[Federal Register Volume 86, Number 56 (Thursday, March 25, 2021)]
[Notices]
[Pages 15944-15948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06206]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-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 or Agency) is requesting 
that any consumer organizations interested in participating in the 
selection of voting and/or nonvoting consumer representatives to serve 
on its advisory committees or panels notify FDA in writing. FDA is also 
requesting nominations for voting and/or nonvoting consumer 
representatives to serve on advisory committees and/or panels for which 
vacancies currently exist or are expected to occur in the near future. 
Nominees recommended to serve as a voting or nonvoting consumer 
representative may be self-nominated or may be nominated by a consumer 
organization. FDA seeks to include the views of 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 April 
26, 2021, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA (see 
ADDRESSES) by April 26, 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 or by mail to 
Advisory Committee Oversight and Management Staff, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver 
Spring, MD 20993-0002.
    Consumer representative nominations should be submitted 
electronically by logging into the FDA Advisory Committee Membership 
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, or by mail to Advisory Committee Oversight and 
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver 
Spring, MD 20993-0002. Additional information about becoming a member 
of an FDA advisory committee can also be obtained by visiting FDA's 
website at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: For questions relating to 
participation in the selection process: Kimberly Hamilton, Advisory 
Committee Oversight and Management Staff, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993-
0002, 301-796-8220, kimberly.hamilton@fda.hhs.gov.
    For questions relating to specific advisory committees or panels, 
contact the appropriate Contact Person listed in table 1.

                  Table 1--Advisory Committee Contacts
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                Contact person                      Committee/panel
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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,
 Rakesh.Raghuwanshi@fda.hhs.gov.
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,
 Christina.Vert@fda.hhs.gov.
Jarrod Collier, Center for Biologics           Cellular, Tissue and Gene
 Evaluation and Research, Food and Drug         Therapies Advisory
 Administration, 10903 New Hampshire Ave.,      Committee.
 Bldg. 71, Silver Spring, MD 20993-0002, 202-
 906-0043, Jarrod.Collier@fda.hhs.gov.
Kathleen Hayes, Center for Biologics           Vaccines and Related
 Evaluation and Research, Food and Drug         Biological Products
 Administration, 10903 New Hampshire Ave.,      Advisory Committee.
 Bldg. 71, Rm. 6307C, Silver Spring, MD 20993-
 0002, 301-796-7864,
 Kathleen.Hayes@fda.hhs.gov.
LaToya 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, Latoya.Bonner@fda.hhs.gov.
Yvette Waples, Center for Drugs Evaluation     Gastrointestinal Drugs
 and Research, Food and Drug Administration,    Advisory Committee,
 10903 New Hampshire Ave., Bldg. 31, Rm.        Pharmaceutical Science
 2510, Silver Spring, MD 20993-0002, 301-796-   and Clinical
 9034, Yvette.Waples@fda.hhs.gov.               Pharmacology Advisory
                                                Committee,
                                                Psychopharmacologic
                                                Drugs Advisory
                                                Committee.
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, James.Swink@fda.hhs.gov.   Devices Panel, Dental
                                                Products Devices Panel,
                                                General Hospital and
                                                Personal Use Devices
                                                Panel, Hematology and
                                                Pathology Devices Panel,
                                                Radiological Devices
                                                Panel.

[[Page 15945]]

