[Federal Register Volume 87, Number 19 (Friday, January 28, 2022)]
[Notices]
[Pages 4616-4620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01724]



[[Page 4616]]

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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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the 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 March 
14, 2022, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA (see 
ADDRESSES) by March 14, 2022. Nominations will be accepted for current 
vacancies and for those that will or may occur through December 31, 
2022.

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#cb8a8884869898bea9a6a2b8b8a2a4a5b88badafaae5a3a3b8e5aca4bd"><span class="__cf_email__" data-cfemail="8bcac8c4c6d8d8fee9e6e2f8f8e2e4e5f8cbedefeaa5e3e3f8a5ece4fd">[email protected]</span></a> 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, <a href="/cdn-cgi/l/email-protection#6b200206090e19071245230a0602071f04052b0d0f0a45030318450c041d"><span class="__cf_email__" data-cfemail="82c9ebefe0e7f0eefbaccae3efebeef6edecc2e4e6e3aceaeaf1ace5edf4">[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
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Rakesh Raghuwanshi, Office of the Chief     FDA Science Board Advisory
 Scientist, Food and Drug Administration,    Committee.
 10903 New Hampshire Ave., Bldg. 1, Rm.
 3309, Silver Spring, MD 20993-0002, 301-
 796-4769, <a href="/cdn-cgi/l/email-protection#91c3f0faf4e2f9bfc3f0f6f9e4e6f0ffe2f9f8d1f7f5f0bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="287a49434d5b40067a494f405d5f49465b4041684e4c490640405b064f475e">[email protected]</span></a>.
Shivana Srivastava, Office of Pediatric     Pediatrics Advisory
 Therapeutics, Office of the Commissioner,   Committee.
 Food and Drug Administration, 10903 New
 Hampshire Ave., Bldg. 32, Rm. 5157,
 Silver Spring, MD 20993-0002, 301-796-
 8695, <a href="/cdn-cgi/l/email-protection#ebb883829d8a858ac5b899829d8a989f8a9d8aab8d8f8ac5838398c58c849d"><span class="__cf_email__" data-cfemail="73201b1a05121d125d20011a05120007120512331517125d1b1b005d141c05">[email protected]</span></a>.
Prabhakara Atreya, Center for Biologics     Allergenics Products
 Evaluation and Research, Food and Drug      Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 71, Rm. 1226, Silver Spring, MD
 20993-0002, 240-402-8006,
 <a href="/cdn-cgi/l/email-protection#e3b39182818b8288829182cda29791869a82a3858782cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="78280a191a101913190a1956390c0a1d0119381e1c195610100b561f170e">[email protected]</span></a>.
LaToya Bonner, Center for Drugs Evaluation  Endocrinologic and Metabolic
 and Research, Food and Drug                 Drugs Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 31, Rm. 2428, Silver Spring, MD
 20993-0002, 301-796-2855,
 <a href="/cdn-cgi/l/email-protection#1c507d4873657d325e737272796e5c7a787d3274746f327b736a"><span class="__cf_email__" data-cfemail="a1edc0f5ced8c08fe3cecfcfc4d3e1c7c5c08fc9c9d28fc6ced7">[email protected]</span></a>.
Moon Hee Choi, Center for Drugs Evaluation  Non-Prescription Drugs
 and Research, Food and Drug                 Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 31, Rm. 2434, Silver Spring, MD
 20993-0002, 301-796-2894,
 <a href="/cdn-cgi/l/email-protection#074a6868694f626229446f686e47616366296f6f7429606871"><span class="__cf_email__" data-cfemail="f4b99b9b9abc9191dab79c9b9db4929095da9c9c87da939b82">[email protected]</span></a>.
Joyce Frimpong, Center for Drugs            Psychopharmacologic Drugs
 Evaluation and Research, Food and Drug      Advisory Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 31, Rm. 2462, Silver Spring, MD
 20993-0002, 301-796-7973,
 <a href="/cdn-cgi/l/email-protection#bbf1d4c2d8de95fdc9d2d6cbd4d5dcfbdddfda95d3d3c895dcd4cd"><span class="__cf_email__" data-cfemail="387257415b5d167e4a51554857565f785e5c591650504b165f574e">[email protected]</span></a>.
Candace Nalls, Center for Devices and       Anesthesiology and
 Radiological Health, Food and Drug          Respiratory Therapy Devices
 Administration, 10903 New Hampshire Ave.,   Panel, Clinical Chemistry
 Bldg. 66, Rm. 5211, Silver Spring, MD       and Clinical Toxicology
 20993-0002, 301-636-0510,                   Devices Panel,
 <a href="/cdn-cgi/l/email-protection#7132101f151012145f3f101d1d02311715105f1919025f161e07"><span class="__cf_email__" data-cfemail="cd8eaca3a9acaea8e383aca1a1be8daba9ace3a5a5bee3aaa2bb">[email protected]</span></a>.                  Gastroenterology and
                                             Urology Devices Panel,
                                             General and Plastic Surgery
                                             Devices Panel.
Akinola Awojope, Center for Devices and     Dental Products Devices
 Radiological Health, Food and Drug          Panel, Obstetrics and
 Administration, 10903 New Hampshire Ave.,   Gynecology Devices Panel,
 Bldg. 66, Rm. 5216, Silver Spring, MD       Orthopaedic and
 20993-0002, 301-636-0512,                   Rehabilitation Devices
 <a href="/cdn-cgi/l/email-protection#de9fb5b7b0b1b2bff09fa9b1b4b1aebb9eb8babff0b6b6adf0b9b1a8"><span class="__cf_email__" data-cfemail="b6f7dddfd8d9dad798f7c1d9dcd9c6d3f6d0d2d798dedec598d1d9c0">[email protected]</span></a>.                Panel.

