Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 62421-62426 [2022-22305]
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Federal Register / Vol. 87, No. 198 / Friday, October 14, 2022 / Notices
worked to address this priority in part
by performing Chemistry,
Manufacturing, and Controls (CMC)
reviews for CDER-regulated and CBERregulated products. CDER or CBER may
issue a product quality, or CMC, IR as
a result of CMC assessments conducted
in support of the application.
IRs from both CDER and CBER are
expected to follow Four-Part Harmony
in which reviewers are expected to
communicate: (1) what was provided,
(2) what is the issue or deficiency, (3)
what is needed, and (4) why it is
needed. This expectation can be found
in CDER’s Manual of Policies and
Procedures (MAPP) 5016.8,
‘‘Communication Guidelines for
Quality-Related Information Requests
and Deficiencies.’’ As a result of FDA’s
implementation of Four-Part Harmony
in CMC–IRs, sponsors should
understand what information FDA
needs to continue their review. The
PDUFA VII goals letter includes
commitments for FDA to update and
conduct training on existing policies
and procedures (MAPPs and Standard
Operating Policy and Procedure
(SOPPs)), to reflect Four-Part Harmony.
CDER MAPP 5016.8, ‘‘Communication
Guidelines for Quality-Related
Information Requests and Deficiencies’’
will be revised and made public. CBER
SOPP 8401.1, ‘‘Issuance of and Review
of Responses to Information Request
Communications to Pending
Applications’’ will also be revised.
In addition to updating the
documents and conducting training,
FDA is committed to contracting with
an independent third party to assess
current practices of CDER, CBER, and
sponsors in communicating through
product quality IRs during application
review and effectiveness of Four-Part
Harmony. This assessment will identify
best practices and areas of improvement
in communications between FDA
review staff and sponsors through
product quality IRs and is the subject of
this task order.
The Statement of Work can be
accessed at: https://www.fda.gov/
industry/prescription-drug-user-fee-
amendments/pdufa-vii-assessment-fdaand-sponsor-communications-throughproduct-quality-information-requests.
Dated: October 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–22335 Filed 10–13–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0008]
Request for Nominations for
Individuals and Consumer
Organizations for Advisory
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
requesting that any consumer
organizations interested in participating
in the selection of voting and/or
nonvoting consumer representatives to
serve on its advisory committees or
panels notify FDA in writing. FDA is
also requesting nominations for voting
and/or nonvoting consumer
representatives to serve on advisory
committees and/or panels for which
vacancies currently exist or are expected
to occur in the near future. Nominees
recommended to serve as a voting or
nonvoting consumer representative may
be self-nominated or may be nominated
by a consumer organization. FDA seeks
to include the views of 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
SUMMARY:
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 28, 2022, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by November 28,
2022. Nominations will be accepted for
current vacancies and for those that will
or may occur through December 31,
2023.
All statements of interest
from consumer organizations interested
in participating in the selection process
should be submitted electronically to
ACOMSSubmissions@fda.hhs.gov or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5122, Silver Spring,
MD 20993–0002.
Consumer representative nominations
should be submitted electronically by
logging into the FDA Advisory
Committee Membership Nomination
Portal: https://www.accessdata.fda.gov/
scripts/FACTRSPortal/FACTRS/
index.cfm, or by mail to Advisory
Committee Oversight and Management
Staff, 10903 New Hampshire Ave., Bldg.
32, Rm. 5122, Silver Spring, MD 20993–
0002. Additional information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s website at https://
www.fda.gov/AdvisoryCommittees/
default.htm.
ADDRESSES:
FOR 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, kimberly.hamilton@
fda.hhs.gov.
For questions relating to specific
advisory committees or panels, contact
the appropriate contact person listed in
table 1.
TABLE 1—ADVISORY COMMITTEE CONTACTS
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Contact person
Committee/panel
Rakesh Raghuwanshi, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3309, Silver
Spring, MD 20993–0002, 301–796–4769, Rakesh.Raghuwanshi@
fda.hhs.gov.
Prabhakara Atreya, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 1226, Silver Spring, MD 20993–0002, 240–402–8006,
Prabhakara.Altreya@fda.hhs.gov.
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FDA Science Board Advisory Committee.
Allergenic Products Advisory Committee.
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TABLE 1—ADVISORY COMMITTEE CONTACTS—Continued
Contact person
Committee/panel
Moon Hee Choi, Center for Drugs Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm.
2434, Silver Spring, MD 20993–0002, 301–796–2894,
MoonHee.Choi@fda.hhs.gov.
She-Chia Chen, Center for Drugs Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 31 Rm.
2438, Silver Spring, MD 20993–0002, 240–402–5343, SheChia.Chen@fda.hhs.gov.
Jessica Seo, Center for Drugs Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm.
2412, Silver Spring, MD 20993–0002, 301–796–7699, Jessica.Seo@
fda.hhs.gov.
Yvette Staples, Center for Drugs Evaluation Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2438, Silver Spring, MD 20993–0002, 301–837–7126, Yvette.Staples@
fda.hhs.gov.
LaToya Bonner, Center for Drugs 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 Drugs 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 Drugs Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm.
2462, Silver Spring, MD 20993–0002, 301–796–7973,
Joyce.Frimpong@fda.hhs.gov.
Candace Nalls, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5211, Silver Spring, MD 20993–0002, 301–636–0510,
Candace.Nalls@fda.hhs.gov.
James Swink, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5211, Silver Spring, MD 20993–0002, 301–796–6313,
James.Swink@fda.hhs.gov.
Akinola Awojope, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5216, Silver Spring, MD 20993–0002, 301–636–0512,
Akinola.Awojope@fda.hhs.gov.
Jarrod Collier, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.
5211, Silver Spring, MD 20993–0002, 240–672–5763,
Jarrod.Collier@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.
