Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 79617-79622 [2024-22292]
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Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices
rooted in comparisons between new
devices and predicate devices. However,
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) does not preclude FDA
from using performance criteria to
facilitate this comparison. If a legally
marketed device performs at certain
levels relevant to its safety and
effectiveness, and a new device meets
those levels of performance for the same
characteristics, FDA could find the new
device as safe and effective as the
legally marketed device. Instead of
reviewing data from direct comparison
testing between the two devices, FDA
could support a finding of substantial
equivalence with data demonstrating
the new device meets the level of
performance of an appropriate predicate
device(s). Under this optional Safety
and Performance Based Pathway, a
submitter of air powered dental
handpieces and air motors, or dental
cement devices could satisfy the
requirement to compare its device with
a legally marketed device by, among
other things, independently
demonstrating that the device’s
performance meets performance criteria
as established in the relevant abovelisted guidance rather than using direct
predicate comparison testing for some of
the performance characteristics.
These guidances are being
implemented without prior public
comment because the Agency has
determined that prior public
participation is not feasible or
appropriate (see section 701(h)(1)(C) of
the FD&C Act (21 U.S.C. 371(h)(1)(C))
and 21 CFR 10.115(g)(2)). FDA has
determined that these guidance
documents present less burdensome
policies that are consistent with public
health. Although these guidances are
II. Electronic Access
Persons interested in obtaining a copy
of the guidances may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. These
guidance documents are also available
at https://www.regulations.gov or
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download
an electronic copy of ‘‘Air Powered
Dental Handpieces and Air Motors—
Performance Criteria for Safety and
Performance Based Pathway,’’ ‘‘Dental
Ceramics—Performance Criteria for
Safety and Performance Based
Pathway,’’ ‘‘Dental Impression
Materials—Performance Criteria for
Safety and Performance Based
Pathway,’’ or ‘‘Dental Cements—
Performance Criteria for Safety and
Performance Based Pathway’’ may send
an email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number GUI00021014 for
‘‘Air Powered Dental Handpieces and
Air Motors—Performance Criteria for
Safety and Performance Based
Pathway,’’ document number
GUI00007014 for ‘‘Dental Ceramics—
Performance Criteria for Safety and
Performance Based Pathway,’’
document number GUI00007013 for
‘‘Dental Impression Materials—
Performance Criteria for Safety and
Performance Based Pathway,’’ or
document number GUI00021005 for
‘‘Dental Cements—Performance Criteria
for Safety and Performance Based
Pathway’’ to identify the guidance you
are requesting.
III. Paperwork Reduction Act of 1995
While these guidances contain no
new collection of information, they do
refer to previously approved FDA
collections of information. The
previously approved collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521). The collections of information in
the following table have been approved
by OMB:
21 CFR part; guidance
Topic
807, subpart E ................................................................................................................................
‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission
Program’’.
Premarket notification ..............
Q-submissions; pre-submissions.
Dated: September 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–22309 Filed 9–27–24; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0008]
BILLING CODE 4164–01–P
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being implemented immediately, FDA
will consider all comments received and
revise the guidance documents as
appropriate.
These guidances are being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
These guidances represent the current
thinking of FDA on ‘‘Air Powered
Dental Handpieces and Air Motors—
Performance Criteria for Safety and
Performance Based Pathway,’’ ‘‘Dental
Ceramics—Performance Criteria for
Safety and Performance Based
Pathway,’’ ‘‘Dental Impression
Materials—Performance Criteria for
Safety and Performance Based
Pathway,’’ and ‘‘Dental Cements—
Performance Criteria for Safety and
Performance Based Pathway.’’ They do
not establish any rights for any person
and are not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
Request for Nominations for
Individuals and Consumer
Organizations for Advisory
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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79617
OMB
control No.
0910–0120
0910–0756
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:
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Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / 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 committee regardless of
their gender identification, religious
affiliation, racial and ethnic
identification, or disability status and,
therefore, encourages nominations of
appropriately qualified candidates from
all groups.
DATES: Any consumer organization
interested in participating in the
selection of an appropriate voting or
nonvoting member to represent
consumer interests on an FDA advisory
committee or panel may send a letter or
email stating that interest to FDA (see
ADDRESSES) by November 14, 2024, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by November 14,
2024.Nominations will be accepted for
current vacancies and for those that will
or may occur through December 31,
2025.