 
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,                            Urology Devices Panel,
 Patricio.Garcia@fda.hhs.gov.                   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, Aden.Asefa@fda.hhs.gov.    Devices Panel,
                                                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, Aden.Asefa@fda.hhs.gov.
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,
 Letise.Williams@fda.hhs.gov.
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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 Advisory Committee--The Science      1--Voting...................  Immediately.
 Board provides advice to the Commissioner of Food
 and Drugs (Commissioner) and other appropriate
 officials on specific complex scientific and
 technical issues important to FDA and its mission,
 including emerging issues within the scientific
 community. Additionally, the Science Board provides
 advice that supports the Agency in keeping pace with
 technical and scientific developments, including in
 regulatory science; and input into the Agency's
 research agenda, and on upgrading its scientific and
 research facilities and training opportunities. It
 also provides, where requested, expert review of
 Agency-sponsored intramural and extramural
 scientific research programs.
Blood Products Advisory Committee--Knowledgeable in    1--Voting...................  October 1, 2021.
 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           1--Voting...................  April 1, 2021.
 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--     1--Voting...................  Immediately.
 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-- 1--Voting...................  September 1, 2021.
 Knowledgeable in the fields of dermatology,
 ophthalmology, internal medicine, pathology,
 immunology, epidemiology or statistics, and other
 related professions.
Gastrointestinal Drugs Advisory Committee--            1--Voting...................  July 1, 2021.
 Knowledgeable in the fields of gastroenterology,
 endocrinology, surgery, clinical pharmacology,
 physiology, pathology, liver function, motility,
 esophagitis, and statistics.
Pharmaceutical Science and Clinical Pharmacology       1--Voting...................  November 1, 2021.
 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--         1--Voting...................  Immediately.
 Knowledgeable in the fields of psychopharmacology,
 psychiatry, epidemiology or statistics, and related
 specialties.
Anesthesiology and Respiratory Therapy Devices Panel-- 1--Nonvoting................  December 1, 2021.
 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      1--Nonvoting................  Immediately.
 cardiologists, electrophysiologists, invasive
 (vascular) radiologists, vascular and cardiothoracic
 surgeons, and cardiologists with special interest in
 congestive heart failure.
Dental Products Devices Panel--Dentists, engineers,    1--Nonvoting................  Immediately.
 and scientists who have expertise in the areas of
 dental implants, dental materials, periodontology,
 tissue engineering, and dental anatomy.

[[Page 15946]]

 
General Hospital and Personal Use Devices Panel--      1--Nonvoting................  Immediately.
 Internists, pediatricians, neonatologists,
 endocrinologists, gerontologists, nurses, biomedical
 engineers, or microbiologists/infection control
 practitioners or experts.
Hematology and Pathology Devices Panel--Hematologists  1--Nonvoting................  March 1, 2021.
 (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            1--Nonvoting................  Immediately.
 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     1--Nonvoting................  Immediately.
 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--           1--Nonvoting................  Immediately.
 Gastroenterologists, urologists, and nephrologists.
General and Plastic Surgery Devices Panel--Surgeons    1--Nonvoting................  Immediately.
 (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    1--Nonvoting................  Immediately.
 perinatology, embryology, reproductive
 endocrinology, pediatric gynecology, gynecological
 oncology, operative hysteroscopy, pelviscopy,
 electrosurgery, laser surgery, assisted reproductive
 technologies, contraception, postoperative
 adhesions, and cervical cancer and colposcopy;
 biostatisticians and engineers with experience in
 obstetrics/gynecology devices; urogynecologists;
 experts in breast care; experts in gynecology in the
 older patient; experts in diagnostic (optical)
 spectroscopy; experts in midwifery; labor and
 delivery nursing.
Immunology Devices Panel--Persons with experience in   1--Nonvoting................  Immediately.
 medical, surgical, or clinical oncology, internal
 medicine, clinical immunology, allergy, molecular
 diagnostics, or clinical laboratory medicine.
Microbiology Devices Panel--Clinicians with an         1--Nonvoting................  Immediately.
 expertise in infectious disease, e.g., pulmonary
 disease specialists, sexually transmitted disease
 specialists, pediatric infectious disease
 specialists, experts in tropical medicine and
 emerging infectious diseases, mycologists; clinical
 microbiologists and virologists; clinical virology
 and microbiology laboratory directors, with
 expertise in clinical diagnosis and in vitro
 diagnostic assays, e.g., hepatologists; molecular
 biologists.
Molecular and Clinical Genetics Devices Panel--        1--Nonvoting................  June 1, 2021.
 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.
Neurological Devices Panel--Neurosurgeons              1--Nonvoting................  December 1, 2021.
 (cerebrovascular and pediatric), neurologists
 (stroke, pediatric, pain management, and movement
 disorders), interventional neuroradiologists,
 psychiatrists, and biostatisticians.
National Mammography Quality Assurance Advisory        4--Voting...................  Immediately.
 Committee--Physician, practitioner, or other health
 professional whose clinical practice, research
 specialization, or professional expertise includes a
 significant focus on mammography.
Patient Engagement Advisory Committee--Experts who     1--Voting...................  May 1, 2021.
 are knowledgeable in areas such as clinical
 research, primary care patient experience, and
 healthcare 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.
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I. Functions and General Description of the Committee Duties

