[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80307-80310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25367]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-3926]


Request for Nominations for Voting Members on Public Advisory 
Panels or Committees; Device Good Manufacturing Practice Advisory 
Committee and the Medical Devices Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for voting members to serve on the Device Good 
Manufacturing Practice Advisory Committee (DGMPAC) and the Medical 
Devices Advisory Committee (MDAC) device panels in the Center for 
Devices and Radiological Health. This annual notice is also in 
accordance with the 21st Century Cures Act, which requires the 
Secretary of Health and Human Services (the Secretary) to provide an 
annual opportunity for patients, representatives of patients, and 
sponsors of medical devices that may be specifically the subject of a 
review by a classification panel to provide recommendations for 
individuals with appropriate expertise to fill voting member positions 
on classification panels. 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: Nominations received on or before January 16, 2024, will be 
given first consideration for membership on the DGMPAC and Panels of 
the MDAC. Nominations received after January 16, 2024, will be 
considered for nomination to the committee as later vacancies occur.

ADDRESSES: All nominations for membership should be submitted 
electronically by logging into the FDA Advisory Nomination Portal at 
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or 
by mail to Advisory Committee Oversight and Management Staff, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, 
Silver Spring, MD 20993-0002. Information about becoming a member on 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: Regarding all nomination questions for 
membership, contact the following persons listed in table 1:

                   Table 1--Primary Contact and Panel
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         Primary contact person                 Committee or panel
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Joannie Adams-White, Office of the       Medical Devices Dispute
 Center Director, Center for Devices      Resolution Panel.
 and Radiological Health, Food and Drug
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 5561, Silver
 Spring, MD 20993, 301-796-5421,
 <a href="/cdn-cgi/l/email-protection#3f75505e5151565a117e5b5e524c126857564b5a7f595b5e1157574c11585049"><span class="__cf_email__" data-cfemail="0d47626c63636468234c696c607e205a656479684d6b696c2365657e236a627b">[email protected]</span></a>.
James P. Swink, Office of Management,    Circulatory System Devices
 Center for Devices and Radiological      Panel, Ophthalmic Devices
 Health, Food and Drug Administration,    Panel.
 10903 New Hampshire Ave., Bldg. 66,
 Rm. 5211, Silver Spring, MD 20993, 301-
 796-6313, <a href="/cdn-cgi/l/email-protection#296348444c5a077a5e404742694f4d480741415a074e465f"><span class="__cf_email__" data-cfemail="b1fbd0dcd4c29fe2c6d8dfdaf1d7d5d09fd9d9c29fd6dec7">[email protected]</span></a>.
Akinola Awojope, Office of Management,   Dental Products Panel,
 Center for Devices and Radiological      Neurological Devices Panel,
 Health, Food and Drug Administration,    Obstetrics and Gynecology
 10903 New Hampshire Ave., Bldg. 66,      Devices Panel, Orthopaedic and
 Rm. 5216, Silver Spring, MD 20993, 301-  Rehabilitation Devices Panel.
 636-0512, <a href="/cdn-cgi/l/email-protection#21604a484f4e4d400f60564e4b4e5144614745400f4949520f464e57"><span class="__cf_email__" data-cfemail="51103a383f3e3d307f10263e3b3e2134113735307f3939227f363e27">[email protected]</span></a>.

[[Page 80308]]

 
Jarrod Collier, Office of Management,    DGMPAC, General Hospital and
 Center for Devices and Radiological      Personal Use Devices Panel,
 Health, Food and Drug Administration,    Hematology and Pathology
 10903 New Hampshire Ave., Bldg. 66,      Devices Panel, Molecular and
 Rm. 5216, Silver Spring, MD 20993, 240-  Clinical Genetics Panel.
 672-5763, <a href="/cdn-cgi/l/email-protection#1b517a6969747f3558747777727e695b7d7f7a35737368357c746d"><span class="__cf_email__" data-cfemail="2963485b5b464d076a464545404c5b694f4d480741415a074e465f">[email protected]</span></a>.
Candace Nalls, Office of Management,     Anesthesiology and Respiratory
 Center for Devices and Radiological      Therapy Devices Panel; Ear,
 Health, Food and Drug Administration,    Nose, and Throat Devices
 10903 New Hampshire Ave., Bldg. 66,      Panel; Gastroenterology and
 Rm. 5214, Silver Spring, MD 20993, 301-  Urology Devices Panel.
 636-0510, <a href="/cdn-cgi/l/email-protection#7231131c161311175c3c131e1e01321416135c1a1a015c151d04"><span class="__cf_email__" data-cfemail="2a694b444e4b494f04644b4646596a4c4e4b04424259044d455c">[email protected]</span></a>.
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SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
members for vacancies listed in table 2:

