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Notice2021-17066

Request for Nominations for Individuals and Consumer Organizations for Advisory Committees

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Published

August 11, 2021

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 women and men, 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.

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<title>Federal Register, Volume 86 Issue 152 (Wednesday, August 11, 2021)</title>
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[Federal Register Volume 86, Number 152 (Wednesday, August 11, 2021)]
[Notices]
[Pages 44024-44028]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-17066]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-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 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 women and men, 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 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
September 27, 2021, for vacancies listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
(see ADDRESSES) by September 27, 2021. Nominations will be accepted for
current vacancies and for those that will or may occur through December
31, 2021.

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#79383a36342a2a0c1b14100a0a1016170a391f1d185711110a571e160f">[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#b7dcdedad5d2c5dbce99dfd6dadedbc3d8d9f7d1d3d699dfdfc499d0d8c1">[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#a8fac9c3cddbc086fac9cfc0dddfc9c6dbc0c1e8ceccc986c0c0db86cfc7de">[email&#160;protected]</a>.
Christina Vert, Center for Biologics Blood Products Advisory
Evaluation and Research, Food and Drug Committee.
Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 6268, Silver Spring, MD
20993-0002, 240-402-8054,
<a href="/cdn-cgi/l/email-protection#74371c061d07001d1a155a22110600341210155a1c1c075a131b02">[email&#160;protected]</a>.
Jarrod Collier, Center for Biologics Cellular, Tissue and Gene
Evaluation and Research, Food and Drug Therapies Advisory
Administration, 10903 New Hampshire Ave., Committee.
Bldg. 71, Silver Spring, MD 20993-0002,
202-906-0043, <a href="/cdn-cgi/l/email-protection#89c3e8fbfbe6eda7cae6e5e5e0ecfbc9efede8a7e1e1faa7eee6ff">[email&#160;protected]</a>.

[[Page 44025]]

