Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting, 65770 [2015-27196]
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65770
Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices
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.
tkelley on DSK3SPTVN1PROD 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 Committees: PulmonaryAllergy 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: https://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,
PADAC@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 committees will discuss
the safety of codeine in children 18
VerDate Sep<11>2014
18:24 Oct 26, 2015
Jkt 238001
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 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 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
PO 00000
Frm 00084
Fmt 4703
Sfmt 4703
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
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 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–27196 Filed 10–26–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3469]
Bulk Drug Substances That Can Be
Used To Compound Drug Products in
Accordance With Section 503B of the
Federal Food, Drug, and Cosmetic Act;
Establishment of a Public Docket
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability;
establishment of public docket.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
developing a list of bulk drug
substances (active ingredients) that can
be used to compound drug products in
accordance with the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (the
503B bulks list). The Agency previously
solicited nominations for the list, but
some of the nominated substances were
not supported by sufficient information
for FDA to evaluate them. FDA is
establishing a public docket where these
substances can be renominated with
sufficient supporting information or to
SUMMARY:
E:\FR\FM\27OCN1.SGM
27OCN1
]]>Agencies
[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]]
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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: https://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, PADAC@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 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 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 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 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 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27196 Filed 10-26-15; 8:45 am]
BILLING CODE 4164-01-P