A. FDA Science Board Advisory Committee

    The Science Board Advisory Committee (Science Board) provides 
advice to the Commissioner of Food and Drugs (Commissioner) and other 
appropriate officials on specific complex scientific and technical 
issues important to FDA and its mission, including emerging issues 
within the scientific community. Additionally, the Science Board 
provides advice that supports the Agency in keeping pace with technical 
and scientific developments, including in regulatory science, and input 
into the Agency's research agenda and on upgrading its scientific and 
research facilities and training opportunities. It also provides, where 
requested, expert review of Agency-sponsored intramural and extramural 
scientific research programs.

B. Blood Products Advisory Committee

    The 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 is

[[Page 15947]]

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 that provides the 
scientific support for regulating these products.

C. Cellular, Tissue, and Gene Therapies Advisory Committee

    The 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 that 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. The Committee also 
considers the quality and relevance of FDA's research program that 
provides scientific support for the regulation of these products.

D. Vaccines and Related Biologic Products Advisory Committee

    The Vaccines and Related Biologic Products Advisory Committee 
reviews and evaluates data concerning the safety, effectiveness, and 
appropriate use of vaccines and related biological products that 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 that provides scientific support for the regulation of 
these products.

E. Dermatologic and Ophthalmic Drugs Advisory Committee

    The 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

    The 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

    The 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 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

    The 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

    The Medical Devices Advisory Committee has established certain 
panels to review and evaluate data on the safety and effectiveness of 
marketed and investigational devices and make recommendations for their 
regulation. With the exception of the Medical Devices Dispute 
Resolution Panel, each panel, according to its specialty area: (1) 
Advises on the classification or reclassification of devices into one 
of three regulatory categories and advises on any possible risks to 
health associated with the use of devices; (2) advises on formulation 
of product development protocols; (3) reviews premarket approval 
applications for medical devices; (4) reviews guidelines and guidance 
documents; (5) recommends exemption of certain devices from the 
application of portions of the Federal Food, Drug, and Cosmetic Act; 
(6) advises on the necessity to ban a device; and (7) responds to 
requests from the Agency to review and make recommendations on specific 
issues or problems concerning the safety and effectiveness of devices. 
With the exception of the Medical Devices Dispute Resolution Panel, 
each panel, according to its specialty area, may also make appropriate 
recommendations to the Commissioner on issues relating to the design of 
clinical studies regarding the safety and effectiveness of marketed and 
investigational devices.
    The Dental Products Panel 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

    The 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; and reporting new developments 
concerning breast imaging that should be considered in the oversight of 
mammography facilities. The Committee also advises the Agency on 
determining whether there exists a shortage of mammography facilities 
in rural and health professional shortage areas and determining the 
effects of personnel on access to the services of such facilities in 
such areas; determining whether there will 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

    The 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

[[Page 15948]]

patient-related topics. The Committee will provide relevant skills and 
perspectives to improve communication of benefits, risks, and clinical 
outcomes and increase integration of patient perspectives into the 
regulatory process for medical devices. The Committee 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 of up to 4 years.
    FDA will review all nominations received within the specified 
timeframes and prepare a ballot containing the names of qualified 
nominees. Names not selected will remain on a list of eligible nominees 
and be reviewed periodically by FDA to determine continued interest. 
Upon selecting qualified nominees for the ballot, FDA will provide 
those consumer organizations that are participating in the selection 
process with the opportunity to vote on the listed nominees. Only 
organizations vote in the selection process. Persons who nominate 
themselves to serve as voting or nonvoting consumer representatives 
will not participate in the selection process.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: March 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06206 Filed 3-24-21; 8:45 am]
BILLING CODE 4164-01-P