                        Table 2--Expertise Needed, Vacancies, and Approximate Date Needed
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               Expertise needed                   Vacancies                 Approximate date needed
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Device Good Manufacturing Practice Advisory                 1  Immediately.
 Committee--Experts in medical device quality               2  June 1, 2024.
 management system requirements/current good
 manufacturing practices, with experience in
 both part 820 (21 CFR part 820) and
 International Organization for
 Standardization (ISO) 13485, are needed to
 provide cross-cutting scientific or clinical
 expertise concerning the particular issue in
 dispute. Vacancies include representatives
 of the interests of the general public and
 government.
Anesthesiology and Respiratory Therapy                      1  December 1, 2024.
 Devices Panel of the Medical Devices
 Advisory Committee--Anesthesiologists,
 pulmonary medicine specialists, or other
 experts who have specialized interests in
 ventilator support, sleep medicine,
 pharmacology, physiology, or the effects and
 complications of anesthesia. FDA is also
 seeking applicants with pediatric expertise
 in these areas.
Circulatory System Devices Panel of the                     3  July 1, 2024.
 Medical Devices Advisory Committee--
 Interventional cardiologists,
 electrophysiologists, invasive (vascular)
 radiologists, vascular and cardiothoracic
 surgeons, and cardiologists with special
 interest in congestive heart failure.
Dental Products Panel of the Medical Devices                7  Immediately.
 Advisory Committee--Dentists, engineers and
 scientists who have expertise in the areas
 of dental implants, dental materials, oral
 and maxillofacial surgery, endodontics,
 periodontology, tissue engineering, snoring/
 sleep therapy, and dental anatomy.
Ear, Nose, and Throat Devices Panel of the                  7  Immediately.
 Medical Devices Advisory Committee--
 Otologists, neurotologists, and audiologists.
Gastroenterology and Urology Devices Panel of               2  January 1, 2024.
 the Medical Devices Advisory Committee--
 Gastroenterologists, urologists, and
 nephrologists.
General Hospital and Personal Use Devices                   1  Immediately.
 Panel of the Medical Devices Advisory                      2  January 1, 2024.
 Committee--Internists, pediatricians,
 neonatologists, endocrinologists,
 gerontologists, nurses, biomedical
 engineers, human factors experts, or
 microbiologists/infection control
 practitioners or experts.
Hematology and Pathology Devices Panel of the               4  Immediately.
 Medical Devices Advisory Committee--
 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 and
 prognostic biomarkers, molecular oncology,
 cancer screening, cancer risk, digital
 pathology, whole slide imaging; devices
 utilizing artificial intelligence/machine
 learning.
Medical Devices Dispute Resolution Panel of                 1  Immediately.
 the Medical Devices Advisory Committee--                   1  October 1, 2024.
 Experts with cross-cutting scientific,
 clinical, analytical or mediation skills.
Molecular and Clinical Genetics Panel of the                2  Immediately.
 Medical Devices Advisory Committee--Experts
 in human genetics, molecular diagnostics,
 and in the clinical management of patients
 with genetic disorders, and (e.g.,
 pediatricians, obstetricians,
 neonatologists). Individuals with training
 in inborn errors of metabolism, biochemical
 and/or molecular genetics, population
 genetics, epidemiology and related
 statistical training, bioinformatics,
 computational genetics/genomics, variant
 classification, cancer genetics/genomics,
 molecular oncology, radiation biology, and
 clinical molecular genetics testing, (e.g.,
 sequencing, whole exome sequencing, whole
 genome sequencing, non-invasive prenatal
 testing, cancer screening, circulating cell
 free/circulating tumor nucleic acid testing,
 digital polymerase chain reaction,
 genotyping, array comparative genomic
 hybridization, etc.). Individuals with
 experience in genetics counseling, medical
 ethics are also desired, and individuals
 with experience in ancillary fields of study
 will be considered.
Neurological Devices Panel of the Medical                   2  Immediately.
 Devices Advisory Committee--Neurosurgeons                  2  December 1, 2023.
 (cerebrovascular and pediatric),
 neurologists (stroke, pediatric, pain
 management, and movement disorders),
 interventional neuroradiologists,
 psychiatrists, and biostatisticians.

[[Page 80309]]

 
Obstetrics and Gynecology Devices Panel of                  2  February 1, 2024.
 the Medical Devices Advisory Committee--
 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.
Ophthalmic Devices Panel of the Medical                     3  November 1, 2024.
 Devices Advisory Committee--Ophthalmologists
 with expertise in corneal-external disease,
 vitreo-retinal surgery, glaucoma, ocular
 immunology, ocular pathology; optometrists;
 vision scientists; and ophthalmic
 professionals with expertise in clinical
 trial design, quality of life assessment,
 electrophysiology, low vision
 rehabilitation, and biostatistics.
Orthopaedic and Rehabilitation Devices Panel                1  Immediately.
 of the Medical Devices Advisory Committee--                2  September 1, 2024.
 Orthopaedic surgeons (joint, spine, trauma,
 reconstruction, sports medicine, hand, foot
 and ankle, and pediatric orthopaedic
 surgeons); rheumatologists; engineers
 (biomedical, biomaterials, and
 biomechanical); experts in rehabilitation
 medicine, and musculoskeletal engineering;
 radiologists specializing in musculoskeletal
 imaging and analyses and biostatisticians.
----------------------------------------------------------------------------------------------------------------