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
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, Silver Spring, MD 20993–0002,
240–402–8054, Christina.Vert@fda.hhs.gov.
Marie DeGregorio, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 1246, Silver Spring, MD
20993–0002, 240–402–4207, Marie.Degregorio@fda.hhs.gov.
Sussan Paydar, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993–0002,
202–657–8533, Sussan.Paydar@fda.hhs.gov.
Joyce Frimpong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2438, Silver Spring, MD 20993–
0002, 301–796–7973, Joyce.Frimpong@fda.hhs.gov.
Yvette Waples, Center for Drug 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.
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.
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Takyiah Stevenson, Center for Drug Evaluation and 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.
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.
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.
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FDA Science Board Advisory Committee.
Blood Products Advisory Committee.
Cellular, Tissue and Gene Therapies Advisory Committee.
Vaccines and Related Biological Products Advisory
Committee.
Anesthetic and Analgesic Drug Products Advisory Committee; Obstetrics, Reproductive and Urologic Drugs
Advisory Committee; Psychopharmacologic Drugs Advisory Committee.
Antimicrobial Drugs Advisory Committee, Drug Safety
and Risk Management Advisory Committee; Non-Prescription Drugs Advisory Committee; Oncologic Drugs
Advisory Committee; Pharmaceutical Science and
Clinical Pharmacology Drugs Advisory Committee.
Cardiovascular and Renal Drugs Advisory Committee;
Dermatologic and Ophthalmic Drugs Advisory Committee; Endocrinologic and Metabolic Drugs Advisory
Committee.
Medical Imaging Advisory Committee.
Gastrointestinal Drugs Advisory Committee; Peripheral
and Central Nervous System 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; General Hospital and
Personal Use Devices Panel; Hematology and Pathology Devices Panel; Immunology Devices Panel; Medical Devices Dispute Resolution Panel; Microbiology
Devices Panel; Molecular and Clinical Genetics Panel;
Radiological Devices Panel.
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TABLE 1—ADVISORY COMMITTEE CONTACTS—Continued
Contact person
Committee/panel
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.
FDA is
requesting nominations for voting and/
SUPPLEMENTARY INFORMATION:
Dental Products Panel; Ophthalmic Devices Panel;
Orthopaedic and Rehabilitation Devices Panel.
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
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—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).
Vaccines and Related Biological Products 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.
Anesthetic and Analgesic Drug Products Advisory Committee—Knowledgeable in the fields of anesthesiology, analgesics (such as: abuse deterrent opioids, novel analgesics, and issues related to
opioid abuse), epidemiology or statistics, and related specialties.
Obstetrics, Reproductive and Urologic Drugs Advisory Committee—Knowledgeable in the fields of
obstetrics, gynecology, urology, pediatrics, epidemiology, or statistics and related specialties.
Psychopharmacologic
Drugs
Advisory
Committee—Knowledgeable
in
the
fields
of
psychopharmacology, psychiatry, epidemiology or statistics, and related specialties.
Antimicrobial Drugs Advisory Committee—Knowledgeable in the fields of infectious disease, internal
medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties.
Drug Safety and Risk Management Advisory Committee—Knowledgeable in risk communication,
risk management, drug safety, medical, behavioral, and biological sciences as they apply to risk
management, and drug abuse.
Non-Prescription Drugs Advisory Committee—Knowledgeable in the fields of internal medicine, family practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and related specialties.
Oncologic Drugs Advisory Committee—Knowledgeable in the fields of general oncology, pediatric
oncology, hematologic oncology, immunologic oncology, biostatistics, and other related professions.
Pharmaceutical Science and Clinical Pharmacology—Knowledgeable in the fields of pharmaceutical
sciences (pharmaceutical manufacturing, bioequivalence research, laboratory analytical techniques, pharmaceutical chemistry, physiochemistry, biochemistry, molecular biology, immunology,
microbiology) and clinical pharmacology (dose-response, pharmacokinetics-pharmacodynamics,
modeling and simulation, pharmacogenomics, clinical trial design, pediatrics and special populations and innovative methods in drug development), biostatistics, related biomedical and pharmacological specialties, current good manufacturing practices, and quality systems implementation.
Cardiovascular and Renal Drugs Advisory Committee—Knowledgeable in the fields of cardiology,
hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics.
Dermatologic and Ophthalmic Drugs Advisory Committee—Knowledgeable in the fields of dermatology, ophthalmology, internal medicine, pathology, immunology, epidemiology or statistics, and
other related professions.
