Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 12945-12950 [2023-04170]
Download as PDF
<![CDATA[
Federal Register / Vol. 88, No. 40 / Wednesday, March 1, 2023 / Notices
Food and Drug Administration
[Docket No. FDA–2023–N–0008]
Request for Nominations for Voting
Members for the Patient Engagement
Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
I. General Description of the Committee
Duties
Notice.
The Food and Drug
Administration (FDA or Agency) is
requesting nominations for voting
members, excluding consumer and
industry representatives, to serve on the
Patient Engagement Advisory
Committee (the Committee) in the
Center for Devices and Radiological
Health. Nominations will be accepted
for upcoming vacancies effective with
this notice. FDA seeks to include the
views of members of all gender groups,
members of all racial and ethnic groups,
and individuals with and without
disabilities on its advisory committees
and, therefore, encourages nominations
of appropriately qualified candidates
from these groups.
DATES: Nominations received on or
before May 1, 2023, will be given first
consideration for membership on the
Committee. Nominations received after
May 1, 2023, will be considered for
nomination to the Committee as later
vacancies occur.
ADDRESSES: All nominations for
membership should be submitted
electronically, by logging into the FDA
Advisory Committee Membership
Nomination Portal (https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm) and
selecting Academician/Practitioner from
the dropdown menu (regardless of
whether Academician/Practitioner
accurately describes the nominee), or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member on an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
ddrumheller on DSK120RN23PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
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, email:
Letise.Williams@fda.hhs.gov.
VerDate Sep<11>2014
18:10 Feb 28, 2023
FDA is
requesting nominations for voting
members to fill upcoming vacancies on
the Patient Engagement Advisory
Committee. This notice does not include
consumer and industry representative
nominations. The Agency will publish
two separate notices announcing the
vacancy of a representative of consumer
interests and vacancy of representatives
of interests of the device manufacturing
industry.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Jkt 259001
The Committee provides 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. It performs its duties by
identifying new approaches, promoting
innovation, recognizing unforeseen risks
or barriers, and identifying unintended
consequences that could result from
FDA policy. The Committee provides
advice on complex scientific issues
related to medical devices, the
regulation of devices, and their use by
patients. 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, devicerelated quality of life measure or health
status issues are among the topics that
may be considered by the Committee.
II. Criteria for Voting Members
The Committee consists of a core of
nine voting members, including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities who
are knowledgeable in areas such as
clinical research, patient or caregiver
experience, healthcare needs of patient
groups in the United States, or are
experienced in the work of patient and
health professional organizations,
scientific methodologies for patientreported outcomes and other clinical
outcome assessments, scientific
methodologies for eliciting patient
preferences, and strategies for
communicating benefits, risks, and
clinical outcomes to patients and
research subjects, as well as other
relevant areas. Members will be invited
to serve for overlapping terms of up to
4 years. Prospective members should
also have an understanding of the broad
spectrum of patients in a particular
disease area. Almost all non-Federal
members of this Committee serve as
Special Government Employees, with
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
12945
the exception of the representatives
from Industry.
III. Nomination Procedures
Any interested person may nominate
one or more qualified individuals for
membership on the Committee. Selfnominations are also accepted.
Nominations must include a cover
letter; a current, complete re´sume´ or
curriculum vitae for each nominee,
including current business and/or home
address, telephone number, and email
address if available, and a signed copy
of the Acknowledgement and Consent
form available at the FDA Advisory
Nomination Portal (see ADDRESSES).
Nominations must specify the advisory
committee for which the nominee is
recommended. Nominations must also
acknowledge that the nominee is aware
of the nomination unless selfnominated. FDA will ask potential
candidates to provide detailed
information concerning such matters
related to financial holdings,
employment, and research grants and/or
contracts to permit evaluation of
possible sources of conflicts of interest.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–04169 Filed 2–28–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0008]
Request for Nominations for
Individuals and Consumer
Organizations for Advisory
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
requesting that any consumer
organizations interested in participating
in the selection of voting and/or
nonvoting consumer representatives to
serve on its advisory committees or
panels notify FDA in writing. FDA is
also requesting nominations for voting
and/or nonvoting consumer
representatives to serve on advisory
committees and/or panels for which
vacancies currently exist or are expected
to occur in the near future. Nominees
SUMMARY:
E:\FR\FM\01MRN1.SGM
01MRN1
12946
Federal Register / Vol. 88, No. 40 / Wednesday, March 1, 2023 / Notices
recommended to serve as a voting or
nonvoting consumer representative may
be self-nominated or may be nominated
by a consumer organization. FDA seeks
to include the views of individuals on
its advisory committees regardless of
their gender identification, religious
affiliation, racial and ethnic
identification, or disability status and,
therefore, encourages nominations of
appropriately qualified candidates from
all groups.
