[Federal Register Volume 84, Number 169 (Friday, August 30, 2019)]
[Notices]
[Pages 45773-45776]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18766]


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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 October 29, 2019 will be given 
first consideration for membership on the DGMPAC and Panels of the 
MDAC. Nominations received after October 29, 2019 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
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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. 5519, Silver
 Spring, MD 20993, 301-796-5421, email:
 Joannie.Adams-White@fda.hhs.gov.
LCDR Sara Anderson, Office of            Dental Products Panel,
 Management, Center for Devices and       Hematology and Pathology
 Radiological Health, Food and Drug       Devices Panel, Orthopaedic and
 Administration, 10903 New Hampshire      Rehabilitation Devices Panel,
 Ave., Bldg. 66, Rm. G616, Silver         Radiological Devices Panel.
 Spring, MD 20993, 301-796-7047, email:
 Sara.Anderson@fda.hhs.gov.
Aden S. Asefa, Office of Management,     Immunology Devices Panel,
 Center for Devices and Radiological      Microbiology Devices Panel,
 Health, Food and Drug Administration,    Neurological Devices Panel,
 10903 New Hampshire Ave., Bldg. 66,      Ophthalmic Devices Panel,
 Rm. G642, Silver Spring, MD 20993, 301-  DGMPAC.
 796-0400, email:
 Aden.Asefa@fda.hhs.gov.
LCDR 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. G610, Silver         Plastic Surgery Devices Panel,
 Spring, MD 20993, 301-796-6875, email:   Obstetrics and Gynecology
 Patricio.Garcia@fda.hhs.gov.             Devices Panel.

[[Page 45774]]

 
Evella F. Washington, Office of          Anesthesiology and Respiratory
 Management, Center for Devices and       Therapy Devices Panel,
 Radiological Health, Food and Drug       Circulatory System Devices
 Administration, 10903 New Hampshire      Panel, General Hospital and
 Ave., Bldg. 66, Rm. G640, Silver         Personal Use Devices Panel,
 Spring, MD 20993 301-796-6683, email:    Molecular and Clinical
 Evella.Washington@fda.hhs.gov.           Genetics 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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DGMPAC--Experts in medical device              4  Immediately.
 quality management system                     1  General Public
 requirements/current Good                     2   Representative.
 Manufacturing Practices, with                 1  Health Professional
 experience in both 21 CFR part 820                Representatives.
 and International Organization for               Government
 Standardization (ISO) 13485, are                  Representative.
 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                 1  12/1/2019.
 Therapy Devices Panel of the MDAC--
 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            1  Immediately.
 the MDAC--Interventional
 cardiologists,
 electrophysiologists, invasive
 (vascular) radiologists, vascular
 and cardiothoracic surgeons, and
 cardiologists with special
 interest in congestive heart
 failure.
Clinical Chemistry and Clinical                1  Immediately.
 Toxicology Panel of the MDAC--                1  3/1/2020.
 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 MDAC--            1  Immediately.
 Dentists, engineers, and                      1  11/1/2019.
 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.
Gastroenterology and Urology                   2  1/1/2020.
 Devices Panel of the MDAC--
 Gastroenterologists, urologists,
 and nephrologists.
General and Plastic Surgery Devices            4  Immediately.
 Panel of the MDAC--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  1/1/2020.
 Devices Panel of the MDAC--
 Internists, pediatricians,
 neonatologists, endocrinologists,
 gerontologists, nurses, biomedical
 engineers, human factors experts,
 or microbiologists/infection
 control practitioners or experts.
Hematology and Pathology Devices               2  3/1/2020.
 Panel of the MDAC--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.
Immunology Devices Panel of the                3  Immediately.
 MDAC--Persons with experience in              2  3/1/2020.
 medical, surgical, or clinical
 oncology, internal medicine,
 clinical immunology, allergy,
 molecular diagnostics, or clinical
 laboratory medicine.
Medical Devices Dispute Resolution             1  10/1/2020.
 Panel of the MDAC--experts with
 cross-cutting scientific,
 clinical, analytical or mediation
 skills.
Microbiology Devices Panel of the              2  3/1/2020.
 MDAC--Infectious disease (ID)
 clinicians (e.g., pulmonary
 disease specialists, sexually
 transmitted disease specialists,
 pediatric ID specialists, tropical
 diseases specialists) and clinical
 microbiologists experienced in
 emerging IDs; 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.

[[Page 45775]]

 
Molecular and Clinical Genetics                2  Immediately.
 Panel of the MDAC--Experts in                 1  6/1/2020.
 human genetics, molecular
 diagnostics, and in the clinical
 management of patients with
 genetic disorders, 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 and medical
 ethics are also desired, and
 individuals with experience in
 ancillary fields of study will be
 considered.
Neurological Devices Panel of the              1  Immediately.
 MDAC--Neurosurgeons                           2  12/1/2019.
 (cerebrovascular and pediatric),
 neurologists (stroke, pediatric,
 pain management, and movement
 disorders), interventional
 neuroradiologists, psychiatrists,
 and biostatisticians.
Obstetrics and Gynecology Devices              2  Immediately.
 Panel of the MDAC--Experts in                 1  2/1/2020.
 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                3  Immediately.
 MDAC--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  Immediately.
 Devices Panel of the MDAC--                   2  9/1/2020.
 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 musculoskeletal
 imaging and analyses, and
 biostatisticians.
Radiological Devices Panel of the              1  2/1/2020.
 MDAC--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.
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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, 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.

[[Page 45776]]

    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. 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 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 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: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18766 Filed 8-29-19; 8:45 am]
 BILLING CODE 4164-01-P


