[Federal Register Volume 70, Number 163 (Wednesday, August 24, 2005)]
[Notices]
[Pages 49656-49659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-16845]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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 certain device panels of the 
Medical Devices Advisory Committee, the National Mammography Quality 
Assurance Advisory Committee, the Device Good Manufacturing Practice 
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 August 31, 2006.
    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: Send all nominations and curricula vitae to the following 
contact persons in table 1 of this document:

                                Table 1.
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              Contact Person                       Committee/Panel
------------------------------------------------------------------------
Nancy J. Pluhowski, Center for Devices and  Certain Device Panels of the
 Radiological Health (HFZ-400), Food and     Medical Devices Advisory
 Drug Administration, 9200 Corporate         Committee
 Blvd., Rockville, MD 20850, 301-594-2022,
 or e-mail: <a href="/cdn-cgi/l/email-protection#8ac4c0dacac9ced8c2a4cccecba4cdc5dc"><span class="__cf_email__" data-cfemail="3d73776d7d7e796f75137b797c137a726b">[email protected]</span></a>
------------------------------------------------------------------------
Charles A. Finder, Center for Devices and   National Mammography Quality
 Radiological Health (HFZ-240), Food and     Assurance Advisory
 Drug Administration, 1350 Piccard Dr.,      Committee
 Rockville, MD 20850, e-mail:
 <a href="/cdn-cgi/l/email-protection#185b595e585b5c4a50365e5c59365f574e"><span class="__cf_email__" data-cfemail="07444641474443554f2941434629404851">[email protected]</span></a>
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Collin L. Figueroa, Center for Devices and  Device Good Manufacturing
 Radiological Health (HFZ-342), Food and     Practice Advisory Committee
 Drug Administration, 2094 Gaither Rd.,
 Rockville, MD 20850, e-mail:
 <a href="/cdn-cgi/l/email-protection#eaa9b2acaaa9aeb8a2c4acaeabc4ada5bc"><span class="__cf_email__" data-cfemail="6a29322c2a292e3822442c2e2b442d253c">[email protected]</span></a>
------------------------------------------------------------------------
Richard V. Kaczmarek, Center for Devices    Technical Electronic Product
 and Radiological Health (HFZ-240), Food     Radiation Safety Standards
 and Drug Administration, 1350 Piccard       Committee
 Dr., Rockville, MD 20850, e-mail:
 <a href="/cdn-cgi/l/email-protection#fdafabb6bdbeb9afb5d3bbb9bcd3bab2ab"><span class="__cf_email__" data-cfemail="b9ebeff2f9fafdebf197fffdf897fef6ef">[email protected]</span></a>
------------------------------------------------------------------------


FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices 
and Radiological Health (HFZ-17), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0450, ext. 114, e-mail: 
<a href="/cdn-cgi/l/email-protection#ffb4b3a8bfbcbbadb7d1b9bbbed1b8b0a9"><span class="__cf_email__" data-cfemail="afe4e3f8efecebfde781e9ebee81e8e0f9">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Vacancies

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

[[Page 49657]]



