Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 44024-44028 [2021-17066]
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44024
Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Annual
responses per
respondent
Average
burden hours
per response
Annual
burden hours
COVID–19 Verbal Screening and Temperature Check ..................................
15,000
260
.033
128,700
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 6 U.S.C. 279.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2021–17255 Filed 8–9–21; 4:15 pm]
BILLING CODE 4184–45–P
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.
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.
SUMMARY:
All statements of interest
from consumer organizations interested
in participating in the selection process
should be submitted electronically to
ACOMSSubmissions@fda.hhs.gov or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5122, Silver Spring,
MD 20993–0002.
Consumer representative nominations
should be submitted electronically by
logging into the FDA Advisory
Committee Membership Nomination
Portal: https://www.accessdata.fda.gov/
scripts/FACTRSPortal/FACTRS/
index.cfm, or by mail to Advisory
Committee Oversight and Management
Staff, 10903 New Hampshire Ave., Bldg.
32, Rm. 5122, Silver Spring, MD 20993–
0002. Additional information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
ADDRESSES:
For
questions relating to participation in the
selection process: Kimberly Hamilton,
Advisory Committee Oversight and
Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5122, Silver Spring,
MD 20993–0002, 301–796–8220,
kimberly.hamilton@fda.hhs.gov.
For questions relating to specific
advisory committees or panels, contact
the appropriate Contact Person listed in
table 1.
FOR FURTHER INFORMATION CONTACT:
TABLE 1—ADVISORY COMMITTEE CONTACTS
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Contact person
Committee/panel
Rakesh Raghuwanshi, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver
Spring, MD 20993–0002, 301–796–4769, Rakesh.Raghuwanshi@
fda.hhs.gov.
Christina Vert, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
6268, Silver Spring, MD 20993–0002, 240–402–8054,
Christina.Vert@fda.hhs.gov.
Jarrod Collier, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver
Spring, MD 20993–0002, 202–906–0043, Jarrod.Collier@
fda.hhs.gov.
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FDA Science Board Advisory Committee.
Blood Products Advisory Committee.
Cellular, Tissue and Gene Therapies Advisory Committee.
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TABLE 1—ADVISORY COMMITTEE CONTACTS—Continued
Contact person
Committee/panel
Kathleen Hayes, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
6307C, Silver Spring, MD 20993–0002, 301–796–7864,
Kathleen.Hayes@fda.hhs.gov.
Yvette Waples, Center for Drugs Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm.
2510, Silver Spring, MD 20993–0002, 301–796–9034,
Yvette.Waples@fda.hhs.gov.
James Swink, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5211, Silver Spring, MD 20993–0002, 301–796–6313,
James.Swink@fda.hhs.gov.
Patricio Garcia, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5216, Silver Spring, MD 20993–0002, 301–796–6875,
Patricio.Garcia@fda.hhs.gov.
Aden Asefa, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5214, Silver Spring, MD 20993–0002, 301–796–0400, Aden.Asefa@
fda.hhs.gov.
Aden Asefa, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5214, Silver Spring, MD 20993–0002, 301–796–0400, Aden.Asefa@
fda.hhs.gov.
Letise Williams, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5407, Silver Spring, MD 20993–0002, 301–796–8398,
Letise.Williams@fda.hhs.gov.
FDA is
requesting nominations for voting and/
SUPPLEMENTARY INFORMATION:
Allergenics Products Advisory Committee, Vaccines and Related Biological Products Advisory Committee.
Gastrointestinal Drugs Advisory Committee, Pharmaceutical Science
and Clinical Pharmacology Advisory Committee,
Psychopharmacologic Drugs Advisory Committee.
Anesthesiology and Respiratory Therapy Devices Panel, Circulatory
Systems Devices Panel, Dental Products Devices Panel, General
Hospital and Personal Use Devices Panel, Hematology and Pathology Devices Panel, Radiological Devices Panel.
Clinical Chemistry and Clinical Toxicology Devices Panel, Gastroenterology and Urology Devices Panel, General and Plastic Surgery
Devices Panel, Obstetrics and Gynecology Devices Panel.
Immunology Devices Panel, Microbiology Devices Panel, Molecular
and Clinical Genetics Devices Panel, Neurological Devices Panel.
National Mammography Quality Assurance Advisory Committee.