DATES: Any consumer organization
interested in participating in the
selection of an appropriate voting or
nonvoting member to represent
consumer interests on an FDA advisory
committee or panel may send a letter or
email stating that interest to FDA (see
ADDRESSES) by April 17, 2023, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by April 17, 2023.
Nominations will be accepted for
current vacancies and for those that will
or may occur through December 31,
2023.
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
ADDRESSES:
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
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
Contact person
Committee/panel
ddrumheller on DSK120RN23PROD with NOTICES
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.
Prabhakara Atreya, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1226, Silver Spring, MD
20993–0002, 240–402–8006, Prabhakara.Altreya@fda.hhs.gov.
Moon Hee Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993–
0002, 301–796–2894, MoonHee.Choi@fda.hhs.gov.
She-Chia Jankowski, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31 Rm. 2438, Silver Spring, MD
20993–0002, 240–402–5343, She-Chia.Jankowski@fda.hhs.gov.
Jessica Seo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2412, Silver Spring, MD 20993–
0002, 301–796–7699, Jessica.Seo@fda.hhs.gov.
Yvette Waples, Center for Drug Evaluation Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 31, Rm. 2438, Silver Spring, MD 20993–0002,
301–837–7126, Yvette.Waples@fda.hhs.gov.
LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2428, Silver Spring, MD 20993–
0002, 301–796–2855, LaToya.Bonner@fda.hhs.gov.
Takyiah Stevenson, Center for Drug Evaluation Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2406, Silver Spring, MD 20993–
0002, 240–402–2507, Takyiah.Stevenson@fda.hhs.gov.
Joyce Frimpong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2426, Silver Spring, MD 20993–
0002, 301–796–7973, Joyce.Frimpong@fda.hhs.gov.
Candace Nalls, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993–
0002, 301–636–0510, Candace.Nalls@fda.hhs.gov.
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.
Akinola Awojope, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD
20993–0002, 301–636–0512, Akinola.Awojope@fda.hhs.gov.
Jarrod Collier, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993–
0002, 240–672–5763, Jarrod.Collier@fda.hhs.gov.
VerDate Sep<11>2014
18:10 Feb 28, 2023
Jkt 259001
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
FDA Science Board Advisory Committee.
Allergenic Products Advisory Committee.
Anesthetic and Analgesic Drug Products Advisory Committee, Non-Prescription Drugs Advisory Committee.
Antimicrobial Drugs Advisory Committee.
Peripheral and Central Nervous System Drugs Advisory
Committee.
Cardiovascular and Renal Drugs Advisory Committee,
Medical Imaging Drugs Advisory Committee.
Endocrinologic and Metabolic Drugs Advisory Committee.
Pharmacy Compounding Advisory Committee.
Psychopharmacologic Drugs Advisory Committee.
Anesthesiology and Respiratory Therapy Devices Panel;
Clinical Chemistry and Clinical Toxicology Devices
Panel; Ear, Nose and Throat Devices Panel; Gastroenterology-Urology Devices Panel; General and Plastic Surgery Devices Panel.
Circulatory System Devices Panel; Microbiology Devices
Panel.
Dental Products Panel; Orthopaedic and Rehabilitation
Devices Panel.
General Hospital and Personal Use Devices Panel; Hematology and Pathology Devices Panel; Molecular and
Clinical Genetics Panel; Ophthalmic Devices Panel;
Radiological Devices Panel.
E:\FR\FM\01MRN1.SGM
01MRN1
12947
Federal Register / Vol. 88, No. 40 / Wednesday, March 1, 2023 / Notices
TABLE 1—ADVISORY COMMITTEE CONTACTS—Continued
Contact person
Committee/panel
James Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993–
0002, 301–796–6313, James.Swink@fda.hhs.gov.
FDA is
requesting nominations for voting and/
SUPPLEMENTARY INFORMATION:
National Mammography Quality Assurance Advisory
Committee.
or nonvoting consumer representatives
for the vacancies listed in table 2:
ddrumheller on DSK120RN23PROD with NOTICES
TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED
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 Administration (Commissioner) and other appropriate officials on
specific complex scientific and technical issues important to FDA and its mission, including
emerging issues within the scientific community. Additionally, the Science Board provides advice that supports the Agency in keeping pace with technical and scientific developments, including in regulatory science; and input into the Agency’s research agenda, and on upgrading
its scientific and research facilities and training opportunities. It also provides, where requested, expert review of Agency-sponsored intramural and extramural scientific research
programs.
Allergenic Products Advisory Committee—Knowledgeable in the fields of allergy, immunology,
pediatrics, internal medicine, biochemistry, and related specialties.
Anesthetic and Analgesic Drug Products Advisory Committee—Knowledgeable in the fields of
anesthesiology, surgery, epidemiology or statistics, and related specialties.
Non-Prescription Drugs Advisory Committee—Knowledgeable in the fields of internal medicine,
family practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and related
specialties.
Antimicrobial Drugs Advisory Committee—Knowledgeable in the fields of infectious disease, internal medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties.
