[Federal Register Volume 81, Number 50 (Tuesday, March 15, 2016)]
[Notices]
[Pages 13796-13797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05748]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Anesthetic and Analgesic Drug Products Advisory Committee and the 
Drug Safety and Risk Management 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). At least one 
portion of the meeting will be closed to the public.
    Name of Committees: Anesthetic and Analgesic Drug Products 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 May 5, 2016, from 8 a.m. 
to 5 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: 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 committees will be asked to discuss new drug 
application (NDA) 208653, benzhydrocodone/acetaminophen oral tablets, 
submitted by KemPharm, Inc., with the proposed indication of short-term 
(up to 14 days)

[[Page 13797]]

management of acute pain. The product has been formulated with the 
intent to provide abuse-deterrent properties. Benzhydrocodone is a 
hydrocodone prodrug which, according to the applicant, is rapidly 
converted into hydrocodone by enzymes in the gastrointestinal tract. 
The active drugs in this fixed-dose combination are hydrocodone and 
acetaminophen. The applicant has submitted data to support abuse-
deterrent properties for this product. The committees will be asked to 
discuss whether the applicant has demonstrated abuse-deterrent 
properties for their product that would support labeling, and whether 
the nasal route of abuse is relevant for combination products made up 
of hydrocodone and acetaminophen.
    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: On May 5, 2016, from 9:15 a.m. to 5 p.m., the meeting is 
open to the public. 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 
April 21, 2016. Oral presentations from the public will be scheduled 
between approximately 1:30 p.m. and 2:30 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 April 13, 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 14, 2016.
    Closed Presentation of Data: On May 5, 2016, from 8 a.m. to 9:15 
a.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential commercial information (5 U.S.C. 
552b(c)(4)). During this session, the committees will discuss the drug 
development program of an investigational abuse-deterrent opioid 
product.
    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 9, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-05748 Filed 3-14-16; 8:45 am]
 BILLING CODE 4164-01-P