National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings, 23325-23326 [2011-10008]
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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
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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.
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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
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Federal Register / Vol. 76, No. 80 / Tuesday, April 26, 2011 / Notices
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
DEPARTMENT OF HOMELAND
SECURITY
Dated: April 20, 2011.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
Transportation Security Administration
[FR Doc. 2011–10008 Filed 4–25–11; 8:45 am]
BILLING CODE 4140–01–P
Transportation Security
Administration, DHS.
ACTION: 60 Day Notice.
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 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.
srobinson on DSKHWCL6B1PROD with NOTICES
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Emphasis Panel; NIBIB K awards
review (1022/10).
Date: June 24, 2011.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Democracy Two Plaza, 6707 Democracy
Boulevard, Suite #242, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Manana Sukhareva, PhD,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
National Institutes of Health, 6707
Democracy Boulevard, Suite 959, Bethesda,
MD 20892, 301–451–3397,
sukharem@mail.nih.gov.
Dated: April 20, 2011.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
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The Transportation Security
Administration (TSA) invites public
comment on one currently approved
information collection requirement,
Office of Management and Budget
(OMB) control number 1652–0047,
abstracted below that we will submit to
OMB for renewal in compliance with
the Paperwork Reduction Act (PRA).
The ICR describes the nature of the
information collection and its expected
burden. OMB approved the collection of
information for six months and TSA
now seeks the maximum three-year
approval. The collection involves the
submission of identifying and other
information by individuals applying for
a TWIC and a customer satisfaction
survey.
DATES: Send your comments by June 27,
2011.
ADDRESSES: Comments may be e-mailed
to TSAPRA@dhs.gov or delivered to the
TSA PRA Officer, Office of Information
Technology (OIT), TSA–11,
Transportation Security Administration,
601 South 12th Street, Arlington, VA
20598–6011.
FOR FURTHER INFORMATION CONTACT:
Joanna Johnson at the above address, or
by telephone (571) 227–3651.
SUPPLEMENTARY INFORMATION:
SUMMARY:
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
BILLING CODE 4140–01–P
Intent To Request Renewal From OMB
of One Current Public Collection of
Information: Transportation Worker
Identification Credential (TWIC)
Program
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2011–10009 Filed 4–25–11; 8:45 am]
[Docket No. TSA–2006–24191]
Comments Invited
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.), an agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid OMB control
number. The ICR documentation is
available at https://www.reginfo.gov.
Therefore, in preparation for OMB
review and approval of the following
information collection, TSA is soliciting
comments to—
(1) Evaluate whether the proposed
information requirement is necessary for
the proper performance of the functions
of the agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden;
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(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 using
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Information Collection Requirement
OMB Control Number 1652–0047;
Transportation Worker Identification
Credential (TWIC) Program. TSA
developed the Transportation Worker
Identification Credential (TWIC)
program to mitigate threats and
vulnerabilities in the national
transportation system. TWIC is a
common credential for all personnel
requiring unescorted access to secure
areas of facilities and vessels regulated
under the Maritime Transportation
Security Act (MTSA) and all mariners
holding U. S. Coast Guard credentials.
Before issuing an individual a TWIC,
TSA performs a security threat
assessment, which requires TSA to
collect certain personal information
such as name, address, and date of birth.
Applicants are also required to provide
fingerprints and undergo a criminal
history records check.
The program implements authorities
set forth in the Aviation and
Transportation Security Act (ATSA)
(Pub. L. 107–71; Nov. 19, 2002; sec.
106), the Maritime Transportation
Security Act of 2002 (MTSA) (Pub. L.
107–295; Nov. 25, 2002; sec. 102), and
the Safe, Accountable, Flexible,
Efficient Transportation Equity Act—A
Legacy for Users (SAFETEA–LU) (Pub.
L. 109–59; Aug. 10, 2005; sec. 7105),
codified at 49 U.S.C. 5103a(g). TSA and
the U. S. Coast Guard (Coast Guard)
issued a joint notice of proposed
rulemaking (NPRM) on May 22, 2006,
71 FR 29396. After consideration of
public comments on the NPRM, TSA
issued a joint final rule with the Coast
Guard on January 25, 2007 (72 FR 3492),
applicable to the maritime
transportation sector that would require
this information collection.
TSA collects data from applicants
during an optional pre-enrollment step
or during the enrollment session at an
enrollment center. TSA will use the
information collected to conduct a
security threat assessment, which
includes: (1) A criminal history records
check; (2) a check of intelligence
databases; and (3) an immigration status
check. TSA invites all TWIC applicants
to complete an optional survey to gather
information on the applicants’ overall
customer satisfaction with the
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[Federal Register Volume 76, Number 80 (Tuesday, April 26, 2011)]
[Notices]
[Pages 23325-23326]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10008]
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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
[[Page 23326]]
Research; 93.849, Kidney Diseases, Urology and Hematology Research,
National Institutes of Health, HHS)
Dated: April 20, 2011.
Anna P. Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-10008 Filed 4-25-11; 8:45 am]
BILLING CODE 4140-01-P
