Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 1510-1515 [2021-00124]
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Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices
Programming Interface (API).
Instructions for navigating the report,
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definitions of the report contents are
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We estimate the burden of the
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity; 21 CFR section
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
Firm initiated recall; § 7.46 ...................................................
Termination of recall; § 7.55 ................................................
Recall status reports; § 7.53 ................................................
2,779
2,095
2,779
1
1
13
2,779
2,095
36,127
25
10
10
69,475
20,950
361,270
Total ..............................................................................
........................
........................
41,001
........................
451,695
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
A review of Agency data shows that
8,337 recalls were conducted during
fiscal years 2017 through 2019, for an
average of 2,779 recalls annually. We
assume an average of 25 hours is needed
to submit the requisite notification to
FDA, for a total annual burden of 69,475
hours. Similarly, during the same
submissions (36,127) by the average
number of annual respondents (2,779)
and assume 10 hours is necessary for
the corresponding information
collection, resulting in 361,270 hours
annually.
period, 6,287 recalls were terminated,
for an average of 2,095 recall
terminations annually, and we assume
an average of 10 hours is needed for the
corresponding information collection
activity. To determine burden
associated with recall status reports we
divided the average number of annual
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Recall communications;
§ 7.49.
2,779 ...........................
1 There
445
Total
annual
disclosures
Average burden per
disclosure
1,236,655 ....................
0.05 (3 minutes) ..........
Total hours
61,832.75
are no capital costs or operating and maintenance costs associated with this collection of information.
To determine burden associated with
recall communication disclosures
described in § 7.49, we calculated an
average of 445 disclosures per recall and
attribute 3 minutes for each disclosure,
resulting in 61,832.75 burden hours
annually.
These estimates reflect an overall
decrease in the average number of
annual responses by 245,846 and a
decrease in the average number of
annual burden hours by 70,949.25 since
our last submission for OMB review and
approval of the information collection.
Dated: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–00125 Filed 1–7–21; 8:45 am]
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Number of
disclosures
per
respondent
Activity; 21 CFR part
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–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) 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
SUMMARY:
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may be nominated by a consumer
organization. FDA seeks to include the
views of women and men, members of
all racial and ethnic groups, and
individuals with and without
disabilities on its advisory committees
and, therefore, encourages nominations
of appropriately qualified candidates
from these groups.
DATES: Any consumer organization
interested in participating in the
selection of an appropriate voting or
nonvoting member to represent
consumer interests on an FDA advisory
committee or panel may send a letter or
email stating that interest to FDA (see
ADDRESSES) by January 29, 2021, for
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by February 8,
2021. Nominations will be accepted for
current vacancies and for those that will
or may occur through December 31,
2021.
ADDRESSES: All statements of interest
from consumer organizations interested
in participating in the selection process
should be submitted electronically to
ACOMSSubmissions@fda.hhs.gov, by
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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, 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. 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:
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
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, email:
Rakesh.Raghuwanshi@fda.hhs.gov.
Christina Vert, Center for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 6268, Silver Spring, MD 20993–0002, 240–402–
8054, email: Christina.Vert@fda.hhs.gov.
Kathleen Hayes, Center for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993–0002, 301–
796–7864, email: Kathleen.Hayes@fda.hhs.gov.
LaTonya Bonner, Center for Drugs Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 31, Rm. 2428, Silver Spring, MD 20992–0002, 301–796–
2855, email: Latoya.Bonner@fda.hhs.gov.
Yinghua Wang, Center for Drugs Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 31, Rm. 2412, Silver Spring, MD 20992–002, 301–796–
9033, email: Yinghua.Wang@fda.hhs.gov.
Yvette Waples, Center for Drugs Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 31, Rm. 2510, Silver Spring, MD 20993–0002, 301–796–
9034, email: Yvette.Waples@fda.hhs.gov.
James Swink, Center for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993–0002, 301–796–
6313, email: James.Swink@fda.hhs.gov.
Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993–0002, 301–796–
6875, email: Patricio.Garcia@fda.hhs.gov.
Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993–0002, 301–796–0400,
email: Aden.Asefa@fda.hhs.gov.
Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993–0002, 301–796–0400,
email: Aden.Asefa@fda.hhs.gov.
Letise Williams, Center for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5407, Silver Spring, MD 20993–0002, 301–796–
8398, email: Letise.Williams@fda.hhs.gov.
FDA is
requesting nominations for voting and/
SUPPLEMENTARY INFORMATION:
FDA Science Board Advisory Committee.
Blood Products Advisory Committee.
Cellular, Tissue and Gene Therapies Advisory
Committee, Vaccines and Related Biological
Products Advisory Committee.
Dermatologic and Ophthalmic Drugs Advisory
Committee.
Gastrointestinal Drugs Advisory Committee,
Pharmaceutical Science and Clinical Pharmacology Advisory Committee.
Psychopharmacologic Drugs Advisory Committee.
Anesthesiology and Respiratory Therapy Devices Panel, Circulatory Systems Devices
Panel, Dental Products Devices Panel, General Hospital and Personal Use Devices
Panel, Hematology and Pathology Devices
Panel, Radiological Devices Panel.