FDA is
requesting nominations for voting and/
SUPPLEMENTARY INFORMATION:
Anesthetic and Analgesic Drug Products Advisory Committee, NonPrescription Drugs Advisory Committee.
Antimicrobial Drugs Advisory Committee.
Arthritis Advisory Committee, Peripheral and Central Nervous System
Drugs Advisory Committee.
Cardiovascular and Renal Drugs Advisory Committee, Medical Imaging
Drugs Advisory Committee.
Endocrinologic and Metabolic Drugs Advisory Committee.
Pharmacy Compounding Advisory Committee.
Psychopharmacologic Drugs Advisory Committee.
Anesthesiology and Respiratory Therapy Devices Panel; Clinical
Chemistry and Clinical Toxicology Devices Panel; Ear, Nose and
Throat Devices Panel; Gastroenterology-Urology Devices Panel;
General and Plastic Surgery Devices Panel.
Circulatory System Devices Panel; Microbiology Devices Panel.
Dental Products Panel; Obstetrics and Gynecology Devices Panel;
Orthopaedic and Rehabilitation Devices Panel.
General Hospital and Personal Use Devices Panel; Hematology and
Pathology Devices Panel; Molecular and Clinical Genetics Panel;
Ophthalmic Devices Panel; Radiological Devices Panel.
National Mammography Quality Assurance Advisory Committee.
or nonvoting consumer representatives
for the vacancies listed in table 2:
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TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED
Approximate date
needed
Committee/panel/areas of expertise needed
Type of vacancy
FDA Science Board Advisory Committee—The Science Board provides advice to the Commissioner
of Food and Drugs Administration (Commissioner) and other appropriate officials on specific complex scientific and technical issues important to FDA and its mission, including emerging issues
within the scientific community. Additionally, the Science Board provides advice that supports the
Agency in keeping pace with technical and scientific developments, including in regulatory science;
and input into the Agency’s research agenda, and on upgrading its scientific and research facilities
and training opportunities. It also provides, where requested, expert review of Agency-sponsored
intramural and extramural scientific research programs.
Allergenic Products Advisory Committee—Knowledgeable in the fields of allergy, immunology, pediatrics, internal medicine, biochemistry, and related specialties.
1—Voting ............
Immediately.
1—Voting ............
Immediately.
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62423
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TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED—Continued
Approximate date
needed
Committee/panel/areas of expertise needed
Type of vacancy
Anesthetic and Analgesic Drug Products Advisory Committee—Knowledgeable in the fields of anesthesiology, surgery, epidemiology or statistics, and related specialties.
Non-Prescription Drugs Advisory Committee—Knowledgeable in the fields of internal medicine, family
practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and related specialties.
Antimicrobial Drugs Advisory Committee—Knowledgeable in the fields of infectious disease, internal
medicine, microbiology, pediatrics, epidemiology or statistics, and related specialties.
Arthritis Advisory Committee—Knowledgeable in the fields of arthritis, rheumatology, orthopedics, epidemiology or statistics, analgesics, and related specialties.
Peripheral and Central Nervous Systems Drugs Advisory Committee—Knowledgeable in the fields of
neurology, neuropharmacology, neuropathology, otolaryngology, epidemiology or statistics, and related specialties.
Cardiovascular and Renal Drugs Advisory Committee—Knowledgeable in the fields of cardiology, hypertension, arrhythmia, angina, congestive heart failure, diuresis, and biostatistics.
Medical Imaging Drugs Advisory Committee—Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics, and related specialties.
Endocrinologic and Metabolic Drugs Advisory Committee—Knowledgeable in the fields of endocrinology, metabolism, epidemiology or statistics, and related specialties.
Pharmacy Compounding Advisory Committee—Knowledgeable in the fields of pharmaceutical
compounding, pharmaceutical manufacturing, pharmacy, medicine, and other related specialties.
Psychopharmacologic Drugs Advisory Committee—Knowledgeable in the fields of
psychopharmacology, psychiatry, epidemiology or statistics, and related specialties.
Anesthesiology and Respiratory Therapy Devices Panel—Anesthesiologists, pulmonary medicine specialists, or other experts who have specialized interests in ventilator support, pharmacology, physiology, or the effects and complications of anesthesia.
Clinical Chemistry and Clinical Toxicology Devices Panel—Doctor of Medicine or Philosophy with experience in clinical chemistry (e.g., cardiac markers), clinical toxicology, clinical pathology, clinical
laboratory medicine, and endocrinology.
Ear, Nose and Throat Devices Panel—Otologists, neurotologists, audiologists ......................................
Gastroenterology-Urology Devices Panel—Gastroenterologists, urologists, and nephrologists ..............
General and Plastic Surgery Devices Panel—Surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic, and endoscopic); dermatologists; experts in biomaterials, lasers, wound
healing, and quality of life; and biostatisticians.
Circulatory System Devices Panel—Interventional cardiologists, electrophysiologists, invasive (vascular) radiologists, vascular and cardiothoracic surgeons, and cardiologists with special interest in
congestive heart failure.
Microbiology Devices Panel—Clinicians with an expertise in infectious disease, e.g., pulmonary disease specialists, sexually transmitted disease specialists, pediatric infectious disease specialists,
experts in tropical medicine and emerging infectious diseases, mycologists; clinical microbiologists
and virologists; clinical virology and microbiology laboratory directors, with expertise in clinical diagnosis and in vitro diagnostic assays, e.g., hepatologists; molecular biologists.
Dental Products Panel—Dentists, engineers and scientists who have expertise in the areas of dental
implants, dental materials, periodontology, tissue engineering, and dental anatomy.
