[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80949-80952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33060]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


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, and the National Mammography 
Quality Assurance Advisory 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, 2012.
    FDA has a special interest in ensuring that women, minority groups, 
and individuals with disabilities are adequately represented on 
advisory committees and, therefore, encourages nominations of 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 and 
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.

[[Page 80950]]



           Table 1--Contact Persons and Committee/Panel Names
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                                         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     Clinical Chemistry and Clinical
 Ave., Bldg. 66, rm. 1544, Silver         Toxicology Devices Panel.
 Spring, MD 20993, 301-796-7046, email:  Dental Products Panel.
 [email protected].              General Hospital and Personal
                                          Use Devices Panel.
                                         Ophthalmic Devices Panel.
Shanika Craig, Center for Devices and    Microbiology Devices Panel.
 Radiological Health, Food and Drug      Obstetrics and Gynecology
 Administration, 10903 New Hampshire      Devices Panel.
 Ave., Bldg. 66, rm. 1613, Silver
 Spring, MD 20993, 301-796-6639, email:
 [email protected].
Lt. Avena Russell, Center for Devices    Device Good Manufacturing
 and Radiological Health, Food and Drug   Practice Advisory Committee.
 Administration, 10903 New Hampshire     Gastroenterology and Urology
 Ave., Bldg. 66, rm. 1535, Silver         Devices Panel.
 Spring, MD 20993, 301-796-3805, email:  General and Plastic Surgery
 [email protected].               Devices Panel.
                                         Neurological Devices Panel.
                                         Orthopedic and Rehabilitation
                                          Devices Panel.
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   Molecular and Clinical Genetics
 [email protected].            Devices Panel.
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SUPPLEMENTARY INFORMATION: 

I. Vacancies

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

                 Table 2--Committee/Panel and Vacancies
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                                  Current &
  Committee/Panel expertise       upcoming      Approximate date needed
            needed                vacancies
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Circulatory System Devices                  2  July 1, 2012.
 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.
Clinical Chemistry and                      2  March 1, 2012.
 Clinical Toxicology Devices
 Panel of the Medical Devices
 Advisory Committee--Doctors
 of medicine or philosophy
 with experience in clinical
 chemistry, clinical
 toxicology, clinical
 pathology, clinical
 laboratory medicine,
 endocrinology, and diabetes.
Dental Products Panel of the                1  November 1, 2012.
 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                1  November 1, 2012.
 Panel of the Medical Devices
 Advisory Committee--
 Otologists, neurotologists,
 and audiologists.
Gastroenterology and Urology                3  January 1, 2013.
 Devices Panel of the Medical
 Devices Advisory Committee-
 Transplant specialists,
 gastroenterologists,
 urologists, and
 nephrologists.
General and Plastic Surgery                 1  Immediately.
 Devices Panel of the Medical               2  September 1, 2012.
 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               1  January 1, 2013.
 Use Devices Panel of the
 Medical Devices Advisory
 Committee--Internists,
 pediatricians,
 neonatologists,
 endocrinologists,
 gerontologists, nurses,
 biomedical engineers or
 microbiologists/infection
 control practitioners or
 experts.
Microbiology Devices Panel of               1  March 1, 2012
 the Medical Devices 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                      1  June 1, 2012.
 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, and
 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 and medical
 ethics are also desired, and
 individuals with experience
 in ancillary fields of study
 will be considered.
Neurological Devices Panel of               2  December 1, 2012.
 the Medical Devices Advisory
 Committee--Neurosurgeons
 (cerebrovascular and
 pediatric), neurologists
 (stroke, pediatric, pain
 management, and movement
 disorders), interventional
 neuroradiologists,
 psychiatrists, and
 biostatisticians.

[[Page 80951]]

 
Obstetrics and Gynecology                   1  February 1, 2012.
 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                 1  Immediately.
 the Medical Devices Advisory                  November 1, 2012.
 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                             2  September 1, 2012.
 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.
National Mammography Quality                3  February 1, 2012.
 Assurance Advisory
 Committee--Physicians,
 practitioners, or other
 health professionals whose
 clinical practice, research
 specialization, or
 professional expertise
 include a significant focus
 on mammography.
Device Good Manufacturing                   2  June 1, 2012.
 Practice Advisory Committee--
 Vacancies include a public
 representative and a health
 professional representative.
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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 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 which 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 make 
recommendations regarding the feasibility and reasonableness of those 
proposed 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. 360(j)), 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

[[Page 80952]]

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.

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.

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 r[eacute]sum[eacute] 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: December 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33060 Filed 12-23-11; 8:45 am]
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