Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 67187-67188 [E8-26965]
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Federal Register / Vol. 73, No. 220 / Thursday, November 13, 2008 / Notices
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melamine-related compounds below 2.5
ppm do not raise public health
concerns. This interim safety/risk
assessment was developed rapidly due
to the extremely time-sensitive need to
understand the nature of the potential
risk. We are seeking public comment on
this interim safety/risk assessment. In
addition, it will undergo expert peer
review.
II. Safety/Risk Assessment
A human health safety/risk
assessment is a scientifically-based
methodology used to estimate risk to
human health from exposure to specific
compounds such as contaminant(s) in
food. The interim safety/risk assessment
of melamine and its analogues builds
upon the 2007 Melamine Safety/Risk
Assessment and considers the
toxicological profile of melamine and its
analogues, including the observed
results from controlled animal studies
conducted with melamine.
For infant formula, there are gaps in
our scientific knowledge about the
toxicity of melamine and its analogues
in infants, including:
1. The consequences of the
continuous use of infant formulas as the
sole source of nutrition;
2. The uncertainties associated with
the possible presence and co-ingestion
of more than one melamine analogue;
and
3. For premature infants with
immature kidney function, the
possibility that they may be fed these
formulas as the sole source of nutrition
and thus on a body weight basis
experience greater levels of intake for a
longer time than is experienced by term
infants. For these reasons, there is too
much uncertainty for FDA to establish
a level of melamine and its analogues in
infant formula that does not raise public
health concerns. However, it is
important to understand that this does
not mean that any exposure to any
detectable level of melamine and
melamine-related compounds in
formula will result in harm to infants.
In food products other than infant
formula, to estimate the level of
melamine that does not raise public
health concerns, FDA used a worst case
exposure scenario in which one-half of
a person’s total daily dietary intake
(Tolerable Daily Intake (TDI), an
estimate of the maximum amount of an
agent to which an individual could be
exposed on a daily basis over the course
of a lifetime without appreciable health
risk) is contaminated with melamine
and its analogues. The TDI used, 0.63
milligrams/kilogram (mg/kg) body
weight/day (bw/d), was developed in
2007 in collaboration with the Food
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17:13 Nov 12, 2008
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Safety and Inspection Service of the
Department of Agriculture and in
consultation with the Centers for
Disease Control and Prevention, the
Environmental Protection Agency, and
the Department of Homeland Security.1
In the present interim safety/risk
assessment, we estimated that if 50
percent of the diet were contaminated at
a level of 2.5 ppm of melamine and its
analogues, a person’s daily intake would
equal 0.063 mg/kg bw/d —a level 10fold below the TDI. Therefore, FDA
concludes that levels of melamine and
melamine-related compounds below 2.5
ppm do not raise public health concerns
in food other than infant formula.
Recognizing the time-sensitive need
for the safety/risk assessment, FDA
invites comments concerning:
1. The assessment approach used;
2. The assumptions made;
3. The data used; and
4. The transparency and clarity of the
report.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
IV. Electronic Access
The interim safety/risk assessment is
available electronically at https://
www.cfsan.fda.gov/~dms/
melamra3.html.
Dated: November 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–26869 Filed 11–12–08; 8:45 am]
BILLING CODE 4160–01–S
1Interim Melamine and Analogues Safety/Risk
Assessment, May 25, 2007 (https://
www.cfsan.fda.gov/~dms/melamra.html).
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67187
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Anesthesiology and Respiratory
Therapy Devices Panel of the Medical
Devices Advisory Committee; Notice of
Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Anesthesiology
and Respiratory Therapy Devices Panel
of the Medical Devices Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 5, 2008, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Neel J. Patel, Center
for Devices and Radiological Health
(HFZ–480), Food and Drug
Administration, 9200 Corporate Blvd.,
240–276–3700, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512624. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: The committee will discuss,
make recommendations and vote on a
premarket approval application,
sponsored by Emphasys Medical, Inc.,
for the Emphasys Zephyr Endobronchial
Valve System, which is intended to
improve forced expiratory volume in the
first second (FEV1) and 6-minute walk
test distance in patients with severe
heterogeneous emphysema who have
received optimal medical management.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
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67188
Federal Register / Vol. 73, No. 220 / Thursday, November 13, 2008 / Notices
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before November 26, 2008.