Clinical Chemistry and Clinical Toxicology Devices Panel, Gastroenterology and Urology
Devices Panel, General and Plastic Surgery
Devices Panel, Obstetrics and Gynecology
Devices Panel.
Immunology Devices Panel, Microbiology Devices Panel, Molecular and Clinical Genetics
Devices Panel, Neurological Devices Panel.
National Mammography Quality Assurance Advisory Committee.
Patient Engagement Advisory Committee.
or nonvoting consumer representatives
for the vacancies listed in table 2:
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TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED
Committee/panel/areas of expertise needed
Type of
vacancy
FDA Science Board Advisory Committee—The Science Board shall provide advice to the 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 will provide
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 will also provide, where requested, expert review of Agency
sponsored intramural and extramural scientific research programs
1—Voting .......
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January 1,
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TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED—Continued
Committee/panel/areas of expertise needed
Type of
vacancy
Blood Products Advisory Committee—Knowledgeable in the fields of clinical and administrative medicine, hematology, immunology, blood banking, surgery, internal medicine, biochemistry, engineering, biological and
physical sciences, biotechnology, computer technology, statistics, epidemiology, sociology/ethics, and other
related professions
Cellular, Tissue and Gene Therapies Advisory Committee—Knowledgeable in the fields of cellular therapies,
tissue transplantation, gene transfer therapies and xenotransplantation (biostatistics, bioethics, hematology/
oncology, human tissues and transplantation, reproductive medicine, general medicine and various medical
specialties including surgery and oncology, immunology, virology, molecular biology, cell biology, developmental biology, tumor biology, biochemistry, rDNA technology, nuclear medicine, gene therapy, infectious
diseases, and cellular kinetics)
Vaccines and Related Biologic Advisory Committee—Knowledgeable in the fields of immunology, molecular
biology, rDNA, virology, bacteriology, epidemiology or biostatistics, allergy, preventive medicine, infectious
diseases, pediatrics, microbiology, and biochemistry
Dermatologic and Ophthalmic Drugs Advisory Committee—Knowledgeable in the fields of dermatology, ophthalmology, internal medicine, pathology, immunology, epidemiology or statistics, and other related professions
Gastrointestinal Drugs Advisory Committee—Knowledgeable in the fields of gastroenterology, endocrinology,
surgery, clinical pharmacology, physiology, pathology, liver function, motility, esophagitis, and statistics
Pharmaceutical Science and Clinical Pharmacology Advisory Committee—Knowledgeable in the fields of
pharmaceutical manufacturing, clinical pharmacology, pharmacokinetics, bioavailability and bioequivalence
research, the design and evaluation of clinical trials, laboratory analytical techniques, pharmaceutical chemistry, physiochemistry, biochemistry, biostatistics, and related biomedical and pharmacological specialties
Psychopharmacologic Drugs Advisory Committee—Knowledgeable in the fields of psychopharmacology, psychiatry, epidemiology or statistics, and related specialties
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
Anesthesiology and Respiratory Therapy Devices Panel—Anesthesiologists, pulmonary medicine specialists,
or other experts who have specialized interests in ventilator support, pharmacology, physiology, or the effects and complications of anesthesia
Circulatory Systems Devices Panel—Interventional cardiologists, electrophysiologists, invasive (vascular) radiologists, vascular and cardiothoracic surgeons, and cardiologists with special interest in congestive heart
failure
Dental Products Devices Panel—Dentists, engineers and scientists who have expertise in the areas of dental
implants, dental materials, periodontology, tissue engineering, and dental anatomy
General Hospital and Personal Use Devices Panel—Internists, pediatricians, neonatologists, endocrinologists,
gerontologists, nurses, biomedical engineers, or microbiologists/infection control practitioners, or experts
Hematology and Pathology Devices Panel—Hematologists (benign and/or malignant hematology),
hematopathologists (general and special hematology, coagulation and hemostasis, and hematological oncology), gynecologists with special interests in gynecological oncology, cytopathologists, and molecular pathologists with special interests in development of predictive biomarkers
Radiological Devices Panel—Physicians with experience in general radiology, mammography, ultrasound,
magnetic resonance, computed tomography, other radiological subspecialties and radiation oncology; scientists with experience in diagnostic devices, radiation physics, statistical analysis, digital imaging and
image analysis
Clinical Chemistry and Clinical Toxicology Devices Panel—Doctor of medicine or philosophy with experience
in clinical chemistry (e.g., cardiac markers), clinical toxicology, clinical pathology, clinical laboratory medicine, and endocrinology
Gastroenterology and Urology Devices Panel—Gastroenterologists, urologists and nephrologists
General and Plastic Surgery Devices Panel—Surgeons (general, plastic, reconstructive, pediatric, thoracic,
abdominal, pelvic and endoscopic); dermatologists; experts in biomaterials, lasers, wound healing, and
quality of life; and biostatisticians
Obstetrics and Gynecology Devices Panel—Experts in perinatology, embryology, reproductive endocrinology,
pediatric gynecology, gynecological oncology, operative hysteroscopy, pelviscopy, electro-surgery, laser surgery, assisted reproductive technologies, contraception, postoperative adhesions, and cervical cancer and
colposcopy; biostatisticians and engineers with experience in obstetrics/gynecology devices;
urogynecologists; experts in breast care; experts in gynecology in the older patient; experts in diagnostic
(optical) spectroscopy; experts in midwifery; labor and delivery nursing
Immunology Devices Panel—Persons with experience in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine
Microbiology Devices Panel—Clinicians with an expertise in infectious disease, e.g., pulmonary disease specialists, sexually transmitted disease specialists, pediatric infectious disease specialists, experts in tropical
medicine and emerging infectious diseases, mycologists; clinical microbiologists and virologists; clinical virology and microbiology laboratory directors, with expertise in clinical diagnosis and in vitro diagnostic assays, e.g., hepatologists; molecular biologists
1—Voting .......
