Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 50338-50343 [2024-12999]
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Federal Register / Vol. 89, No. 115 / Thursday, June 13, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–287–22]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
August 12, 2024.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number: ll, Room C4–26–05,
7500 Security Boulevard Baltimore,
Maryland 21244–1850.
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SUMMARY:
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To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–287–22 Home Office Cost
Statement
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Extension without change of a
previously approved collection; Title of
Information Collection: Home Office
Cost Statement; Use: A home office/
chain organization (HO/CO) submits the
home office cost statement annually as
the documentary support required for a
provider that is a member of the HO/CO
to be reimbursed for HO/CO costs
claimed in the provider’s cost report
(see 42 CFR 413.24(f)(5)(i)(E)(1) and (2)).
The relationship of the HO/CO is that
of a related organization to a provider
(see 42 CFR 413.17). A HO/CO usually
furnishes central management and
administrative services, e.g., centralized
accounting, purchasing, personnel
services, management direction and
control, and other services. To the
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extent that the HO/CO furnishes
services related to patient care to a
provider, the reasonable costs of such
services are included in the provider’s
cost report and are reimbursable as part
of the provider’s costs.
CMS requires the form to determine a
HO/CO’s reasonable cost incurred in
furnishing management and
administrative services to Medicare
providers, each of which includes the
costs in their cost report for
reimbursement. A Medicare-certified
provider includes costs allocated from
the home office cost statement in the
provider’s costs used by CMS for rate
setting; payment refinement activities,
including developing a market basket;
and Medicare Trust Fund projections;
and to support program operations.
Additionally, the Medicare Payment
Advisory Commission (MedPAC) uses
the cost report data to calculate
Medicare margins (a measure of the
relationship between Medicare’s
payments and providers’ Medicare
costs) and analyze data to formulate
Medicare Program recommendations to
Congress. Form Number: CMS–287–22
(OMB control number: 0938–0202);
Frequency: Yearly; Affected Public:
Private Sector; Business or other forprofits, Not-for-profit institutions;
Number of Respondents: 1,646; Total
Annual Responses: 1,646; Total Annual
Hours: 767,036. (For policy questions
regarding this collection contact Gail S.
Duncan at (410) 786–7278.)
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–13032 Filed 6–12–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0008]
Request for Nominations for
Individuals and Consumer
Organizations for Advisory
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
requesting that any consumer
organizations interested in participating
in the selection of voting and/or
nonvoting consumer representatives to
serve on its advisory committees or
panels notify FDA in writing. FDA is
SUMMARY:
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Federal Register / Vol. 89, No. 115 / Thursday, June 13, 2024 / Notices
also requesting nominations for voting
and/or nonvoting consumer
representatives to serve on advisory
committees and/or panels for which
vacancies currently exist or are expected
to occur in the near future. Nominees
recommended to serve as a voting or
nonvoting consumer representative may
be self-nominated or may be nominated
by a consumer organization. FDA seeks
to include the views of individuals on
its advisory committee regardless of
their gender identification, religious
affiliation, racial and ethnic
identification, or disability status and,
therefore, encourages nominations of
appropriately qualified candidates from
all groups.
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 July 29, 2024, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by July 29, 2024.
Nominations will be accepted for
current vacancies and for those that will
or may occur through December 31,
2024.
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/
ADDRESSES:
50339
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
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.
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.
Yvette Waples, Center for Drug Evaluation 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.
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.
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.
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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.
Joannie Adams-White, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5561, Silver Spring, MD
20993–0002, 301–796–5421, Joannie.Adams-White@fda.hhs.gov.
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FDA Science Board Advisory Committee.
Anesthetic and Analgesic Drug Products Advisory Committee; Drug Safety and Risk Management Advisory
Committee; Non-Prescription Drugs Advisory Committee.
Antimicrobial Drugs Advisory Committee; Oncologic
Drugs Advisory Committee.
Cardiovascular and Renal Drugs Advisory Committee;
Endocrinologic and Metabolic Drugs Advisory Committee.
Medical Imaging Advisory Committee; Pharmacy
Compounding Advisory Committee.
Obstetrics, Reproductive and Urologic Drugs Advisory
Committee; Psychopharmacologic 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;
Microbiology Devices Panel; Molecular and Clinical
Genetics Panel; Radiological Devices Panel.