[[Page 4617]]

 
James Swink, Center for Devices and         Circulatory System Devices
 Radiological Health, Food and Drug          Panel, Immunology Devices
 Administration, 10903 New Hampshire Ave.,   Panel, Microbiology Devices
 Bldg. 66, Rm. 5211, Silver Spring, MD       Panel, Ophthalmic Devices
 20993-0002, 301-796-6313,                   Panel.
 <a href="/cdn-cgi/l/email-protection#a6ecc7cbc3d588f5d1cfc8cde6c0c2c788ceced588c1c9d0"><span class="__cf_email__" data-cfemail="d399b2beb6a0fd80a4babdb893b5b7b2fdbbbba0fdb4bca5">[email protected]</span></a>.
Jarrod Collier, Center for Devices and      General Hospital and
 Radiological Health, Food and Drug          Personal Use Devices Panel,
 Administration, 10903 New Hampshire Ave.,   Hematology and Pathology
 Bldg. 71, Rm. 1333, Silver Spring, MD       Devices Panel, Molecular
 20993-0002, 240-672-5763,                   and Clinical Genetics
 <a href="/cdn-cgi/l/email-protection#357f5447475a511b765a59595c5047755351541b5d5d461b525a43"><span class="__cf_email__" data-cfemail="642e0516160b004a270b08080d0116240200054a0c0c174a030b12">[email protected]</span></a>.                 Devices Panel, National
                                             Mammography Quality
                                             Assurance Advisory
                                             Committee, Radiology
                                             Devices Panel.
Letise Williams, Center for Devices and     Patient Engagement Advisory
 Radiological Health, Food and Drug          Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 66, Rm. 5407, Silver Spring, MD
 20993-0002, 301-796-8398,
 <a href="/cdn-cgi/l/email-protection#a0ecc5d4c9d3c58ef7c9ccccc9c1cdd3e0c6c4c18ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="571b32233e243279003e3b3b3e363a2417313336793f3f2479303821">[email protected]</span></a>.
------------------------------------------------------------------------


SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
and/or nonvoting consumer representatives for the vacancies listed in 
table 2:

      Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
  Committee/panel/areas of expertise needed          Type of  vacancy              Approximate date needed
----------------------------------------------------------------------------------------------------------------
FDA Science Board Advisory Committee--The     1--Voting....................  Immediately.
 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.
Pediatrics Advisory Committee--Knowledgeable  1--Voting....................  June 1, 2022.
 in pediatric research, pediatric
 subspecialties, statistics, and/or
 biomedical ethics. The core of voting
 members shall also include one
 representative from a pediatric health
 organization and one representative from a
 relevant patient or patient-family
 organization and may include one
 technically qualified member, selected by
 the Commissioner or designee, who is
 identified with consumer interests and is
 recommended by either a consortium of
 consumer-oriented organizations or other
 interested persons.
Allergenics Products Advisory Committee--     1--Voting....................  Immediately.
 Knowledgeable in the fields of allergy,
 immunology, pediatrics, internal medicine,
 biochemistry, and related specialties.
Endocrinologic and Metabolic Drugs Advisory   1--Voting....................  July 1, 2022.
 Committee--Knowledgeable in the fields of
 endocrinology, metabolism, epidemiology or
 statistics, and related specialties.
Non-Prescription Drugs Advisory Committee--   1--Voting....................  June 1, 2022.
 Knowledgeable in the fields of internal
 medicine, family practice, clinical
 toxicology, clinical pharmacology,
 pharmacy, dentistry, and related
 specialties.
Psychopharmacologic Drugs Advisory            1--Voting....................  July 1, 2022.
 Committee--Knowledgeable in the fields of
 psychopharmacology, psychiatry,
 epidemiology or statistics, and related
 specialties.
Anesthesiology and Respiratory Therapy        1--Nonvoting.................  Immediately.
 Devices Panel--Anesthesiologists, pulmonary
 medicine specialists, or other experts who
 have specialized interests in ventilator
 support, pharmacology, physiology, or the
 effects and complications of anesthesia.
Clinical Chemistry and Clinical Toxicology    1--Nonvoting.................  Immediately.
 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--  1--Nonvoting.................  Immediately.
 Gastroenterologists, urologists, and
 nephrologists.
General and Plastic Surgery Devices Panel--   1--Nonvoting.................  Immediately.
 Surgeons (general, plastic, reconstructive,
 pediatric, thoracic, abdominal, pelvic, and
 endoscopic); dermatologists; experts in
 biomaterials, lasers, wound healing, and
 quality of life; and biostatisticians.
Dental Products Devices Panel--Dentists,      1--Nonvoting.................  Immediately.
 engineers, and scientists who have
 expertise in the areas of dental implants,
 dental materials, periodontology, tissue
 engineering, and dental anatomy.
Obstetrics and Gynecology Devices Panel--     1--Nonvoting.................  Immediately.
 Experts in perinatology, embryology,
 reproductive endocrinology, pediatric
 gynecology, gynecological oncology,
 operative hysteroscopy, pelviscopy,
 electrosurgery, laser surgery, assisted
 reproductive technologies, contraception,
 postoperative adhesions, and cervical
 cancer and colposcopy; biostatisticians and
 engineers with experience in obstetrics/
 gynecology devices; urogynecologists;
 experts in breast care; experts in
 gynecology in the older patient; experts in
 diagnostic (optical) spectroscopy; experts
 in midwifery; labor and delivery nursing.
Orthopaedic and Rehabilitation Devices        1--Nonvoting.................  Immediately.
 Panel--Orthopedic surgeons (joint spine,
 trauma, and pediatric); rheumatologists;
 engineers (biomedical, biomaterials, and
 biomechanical); experts in rehabilitation
 medicine, sports medicine, and connective
 tissue engineering; and biostatisticians.
Circulatory Systems Devices Panel--           1--Nonvoting.................  Immediately.
 Interventional cardiologists,
 electrophysiologists, invasive (vascular)
 radiologists, vascular and cardiothoracic
 surgeons, and cardiologists with special
 interest in congestive heart failure.

[[Page 4618]]

