Request for Nominations for Voting Members on Public Advisory Panels or Committees, 36458-36462 [E7-12799]
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Eastern time by the deadline listed in
the DATES section at the beginning of
this Notice.
V. Responsiveness Criteria
Each application submitted will be
screened to determine whether it was
received by the closing date and time.
Applications received by the closing
date and time will be screened for
completeness and conformity with the
requirements outlined in Sections III
and IV of this Notice and the Program
Announcement. Only complete
applications that meet these
requirements will be reviewed and
evaluated competitively.
VI. Application Review Information
Eligible applications in response to
this announcement will be reviewed
according to the following evaluation
criteria:
• Purpose and Need for Assistance—
(20 points)
• Approach, Workplan and
Activities—(30 points)
• Outcomes/Evaluation/
Dissemination—(25 points)
• Level of Effort—(25 points).
forth in section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of research grant applications in
response to PA 07–318, ‘‘Center to Protect
Worker Rights.’’
For Further Information Contact: George
Bockosh, M.S., Designated Federal Officer,
626 Cochran Mill Road, Pittsburgh, PA
15236, telephone 412.386.6465.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: June 27, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–12837 Filed 7–2–07; 8:45 am]
BILLING CODE 4163–18–P
evaluation of individual research grant and
cooperative agreement applications
submitted in response to one Fiscal Year
2007 Request for Applications related to the
following individual research announcement:
RFA–CE–07–011, ‘‘Multi-Level Parent
Training Effectiveness Trial—Phase II (U49).’’
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information: Jane
Suen, NCIPC/ERPO, CDC, 4770 Buford
Highway, NE., M/S K02, Atlanta, Georgia
30341–3724, telephone 770/488–4281, or
Tony Johnson, telephone 770/488–1556.
The Director, Management Analysis
and Services Office has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both CDC and
the Agency for Toxic Substances and
Disease Registry.
Dated: June 27, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. E7–12822 Filed 7–2–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
VII. Agency Contacts
Direct inquiries regarding
programmatic issues to U.S. Department
of Health and Human Services,
Administration on Aging, Office of
Evaluation, Washington, DC 20201,
telephone: (202) 357–0145.
Centers for Disease Control and
Prevention
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Center for Injury Prevention
and Control Initial Review Group
(NCIPC/IRG)
Food and Drug Administration
Dated: June 28, 2007.
Josefina G. Carbonell,
Assistant Secretary for Aging.
[FR Doc. E7–12858 Filed 7–2–07; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Disease, Disability, and Injury
Prevention and Control—Special
Emphasis Panel: Center To Protect
Worker Rights, Program
Announcement (PA) 07–318
jlentini on PROD1PC65 with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
aforementioned committee:
Time and Date: 1 p.m.–2 p.m., July 18,
2007 (Closed).
Place: 626 Cochran Mill Road, Building 20,
Room 313, Pittsburgh, PA 15236.
Status: The meeting will be closed to the
public in accordance with provisions set
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In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
aforementioned committee:
Times and Date:
2 p.m.–2:30 p.m., July 31, 2007 (Open).
2:30 p.m.–5 p.m., July 31, 2007 (Closed).
Place: The conference call will originate at
the Centers for Disease Control and
Prevention, Yale Building, Koger Center,
Atlanta, Georgia.
Status: Portions of the meetings will be
closed to the public in accordance with
provisions set forth in Section 552b(c)(4) and
(6), Title 5, U.S.C., and the Determination of
the Director, Management Analysis and
Services Office, CDC, pursuant to Section
10(d) of Public Law 92–463.
Purpose: This group is charged with
providing advice and guidance to the
Secretary, Department of Health and Human
Services, and the Director, CDC, concerning
the scientific and technical merit of grant and
cooperative agreement applications received
from academic institutions and other public
and private profit and nonprofit
organizations, including State and local
government agencies, to conduct specific
injury research that focuses on prevention
and control.
Matters To Be Discussed: The meeting will
include the review, discussion, and
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Request for Nominations for Voting
Members on Public Advisory Panels or
Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 August 31, 2008.
