[Federal Register Volume 81, Number 49 (Monday, March 14, 2016)]
[Notices]
[Pages 13372-13373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05573]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0820]


Drug Safety and Risk Management Advisory Committee and the 
Anesthetic and Analgesic Drug Products Advisory Committee; Notice of 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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: Drug Safety and Risk Management Advisory 
Committee and the Anesthetic and Analgesic Drug Products 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 May 3, 2016, from 8 a.m. 
to 5 p.m. and May 4, 2016, from 8 a.m. to 5 p.m.

ADDRESSES: FDA is opening a docket for public comment on this meeting. 
The docket number is FDA-2016-N-0820. The docket will open for public 
comment on March 14, 2016. The docket will close on June 4, 2016. 
Interested persons may submit either electronic or written comments 
regarding this meeting. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. All comments received will be posted 
without change, including any personal information provided. It is only 
necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday. Comments received on 
or before April 19, 2016, will be provided to the committees before the 
meeting.
    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: Stephanie L. Begansky, 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: [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 Food and Drug Administration Amendments Act of 2007 
(Pub. L. 110-85) requires FDA to bring, at least annually, one or more 
drugs with Risk Evaluation and Mitigation Strategies (REMS) with 
Elements to Assure Safe Use (ETASU) before its Drug Safety and Risk 
Management Advisory Committee (DSaRM). On May 3 and 4, 2016, the 
committees will discuss results from assessments of the extended-
release and long-acting (ER/LA) Opioid Analgesics REMS. The Agency will 
seek the committees' comments as to whether this REMS with ETASU 
assures safe use, is not unduly burdensome to patient access to the 
drugs, and to the extent practicable, minimizes the burden to the 
healthcare delivery system.
    The ER/LA Opioid Analgesics REMS requires that prescriber training 
will be made available to healthcare providers who prescribe ER/LA 
opioid analgesics. Training is considered ``REMS-compliant'' if: (1) 
It, for training provided by continuing education providers, is offered 
by an accredited provider to licensed prescribers, (2) it includes all 
elements of the FDA Blueprint for Prescriber Education for ER/LA Opioid 
Analgesics (Blueprint), (3) it includes a knowledge assessment of all 
the sections of the Blueprint, and (4) it is subject to independent 
audit to confirm that conditions of the REMS training have been met. 
The Agency will seek the committees' input on possible modifications to 
the ER/LA Opioid Analgesics REMS, including expansion of the scope and 
content of prescriber training and expansion of the REMS program to 
include immediate-release opioids.
    Comments from the public can be submitted to the docket (see the 
ADDRESSES section) on a broad evaluation of the ER/LA Opioid Analgesics 
REMS program and whether the ER/LA opioid analgesics REMS should be 
modified as well as any proposed modifications. Comments may include 
but are not limited to: (1) Alternative methodologies for evaluating 
the overall impact of the program on knowledge and behavior by 
prescribers and patients, (2) the overall impact of the REMS on the 
adverse events it is intended to mitigate; (3) whether the FDA 
Blueprint or other tools (e.g., Medication Guide or Patient Counseling 
Document) should be revised and/or expanded; (4) the use of the 
continuing education as a component of the REMS as a mechanism for 
providing prescriber training; (5) whether to expand the REMS program 
to include immediate-release opioids; and (6) how additional REMS tools 
or ETASU (e.g., required prescriber or pharmacist training, required 
patient agreements), if recommended, may impact the healthcare delivery 
system and patient access to ER/LA opioid analgesics.
    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

[[Page 13373]]

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. 
All electronic and written submissions submitted to the Docket (see the 
ADDRESSES section) on or before April 19, 2016, will be provided to the 
committees. Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. and 12:30 p.m. on May 4, 2016. 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 
April 11, 2016. 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 April 12, 2016.
    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 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 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: March 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-05573 Filed 3-11-16; 8:45 am]
 BILLING CODE 4164-01-P