October 1,
2021.
1—Voting .......
April 1, 2021.
1—Voting .......
September 1,
2021.
1—Voting .......
September 1,
2021.
1—Voting .......
July 1, 2021.
1—Voting .......
November 1,
2021.
1—Voting .......
Immediately
1—Non-Voting
Immediately.
1—Non-Voting
December 1,
2021.
1—Non-Voting
Immediately.
1—Non-Voting
Immediately.
1—Non-Voting
Immediately.
1—Non-Voting
March 1, 2021.
1—Non-Voting
Immediately.
1—Non-Voting
Immediately.
1—Non-Voting
1—Non-Voting
Immediately.
Immediately.
1—Non-Voting
Immediately.
1—Non-Voting
Immediately.
1—Non-Voting
Immediately.
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TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE DATE
NEEDED—Continued
Committee/panel/areas of expertise needed
Type of
vacancy
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
Dental Products Devices Panel—Dentists, engineers and scientists who have expertise in the areas of dental
implants, dental materials, periodontology, tissue engineering, and dental anatomy
Neurological Devices Panel—Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric,
pain management, and movement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians
National Mammography Quality Assurance Advisory Committee—Physician, practitioner, or other health professional whose clinical practice, research specialization, or professional expertise includes a significant
focus on mammography
1—Non-Voting
June 1, 2021.
1—Non-Voting
Immediately.
1—Non-Voting
December 1,
2021.
4—Voting .......
Patient Engagement Advisory Committee—Experts who are knowledgeable in areas such as clinical research,
primary care patient experience, and health care needs of patient groups in the United States. Selected
Committee members may also be experienced in the work of patient and health professional organizations;
methodologies for eliciting patient preferences; and strategies for communicating benefits, risks and clinical
outcomes to patients and research subjects
1—Voting .......
2—Immediately
2—February 1,
2021.
May 1, 2021.
I. Functions and General Description of
the Committee Duties
C. Cellular, Tissue and Gene Therapies
Advisory Committee
F. Gastrointestinal Drugs Advisory
Committee
A. FDA Science Board Advisory
Committee
Reviews and evaluates available data
relating to the safety, effectiveness, and
appropriate use of human cells, human
tissues, gene transfer therapies and
xenotransplantation products which are
intended for transplantation,
implantation, infusion and transfer in
the prevention and treatment of a broad
spectrum of human diseases and in the
reconstruction, repair or replacement of
tissues for various conditions, as well as
considers the quality and relevance of
FDA’s research program which provides
scientific support for the regulation of
these products.
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of gastrointestinal diseases.
The Science Board shall provide
advice to the 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 will provide 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 will also
provide, where requested, expert review
of Agency sponsored intramural and
extramural scientific research programs.
B. Blood Products Advisory Committee
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Reviews and evaluates available data
concerning the safety, effectiveness, and
appropriate use of blood products
derived from blood and serum or
biotechnology which are intended for
use in the diagnosis, prevention, or
treatment of human diseases as well as
the safety, effectiveness, and labeling of
the products, on clinical and laboratory
studies involving such products, on the
affirmation or revocation of biological
product licenses, and on the quality and
relevance of FDA’s research program
which provides the scientific support
for regulating these products.
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D. Vaccines and Related Biologic
Products Advisory Committee
Reviews and evaluates data
concerning the safety, effectiveness, and
appropriate use of vaccines and related
biological products which are intended
for use in the prevention, treatment, or
diagnosis of human diseases, as well as
considers the quality and relevance of
FDA’s research program which provides
scientific support for the regulation of
these products.
E. Dermatologic and Ophthalmic 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 dermatologic and ophthalmic
disorders.
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G. Pharmaceutical Science and Clinical
Pharmacology Advisory Committee
Provides advice on scientific and
technical issues concerning the safety,
and effectiveness of human generic drug
products for use in the treatment of a
broad spectrum of human diseases, and
as required, any other product for which
the FDA has regulatory responsibility.
The committee may also review Agency
sponsored intramural and extramural
biomedical research programs in
support of FDA’s generic drug
regulatory responsibilities.