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
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possible, nominations should be
received at least 6 months before the
date of scheduled vacancies for each
year, as indicated in this notice.
Send all nominations and
curricula vitae to the following contact
persons listed in table 1 of this
document:
ADDRESSES:
TABLE 1.
Contact Person
Committee/Panel
Geretta P. Wood, Center for Devices and Radiological Health (HFZ–400), Food
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–
3993, or e-mail Geretta.Wood@fda.hhs.gov
Certain Device Panels of the Medical Devices Advisory
Committee
Nancy M. Wynne, Center for Devices and Radiological Health (HFZ–240), Food
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, e-mail:
Nancy.Wynne@fda.hhs.gov
National Mammography Quality Assurance Advisory
Committee
Collin L. Figueroa, Center for Devices and Radiological Health (HFZ–342), Food
and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, e-mail:
Collin.Figueroa@fda.hhs.gov
Device Good Manufacturing Practice Advisory Committee
Richard V. Kaczmarek, Center for Devices and Radiological Health (HFZ–240),
Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, e-mail:
Richard.Kaczmarek@fda.hhs.gov
Technical Electronic Product Radiation Safety Standards
Committee
FOR FURTHER INFORMATION CONTACT:
Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ–17), Food
and Drug Administration, 7520 Standish
Pl., Rockville, MD 20855, 240–276–
8938, e-mail:
Kathleen.Walker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Vacancies
FDA is requesting nominations of
voting members for vacancies listed as
follows:
TABLE 2.
Current & Upcoming Vacancies
Approximate Date Needed
Anesthesiology and 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
2
3
Immediately
December 1, 2007
Circulatory System Devices 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
3
July 1, 2008
Clinical Chemistry and 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
2
March 1, 2008
Dental Products Panel of the 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
2
3
Immediately
November 1, 2007
General and Plastic Surgery 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
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Committee/Panel Expertise Needed
2
2
1
Immediately
September 1, 2007
September 1, 2008
Hematology and Pathology Devices 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
2
March 1, 2008
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TABLE 2.—Continued
Current & Upcoming Vacancies
Approximate Date Needed
Immunology Devices Panel of the Medical Devices Advisory
Committee—persons with experience in medical, surgical, or
clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine
3
March 1, 2008
Microbiology Devices Panel of 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, 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
4
Immediately
Molecular and Clinical 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. Individuals with
experience in genetic counseling, medical ethics as well as
ancillary fields of study will be considered
4
3
Immediately
June 1, 2008
Neurological Devices Panel of the Medical Devices Advisory
Committee—neurosurgeons (cerebrovascular and pediatric),
neurologists (stroke, pediatric, pain management, and movement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians
2
December 1, 2007
Obstetrics and Gynecology 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
1
February 1, 2008
Orthopaedic and 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
2
1
Immediately
September 1, 2008
Radiological Devices Panel of the Medical Devices Advisory
Committee—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
2
February 1, 2008
National Mammography Quality Assurance Advisory Committee—physician, practitioner, or other health professional
whose clinical practice, research specialization, or professional expertise includes a significant focus on mammography
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Committee/Panel Expertise Needed
4
February 1, 2008
Device Good Manufacturing Practice Advisory Committee:
Nine vacancies occurring immediately; three government
representatives, two industry representatives, two public representatives and two health professionals
9
Immediately
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TABLE 2.—Continued
Committee/Panel Expertise Needed
Current & Upcoming Vacancies
Approximate Date Needed
Technical Electronic Product Radiation Safety Standards Committee—15 vacancies occurring immediately, five government representatives, five industry representative and five
general public representatives
15
Immediately
jlentini on PROD1PC65 with NOTICES
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 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-thecounter 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
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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
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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 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
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Federal Register / Vol. 72, No. 127 / Tuesday, July 3, 2007 / Notices
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 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.
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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.
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Self-nominations are also accepted.