Oral presentations from the public will
be scheduled for approximately 30
minutes at the beginning of the
committee deliberations and for
approximately 30 minutes near the end
of committee deliberations. Those
desiring to make formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before
November 20, 2008. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by November 24, 2008.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams, Conference Management
Staff, at 240–276–8932, at least 7 days
in advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/oc/advisory/
default.htm for procedures on public
conduct during advisory committee
meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
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Dated: November 5, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–26965 Filed 11–12–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0581]
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
for Nonvoting Industry Representative
on Public Advisory Committees and
Request for Nominations for
Nonvoting Industry Representative on
Public Advisory Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of
nonvoting industry representatives to
serve on its public advisory committees
for the Center for Biologics Evaluation
and Research (CBER) notify FDA in
writing. FDA is also requesting
nominations for nonvoting industry
representatives to serve on CBER’s
public advisory committees. A nominee
may either be self-nominated or
nominated by an organization to serve
as a nonvoting industry representative.
Nominations will be accepted for
upcoming 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 the interest to
FDA by December 15, 2008, for
vacancies listed in the notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by December 15, 2008.
ADDRESSES: All letters of interest and
nominations should be submitted in
writing to Gail Dapolito (see FOR
FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Gail
Dapolito, Division of Scientific Advisors
and Consultants, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20892,
301–827–1289,
gail.dapolito@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
agency requests nominations for
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nonvoting industry representatives to
the following advisory committees.
I. CBER Advisory Committees
A. The Cellular, Tissue and Gene
Therapies Advisory Committee
The Committee reviews and evaluates
available data relating to the safety,
effectiveness, and appropriate use of
human cells, human tissues, gene
transfer therapies and
xenotransplantation products which are
intended for transplantation,
implantation, infusion and transfer in
the prevention and treatment of a broad
spectrum of human diseases and in the
reconstruction, repair or replacement of
tissues for various conditions. The
Committee also considers the quality
and relevance of FDA’s research
program which provides scientific
support for the regulation of these
products, and makes appropriate
recommendations to the Commissioner
of Food and Drugs (the Commissioner).
B. Vaccines and Related Biological
Products Advisory Committee
The Committee reviews and evaluates
data concerning the safety,
effectiveness, and appropriate use of
vaccines and related biological products
which are intended for use in the
prevention, treatment, or diagnosis of
human diseases, and, as required, any
other product for which FDA has
regulatory responsibility. The
Committee as considers the quality and
relevance of FDA’s research program
which provides scientific support for
the regulation of these products and
makes appropriate recommendations to
the Commissioner.
C. Transmissible Spongiform
Encephalopathies Advisory Committee
The Committee reviews and evaluates
available scientific data concerning the
safety of products which may be at risk
for transmission of spongiform
encephalopathies having an impact on
the public health as determined by the
Commissioner. The Committee will
make recommendations to the
Commissioner regarding the regulation
of such products.
II. 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
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]]>Agencies
[Federal Register Volume 73, Number 220 (Thursday, November 13, 2008)]
[Notices]
[Pages 67187-67188]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26965]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0038]
Anesthesiology and Respiratory Therapy Devices Panel of the
Medical Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Anesthesiology and Respiratory Therapy Devices
Panel of the Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on December 5, 2008, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and
C, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Neel J. Patel, Center for Devices and Radiological
Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd.,
240-276-3700, or FDA Advisory Committee Information Line, 1-800-741-
8138 (301-443-0572 in the Washington, DC area), code 3014512624. Please
call the Information Line for up-to-date information on this meeting. A
notice in the Federal Register about last minute modifications that
impact a previously announced advisory committee meeting cannot always
be published quickly enough to provide timely notice. Therefore, you
should always check the agency's Web site and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: The committee will discuss, make recommendations and vote
on a premarket approval application, sponsored by Emphasys Medical,
Inc., for the Emphasys Zephyr Endobronchial Valve System, which is
intended to improve forced expiratory volume in the first second (FEV1)
and 6-minute walk test distance in patients with severe heterogeneous
emphysema who have received optimal medical management. FDA intends to
make background material available to the public no later than 2
business days before the meeting.
[[Page 67188]]
If FDA is unable to post the background material on its Web site prior
to the meeting, the background material will be made publicly available
at the location of the advisory committee meeting, and the background
material will be posted on FDA's Web site after the meeting. Background
material is available at https://www.fda.gov/ohrms/dockets/ac/
acmenu.htm, click on the year 2008 and scroll down to the appropriate
advisory committee link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 26, 2008. Oral presentations from the public will be scheduled
for approximately 30 minutes at the beginning of the committee
deliberations and for approximately 30 minutes near the end of
committee deliberations. Those desiring to make formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before November 20, 2008. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by November
24, 2008.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Conference Management Staff, at 240-276-8932, at least 7 days in
advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 5, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-26965 Filed 11-12-08; 8:45 am]
BILLING CODE 4160-01-S