Peripheral and Central Nervous Systems Drugs Advisory Committee—Knowledgeable in the
fields of neurology, neuropharmacology, neuropathology, otolaryngology, epidemiology or statistics, and related specialties.
Cardiovascular and Renal Drugs Advisory Committee—Knowledgeable in the fields of cardiology, hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics.
Medical Imaging Drugs Advisory Committee—Knowledgeable in the fields of nuclear medicine,
radiology, epidemiology, statistics, and related specialties.
Endocrinologic and Metabolic Drugs Advisory Committee—Knowledgeable in the fields of endocrinology, metabolism, epidemiology or statistics, and related specialties.
Pharmacy Compounding Advisory Committee—Knowledgeable in the fields of pharmaceutical
compounding, pharmaceutical manufacturing, pharmacy, medicine, and other related specialties.
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.
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.
Ear, Nose and Throat Devices Panel—Otologists, neurotologists, audiologists ............................
Gastroenterology-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.
Circulatory System Devices Panel—Interventional cardiologists, electrophysiologists, invasive
(vascular) radiologists, vascular and cardiothoracic surgeons, and cardiologists with special
interest in congestive heart failure.
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, and mycologists; clinical microbiologists and virologists; clinical virology and microbiology laboratory directors, with
expertise in clinical diagnosis and in vitro diagnostic assays, e.g., hepatologists; molecular biologists.
Dental Products Panel—Dentists, engineers and scientists who have expertise in the areas of
dental implants, dental materials, periodontology, tissue engineering, and dental anatomy.
1—Voting ...................
Immediately.
1—Voting ...................
Immediately.
1—Voting ...................
April 1, 2023.
1—Voting ...................
Immediately.
1—Voting ...................
May 1, 2023.
1—Voting ...................
February 1, 2023.
1—Voting ...................
July 1, 2023.
1—Voting ...................
Immediately.
1—Voting ...................
Immediately.
1—Voting ...................
October 1, 2023.
1—Voting ...................
Immediately.
1—Nonvoting .............
Immediately.
1—Nonvoting .............
Immediately.
1—Nonvoting .............
1—Nonvoting .............
1—Nonvoting .............
November 1, 2023.
Immediately.
Immediately.
1—Nonvoting .............
Immediately.
1—Nonvoting .............
Immediately.
1—Nonvoting .............
Immediately.
VerDate Sep<11>2014
18:10 Feb 28, 2023
Jkt 259001
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
E:\FR\FM\01MRN1.SGM
01MRN1
12948
Federal Register / Vol. 88, No. 40 / Wednesday, March 1, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES
TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED—Continued
Approximate date
needed
Committee/panel/areas of expertise needed
Type of vacancy
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; experts in labor and delivery nursing.
Orthopaedic and Rehabilitation Devices Panel—Orthopedic surgeons (joint spine, trauma, and
pediatric); rheumatologists; engineers (biomedical, biomaterials, and biomechanical); experts
in rehabilitation medicine, sports medicine, and connective tissue engineering; and biostatisticians.
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.
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.
Ophthalmic Devices Panel—Ophthalmists with expertise in corneal-external disease, vitreo-retinal surgery, glaucoma, ocular immunology, ocular pathology; optometrists; vision scientists;
and ophthalmic professionals with expertise in clinical trial design, quality of life assessment,
electrophysiology, low vision rehabilitation, and biostatistics.
Radiological Devices Panel—Physicians with experience in general radiology, mammography,
ultrasound, magnetic resonance, computed tomography, other radiological subspecialties,
and radiation oncology; scientists with experience in diagnostic devices, radiation physics,
statistical analysis, digital imaging, and image analysis.
National Mammography Quality Assurance Advisory Committee—Physician, practitioner, or
other health professional whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography.
1—Nonvoting .............
Immediately.
1—Nonvoting .............
Immediately.
1—Nonvoting .............
Immediately.
1—Nonvoting .............
Immediately.
1—Nonvoting .............
Immediately.
1—Nonvoting .............
Immediately.
1—Nonvoting .............
Immediately.
3—Voting ...................
Immediately.
I. Functions and General Description of
the Committee Duties
B. Allergenic Products Advisory
Committee
A. FDA Science Board Advisory
Committee
Reviews and evaluates available data
concerning the safety, effectiveness, and
adequacy of labeling of marketed and
investigational allergenic biological
products or materials that are
administered to humans for the
diagnosis, prevention, or treatment of
allergies and allergic disease, and makes
appropriate recommendations to the
Commissioner regarding the affirmation
or revocation of biological product
licenses; on the safety, effectiveness,
and labeling of the products; on clinical
and laboratory studies of such products;
on amendments or revisions to
regulations governing the manufacture,
testing, and licensing of allergenic
biological products; and on the quality
and relevance of FDA’s research
programs.
of marketed and investigational human
drug products for use in anesthesiology
and surgery.