 
Immunology Devices Panel--Persons with        1--Nonvoting.................  Immediately.
 experience in medical, surgical, or
 clinical oncology, internal medicine,
 clinical immunology, allergy, molecular
 diagnostics, or clinical laboratory
 medicine.
Microbiology Devices Panel--Clinicians with   1--Nonvoting.................  Immediately.
 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.
Ophthalmic Devices Panel--Ophthalmists with   1--Nonvoting.................  Immediately.
 expertise in corneal-external disease,
 vitreo-retinal surgery, glaucoma, ocular
 immunology, ocular pathology; optometrists;
 vision scientists; and ophthalmic
 professionals with expertise in clinical
 trial design, quality of life assessment,
 electrophysiology, low vision
 rehabilitation, and biostatistics.
General Hospital and Personal Use Devices     1--Nonvoting.................  Immediately.
 Panel--Internists, pediatricians,
 neonatologists, endocrinologists,
 gerontologists, nurses, biomedical
 engineers, or microbiologists/infection
 control practitioners or experts.
Hematology and Pathology Devices Panel--      1--Nonvoting.................  Immediately.
 Hematologists (benign and/or malignant
 hematology), hematopathologists (general
 and special hematology, coagulation and
 hemostasis, and hematological oncology),
 gynecologists with special interests in
 gynecological oncology, cytopathologists,
 and molecular pathologists with special
 interests in development of predictive
 biomarkers.
Molecular and Clinical Genetics Devices       1--Nonvoting.................  Immediately.
 Panel--Experts in human genetics and in the
 clinical management of patients with
 genetic disorders, e.g., pediatricians,
 obstetricians, neonatologists. The Agency
 is also interested in considering
 candidates with training in inborn errors
 of metabolism, biochemical and/or molecular
 genetics, population genetics,
 epidemiology, and related statistical
 training. Additionally, individuals with
 experience in genetic counseling, medical
 ethics, as well as ancillary fields of
 study will be considered.
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.
National Mammography Quality Assurance        4--Voting....................  Immediately.
 Advisory 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--       1--Voting....................  Immediately.
 Experts who 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.
----------------------------------------------------------------------------------------------------------------

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. Pediatrics Advisory Committee

    The Committee advises and makes recommendations to the Commissioner 
regarding (1) pediatric research; (2) identification of research 
priorities related to pediatric therapeutics and the need for 
additional treatments of specific pediatric diseases or conditions; (3) 
the ethics, design, and analysis of clinical trials related to 
pediatric therapeutics; (4) pediatric labeling disputes; (5) pediatric 
labeling changes; (6) adverse event reports for drugs granted pediatric 
exclusivity and any safety issues that may occur; (7) any other 
pediatric issue or pediatric labeling dispute involving FDA regulated 
products; (8) research involving children as subjects; and (9) any 
other matter involving pediatrics for which FDA has regulatory 
responsibility. The Committee also advises and makes recommendations to 
the Secretary of Health and Human Services (HHS) directly or to the 
Secretary of HHS through the Commissioner on research involving 
children as subjects that is conducted or supported by the Department 
of Health and Human Services.

C. Allergenics Advisory Committee

    Reviews and evaluates available data concerning the safety, 
effectiveness, and adequacy of labeling of marketed and investigational 
allergenic biological products or materials that are administered to 
humans for the diagnosis, prevention, or treatment of allergies and 
allergic disease as well as the affirmation or revocation of biological 
product licenses, on the safety, effectiveness, and labeling of the 
products, on clinical and laboratory studies of such products, on 
amendments or revisions to regulations governing the manufacture, 
testing, and licensing of allergenic biological products, and on the 
quality and relevance of FDA's research programs.

D. Endocrinologic and Metabolic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness

[[Page 4619]]

of marketed and investigational human drug products for use in the 
treatment of endocrine and metabolic disorders.

E. Nonprescription Drugs Advisory Committee

    Review and evaluate available data concerning the safety and 
effectiveness of over-the-counter (nonprescription) human drug 
products, or any other FDA-regulated product, for use in the treatment 
of a broad spectrum of human symptoms and diseases and advise the 
Commissioner either on the promulgation of monographs establishing 
conditions under which these drugs are generally recognized as safe and 
effective and not misbranded or on the approval of new drug 
applications for such drugs. The Committee will serve as a forum for 
the exchange of views regarding the prescription and nonprescription 
status, including switches from one status to another, of these various 
drug products and combinations thereof. The Committee may also conduct 
peer review of Agency-sponsored intramural and extramural scientific 
biomedical programs in support of FDA's mission and regulatory 
responsibilities.

F. 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.

G. 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.

H. 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 exist a sufficient number of 
medical physicists; and determining the costs and benefits of 
compliance with these requirements.

I. 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 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

[[Page 4620]]

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), 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: January 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01724 Filed 1-27-22; 8:45 am]
BILLING CODE 4164-01-P


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