Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 23324-23325 [2011-10003]
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Federal Register / Vol. 76, No. 80 / Tuesday, April 26, 2011 / Notices
NICEATM. NICEATM administers
ICCVAM, provides scientific and
operational support for ICCVAM-related
activities, and conducts independent
validation studies to assess the
usefulness and limitations of new,
revised, and alternative test methods
and strategies. NICEATM and ICCVAM
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and improved test methods and
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ICCVAM welcome the public
nomination of new, revised, and
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harmonization of new, revised, and
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Additional information about SACATM,
including the charter, roster, and
records of past meetings, can be found
at https://ntp.niehs.nih.gov/go/167.
Dated: April 18, 2011.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2011–10020 Filed 4–25–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
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Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: State Plan for the Temporary
Assistance of Needy Families (TANF).
OMB No. 0970–0145.
Description: The State plan is a
mandatory statement submitted to the
Secretary of the Department of Health
and Human Services by the State. It
consists of an outline specifying how
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Chief Executive Officer. It is used to
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Authority to require States to submit
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section 402 of the Social Security Act,
as amended by Public Law 104–193, the
Personal Responsibility and Work
Opportunity Reconciliation Act of 1996.
States are required to submit new plans
periodically (i.e., within a 27-month
period).
We are proposing to continue the
information collection without change.
Respondents: The 50 States of the
United States, the District of Columbia,
Guam, Puerto Rico, and the Virgin
Islands.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
srobinson on DSKHWCL6B1PROD with NOTICES
Title Amendments ............................................................................................
State Plan ........................................................................................................
Estimated Total Annual Burden
Hours: 594.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
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information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
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Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
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proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
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Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2011–9956 Filed 4–25–11; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00053
Fmt 4703
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Number of
responses per
respondent
Average
burden hours
per response
1
1
ACTION:
3
30
Total
burden hours
54
540
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: Endocrinologic
and Metabolic Drugs 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 May 19, 2011, from 8 a.m. to 5
p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD 20910.
The hotel telephone number is 301–
589–5200.
Contact Person: Paul Tran, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX 301–847–8533, e-mail:
EDMAC@fda.hhs.gov, or FDA Advisory
E:\FR\FM\26APN1.SGM
26APN1
srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 80 / Tuesday, April 26, 2011 / Notices
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. 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: On May 19, 2011, the
committee will discuss the findings of
the Action to Control Cardiovascular
Risk in Diabetes-Lipid (ACCORD Lipid)
trial as they relate to the efficacy and
safety of the approved new drug
application (NDA) 22224, TRILIPIX
(fenofibric acid) delayed release
capsules, manufactured by Abbott
Laboratories.
TRILIPIX (fenofibric acid), an active
form of fenofibrate, is indicated for use
in combination with a 3-hydroxy-3methyl-glutaryl-coenzyme A reductase
inhibitor, commonly referred to as a
‘‘statin’’, to lower high levels of serum
triglycerides and raise low levels of
high-density lipoprotein cholesterol in
patients with mixed dyslipidemia and
coronary heart disease (CHD) or CHD
risk equivalent who are on optimal
statin therapy to achieve their lowdensity lipoprotein cholesterol goal.
The ACCORD Lipid study was a
randomized, double-blind, placebocontrolled add-on trial, which is the
kind of clinical trial designed to provide
data with strong measures of accuracy
and reliability. The ACCORD Lipid
study evaluated the efficacy and safety
of adding fenofibrate therapy to
treatment with the statin, simvastatin in
subjects with type 2 diabetes mellitus.
The results of the ACCORD Lipid trial
indicated that there was no statistically
significant difference in the proportion
of clinical trial subjects treated with
simvastatin plus placebo verus
simvastatin plus fenofibrate who
experienced a major adverse cardiac
event. In a prespecified subgroup
analysis from the ACCORD Lipid trial,
there was an increase in the proportion
of female trial subjects treated with
simvastatin plus fenofibrate versus
simvastatin plus placebo who
experienced a major adverse cardiac
event. The clinical significance of this
finding is unclear.