Nominations will include complete
curriculum vitae of each nominee,
current business address and telephone
number. Nominations will specify the
advisory panel(s) or advisory
committee(s) for which the nominee is
recommended. Nominations will
include confirmation that the nominee
is aware of the nomination, is willing to
serve as a member of the advisory
committee if selected, and appears to
have no conflict of interest that would
preclude membership. Potential
candidates will be required 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: June 26, 2007.
Randall W. Lutter
Deputy Commissioner for Policy.
[FR Doc. E7–12799 Filed 7–2–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 1998N–0359] (formerly 98N–
0359)
Program Priorities in the Center for
Food Safety and Applied Nutrition;
Request for Comments
AGENCY:
Food and Drug Administration,
Notice; request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is requesting
comments concerning the establishment
of program priorities in the Center for
Food Safety and Applied Nutrition
(CFSAN) for fiscal year (FY) 2008. As
part of its annual planning, budgeting,
and resource allocation process, CFSAN
is reviewing its programs to set
priorities and establish work product
expectations. This notice is being
published to give the public an
opportunity to provide input into the
priority-setting process.
DATES: Submit written or electronic
comments by September 4, 2007.
ADDRESSES: Submit written comments
concerning this document to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Submit electronic comments
PO 00000
FOR FURTHER INFORMATION CONTACT:
Tracy Summers, Center for Food Safety
and Applied Nutrition (HFS–007), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20740, e-mail:
Tsummers@.fda.hhs.gov, 301–827–1603.
SUPPLEMENTARY INFORMATION:
I. Background
On June 5, 2007, CFSAN released a
document entitled ‘‘FY 2007 Report to
Stakeholders.’’ The document, a copy of
which is available on CFSAN’s Web
page (https://www.cfsan.fda.gov/~dms/
cfsan607.html), includes the Center’s
priority workplan for fiscal year 2007,
i.e., October 1, 2006, through September
30, 2007. The FY 2007 workplan is
based on input we received from our
stakeholders (see 71 FR 37083; June 29,
2006), as well as input generated
internally. Throughout the prioritysetting process, we focused on one
central question: ‘‘Where do we do the
most good for consumers and the overall
public health?’’
The FY 2007 workplan is structured
like the FY 2006 plan. It contains only
those activities previously listed as ‘‘A’’
list items. Our goal is to fully complete
at least 90 percent of the activities listed
under sections 1 through 4 of the FY
2007 workplan by the end of the FY,
September 30, 2007. The FY 2006
workplan also includes a fifth section
entitled, ‘‘Priority Ongoing Activities.’’
Many of these activities are core
functions that we perform on a regular
basis and are among our very highest
priorities.
II. 2008 CFSAN Program Priorities
HHS.
ACTION:
to https://www.fda.gov/dockets/
ecomments.
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FDA is requesting comments on what
program priorities CFSAN should
consider establishing for FY 2008. The
input will be used to develop CFSAN’s
FY 2008 workplan. The workplan will
set forth the Center’s program priorities
for the period of October 1, 2007,
through September 30, 2008. FDA
intends to make the FY 2008 workplan
available on its Web site.
The format of the FY 2008 workplan
will be similar to the FY 2007 workplan
in that it will be divided into the
following five sections:
(1) Food Defense
(2) Food Safety
(3) Nutrition and Labeling
(4) Dietary Supplements and
Cosmetics
(5) Priority On-Going Activities
While there will likely be continuity
and follow-through on many activities
between the 2007 and 2008 work plans,
the final FY 2008 Congressional
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]]>Agencies
[Federal Register Volume 72, Number 127 (Tuesday, July 3, 2007)]
[Notices]
[Pages 36458-36462]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-12799]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 August 31, 2008.
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
[[Page 36459]]
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 listed in table 1 of this document:
Table 1.