                                                    Table 2.
----------------------------------------------------------------------------------------------------------------
       Committee/Panel Expertise Needed          Current & Upcoming Vacancies         Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
Anesthesiology and Respiratory Therapy         2                                 Immediately
 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
----------------------------------------------------------------------------------------------------------------
Clinical Chemistry and Clinical Toxicology      2                                March 1, 2006
 Devices 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 Medical Devices   2                                 November 1, 2005
 Advisory Committee--dentists, engineers and
 scientists who have expertise in the areas
 of dental implants, dental materials,
 temporomandibular joint (TMJ) dysfunction,
 tissue engineering, and dental anatomy
----------------------------------------------------------------------------------------------------------------
Gastroenterology and Urology Devices Panel of  1                                 Immediately
 the Medical Devices Advisory Committee--      1                                 January 1, 2006
 gastroenterologists, urologists and
 nephrologists
----------------------------------------------------------------------------------------------------------------
General and Plastic Surgery Devices Panel of   2                                 September 1, 2005
 the Medical Devices Advisory Committee--      2                                 September 1, 2006
 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 Devices      3                                 Immediately
 Panel of the Medical Devices Advisory         4                                 January 1, 2006
 Committee--internists, pediatricians,
 neonatologists, endocrinologists,
 gerontologists, nurses, biomedical engineers
 or microbiologists/infection control
 practitioners or experts
----------------------------------------------------------------------------------------------------------------
Hematology and Pathology Devices Panel of the  3                                 March 1, 2006
 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
----------------------------------------------------------------------------------------------------------------
Medical Devices Dispute Resolution Panel of    1                                 October 1, 2005
 the Medical Devices Advisory Committee--
 experts with broad, cross-cutting
 scientific, clinical, analytical or
 mediation skills
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Microbiology Devices Panel of the Medical      3                                 Immediately
 Devices Advisory Committee--infectious        2                                 March 1, 2006
 disease clinicians, e.g., pulmonary disease
 specialists, sexually transmitted disease
 specialists, pediatric infectious disease
 specialists, experts in tropical medicine
 and emerging infectious diseases,
 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
----------------------------------------------------------------------------------------------------------------
Neurological Devices Panel of the Medical      3                                 December 1, 2005
 Devices Advisory Committee--neurosurgeons
 (cerebrovascular and pediatric),
 neurologists (stroke, pediatric, pain
 management, and movement disorders),
 interventional neuroradiologists,
 psychiatrists, and biostatisticians
----------------------------------------------------------------------------------------------------------------

[[Page 49658]]

 
Obstetrics and Gynecology Devices Panel of     1                                 February 1, 2006
 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
----------------------------------------------------------------------------------------------------------------
Orthopaedic and Rehabilitation Devices Panel   1                                 Immediately
 of the Medical Devices Advisory Committee--   1                                 September 1, 2005
 orthopedic surgeons (joint, spine, trauma,    3                                 September 1, 2006
 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      2                                 February 1, 2006
 Devices Advisory Committee--physicians with
 experience in general radiology,
 mammography, other radiological
 subspecialties and radiation oncology;
 scientists with experience in diagnostic
 devices, radiation physics, statistical
 analysis, digital imaging and image analysis
----------------------------------------------------------------------------------------------------------------
National Mammography Quality Assurance         2                                 February 1, 2006
 Advisory Committee--one medical physicist,
 one physician, practitioner, or other health
 professional whose clinical practice,
 research specialization, or professional
 expertise includes a significant focus on
 mammography
----------------------------------------------------------------------------------------------------------------
Device Good Manufacturing Practice Advisory    9                                 Immediately
 Committee: Nine vacancies occurring
 immediately; three government
 representatives, two industry
 representatives, two public representatives
 and two health professionals
----------------------------------------------------------------------------------------------------------------
Technical Electronic Product Radiation Safety  5                                 Immediately
 Standards Committee--Five vacancies           5                                 January 1, 2006
 occurring immediately, two government
 representatives, one industry representative
 and two general public representatives; five
 vacancies occurring January 1, 2006, one
 industry representative, two government
 representatives and two general public
 representatives
----------------------------------------------------------------------------------------------------------------

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 the Federal Food, Drug, and 
Cosmetic Act (the 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 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.

[[Page 49659]]

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 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 or employees of any Federal, 
State, or local government; (2) two shall be representatives of 
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 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 shall 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 government representative or 
health professional 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 or industry, 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 must 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 shall 
include complete curriculum vitae of each nominee, current business 
address and telephone number, and shall state that the nominee is aware 
of the nomination, is willing to serve as a member, and appears to have 
no conflict of interest that would preclude membership. FDA will ask 
the potential candidates to provide detailed information concerning 
such matters as 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 18, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-16845 Filed 8-23-05; 8:45 am]
BILLING CODE 4160-01-S


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