Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on Public Advisory Panels, 73035-73036 [2012-29574]
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Federal Register / Vol. 77, No. 236 / Friday, December 7, 2012 / Notices
requesting nominations for nonvoting
industry representatives to certain
panels identified in the following
paragraphs.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry
Representatives and Request for
Nominations for Nonvoting Industry
Representatives on Public Advisory
Panels
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organization interested in
participating in the selection of
nonvoting industry representatives to
serve on the Medical Devices Advisory
Committee (MDAC) in the Center for
Devices and Radiological Health (CDRH)
notify FDA in writing. FDA is also
requesting nominations for nonvoting
industry representatives to serve on
certain device panels of the MDAC in
the CDRH. A nominee may either be
self-nominated or nominated by an
organization to serve as a nonvoting
industry representative. Nominations
will be accepted for current vacancies
effective with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
the FDA by January 7, 2013, for the
vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by January 7, 2013.
ADDRESSES: All letters of interest and
nominations should be submitted in
writing to Margaret Ames (see FOR
FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Margaret Ames, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5234, Silver Spring,
MD 20993. 301–796–5960, FAX: 301–
847–8505, email:
margaret.ames@fda.hhs.gov.
SUMMARY:
Section
520(f)(3)of the Federal Food, Drug and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360j(f)(3)), as amended by the Medical
Device Amendments of 1976, provides
that each medical device panel include
one nonvoting member to represent the
interests of the medical device
manufacturing industry. The Agency is
tkelley on DSK3SPTVN1PROD with
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
18:05 Dec 06, 2012
Jkt 229001
73035
recommendations to the Commissioner
of Food and Drugs.
I. Functions of MDAC
(1) Review and evaluate data on the
safety and effectiveness of marketed and
investigational devices and make
recommendations for their regulation;
(2) advise the Commissioner of Food
and Drugs (the Commissioner) regarding
recommended classification or
reclassification of these devices into one
of three regulatory categories; (3) advise
on any possible risks to health
associated with the use of devices; (4)
advise on formulation of product
development protocols; (5) review
premarket approval applications for
medical devices; (6) review guidelines
and guidance documents; (7)
recommend exemption to certain
devices from the application of portions
of the Act; (8) advise on the necessity to
ban a device; (9) respond to requests
from the agency to review and make
recommendations on specific issues or
problems concerning the safety and
effectiveness of devices; and (10) make
recommendations on the quality in the
design of clinical studies regarding the
safety and effectiveness of marketed and
investigational devices.
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational devices
for use in the neurological system and
makes appropriate recommendations to
the Commissioner of Food and Drugs.
A. Circulatory System Devices Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational devices
for use in the circulatory and vascular
systems and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
B. Ear, Nose and Throat Devices Panel
Reviews and evaluates data
concerning the safety and effectiveness
of market and investigational ear, nose
and throat devices and make
appropriate recommendations to the
Commissioner of Food and Drugs.
C. Gastroenterology and Urology
Devices Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational
gastroenterology, urology and
nephrology devices and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
D. General Hospital and Personal Use
Devices Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational general
hospital, infection control and personal
use devices and makes appropriate
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
E. Neurological Devices Panel
F. Obstetrics and Gynecology Devices
Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational
obstetrics and gynecology devices and
makes appropriate recommendations to
the Commissioner of Food and Drugs.
G. Ophthalmic Devices Panel
Reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational devices
for use in the eye and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
II. Qualifications
Persons nominated for the device
panels should be full-time employees of
firms that manufacture products that
would come before the panel, or
consulting firms that represent
manufacturers, or have similar
appropriate ties to industry.
III. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for a particular device panel.
The interested organizations are not
bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within the 60
days, the Commissioner will select the
nonvoting member to represent industry
interests.
E:\FR\FM\07DEN1.SGM
07DEN1
73036
Federal Register / Vol. 77, No. 236 / Friday, December 7, 2012 / Notices
IV. Application Procedure
Individuals may self nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
contact person (see FOR FURTHER
INFORMATION CONTACT) within 30 days of
publication of this document (see
DATES). FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process for the panel.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
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.
Specifically, in this document,
nominations for nonvoting
representatives of industry interests are
encouraged from the device
manufacturing industry.
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 3, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel. NICHD T32
Teleconference Review.
Date: December 18, 2012.
Time: 1:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Health, 6100
Executive Boulevard, Rockville, MD 20852,
(Telephone Conference Call).
Contact Person: Sherry L. Dupere, Ph.D.,
Director, Division of Scientific Review,
Division of Scientific Review, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, NIH, 6100
Executive Blvd., Room 5b01, Bethesda, MD
20892, 301–451–3415, duperes@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Place: National Institutes of Health, 6116
Executive Boulevard, Room 611, Rockville,
MD 20852, (Telephone Conference Call).
Contact Person: Kenneth L. Bielat, Ph.D.,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
6116 Executive Boulevard, Room 7147,
Bethesda, MD 20892–8329, 301–496–7576,
bielatk@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: December 3, 2012.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2012–29557 Filed 12–6–12; 8:45 am]
National Center for Complementary &
Alternative Medicine; Notice of Meeting
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
[FR Doc. 2012–29574 Filed 12–6–12; 8:45 am]
BILLING CODE 4160–01–P
National Cancer Institute; Notice of
Closed Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
National Institutes of Health
tkelley on DSK3SPTVN1PROD with
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
VerDate Mar<15>2010
18:05 Dec 06, 2012
Jkt 229001
Name of Committee: National Cancer
Institute Special Emphasis Panel, Novel
Imaging Agents to Expand the Clinical
Toolkit for Cancer Diagnosis, Staging and
Treatment.
