National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings, 42339 [2014-16981]
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Federal Register / Vol. 79, No. 139 / Monday, July 21, 2014 / Notices
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committees will discuss
new drug application (NDA) 206089
(oral testosterone undecanoate tablets),
submitted by Clarus Therapeutics, for
the proposed indication of testosterone
replacement therapy in males for
conditions associated with a deficiency
or absence of endogenous testosterone:
Primary hypogonadism (congenital or
acquired) and hypogonadotropic
hypogonadism (congenital or acquired).
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 meeting
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 September 3, 2014.
Oral presentations from the public will
be scheduled between approximately
10:45 a.m. and 11:45 a.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 August 25, 2014. 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 August 26, 2014.
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
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disabilities or special needs. If you
require special accommodations due to
a disability, please contact Kalyani
Bhatt 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).
Conferences and Scientific Meetings (Parent
R13/U13).
Date: August 19–22, 2014.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Room
3201 B, 6700B Rockledge Drive, Bethesda,
MD 20817 (Virtual Meeting).
Contact Person: Travis J. Taylor, Ph.D.,
Scientific Review Program, DEA/NIAID/NIH/
DHHS, 6700–B Rockledge Dr., MSC–7616,
Bethesda, MD 20892–7616, 301–496–2550,
Travis.Taylor@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: July 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–17081 Filed 7–18–14; 8:45 am]
Dated: July 15, 2014.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
BILLING CODE 4164–01–P
[FR Doc. 2014–16981 Filed 7–18–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious 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
Allergy and Infectious Diseases Special
Emphasis Panel; Synthesis of Therapeutic
Agents for Treatment of Infectious Disease.
Date: August 7, 2014.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, Room
3119, 6700B Rockledge Drive, Bethesda, MD
20817 (Telephone Conference Call).
Contact Person: Jay Bruce Sundstrom,
Ph.D., Scientific Review Officer, Scientific
Review Program, DEA/NIAID/NIH/DHHS,
6700B Rockledge Drive, MSC–7616 Bethesda,
MD 20892, (301) 496–7042, sundstromj@
niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIH Support for
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DEPARTMENT OF HOMELAND
SECURITY
Transportation Security Administration
Extension of Agency Information
Collection Activity Under OMB Review:
Exercise Information System (EXIS)
Transportation Security
Administration, DHS.
ACTION: 30-day Notice.
AGENCY:
This notice announces that
the Transportation Security
Administration (TSA) has forwarded the
Information Collection Request (ICR),
Office of Management and Budget
(OMB) control number 1652–0057,
abstracted below to OMB for review and
approval of an extension of the
currently approved collection under the
Paperwork Reduction Act (PRA). The
ICR describes the nature of the
information collection and its expected
burden. TSA published a Federal
Register notice, with a 60-day comment
period soliciting comments, of the
following collection of information on
May 1, 2014 (79 FR 24742). EXIS is a
web portal designed to serve
stakeholders in the transportation
industry in regard to security training
exercises. EXIS provides stakeholders
with transportation security exercise
scenarios and objectives, best practices
and lessons learned, and a repository of
the user’s own historical exercise data
for use in future exercises. It also allows
stakeholders to design their own
security exercises based on the unique
needs of their specific transportation
mode or method of operation. Utilizing
SUMMARY:
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Agencies
[Federal Register Volume 79, Number 139 (Monday, July 21, 2014)]
[Notices]
[Page 42339]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16981]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious 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 Allergy and Infectious
Diseases Special Emphasis Panel; Synthesis of Therapeutic Agents for
Treatment of Infectious Disease.
Date: August 7, 2014.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, Room 3119, 6700B Rockledge
Drive, Bethesda, MD 20817 (Telephone Conference Call).
Contact Person: Jay Bruce Sundstrom, Ph.D., Scientific Review
Officer, Scientific Review Program, DEA/NIAID/NIH/DHHS, 6700B
Rockledge Drive, MSC-7616 Bethesda, MD 20892, (301) 496-7042,
sundstromj@niaid.nih.gov.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel; NIH Support for Conferences and
Scientific Meetings (Parent R13/U13).
Date: August 19-22, 2014.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Room 3201 B, 6700B
Rockledge Drive, Bethesda, MD 20817 (Virtual Meeting).
Contact Person: Travis J. Taylor, Ph.D., Scientific Review
Program, DEA/NIAID/NIH/DHHS, 6700-B Rockledge Dr., MSC-7616,
Bethesda, MD 20892-7616, 301-496-2550, Travis.Taylor@nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: July 15, 2014.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-16981 Filed 7-18-14; 8:45 am]
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