Obstetrics and Gynecology Devices Panel—Experts in perinatology, embryology, reproductive endocrinology, pediatric gynecology, gynecological oncology, operative hysteroscopy, pelviscopy,
electrosurgery, laser surgery, assisted reproductive technologies, contraception, postoperative adhesions, and cervical cancer and colposcopy; biostatisticians and engineers with experience in obstetrics/gynecology devices; urogynecologists; experts in breast care; experts in gynecology in the
older patient; experts in diagnostic (optical) spectroscopy; experts in midwifery; labor and delivery
nursing.
Orthopaedic and Rehabilitation Devices Panel—Orthopedic surgeons (joint spine, trauma, and pediatric); rheumatologists; engineers (biomedical, biomaterials, and biomechanical); experts in rehabilitation medicine, sports medicine, and connective tissue engineering; and biostatisticians.
General Hospital and Personal Use Devices Panel—Internists, pediatricians, neonatologists,
endocrinologists, gerontologists, nurses, biomedical engineers, or microbiologists/infection control
practitioners or experts.
Hematology and Pathology Devices Panel—Hematologists (benign and/or malignant hematology),
hematopathologists (general and special hematology, coagulation and hemostasis, and
hematological oncology), gynecologists with special interests in gynecological oncology,
cytopathologists, and molecular pathologists with special interests in development of predictive biomarkers.
Molecular and Clinical Genetics Devices Panel—Experts in human genetics and in the clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, neonatologists. The
Agency is also interested in considering candidates with training in inborn errors of metabolism,
biochemical and/or molecular genetics, population genetics, epidemiology, and related statistical
training. Additionally, individuals with experience in genetic counseling, medical ethics, as well as
ancillary fields of study will be considered.
1—Voting ............
April 1, 2023.
1—Voting ............
Immediately.
1—Voting ............
May 1, 2023.
1—Voting ............
December 1, 2023.
1—Voting ............
February 1, 2023.
1—Voting ............
July 1, 2023.
1—Voting ............
Immediately.
1—Voting ............
Immediately.
1—Voting ............
October 1, 2023.
1—Voting ............
Immediately.
1—Nonvoting ......
Immediately.
1—Nonvoting ......
Immediately.
1—Nonvoting ......
1—Nonvoting ......
1—Nonvoting ......
November 1, 2023.
Immediately.
Immediately.
1—Nonvoting ......
Immediately.
1—Nonvoting ......
Immediately.
1—Nonvoting ......
Immediately.
1—Nonvoting ......
Immediately.
1—Nonvoting ......
Immediately.
1—Nonvoting ......
Immediately.
1—Nonvoting ......
Immediately.
1—Nonvoting ......
Immediately.
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TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED—Continued
Type of vacancy
Ophthalmic Devices Panel—Ophthalmists with expertise in corneal-external disease, vitreo-retinal surgery, glaucoma, ocular immunology, ocular pathology; optometrists; vision scientists; and ophthalmic professionals with expertise in clinical trial design, quality of life assessment,
electrophysiology, low vision rehabilitation, and biostatistics.
Radiological Devices Panel—Physicians with experience in general radiology, mammography,
ultrasound, magnetic resonance, computed tomography, other radiological subspecialties, and radiation oncology; scientists with experience in diagnostic devices, radiation physics, statistical analysis, digital imaging, and image analysis.
National Mammography Quality Assurance Advisory Committee—Physician, practitioner, or other
health professional whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography.
1—Nonvoting ......
Immediately.
1—Nonvoting ......
Immediately.
3—Voting ............
Immediately.
I. Functions and General Description of
the Committee Duties
C. Anesthetic and Analgesic Drug
Products Advisory Committee
of arthritis, rheumatism, and related
diseases.
A. FDA Science Board Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in anesthesiology
and surgery.
G. Peripheral and Central Nervous
System Drugs Advisory Committee
The Science Board Advisory
Committee (Science Board) provides
advice to the Commissioner of Food and
Drugs (Commissioner) and other
appropriate officials on specific
complex scientific and technical issues
important to FDA and its mission,
including emerging issues within the
scientific community. Additionally, the
Science Board provides advice that
supports the Agency in keeping pace
with technical and scientific
developments, including in regulatory
science, and input into the Agency’s
research agenda and on upgrading its
scientific and research facilities and
training opportunities. It also provides,
where requested, expert review of
Agency-sponsored intramural and
extramural scientific research programs.
B. Allergenic Products Advisory
Committee
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Approximate date
needed
Committee/panel/areas of expertise needed
Reviews and evaluates available data
concerning the safety, effectiveness, and
adequacy of labeling of marketed and
investigational allergenic biological
products or materials that are
administered to humans for the
diagnosis, prevention, or treatment of
allergies and allergic disease and makes
appropriate recommendations to the
Commissioner regarding the affirmation
or revocation of biological product
licenses, on the safety, effectiveness,
and labeling of the products, on clinical
and laboratory studies of such products,
on amendments or revisions to
regulations governing the manufacture,
testing, and licensing of allergenic
biological products, and on the quality
and relevance of FDA’s research
programs.
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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
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. Arthritis Advisory Committee
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
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Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of neurologic diseases.
H. Cardiovascular and Renal Drugs
Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of cardiovascular and renal disorders.
I. Medical Imaging Drugs Advisory
Committee
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in diagnostic and
therapeutic procedures using
radioactive pharmaceuticals and
contrast media used in diagnostic
radiology.
J. Endocrinologic and Metabolic Drugs
Advisory Committee
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of endocrine and metabolic disorders.
K. Pharmacy Compounding Advisory
Committee
Provides advice on scientific,
technical, and medical issues
concerning drug compounding by
pharmacists and licensed practitioners.
L. Psychopharmacologic Drugs Advisory
Committee
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
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drug products for use in the practice of
psychiatry and related fields.
M. Medical Devices Advisory Committee
Panels
The Medical Devices Advisory
Committee has established certain
panels to review and evaluate data on
the safety and effectiveness of marketed
and investigational devices and make
recommendations for their regulation.
