Anti-Infective Drugs Advisory Committee; Notice of Meeting, 8462-8463 [2014-02942]
Download as PDF
<![CDATA[
8462
Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Notices
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Karl Koerper
OPRE Reports Clearance Officer.
[FR Doc. 2014–02949 Filed 2–11–14; 8:45 am]
BILLING CODE 4184–22–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Synergizing Efforts in Standards
Development for Cellular Therapies
and Regenerative Medicine Products;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), Center for Biologics Evaluation
and Research (CBER), is announcing a
public workshop entitled ‘‘Synergizing
Efforts in Standards Development for
Cellular Therapies and Regenerative
Medicine Products.’’ The purpose of the
public workshop is to bring together a
broad range of stakeholders to discuss
current and future standards
development activities involving
cellular therapies and regenerative
medicine products. This public
workshop is being rescheduled due to
the government shutdown.
Date and Time: The public workshop
will be held on March 31, 2014, from
8:30 a.m. to 4:30 p.m.
Location: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503 A), Silver Spring, MD 20993–0002.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. Please visit the following
Web site for location, parking, security,
and travel information: https://www.fda.
gov/AboutFDA/WorkingatFDA/
BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
Contact Person: Sherri Revell, Center
for Biologics Evaluation and Research
(HFM–49), Food and Drug
Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852–1448,
301–827–2000, FAX: 301–827–3079,
email: CBERPublicEvents@fda.hhs.gov
(Subject line: SESDCTRMP Workshop).
VerDate Mar<15>2010
17:11 Feb 11, 2014
Jkt 232001
Registration: Mail or fax your
registration information (including
name, title, firm name, address,
telephone, and fax numbers) to Sherri
Revell (see Contact Person) or email to
CBERPublicEvents@fda.hhs.gov (Subject
line: SESDCTRMP Workshop
Registration) by March 24, 2014. There
is no registration fee for the public
workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at 7:30
a.m.
Streaming Webcast of the Public
Workshop: For those unable to attend in
person, FDA will Webcast the public
workshop. To join the Webcast of the
public workshop, please go to: https://
collaboration.fda.gov/
sesdctrmpworkshop/. If you have never
attended an Adobe Connect meeting
before, test your connection at https://
collaboration.fda.gov/common/help/en/
support/meeting_test.htm. Get a quick
overview: https://www.adobe.com/go/
connectpro_overview. Registration is not
required for those attending via Adobe
Connect.
If you need special accommodations
due to a disability, please contact Sherri
Revell (see Contact Person) at least 7
days in advance.
SUPPLEMENTARY INFORMATION:
Standardization efforts concerning the
clinical development of cellular
therapies and regenerative medicine
products have generated a great deal of
interest. These efforts include standards
development, expert opinion position
papers, and professional practice
guidelines. However, relatively little is
done to coordinate the various existing
efforts. In the public workshop, FDA
hopes to bring together a broad range of
stakeholders of cellular therapies and
regenerative medicine products in order
to:
• Inform stakeholders about the types
of standards and standards
organizations that are available
currently, the role that the Federal
Agencies play in standards
development, and the potential role that
stakeholders can play in standards
development.
• Provide a high-level overview of
current standards development
activities in the fields of cellular therapy
and regenerative medicine and the
regulatory application of standards.
• Provide opportunity for discussion
of areas of high interest for current or
future standards development in the
fields of cellular therapy and
regenerative medicine and to explore
ways to minimize redundancy and
maximize collaboration.
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
We encourage all who have an
interest in the development of cellular
therapies and regenerative medicine
products to attend the public workshop.
This public workshop is being
rescheduled due to the government
shutdown. It was originally scheduled
for October 7, 2013 (see 78 FR 43889,
July 22, 2013). Those who registered for
the original workshop date must register
again for the rescheduled date (see
Registration).
