[Federal Register Volume 85, Number 200 (Thursday, October 15, 2020)]
[Notices]
[Pages 65412-65415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22875]


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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 December 14, 2020 will be 
given first consideration for membership on the DGMPAC and Panels of 
the MDAC. Nominations received after December 14, 2020 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: 
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 Committee or Panel
------------------------------------------------------------------------
         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, email:
 Joannie.Adams-White@fda.hhs.gov.
Aden S. Asefa, Office of Management,     Dental Products Panel,
 Center for Devices and Radiological      Immunology Devices Panel,
 Health, Food and Drug Administration,    Microbiology Devices Panel,
 10903 New Hampshire Ave., Bldg. 66,      Neurological Devices Panel,
 Rm. 5214, Silver Spring, MD 20993, 301-  Ophthalmic Devices Panel,
 796-0400, email:                         DGMPAC.
 Aden.Asefa@fda.hhs.gov.

[[Page 65413]]

 
CDR Patricio G. Garcia, Office of        Clinical Chemistry and Clinical
 Management, Center for Devices and       Toxicology Devices Panel,
 Radiological Health, Food and Drug       Gastroenterology and Urology
 Administration,10903 New Hampshire       Devices Panel, General and
 Ave., Bldg. 66, Rm. 5216, Silver         Plastic Surgery Devices Panel,
 Spring, MD 20993, 301-796-6875, email:   Obstetrics and Gynecology
 Patricio.Garcia@fda.hhs.gov.             Devices Panel, Orthopaedic and
                                          Rehabilitation Devices Panel.
James P. Swink, Office of Management,    Anesthesiology and Respiratory
 Center for Devices and Radiological      Therapy Devices Panel,
 Health, Food and Drug Administration,    Circulatory System Devices
 10903 New Hampshire Ave., Bldg. 66,      Panel, Ear, Nose and Throat
 Rm. 5211, Silver Spring, MD 20993, 301-  Devices Panel, Hematology and
 796-6313, email:                         Pathology Devices Panel,
 James.Swink@fda.hhs.gov.                 General Hospital and Personal
                                          Use Devices Panel, Molecular
                                          and Clinical Genetics Panel,
                                          Radiological Devices Panel.
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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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                                                      Approximate date
         Expertise needed              Vacancies           needed
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Device Good Manufacturing Practice               4  Immediately.
 Advisory Committee--Experts in                  1  General Public
 medical device quality management               2   Representative.
 system requirements/current Good                1  Health Professional
 Manufacturing Practices, with                       Representatives.
 experience in both 21 CFR part                     Government
 820 and International                               Representative.
 Organization for Standardization
 (ISO) 13485, are needed to
 provide cross-cutting scientific
 or clinical expertise concerning
 the particular issue in dispute.
 Vacancies include a
 representative of the interests
 of the general public,
 government, and representatives
 of the interests of physicians
 and other health professionals.
Anesthesiology and Respiratory                   2  Immediately.
 Therapy 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                 1  July 1, 2021.
 of the Medical Devices Advisory
 Committee--Interventional
 cardiologists,
 electrophysiologists, invasive
 (vascular) radiologists, vascular
 and cardiothoracic surgeons, and
 cardiologists with special
 interest in congestive heart
 failure.
Clinical Chemistry and Clinical                  2  Immediately.
 Toxicology Panel of the Medical                 3  3/1/2021.
 Devices Advisory Committee--
 Doctors of medicine or philosophy
 with experience in clinical
 chemistry (e.g., cardiac
 markers), clinical toxicology,
 clinical pathology, clinical
 laboratory medicine, and
 endocrinology.
Dental Products Panel of the                     1  11/01/2020.
 Medical Devices 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                    3  11/01/2020.
 Panel of the Medical Devices
 Advisory Committee--Otologists,
 neurotologists, audiologists.
Gastroenterology and Urology                     2  Immediately.
 Devices Panel of the Medical                    3  1/1/2021.
 Devices Advisory Committee--
 Gastroenterologists, urologists,
 and nephrologists.
General and Plastic Surgery                      1  Immediately.
 Devices Panel of the Medical                    3  09/01/2021.
 Devices Advisory Committee--
 Surgeons (general, plastic,
 reconstructive, pediatric,
 thoracic, abdominal, pelvic and
 endoscopic); dermatologists;
 experts in biomaterials, lasers,
 wound healing, and quality of
 life; and biostatisticians.
General Hospital and Personal Use                1  Immediately.
 Devices Panel of the Medical
 Devices Advisory Committee--
 Internists, pediatricians,
 neonatologists, endocrinologists,
 gerontologists, nurses,
 biomedical engineers, human
 factors experts, or
 microbiologists/infection control
 practitioners or experts.
Hematology and Pathology Devices                 2  3/1/2021.
 Panel of the 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; and devices utilizing
 artificial intelligence/machine
 learning.
Immunology Devices Panel of the                  5  Immediately.
 Medical Devices Advisory                        2  3/1/2021.
 Committee--Persons with
 experience in medical, surgical,
 or clinical oncology, internal
 medicine, clinical immunology,
 allergy, molecular diagnostics,
 or clinical laboratory medicine.
Medical Devices Dispute Resolution               1  10/1/2021.
 Panel of the Medical Devices
 Advisory Committee--Experts with
 cross-cutting scientific,
 clinical, analytical, or
 mediation skills.