Date: March 7, 2013.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate contract
proposals.
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
Dated: December 3, 2012.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–29559 Filed 12–6–12; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Council for
Complementary and Alternative
Medicine.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council for Complementary and Alternative
Medicine.
Date: February 1, 2013.
Closed: 8:30 a.m. to 10:30 a.m.
E:\FR\FM\07DEN1.SGM
07DEN1
]]>Agencies
[Federal Register Volume 77, Number 236 (Friday, December 7, 2012)]
[Notices]
[Pages 73035-73036]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29574]
[[Page 73035]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for Nonvoting Industry
Representatives and Request for Nominations for Nonvoting Industry
Representatives on Public Advisory Panels
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organization interested in participating in the selection of
nonvoting industry representatives to serve on the Medical Devices
Advisory Committee (MDAC) in the Center for Devices and Radiological
Health (CDRH) notify FDA in writing. FDA is also requesting nominations
for nonvoting industry representatives to serve on certain device
panels of the MDAC in the CDRH. A nominee may either be self-nominated
or nominated by an organization to serve as a nonvoting industry
representative. Nominations will be accepted for current vacancies
effective with this notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to the FDA by
January 7, 2013, for the vacancies listed in this notice. Concurrently,
nomination materials for prospective candidates should be sent to FDA
by January 7, 2013.
ADDRESSES: All letters of interest and nominations should be submitted
in writing to Margaret Ames (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Margaret Ames, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5234, Silver Spring, MD 20993. 301-796-5960, FAX:
301-847-8505, email: margaret.ames@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section 520(f)(3)of the Federal Food, Drug
and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(f)(3)), as amended by
the Medical Device Amendments of 1976, provides that each medical
device panel include one nonvoting member to represent the interests of
the medical device manufacturing industry. The Agency is requesting
nominations for nonvoting industry representatives to certain panels
identified in the following paragraphs.
I. Functions of MDAC
(1) Review and evaluate data on the safety and effectiveness of
marketed and investigational devices and make recommendations for their
regulation; (2) advise the Commissioner of Food and Drugs (the
Commissioner) regarding recommended classification or reclassification
of these devices into one of three regulatory categories; (3) advise on
any possible risks to health associated with the use of devices; (4)
advise on formulation of product development protocols; (5) review
premarket approval applications for medical devices; (6) review
guidelines and guidance documents; (7) recommend exemption to certain
devices from the application of portions of the Act; (8) advise on the
necessity to ban a device; (9) respond to requests from the agency to
review and make recommendations on specific issues or problems
concerning the safety and effectiveness of devices; and (10) make
recommendations on the quality in the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
A. Circulatory System Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational devices for use in the circulatory and
vascular systems and makes appropriate recommendations to the
Commissioner of Food and Drugs.
B. Ear, Nose and Throat Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of market and investigational ear, nose and throat devices and make
appropriate recommendations to the Commissioner of Food and Drugs.
C. Gastroenterology and Urology Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational gastroenterology, urology and
nephrology devices and makes appropriate recommendations to the
Commissioner of Food and Drugs.
D. General Hospital and Personal Use Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational general hospital, infection control and
personal use devices and makes appropriate recommendations to the
Commissioner of Food and Drugs.
E. Neurological Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational devices for use in the neurological
system and makes appropriate recommendations to the Commissioner of
Food and Drugs.
F. Obstetrics and Gynecology Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational obstetrics and gynecology devices and
makes appropriate recommendations to the Commissioner of Food and
Drugs.
G. Ophthalmic Devices Panel
Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational devices for use in the eye and makes
appropriate recommendations to the Commissioner of Food and Drugs.
II. Qualifications
Persons nominated for the device panels should be full-time
employees of firms that manufacture products that would come before the
panel, or consulting firms that represent manufacturers, or have
similar appropriate ties to industry.
III. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations; and a list of all nominees
along with their current resumes. The letter will also state that it is
the responsibility of the interested organizations to confer with one
another and to select a candidate, within 60 days after the receipt of
the FDA letter, to serve as the nonvoting member to represent industry
interests for a particular device panel. The interested organizations
are not bound by the list of nominees in selecting a candidate.
However, if no individual is selected within the 60 days, the
Commissioner will select the nonvoting member to represent industry
interests.
[[Page 73036]]
IV. Application Procedure
Individuals may self nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA contact
person (see FOR FURTHER INFORMATION CONTACT) within 30 days of
publication of this document (see DATES). FDA will forward all
nominations to the organizations expressing interest in participating
in the selection process for the panel. (Persons who nominate
themselves as nonvoting industry representatives will not participate
in the selection process).
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. Specifically, in
this document, nominations for nonvoting representatives of industry
interests are encouraged from the device manufacturing industry.
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 3, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-29574 Filed 12-6-12; 8:45 am]
BILLING CODE 4160-01-P