Dental Products Panel; Ophthalmic Devices Panel;
Orthopaedic and Rehabilitation Devices Panel.
Medical Devices Dispute Resolution Panel.
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FDA is
requesting nominations for voting and/
SUPPLEMENTARY INFORMATION:
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 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.
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.
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.
Antimicrobial Drugs Advisory Committee—Knowledgeable in the fields of infectious disease, internal
medicine, microbiology, pediatrics, epidemiology or statistics, 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.
Cardiovascular and Renal Drugs Advisory Committee—Knowledgeable in the fields of cardiology,
hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics.
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.
Pharmacy Compounding Advisory Committee—Knowledgeable in the fields of pharmaceutical
compounding, pharmaceutical manufacturing, pharmacy, medicine, 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.
Peripheral and Central Nervous Systems Drugs Advisory Committee—Knowledgeable in the fields
of neurology, neuropharmacology, neuropathology, otolaryngology, 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.
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.
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.
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November 1, 2024.
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1—Voting ...............
July 2024.
1—Voting ...............
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TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED—Continued
Type of vacancy
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.
Medical Devices Dispute Resolution Panel—Experts with broad, cross-cutting scientific, clinical, analytical or mediation skills.
1—Nonvoting .........
Immediately.
1—Nonvoting .........
Immediately.
1—Nonvoting .........
Immediately.
1—Nonvoting .........
Immediately.
1—Nonvoting .........
Immediately.
1—Nonvoting .........
October 1, 2024.
I. Functions and General Description of
the Committee Duties
C. Drug Safety and Risk Management
Advisory Committee
A. FDA Science Board 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 regarding
safety, efficacy, and abuse potential of
drugs or other substances, and
recommends actions to be taken by HHS
regarding the marketing, investigation,
and control of such drugs or other
substances.
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. Anesthetic and Analgesic Drug
Products Advisory Committee
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Approximate date
needed
Committee/panel/areas of expertise needed
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
of Food and Drugs Administration.
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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
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and combinations thereof. The
Committee may also conduct peer
review of Agency-sponsored intramural
and extramural scientific biomedical
programs in support of FDA’s mission
and regulatory responsibilities.
E. Antimicrobial Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of infectious diseases and disorders.
F. 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.
G. 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.
H. 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.
I. Medical Imaging Drugs Advisory
Committee
Reviews and evaluates data
concerning the safety and effectiveness
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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. Pharmacy Compounding Drugs
Advisory Committee
Provides advice on scientific,
technical, and medical issues
concerning drug compounding under
sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act, and, as
required, any other product for which
FDA has regulatory responsibility.
K. Obstetrics, Reproductive, and
Urologic Drugs 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.
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.
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M. 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.
N. 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
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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.
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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 résumé.
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.
FDA will review all nominations
received within the specified
timeframes and prepare a ballot
containing the names of qualified
nominees. Names of qualified nominees
not selected will remain on a list of
eligible nominees and be reviewed
periodically by FDA to determine
continued interest. After preparing 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
E:\FR\FM\13JNN1.SGM
13JNN1
Federal Register / Vol. 89, No. 115 / Thursday, June 13, 2024 / Notices
U.S.C. 1001 et seq.) and 21 CFR part 14,
relating to advisory committees.
Dated: June 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–12999 Filed 6–12–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–4466]
Jonathan R. Shaver: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) permanently
debarring Jonathan R. Shaver from
providing services in any capacity to a
person that has an approved or pending
drug product application. FDA bases
this order on a finding that Mr. Shaver
was convicted of a felony under Federal
law for conduct that relates to the
regulation of a drug product under the
FD&C Act. Mr. Shaver was given notice
of the proposed debarment and an
opportunity to request a hearing within
the timeframe prescribed by regulation.
As of February 16, 2024 (30 days after
receipt of the notice), Mr. Shaver has
not responded. Mr. Shaver’s failure to
respond and request a hearing
constitutes a waiver of Mr. Shaver’s
right to a hearing concerning this
matter.
DATES: This order is applicable June 13,
2024.
ADDRESSES: Any application by Mr.