H. Psychopharmacologic Drugs
Advisory Committee
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
products for use in the practice of
psychiatry and related fields.
I. Certain Panels of the Medical Devices
Advisory Committee
Reviews and evaluates data on the
safety and effectiveness of marketed and
investigational devices and makes
recommendations for their regulation.
With the exception of the Medical
Devices Dispute Resolution Panel, each
panel, according to its specialty area,
advises on the classification or
reclassification of devices into one of
three regulatory categories; advises on
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any possible risks to health associated
with the use of devices; advises on
formulation of product development
protocols; reviews premarket approval
applications for medical devices;
reviews guidelines and guidance
documents; recommends exemption of
certain devices from the application of
portions of the Federal Food, Drug, and
Cosmetic Act; advises on the necessity
to ban a device; and 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 of Food and Drugs on
issues relating to the design of clinical
studies regarding the safety and
effectiveness of marketed and
investigational devices.
The Dental Products Panel also
functions at times as a dental drug
panel. The functions of the dental drug
panel are to evaluate and recommend
whether various prescription drug
products should be changed to over-thecounter status and to evaluate data and
make recommendations concerning the
approval of new dental drug products
for human use.
The Medical Devices Dispute
Resolution Panel provides advice to the
Commissioner on complex or contested
scientific issues between FDA and
medical device sponsors, applicants, or
manufacturers relating to specific
products, marketing applications,
regulatory decisions and actions by
FDA, and Agency guidance and
policies. The Panel makes
recommendations on issues that are
lacking resolution, are highly complex
in nature, or result from challenges to
regular advisory panel proceedings or
Agency decisions or actions.
J. National Mammography Quality
Assurance Advisory Committee
Advises the Agency on the following
development of appropriate quality
standards and regulations for
mammography facilities; standards and
regulations for bodies accrediting
mammography facilities under this
program; regulations with respect to
sanctions; procedures for monitoring
compliance with standards; establishing
a mechanism to investigate consumer
complaints; reporting new
developments concerning breast
imaging which should be considered in
the oversight of mammography
facilities. As well as determining
whether there exists a shortage of
mammography facilities in rural and
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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 exist a sufficient number of
medical physicists after October 1, 1999;
and determining the costs and benefits
of compliance with these requirements.
K. Patient Engagement Advisory
Committee
Advises the Agency, on complex
issues relating to medical devices, the
regulation of devices, and their use by
patients. The Committee may consider
topics such as: Agency guidance and
policies, clinical trial or registry design,
patient preference study design, benefitrisk determinations, device labeling,
unmet clinical needs, available
alternatives, patient reported outcomes
and device-related quality of life or
health status issues, and other patientrelated topics. The Committee will
provide relevant skills and perspectives,
in order to improve communication of
benefits, risks, clinical outcomes, and
increase integration of patient
perspectives into the regulatory process
for medical devices. It will perform its
duties by discussing and providing
advice and recommendation in ways
such as: Identifying new approaches,
promoting innovation, recognizing
unforeseen risks or barriers, and
identifying unintended consequences
that could result from FDA policy.
II. Criteria for Members
Persons nominated for membership as
consumer representatives on
committees or panels should meet the
following criteria: (1) Demonstrate an
affiliation with and/or active
participation in consumer or
community-based organizations, (2) be
able to analyze technical data, (3)
understand research design, (4) discuss
benefits and risks, and (5) evaluate the
safety and efficacy of products under
review. The consumer representative
should be able to represent the
consumer perspective on issues and
actions before the advisory committee;
serve as a liaison between the
committee and interested consumers,
associations, coalitions, and consumer
organizations; and facilitate dialogue
with the advisory committees on
scientific issues that affect consumers.
III. Selection Procedures
Selection of members representing
consumer interests is conducted
through procedures that include the use
of organizations representing the public
interest and public advocacy groups.
These organizations recommend
nominees for the Agency’s selection.
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Representatives from the consumer
health branches of Federal, State, and
local governments also may participate
in the selection process. Any consumer
organization interested in participating
in the selection of an appropriate voting
or nonvoting member to represent
consumer interests should send a letter
stating that interest to FDA (see
ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 30 days, FDA
will compile a list of consumer
organizations that will participate in the
selection process and will forward to
each such organization a ballot listing at
least two qualified nominees selected by
the Agency based on the nominations
received, together with each nominee’s
current curriculum vitae or 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 section of this document),
and a list of consumer or communitybased 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 up to 4 years.
FDA will review all nominations
received within the specified
timeframes and prepare a ballot
containing the names of qualified
nominees. Names not selected will
remain on a list of eligible nominees
and be reviewed periodically by FDA to
determine continued interest. Upon
selecting qualified nominees for the
ballot, FDA will provide those
E:\FR\FM\08JAN1.SGM
08JAN1
Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
consumer organizations that are
participating in the selection process
with the opportunity to vote on the
listed nominees. Only organizations
vote in the selection process. Persons
who nominate themselves to serve as
voting or nonvoting consumer
representatives will not participate in
the selection process.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–00124 Filed 1–7–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3240]
List of Bulk Drug Substances for
Which There Is a Clinical Need Under
Section 503B of the Federal Food,
Drug, and Cosmetic Act; Reopening of
the Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
reopening the comment period for a
notice that appeared in the Federal
Register of July 31, 2020, in which FDA
identified certain bulk drug substances
(active pharmaceutical ingredients) that
FDA has considered and proposes to
include or not include on the list of bulk
drug substances for which there is a
clinical need (the 503B Bulks List). The
Agency is taking this action in response
to a request received during the initial
comment period, which asked the
Agency to allow interested persons
additional time to submit comments.