Endocrinologic and Metabolic Drugs Advisory Committee—Knowledgeable in the fields of endocrinology, metabolism, epidemiology or statistics, and related specialties.
Medical Imaging Drugs Advisory Committee—Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics, and related specialties.
1—Voting ...............
Immediately.
1—Voting ...............
October 1, 2025.
1—Voting ...............
April 1, 2025.
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February 1, 2025.
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November 1, 2024.
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December 1, 2025.
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TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED—Continued
Type of vacancy
Peripheral and Central Nervous Systems Drugs Advisory Committee—Knowledgeable in the fields
of neurology, pediatric neurology, epidemiology, 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 ...................................
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.
General Hospital and Personal Use Devices Panel—Internists, pediatricians, neonatologists,
endocrinologists, 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 homeostasis, and
hematological oncology), gynecologists with special interests in gynecological oncology,
cytopathologists, and molecular pathologists with special interests in development of predictive
biomarkers.
Immunology Devices Panel—Persons with experience in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine.
Medical Devices Dispute Resolution Panel—Experts with broad, cross-cutting scientific, clinical, analytical or mediation skills.
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.
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.
Dental Products Panel—Dentists, engineers and scientists who have expertise in the areas of dental implants, dental materials, periodontology, tissue engineering, and dental anatomy.
Ophthalmic Devices Panel—Ophthalmologists with expertise in corneal-external disease, vitreo-retinal surgery, glaucoma, ocular immunology, ocular pathology; optometrists; vision scientists; and
ophthalmic professionals with expertise in clinical trial design, quality of life assessment,
electrophysiology, low vision rehabilitation, and biostatistics.
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.
1—Voting ...............
Immediately.
1—Nonvoting .........
Immediately.
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Immediately.
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October 1, 2024.
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I. Functions and General Description of
the Committee Duties
A. FDA Science Board Advisory
Committee
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Approximate date
needed
Committee/panel/areas of expertise needed
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
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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.
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B. 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 which are 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, and on the quality and
relevance of FDA’s research program
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which provides the scientific support
for regulating these products.
C. Cellular, Tissue, and Gene Therapies
Reviews and evaluates available data
relating to the safety, effectiveness, and
appropriate use of human cells, human
tissues, gene transfer therapies, and
xenotransplantation products which 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, as well as
considers the quality and relevance of
FDA’s research program which provides
scientific support for the regulation of
these products.
D. Vaccines and Related Biological
Products
Reviews and evaluates data
concerning the safety, effectiveness, and
appropriate use of vaccines and related
biological products which 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 which provides
scientific support for the regulation of
these products.
E. Anesthetic and Analgesic Drug
Products Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products including analgesics, e.g.,
abuse-deterrent opioids, novel
analgesics, and issues related to opioid
abuse, and those for use in
anesthesiology, and makes appropriate
recommendations to the Commissioner.
F. Obstetrics, Reproductive and Urologic
Products Advisory Committee
Reviews and evaluates data on the
safety and effectiveness of marketed and
investigational human drug products for
use in the practice of obstetrics,
gynecology, urology, and related
specialties.
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G. 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.
H. 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.
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I. Drug Safety and Risk Management
Advisory Committee
Reviews and evaluates information on
risk management, risk communication,
and quantitative evaluation of
spontaneous reports for drugs for
human use and for any other product for
which FDA has regulatory
responsibility. Advises on the scientific
and medical evaluation of all
information gathered by the Department
of Health and Human Services (HHS)
and the Department of Justice with
regard to safety, efficacy, and abuse
potential of drugs or other substances,
and recommends actions to be taken by
HHS with regard to the marketing,
investigation, and control of such drugs
or other substances.
J. 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
and extramural scientific biomedical
programs in support of FDA’s mission
and regulatory responsibilities.
K. Oncologic 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 cancer.
L. Pharmaceutical Science and Clinical
Pharmacology
Reviews and evaluates scientific,
clinical, and technical issues related to
the safety and effectiveness of drug
products for use in the treatment of a
broad spectrum of human diseases, the
quality characteristics which such drugs
purport or are represented to have, and
as required, any other product for which
FDA has regulatory responsibility, and
make appropriate recommendations to
the Commissioner. The Committee may
also review Agency-sponsored
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intramural and extramural biomedical
research programs in support of FDA’s
drug regulatory responsibilities and its
critical path initiatives related to
improving the efficacy and safety of
drugs and improving the efficiency of
drug development.
