[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]


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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.

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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 <a href="/cdn-cgi/l/email-protection#b8f9fbf7f5ebebcddad5d1cbcbd1d7d6cbf8dedcd996d0d0cb96dfd7ce"><span class="__cf_email__" data-cfemail="89c8cac6c4dadafcebe4e0fafae0e6e7fac9efede8a7e1e1faa7eee6ff">[email protected]</span></a>, 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 http://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: <a href="/cdn-cgi/l/email-protection#afc4c6c2cdcaddc3d681c7cec2c6c3dbc0c1efc9cbce81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="94fffdf9f6f1e6f8edbafcf5f9fdf8e0fbfad4f2f0f5bafcfce7baf3fbe2">[email protected]</span></a>.
    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        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: <a href="/cdn-cgi/l/email-protection#b7e5d6dcd2c4df99e5d6d0dfc2c0d6d9c4dfdef7d1d3d699dfdfc499d0d8c1"><span class="__cf_email__" data-cfemail="bdefdcd6d8ced593efdcdad5c8cadcd3ced5d4fddbd9dc93d5d5ce93dad2cb">[email protected]</span></a>.
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:
 <a href="/cdn-cgi/l/email-protection#96d5fee4ffe5e2fff8f7b8c0f3e4e2d6f0f2f7b8fefee5b8f1f9e0"><span class="__cf_email__" data-cfemail="6d2e051f041e1904030c433b081f192d0b090c4305051e430a021b">[email protected]</span></a>.
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
 <a href="/cdn-cgi/l/email-protection#95def4e1fdf9f0f0fbbbddf4ecf0e6d5f3f1f4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="91daf0e5f9fdf4f4ffbfd9f0e8f4e2d1f7f5f0bff9f9e2bff6fee7">[email protected]</span></a>.                    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: <a href="/cdn-cgi/l/email-protection#531f32273c2a327d113c3d3d3621133537327d3b3b207d343c25"><span class="__cf_email__" data-cfemail="5915382d362038771b3637373c2b193f3d387731312a773e362f">[email protected]</span></a>.
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: <a href="/cdn-cgi/l/email-protection#c59cacaba2adb0a4eb92a4aba285a3a1a4ebadadb6eba2aab3"><span class="__cf_email__" data-cfemail="bce5d5d2dbd4c9dd92ebddd2dbfcdad8dd92d4d4cf92dbd3ca">[email protected]</span></a>.         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: <a href="/cdn-cgi/l/email-protection#6d341b08191908433a0c1d01081e2d0b090c4305051e430a021b"><span class="__cf_email__" data-cfemail="411837243535246f1620312d2432012725206f2929326f262e37">[email protected]</span></a>.
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
 <a href="/cdn-cgi/l/email-protection#602a010d05134e3317090e0b200604014e0808134e070f16"><span class="__cf_email__" data-cfemail="397358545c4a176a4e505752795f5d581751514a175e564f">[email protected]</span></a>.                       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,
 <a href="/cdn-cgi/l/email-protection#d686b7a2a4bfb5bfb9f891b7a4b5bfb796b0b2b7f8bebea5f8b1b9a0"><span class="__cf_email__" data-cfemail="a7f7c6d3d5cec4cec889e0c6d5c4cec6e7c1c3c689cfcfd489c0c8d1">[email protected]</span></a>.                   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,
 <a href="/cdn-cgi/l/email-protection#96d7f2f3f8b8d7e5f3f0f7d6f0f2f7b8fefee5b8f1f9e0"><span class="__cf_email__" data-cfemail="b7f6d3d2d999f6c4d2d1d6f7d1d3d699dfdfc499d0d8c1">[email protected]</span></a>.                        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:
 <a href="/cdn-cgi/l/email-protection#7f3e1b1a11513e0c1a191e3f191b1e5117170c51181009"><span class="__cf_email__" data-cfemail="1e5f7a7b70305f6d7b787f5e787a7f3076766d30797168">[email protected]</span></a>.
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:
 <a href="/cdn-cgi/l/email-protection#6b270e1f02180e453c020707020a06182b0d0f0a45030318450c041d"><span class="__cf_email__" data-cfemail="4c002938253f29621b252020252d213f0c2a282d6224243f622b233a">[email protected]</span></a>.
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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
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 Committee/panel/areas
  of expertise needed       Type of vacancy      Approximate date needed
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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


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