[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Notices]
[Pages 42659-42662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18216]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3079]


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 and device panels of the 
Medical Devices Advisory Committee 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 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 22, 2018 will be given 
first consideration for membership on the Device Good Manufacturing 
Practice Advisory Committee and Panels of the Medical Devices Advisory 
Committee. Nominations received after October 22, 2018 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.

FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for 
membership, contact the following persons listed in table 1:

[[Page 42660]]



             Table 1--Panel and Advisory Committee Contacts
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  Primary contact person or designated
             federal officer                      Committee/panel
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Joannie Adams-White, Office of the        Medical Devices Dispute
 Center Director, Center for Devices and   Resolution Panel.
 Radiological Health, Food and Drug
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 5519, Silver
 Spring, MD 20993, 301-796-5421, email:
 [email protected].
LCDR Sara Anderson, Office of Device      Dental Products Panel.
 Evaluation, Center for Devices and       Hematology and Pathology
 Radiological Health, Food and Drug        Devices Panel.
 Administration, 10903 New Hampshire      Orthopaedic and Rehabilitation
 Ave., Bldg. 66, Rm. G616, Silver          Devices Panel.
 Spring, MD 20993, 301-796-7047, email:   Radiological Devices Panel.
 [email protected].
Aden S. Asefa, Office of Device           Immunology Devices Panel.
 Evaluation, Center for Devices and       Microbiology Devices Panel.
 Radiological Health, Food and Drug       Neurological Devices Panel.
 Administration, 10903 New Hampshire      Ophthalmic Devices Panel.
 Ave., Bldg. 66, Rm. G642, Silver         Device Good Manufacturing
 Spring, MD 20993, 301-796-0400, email:    Practice Advisory Committee.
 [email protected].
LCDR Patricio G. Garcia, Office of        Clinical Chemistry and
 Device Evaluation, Center for Devices     Clinical Toxicology Devices
 and Radiological Health, Food and Drug    Panel.
 Administration,10903 New Hampshire       Gastroenterology and Urology
 Ave., Bldg. 66, Rm. G610, Silver          Devices Panel.
 Spring, MD 20993, 301-796-6875, email:   General and Plastic Surgery
 [email protected].              Devices Panel.
                                          Obstetrics and Gynecology
                                           Devices Panel.
Evella F. Washington, Office of Device    Anesthesiology and Respiratory
 Evaluation, Center for Devices and        Therapy Devices Panel.
 Radiological Health, Food and Drug       Circulatory System Devices
 Administration, 10903 New Hampshire       Panel.
 Ave., Bldg. 66, Rm. G640, Silver         Ear, Nose and Throat Devices
 Spring, MD 20993, 301-796-6683, email:    Panel.
 [email protected].           General Hospital and Personal
                                           Use Devices Panel.
                                          Molecular and Clinical
                                           Genetics Devices Panel.
------------------------------------------------------------------------

    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.

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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         Committee/panel expertise needed                     Vacancies               Approximate date needed
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Device Good Manufacturing Practice Advisory         1 General Public               Immediately.
 Committee--Experts needed to provide cross-         Representative.               .............................
 cutting scientific or clinical expertise           2 Health Professional          6/1/2019.
 concerning the particular issue in dispute.         Representatives..
 Vacancies include a representative of the          1 Government Representative..
 interests of the general public and government
 and representatives of the interests of
 physicians and other health professionals.
Anesthesiology and Respiratory Therapy Devices      1............................  Immediately.
 Panel of the Medical Devices Advisory Committee--  3............................  11/30/2018.
 Anesthesiologists, pulmonary medicine
 specialists, or other experts who have
 specialized interests in ventilator support,
 pharmacology, physiology, or the effects and
 complications of anesthesia.
Circulatory System Devices Panel of the Medical     3............................  Immediately.
 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 Toxicology Panel    1............................  2/28/2019.
 of the Medical 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 Medical Devices        2............................  10/31/2018.
 Advisory Committee--Dentists, engineers, and
 scientists who have expertise in the areas of
 dental implants, dental materials,
 periodontology, tissue engineering, and dental
 anatomy.
Ear, Nose and Throat Devices Panel of the Medical   3............................  10/31/2018.
 Devices Advisory Committee--Otologists,
 neurotologists, audiologists.
Gastroenterology and Urology Devices Panel of the   0............................  N/A.
 Medical Devices Advisory Committee--
 Gastroenterologists, urologists, and
 nephrologists.
General and Plastic Surgery Devices Panel of the    1............................  Immediately.
 Medical Devices Advisory Committee--Surgeons       1............................  8/31/2018.
 (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 Devices Panel of  3............................  Immediately.
 the Medical Devices Advisory Committee--           3............................  12/31/2018.
 Internists, pediatricians, neonatologists,
 endocrinologists, gerontologists, nurses,
 biomedical engineers or microbiologists/infection
 control practitioners or experts.