With the exception of the Medical
Devices Dispute Resolution Panel, each
panel, according to its specialty area: (1)
advises on the classification or
reclassification of devices into one of
three regulatory categories and advises
on any possible risks to health
associated with the use of devices; (2)
advises on formulation of product
development protocols; (3) reviews
premarket approval applications for
medical devices; (4) reviews guidelines
and guidance documents; (5)
recommends exemption of certain
devices from the application of portions
of the Federal Food, Drug, and Cosmetic
Act; (6) advises on the necessity to ban
a device; and (7) responds to requests
from the Agency to review and make
recommendations on specific issues or
problems concerning the safety and
effectiveness of devices. With the
exception of the Medical Devices
Dispute Resolution Panel, each panel,
according to its specialty area, may also
make appropriate recommendations to
the Commissioner on issues relating to
the design of clinical studies regarding
the safety and effectiveness of marketed
and investigational devices.
The Dental Products Panel reviews
and evaluates data concerning the safety
and effectiveness of marketed and
investigational products for use in
dentistry, endodontics or bone
physiology relative to the oral and
maxillofacial area.
The Medical Devices Dispute
Resolution Panel provides advice to the
Commissioner on complex or contested
scientific issues between FDA and
medical device sponsors, applicants, or
manufacturers relating to specific
products, marketing applications,
regulatory decisions and actions by
FDA, and Agency guidance and
policies. The Panel makes
recommendations on issues that are
lacking resolution, are highly complex
in nature, or result from challenges to
regular advisory panel proceedings or
Agency decisions or actions.
N. National Mammography Quality
Assurance Advisory Committee
Advises the Agency on the
development of appropriate quality
standards and regulations for
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mammography facilities; standards and
regulations for bodies accrediting
mammography facilities under this
program; regulations with respect to
sanctions; procedures for monitoring
compliance with standards; establishing
a mechanism to investigate consumer
complaints; reporting new
developments concerning breast
imaging that should be considered in
the oversight of mammography
facilities. The Committee also advises
on determining whether there exists a
shortage of mammography facilities in
rural and health professional shortage
areas and determining the effects of
personnel on access to the services of
such facilities in such areas;
determining whether there will be a
sufficient number of medical physicists
after October 1, 1999; and determining
the costs and benefits of compliance
with these requirements.
II. Criteria for Members
Persons nominated for membership as
consumer representatives on
committees or panels should meet the
following criteria: (1) demonstrate an
affiliation with and/or active
participation in consumer or
community-based organizations, (2) be
able to analyze technical data, (3)
understand research design, (4) discuss
benefits and risks, and (5) evaluate the
safety and efficacy of products under
review. The consumer representative
should be able to represent the
consumer perspective on issues and
actions before the advisory committee;
serve as a liaison between the
committee and interested consumers,
associations, coalitions, and consumer
organizations; and facilitate dialogue
with the advisory committees on
scientific issues that affect consumers.
III. Selection Procedures
Selection of members representing
consumer interests is conducted
through procedures that include the use
of organizations representing the public
interest and public advocacy groups.
These organizations recommend
nominees for the Agency’s selection.
Representatives from the consumer
health branches of Federal, State, and
local governments also may participate
in the selection process. Any consumer
organization interested in participating
in the selection of an appropriate voting
or nonvoting member to represent
consumer interests should send a letter
stating that interest to FDA (see
ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 45 days, FDA
will compile a list of consumer
organizations that will participate in the
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selection process and will forward to
each such organization a ballot listing at
least two qualified nominees selected by
the Agency based on the nominations
received, together with each nominee’s
current curriculum vitae or re´sume´.
Ballots are to be filled out and returned
to FDA within 30 days. The nominee
receiving the highest number of votes
ordinarily will be selected to serve as
the member representing consumer
interests for that particular advisory
committee or panel.
IV. Nomination Procedures
Any interested person or organization
may nominate one or more qualified
persons to represent consumer interests
on the Agency’s advisory committees or
panels. Self-nominations are also
accepted. Nominations must include a
current, complete re´sume´ or curriculum
vitae for each nominee and a signed
copy of the Acknowledgement and
Consent form available at the FDA
Advisory Nomination Portal (see
ADDRESSES), and a list of consumer or
community-based organizations for
which the candidate can demonstrate
active participation.
Nominations must also specify the
advisory committee(s) or panel(s) for
which the nominee is recommended. In
addition, nominations must also
acknowledge that the nominee is aware
of the nomination unless selfnominated. FDA will ask potential
candidates to provide detailed
information concerning such matters as
financial holdings, employment, and
research grants and/or contracts to
permit evaluation of possible sources of
conflicts of interest. Members will be
invited to serve for terms of up to 4
years.
FDA will review all nominations
received within the specified
timeframes and prepare a ballot
containing the names of qualified
nominees. Names not selected will
remain on a list of eligible nominees
and be reviewed periodically by FDA to
determine continued interest. 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.
E:\FR\FM\14OCN1.SGM
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Federal Register / Vol. 87, No. 198 / Friday, October 14, 2022 / Notices
Dated: October 6, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Text Analysis of Proprietary Drug
Name Interpretations
OMB Control Number 0910—NEW
[FR Doc. 2022–22305 Filed 10–13–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–1026]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Text Analysis of
Proprietary Drug Name Interpretations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by November
14, 2022.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The title
of this information collection is ‘‘Text
Analysis of Proprietary Drug Name
Interpretations.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
ADDRESSES:
jspears on DSK121TN23PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
For copies of the questionnaire: Office
of Prescription Drug Promotion (OPDP)
Research Team, DTCresearch@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:22 Oct 13, 2022
Jkt 259001
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct
research relating to health information.
