[Federal Register Volume 78, Number 26 (Thursday, February 7, 2013)]
[Notices]
[Pages 9060-9063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02793]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]


Request for Nominations for Voting Members on Public Advisory 
Panels or Committees

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, certain device panels of the 
Medical Devices Advisory Committee, the National Mammography Quality 
Assurance Advisory Committee, and the Technical Electronic Products 
Radiation Safety Standards Committee in the Center for Devices and 
Radiological Health. Nominations will be accepted for current vacancies 
and those that will or may occur through December 31, 2013.
    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: Because scheduled vacancies occur on various dates throughout 
each year, no cutoff date is established for the receipt of 
nominations. However, when possible, nominations should be received at 
least 6 months before the date of scheduled vacancies for each year, as 
indicated in this notice.

ADDRESSES: All nominations for membership should be sent electronically 
to [email protected], or by mail to Advisory Committee Oversight & 
Management Staff, 10903 New Hampshire Ave., Bldg. 32, rm. 5103, Silver 
Spring, MD 20993-0002. Information about becoming a member on a FDA 
advisory committee can also be obtained by visiting FDA's Web site at 
http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: For specific Committee/Panel 
questions, contact the following persons listed in table 1 of this 
document.

                                 Table 1
------------------------------------------------------------------------
                                         Committee/certain device panels
             Contact person              of the medical devices advisory
                                                    committee
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LCDR Sara Anderson, Center for Devices   National Mammography Quality
 and Radiological Health, Food and Drug   Assurance Advisory Committee.
 Administration, 10903 New Hampshire     Dental Products Panel.
 Ave., Bldg. 66, rm. 1544, Silver        Hematology and Pathology
 Spring, MD 20993, 301-796-7046, email:   Devices Panel.
 [email protected].              Orthopaedic and Rehabilitation
                                          Devices Panel.
Shanika Craig, Center for Devices and    Technical Electronic Product
 Radiological Health, Food and Drug       Radiation Safety Standards
 Administration, 10903 New Hampshire      Committee.
 Ave., Bldg. 66, rm. 1613, Silver        Anesthesiology and Respiratory
 Spring, MD 20993, 301-796-6639, email:   Therapy Devices Panel.
 [email protected].              Gastroenterology and Urology
                                          Devices Panel.
                                         Microbiology Devices Panel.
                                         Obstetrics and Gynecology
                                          Devices Panel.
                                         Radiological Devices Panel.
Natasha Facey, Center for Devices and    Device Good Manufacturing
 Radiological Health, Food and Drug       Practice Advisory Committee.
 Administration, 10903 New Hampshire     General Hospital and Personal
 Ave., Bldg. 66, rm. 1544, Silver         Use Devices Panel.
 Spring, MD 20993, 301-796-5290, email:  Immunology Devices Panel.
 [email protected].              Ophthalmic Devices Panel.
                                         Neurological Devices Panel.

[[Page 9061]]

 
Pamela D. Scott, Center for Devices and  Medical Devices Dispute
 Radiological Health, Food and Drug       Resolution Panel.
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, rm. 5406, Silver
 Spring, MD 20993, 301-796-5433, email:
 [email protected].
Jamie Waterhouse, Center for Devices     Circulatory System Devices
 and Radiological Health, Food and Drug   Panel.
 Administration, 10903 New Hampshire     Ear, Nose and Throat Devices
 Ave., Bldg. 66, rm. 1544, Silver         Panel.
 Spring, MD 20993, 301-796-3036, email:  General and Plastic Surgery
 [email protected].            Devices Panel.
                                         Molecular and Clinical Genetics
                                          Devices Panel.
------------------------------------------------------------------------


SUPPLEMENTARY INFORMATION: 

I. Vacancies

    FDA is requesting nominations of voting members for vacancies 
listed as follows:

                                 Table 2
------------------------------------------------------------------------
                                Current and
  Committee/panel expertise      upcoming       Approximate date needed
           needed                vacancies
------------------------------------------------------------------------
Anesthesiology and                         3  December 1, 2013.
 Respiratory 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.
Circulatory System Devices                 1  July 1, 2013.
 Panel 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.
Dental Products Panel of the               3  November 1, 2013.
 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               3  November 1, 2013.
 Panel of the Medical
 Devices Advisory Committee--
 Otologists, neurotologists,
 audiologists.
Gastroenterology and Urology               3  Immediately.
 Devices Panel of the                      2  January 1, 2014.
 Medical Devices Advisory
 Committee--Transplant
 specialists,
 gastroenterologists,
 urologists and
 nephrologists.
General and Plastic Surgery                2  September 1, 2013.
 Devices Panel of the
 Medical 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                       1  Immediately.
 Personal Use Devices Panel                3  January 1, 2014.
 of the Medical Devices
 Advisory Committee--
 Internists, pediatricians,
 neonatologists,
 endocrinologists,
 gerontologists, nurses,
 biomedical engineers or
 microbiologists/infection
 control practitioners or
 experts.
Hematology and Pathology of                4  March 1, 2013.
 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                1  Immediately.
 the Medical Devices                       1  March 1, 2013.
 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                    1  October 1, 2013.
 Resolution Panel of the
 Medical Devices Advisory
 Committee--Experts with
 broad, cross-cutting
 scientific, engineering,
 clinical, analytical or
 mediation skills who are
 familiar with the materials
 and/or operating mechanisms
 related to addressing
 complex or contested
 scientific issues.
Microbiology Devices Panel                 1  Immediately.
 of the Medical Devices                    3  March 1, 2013.
 Advisory Committee--
 Infectious disease
 clinicians, e.g., pulmonary
 disease specialists,
 sexually transmitted
 disease specialists,
 pediatric infectious
 disease specialists,
 experts in tropical
 medicine and emerging
 infectious diseases,
 biofilm development;
 mycologists; clinical
 microbiologists and
 virologists; clinical
 virology and microbiology
 laboratory directors, with
 expertise in clinical
 diagnosis and in vitro
 diagnostic assays, e.g.,
 hepatologists; molecular
 biologists.
Molecular and Clinical                     2  June 1, 2013.
 Genetics 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                 1  December 1, 2013.
 of the Medical Devices
 Advisory Committee--
 Neurosurgeons
 (cerebrovascular and
 pediatric), neurologists
 (stroke, pediatric, pain
 management, and movement
 disorders), interventional
 neuroradiologists,
 psychiatrists, and
 biostatisticians.

