterology and
                                              Urology Devices Panel,
                                              General and Plastic
                                              Surgery Devices Panel.
James Swink, Center for Devices and          Circulatory System Devices
 Radiological Health, Food and Drug           Panel, Immunology Devices
 Administration, 10903 New Hampshire Ave.,    Panel, Microbiology
 Bldg. 66, Rm. 5211, Silver Spring, MD        Devices Panel.
 20993-0002, 301-796-6313,
 [email protected].
Akinola Awojope, Center for Devices and      Dental Products Devices
 Radiological Health, Food and Drug           Panel, Obstetrics and
 Administration, 10903 New Hampshire Ave.,    Gynecology Devices Panel,
 Bldg. 66, Rm. 5216, Silver Spring, MD        Orthopaedic and
 20993-0002, 301-636-0512,                    Rehabilitation Devices
 [email protected].                 Panel.
Jarrod Collier, Center for Devices and       General Hospital and
 Radiological Health, Food and Drug           Personal Use Devices
 Administration, 10903 New Hampshire Ave.,    Panel, Hematology and
 Bldg. 66, Rm. 5211, Silver Spring, MD        Pathology Devices Panel,
 20993-0002, 240-672-5763,                    Molecular and Clinical
 [email protected].                  Genetics Devices Panel,
                                              Ophthalmic Devices Panel,
                                              Radiology Devices Panel.

[[Page 39528]]

 
James Swink, Center for Devices and          National Mammography
 Radiological Health, Food and Drug           Quality Assurance Advisory
 Administration, 10903 New Hampshire Ave.,    Committee.
 Bldg. 66, Rm. 5211, Silver Spring, MD
 20993-0002, 301-796-6313,
 [email protected].
------------------------------------------------------------------------


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                           Approximate date
         expertise needed            Type of vacancy         needed
------------------------------------------------------------------------
FDA Science Board Advisory         1--Voting.........  Immediately.
 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.
Allergenics Products Advisory      1--Voting.........  Immediately.
 Committee--Knowledgeable in the
 fields of allergy, immunology,
 pediatrics, internal medicine,
 biochemistry, and related
 specialties.
Anesthetic and Analgesic Drug      1--Voting.........  April 1, 2023.
 Products Advisory Committee--
 Knowledgeable in the fields of
 anesthesiology, surgery,
 epidemiology or statistics, and
 related specialties.
Non-Prescription Drugs Advisory    1--Voting.........  Immediately.
 Committee--Knowledgeable in the
 fields of internal medicine,
 family practice, clinical
 toxicology, clinical
 pharmacology, pharmacy,
 dentistry, and related
 specialties.
Antimicrobial Drugs Advisory       1--Voting.........  May 1, 2023.
 Committee--Knowledgeable in the
 fields of infectious disease,
 internal medicine, microbiology,
 pediatrics, epidemiology or
 statistics, and related
 specialties.
Arthritis Drugs Advisory           1--Voting.........  December 1, 2023.
 Committee--Knowledgeable in the
 fields of arthritis,
 rheumatology, orthopedics,
 epidemiology or statistics,
 analgesics, and related
 specialties.
Peripheral and Central Nervous     1--Voting.........  February 1, 2023.
 Systems Drugs Advisory
 Committee--Knowledgeable in the
 fields of neurology,
 neuropharmacology,
 neuropathology, otolaryngology,
 epidemiology or statistics, and
 related specialties.
Cardiovascular Drugs Advisory      1--Voting.........  July 1, 2023.
 Committee--Knowledgeable in the
 fields of cardiology,
 hypertension, arrhythmia,
 angina, congestive heart
 failure, diuresis, and
 biostatistics.
Medical Imaging Drugs Advisory     1--Voting.........  Immediately.
 Committee--Knowledgeable in the
 fields of nuclear medicine,
 radiology, epidemiology,
 statistics, and related
 specialties.
Endocrinologic and Metabolic       1--Voting.........  July 1, 2022.
 Drugs Advisory Committee--
 Knowledgeable in the fields of
 endocrinology, metabolism,
 epidemiology or statistics, and
 related specialties.
Pharmacy Compounding Drugs         1--Voting.........  October 1, 2023.
 Advisory Committee--
 Knowledgeable in the fields of
 pharmaceutical compounding,
 pharmaceutical manufacturing,
 pharmacy, medicine, and other
 related specialties.
Psychopharmacologic Drugs          1--Voting.........  July 1, 2022.
 Advisory Committee--
 Knowledgeable in the fields of
 psychopharmacology, psychiatry,
 epidemiology or statistics, and
 related specialties.
Anesthesiology and Respiratory     1--Nonvoting......  Immediately.
 Therapy Devices Panel--
 Anesthesiologists, pulmonary
 medicine specialists, or other
 experts who have specialized
 interests in ventilator support,
 pharmacology, physiology, or the
 effects and complications of
 anesthesia.
Clinical Chemistry and Clinical    1--Nonvoting......  Immediately.
 Toxicology Devices Panel--Doctor
 of Medicine or Philosophy with
 experience in clinical chemistry
 (e.g., cardiac markers),
 clinical toxicology, clinical
 pathology, clinical laboratory
 medicine, and endocrinology.
Ear, Nose and Throat Devices       1--Nonvoting......  November 1, 2023.
 Panel--Otologists,
 neurotologists, audiologists.
Gastroenterology and Urology       1--Nonvoting......  Immediately.
 Devices Panel--
 Gastroenterologists, urologists,
 and nephrologists.
General and Plastic Surgery        1--Nonvoting......  Immediately.
 Devices Panel--Surgeons
 (general, plastic,
 reconstructive, pediatric,
 thoracic, abdominal, pelvic and
 endoscopic); dermatologists;
 experts in biomaterials, lasers,
 wound healing, and quality of
 life; and biostatisticians.
Circulatory System Devices Panel-- 1--Nonvoting......  Immediately.
 Interventional cardiologists,
 electrophysiologists, invasive
 (vascular) radiologists,
 vascular and cardiothoracic
 surgeons, and cardiologists with
 special interest in congestive
 heart failure.