M. 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.
N. Dermatologic and Ophthalmic Drugs
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of dermatologic and ophthalmic
disorders.
O. 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.
P. 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.
Q. 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.
R. 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.
S. 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
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Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices
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.
ddrumheller on DSK120RN23PROD with NOTICES1
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.
VerDate Sep<11>2014
17:51 Sep 27, 2024
Jkt 262001
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 45 days of the end of this 30day period, 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 resume. 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 résumé 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.
PO 00000
Frm 00122
Fmt 4703
Sfmt 4703
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: September 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–22292 Filed 9–27–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Statement of Organization, Functions,
and Delegations of Authority
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration’s (FDA), Center for
Veterinary Medicine’s (CVM), Office of
Management (OM) and Office of New
Animal Drug Evaluation (ONADE) have
modified their organizational structures.
The new organizational structures were
approved by the Secretary of Health and
Human Services on July 22, 2024.
FOR FURTHER INFORMATION CONTACT:
Yashika Rahaman, Director, Office of
Planning, Evaluation, and Risk
Management, Office of Finance, Budget,
Acquisitions, and Planning, Food and
Drug Administration, 4041 Powder Mill
Rd., Beltsville, MD 20705–4304, 301–
796–3843.
SUMMARY:
I. Introduction
Part D, Chapter D–B, (Food and Drug
Administration), the Statement of
Organization, Functions and
Delegations of Authority for the
Department of Health and Human
Services (35 FR 3685, February 25,
1970, 60 FR 56606, November 9, 1995,
E:\FR\FM\30SEN1.SGM
30SEN1
]]>Agencies
[Federal Register Volume 89, Number 189 (Monday, September 30, 2024)]
[Notices]
[Pages 79617-79622]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22292]
-----------------------------------------------------------------------
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 79618]]
recommended to serve as a voting or nonvoting consumer representative
may be self-nominated or may be nominated by a consumer organization.
FDA seeks to include the views of individuals on its advisory committee
regardless of their gender identification, religious affiliation,
racial and ethnic identification, or disability status and, therefore,
encourages nominations of appropriately qualified candidates from all
groups.
DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to FDA (see ADDRESSES) by
November 14, 2024, for vacancies listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
(see ADDRESSES) by November 14, 2024.Nominations will be accepted for
current vacancies and for those that will or may occur through December
31, 2025.
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].
Christina Vert, Center for Biologics Blood Products Advisory
Evaluation and Research, Food and Drug Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 71, Silver Spring, MD 20993-
0002, 240-402-8054,
[email protected].
Marie DeGregorio, Center for Biologics Cellular, Tissue and Gene
Evaluation and Research, Food and Drug Therapies Advisory Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 1246, Silver
Spring, MD 20993-0002, 240-402-4207,
[email protected].
Sussan Paydar, Center for Biologics Vaccines and Related
Evaluation and Research, Food and Drug Biological Products Advisory
Administration, 10903 New Hampshire Committee.
Ave., Bldg. 71, Silver Spring, MD 20993-
0002, 202-657-8533,
[email protected].
Joyce Frimpong, Center for Drug Anesthetic and Analgesic Drug
Evaluation and Research, Food and Drug Products Advisory Committee;
Administration, 10903 New Hampshire Obstetrics, Reproductive and
Ave., Bldg. 31, Rm. 2438, Silver Urologic Drugs Advisory
Spring, MD 20993-0002, 301-796-7973, Committee;
[email protected]. Psychopharmacologic Drugs
Advisory Committee.
Yvette Waples, Center for Drug Antimicrobial Drugs Advisory
Evaluation and Research, Food and Drug Committee, Drug Safety and
Administration, 10903 New Hampshire Risk Management Advisory
Ave., Bldg. 31, Rm. 2510, Silver Committee; Non-Prescription
Spring, MD 20993-0002, 301-796-9034, Drugs Advisory Committee;
[email protected]. Oncologic Drugs Advisory
Committee; Pharmaceutical
Science and Clinical
Pharmacology Drugs Advisory
Committee.
LaToya Bonner, Center for Drug Cardiovascular and Renal Drugs
Evaluation and Research, Food and Drug Advisory Committee;
Administration, 10903 New Hampshire Dermatologic and Ophthalmic
Ave., Bldg. 31, Rm. 2428, Silver Drugs Advisory Committee;
Spring, MD 20993-0002, 301-796-2855, Endocrinologic and Metabolic
[email protected]. Drugs Advisory Committee.