The Science Board Advisory
Committee (Science Board) provides
advice to the Commissioner of Food and
Drugs (Commissioner) and other
appropriate officials on specific
complex scientific and technical issues
important to FDA and its mission,
including emerging issues within the
scientific community. Additionally, the
Science Board provides advice that
supports the Agency in keeping pace
with technical and scientific
developments, including in regulatory
science, and input into the Agency’s
research agenda and on upgrading its
scientific and research facilities and
training opportunities. It also provides,
where requested, expert review of
Agency-sponsored intramural and
extramural scientific research programs.
VerDate Sep<11>2014
18:10 Feb 28, 2023
Jkt 259001
C. Anesthetic and Analgesic Drug
Products Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
D. Nonprescription Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of over-the-counter (nonprescription)
human drug products, or any other
FDA-regulated product, for use in the
treatment of a broad spectrum of human
symptoms and diseases, and advises the
Commissioner either on the
promulgation of monographs
establishing conditions under which
these drugs are generally recognized as
safe and effective and not misbranded or
on the approval of new drug
applications for such drugs. The
Committee serves as a forum for the
exchange of views regarding the
prescription and nonprescription status,
including switches from one status to
another, of these various drug products
and combinations thereof. The
Committee may also conduct peer
review of Agency-sponsored intramural
E:\FR\FM\01MRN1.SGM
01MRN1
Federal Register / Vol. 88, No. 40 / Wednesday, March 1, 2023 / Notices
and extramural scientific biomedical
programs in support of FDA’s mission
and regulatory responsibilities.
M. Medical Devices Advisory Committee
Panels
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of endocrine and metabolic disorders.
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 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.
K. Pharmacy Compounding Advisory
Committee
N. National Mammography Quality
Assurance Advisory Committee
Provides advice on scientific,
technical, and medical issues
concerning drug compounding by
pharmacists and licensed practitioners.
Advises the Agency on the
development of appropriate quality
standards and regulations for
mammography facilities; standards and
regulations for bodies accrediting
mammography facilities under this
program; regulations with respect to
sanctions; procedures for monitoring
compliance with standards; establishing
a mechanism to investigate consumer
complaints; and reporting new
developments concerning breast
E. Antimicrobial Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of infectious diseases and disorders.
F. Arthritis Advisory Committee
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of arthritis, rheumatism, and related
diseases.
G. Peripheral and Central Nervous
System Drugs Advisory Committee
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of neurologic diseases.
H. Cardiovascular and Renal Drugs
Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of cardiovascular and renal disorders.
I. Medical Imaging Drugs Advisory
Committee
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in diagnostic and
therapeutic procedures using
radioactive pharmaceuticals and
contrast media used in diagnostic
radiology.
ddrumheller on DSK120RN23PROD with NOTICES
J. Endocrinologic and Metabolic Drugs
Advisory Committee
L. Psychopharmacologic Drugs Advisory
Committee
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the practice of
psychiatry and related fields.
VerDate Sep<11>2014
18:10 Feb 28, 2023
Jkt 259001
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
12949
imaging that should be considered in
the oversight of mammography
facilities. The Committee also advises
on determining whether there exists a
shortage of mammography facilities in
rural and health professional shortage
areas and determining the effects of
personnel on access to the services of
such facilities in such areas;
determining whether there will be a
sufficient number of medical physicists
after October 1, 1999; and determining
the costs and benefits of compliance
with these requirements.
II. Criteria for Members
Persons nominated for membership as
consumer representatives on
committees or panels should meet the
following criteria: (1) demonstrate an
affiliation with and/or active
participation in consumer or
community-based organizations, (2) be
able to analyze technical data, (3)
understand research design, (4) discuss
benefits and risks, and (5) evaluate the
safety and efficacy of products under
review. The consumer representative
should be able to represent the
consumer perspective on issues and
actions before the advisory committee;
serve as a liaison between the
committee and interested consumers,
associations, coalitions, and consumer
organizations; and facilitate dialogue
with the advisory committees on
scientific issues that affect consumers.
III. Selection Procedures
Selection of members representing
consumer interests is conducted
through procedures that include the use
of organizations representing the public
interest and public advocacy groups.
These organizations recommend
nominees for the Agency’s selection.
Representatives from the consumer
health branches of Federal, State, and
local governments also may participate
in the selection process. Any consumer
organization interested in participating
in the selection of an appropriate voting
or nonvoting member to represent
consumer interests should send a letter
stating that interest to FDA (see
ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 45 days, FDA
will compile a list of consumer
organizations that will participate in the
selection process and will forward to
each such organization a ballot listing at
least two qualified nominees selected by
the Agency based on the nominations
received, together with each nominee’s
current curriculum vitae or re´sume´.
