[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Page 65770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27196]
[[Page 65770]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee
and the Drug Safety and Risk Management 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 Committees: Pulmonary-Allergy Drugs Advisory Committee and
the Drug Safety and Risk Management Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on December 10, 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: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Contact Person: Cindy Hong, 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 protected], 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 http://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 committees will discuss the safety of codeine in
children 18 years of age and younger. Codeine (most often in
combination with acetaminophen) is used for the treatment of pain in
children; however, it is contraindicated for the management of pain
after tonsillectomy and/or adenoidectomy. Codeine (in combination with
other medicines) is used for the relief of cough associated with upper
respiratory allergies or the common cold in children.
Codeine is available by prescription and also through the over-the-
counter (OTC) Drug Monograph for Cold, Cough, Allergy, Bronchodilator,
and Antiasthmatic Drug Products (21 CFR 341.14, 21 CFR 341.74, and 21
CFR 341.90).
The focus of the meeting will be the risk of serious adverse
events, such as respiratory depression and death, including reports in
children who are CYP2D6 ultra-rapid metabolizers. The committees will
discuss whether the use of codeine in children should be restricted
further beyond the current contraindication described previously and
whether codeine should be available through the OTC Drug Monograph.
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 http://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 committees.
Written submissions may be made to the contact person on or before
November 24, 2015. Oral presentations from the public will be scheduled
between approximately 11 a.m. and 12 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 November 16, 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 November 17, 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
disabilities. If you require accommodations due to a disability, please
contact Cindy Hong 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 http://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 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27196 Filed 10-26-15; 8:45 am]
BILLING CODE 4164-01-P