[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Notices]
[Pages 45936-45937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19670]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0055]


Gastrointestinal Drugs 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 Gastrointestinal Drugs 
Advisory Committee. The general function of the committee is to provide 
advice and recommendations to FDA on regulatory issues. The meeting 
will be open to the public. FDA is establishing a docket for public 
comment on this document.

DATES: The meeting will be held on October 18, 2018, from 8 a.m. to 5 
p.m.

ADDRESSES: Bethesda Marriott, 5151 Pooks Hill Rd., the Grand Ballroom, 
Bethesda, MD 20814. The conference center's telephone number is 301-
897-9400. 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. Information 
about the Bethesda Marriott can be accessed at: https://www.marriott.com/hotels/travel/wasbt-bethesda-marriott/.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2018-N-0055. The docket will close on October 
16, 2018. Submit either electronic or written comments on this public 
meeting by October 16, 2018. Please note that late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before October 16, 2018. The https://www.regulations.gov 
electronic filing system will accept comments until midnight Eastern 
Time at the end of October 16, 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 October 9, 2018, will be provided to 
the committee. 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-0055 for ``Gastrointestinal Drugs Advisory Committee; Notice 
of Meeting; Establishment of a Public

[[Page 45937]]

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: Jay R. Fajiculay, 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 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 committee will discuss new drug application (NDA) 
210166 for prucalopride tablets for oral administration, submitted by 
Shire Development, LLC, proposed for the treatment of chronic 
idiopathic constipation in adults.
    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: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
All electronic and written submissions submitted to the Docket (see 
ADDRESSES) on or before October 9, 2018, will be provided to the 
committee. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 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 October 1, 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 October 2, 2018.
    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 Jay Fajiculay (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: September 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19670 Filed 9-10-18; 8:45 am]
 BILLING CODE 4164-01-P