Kathleen Hayes, Center for Biologics Allergenics Products
Evaluation and Research, Food and Drug Advisory Committee,
Administration, 10903 New Hampshire Ave., Vaccines and Related
Bldg. 71, Rm. 6307C, Silver Spring, MD Biological Products
20993-0002, 301-796-7864, Advisory Committee.
<a href="/cdn-cgi/l/email-protection#81cae0f5e9ede4e4efafc9e0f8e4f2c1e7e5e0afe9e9f2afe6eef7">[email&#160;protected]</a>.
Yvette Waples, Center for Drugs Evaluation Gastrointestinal Drugs
and Research, Food and Drug Advisory Committee,
Administration, 10903 New Hampshire Ave., Pharmaceutical Science and
Bldg. 31, Rm. 2510, Silver Spring, MD Clinical Pharmacology
20993-0002, 301-796-9034, Advisory Committee,
<a href="/cdn-cgi/l/email-protection#b2ebc4d7c6c6d79ce5d3c2ded7c1f2d4d6d39cdadac19cd5ddc4">[email&#160;protected]</a>. Psychopharmacologic Drugs
Advisory Committee.
James Swink, Center for Devices and Anesthesiology and
Radiological Health, Food and Drug Respiratory Therapy Devices
Administration, 10903 New Hampshire Ave., Panel, Circulatory Systems
Bldg. 66, Rm. 5211, Silver Spring, MD Devices Panel, Dental
20993-0002, 301-796-6313, Products Devices Panel,
<a href="/cdn-cgi/l/email-protection#6e240f030b1d403d190700052e080a0f4006061d40090118">[email&#160;protected]</a>. General Hospital and
Personal Use Devices Panel,
Hematology and Pathology
Devices Panel, Radiological
Devices Panel.
Patricio Garcia, Center for Devices and Clinical Chemistry and
Radiological Health, Food and Drug Clinical Toxicology Devices
Administration, 10903 New Hampshire Ave., Panel, Gastroenterology and
Bldg. 66, Rm. 5216, Silver Spring, MD Urology Devices Panel,
20993-0002, 301-796-6875, General and Plastic Surgery
<a href="/cdn-cgi/l/email-protection#90c0f1e4e2f9f3f9ffbed7f1e2f3f9f1d0f6f4f1bef8f8e3bef7ffe6">[email&#160;protected]</a>. Devices Panel, Obstetrics
and Gynecology Devices
Panel.
Aden Asefa, Center for Devices and Immunology Devices Panel,
Radiological Health, Food and Drug Microbiology Devices Panel,
Administration, 10903 New Hampshire Ave., Molecular and Clinical
Bldg. 66, Rm. 5214, Silver Spring, MD Genetics Devices Panel,
20993-0002, 301-796-0400, Neurological Devices Panel.
<a href="/cdn-cgi/l/email-protection#f1b095949fdfb082949790b1979590df999982df969e87">[email&#160;protected]</a>.
Aden Asefa, Center for Devices and National Mammography Quality
Radiological Health, Food and Drug Assurance Advisory
Administration, 10903 New Hampshire Ave., Committee.
Bldg. 66, Rm. 5214, Silver Spring, MD
20993-0002, 301-796-0400,
<a href="/cdn-cgi/l/email-protection#98d9fcfdf6b6d9ebfdfef9d8fefcf9b6f0f0ebb6fff7ee">[email&#160;protected]</a>.
Letise Williams, Center for Devices and Patient Engagement Advisory
Radiological Health, Food and Drug Committee.
Administration, 10903 New Hampshire Ave.,
Bldg. 66, Rm. 5407, Silver Spring, MD
20993-0002, 301-796-8398,
<a href="/cdn-cgi/l/email-protection#18547d6c716b7d364f7174747179756b587e7c793670706b367f776e">[email&#160;protected]</a>.
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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 1--Voting.................... Immediately.
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.
Blood Products Advisory Committee-- 1--Voting.................... October 1, 2021.
Knowledgeable in the fields of clinical and
administrative medicine, hematology,
immunology, blood banking, surgery,
internal medicine, biochemistry,
engineering, biological and physical
sciences, biotechnology, computer
technology, statistics, epidemiology,
sociology/ethics, and other related
professions.
Cellular, Tissue and Gene Therapies Advisory 1--Voting.................... Immediately.
Committee--Knowledgeable in the fields of
cellular therapies, tissue transplantation,
gene transfer therapies and
xenotransplantation (biostatistics,
bioethics, hematology/oncology, human
tissues and transplantation, reproductive
medicine, general medicine, and various
medical specialties, including surgery and
oncology, immunology, virology, molecular
biology, cell biology, developmental
biology, tumor biology, biochemistry, rDNA
technology, nuclear medicine, gene therapy,
infectious diseases, and cellular
kinetics).
Allergenics Products Advisory Committee-- 1--Voting.................... September 1, 2021.
Knowledgeable in the fields of allergy,
immunology, pediatrics, internal medicine,
biochemistry, and related specialties.
Vaccines and Related Biologic Advisory 1--Voting.................... Immediately.
Committee--Knowledgeable in the fields of
immunology, molecular biology, rDNA,
virology, bacteriology, epidemiology or
biostatistics, allergy, preventive
medicine, infectious diseases, pediatrics,
microbiology, and biochemistry.
Gastrointestinal Drugs Advisory Committee-- 1--Voting.................... July 1, 2021.
Knowledgeable in the fields of
gastroenterology, endocrinology, surgery,
clinical pharmacology, physiology,
pathology, liver function, motility,
esophagitis, and statistics.
Pharmaceutical Science and Clinical 1--Voting.................... November 1, 2021.
Pharmacology Advisory Committee--
Knowledgeable in the fields of
pharmaceutical manufacturing, clinical
pharmacology, pharmacokinetics,
bioavailability and bioequivalence
research, the design and evaluation of
clinical trials, laboratory analytical
techniques, pharmaceutical chemistry,
physiochemistry, biochemistry,
biostatistics, and related biomedical and
pharmacological specialties.