DATES: FDA is reopening the comment
period on the notice published on July
31, 2020 (85 FR 46126). Submit either
electronic or written comments by
February 8, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 8,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 8, 2021.
tkelley on DSKBCP9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
21:23 Jan 07, 2021
Jkt 253001
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–3240 for ‘‘List of Bulk Drug
Substances for Which There is a Clinical
Need Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
1515
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ 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.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, 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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Dominic Markwordt, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5104,
Silver Spring, MD 20993, 301–796–
9349.
SUPPLEMENTARY INFORMATION: In the
Federal Register of July 31, 2020 (85 FR
46126), FDA published a notice that
identified four bulk drug substances that
FDA considered and proposed to
include on the 503B Bulks List:
diphenylcyclopropenone (DPCP),
glycolic acid, squaric acid dibutyl ester
(SADBE), and trichloroacetic acid
(TCA). The July 31, 2020, notice also
identified 19 bulk drug substances that
FDA considered and proposed not to
include on the 503B Bulks List:
Diazepam, dobutamine hydrochloride
E:\FR\FM\08JAN1.SGM
08JAN1
]]>Agencies
[Federal Register Volume 86, Number 5 (Friday, January 8, 2021)]
[Notices]
[Pages 1510-1515]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00124]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-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) is requesting that any
consumer organizations interested in participating in the selection of
voting and/or nonvoting consumer representatives to serve on its
advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may be self-nominated or may be nominated by a consumer
organization. FDA seeks to include the views of women and men, members
of all racial and ethnic groups, and individuals with and without
disabilities on its advisory committees and, therefore, encourages
nominations of appropriately qualified candidates from these groups.
DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to FDA (see ADDRESSES) by January
29, 2021, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by February 8, 2021. Nominations will be accepted for
current vacancies and for those that will or may occur through December
31, 2021.
ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process should be
submitted electronically to [email protected], by
[[Page 1511]]
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, 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. 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: [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
Scientist, Food and Drug Administration, Advisory Committee.
10903 New Hampshire Ave., Bldg. 1, Rm. 3309,
Silver Spring, MD 20993-0002, 301-796-4769,
email: [email protected].
Christina Vert, Center for Biologics Blood Products Advisory
Evaluation and Research, Food and Drug Committee.
Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 6268, Silver Spring, MD 20993-
0002, 240-402-8054, email:
[email protected].
Kathleen Hayes, Center for Biologics Cellular, Tissue and Gene
Evaluation and Research, Food and Drug Therapies Advisory
Administration, 10903 New Hampshire Ave., Committee, Vaccines and
Bldg. 71, Rm. 6307C, Silver Spring, MD 20993- Related Biological
0002, 301-796-7864, email: Products Advisory
[email protected]. Committee.
LaTonya Bonner, Center for Drugs Evaluation Dermatologic and
and Research, Food and Drug Administration, Ophthalmic Drugs
10903 New Hampshire Ave., Bldg. 31, Rm. Advisory Committee.
2428, Silver Spring, MD 20992-0002, 301-796-
2855, email: [email protected].
Yinghua Wang, Center for Drugs Evaluation and Gastrointestinal Drugs
Research, Food and Drug Administration, Advisory Committee,
10903 New Hampshire Ave., Bldg. 31, Rm. Pharmaceutical Science
2412, Silver Spring, MD 20992-002, 301-796- and Clinical
9033, email: [email protected]. Pharmacology Advisory
Committee.
Yvette Waples, Center for Drugs Evaluation Psychopharmacologic Drugs
and Research, Food and Drug Administration, Advisory Committee.
10903 New Hampshire Ave., Bldg. 31, Rm.
2510, Silver Spring, MD 20993-0002, 301-796-
9034, email: [email protected].
James Swink, Center for Devices and Anesthesiology and
Radiological Health, Food and Drug Respiratory Therapy
Administration, 10903 New Hampshire Ave., Devices Panel,
Bldg. 66, Rm. 5211, Silver Spring, MD 20993- Circulatory Systems
0002, 301-796-6313, email: Devices Panel, Dental
[email protected]. Products Devices Panel,
General Hospital and
Personal Use Devices
Panel, Hematology and
Pathology Devices Panel,
Radiological Devices
Panel.
Patricio Garcia, Center for Devices and Clinical Chemistry and
Radiological Health, Food and Drug Clinical Toxicology
Administration, 10903 New Hampshire Ave., Devices Panel,
Bldg. 66, Rm. 5216, Silver Spring, MD 20993- Gastroenterology and
0002, 301-796-6875, email: Urology Devices Panel,
[email protected]. General and Plastic
Surgery Devices Panel,
Obstetrics and
Gynecology Devices
Panel.