Shaver for special termination of
debarment under section 306(d)(4) of
the FD&C Act (21 U.S.C. 335a(d)(4)) may
be submitted at any time as follows:
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
Electronic Submissions
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
An application submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
application will be made public, you are
solely responsible for ensuring that your
application does not include any
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
VerDate Sep<11>2014
19:28 Jun 12, 2024
Jkt 262001
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
application, that information will be
posted on https://www.regulations.gov.
• If you want to submit an
application with confidential
information that you do not wish to be
made available to the public, submit the
application as a written/paper
submission and in the manner detailed
(see ‘‘Written/Paper Submissions’’ and
‘‘Instructions’’).
Written/Paper Submissions
• 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 a written/paper application
submitted to the Dockets Management
Staff, FDA will post your application, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All applications must
include the Docket No. FDA–2023–N–
4466. Received applications 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 an application with confidential
information that you do not wish to be
made publicly available, submit your
application 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 your application.
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
Staff. Any information marked as
‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
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50343
Docket: For access to the docket, go to
https://www.regulations.gov and insert
the docket number, found in brackets in
the heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852 between 9 a.m.
and 4 p.m., Monday through Friday,
240–402–7500. Publicly available
submissions may be seen in the docket.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Compliance
and Enforcement, Office of Policy,
Compliance, and Enforcement, Office of
Regulatory Affairs, Food and Drug
Administration, 240–402–8743,
debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(a)(2)(B) of the FD&C Act
requires debarment of an individual
from providing services in any capacity
to a person that has an approved or
pending drug product application if
FDA finds that the individual has been
convicted of a felony under Federal law
for conduct relating to the regulation of
any drug product under the FD&C Act.
On September 19, 2023, Mr. Shaver was
convicted as defined in section 306(l)(1)
of the FD&C Act in the U.S. District
Court for the Eastern District of TexasBeaumont Division when the court
accepted his plea of guilty and entered
judgment against him for the offense of
Conspiracy to Traffick in Drugs with
Counterfeit Mark in violation of 18
U.S.C. 371 and 18 U.S.C. 2320(a)(4). The
underlying facts supporting the
conviction are as follows:
As contained in the Second
Superseding Indictment, and as
contained in Factual Basis and
Stipulation memorandum, between
April 2015 and January 2019, Mr.
Shaver conspired to distribute
misbranded and counterfeit cough
syrup. Mr. Shaver worked for Woodfield
Pharmaceutical LLC, within its
manufacturing and operations division
and then later as Production Manager.
Woodfield Pharmaceutical LLC was a
part of a group of pharmaceutical
companies which included Woodfield
Pharmaceutical LLC, a contract
manufacturing company, and Woodfield
Distribution LLC, a third-party logistics
company (collectively, Woodfield). On
April 25, 2014, Woodfield acquired
Pernix Manufacturing LLC (Pernix). In
January 2014, Pernix entered into an
agreement with Byron A. Marshall and
his Drug Trafficking Organization (DTO)
to copy and manufacture cough syrup
according to the directions of Marshall
and his associates. Marshall was not
E:\FR\FM\13JNN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 115 (Thursday, June 13, 2024)]
[Notices]
[Pages 50338-50343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12999]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0008]
Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting
that any consumer organizations interested in participating in the
selection of voting and/or nonvoting consumer representatives to serve
on its advisory committees or panels notify FDA in writing. FDA is
[[Page 50339]]
also requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may be self-nominated or may be nominated by a consumer
organization. FDA seeks to include the views of individuals on its
advisory committee regardless of their gender identification, religious
affiliation, racial and ethnic identification, or disability status
and, therefore, encourages nominations of appropriately qualified
candidates from all groups.
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 July
29, 2024, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by July 29, 2024. Nominations will be accepted for current
vacancies and for those that will or may occur through December 31,
2024.
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].
Moon Hee Choi, Center for Drug Anesthetic and Analgesic Drug
Evaluation and Research, Food and Drug Products Advisory Committee;
Administration, 10903 New Hampshire Drug Safety and Risk
Ave., Bldg. 31, Rm. 2434, Silver Management Advisory
Spring, MD 20993-0002, 301-796-2894, Committee; Non-Prescription
[email protected]. Drugs Advisory Committee.
