The 2015 Office of Regulatory Science and Innovation Science Symposium, 10700-10701 [2015-04123]
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10700
Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Cardiovascular and Renal Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
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: Cardiovascular
and Renal 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 April 15, 2015, from 8 a.m. to
4 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Kristina Toliver,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2417, Silver Spring,
MD 20903–0002, 301–796–9001, FAX:
301–847–8533, CRDAC@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). 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 at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
new drug application New Drug
Application 204958, cangrelor injection,
submitted by The Medicines Company,
for the proposed indication of reduction
of thrombotic cardiovascular events
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including stent thrombosis (events
related to blood clots in a stent, a device
inserted to keep the artery open) in
patients with coronary artery disease
undergoing percutaneous coronary
intervention (PCI). PCI refers to the
opening of narrowed blood vessels
supplying the heart muscle by a balloon
inserted through an artery puncture
with or without a stent.
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 April 1, 2015. 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 March
24, 2015. 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 March 25, 2015.
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 Kristina
Toliver at least 7 days in advance of the
meeting.
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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: February 24, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–04128 Filed 2–26–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
The 2015 Office of Regulatory Science
and Innovation Science Symposium
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: The 2015 Office of Regulatory
Science and Innovation (ORSI) Science
Symposium.
The purpose of the public workshop
is to increase scientific collaborations
with government institutions, academia,
industry and other stakeholders,
working to improve science, training,
and networking in accordance with the
FDA mission of the advancement of
regulatory science. This venue will also
enhance knowledge and awareness of
the FDA ORSI resources and provide
guidance of its available services.
Date and Time: The public workshop
will be held on Monday, April 27, 2015,
from 8:15 a.m. to 5:30 p.m.
Location: The public workshop will
be held at the FDA White Oak Campus
located at 10903 New Hampshire Ave.,
Bldg. 31, Great Room, Silver Spring, MD
20903. Entrance for the public
workshop participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm or contact us at
2015ORSIScienceSymposium@
fda.hhs.gov.]
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mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices
Contact Person: Diane Rose, Food and
Drug Administration, 10903 New
Hampshire Avenue, Bldg. 1, Rm. 4233,
Silver Spring, MD 20993. 301–796–
9600, diane.rose@fda.hhs.gov.
Registration: On-line registration is
required (including name, title,
affiliation, address, email, telephone
and FAX numbers) by April 15, 2015.
Those without Internet access should
contact Diane Rose (see Contact Person)
to register. There is no fee for the public
workshop. Early registration is
recommended as seating is limited to
the first 300 registrants. Registration on
the day of the public workshop will be
provided on a space available basis from
7:45 a.m. to 8:15 a.m. provided the 300person registration limit has not been
met. Please register at: https://
www.eventbrite.com/e/2015-orsiscience-symposium-tickets14591440391?utm_campaign=new_
event_email&utm_medium=email&utm_
source=eb_email&utm_
term=viewmyevent_button or email us at
2015ORSIScienceSymposium@
fda.hhs.gov if you have additional
questions. A lite breakfast and lunch are
available for pre-purchase.
If you need special accommodations
due to a disability, please contact Diane
Rose (see Contact Person) at least 7 days
in advance.
Streaming Webcast of the Public
Workshop: This public workshop will
also be Webcast. Persons interested in
viewing the Webcast must register
online or call us at 301–796–9600 by
April 15, 2015. Early registration is
recommended because Webcast lines
are limited. Organizations are required
to register all participants, but to view
the Webcast using one connection per
location. Webcast participants will be
sent technical system requirements after
registration and will be sent connection
access information after April 23, 2015.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://
inside.fda.gov:9003/ora/
southwestregion/dallas/
ucm234468.htm. (FDA has verified the
Web site addresses in this document,
but FDA is not responsible for any
subsequent changes to the Web sites
after this document publishes in the
Federal Register.)
Dated: February 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–04123 Filed 2–26–15; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Pathways, Biomarkers in Addiction
and Schizophrenia.
Date: March 12, 2015.