[[Page 44026]]

Psychopharmacologic Drugs Advisory 1--Voting.................... Immediately.
Committee--Knowledgeable in the fields of
psychopharmacology, psychiatry,
epidemiology or statistics, and related
specialties.
Anesthesiology and Respiratory Therapy 1--Nonvoting................. December 1, 2021.
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.
Circulatory Systems Devices Panel-- 1--Nonvoting................. Immediately.
Interventional cardiologists,
electrophysiologists, invasive (vascular)
radiologists, vascular and cardiothoracic
surgeons, and cardiologists with special
interest in congestive heart failure.
Dental Products Devices Panel--Dentists, 1--Nonvoting................. Immediately.
engineers, and scientists who have
expertise in the areas of dental implants,
dental materials, periodontology, tissue
engineering, and dental anatomy.
General Hospital and Personal Use Devices 1--Nonvoting................. Immediately.
Panel--Internists, pediatricians,
neonatologists, endocrinologists,
gerontologists, nurses, biomedical
engineers, or microbiologists/infection
control practitioners or experts.
Hematology and Pathology Devices Panel-- 1--Nonvoting................. Immediately.
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.
Radiological Devices Panel--Physicians with 1--Nonvoting................. Immediately.
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.
Clinical Chemistry and Clinical Toxicology 1--Nonvoting................. Immediately.
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.
Gastroenterology and Urology Devices Panel-- 1--Nonvoting................. Immediately.
Gastroenterologists, urologists, and
nephrologists.
General and Plastic Surgery Devices Panel-- 1--Nonvoting................. Immediately.
Surgeons (general, plastic, reconstructive,
pediatric, thoracic, abdominal, pelvic, and
endoscopic); dermatologists; experts in
biomaterials, lasers, wound healing, and
quality of life; and biostatisticians.
Obstetrics and Gynecology Devices Panel-- 1--Nonvoting................. Immediately.
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.
Immunology Devices Panel--Persons with 1--Nonvoting................. Immediately.
experience in medical, surgical, or
clinical oncology, internal medicine,
clinical immunology, allergy, molecular
diagnostics, or clinical laboratory
medicine.
Microbiology Devices Panel--Clinicians with 1--Nonvoting................. Immediately.
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.
Molecular and Clinical Genetics Devices 1--Nonvoting................. Immediately.
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.
Neurological Devices Panel--Neurosurgeons 1--Nonvoting................. December 1, 2021.
(cerebrovascular and pediatric),
neurologists (stroke, pediatric, pain
management, and movement disorders),
interventional neuroradiologists,
psychiatrists, and biostatisticians.
National Mammography Quality Assurance 4--Voting.................... Immediately.
Advisory Committee--Physician,
practitioner, or other health professional
whose clinical practice, research
specialization, or professional expertise
includes a significant focus on
mammography.
Patient Engagement Advisory Committee-- 1--Voting.................... Immediately.
Experts who are knowledgeable in areas such
as clinical research, primary care patient
experience, and healthcare needs of patient
groups in the United States. Selected
Committee members may also be experienced
in the work of patient and health
professional organizations; methodologies
for eliciting patient preferences; and
strategies for communicating benefits,
risks, and clinical outcomes to patients
and research subjects.
----------------------------------------------------------------------------------------------------------------

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

[[Page 44027]]

Agency-sponsored intramural and extramural scientific research
programs.

B. Blood Products Advisory Committee

The Blood Products Advisory Committee reviews and evaluates
available data concerning the safety, effectiveness, and appropriate
use of blood products derived from blood and serum or biotechnology.
The Committee reviews and evaluates these products or biotechnology
which are also intended for use in the diagnosis, prevention, or
treatment of human diseases, as well as the safety, effectiveness, and
labeling of the products, on clinical and laboratory studies involving
such products, on the affirmation or revocation of biological product
licenses. The Committee also reviews and evaluates the quality and
relevance of FDA's research program that provides the scientific
support for regulating these products.