Ballots are to be filled out and returned
to FDA within 30 days. The nominee
receiving the highest number of votes
E:\FR\FM\01MRN1.SGM
01MRN1
ddrumheller on DSK120RN23PROD with NOTICES
12950
Federal Register / Vol. 88, No. 40 / Wednesday, March 1, 2023 / Notices
ordinarily will be selected to serve as
the member representing consumer
interests for that particular advisory
committee or panel.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
IV. Nomination Procedures
[Docket Nos. FDA–2018–E–4422, FDA–
2018–E–4827, and FDA–2018–E–4427]
Food and Drug Administration
Any interested person or organization
may nominate one or more qualified
persons to represent consumer interests
on the Agency’s advisory committees or
panels. Self-nominations are also
accepted. Nominations must include a
current, complete re´sume´ or curriculum
vitae for each nominee and a signed
copy of the Acknowledgement and
Consent form available at the FDA
Advisory Nomination Portal (see
ADDRESSES), and a list of consumer or
community-based organizations for
which the candidate can demonstrate
active participation.
Nominations must also specify the
advisory committee(s) or panel(s) for
which the nominee is recommended. In
addition, nominations must also
acknowledge that the nominee is aware
of the nomination unless selfnominated. FDA will ask potential
candidates to provide detailed
information concerning such matters as
financial holdings, employment, and
research grants and/or contracts to
permit evaluation of possible sources of
conflicts of interest. Members will be
invited to serve for terms of up to 4
years.
FDA will review all nominations
received within the specified
timeframes and prepare a ballot
containing the names of qualified
nominees. Names not selected will
remain on a list of eligible nominees
and be reviewed periodically by FDA to
determine continued interest. After
selecting qualified nominees for the
ballot, FDA will provide those
consumer organizations that are
participating in the selection process
with the opportunity to vote on the
listed nominees. Only organizations
vote in the selection process. Persons
who nominate themselves to serve as
voting or nonvoting consumer
representatives will not participate in
the selection process.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–04170 Filed 2–28–23; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
18:10 Feb 28, 2023
Jkt 259001
Determination of Regulatory Review
Period for Purposes of Patent
Extension; VYZULTA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for VYZULTA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect must submit either electronic
or written comments and ask for a
redetermination by May 1, 2023.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 28, 2023. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
May 1, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2018–E–4422, FDA–2018–E–4827, and
FDA–2018–E–4427 for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
VYZULTA.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
E:\FR\FM\01MRN1.SGM
01MRN1
]]>Agencies
[Federal Register Volume 88, Number 40 (Wednesday, March 1, 2023)]
[Notices]
[Pages 12945-12950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04170]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0008]
Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
requesting that any consumer organizations interested in participating
in the selection of voting and/or nonvoting consumer representatives to
serve on its advisory committees or panels notify FDA in writing. FDA
is also requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees
[[Page 12946]]
recommended to serve as a voting or nonvoting consumer representative
may be self-nominated or may be nominated by a consumer organization.
FDA seeks to include the views of individuals on its advisory
committees regardless of their gender identification, religious
affiliation, racial and ethnic identification, or disability status
and, therefore, encourages nominations of appropriately qualified
candidates from all groups.
DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to FDA (see ADDRESSES) by April
17, 2023, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by April 17, 2023. Nominations will be accepted for current
vacancies and for those that will or may occur through December 31,
2023.
ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process should be
submitted electronically to [email protected] or by mail to
Advisory Committee Oversight and Management Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002.
Consumer representative nominations should be submitted
electronically by logging into the FDA Advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002. Additional information about becoming a member
of an FDA advisory committee can also be obtained by visiting FDA's
website at https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: For questions relating to
participation in the selection process: Kimberly Hamilton, Advisory
Committee Oversight and Management Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993-
0002, 301-796-8220, [email protected].
For questions relating to specific advisory committees or panels,
contact the appropriate contact person listed in table 1.
Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
Contact person Committee/panel
------------------------------------------------------------------------
Rakesh Raghuwanshi, Office of the Chief FDA Science Board Advisory
Scientist, Food and Drug Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3309, Silver Spring,
MD 20993-0002, 301-796-4769,
[email protected].
Prabhakara Atreya, Center for Biologics Allergenic Products Advisory
Evaluation and Research, Food and Drug Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 1226, Silver
Spring, MD 20993-0002, 240-402-8006,
[email protected].
Moon Hee Choi, Center for Drug Anesthetic and Analgesic Drug
Evaluation and Research, Food and Drug Products Advisory Committee,
Administration, 10903 New Hampshire Non-Prescription Drugs
Ave., Bldg. 31, Rm. 2434, Silver Advisory Committee.
Spring, MD 20993-0002, 301-796-2894,
[email protected].
She-Chia Jankowski, Center for Drug Antimicrobial Drugs Advisory
Evaluation and Research, Food and Drug Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 31 Rm. 2438, Silver Spring,
MD 20993-0002, 240-402-5343, [email protected].
Jessica Seo, Center for Drug Evaluation Peripheral and Central Nervous
and Research, Food and Drug System Drugs Advisory
Administration, 10903 New Hampshire Committee.