Patient Engagement Advisory Committee.
or nonvoting consumer representatives
for the vacancies listed in table 2:
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TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED
Committee/panel/areas of expertise needed
Type of
vacancy
FDA Science Board Advisory Committee—The Science Board provides advice to the Commissioner of
Food and Drugs (Commissioner) and other appropriate officials on specific complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice that supports the Agency in keeping pace with
technical and scientific developments, including in regulatory science; and input into the Agency’s research agenda, and on upgrading its scientific and research facilities and training opportunities. It also
provides, where requested, expert review of Agency-sponsored intramural and extramural scientific research programs.
Blood Products Advisory Committee—Knowledgeable in the fields of clinical and administrative medicine,
hematology, immunology, blood banking, surgery, internal medicine, biochemistry, engineering, biological and physical sciences, biotechnology, computer technology, statistics, epidemiology, sociology/ethics, and other related professions.
Cellular, Tissue and Gene Therapies Advisory 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—Knowledgeable in the fields of allergy, immunology, pediatrics, internal medicine, biochemistry, and related specialties.
Vaccines and Related Biologic Advisory Committee—Knowledgeable in the fields of immunology, molecular biology, rDNA, virology, bacteriology, epidemiology or biostatistics, allergy, preventive medicine,
infectious diseases, pediatrics, microbiology, and biochemistry.
Gastrointestinal Drugs Advisory Committee—Knowledgeable in the fields of gastroenterology, endocrinology, surgery, clinical pharmacology, physiology, pathology, liver function, motility, esophagitis, and
statistics.
Pharmaceutical Science and Clinical 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.
1—Voting .......
Immediately.
1—Voting .......
October 1, 2021.
1—Voting .......
Immediately.
1—Voting .......
September 1, 2021.
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Immediately.
1—Voting .......
July 1, 2021.
1—Voting .......
November 1, 2021.
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TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED—Continued
Committee/panel/areas of expertise needed
Type of
vacancy
Psychopharmacologic Drugs Advisory Committee—Knowledgeable in the fields of psychopharmacology,
psychiatry, epidemiology or statistics, and related specialties.
Anesthesiology and Respiratory Therapy Devices Panel—Anesthesiologists, pulmonary medicine specialists, or other experts who have specialized interests in ventilator support, pharmacology, physiology, or
the effects and complications of anesthesia.
Circulatory Systems Devices Panel—Interventional cardiologists, electrophysiologists, invasive (vascular)
radiologists, vascular and cardiothoracic surgeons, and cardiologists with special interest in congestive
heart failure.
Dental Products Devices Panel—Dentists, 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 Panel—Internists, pediatricians, neonatologists,
endocrinologists, gerontologists, nurses, biomedical engineers, or microbiologists/infection control practitioners or experts.
Hematology and Pathology Devices Panel—Hematologists (benign and/or malignant hematology),
hematopathologists (general and special hematology, coagulation and hemostasis, and hematological
oncology), gynecologists with special interests in gynecological oncology, cytopathologists, and molecular pathologists with special interests in development of predictive biomarkers.
Radiological Devices Panel—Physicians with experience in general radiology, mammography,
ultrasound, magnetic resonance, computed tomography, other radiological subspecialties and radiation
oncology; scientists with experience in diagnostic devices, radiation physics, statistical analysis, digital
imaging, and image analysis.
Clinical Chemistry and Clinical Toxicology Devices Panel—Doctor of Medicine or Philosophy with experience in clinical chemistry (e.g., cardiac markers), clinical toxicology, clinical pathology, clinical laboratory medicine, and endocrinology.
Gastroenterology and Urology Devices Panel—Gastroenterologists, urologists, and nephrologists.
General and Plastic Surgery Devices Panel—Surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic, and endoscopic); dermatologists; experts in biomaterials, lasers, wound healing, and quality of life; and biostatisticians.
Obstetrics and Gynecology Devices Panel—Experts in perinatology, embryology, reproductive endocrinology, pediatric gynecology, gynecological oncology, operative hysteroscopy, pelviscopy,
electrosurgery, laser surgery, assisted reproductive technologies, contraception, postoperative adhesions, and cervical cancer and colposcopy; biostatisticians and engineers with experience in obstetrics/
gynecology devices; urogynecologists; experts in breast care; experts in gynecology in the older patient; experts in diagnostic (optical) spectroscopy; experts in midwifery; labor and delivery nursing.
Immunology Devices Panel—Persons with experience in medical, surgical, or clinical oncology, internal
medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine.
Microbiology Devices Panel—Clinicians with an expertise in infectious disease, e.g., pulmonary disease
specialists, sexually transmitted disease specialists, pediatric infectious disease specialists, experts in
tropical medicine and emerging infectious diseases, mycologists; clinical microbiologists and virologists; clinical virology and microbiology laboratory directors, with expertise in clinical diagnosis and in
vitro diagnostic assays, e.g., hepatologists; molecular biologists.
