82 FR 28661 - Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 120 (June 23, 2017)

The Food and Drug Administration (FDA or Agency) 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. In accordance with the 21st Century Cures Act, this notice provides an annual opportunity for patients, representatives of patients, and sponsors of medical device submissions 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.

[Federal Register Volume 82, Number 120 (Friday, June 23, 2017)]
[Notices]
[Pages 28661-28664]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-13182]



[[Page 28661]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


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 or Agency) 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. In accordance with the 21st Century Cures Act, 
this notice provides an annual opportunity for patients, 
representatives of patients, and sponsors of medical device submissions 
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 August 22, 2017, 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 August 22, 2017, 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 Web site 
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--Committee Contact
------------------------------------------------------------------------
  Primary contact person or designated
            federal officer                         Committee
------------------------------------------------------------------------
Sara Anderson, Office of Device          Dental Products Panel,
 Evaluation, 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
 Spring, MD 20993, 301-796-7047, email:
 [email protected].
Aden S. Asefa, Office of Device          General Hospital and Personal
 Evaluation, Center for Devices and       Use Devices Panel,
 Radiological Health, Food and Drug       Neurological Devices Panel,
 Administration, 10903 New Hampshire      Ophthalmic Devices Panel,
 Ave., Bldg. 66, Rm. G642, Silver         Immunology Devices Panel,
 Spring, MD 20993, 301-796-0400, email:   Device Good Manufacturing
 [email protected].                  Practice Advisory Committee.
Shanika Craig, Office of Device          Anesthesiology and Respiratory
 Evaluation, Center for Devices and       Therapy Devices Panel,
 Radiological Health, Food and Drug       Microbiology Devices Panel,
 Administration, 10903 New Hampshire      Obstetrics and Gynecology
 Ave., Bldg. 66, Rm. G644, Silver         Devices Panel, Radiological
 Spring, MD 20993, 301-796-6639, email:   Devices Panel.
 [email protected].
Patricio G. Garcia, Office of Device     Clinical Chemistry and Clinical
 Evaluation, Center for Devices and       Toxicology 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:
 [email protected].
Pamela Scott, Office of the Center       Medical Devices Dispute
 Director, Center for Devices and         Resolution Panel.
 Radiological Health, Food and Drug
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 5572, Silver
 Spring, MD 20993, 301-796-5433, email:
 [email protected].
Evella F. Washington, Office of Device   Circulatory System Devices
 Evaluation, Center for Devices and       Panel, Ear, Nose and Throat
 Radiological Health, Food and Drug       Devices Panel, Molecular and
 Administration, 10903 New Hampshire      Clinical Genetics Devices
 Ave., Bldg. 66, Rm. G640, Silver         Panel.
 Spring, MD 20993, 301-796-6683, email:
 [email protected].
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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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                                       Upcoming       Approximate date
    Committee expertise needed         vacancies           needed
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Device Good Manufacturing Practice               5  Immediately: Health
 Advisory Committee--Experts                         Professional (2).
 needed to provide cross-cutting                    June 1, 2017:
 scientific or clinical expertise                    Government
 concerning the particular issue                     Representatives (2)
 in dispute. Vacancies include a                     and General Public
 public representative and a                         Representative (1).
 government representative.
Anesthesiology and Respiratory                   3  December 1, 2017.
 Therapy Devices Panel of the
 Medical Devices Advisory
 Committee--Anesthesiologists,
 pulmonary medicine specialists,
 or other experts who have
 specialized interests in
 ventilator support, pharmacology,
 physiology, or the effects and
 complications of anesthesia.

[[Page 28662]]

 
Circulatory System Devices Panel                 1  July 1, 2017.
 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
 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                     3  November 1, 2017.
 Medical Devices 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               1  Immediately.
 of the Medical Devices Advisory                 3  November 1, 2017.
 Committee--Otologists,
 neurotologists, and audiologists.
Gastroenterology and Urology,                    1  Immediately.
 Devices Panel of the Medical                    2  January 1, 2018.
 Devices Advisory Committee--
 Gastroenterologists, urologists,
 and nephrologists.
General and Plastic Surgery                      1  Immediately.
 Devices Panel of the Medical                    2  September 1, 2017.
 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                    2  January 1, 2018.
 Devices Advisory Committee--
 Internists, pediatricians,
 neonatologists, endocrinologists,
 gerontologists, nurses,
 biomedical engineers or
 microbiologists/infection control
 practitioners or experts.
Hematology and Pathology Devices                 1  Immediately.
 Panel of the 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                  3  Immediately.
 Medical Devices Advisory
 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  Immediately.
 Panel of the Medical Devices                    1  October 1, 2017.
 Advisory Committee--Experts with
 cross-cutting scientific,
 clinical, analytical or mediation
 skills.
Microbiology Devices Panel of the                5  Immediately.
 Medical Devices Advisory
 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                  2  June 1, 2017.
 Devices Panel of the Medical
 Devices Advisory Committee--
 Experts in human 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
 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                4  Immediately.
 Medical Devices Advisory                        1  December 1, 2017.
 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                    3  February 1, 2018.
 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                  1  Immediately.
 Medical Devices Advisory                        2  November 1, 2017.
 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.

[[Page 28663]]

 
Orthopaedic and Rehabilitation                   2  September 1, 2017.
 Devices Panel of the Medical
 Devices Advisory Committee--
 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                1  Immediately.
 Medical Devices Advisory--
 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. Device Good Manufacturing Practice Advisory Committee

    The Committee reviews regulations proposed for issuance 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 with regard to 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 (the 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. 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 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 Medical Devices Advisory Committee. 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

[[Page 28664]]

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 of this document. 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 and/or home address, 
telephone number, and email address if available. 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: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13182 Filed 6-22-17; 8:45 am]
 BILLING CODE 4164-01-P