Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting, 63481 [2013-24908]
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Federal Register / Vol. 78, No. 206 / Thursday, October 24, 2013 / Notices
d. The overall framework to evaluate
the quality of the meta-analysis;
whether there is a basis for establishing
a hierarchy of evidence for judging the
quality of the meta-analysis.
Dated: October 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–24939 Filed 10–23–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Peripheral and Central Nervous
System 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: Peripheral and
Central Nervous System 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 13, 2013, from 8 a.m.
to 5 p.m.
Location: Sheraton Silver Spring
Hotel, Cypress Ballroom, 8777 Georgia
Ave., Silver Spring, MD 20910. The
hotel’s telephone number is 301–589–
0800.
Contact Person for More Information:
Glendolynn S. Johnson, 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, email:
PCNS@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
VerDate Mar<15>2010
17:25 Oct 23, 2013
Jkt 232001
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
supplemental biologics license
application (sBLA) 103948–5139,
alemtuzumab injection, proposed trade
name LEMTRADA, submitted by
Genzyme Corporation, a Sanofi
Company. The proposed indication is
for the treatment of patients with
relapsing forms of multiple sclerosis to
slow or reverse the accumulation of
physical disability and reduce the
frequency of clinical exacerbations.
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 November 6, 2013.
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
30, 2013. 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 October 31, 2013.
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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
63481
require special accommodations due to
a disability, please contact Glendolynn
S. Johnson 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: October 18, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–24908 Filed 10–23–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1277]
Therapeutic Area Standards Initiative
Project Plan; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the Therapeutic Area
Standards Initiative Project Plan. This
therapeutic area (TA) Project Plan will
be the primary document for guiding all
major aspects of FDA’s multi-year
initiative to develop and implement TA
standards to support the regulatory
review process for drugs and biologics.
The TA Project Plan will be updated
annually and made available for public
comment.
DATES: Although you can comment on
this TA Project Plan at any time, to
ensure that the Agency considers your
comment on this TA Project Plan before
it begins work on the next version of the
TA Project Plan, submit either
electronic or written comments on the
TA Project Plan by December 23, 2013.
ADDRESSES: Submit written requests for
single copies of the TA Project Plan to
the Division of Drug Information, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002 or Office
of Communication, Outreach and
Development (HFM–40). Send one selfaddressed adhesive label to assist that
SUMMARY:
E:\FR\FM\24OCN1.SGM
24OCN1
]]>Agencies
[Federal Register Volume 78, Number 206 (Thursday, October 24, 2013)]
[Notices]
[Page 63481]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24908]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Peripheral and Central Nervous System 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: Peripheral and Central Nervous System 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 13, 2013, from
8 a.m. to 5 p.m.
Location: Sheraton Silver Spring Hotel, Cypress Ballroom, 8777
Georgia Ave., Silver Spring, MD 20910. The hotel's telephone number is
301-589-0800.
Contact Person for More Information: Glendolynn S. Johnson, 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, email: PCNS@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 supplemental biologics license
application (sBLA) 103948-5139, alemtuzumab injection, proposed trade
name LEMTRADA, submitted by Genzyme Corporation, a Sanofi Company. The
proposed indication is for the treatment of patients with relapsing
forms of multiple sclerosis to slow or reverse the accumulation of
physical disability and reduce the frequency of clinical exacerbations.
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
November 6, 2013. 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 30, 2013. 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 October 31, 2013.
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 Glendolynn S.
Johnson 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: October 18, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-24908 Filed 10-23-13; 8:45 am]
BILLING CODE 4160-01-P
