[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)]
[Notices]
[Pages 24130-24131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11166]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1797]


Joint Meeting of the Anesthetic and Analgesic Drug Products 
Advisory Committee and the Drug Safety and Risk Management Advisory 
Committee; Notice of Meeting; Establishment of a Public Docket; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Anesthetic and Analgesic Drug 
Products Advisory Committee and the Drug Safety and Risk Management 
Advisory Committee. The general function of the committees is to 
provide advice and recommendations to FDA on regulatory issues. At 
least one portion of the meeting will be closed to the public. FDA is 
establishing a docket for public comment on this document.

DATES: The meeting will be held on June 26, 2018, from 8 a.m. to 5 p.m.

ADDRESSES: DoubleTree by Hilton Hotel Bethesda--Washington DC, Grand 
Ballroom, 8120 Wisconsin Ave., Bethesda, MD 20814-3624. The conference 
center's telephone number is 301-652-2000. Answers to commonly asked 
questions about FDA Advisory Committee meetings 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. Information 
about the DoubleTree by Hilton Hotel Bethesda--Washington DC Conference 
Center can be accessed at: http://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-hotel-bethesda-washington-dc-WASBHDT/index.html.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2018-N-1797. The docket will close on June 25, 
2018. Submit either electronic or written comments on this public 
meeting by June 25, 2018. Please note that late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before June 25, 2018. The https://www.regulations.gov electronic 
filing system will accept comments until midnight Eastern Time at the 
end of June 25, 2018. Comments received by mail/hand delivery/courier 
(for written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is on or before 
that date.
    Comments received on or before June 12, 2018, will be provided to 
the committees. Comments received after that date will be taken into 
consideration by FDA.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-1797 for ``Joint Meeting of the Anesthetic and Analgesic 
Drug Products Advisory Committee and the Drug Safety and Risk 
Management Advisory Committee; Notice of Meeting; Establishment of a 
Public Docket; Request for Comments.'' Received comments, those filed 
in a timely manner (see ADDRESSES), will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review 
this copy, including the claimed confidential information, in its 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify the information as ``confidential.'' Any 
information marked as ``confidential'' will not be disclosed except in 
accordance with 21 CFR 10.20 and other applicable disclosure law. For 
more information about FDA's posting of comments to public dockets, see 
80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Yinghua Wang, 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

[[Page 24131]]

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 FDA's website 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.

SUPPLEMENTARY INFORMATION: 
    Agenda: The committees will discuss new drug application 022324, 
oxycodone extended-release capsules, submitted by Pain Therapeutics, 
with the proposed indication of the management of pain severe enough to 
require daily, around-the-clock, long-term opioid treatment and for 
which alternative treatment options are inadequate. The product is 
intended to have abuse-deterrent properties based on its 
physicochemical properties. The committees will be asked to discuss 
whether the data submitted by the Applicant are sufficient to support 
labeling of the product with the properties expected to deter abuse.
    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 website 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 website 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: On June 26, 2018, from 9:30 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 committees. All electronic and written submissions submitted to the 
Docket (see ADDRESSES) on or before June 12, 2018, will be provided to 
the committees. Oral presentations from the public will be scheduled 
between approximately between 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 June 4, 2018. 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 June 5, 2018.
    Closed Committee Deliberations: On June 26, 2018, from 8 a.m. to 
9:30 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 opioid formulation with 
properties designed to deter abuse.
    Persons attending FDA's advisory committee meetings are advised 
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] or 301-796-4540.
    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 Yinghua Wang (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website 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: May 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11166 Filed 5-23-18; 8:45 am]
 BILLING CODE 4164-01-P