Yvette Waples, Center for Drug Antimicrobial Drugs Advisory
Evaluation Research, Food and Drug Committee; Oncologic Drugs
Administration, 10903 New Hampshire Advisory Committee.
Ave., Bldg. 31, Rm. 2510, Silver
Spring, MD 20993-0002, 301-796-9034,
[email protected].
LaToya Bonner, Center for Drug Cardiovascular and Renal Drugs
Evaluation and Research, Food and Drug Advisory Committee;
Administration, 10903 New Hampshire Endocrinologic and Metabolic
Ave., Bldg. 31, Rm. 2428, Silver Drugs Advisory Committee.
Spring, MD 20993-0002, 301-796-2855,
[email protected].
Takyiah Stevenson, Center for Drug Medical Imaging Advisory
Evaluation Research, Food and Drug Committee; Pharmacy
Administration, 10903 New Hampshire Compounding Advisory
Ave., Bldg. 31, Rm. 2406, Silver Committee.
Spring, MD 20993-0002, 240-402-2507,
[email protected].
Joyce Frimpong, Center for Drug Obstetrics, Reproductive and
Evaluation and Research, Food and Drug Urologic Drugs Advisory
Administration, 10903 New Hampshire Committee;
Ave., Bldg. 31, Rm. 2426, Silver Psychopharmacologic Drugs
Spring, MD 20993-0002, 301-796-7973, Advisory Committee.
[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].
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; Microbiology
Devices Panel; Molecular and
Clinical Genetics Panel;
Radiological Devices Panel.
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].
Joannie Adams-White, Center for Devices Medical Devices Dispute
and Radiological Health, Food and Drug Resolution Panel.
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5561, Silver
Spring, MD 20993-0002, 301-796-5421,
[email protected].
------------------------------------------------------------------------
[[Page 50340]]
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.
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.
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.
Antimicrobial Drugs Advisory Committee-- 1--Voting......................... Immediately.
Knowledgeable in the fields of
infectious disease, internal medicine,
microbiology, pediatrics, epidemiology
or statistics, 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.
Cardiovascular and Renal Drugs Advisory 1--Voting......................... Immediately.
Committee--Knowledgeable in the fields
of cardiology, hypertension,
arrhythmia, angina, congestive heart
failure, diuresis, and biostatistics.
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.
Pharmacy Compounding Advisory Committee-- 1--Voting......................... Immediately.
Knowledgeable in the fields of
pharmaceutical compounding,
pharmaceutical manufacturing, pharmacy,
medicine, and related specialties.
Obstetrics, Reproductive and Urologic 1--Voting......................... July 2024.
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.
Peripheral and Central Nervous Systems 1--Voting......................... Immediately.
Drugs Advisory Committee--Knowledgeable
in the fields of neurology,
neuropharmacology, neuropathology,
otolaryngology, 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...................... Immediately.
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.
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.
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.
[[Page 50341]]
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.
Medical Devices Dispute Resolution 1--Nonvoting...................... October 1, 2024.
Panel--Experts with broad, cross-
cutting scientific, clinical,
analytical or mediation skills.
----------------------------------------------------------------------------------------------------------------
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. 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 of Food and
Drugs Administration.
C. 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 regarding safety,
efficacy, and abuse potential of drugs or other substances, and
recommends actions to be taken by HHS regarding the marketing,
investigation, and control of such drugs or other substances.
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 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. 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.
G. 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.
H. 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.
I. Medical Imaging Drugs Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
[[Page 50342]]
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. Pharmacy Compounding Drugs Advisory Committee
Provides advice on scientific, technical, and medical issues
concerning drug compounding under sections 503A and 503B of the Federal
Food, Drug, and Cosmetic Act, and, as required, any other product for
which FDA has regulatory responsibility.
K. Obstetrics, Reproductive, and Urologic Drugs 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.
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. 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.
N. 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.
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
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 of qualified nominees not selected will remain on a
list of eligible nominees and be reviewed periodically by FDA to
determine continued interest. After preparing 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
[[Page 50343]]
U.S.C. 1001 et seq.) and 21 CFR part 14, relating to advisory
committees.
Dated: June 10, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12999 Filed 6-12-24; 8:45 am]
BILLING CODE 4164-01-P