Ave., Bldg. 31, Rm. 2412, Silver
Spring, MD 20993-0002, 301-796-7699,
[email protected].
Yvette Waples, Center for Drug Cardiovascular and Renal Drugs
Evaluation Research, Food and Drug Advisory Committee, Medical
Administration, 10903 New Hampshire Imaging Drugs Advisory
Ave., Bldg. 31, Rm. 2438, Silver Committee.
Spring, MD 20993-0002, 301-837-7126,
[email protected].
LaToya Bonner, Center for Drug Endocrinologic and Metabolic
Evaluation and Research, Food and Drug Drugs Advisory Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2428, Silver
Spring, MD 20993-0002, 301-796-2855,
[email protected].
Takyiah Stevenson, Center for Drug Pharmacy Compounding Advisory
Evaluation Research, Food and Drug Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2406, Silver
Spring, MD 20993-0002, 240-402-2507,
[email protected].
Joyce Frimpong, Center for Drug Psychopharmacologic Drugs
Evaluation and Research, Food and Drug Advisory Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2426, Silver
Spring, MD 20993-0002, 301-796-7973,
[email protected].
Candace Nalls, Center for Devices and Anesthesiology and Respiratory
Radiological Health, Food and Drug Therapy Devices Panel;
Administration, 10903 New Hampshire Clinical Chemistry and
Ave., Bldg. 66, Rm. 5211, Silver Clinical Toxicology Devices
Spring, MD 20993-0002, 301-636-0510, Panel; Ear, Nose and Throat
[email protected]. Devices Panel;
Gastroenterology-Urology
Devices Panel; General and
Plastic Surgery Devices
Panel.
James Swink, Center for Devices and Circulatory System Devices
Radiological Health, Food and Drug Panel; Microbiology Devices
Administration, 10903 New Hampshire Panel.
Ave., Bldg. 66, Rm. 5211, Silver
Spring, MD 20993-0002, 301-796-6313,
[email protected].
Akinola Awojope, Center for Devices and Dental Products Panel;
Radiological Health, Food and Drug Orthopaedic and
Administration, 10903 New Hampshire Rehabilitation Devices Panel.
Ave., Bldg. 66, Rm. 5216, Silver
Spring, MD 20993-0002, 301-636-0512,
[email protected].
Jarrod Collier, Center for Devices and General Hospital and Personal
Radiological Health, Food and Drug Use Devices Panel; Hematology
Administration, 10903 New Hampshire and Pathology Devices Panel;
Ave., Bldg. 66, Rm. 5214, Silver Molecular and Clinical
Spring, MD 20993-0002, 240-672-5763, Genetics Panel; Ophthalmic
[email protected]. Devices Panel; Radiological
Devices Panel.
[[Page 12947]]
James Swink, Center for Devices and National Mammography Quality
Radiological Health, Food and Drug Assurance Advisory Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5211, Silver
Spring, MD 20993-0002, 301-796-6313,
[email protected].
------------------------------------------------------------------------
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
and/or nonvoting consumer representatives for the vacancies listed in
table 2:
Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
Committee/panel/areas of expertise
needed Type of vacancy Approximate date needed
----------------------------------------------------------------------------------------------------------------
FDA Science Board Advisory Committee-- 1--Voting.......................... Immediately.
The Science Board provides advice to
the Commissioner of Food and Drugs
Administration (Commissioner) and
other appropriate officials on
specific complex scientific and
technical issues important to FDA and
its mission, including emerging issues
within the scientific community.
Additionally, the Science Board
provides advice that supports the
Agency in keeping pace with technical
and scientific developments, including
in regulatory science; and input into
the Agency's research agenda, and on
upgrading its scientific and research
facilities and training opportunities.
It also provides, where requested,
expert review of Agency-sponsored
intramural and extramural scientific
research programs.
Allergenic Products Advisory Committee-- 1--Voting.......................... Immediately.
Knowledgeable in the fields of
allergy, immunology, pediatrics,
internal medicine, biochemistry, and
related specialties.
Anesthetic and Analgesic Drug Products 1--Voting.......................... April 1, 2023.
Advisory Committee--Knowledgeable in
the fields of anesthesiology, surgery,
epidemiology or statistics, and
related specialties.
Non-Prescription Drugs Advisory 1--Voting.......................... Immediately.
Committee--Knowledgeable in the fields
of internal medicine, family practice,
clinical toxicology, clinical
pharmacology, pharmacy, dentistry, and
related specialties.
Antimicrobial Drugs Advisory Committee-- 1--Voting.......................... May 1, 2023.
Knowledgeable in the fields of
infectious disease, internal medicine,
microbiology, pediatrics, epidemiology
or statistics, and related specialties.
Peripheral and Central Nervous Systems 1--Voting.......................... February 1, 2023.
Drugs Advisory Committee--
Knowledgeable in the fields of
neurology, neuropharmacology,
neuropathology, otolaryngology,
epidemiology or statistics, and
related specialties.