Section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 393(d)(2)(C)) authorizes
FDA to conduct research relating to
drugs and other FDA-regulated products
in carrying out the provisions of the
FD&C Act.
The Office of Prescription Drug
Promotion’s (OPDP) mission is to
protect the public health by helping to
ensure that prescription drug promotion
is truthful, balanced, and accurately
communicated. OPDP’s research
program provides scientific evidence to
help ensure that our policies related to
prescription drug promotion will have
the greatest benefit to public health.
Toward that end, we have consistently
conducted research to evaluate the
aspects of prescription drug promotion
that are most central to our mission. Our
research focuses in particular on three
main topic areas: advertising features,
including content and format; target
populations; and research quality.
Through the evaluation of advertising
features, we assess how elements such
as graphics, format, and disease and
product characteristics impact the
communication and understanding of
prescription drug risks and benefits.
Focusing on target populations allows
us to evaluate how understanding of
prescription drug risks and benefits may
vary as a function of audience, and our
focus on research quality aims at
maximizing the quality of research data
through analytical methodology
development and investigation of
sampling and response issues. This
study will inform all three topic areas.
Because we recognize the strength of
data and the confidence in the robust
nature of the findings are improved
through the results of multiple
converging studies, we continue to
develop evidence to inform our
thinking. We evaluate the results from
our studies within the broader context
of research and findings from other
sources, and this larger body of
knowledge collectively informs our
policies as well as our research program.
Our research is documented on our
home page, which can be found at
https://www.fda.gov/about-fda/centerdrug-evaluation-and-research-cder/
office-prescription-drug-promotionopdp-research. The website includes
links to the latest Federal Register
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
notices and peer-reviewed publications
produced by our office.
As part of the prescription drug
regulatory review process, sponsors
propose proprietary names for their
products. These names undergo a
proprietary name review that involves
the Office of Surveillance and
Epidemiology, the relevant medical
office, and OPDP. OPDP reviews names
to assess for alignment with the FD&C
Act, which provides, among other
things, that labeling can misbrand a
product if false or misleading
representations are made (see 21 U.S.C.
321(n) and 352(a)). A proprietary name
that appears in labeling could result in
such misbranding if it is false or
misleading. OPDP reviews, among other
things, whether names: (1) overstate the
efficacy or safety of the drug, (2) suggest
drug indications that are not accurate,
(3) suggest superiority without
substantiation, or (4) are of a fanciful
nature that misleadingly implies unique
effectiveness or composition. It would
be helpful in OPDP’s review of
promotional implications of proprietary
names for data on consumer and
prescriber interpretations of proposed
proprietary names to be more readily
available for consideration. The
proposed research will use text analysis
(e.g., topic modeling and sentiment
analysis) to learn how consumer and
primary care physician (PCP)
populations interpret prescription drug
names, which will assist OPDP’s
consideration of promotional
implications.
This proposed research builds upon
and extends OPDP’s research entitled
‘‘Empirical Study of Promotional
Implications of Proprietary Prescription
Drug Names’’ (86 FR 14440; March 16,
2021). That research involves an
experimental design intended to assess
names that potentially overstate the
efficacy of a product. In contrast, the
proposed research involves a survey
design that comprises primarily openended questions intended to generate
text for analysis, an approach that is
unrestricted in its ability to assess text
with different types of promotional
implications (e.g., minimization of risk
and unsubstantiated claims of
superiority, in addition to overstatement
of efficacy). The proposed research will
add to the depth and breadth of
knowledge we can draw from during the
review of proposed proprietary drug
names.
The key objectives of the proposed
research are as follows:
1. To apply new techniques such as
topic modeling and sentiment analysis
(forms of text analysis) to answer
OPDP’s research questions about
E:\FR\FM\14OCN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 198 (Friday, October 14, 2022)]
[Notices]
[Pages 62421-62426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22305]
-----------------------------------------------------------------------
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 Agency) is requesting
that any consumer organizations interested in participating in the
selection of voting and/or nonvoting consumer representatives to serve
on its advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may be self-nominated or may be nominated by a consumer
organization. FDA seeks to include the views of 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 28, 2022, for vacancies listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
(see ADDRESSES) by November 28, 2022. Nominations will be accepted for
current vacancies and for those that will or may occur through December
31, 2023.
ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process should be
submitted electronically to [email protected] or by mail to
Advisory Committee Oversight and Management Staff, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002.
Consumer representative nominations should be submitted
electronically by logging into the FDA Advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002. Additional information about becoming a member
of an FDA advisory committee can also be obtained by visiting FDA's
website at https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT:
For questions relating to participation in the selection process:
Kimberly Hamilton, Advisory Committee Oversight and Management Staff,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm.
5122, Silver Spring, MD 20993-0002, 301-796-8220,
[email protected].
For questions relating to specific advisory committees or panels,
contact the appropriate contact person listed in table 1.
Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
Contact person Committee/panel
------------------------------------------------------------------------
Rakesh Raghuwanshi, Office of the Chief FDA Science Board Advisory
Scientist, Food and Drug Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 3309, Silver
Spring, MD 20993-0002, 301-796-4769,
[email protected].
Prabhakara Atreya, Center for Biologics Allergenic Products Advisory
Evaluation and Research, Food and Drug Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 1226, Silver
Spring, MD 20993-0002, 240-402-8006,
[email protected].
[[Page 62422]]
Moon Hee Choi, Center for Drugs Anesthetic and Analgesic Drug
Evaluation and Research, Food and Drug Products Advisory Committee,
Administration, 10903 New Hampshire Non-Prescription Drugs
Ave., Bldg. 31, Rm. 2434, Silver Advisory Committee.
Spring, MD 20993-0002, 301-796-2894,
[email protected].
She-Chia Chen, Center for Drugs Antimicrobial Drugs Advisory
Evaluation and Research, Food and Drug Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 31 Rm. 2438, Silver
Spring, MD 20993-0002, 240-402-5343,
[email protected].