Aden Asefa, Center for Devices and Immunology Devices Panel,
Radiological Health, Food and Drug Microbiology Devices
Administration, 10903 New Hampshire Ave., Panel, Molecular and
Bldg. 66, Rm. 5214, Silver Spring, MD 20993- Clinical Genetics
0002, 301-796-0400, email: Devices Panel,
[email protected]. Neurological Devices
Panel.
Aden Asefa, Center for Devices and National Mammography
Radiological Health, Food and Drug Quality Assurance
Administration, 10903 New Hampshire Ave., Advisory Committee.
Bldg. 66, Rm. 5214, Silver Spring, MD 20993-
0002, 301-796-0400, email:
[email protected].
Letise Williams, Center for Devices and Patient Engagement
Radiological Health, Food and Drug Advisory Committee.
Administration, 10903 New Hampshire Ave.,
Bldg. 66, Rm. 5407, Silver Spring, MD 20993-
0002, 301-796-8398, email:
[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 1--Voting.............. January 1, 2021.
Advisory Committee--
The Science Board
shall provide advice
to the 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 will
provide 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
will also provide,
where requested,
expert review of
Agency sponsored
intramural and
extramural scientific
research programs
[[Page 1512]]
Blood Products 1--Voting.............. October 1, 2021.
Advisory Committee--
Knowledgeable in the
fields of clinical
and administrative
medicine, hematology,
immunology, blood
banking, surgery,
internal medicine,
biochemistry,
engineering,
biological and
physical sciences,
biotechnology,
computer technology,
statistics,
epidemiology,
sociology/ethics, and
other related
professions
Cellular, Tissue and 1--Voting.............. April 1, 2021.
Gene Therapies
Advisory Committee--
Knowledgeable in the
fields of cellular
therapies, tissue
transplantation, gene
transfer therapies
and
xenotransplantation
(biostatistics,
bioethics, hematology/
oncology, human
tissues and
transplantation,
reproductive
medicine, general
medicine and various
medical specialties
including surgery and
oncology, immunology,
virology, molecular
biology, cell
biology,
developmental
biology, tumor
biology,
biochemistry, rDNA
technology, nuclear
medicine, gene
therapy, infectious
diseases, and
cellular kinetics)
Vaccines and Related 1--Voting.............. September 1, 2021.
Biologic Advisory
Committee--Knowledgea
ble in the fields of
immunology, molecular
biology, rDNA,
virology,
bacteriology,
epidemiology or
biostatistics,
allergy, preventive
medicine, infectious
diseases, pediatrics,
microbiology, and
biochemistry
Dermatologic and 1--Voting.............. September 1, 2021.
Ophthalmic Drugs
Advisory Committee--
Knowledgeable in the
fields of
dermatology,
ophthalmology,
internal medicine,
pathology,
immunology,
epidemiology or
statistics, and other
related professions
Gastrointestinal Drugs 1--Voting.............. July 1, 2021.
Advisory Committee--
Knowledgeable in the
fields of
gastroenterology,
endocrinology,
surgery, clinical
pharmacology,
physiology,
pathology, liver
function, motility,
esophagitis, and
statistics
Pharmaceutical Science 1--Voting.............. November 1, 2021.
and Clinical
Pharmacology Advisory
Committee--Knowledgea
ble in the fields of
pharmaceutical
manufacturing,
clinical
pharmacology,
pharmacokinetics,
bioavailability and
bioequivalence
research, the design
and evaluation of
clinical trials,
laboratory analytical
techniques,
pharmaceutical
chemistry,
physiochemistry,
biochemistry,
biostatistics, and
related biomedical
and pharmacological
specialties
Psychopharmacologic 1--Voting.............. Immediately
Drugs Advisory
Committee--Knowledgea
ble in the fields of
psychopharmacology,
psychiatry,
epidemiology or
statistics, and
related specialties
Clinical Chemistry and 1--Non-Voting.......... Immediately.
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
Anesthesiology and 1--Non-Voting.......... December 1, 2021.
Respiratory Therapy
Devices Panel--
Anesthesiologists,
pulmonary medicine
specialists, or other
experts who have
specialized interests
in ventilator
support,
pharmacology,
physiology, or the
effects and
complications of
anesthesia
Circulatory Systems 1--Non-Voting.......... Immediately.
Devices Panel--
Interventional
cardiologists,
electrophysiologists,
invasive (vascular)
radiologists,
vascular and
cardiothoracic
surgeons, and
cardiologists with
special interest in
congestive heart
failure
Dental Products 1--Non-Voting.......... Immediately.
Devices Panel--
Dentists, engineers
and scientists who
have expertise in the
areas of dental
implants, dental
materials,
periodontology,
tissue engineering,
and dental anatomy
General Hospital and 1--Non-Voting.......... Immediately.