[[Page 39529]]

 
Immunology Devices Panel--Persons  1--Nonvoting......  Immediately.
 with experience in medical,
 surgical, or clinical oncology,
 internal medicine, clinical
 immunology, allergy, molecular
 diagnostics, or clinical
 laboratory medicine.
Microbiology Devices Panel--       1--Nonvoting......  Immediately.
 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.
Dental Products Devices Panel--    1--Nonvoting......  Immediately.
 Dentists, engineers and
 scientists who have expertise in
 the areas of dental implants,
 dental materials,
 periodontology, tissue
 engineering, and dental anatomy.
Obstetrics and Gynecology Devices  1--Nonvoting......  Immediately.
 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.
Orthopaedic and Rehabilitation     1--Nonvoting......  Immediately.
 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.
General Hospital and Personal Use  1--Nonvoting......  Immediately.
 Devices Panel--Internists,
 pediatricians, neonatologists,
 endocrinologists,
 gerontologists, nurses,
 biomedical engineers, or
 microbiologists/infection
 control practitioners or experts.
Hematology and Pathology Devices   1--Nonvoting......  Immediately.
 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.
Molecular and Clinical Genetics    1--Nonvoting......  Immediately.
 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.
Ophthalmic Devices Panel--         1--Nonvoting......  Immediately.
 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.
Radiological Devices Panel--       1--Nonvoting......  Immediately.
 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.
National Mammography Quality       3--Voting.........  Immediately.
 Assurance Advisory Committee--
 Physician, practitioner, or
 other health professional whose
 clinical practice, research
 specialization, or professional
 expertise includes a significant
 focus on mammography.
------------------------------------------------------------------------

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. Allergenics Drugs 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, as well as the affirmation or revocation of 
biological product licenses, on the safety, effectiveness, and labeling 
of the

[[Page 39530]]

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 Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in anesthesiology and surgery.

D. Nonprescription Drugs Advisory Committee

    Review and evaluate 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 advise 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 will serve 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 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 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 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

    Provides advice on scientific, technical, and medical issues 
concerning drug compounding by pharmacists and licensed practitioners.

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 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. 
Except for 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 Dental Products Devices Panel also functions at times as a 
dental drug panel. The functions of the dental drug panel are to 
evaluate and recommend whether various prescription drug products 
should be changed to over-the-counter status and to evaluate data and 
make recommendations concerning the approval of new dental drug 
products for human use.
    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

    Advise the Agency on the following: 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 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 exist enough 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

[[Page 39531]]

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 
r[eacute]sum[eacute]. 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 r[eacute]sum[eacute] 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 section of this document), 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 
self-nominated. FDA will ask potential candidates to provide detailed 
information concerning such matters as financial holdings, employment, 
and research grants and/or contracts to permit evaluation of possible 
sources of conflicts of interest. Members will be invited to serve for 
terms of up to 4 years.
    FDA will review all nominations received within the specified 
timeframes and prepare a ballot containing the names of qualified 
nominees. Names 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: June 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14135 Filed 6-30-22; 8:45 am]
BILLING CODE 4164-01-P