Jessica Seo, Center for Drugs Arthritis Advisory Committee,
Evaluation and Research, Food and Drug Peripheral and Central Nervous
Administration, 10903 New Hampshire System Drugs Advisory
Ave., Bldg. 31, Rm. 2412, Silver Committee.
Spring, MD 20993-0002, 301-796-7699,
[email protected].
Yvette Staples, Center for Drugs Cardiovascular and Renal Drugs
Evaluation Research, Food and Drug Advisory Committee, Medical
Administration, 10903 New Hampshire Imaging Drugs Advisory
Ave., Bldg. 31, Rm. 2438, Silver Committee.
Spring, MD 20993-0002, 301-837-7126,
[email protected].
LaToya Bonner, Center for Drugs Endocrinologic and Metabolic
Evaluation and Research, Food and Drug Drugs Advisory Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2428, Silver
Spring, MD 20993-0002, 301-796-2855,
[email protected].
Takyiah Stevenson, Center for Drugs Pharmacy Compounding Advisory
Evaluation Research, Food and Drug Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2406, Silver
Spring, MD 20993-0002, 240-402-2507,
[email protected].
Joyce Frimpong, Center for Drugs Psychopharmacologic Drugs
Evaluation and Research, Food and Drug Advisory Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2462, Silver
Spring, MD 20993-0002, 301-796-7973,
[email protected].
Candace Nalls, Center for Devices and Anesthesiology and Respiratory
Radiological Health, Food and Drug Therapy Devices Panel;
Administration, 10903 New Hampshire Clinical Chemistry and
Ave., Bldg. 66, Rm. 5211, Silver Clinical Toxicology Devices
Spring, MD 20993-0002, 301-636-0510, Panel; Ear, Nose and Throat
[email protected]. Devices Panel;
Gastroenterology-Urology
Devices Panel; General and
Plastic Surgery Devices Panel.
James Swink, Center for Devices and Circulatory System Devices
Radiological Health, Food and Drug Panel; Microbiology Devices
Administration, 10903 New Hampshire Panel.
Ave., Bldg. 66, Rm. 5211, Silver
Spring, MD 20993-0002, 301-796-6313,
[email protected].
Akinola Awojope, Center for Devices and Dental Products Panel;
Radiological Health, Food and Drug Obstetrics and Gynecology
Administration, 10903 New Hampshire Devices Panel; Orthopaedic and
Ave., Bldg. 66, Rm. 5216, Silver Rehabilitation Devices Panel.
Spring, MD 20993-0002, 301-636-0512,
[email protected].
Jarrod Collier, Center for Devices and General Hospital and Personal
Radiological Health, Food and Drug Use Devices Panel; Hematology
Administration, 10903 New Hampshire and Pathology Devices Panel;
Ave., Bldg. 66, Rm. 5211, Silver Molecular and Clinical
Spring, MD 20993-0002, 240-672-5763, Genetics Panel; Ophthalmic
[email protected]. Devices Panel; Radiological
Devices Panel.
James Swink, Center for Devices and National Mammography Quality
Radiological Health, Food and Drug Assurance Advisory Committee.
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5211, Silver
Spring, MD 20993-0002, 301-796-6313,
[email protected].
------------------------------------------------------------------------
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
and/or nonvoting consumer representatives for the vacancies listed in
table 2:
Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
Committee/panel/areas of expertise
needed Type of vacancy Approximate date needed
----------------------------------------------------------------------------------------------------------------
FDA Science Board Advisory Committee-- 1--Voting........................ Immediately.
The Science Board provides advice to
the Commissioner of Food and Drugs
Administration (Commissioner) and other
appropriate officials on specific
complex scientific and technical issues
important to FDA and its mission,
including emerging issues within the
scientific community. Additionally, the
Science Board provides advice that
supports the Agency in keeping pace
with technical and scientific
developments, including in regulatory
science; and input into the Agency's
research agenda, and on upgrading its
scientific and research facilities and
training opportunities. It also
provides, where requested, expert
review of Agency-sponsored intramural
and extramural scientific research
programs.
Allergenic Products Advisory Committee-- 1--Voting........................ Immediately.
Knowledgeable in the fields of allergy,
immunology, pediatrics, internal
medicine, biochemistry, and related
specialties.
[[Page 62423]]
Anesthetic and Analgesic Drug Products 1--Voting........................ April 1, 2023.
Advisory Committee--Knowledgeable in
the fields of anesthesiology, surgery,
epidemiology or statistics, and related
specialties.
Non-Prescription Drugs Advisory 1--Voting........................ Immediately.
Committee--Knowledgeable in the fields
of internal medicine, family practice,
clinical toxicology, clinical
pharmacology, pharmacy, dentistry, and
related specialties.
Antimicrobial Drugs Advisory Committee-- 1--Voting........................ May 1, 2023.
Knowledgeable in the fields of
infectious disease, internal medicine,
microbiology, pediatrics, epidemiology
or statistics, and related specialties.
Arthritis Advisory Committee-- 1--Voting........................ December 1, 2023.
Knowledgeable in the fields of
arthritis, rheumatology, orthopedics,
epidemiology or statistics, analgesics,
and related specialties.
Peripheral and Central Nervous Systems 1--Voting........................ February 1, 2023.
Drugs Advisory Committee--Knowledgeable
in the fields of neurology,
neuropharmacology, neuropathology,
otolaryngology, epidemiology or
statistics, and related specialties.
Cardiovascular and Renal Drugs Advisory 1--Voting........................ July 1, 2023.
Committee--Knowledgeable in the fields
of cardiology, hypertension,
arrhythmia, angina, congestive heart
failure, diuresis, and biostatistics.
Medical Imaging Drugs Advisory 1--Voting........................ Immediately.