Takyiah Stevenson, Center for Drug Medical Imaging Advisory
Evaluation and Research, Food and Drug Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2406, Silver
Spring, MD 20993-0002, 240-402-2507,
[email protected].
Jessica Seo, Center for Drug Evaluation Gastrointestinal Drugs
and Research, Food and Drug Advisory Committee;
Administration, 10903 New Hampshire Peripheral and Central
Ave., Bldg. 31, Rm. 2412, Silver Nervous System Drugs Advisory
Spring, MD 20993-0002, 301-796-7699, Committee.
[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; General Hospital and
Administration, 10903 New Hampshire Personal Use Devices Panel;
Ave., Bldg. 66, Rm. 5211, Silver Hematology and Pathology
Spring, MD 20993-0002, 301-796-6313, Devices Panel; Immunology
[email protected]. Devices Panel; Medical
Devices Dispute Resolution
Panel; Microbiology Devices
Panel; Molecular and Clinical
Genetics Panel; Radiological
Devices Panel.
[[Page 79619]]
Akinola Awojope, Center for Devices and Dental Products Panel;
Radiological Health, Food and Drug Ophthalmic Devices Panel;
Administration, 10903 New Hampshire Orthopaedic and
Ave., Bldg. 66, Rm. 5216, Silver Rehabilitation Devices Panel.
Spring, MD 20993-0002, 301-636-0512,
[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
(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, 2025.
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-- 1--Voting......................... April 1, 2025.
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).
Vaccines and Related Biological Products 1--Voting......................... February 1, 2025.
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.
Anesthetic and Analgesic Drug Products 1--Voting......................... Immediately.
Advisory Committee--Knowledgeable in
the fields of anesthesiology,
analgesics (such as: abuse deterrent
opioids, novel analgesics, and issues
related to opioid abuse), epidemiology
or statistics, and related specialties.
Obstetrics, Reproductive and Urologic 1--Voting......................... Immediately.
Drugs Advisory Committee--Knowledgeable
in the fields of obstetrics,
gynecology, urology, pediatrics,
epidemiology, or statistics and related
specialties.
Psychopharmacologic Drugs Advisory 1--Voting......................... Immediately.
Committee--Knowledgeable in the fields
of psychopharmacology, psychiatry,
epidemiology or statistics, and related
specialties.
Antimicrobial Drugs Advisory Committee-- 1--Voting......................... Immediately.
Knowledgeable in the fields of
infectious disease, internal medicine,
microbiology, pediatrics, epidemiology
or statistics, and related specialties.
Drug Safety and Risk Management Advisory 1--Voting......................... Immediately.
Committee--Knowledgeable in risk
communication, risk management, drug
safety, medical, behavioral, and
biological sciences as they apply to
risk management, and drug abuse.
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.
Oncologic Drugs Advisory Committee-- 1--Voting......................... November 1, 2024.
Knowledgeable in the fields of general
oncology, pediatric oncology,
hematologic oncology, immunologic
oncology, biostatistics, and other
related professions.
Pharmaceutical Science and Clinical 1--Voting......................... December 1, 2025.
Pharmacology--Knowledgeable in the
fields of pharmaceutical sciences
(pharmaceutical manufacturing,
bioequivalence research, laboratory
analytical techniques, pharmaceutical
chemistry, physiochemistry,
biochemistry, molecular biology,
immunology, microbiology) and clinical
pharmacology (dose-response,
pharmacokinetics-pharmacodynamics,
modeling and simulation,
pharmacogenomics, clinical trial
design, pediatrics and special
populations and innovative methods in
drug development), biostatistics,
related biomedical and pharmacological
specialties, current good manufacturing
practices, and quality systems
implementation.
Cardiovascular and Renal Drugs Advisory 1--Voting......................... Immediately.
Committee--Knowledgeable in the fields
of cardiology, hypertension,
arrhythmia, angina, congestive heart
failure, diuresis, and biostatistics.
Dermatologic and Ophthalmic Drugs 1--Voting......................... September 1, 2025.
Advisory Committee--Knowledgeable in
the fields of dermatology,
ophthalmology, internal medicine,
pathology, immunology, epidemiology or
statistics, and other related
professions.