Molecular and Clinical Genetics Devices Panel—Experts in human genetics and in the clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, neonatologists. The Agency is
also interested in considering candidates with training in inborn errors of metabolism, biochemical and/
or molecular genetics, population genetics, epidemiology, and related statistical training. Additionally,
individuals with experience in genetic counseling, medical ethics, as well as ancillary fields of study will
be considered.
Neurological Devices Panel—Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, and movement disorders), interventional neuroradiologists, psychiatrists, and
biostatisticians.
National Mammography Quality Assurance Advisory Committee—Physician, practitioner, or other health
professional whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography.
Patient Engagement Advisory Committee—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.
1—Voting .......
Immediately.
1—Nonvoting
December 1, 2021.
1—Nonvoting
Immediately.
1—Nonvoting
Immediately.
1—Nonvoting
Immediately.
1—Nonvoting
Immediately.
1—Nonvoting
Immediately.
1—Nonvoting
Immediately.
1—Nonvoting
1—Nonvoting
Immediately.
Immediately.
1—Nonvoting
Immediately.
1—Nonvoting
Immediately.
1—Nonvoting
Immediately.
1—Nonvoting
Immediately.
1—Nonvoting
December 1, 2021.
4—Voting .......
Immediately.
1—Voting .......
Immediately.
I. Functions and General Description of
the Committee Duties
A. FDA Science Board Advisory
Committee
The Science Board Advisory
Committee (Science Board) provides
advice to the Commissioner of Food and
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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
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needed
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
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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.
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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
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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
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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-thecounter 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
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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.
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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
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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 re´sume´.
Ballots are to be filled out and returned
to FDA within 30 days. The nominee
receiving the highest number of votes
ordinarily will be selected to serve as
the member representing consumer
interests for that particular advisory
committee or panel.
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.
IV. Nomination Procedures
Any interested person or organization
may nominate one or more qualified
persons to represent consumer interests
on the Agency’s advisory committees or
panels. Self-nominations are also
accepted. Nominations must include a
current, complete re´sume´ or curriculum
vitae for each nominee and a signed
copy of the Acknowledgement and
Consent form available at the FDA
Advisory Nomination Portal (see
ADDRESSES), and a list of consumer or
community-based organizations for
which the candidate can demonstrate
active participation.
Nominations must also specify the
advisory committee(s) or panel(s) for
which the nominee is recommended. In
addition, nominations must also
acknowledge that the nominee is aware
of the nomination unless selfnominated. FDA will ask potential
candidates to provide detailed
information concerning such matters as
financial holdings, employment, and
research grants and/or contracts to
permit evaluation of possible sources of
conflicts of interest. Members will be
invited to serve for terms of up to 4
years.
FDA will review all nominations
received within the specified
timeframes and prepare a ballot
containing the names of qualified
nominees. Names not selected will
remain on a list of eligible nominees
and be reviewed periodically by FDA to
determine continued interest. 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
Patient Engagement Advisory
Committee; Notice of Meeting
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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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0008]
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA) is announcing a
forthcoming public advisory committee
meeting of the Patient Engagement
Advisory Committee. The general
function of the committee is to provide
advice to the Commissioner of Food and
Drugs, or designee, on complex
scientific issues relating to medical
devices, the regulation of devices, and
their use by patients. The meeting will
be open to the public.
DATES: The meeting will take place
virtually on October 6, 2021, from 10
a.m. to 5 p.m. Eastern Time.
ADDRESSES: Please note that due to the
impact of this COVID–19 pandemic, all
meeting participants will be joining this
advisory committee meeting via an
online teleconferencing platform.
Answers to commonly asked questions
about FDA advisory committee meetings
may be accessed at: https://
www.fda.gov/AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Information on how to access the
webcast will be made available no later
than 2 business days prior to the
meeting at https://www.fdalive.com/
peac.
FOR FURTHER INFORMATION CONTACT:
Letise Williams, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5441, Silver Spring,
MD 20993–0002, letise.williams@
SUMMARY:
E:\FR\FM\11AUN1.SGM
11AUN1
]]>Agencies
[Federal Register Volume 86, Number 152 (Wednesday, August 11, 2021)]
[Notices]
[Pages 44024-44028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.
-----------------------------------------------------------------------
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 [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].
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,
[email protected].
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, [email protected].
[[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.
[email protected].
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,
[email protected]. 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,
[email protected]. 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
[email protected]. 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.
[email protected].
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,
[email protected].
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,
[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 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