Committee--Knowledgeable in the fields
of nuclear medicine, radiology,
epidemiology, statistics, and related
specialties.
Endocrinologic and Metabolic Drugs 1--Voting........................ Immediately.
Advisory Committee--Knowledgeable in
the fields of endocrinology,
metabolism, epidemiology or statistics,
and related specialties.
Pharmacy Compounding Advisory Committee-- 1--Voting........................ October 1, 2023.
Knowledgeable in the fields of
pharmaceutical compounding,
pharmaceutical manufacturing, pharmacy,
medicine, and other related specialties.
Psychopharmacologic Drugs Advisory 1--Voting........................ Immediately.
Committee--Knowledgeable in the fields
of psychopharmacology, psychiatry,
epidemiology or statistics, and related
specialties.
Anesthesiology and Respiratory Therapy 1--Nonvoting..................... Immediately.
Devices Panel--Anesthesiologists,
pulmonary medicine specialists, or
other experts who have specialized
interests in ventilator support,
pharmacology, physiology, or the
effects and complications of anesthesia.
Clinical Chemistry and Clinical 1--Nonvoting..................... Immediately.
Toxicology Devices Panel--Doctor of
Medicine or Philosophy with experience
in clinical chemistry (e.g., cardiac
markers), clinical toxicology, clinical
pathology, clinical laboratory
medicine, and endocrinology.
Ear, Nose and Throat Devices Panel-- 1--Nonvoting..................... November 1, 2023.
Otologists, neurotologists,
audiologists.
Gastroenterology-Urology Devices Panel-- 1--Nonvoting..................... Immediately.
Gastroenterologists, urologists, and
nephrologists.
General and Plastic Surgery Devices 1--Nonvoting..................... Immediately.
Panel--Surgeons (general, plastic,
reconstructive, pediatric, thoracic,
abdominal, pelvic, and endoscopic);
dermatologists; experts in
biomaterials, lasers, wound healing,
and quality of life; and
biostatisticians.
Circulatory System Devices Panel-- 1--Nonvoting..................... Immediately.
Interventional cardiologists,
electrophysiologists, invasive
(vascular) radiologists, vascular and
cardiothoracic surgeons, and
cardiologists with special interest in
congestive heart failure.
Microbiology Devices Panel--Clinicians 1--Nonvoting..................... Immediately.
with an expertise in infectious
disease, e.g., pulmonary disease
specialists, sexually transmitted
disease specialists, pediatric
infectious disease specialists, experts
in tropical medicine and emerging
infectious diseases, mycologists;
clinical microbiologists and
virologists; clinical virology and
microbiology laboratory directors, with
expertise in clinical diagnosis and in
vitro diagnostic assays, e.g.,
hepatologists; molecular biologists.
Dental Products Panel--Dentists, 1--Nonvoting..................... Immediately.
engineers and scientists who have
expertise in the areas of dental
implants, dental materials,
periodontology, tissue engineering, and
dental anatomy.
Obstetrics and Gynecology Devices Panel-- 1--Nonvoting..................... Immediately.
Experts in perinatology, embryology,
reproductive endocrinology, pediatric
gynecology, gynecological oncology,
operative hysteroscopy, pelviscopy,
electrosurgery, laser surgery, assisted
reproductive technologies,
contraception, postoperative adhesions,
and cervical cancer and colposcopy;
biostatisticians and engineers with
experience in obstetrics/gynecology
devices; urogynecologists; experts in
breast care; experts in gynecology in
the older patient; experts in
diagnostic (optical) spectroscopy;
experts in midwifery; labor and
delivery nursing.
Orthopaedic and Rehabilitation Devices 1--Nonvoting..................... Immediately.
Panel--Orthopedic surgeons (joint
spine, trauma, and pediatric);
rheumatologists; engineers (biomedical,
biomaterials, and biomechanical);
experts in rehabilitation medicine,
sports medicine, and connective tissue
engineering; and biostatisticians.
General Hospital and Personal Use 1--Nonvoting..................... Immediately.
Devices Panel--Internists,
pediatricians, neonatologists,
endocrinologists, gerontologists,
nurses, biomedical engineers, or
microbiologists/infection control
practitioners or experts.
Hematology and Pathology Devices Panel-- 1--Nonvoting..................... Immediately.
Hematologists (benign and/or malignant
hematology), hematopathologists
(general and special hematology,
coagulation and hemostasis, and
hematological oncology), gynecologists
with special interests in gynecological
oncology, cytopathologists, and
molecular pathologists with special
interests in development of predictive
biomarkers.
Molecular and Clinical Genetics Devices 1--Nonvoting..................... Immediately.
Panel--Experts in human genetics and in
the clinical management of patients
with genetic disorders, e.g.,
pediatricians, obstetricians,
neonatologists. The Agency is also
interested in considering candidates
with training in inborn errors of
metabolism, biochemical and/or
molecular genetics, population
genetics, epidemiology, and related
statistical training. Additionally,
individuals with experience in genetic
counseling, medical ethics, as well as
ancillary fields of study will be
considered.
[[Page 62424]]
Ophthalmic Devices Panel--Ophthalmists 1--Nonvoting..................... Immediately.
with expertise in corneal-external
disease, vitreo-retinal surgery,
glaucoma, ocular immunology, ocular
pathology; optometrists; vision
scientists; and ophthalmic
professionals with expertise in
clinical trial design, quality of life
assessment, electrophysiology, low
vision rehabilitation, and
biostatistics.
Radiological Devices Panel--Physicians 1--Nonvoting..................... Immediately.
with experience in general radiology,
mammography, ultrasound, magnetic
resonance, computed tomography, other
radiological subspecialties, and
radiation oncology; scientists with
experience in diagnostic devices,
radiation physics, statistical
analysis, digital imaging, and image
analysis.