Endocrinologic and Metabolic Drugs 1--Voting......................... Immediately.
Advisory Committee--Knowledgeable in
the fields of endocrinology,
metabolism, epidemiology or statistics,
and related specialties.
Medical Imaging Drugs Advisory 1--Voting......................... Immediately.
Committee--Knowledgeable in the fields
of nuclear medicine, radiology,
epidemiology, statistics, and related
specialties.
[[Page 79620]]
Peripheral and Central Nervous Systems 1--Voting......................... Immediately.
Drugs Advisory Committee--Knowledgeable
in the fields of neurology, pediatric
neurology, epidemiology, 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...................... Immediately.
Otologists, neurotologists,
audiologists.
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.
General Hospital and Personal Use 1--Nonvoting...................... Immediately.
Devices Panel--Internists,
pediatricians, neonatologists,
endocrinologists, 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 homeostasis, and
hematological oncology), gynecologists
with special interests in gynecological
oncology, cytopathologists, and
molecular pathologists with special
interests in development of predictive
biomarkers.
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.
Medical Devices Dispute Resolution 1--Nonvoting...................... October 1, 2024.
Panel--Experts with broad, cross-
cutting scientific, clinical,
analytical or mediation skills.
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, 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.
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.
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.
Ophthalmic Devices Panel-- 1--Nonvoting...................... Immediately.
Ophthalmologists with expertise in
corneal-external disease, vitreo-
retinal surgery, glaucoma, ocular
immunology, ocular pathology;
optometrists; vision scientists; and
ophthalmic professionals with expertise
in clinical trial design, quality of
life assessment, electrophysiology, low
vision rehabilitation, and
biostatistics.
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.
----------------------------------------------------------------------------------------------------------------
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. 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 which are 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, and on the quality and relevance of FDA's
research program
[[Page 79621]]
which provides the scientific support for regulating these products.
C. Cellular, Tissue, and Gene Therapies
Reviews and evaluates available data relating to the safety,
effectiveness, and appropriate use of human cells, human tissues, gene
transfer therapies, and xenotransplantation products which 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, as well as considers the quality and relevance of FDA's
research program which provides scientific support for the regulation
of these products.
D. Vaccines and Related Biological Products
Reviews and evaluates data concerning the safety, effectiveness,
and appropriate use of vaccines and related biological products which
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 which provides scientific support for the regulation
of these products.
E. Anesthetic and Analgesic Drug Products Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products
including analgesics, e.g., abuse-deterrent opioids, novel analgesics,
and issues related to opioid abuse, and those for use in
anesthesiology, and makes appropriate recommendations to the
Commissioner.
F. Obstetrics, Reproductive and Urologic Products Advisory Committee
Reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drug products for use in the
practice of obstetrics, gynecology, urology, and related specialties.
G. 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.
H. 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.
I. Drug Safety and Risk Management Advisory Committee
Reviews and evaluates information on risk management, risk
communication, and quantitative evaluation of spontaneous reports for
drugs for human use and for any other product for which FDA has
regulatory responsibility. Advises on the scientific and medical
evaluation of all information gathered by the Department of Health and
Human Services (HHS) and the Department of Justice with regard to
safety, efficacy, and abuse potential of drugs or other substances, and
recommends actions to be taken by HHS with regard to the marketing,
investigation, and control of such drugs or other substances.
J. 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 and extramural scientific
biomedical programs in support of FDA's mission and regulatory
responsibilities.
K. Oncologic 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 cancer.
L. Pharmaceutical Science and Clinical Pharmacology
Reviews and evaluates scientific, clinical, and technical issues
related to the safety and effectiveness of drug products for use in the
treatment of a broad spectrum of human diseases, the quality
characteristics which such drugs purport or are represented to have,
and as required, any other product for which FDA has regulatory
responsibility, and make appropriate recommendations to the
Commissioner. The Committee may also review Agency-sponsored intramural
and extramural biomedical research programs in support of FDA's drug
regulatory responsibilities and its critical path initiatives related
to improving the efficacy and safety of drugs and improving the
efficiency of drug development.
M. 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.
N. Dermatologic and Ophthalmic Drugs
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of dermatologic and ophthalmic disorders.
O. 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.
P. 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.
Q. 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.
R. 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.
S. 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
[[Page 79622]]
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.
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 45 days of the end of this 30-day period, 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 resume. 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.
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: September 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-22292 Filed 9-27-24; 8:45 am]
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