[[Page 42661]]

 
Hematology and Pathology Devices Panel of the       1............................  2/28/2019.
 Medical Devices Advisory Committee--Hematologists
 (benign and/or malignant hematology),
 hematopathologists (general and special
 hematology, coagulation and homeostasis, and
 hematological oncology), gynecologists with
 special interests in gynecological oncology,
 cytopathologists, and molecular pathologists with
 special interests in development of predictive
 and prognostic biomarkers.
Immunology Devices Panel of the Medical Devices     1............................  Immediately.
 Advisory Committee--Persons with experience in     2............................  2/28/19.
 medical, surgical, or clinical oncology, internal
 medicine, clinical immunology, allergy, molecular
 diagnostics, or clinical laboratory medicine.
Medical Devices Dispute Resolution Panel of the     1............................  9/30/2018.
 Medical Devices Advisory Committee--Experts with
 broad, cross-cutting scientific, clinical,
 analytical, or mediation skills.
Microbiology Devices Panel of the Medical Devices   2............................  Immediately.
 Advisory Committee--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 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 Devices Panel of    3............................  Immediately.
 the Medical Devices Advisory Committee--Human      2............................  5/31/2019.
 genetics 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, and clinical
 molecular genetics testing (e.g., genotyping,
 array comparative genomic hybridization (CGH),
 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 Devices   1............................  Immediately.
 Advisory Committee--Neurosurgeons
 (cerebrovascular and pediatric), neurologists
 (stroke, pediatric, pain management, and movement
 disorders), interventional neuroradiologists,
 psychiatrists, and biostatisticians.
Obstetrics and Gynecology Devices Panel of the      1............................  Immediately.
 Medical Devices Advisory Committee--Perinatology,  2............................  1/31/2019.
 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 Devices     2............................  Immediately.
 Advisory Committee--Ophthalmologists specializing  3............................  10/31/2018.
 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 Devices Panel of     2............................  8/31/2018.
 the Medical Devices Advisory Committee--           1............................  8/31/2019.
 Orthopaedic surgeons (joint, spine, trauma, and
 pediatric); rheumatologists; engineers
 (biomedical, biomaterials, and biomechanical);
 experts in rehabilitation medicine, sports
 medicine, and connective tissue engineering; and
 biostatisticians.
Radiological Devices Panel of the Medical Devices   3............................  Immediately.
 Advisory Committee--Physicians with experience in  3............................  1/31/2019.
 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. Device Good Manufacturing Practice Advisory Committee

    The Committee 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 
Committee 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. Medical Devices Advisory Committee

    The Committee reviews and evaluates data on the safety and 
effectiveness of marketed and investigational devices and makes 
recommendations for their regulation. The panels engage in a number of 
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

[[Page 42662]]

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. Device Good Manufacturing Practice Advisory Committee

    The Committee consists of a core of nine members including the 
Chair. Members and the Chair are selected by the Secretary of Health 
and Human Services. 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. To be eligible for selection 
as a representative of the general public, nominees should possess 
appropriate qualifications to understand and contribute to the 
committee'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 serves as Special Government Employees. Members are invited 
to serve for overlapping terms of 4 years. The particular needs at this 
time for this committee are listed in table 2 of this document.

B. Panels of the Medical Devices Advisory Committee

    The Medical Devices Advisory Committee (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 particular needs at this time 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 resume 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 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18216 Filed 8-22-18; 8:45 am]
BILLING CODE 4164-01-P