------------------------------------------------------------------------
Contact Person Committee/Panel
------------------------------------------------------------------------
Geretta P. Wood, 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, 240-276-
3993, or e-mail
Geretta.Wood@fda.hhs.gov
------------------------------------------------------------------------
Nancy M. Wynne, Center for Devices and National Mammography Quality
Radiological Health (HFZ-240), Food and Assurance Advisory Committee
Drug Administration, 1350 Piccard Dr.,
Rockville, MD 20850, e-mail:
Nancy.Wynne@fda.hhs.gov
------------------------------------------------------------------------
Collin L. Figueroa, Center for Devices Device Good Manufacturing
and Radiological Health (HFZ-342), Food Practice Advisory Committee
and Drug Administration, 2094 Gaither
Rd., Rockville, MD 20850, e-mail:
Collin.Figueroa@fda.hhs.gov
------------------------------------------------------------------------
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:
Richard.Kaczmarek@fda.hhs.gov
------------------------------------------------------------------------
FOR FURTHER INFORMATION CONTACT: Kathleen L. Walker, Center for Devices
and Radiological Health (HFZ-17), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 240-276-8938, e-mail:
Kathleen.Walker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Vacancies
FDA is requesting nominations of voting members for vacancies
listed as follows:
Table 2.
----------------------------------------------------------------------------------------------------------------
Committee/Panel Expertise Needed Current & Upcoming Vacancies Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
Anesthesiology and Respiratory Therapy 2 Immediately
Devices Panel of the Medical Devices 3 December 1, 2007
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 Panel of the 3 July 1, 2008
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 Toxicology 2 March 1, 2008
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 Medical Devices 2 Immediately
Advisory Committee--dentists, engineers and 3 November 1, 2007
scientists who have expertise in the areas
of dental implants, dental materials,
periodontology, tissue engineering, and
dental anatomy
----------------------------------------------------------------------------------------------------------------
General and Plastic Surgery Devices Panel of 2 Immediately
the Medical Devices Advisory Committee-- 2 September 1, 2007
surgeons (general, plastic, reconstructive, 1 September 1, 2008
pediatric, thoracic, abdominal, pelvic and
endoscopic); dermatologists; experts in
biomaterials, lasers, wound healing, and
quality of life; and biostatisticians
----------------------------------------------------------------------------------------------------------------
Hematology and Pathology Devices Panel of the 2 March 1, 2008
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
[[Page 36460]]
----------------------------------------------------------------------------------------------------------------
Immunology Devices Panel of the Medical 3 March 1, 2008
Devices Advisory Committee--persons with
experience in medical, surgical, or clinical
oncology, internal medicine, clinical
immunology, allergy, molecular diagnostics,
or clinical laboratory medicine
----------------------------------------------------------------------------------------------------------------
Microbiology Devices Panel of the Medical 4 Immediately
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,
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 Genetics Devices Panel 4 Immediately
of the Medical Devices Advisory Committee-- 3 June 1, 2008
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.
Individuals with experience in genetic
counseling, medical ethics as well as
ancillary fields of study will be considered
----------------------------------------------------------------------------------------------------------------
Neurological Devices Panel of the Medical 2 December 1, 2007
Devices 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 1 February 1, 2008
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 2 Immediately
of the Medical Devices Advisory Committee-- 1 September 1, 2008
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 of the Medical 2 February 1, 2008
Devices Advisory Committee--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
----------------------------------------------------------------------------------------------------------------
National Mammography Quality Assurance 4 February 1, 2008
Advisory Committee--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
[[Page 36461]]
----------------------------------------------------------------------------------------------------------------
Technical Electronic Product Radiation Safety 15 Immediately
Standards Committee--15 vacancies occurring
immediately, five government
representatives, five industry
representative and five 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 of 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.
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 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
[[Page 36462]]
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 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 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 will
include complete curriculum vitae of each nominee, current business
address and telephone number. Nominations will specify the advisory
panel(s) or advisory committee(s) for which the nominee is recommended.
Nominations will include confirmation that the nominee is aware of the
nomination, is willing to serve as a member of the advisory committee
if selected, and appears to have no conflict of interest that would
preclude membership. Potential candidates will be required 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: June 26, 2007.
Randall W. Lutter
Deputy Commissioner for Policy.
[FR Doc. E7-12799 Filed 7-2-07; 8:45 am]
BILLING CODE 4160-01-S