Personal Use Devices
Panel--Internists,
pediatricians,
neonatologists,
endocrinologists,
gerontologists,
nurses, biomedical
engineers, or
microbiologists/
infection control
practitioners, or
experts
Hematology and 1--Non-Voting.......... March 1, 2021.
Pathology Devices
Panel--Hematologists
(benign and/or
malignant
hematology),
hematopathologists
(general and special
hematology,
coagulation and
hemostasis, and
hematological
oncology),
gynecologists with
special interests in
gynecological
oncology,
cytopathologists, and
molecular
pathologists with
special interests in
development of
predictive biomarkers
Radiological Devices 1--Non-Voting.......... Immediately.
Panel--Physicians
with experience in
general radiology,
mammography,
ultrasound, magnetic
resonance, computed
tomography, other
radiological
subspecialties and
radiation oncology;
scientists with
experience in
diagnostic devices,
radiation physics,
statistical analysis,
digital imaging and
image analysis
Clinical Chemistry and 1--Non-Voting.......... Immediately.
Clinical Toxicology
Devices Panel--Doctor
of medicine or
philosophy with
experience in
clinical chemistry
(e.g., cardiac
markers), clinical
toxicology, clinical
pathology, clinical
laboratory medicine,
and endocrinology
Gastroenterology and 1--Non-Voting.......... Immediately.
Urology Devices
Panel--Gastroenterolo
gists, urologists and
nephrologists
General and Plastic 1--Non-Voting.......... Immediately.
Surgery Devices
Panel--Surgeons
(general, plastic,
reconstructive,
pediatric, thoracic,
abdominal, pelvic and
endoscopic);
dermatologists;
experts in
biomaterials, lasers,
wound healing, and
quality of life; and
biostatisticians
Obstetrics and 1--Non-Voting.......... Immediately.
Gynecology Devices
Panel--Experts in
perinatology,
embryology,
reproductive
endocrinology,
pediatric gynecology,
gynecological
oncology, operative
hysteroscopy,
pelviscopy, electro-
surgery, laser
surgery, assisted
reproductive
technologies,
contraception,
postoperative
adhesions, and
cervical cancer and
colposcopy;
biostatisticians and
engineers with
experience in
obstetrics/gynecology
devices;
urogynecologists;
experts in breast
care; experts in
gynecology in the
older patient;
experts in diagnostic
(optical)
spectroscopy; experts
in midwifery; labor
and delivery nursing
Immunology Devices 1--Non-Voting.......... Immediately.
Panel--Persons with
experience in
medical, surgical, or
clinical oncology,
internal medicine,
clinical immunology,
allergy, molecular
diagnostics, or
clinical laboratory
medicine
Microbiology Devices 1--Non-Voting.......... Immediately.
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
[[Page 1513]]
Molecular and Clinical 1--Non-Voting.......... June 1, 2021.
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
Dental Products 1--Non-Voting.......... Immediately.
Devices Panel--
Dentists, engineers
and scientists who
have expertise in the
areas of dental
implants, dental
materials,
periodontology,
tissue engineering,
and dental anatomy
Neurological Devices 1--Non-Voting.......... December 1, 2021.
Panel--Neurosurgeons
(cerebrovascular and
pediatric),
neurologists (stroke,
pediatric, pain
management, and
movement disorders),
interventional
neuroradiologists,
psychiatrists, and
biostatisticians
National Mammography 4--Voting.............. 2--Immediately
Quality Assurance 2--February 1, 2021.
Advisory Committee--
Physician,
practitioner, or
other health
professional whose
clinical practice,
research
specialization, or
professional
expertise includes a
significant focus on
mammography
Patient Engagement 1--Voting.............. May 1, 2021.
Advisory Committee--
Experts who are
knowledgeable in
areas such as
clinical research,
primary care patient
experience, and
health care needs of
patient groups in the
United States.
Selected Committee
members may also be
experienced in the
work of patient and
health professional
organizations;
methodologies for
eliciting patient
preferences; and
strategies for
communicating
benefits, risks and
clinical outcomes to
patients and research
subjects
------------------------------------------------------------------------
I. Functions and General Description of the Committee Duties
A. FDA Science Board Advisory Committee
The Science Board shall provide advice to the 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
will provide 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 will
also provide, where requested, expert review of Agency sponsored
intramural and extramural scientific research programs.
B. Blood Products Advisory Committee
Reviews and evaluates available data concerning the safety,
effectiveness, and appropriate use of blood products derived from blood
and serum or biotechnology which are intended for use in the diagnosis,
prevention, or treatment of human diseases as well as the safety,
effectiveness, and labeling of the products, on clinical and laboratory
studies involving such products, on the affirmation or revocation of
biological product licenses, and on the quality and relevance of FDA's
research program which provides the scientific support for regulating
these products.
C. Cellular, Tissue and Gene Therapies Advisory Committee
Reviews and evaluates available data relating to the safety,
effectiveness, and appropriate use of human cells, human tissues, gene
transfer therapies and xenotransplantation products which are intended
for transplantation, implantation, infusion and transfer in the
prevention and treatment of a broad spectrum of human diseases and in
the reconstruction, repair or replacement of tissues for various
conditions, as well as considers the quality and relevance of FDA's
research program which provides scientific support for the regulation
of these products.
