Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting, 65770 [2015-27196]

Download as PDF 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

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