[[Page 9062]]

 
Obstetrics and Gynecology                  2  February 1, 2013.
 Devices Panel of 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                2  November 1, 2013.
 the Medical Devices
 Advisory 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                            3  September 1, 2013.
 Rehabilitation Devices
 Panel of the Medical
 Devices Advisory Committee--
 Orthopedic 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                 2  February 1, 2013.
 of the 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.
Device Good Manufacturing                  2  June 1, 2013.
 Practice Advisory
 Committee--Vacancies
 include a public
 representative and a
 government representative.
National Mammography Quality               1  February 1, 2013.
 Assurance Advisory
 Committee--Physicians,
 practitioners, or other
 health professionals whose
 clinical practice, research
 specialization, or
 professional expertise
 include a significant focus
 on mammography.
Technical Electronic Product               2  January 1, 2014.
 Radiation Safety Standards
 Advisory Committee--
 Vacancies include general
 public representative and a
 government representative.
------------------------------------------------------------------------

II. Functions

A. 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 of what 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 of Food and Drugs (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.

B. National Mammography Quality Assurance Advisory Committee

    The functions of the committee are to advise FDA on the following 
topics: (1) Developing appropriate quality standards and regulations 
for mammography facilities; (2) developing appropriate standards and 
regulations for bodies accrediting mammography facilities under this 
program; (3) developing regulations with respect to sanctions; (4) 
developing procedures for monitoring compliance with standards; (5) 
establishing a mechanism to investigate consumer complaints; (6) 
reporting new developments concerning breast imaging that should be 
considered in the oversight of mammography facilities; (7) determining 
whether there exists a shortage of mammography facilities in rural and 
health professional shortage areas and determining the effects of 
personnel on access to the services of such facilities in such areas; 
(8) determining whether there will exist a sufficient number of medical 
physicists after October 1, 1999; and (9) determining the costs and 
benefits of compliance with these requirements.

C. Device Good Manufacturing Practice Advisory Committee

    The functions of the committee are to review proposed regulations 
issuance regarding good manufacturing practices governing the methods 
used in, and the facilities and controls used for, manufacture, 
packaging, storage, installation, and servicing of devices, and to make 
recommendations regarding the feasibility and reasonableness of those 
proposed

[[Page 9063]]

regulations. The committee also reviews and makes recommendations on 
proposed guidelines developed to assist the medical device industry in 
meeting the good manufacturing practice requirements, and provides 
advice with regard to any petition submitted by a manufacturer for an 
exemption or variance from good manufacturing practice regulations.
    Section 520 of the FD&C Act, (21 U.S.C. 360j), as amended, provides 
that the Device Good Manufacturing Practice Advisory Committee shall be 
composed of nine members as follows: (1) Three of the members shall be 
appointed from persons who are officers or employees of any Federal, 
State, or local government; (2) two shall be representatives of the 
interests of the device manufacturing industry; (3) two shall be 
representatives of the interests of physicians and other health 
professionals; and (4) two shall be representatives of the interests of 
the general public.

D. Technical Electronic Product Radiation Safety Standards Committee

    The function of the committee is to provide advice and consultation 
on the technical feasibility, reasonableness, and practicability of 
performance standards for electronic products to control the emission 
of radiation from such products. The committee may recommend electronic 
product radiation safety standards for consideration.
    Section 534(f) of the FD&C Act (21 U.S.C. 360kk(f)), as amended by 
the Safe Medical Devices Act of 1990, provides that the Technical 
Electronic Product Radiation Safety Standards Committee include five 
members from governmental Agencies, including State or Federal 
Governments; five members from the affected industries; and five 
members from the general public, of which at least one shall be a 
representative of organized labor.

III. Qualifications

A. 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 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 section I of this document. The 
term of office is up to 4 years, depending on the appointment date.

B. National Mammography Quality Assurance Advisory Committee

    Persons nominated for membership should be physicians, 
practitioners, and other health professionals, whose clinical practice, 
research specialization, or professional expertise include a 
significant focus on mammography and individuals identified with 
consumer interests. Prior experience on Federal public advisory 
committees in the same or similar subject areas will also be considered 
relevant professional expertise.
    The particular needs at this time for this committee are listed in 
section I of this document. The term of office is up to 4 years, 
depending on the appointment date.

C. Device Good Manufacturing Practice Advisory Committee

    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. The particular 
needs at this time for this committee are listed in section I of this 
document. The term of office is up to 4 years, depending on the 
appointment date.

D. Technical Electronic Product Radiation Safety Standards Committee

    Persons nominated should be technically qualified by training and 
experience in one or more fields of science or engineering applicable 
to electronic product radiation safety. The particular needs at this 
time for this committee are listed in section I of this document. The 
term of office is up to 4 years, depending on the appointment date.

IV. Nomination Procedures

    Any interested person may nominate one or more qualified persons 
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, and their current business address and/or home address, 
telephone number, and email address if available. Nominations must 
specify the advisory panel(s) or 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: February 1, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-02793 Filed 2-6-13; 8:45 am]
BILLING CODE 4160-01-P