Time: 2:00 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Julius Cinque, MS,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5186,
MSC 7846, Bethesda, MD 20892, (301) 435–
1252, cinquej@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Synaptic Development and
Function.
Date: March 13, 2015.
Time: 12:00 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Deborah L. Lewis, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4183,
MSC 7850, Bethesda, MD 20892, 301–408–
9129, lewisdeb@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: AIDS and Related
Research Integrated Review Group; AIDS
Discovery and Development of Therapeutics
Study Section.
Date: March 19, 2015.
Time: 8:00 a.m. to 6:00 p.m.
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10701
Agenda: To review and evaluate grant
applications.
Place: The Fairmont Washington, DC, 2401
M Street NW., Washington, DC 20037.
Contact Person: Shiv A. Prasad, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5220,
MSC 7852, Bethesda, MD 20892, 301–443–
5779, prasads@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Endocrinology, Metabolism,
Nutrition and Reproductive Sciences.
Date: March 24, 2015.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Dianne Hardy, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6175,
MSC 7892, Bethesda, MD 20892, 301–435–
1154, dianne.hardy@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: February 23, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–04057 Filed 2–26–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; 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 Heart, Lung,
and Blood Institute Special Emphasis Panel;
Cardiovascular Development Consortium.
Date: March 19, 2015.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
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]]>Agencies
[Federal Register Volume 80, Number 39 (Friday, February 27, 2015)]
[Notices]
[Pages 10700-10701]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-04123]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
The 2015 Office of Regulatory Science and Innovation Science
Symposium
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled: The 2015 Office of Regulatory Science and Innovation
(ORSI) Science Symposium.
The purpose of the public workshop is to increase scientific
collaborations with government institutions, academia, industry and
other stakeholders, working to improve science, training, and
networking in accordance with the FDA mission of the advancement of
regulatory science. This venue will also enhance knowledge and
awareness of the FDA ORSI resources and provide guidance of its
available services.
Date and Time: The public workshop will be held on Monday, April
27, 2015, from 8:15 a.m. to 5:30 p.m.
Location: The public workshop will be held at the FDA White Oak
Campus located at 10903 New Hampshire Ave., Bldg. 31, Great Room,
Silver Spring, MD 20903. Entrance for the public workshop participants
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm or
contact us at 2015ORSIScienceSymposium@fda.hhs.gov.]
[[Page 10701]]
Contact Person: Diane Rose, Food and Drug Administration, 10903 New
Hampshire Avenue, Bldg. 1, Rm. 4233, Silver Spring, MD 20993. 301-796-
9600, diane.rose@fda.hhs.gov.
Registration: On-line registration is required (including name,
title, affiliation, address, email, telephone and FAX numbers) by April
15, 2015. Those without Internet access should contact Diane Rose (see
Contact Person) to register. There is no fee for the public workshop.
Early registration is recommended as seating is limited to the first
300 registrants. Registration on the day of the public workshop will be
provided on a space available basis from 7:45 a.m. to 8:15 a.m.
provided the 300-person registration limit has not been met. Please
register at: https://www.eventbrite.com/e/2015-orsi-science-symposium-tickets-14591440391?utm_campaign=new_event_email&utm_medium=email&utm_source=eb_email&utm_term=viewmyevent_button or email us at
2015ORSIScienceSymposium@fda.hhs.gov if you have additional questions.
A lite breakfast and lunch are available for pre-purchase.
If you need special accommodations due to a disability, please
contact Diane Rose (see Contact Person) at least 7 days in advance.
Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online or call us at 301-796-9600 by April 15, 2015. Early
registration is recommended because Webcast lines are limited.
Organizations are required to register all participants, but to view
the Webcast using one connection per location. Webcast participants
will be sent technical system requirements after registration and will
be sent connection access information after April 23, 2015. If you have
never attended a Connect Pro event before, test your connection at
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.
To get a quick overview of the Connect Pro program, visit https://inside.fda.gov:9003/ora/southwestregion/dallas/ucm234468.htm. (FDA has
verified the Web site addresses in this document, but FDA is not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.)
Dated: February 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-04123 Filed 2-26-15; 8:45 am]
BILLING CODE 4164-01-P
