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Notice2022-14135

Request for Nominations for Individuals and Consumer Organizations for Advisory Committees

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Published

July 1, 2022

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committee regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups.

Full Text

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[Federal Register Volume 87, Number 126 (Friday, July 1, 2022)]
[Notices]
[Pages 39526-39531]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.

-----------------------------------------------------------------------

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 <a href="/cdn-cgi/l/email-protection#bdfcfef2f0eeeec8dfd0d4ceced4d2d3cefddbd9dc93d5d5ce93dad2cb">[email&#160;protected]</a> 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: <a href="https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm">https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm</a>, 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 <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.

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, <a href="/cdn-cgi/l/email-protection#490220242b2c3b25306701282420253d2627092f2d286721213a672e263f">[email&#160;protected]</a>.
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, <a href="/cdn-cgi/l/email-protection#93c1f2f8f6e0fbbdc1f2f4fbe6e4f2fde0fbfad3f5f7f2bdfbfbe0bdf4fce5">[email&#160;protected]</a>.
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,
<a href="/cdn-cgi/l/email-protection#76260417141e171d17041758370204130f1736101217581e1e0558111900">[email&#160;protected]</a>.
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,
<a href="/cdn-cgi/l/email-protection#84c9ebebeacce1e1aac7ecebedc4e2e0e5aaececf7aae3ebf2">[email&#160;protected]</a>.
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, <a href="/cdn-cgi/l/email-protection#8edde6eba3cde6e7efa0cde6ebe0cee8eaefa0e6e6fda0e9e1f8">[email&#160;protected]</a>.
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,
<a href="/cdn-cgi/l/email-protection#c983acbabaa0aaa8e79aaca689afada8e7a1a1bae7aea6bf">[email&#160;protected]</a>.
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, <a href="/cdn-cgi/l/email-protection#a8e2c7d1cbcd86f1dde8ceccc986c0c0db86cfc7de">[email&#160;protected]</a>.
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,
<a href="/cdn-cgi/l/email-protection#b1fdd0e5dec8d09ff3dedfdfd4c3f1d7d5d09fd9d9c29fd6dec7">[email&#160;protected]</a>.
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,
<a href="/cdn-cgi/l/email-protection#90c4f1fbe9f9f1f8bec3e4f5e6f5fee3fffed0f6f4f1bef8f8e3bef7ffe6">[email&#160;protected]</a>.
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,
<a href="/cdn-cgi/l/email-protection#e5af8a9c8680cba3978c88958a8b82a5838184cb8d8d96cb828a93">[email&#160;protected]</a>.
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,
<a href="/cdn-cgi/l/email-protection#a6e5c7c8c2c7c5c388e8c7cacad5e6c0c2c788ceced588c1c9d0">[email&#160;protected]</a>. 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,
<a href="/cdn-cgi/l/email-protection#7d371c10180e532e0a1413163d1b191c5315150e531a120b">[email&#160;protected]</a>.
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
<a href="/cdn-cgi/l/email-protection#92d3f9fbfcfdfef3bcd3e5fdf8fde2f7d2f4f6f3bcfafae1bcf5fde4">[email&#160;protected]</a>. 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
<a href="/cdn-cgi/l/email-protection#a4eec5d6d6cbc08ae7cbc8c8cdc1d6e4c2c0c58accccd78ac3cbd2">[email&#160;protected]</a>. 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,
<a href="/cdn-cgi/l/email-protection#fab09b979f89d4a98d939491ba9c9e9bd4929289d49d958c">[email&#160;protected]</a>.
------------------------------------------------------------------------

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

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