An additional safety concern
associated with the use of fenofibrate
VerDate Mar<15>2010
16:09 Apr 25, 2011
Jkt 223001
plus simvastatin, or any other statin, is
muscle toxicity.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
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/
AdvisoryCommittees/Calendar/
default.htm. 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 May 12, 2011. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making 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 May 5,
2011. 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 May 6, 2011.
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 Paul Tran 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/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
PO 00000
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23325
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–10003 Filed 4–25–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
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 meetings.
The meetings 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 Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; DEM Fellowships.
Date: June 15–16, 2011.
Time: 6 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crowne Plaza Washington National
Airport, 1489 Jefferson Davis Hwy, Arlington,
VA 22202.
Contact Person: Michael W. Edwards, PhD,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 750, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8886,
edwardsm@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; Fellowships in
Digestive Diseases and Nutrition
Date: June 22, 2011.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Georgetown Suites, 1000 29th Street,
NW., Washington, DC 20007
Contact Person: Thomas A. Tatham, PhD,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 760, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–3993,
tathamt@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
E:\FR\FM\26APN1.SGM
26APN1
]]>Agencies
[Federal Register Volume 76, Number 80 (Tuesday, April 26, 2011)]
[Notices]
[Pages 23324-23325]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10003]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Endocrinologic and Metabolic Drugs 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: Endocrinologic and Metabolic Drugs 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 May 19, 2011, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD 20910. The hotel telephone number is
301-589-5200.
Contact Person: Paul Tran, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm.
2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX 301-847-8533, e-
mail: EDMAC@fda.hhs.gov, or FDA Advisory
[[Page 23325]]
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), and follow the prompts to the desired center or
product area. 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: On May 19, 2011, the committee will discuss the findings of
the Action to Control Cardiovascular Risk in Diabetes-Lipid (ACCORD
Lipid) trial as they relate to the efficacy and safety of the approved
new drug application (NDA) 22224, TRILIPIX (fenofibric acid) delayed
release capsules, manufactured by Abbott Laboratories.
TRILIPIX (fenofibric acid), an active form of fenofibrate, is
indicated for use in combination with a 3-hydroxy-3-methyl-glutaryl-
coenzyme A reductase inhibitor, commonly referred to as a ``statin'',
to lower high levels of serum triglycerides and raise low levels of
high-density lipoprotein cholesterol in patients with mixed
dyslipidemia and coronary heart disease (CHD) or CHD risk equivalent
who are on optimal statin therapy to achieve their low-density
lipoprotein cholesterol goal.
The ACCORD Lipid study was a randomized, double-blind, placebo-
controlled add-on trial, which is the kind of clinical trial designed
to provide data with strong measures of accuracy and reliability. The
ACCORD Lipid study evaluated the efficacy and safety of adding
fenofibrate therapy to treatment with the statin, simvastatin in
subjects with type 2 diabetes mellitus. The results of the ACCORD Lipid
trial indicated that there was no statistically significant difference
in the proportion of clinical trial subjects treated with simvastatin
plus placebo verus simvastatin plus fenofibrate who experienced a major
adverse cardiac event. In a prespecified subgroup analysis from the
ACCORD Lipid trial, there was an increase in the proportion of female
trial subjects treated with simvastatin plus fenofibrate versus
simvastatin plus placebo who experienced a major adverse cardiac event.
The clinical significance of this finding is unclear.
An additional safety concern associated with the use of fenofibrate
plus simvastatin, or any other statin, is muscle toxicity.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. 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/AdvisoryCommittees/Calendar/default.htm. 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 May
12, 2011. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those individuals interested in making
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 May 5, 2011. 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 May 6, 2011.
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 Paul Tran 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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: April 21, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-10003 Filed 4-25-11; 8:45 am]
BILLING CODE 4160-01-P