D. Vaccines and Related Biologic Products Advisory Committee
Reviews and evaluates data concerning the safety, effectiveness,
and appropriate use of vaccines and related biological products which
are intended for use in the prevention, treatment, or diagnosis of
human diseases, as well as considers the quality and relevance of FDA's
research program which provides scientific support for the regulation
of these products.
E. Dermatologic and Ophthalmic 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 dermatologic and ophthalmic disorders.
F. Gastrointestinal Drugs Advisory Committee
Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of gastrointestinal diseases.
G. Pharmaceutical Science and Clinical Pharmacology Advisory Committee
Provides advice on scientific and technical issues concerning the
safety, and effectiveness of human generic drug products for use in the
treatment of a broad spectrum of human diseases, and as required, any
other product for which the FDA has regulatory responsibility. The
committee may also review Agency sponsored intramural and extramural
biomedical research programs in support of FDA's generic drug
regulatory responsibilities.
H. Psychopharmacologic Drugs Advisory Committee
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human products for use in the practice
of psychiatry and related fields.
I. Certain Panels of the Medical Devices Advisory Committee
Reviews and evaluates data on the safety and effectiveness of
marketed and investigational devices and makes recommendations for
their regulation. With the exception of the Medical Devices Dispute
Resolution Panel, each panel, according to its specialty area, advises
on the classification or reclassification of devices into one of three
regulatory categories; advises on
[[Page 1514]]
any possible risks to health associated with the use of devices;
advises on formulation of product development protocols; reviews
premarket approval applications for medical devices; reviews guidelines
and guidance documents; recommends exemption of certain devices from
the application of portions of the Federal Food, Drug, and Cosmetic
Act; advises on the necessity to ban a device; and 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 of Food and Drugs on issues
relating to the design of clinical studies regarding the safety and
effectiveness of marketed and investigational devices.
The Dental Products Panel also functions at times as a dental drug
panel. The functions of the dental drug panel are to evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status and to evaluate data and make
recommendations concerning the approval of new dental drug products for
human use.
The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies. The Panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or Agency decisions or actions.
J. National Mammography Quality Assurance Advisory Committee
Advises the Agency on the following development of appropriate
quality standards and regulations for mammography facilities; standards
and regulations for bodies accrediting mammography facilities under
this program; regulations with respect to sanctions; procedures for
monitoring compliance with standards; establishing a mechanism to
investigate consumer complaints; reporting new developments concerning
breast imaging which should be considered in the oversight of
mammography facilities. As well as 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 exist a sufficient number of medical physicists after
October 1, 1999; and determining the costs and benefits of compliance
with these requirements.
K. Patient Engagement Advisory Committee
Advises the Agency, on complex issues relating to medical devices,
the regulation of devices, and their use by patients. The Committee may
consider topics such as: Agency guidance and policies, clinical trial
or registry design, patient preference study design, benefit-risk
determinations, device labeling, unmet clinical needs, available
alternatives, patient reported outcomes and device-related quality of
life or health status issues, and other patient-related topics. The
Committee will provide relevant skills and perspectives, in order to
improve communication of benefits, risks, clinical outcomes, and
increase integration of patient perspectives into the regulatory
process for medical devices. It will perform its duties by discussing
and providing advice and recommendation in ways such as: Identifying
new approaches, promoting innovation, recognizing unforeseen risks or
barriers, and identifying unintended consequences that could result
from FDA policy.
II. Criteria for Members
Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
Demonstrate an affiliation with and/or active participation in consumer
or community-based organizations, (2) be able to analyze technical
data, (3) understand research design, (4) discuss benefits and risks,
and (5) evaluate the safety and efficacy of products under review. The
consumer representative should be able to represent the consumer
perspective on issues and actions before the advisory committee; serve
as a liaison between the committee and interested consumers,
associations, coalitions, and consumer organizations; and facilitate
dialogue with the advisory committees on scientific issues that affect
consumers.
III. Selection Procedures
Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
r[eacute]sum[eacute]. Ballots are to be filled out and returned to FDA
within 30 days. The nominee receiving the highest number of votes
ordinarily will be selected to serve as the member representing
consumer interests for that particular advisory committee or panel.
IV. Nomination Procedures
Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Nominations must include a current, complete r[eacute]sum[eacute] or
curriculum vitae for each nominee and a signed copy of the
Acknowledgement and Consent form available at the FDA Advisory
Nomination Portal (see ADDRESSES section of this document), 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 up to 4 years.
FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
Upon selecting qualified nominees for the ballot, FDA will provide
those
[[Page 1515]]
consumer organizations that are participating in the selection process
with the opportunity to vote on the listed nominees. Only organizations
vote in the selection process. Persons who nominate themselves to serve
as voting or nonvoting consumer representatives will not participate in
the selection process.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: January 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00124 Filed 1-7-21; 8:45 am]
BILLING CODE 4164-01-P
