Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting, 27314 [2014-10903]
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27314
Federal Register / Vol. 79, No. 92 / Tuesday, May 13, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Anesthetic and Analgesic Drug
Products 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: Anesthetic and
Analgesic Drug 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 June 11, 2014, from 8 a.m. to 5
p.m., and June 12, 2014, from 8 a.m. to
1 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
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: Stephanie L.
Begansky, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, Rm. 2147, Silver Spring,
MD 20993–0002, 301–796–9001, Fax:
301–847–8533, email: AADPAC@
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.
VerDate Mar<15>2010
19:27 May 12, 2014
Jkt 232001
Agenda: The committee will discuss
the potential cardiovascular risk
associated with products in the class of
peripherally acting opioid receptor
antagonists and the necessity, timing,
design, and size of cardiovascular
outcomes trials to support approval of
products in the class for the proposed
indication of opioid-induced
constipation in patients taking opioids
for chronic pain.
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 May 28, 2014. Oral
presentations from the public will be
scheduled between approximately 9
a.m. and 10 a.m. on June 12, 2014.
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 19, 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 May 20, 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 Stephanie L.
Begansky at least 7 days in advance of
the meeting.
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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: May 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–10903 Filed 5–12–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–E–1230]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; SURFAXIN
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
SURFAXIN and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions (two copies are required) and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to https://
www.regulations.gov at Docket No.
FDA–2013–S–0610.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of
Management, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6257,
Silver Spring, MD 20993–0002, 301–
796–7900.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
SUMMARY:
E:\FR\FM\13MYN1.SGM
13MYN1
]]>Agencies
[Federal Register Volume 79, Number 92 (Tuesday, May 13, 2014)]
[Notices]
[Page 27314]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10903]
[[Page 27314]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Anesthetic and Analgesic Drug Products 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: Anesthetic and Analgesic Drug 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 June 11, 2014, from 8
a.m. to 5 p.m., and June 12, 2014, from 8 a.m. to 1 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 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: Stephanie L. Begansky, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, Rm. 2147, Silver Spring, MD 20993-0002, 301-796-9001, Fax:
301-847-8533, email: AADPAC@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 the potential cardiovascular
risk associated with products in the class of peripherally acting
opioid receptor antagonists and the necessity, timing, design, and size
of cardiovascular outcomes trials to support approval of products in
the class for the proposed indication of opioid-induced constipation in
patients taking opioids for chronic pain.
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 May
28, 2014. Oral presentations from the public will be scheduled between
approximately 9 a.m. and 10 a.m. on June 12, 2014. 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 19, 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 May 20, 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 Stephanie L.
Begansky 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: May 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10903 Filed 5-12-14; 8:45 am]
BILLING CODE 4160-01-P