Cardiovascular and Renal Drugs Advisory 1--Voting.......................... July 1, 2023.
Committee--Knowledgeable in the fields
of cardiology, hypertension,
arrhythmia, angina, congestive heart
failure, diuresis, and biostatistics.
Medical Imaging Drugs Advisory 1--Voting.......................... Immediately.
Committee--Knowledgeable in the fields
of nuclear medicine, radiology,
epidemiology, statistics, and related
specialties.
Endocrinologic and Metabolic Drugs 1--Voting.......................... Immediately.
Advisory Committee--Knowledgeable in
the fields of endocrinology,
metabolism, epidemiology or
statistics, and related specialties.
Pharmacy Compounding Advisory 1--Voting.......................... October 1, 2023.
Committee--Knowledgeable in the fields
of pharmaceutical compounding,
pharmaceutical manufacturing,
pharmacy, medicine, and other related
specialties.
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....................... Immediately.
Devices Panel--Anesthesiologists,
pulmonary medicine specialists, or
other experts who have specialized
interests in ventilator support,
pharmacology, physiology, or the
effects and complications of
anesthesia.
Clinical Chemistry and Clinical 1--Nonvoting....................... Immediately.
Toxicology Devices Panel--Doctor of
Medicine or Philosophy with experience
in clinical chemistry (e.g., cardiac
markers), clinical toxicology,
clinical pathology, clinical
laboratory medicine, and endocrinology.
Ear, Nose and Throat Devices Panel-- 1--Nonvoting....................... November 1, 2023.
Otologists, neurotologists,
audiologists.
Gastroenterology-Urology Devices Panel-- 1--Nonvoting....................... Immediately.
Gastroenterologists, urologists, and
nephrologists.
General and Plastic Surgery Devices 1--Nonvoting....................... Immediately.
Panel--Surgeons (general, plastic,
reconstructive, pediatric, thoracic,
abdominal, pelvic and endoscopic);
dermatologists; experts in
biomaterials, lasers, wound healing,
and quality of life; and
biostatisticians.
Circulatory System Devices Panel-- 1--Nonvoting....................... Immediately.
Interventional cardiologists,
electrophysiologists, invasive
(vascular) radiologists, vascular and
cardiothoracic surgeons, and
cardiologists with special interest in
congestive heart failure.
Microbiology Devices Panel--Clinicians 1--Nonvoting....................... Immediately.
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, and
mycologists; clinical microbiologists
and virologists; clinical virology and
microbiology laboratory directors,
with expertise in clinical diagnosis
and in vitro diagnostic assays, e.g.,
hepatologists; molecular biologists.
Dental Products 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.
[[Page 12948]]
Obstetrics and Gynecology Devices 1--Nonvoting....................... Immediately.
Panel--Experts in perinatology,
embryology, reproductive
endocrinology, pediatric gynecology,
gynecological oncology, operative
hysteroscopy, pelviscopy,
electrosurgery, laser surgery,
assisted reproductive technologies,
contraception, postoperative
adhesions, and cervical cancer and
colposcopy; biostatisticians and
engineers with experience in
obstetrics/gynecology devices;
urogynecologists; experts in breast
care; experts in gynecology in the
older patient; experts in diagnostic
(optical) spectroscopy; experts in
midwifery; experts in labor and
delivery nursing.
Orthopaedic and Rehabilitation Devices 1--Nonvoting....................... Immediately.
Panel--Orthopedic surgeons (joint
spine, trauma, and pediatric);
rheumatologists; engineers
(biomedical, biomaterials, and
biomechanical); experts in
rehabilitation medicine, sports
medicine, and connective tissue
engineering; and biostatisticians.
General Hospital and Personal Use 1--Nonvoting....................... Immediately.
Devices Panel--Internists,
pediatricians, neonatologists,
endocrinologists, gerontologists,
nurses, biomedical engineers, or
microbiologists/infection control
practitioners or experts.
Hematology and Pathology Devices 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.
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.
Ophthalmic Devices Panel--Ophthalmists 1--Nonvoting....................... Immediately.
with expertise in corneal-external
disease, vitreo-retinal surgery,
glaucoma, ocular immunology, ocular
pathology; optometrists; vision
scientists; and ophthalmic
professionals with expertise in
clinical trial design, quality of life
assessment, electrophysiology, low
vision rehabilitation, and
biostatistics.
Radiological Devices Panel--Physicians 1--Nonvoting....................... Immediately.
with experience in general radiology,
mammography, ultrasound, magnetic
resonance, computed tomography, other
radiological subspecialties, and
radiation oncology; scientists with
experience in diagnostic devices,
radiation physics, statistical
analysis, digital imaging, and image
analysis.
National Mammography Quality Assurance 3--Voting.......................... Immediately.
Advisory Committee--Physician,
practitioner, or other health
professional whose clinical practice,
research specialization, or
professional expertise includes a
significant focus on mammography.