[[Page 65414]]

 
Microbiology Devices Panel of the                2  Immediately.
 Medical Devices Advisory                        3  3/1/2021.
 Committee--Infectious disease
 clinicians (e.g. pulmonary
 disease specialists, sexually
 transmitted disease specialists,
 pediatric ID specialists,
 tropical diseases specialists)
 and clinical microbiologists
 experienced in emerging
 infectious diseases; clinical
 microbiology laboratory
 directors; molecular biologists
 with experience in in vitro
 diagnostic device testing;
 virologists; hepatologists; or
 clinical oncologists experienced
 with tumor resistance and
 susceptibility.
Molecular and Clinical Genetics                  1  Immediately.
 Panel of the Medical Devices                    1  6/1/2021.
 Advisory Committee--Experts in
 human genetics, molecular
 diagnostics, and in the clinical
 management of patients with
 genetic disorders, e.g.,
 pediatricians, obstetricians, and
 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 PCR, genotyping, array
 CGH, etc.). Individuals with
 experience in genetics counseling
 and medical ethics are also
 desired, and individuals with
 experience in ancillary fields of
 study will be considered.
Neurological Devices Panel of the                3  Immediately.
 Medical Devices Advisory                        3  12/1/2020.
 Committee--Neurosurgeons
 (cerebrovascular and pediatric),
 neurologists (stroke, pediatric,
 pain management, and movement
 disorders), interventional
 neuroradiologists, psychiatrists,
 and biostatisticians.
Obstetrics and Gynecology Devices                1  Immediately.
 Panel of the Medical Devices                    2  2/1/2021.
 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; and labor and delivery
 nursing.
Ophthalmic Devices Panel of the                  2  Immediately.
 Medical Devices Advisory                        2  11/01/2020.
 Committee--Ophthalmologists
 specializing in cataract and
 refractive surgery and vitreo-
 retinal surgery, in addition to
 vision scientists, optometrists,
 and biostatisticians practiced in
 ophthalmic clinical trials.
Orthopaedic and Rehabilitation                   2  9/1/2021.
 Devices Panel of the Medical
 Devices Advisory Committee--
 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; and radiologists
 specializing musculoskeletal
 imaging and analyses and
 biostatisticians.
Radiological Devices Panel of the                2  2/1/2021.
 Medical Devices Advisory
 Committee--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.
------------------------------------------------------------------------

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. 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,

[[Page 65415]]

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 21 CFR 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 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 Non-Voting 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. 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 committee(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: October 7, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22875 Filed 10-14-20; 8:45 am]
BILLING CODE 4164-01-P