I. General Description of the Committees Duties

A. DGMPAC

    The DGMPAC reviews regulations proposed for promulgation regarding 
good manufacturing practices governing the methods used in, and the 
facilities and controls used for, the manufacture, packing, storage and 
installation of devices, and makes recommendations to the Commissioner 
of Food and Drugs (the Commissioner) regarding the feasibility and 
reasonableness of those proposed regulations. The DGMPAC also advises 
the Commissioner on any petition submitted by a manufacturer for an 
exemption or variance from good manufacturing practice regulations that 
is referred to the committee.

B. Panels of MDAC

    The MDAC reviews and evaluates data on the safety and effectiveness 
of marketed and investigational devices and makes recommendations for 
their regulation. The panels engage in many activities to fulfill the 
functions the Federal Food, Drug, and Cosmetic Act (FD&C Act) envisions 
for device advisory panels. With the exception of the Medical Devices 
Dispute Resolution Panel, each panel, according to its specialty area, 
performs the following duties: (1) advises the Commissioner regarding 
recommended classification or reclassification of devices into one of 
three regulatory categories, (2) advises on any possible risks to 
health associated with the use of devices, (3) advises on formulation 
of product development protocols, (4) reviews premarket approval 
applications for medical devices, (5) reviews guidelines and guidance 
documents, (6) recommends exemption of certain devices from the 
application of portions of the FD&C Act, (7) advises on the necessity 
to ban a device, and (8) 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.

II. Criteria for Voting Members

A. DGMPAC

    The DGMPAC consists of a core of nine members including the Chair. 
Members and the Chair are selected by the Secretary. Persons nominated 
for membership as a health professional or officer or employee of any 
Federal, State, or local government should have knowledge of or 
expertise in any one or more of the following areas: quality assurance 
concerning the design, manufacture, and use of medical devices in 
accordance with part 820 and/or ISO 13485. To be eligible for selection 
as a representative of the general public, nominees should possess 
appropriate qualifications to understand and contribute to the DGMPAC's 
work. Three of the members shall be officers or employees of any State 
or local government or of the Federal Government; two shall be 
representative of the interests of the device manufacturing industry; 
two shall be representatives of the interests of physicians and other 
health professionals; and two shall be representatives of the interests 
of the general public. FDA is publishing a separate document announcing 
the Request for Nominations Notification for Non-Voting Representatives 
of the interests of the device manufacturing industry. Almost all non-
Federal members of this committee serve as Special Government 
Employees. Members are invited to serve for overlapping terms of 4 
years. The current needs for the DGMPAC are listed in table 2.

B. Panels of the MDAC

    The MDAC with its 18 panels shall consist of a maximum of 159 
standing members. Members are selected by the Commissioner or designee 
from among authorities in clinical and administrative medicine, 
engineering, biological and physical sciences, and other related 
professions. Almost all non-Federal members of this committee serve as 
Special Government

[[Page 80310]]

Employees. A maximum of 122 members shall be standing voting members 
and 37 shall be nonvoting members who serve as representatives of 
consumer interests and of industry interests. FDA is publishing 
separate documents announcing the Request for Nominations Notification 
for Nonvoting Representatives on certain panels of the MDAC. Persons 
nominated for membership on the panels should have adequately 
diversified experience appropriate to the work of the panel in such 
fields as clinical and administrative medicine, engineering, biological 
and physical sciences, statistics, and other related professions. The 
nature of specialized training and experience necessary to qualify the 
nominee as an expert suitable for appointment may include experience in 
medical practice, teaching, and/or research relevant to the field of 
activity of the panel. The current needs for each panel are listed in 
table 2. Members will be invited to serve for terms of up to 4 years.

III. Nomination Procedures

    Any interested person may nominate one or more qualified 
individuals for membership on one or more of the advisory panels or 
advisory committees. Self-nominations are also accepted. Nominations 
must include a current, complete r[eacute]sum[eacute] or curriculum 
vitae for each nominee, including current business address, telephone 
number, and email address if available and a signed copy of the 
Acknowledgement and Consent form available at the FDA Advisory 
Nomination Portal (see ADDRESSES). Nominations must also specify the 
advisory committees or panel(s) for which the nominee is recommended. 
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 related to 
financial holdings, employment, and research grants and/or contracts to 
permit evaluation of possible sources of conflict of interest.
    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: November 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25367 Filed 11-16-23; 8:45 am]
BILLING CODE 4164-01-P


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