----------------------------------------------------------------------------------------------------------------
I. Functions and General Description of the Committee Duties
A. FDA Science Board Advisory Committee
The Science Board Advisory Committee (Science Board) provides
advice to the Commissioner of Food and Drugs (Commissioner) and other
appropriate officials on specific complex scientific and technical
issues important to FDA and its mission, including emerging issues
within the scientific community. Additionally, the Science Board
provides advice that supports the Agency in keeping pace with technical
and scientific developments, including in regulatory science, and input
into the Agency's research agenda and on upgrading its scientific and
research facilities and training opportunities. It also provides, where
requested, expert review of Agency-sponsored intramural and extramural
scientific research programs.
B. Allergenic Products Advisory Committee
Reviews and evaluates available data concerning the safety,
effectiveness, and adequacy of labeling of marketed and investigational
allergenic biological products or materials that are administered to
humans for the diagnosis, prevention, or treatment of allergies and
allergic disease, and makes appropriate recommendations to the
Commissioner regarding the affirmation or revocation of biological
product licenses; on the safety, effectiveness, and labeling of the
products; on clinical and laboratory studies of such products; on
amendments or revisions to regulations governing the manufacture,
testing, and licensing of allergenic biological products; and on the
quality and relevance of FDA's research programs.
C. Anesthetic and Analgesic Drug Products Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in anesthesiology and surgery.
D. Nonprescription Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of over-the-counter (nonprescription) human drug
products, or any other FDA-regulated product, for use in the treatment
of a broad spectrum of human symptoms and diseases, and advises the
Commissioner either on the promulgation of monographs establishing
conditions under which these drugs are generally recognized as safe and
effective and not misbranded or on the approval of new drug
applications for such drugs. The Committee serves as a forum for the
exchange of views regarding the prescription and nonprescription
status, including switches from one status to another, of these various
drug products and combinations thereof. The Committee may also conduct
peer review of Agency-sponsored intramural
[[Page 12949]]
and extramural scientific biomedical programs in support of FDA's
mission and regulatory responsibilities.
E. Antimicrobial Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of infectious diseases and disorders.
F. Arthritis Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
treatment of arthritis, rheumatism, and related diseases.
G. Peripheral and Central Nervous System Drugs Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
treatment of neurologic diseases.
H. Cardiovascular and Renal Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of cardiovascular and renal disorders.
I. Medical Imaging Drugs Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in
diagnostic and therapeutic procedures using radioactive pharmaceuticals
and contrast media used in diagnostic radiology.
J. Endocrinologic and Metabolic Drugs Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
treatment of endocrine and metabolic disorders.
K. Pharmacy Compounding Advisory Committee
Provides advice on scientific, technical, and medical issues
concerning drug compounding by pharmacists and licensed practitioners.
L. Psychopharmacologic Drugs Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
practice of psychiatry and related fields.
M. Medical Devices Advisory Committee Panels
The Medical Devices Advisory Committee has established certain
panels to review and evaluate data on the safety and effectiveness of
marketed and investigational devices and make recommendations for their
regulation. With the exception of the Medical Devices Dispute
Resolution Panel, each panel, according to its specialty area: (1)
advises on the classification or reclassification of devices into one
of three regulatory categories and advises on any possible risks to
health associated with the use of devices; (2) advises on formulation
of product development protocols; (3) reviews premarket approval
applications for medical devices; (4) reviews guidelines and guidance
documents; (5) recommends exemption of certain devices from the
application of portions of the 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 Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies. The Panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or Agency decisions or actions.
N. National Mammography Quality Assurance Advisory Committee
Advises the Agency on the development of appropriate quality
standards and regulations for mammography facilities; standards and
regulations for bodies accrediting mammography facilities under this
program; regulations with respect to sanctions; procedures for
monitoring compliance with standards; establishing a mechanism to
investigate consumer complaints; and reporting new developments
concerning breast imaging that should be considered in the oversight of
mammography facilities. The Committee also advises on determining
whether there exists a shortage of mammography facilities in rural and
health professional shortage areas and determining the effects of
personnel on access to the services of such facilities in such areas;
determining whether there will be a sufficient number of medical
physicists after October 1, 1999; and determining the costs and
benefits of compliance with these requirements.
II. Criteria for Members
Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
demonstrate an affiliation with and/or active participation in consumer
or community-based organizations, (2) be able to analyze technical
data, (3) understand research design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy of products under review. The
consumer representative should be able to represent the consumer
perspective on issues and actions before the advisory committee; serve
as a liaison between the committee and interested consumers,
associations, coalitions, and consumer organizations; and facilitate
dialogue with the advisory committees on scientific issues that affect
consumers.
III. Selection Procedures
Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 45 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
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
[[Page 12950]]
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.
After selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting or nonvoting consumer representatives
will not participate in the selection process.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: February 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04170 Filed 2-28-23; 8:45 am]
BILLING CODE 4164-01-P