C. Cellular, Tissue, and Gene Therapies Advisory Committee

The Cellular, Tissue, and Gene Therapies Advisory Committee reviews
and evaluates available data relating to the safety, effectiveness, and
appropriate use of human cells, human tissues, gene transfer therapies
and xenotransplantation products that are intended for transplantation,
implantation, infusion and transfer in the prevention and treatment of
a broad spectrum of human diseases, and in the reconstruction, repair,
or replacement of tissues for various conditions. The Committee also
considers the quality and relevance of FDA's research program that
provides scientific support for the regulation of these products.

D. Allergenics 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 as well as 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.

E. Vaccines and Related Biologic Products Advisory Committee

The Vaccines and Related Biologic Products Advisory Committee
reviews and evaluates data concerning the safety, effectiveness, and
appropriate use of vaccines and related biological products that are
intended for use in the prevention, treatment, or diagnosis of human
diseases, as well as considers the quality and relevance of FDA's
research program that provides scientific support for the regulation of
these products.

F. Gastrointestinal Drugs Advisory Committee

The Gastrointestinal Drugs Advisory Committee reviews and evaluates
available data concerning the safety and effectiveness of marketed and
investigational human drug products for use in the treatment of
gastrointestinal diseases.

G. Pharmaceutical Science and Clinical Pharmacology Advisory Committee

The Pharmaceutical Science and Clinical Pharmacology Advisory
Committee provides advice on scientific and technical issues concerning
the safety and effectiveness of human generic drug products for use in
the treatment of a broad spectrum of human diseases and as required,
any other product for which FDA has regulatory responsibility. The
Committee may also review Agency-sponsored intramural and extramural
biomedical research programs in support of FDA's generic drug
regulatory responsibilities.

H. Psychopharmacologic Drugs Advisory Committee

The Psychopharmacologic Drugs Advisory Committee reviews and
evaluates data concerning the safety and effectiveness of marketed and
investigational human products for use in the practice of psychiatry
and related fields.

I. Certain Panels of the Medical Devices Advisory Committee

The Medical Devices Advisory Committee has established certain
panels to review and evaluate data on the safety and effectiveness of
marketed and investigational devices and make recommendations for their
regulation. With the exception of the Medical Devices Dispute
Resolution Panel, each panel, according to its specialty area: (1)
Advises on the classification or reclassification of devices into one
of three regulatory categories and advises on any possible risks to
health associated with the use of devices; (2) advises on formulation
of product development protocols; (3) reviews premarket approval
applications for medical devices; (4) reviews guidelines and guidance
documents; (5) recommends exemption of certain devices from the
application of portions of the Federal Food, Drug, and Cosmetic Act;
(6) advises on the necessity to ban a device; and (7) responds to
requests from the Agency to review and make recommendations on specific
issues or problems concerning the safety and effectiveness of devices.
With the exception of the Medical Devices Dispute Resolution Panel,
each panel, according to its specialty area, may also make appropriate
recommendations to the Commissioner on issues relating to the design of
clinical studies regarding the safety and effectiveness of marketed and
investigational devices.
The Dental Products 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.

J. National Mammography Quality Assurance Advisory Committee

The National Mammography Quality Assurance Advisory Committee
advises 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 the Agency 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 exist a sufficient number of

[[Page 44028]]

medical physicists; and determining the costs and benefits of
compliance with these requirements.

K. Patient Engagement Advisory Committee

The Patient Engagement Advisory Committee advises the Agency on
complex issues relating to medical devices, the regulation of devices,
and their use by patients. The Committee may consider topics such as
Agency guidance and policies, clinical trial or registry design,
patient preference study design, benefit-risk determinations, device
labeling, unmet clinical needs, available alternatives, patient
reported outcomes and device-related quality of life or health status
issues, and other patient-related topics. The Committee will provide
relevant skills and perspectives to improve communication of benefits,
risks, and clinical outcomes and increase integration of patient
perspectives into the regulatory process for medical devices. The
Committee will perform its duties by discussing and providing advice
and recommendation in ways such as identifying new approaches,
promoting innovation, recognizing unforeseen risks or barriers, and
identifying unintended consequences that could result from FDA policy.

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 30 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), 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.
Upon 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: August 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-17066 Filed 8-10-21; 8:45 am]
BILLING CODE 4164-01-P

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