National Mammography Quality Assurance 3--Voting........................ Immediately.
Advisory Committee--Physician,
practitioner, or other health
professional whose clinical practice,
research specialization, or
professional expertise includes a
significant focus on mammography.
----------------------------------------------------------------------------------------------------------------
I. Functions and General Description of the Committee Duties
A. FDA Science Board Advisory Committee
The Science Board Advisory Committee (Science Board) provides
advice to the Commissioner of Food and Drugs (Commissioner) and other
appropriate officials on specific complex scientific and technical
issues important to FDA and its mission, including emerging issues
within the scientific community. Additionally, the Science Board
provides advice that supports the Agency in keeping pace with technical
and scientific developments, including in regulatory science, and input
into the Agency's research agenda and on upgrading its scientific and
research facilities and training opportunities. It also provides, where
requested, expert review of Agency-sponsored intramural and extramural
scientific research programs.
B. Allergenic Products Advisory Committee
Reviews and evaluates available data concerning the safety,
effectiveness, and adequacy of labeling of marketed and investigational
allergenic biological products or materials that are administered to
humans for the diagnosis, prevention, or treatment of allergies and
allergic disease and makes appropriate recommendations to the
Commissioner regarding the affirmation or revocation of biological
product licenses, on the safety, effectiveness, and labeling of the
products, on clinical and laboratory studies of such products, on
amendments or revisions to regulations governing the manufacture,
testing, and licensing of allergenic biological products, and on the
quality and relevance of FDA's research programs.
C. Anesthetic and Analgesic Drug Products Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in anesthesiology and surgery.
D. Nonprescription Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of over-the-counter (nonprescription) human drug
products, or any other FDA-regulated product, for use in the treatment
of a broad spectrum of human symptoms and diseases and advises the
Commissioner either on the promulgation of monographs establishing
conditions under which these drugs are generally recognized as safe and
effective and not misbranded or on the approval of new drug
applications for such drugs. The Committee serves as a forum for the
exchange of views regarding the prescription and nonprescription
status, including switches from one status to another, of these various
drug products and combinations thereof. The Committee may also conduct
peer review of Agency sponsored intramural and extramural scientific
biomedical programs in support of FDA's mission and regulatory
responsibilities.
E. Antimicrobial Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of infectious diseases and disorders.
F. Arthritis Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
treatment of arthritis, rheumatism, and related diseases.
G. Peripheral and Central Nervous System Drugs Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
treatment of neurologic diseases.
H. Cardiovascular and Renal Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of cardiovascular and renal disorders.
I. Medical Imaging Drugs Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in
diagnostic and therapeutic procedures using radioactive pharmaceuticals
and contrast media used in diagnostic radiology.
J. Endocrinologic and Metabolic Drugs Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in the
treatment of endocrine and metabolic disorders.
K. Pharmacy Compounding Advisory Committee
Provides advice on scientific, technical, and medical issues
concerning drug compounding by pharmacists and licensed practitioners.
L. Psychopharmacologic Drugs Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human
[[Page 62425]]
drug products for use in the practice of psychiatry and related fields.
M. Medical Devices Advisory Committee Panels
The Medical Devices Advisory Committee has established certain
panels to review and evaluate data on the safety and effectiveness of
marketed and investigational devices and make recommendations for their
regulation. With the exception of the Medical Devices Dispute
Resolution Panel, each panel, according to its specialty area: (1)
advises on the classification or reclassification of devices into one
of three regulatory categories and advises on any possible risks to
health associated with the use of devices; (2) advises on formulation
of product development protocols; (3) reviews premarket approval
applications for medical devices; (4) reviews guidelines and guidance
documents; (5) recommends exemption of certain devices from the
application of portions of the Federal Food, Drug, and Cosmetic Act;
(6) advises on the necessity to ban a device; and (7) responds to
requests from the Agency to review and make recommendations on specific
issues or problems concerning the safety and effectiveness of devices.
With the exception of the Medical Devices Dispute Resolution Panel,
each panel, according to its specialty area, may also make appropriate
recommendations to the Commissioner on issues relating to the design of
clinical studies regarding the safety and effectiveness of marketed and
investigational devices.
The Dental Products Panel reviews and evaluates data concerning the
safety and effectiveness of marketed and investigational products for
use in dentistry, endodontics or bone physiology relative to the oral
and maxillofacial area.
The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies. The Panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or Agency decisions or actions.
N. National Mammography Quality Assurance Advisory Committee
Advises the Agency on the development of appropriate quality
standards and regulations for mammography facilities; standards and
regulations for bodies accrediting mammography facilities under this
program; regulations with respect to sanctions; procedures for
monitoring compliance with standards; establishing a mechanism to
investigate consumer complaints; reporting new developments concerning
breast imaging that should be considered in the oversight of
mammography facilities. The Committee also advises on determining
whether there exists a shortage of mammography facilities in rural and
health professional shortage areas and determining the effects of
personnel on access to the services of such facilities in such areas;
determining whether there will be a sufficient number of medical
physicists after October 1, 1999; and determining the costs and
benefits of compliance with these requirements.
II. Criteria for Members
Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
demonstrate an affiliation with and/or active participation in consumer
or community-based organizations, (2) be able to analyze technical
data, (3) understand research design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy of products under review. The
consumer representative should be able to represent the consumer
perspective on issues and actions before the advisory committee; serve
as a liaison between the committee and interested consumers,
associations, coalitions, and consumer organizations; and facilitate
dialogue with the advisory committees on scientific issues that affect
consumers.
III. Selection Procedures
Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 45 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
r[eacute]sum[eacute]. Ballots are to be filled out and returned to FDA
within 30 days. The nominee receiving the highest number of votes
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.
[[Page 62426]]
Dated: October 6, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22305 Filed 10-13-22; 8:45 am]
BILLING CODE 4164-01-P
