Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting, 55689-55690 [2011-22863]
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Federal Register / Vol. 76, No. 174 / Thursday, September 8, 2011 / Notices
AI/AN/NA American Indian/Alaska
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Americans
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Division Staff Division and/or
Operating Division
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U.S.C. United States Code
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:
ACTION:
15. Policy Review
ACF shall review and, if necessary,
revise its Tribal Consultation Policy no
less than every 2 years. Should ACF
determine that the policy requires
revision, the TFWG will be convened to
develop the revisions.
16. Retention of Executive Branch
Authorities
Nothing in this policy waives the
Government’s deliberative process
privilege, including when the
Department is specifically requested by
Members of Congress to respond to or
report on proposed legislation. The
development of such responses and
related policy documents is a part of the
deliberative process by the Executive
Branch and should remain confidential.
Nothing in the Policy creates a right
of action against the Department for
failure to comply with this Policy nor
creates any right, substantive or
procedural, enforceable at law by a
party against the United States, its
agencies, or any individual.
17. Effective Date
sroberts on DSK5SPTVN1PROD with NOTICES
This policy is effective on the date of
signature by the Assistant Secretary for
Children and Families and shall apply
to all ACF program offices.
Dated: August 18, 2011.
George H. Sheldon,
Acting Assistant Secretary for Children and
Families.
[FR Doc. 2011–22825 Filed 9–7–11; 8:45 am]
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Food and Drug Administration,
HHS.
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 November 2, 2011, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. 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:
EMDAC@fda.hhs.gov, or FDA Advisory
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 November 2, 2011, the
committee will discuss supplemental
new drug applications 21–687 and 21–
445, VYTORIN (ezetimibe/simvastatin)
and ZETIA (ezetimibe) tablets,
respectively, MSP (Merck/ScheringPlough) Singapore Company, LLC.
Simvastatin lowers lipids (fats that
circulate in the bloodstream, including
cholesterol) by inhibiting 3-hydroxy-3methyl-glutaryl-CoA reductase, which is
an enzyme involved in producing lipids
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55689
in the body, and ezetimibe lowers lipids
by inhibiting the absorption of
cholesterol from the intestine. The
proposed indication (use) of ZETIA in
combination with simvastatin or
VYTORIN is to reduce major
cardiovascular events in patients with
chronic kidney disease based on the
results of the Study of Heart and Renal
Protection (SHARP). SHARP was a
clinical trial that studied the effect of
VYTORIN compared with placebo on
the occurrence of major cardiovascular
events in patients with chronic kidney
disease who did not have a history of
myocardial infarction or coronary
revascularization (heart bypass surgery
or opening heart vessels with a balloon
or stents). The primary outcome of
major cardiovascular events was defined
as the first occurrence of either nonfatal
myocardial infarction, cardiac death,
stroke, or coronary or noncoronary
revascularization (including
nontraumatic amputation). The primary
analysis demonstrated that assignment
to VYTORIN significantly reduced the
relative risk of a major cardiovascular
event by 16% compared to placebo.
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 October 19, 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 October
11, 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
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55690
Federal Register / Vol. 76, No. 174 / Thursday, September 8, 2011 / Notices
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by October 12, 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/Advisory
Committees/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: September 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–22863 Filed 9–7–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; The SSA–NIH
Collaboration To Improve the Disability
Determination Process: Validation of
IRT–CAT Tools
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
Clinical Center, the National Institutes
of Health (NIH) will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
and Budget (OMB) for review and
approval.
Proposed Collection: Title: The SSA–
NIH Collaboration to Improve the
Disability Determination Process:
Validation of IRT–CAT tools. Type of
Information Collection Request: NEW.
Need and Use of Information Collection:
The Epidemiology and Biostatistics
section in RMD will be collecting
information through a contractor
(Boston University—Health and
Disability Research Institute (BU–HDR))
and subcontractor for validation of the
Computer Adaptive Tests which are
being developed to assist in the SSA
disability determination process. The
utilization of CAT technology could
potentially allow the SSA to collect
SUMMARY:
more relevant and precise data about
human functioning in a faster, more
efficient fashion. To validate the CAT
assessments that have been developed,
the contractor will administer both the
BU–HDR CAT and established legacy
instruments in a small sample of adults
who report their current employment
status as ‘‘permanently disabled’’.