Transcripts: Please be advised that as
soon as possible after a transcript of the
public workshop is available, it will be
accessible at: https://www.fda.gov/
BiologicsBloodVaccines/NewsEvents/
WorkshopsMeetingsConferences/
TranscriptsMinutes/default.htm.
Transcripts of the public workshop may
also be requested in writing from the
Division of Freedom of Information
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.
Dated: February 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–03015 Filed 2–11–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Anti-Infective 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: Anti-Infective
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 March 31, 2014, from 8 a.m. to
5 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.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
E:\FR\FM\12FEN1.SGM
12FEN1
mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 29 / Wednesday, February 12, 2014 / Notices
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Jennifer Shepherd,
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, AIDAC@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: During the morning session,
the committee will discuss new drug
applications (NDAs) 205–435 and 205–
436, tedizolid phosphate tablets and
tedizolid phosphate injection, submitted
by Trius Therapeutics, respectively, for
the proposed indication of treatment of
acute bacterial skin and skin structure
infections.
During the afternoon session, the
committee will discuss NDA 021–883,
dalbavancin hydrochloride for
intravenous injection, submitted by
Durata Therapeutics International B.V.,
for the proposed indication of treatment
of acute bacterial skin and skin structure
infections.
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 March 17, 2014.
Oral presentations from the public will
be scheduled between approximately
VerDate Mar<15>2010
17:59 Feb 11, 2014
Jkt 232001
10:45 a.m. to 11:15 a.m., and 3:45 p.m.
to 4:15 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 7,
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 March 10, 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
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Jennifer
Shepherd 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: February 6, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2014–02942 Filed 2–11–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00035
Fmt 4703
Sfmt 4703
8463
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Vaccines and
Related Biological Products 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 March 20, 2014, from 11:30 a.m.
to approximately 3:20 p.m.
Location: Rockwall II, Conference
Room 1033, 5515 Security Lane,
Rockville, MD 20852. The public is
welcome to attend the meeting at the
specified location where a
speakerphone will be provided. Public
participation in the meeting is limited to
the use of the speakerphone in the
conference room.
Contact Person: Prabha Atreya or
Denise Royster, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, 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: On March 20, 2014, the
committee will meet in open session to
hear updates of the research programs in
the Laboratory of Respiratory and
Special Pathogens, Division of Bacterial,
Parasitic and Allergenic Products, and
in the Laboratory of Hepatitis Viruses,
Division of Viral Products, Center for
Biologics Evaluation and Research,
FDA.
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/
E:\FR\FM\12FEN1.SGM
12FEN1
]]>Agencies
[Federal Register Volume 79, Number 29 (Wednesday, February 12, 2014)]
[Notices]
[Pages 8462-8463]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02942]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Anti-Infective 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: Anti-Infective 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 March 31, 2014, from 8
a.m. to 5 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. Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/default.htm; under
[[Page 8463]]
the heading ``Resources for You,'' click on ``Public Meetings at the
FDA White Oak Campus.'' Please note that visitors to the White Oak
Campus must enter through Building 1.
Contact Person: Jennifer Shepherd, 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, AIDAC@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: During the morning session, the committee will discuss new
drug applications (NDAs) 205-435 and 205-436, tedizolid phosphate
tablets and tedizolid phosphate injection, submitted by Trius
Therapeutics, respectively, for the proposed indication of treatment of
acute bacterial skin and skin structure infections.
During the afternoon session, the committee will discuss NDA 021-
883, dalbavancin hydrochloride for intravenous injection, submitted by
Durata Therapeutics International B.V., for the proposed indication of
treatment of acute bacterial skin and skin structure infections.
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
March 17, 2014. Oral presentations from the public will be scheduled
between approximately 10:45 a.m. to 11:15 a.m., and 3:45 p.m. to 4:15
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 7, 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 March 10, 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 disabilities or special needs. If you require special
accommodations due to a disability, please contact Jennifer Shepherd 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: February 6, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-02942 Filed 2-11-14; 8:45 am]
BILLING CODE 4160-01-P