Individuals will complete the CAT tools
for the functional domains of Physical
Demands and Interpersonal Interactions
along with established legacy
instruments. For the domain of physical
function, individuals will complete the
BU–HDR CAT; the PROMIS Item Bank
v 1.0—Physical Functioning © PROMIS
Health Organization and PROMIS
Cooperative Group; and The Short Form
(36) Health SurveyTM (SF–36). For the
domain of interpersonal interactions,
individuals will complete the BU–HDR
CAT, the SF–36 and the BASIS–24©
(Behavior and Symptom Identification
Scale). Data collected will be used to
validate the BU–HDR CAT tools.
Without this information, completion of
the BU–HDR CAT tools will not be
possible. Frequency of Response: Once.
Affected Public: Individuals who have
opted in to participate in web surveys
through a survey research firm. Type of
Respondents: Adults who indicate
‘‘permanently disabled’’ as a working
status. There are no Capital Costs,
Operating Costs and/or Maintenance
Costs to report. The annual reporting
burden is as follows:
A.12–1—ESTIMATES OF HOUR BURDEN
Type of
respondents
Number of
respondents
Frequency of
response
Average
time per
response
Annual hour
burden
1,000
1
0.5
500.00
Totals ........................................................................................................
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Patients ............................................................................................................
........................
........................
........................
500.00
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
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of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Ms. Meghan
Gleason, Rehabilitation Medicine
Department, Clinical Research Center,
NIH, Building 10, Room 1–2420, 9000
Rockville Pike, Bethesda, MD 20892, or
call non-toll-free number (301) 443–
9085 or E-mail your request, including
your address to:
meghan.gleason@nih.gov.
FOR FURTHER INFORMATION CONTACT:
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Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
DATES:
Dated: August 29, 2011.
Elizabeth K Rasch,
Chief, Epidemiology and Biostatistics Section,
Rehabilitation Medicine Department, Clinical
Research Center, National Institutes of
Health.
[FR Doc. 2011–22999 Filed 9–7–11; 8:45 am]
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]]>Agencies
[Federal Register Volume 76, Number 174 (Thursday, September 8, 2011)]
[Notices]
[Pages 55689-55690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22863]
-----------------------------------------------------------------------
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 November 2, 2011, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. 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: EMDAC@fda.hhs.gov, or FDA Advisory 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 November 2, 2011, the committee will discuss
supplemental new drug applications 21-687 and 21-445, VYTORIN
(ezetimibe/simvastatin) and ZETIA (ezetimibe) tablets, respectively,
MSP (Merck/Schering-Plough) Singapore Company, LLC. Simvastatin lowers
lipids (fats that circulate in the bloodstream, including cholesterol)
by inhibiting 3-hydroxy-3-methyl-glutaryl-CoA reductase, which is an
enzyme involved in producing lipids in the body, and ezetimibe lowers
lipids by inhibiting the absorption of cholesterol from the intestine.
The proposed indication (use) of ZETIA in combination with simvastatin
or VYTORIN is to reduce major cardiovascular events in patients with
chronic kidney disease based on the results of the Study of Heart and
Renal Protection (SHARP). SHARP was a clinical trial that studied the
effect of VYTORIN compared with placebo on the occurrence of major
cardiovascular events in patients with chronic kidney disease who did
not have a history of myocardial infarction or coronary
revascularization (heart bypass surgery or opening heart vessels with a
balloon or stents). The primary outcome of major cardiovascular events
was defined as the first occurrence of either nonfatal myocardial
infarction, cardiac death, stroke, or coronary or noncoronary
revascularization (including nontraumatic amputation). The primary
analysis demonstrated that assignment to VYTORIN significantly reduced
the relative risk of a major cardiovascular event by 16% compared to
placebo.
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
October 19, 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 October 11, 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
[[Page 55690]]
speakers for the scheduled open public hearing session. The contact
person will notify interested persons regarding their request to speak
by October 12, 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: September 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-22863 Filed 9-7-11; 8:45 am]
BILLING CODE 4160-01-P
