[Federal Register Volume 89, Number 155 (Monday, August 12, 2024)]
[Notices]
[Pages 65635-65637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17926]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3569]


Gastrointestinal Drugs Advisory Committee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments--Supplemental 
New Drug Application 207999 S-011 for OCALIVA (obeticholic acid) Oral 
Tablets

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 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.

[[Page 65636]]


DATES: The meeting will be held on September 13, 2024, from 8:30 a.m. 
to 5 p.m. Eastern Time.

ADDRESSES: The public may attend the meeting at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503), Silver Spring, MD 20993-0002. The public will also 
have the option to participate, and the advisory committee meeting will 
be heard, viewed, captioned, and recorded through an online 
teleconferencing and/or video conferencing platform.
    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.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2024-N-3569. The docket will close on 
September 12, 2024. Please note that late, untimely filed comments will 
not be considered. The https://www.regulations.gov electronic filing 
system will accept comments until 11:59 p.m. Eastern Time at the end of 
September 12, 2024. Comments received by mail/hand delivery/courier 
(for written/paper submissions) will be considered timely if they are 
received on or before that date.
    Comments received on or before August 29, 2024, will be provided to 
the Committee. Comments received after that date will be taken into 
consideration by FDA. In the event that the meeting is cancelled, FDA 
will continue to evaluate any relevant applications or information, and 
consider any comments submitted to the docket, as appropriate.
    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-2024-N-3569 for ``Gastrointestinal Drugs Advisory Committee; Notice 
of Meeting; Establishment of a Public Docket; Request for Comments--
Supplemental New Drug Application 207999 S-011 for OCALIVA (obeticholic 
acid) Oral Tablets.'' 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Jessica Seo, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-7699, 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 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 the 
meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: The Committee will discuss supplemental new drug 
application (sNDA) 207999 S-011, for OCALIVA (obeticholic acid) 5 mg 
titrated to 10 mg oral tablets, administered once a day, submitted by 
Intercept Pharmaceuticals, Inc., to fulfill the accelerated approval 
postmarketing requirements specified in the OCALIVA approval letter 
dated May 27, 2016. The sNDA included data proposed to describe and 
verify clinical benefit for the indication for the treatment of adult 
patients with primary biliary cholangitis without cirrhosis or with 
compensated cirrhosis who do not have evidence of portal hypertension, 
either in combination with ursodeoxycholic acid (UDCA) with an 
inadequate response to UDCA or as

[[Page 65637]]

monotherapy in patients unable to tolerate UDCA.
    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 on FDA's website at 
the time of the advisory committee meeting. Background material and the 
link to the online teleconference and/or video conference meeting will 
be available at the location of the advisory committee meeting and at 
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll 
down to the appropriate advisory committee meeting link. The meeting 
presentations will also be heard, viewed, captioned, and recorded 
through an online teleconferencing and/or video conferencing platform. 
The online presentation of materials will include slide presentations 
with audio and video components in a manner that most closely resembles 
an in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the Committee. 
All electronic and written submissions to the Docket (see ADDRESSES) on 
or before August 29, 2024, will be provided to the Committee. Oral 
presentations from the public will be scheduled between approximately 
1:30 p.m. to 2:30 p.m. Eastern Time. 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, whether they would like to present online or in-person, 
and an indication of the approximate time requested to make their 
presentation on or before August 21, 2024. 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. 
Similarly, room for interested persons to participate in-person may be 
limited. If the number of registrants requesting to speak in-person 
during the open public hearing is greater than can be reasonably 
accommodated in the venue for the in-person portion of the advisory 
committee meeting, FDA may conduct a lottery to determine the speakers 
who will be invited to participate in-person. The contact person will 
notify interested persons regarding their request to speak by August 
22, 2024. 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 Jessica Seo (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. 1001 et seq.). This meeting notice also serves 
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 
14.22(b), (f), and (g) relating to the location of advisory committee 
meetings are hereby waived to allow for this meeting to take place 
using an online meeting platform in conjunction with the physical 
meeting room (see location). This waiver is in the interest of allowing 
greater transparency and opportunities for public participation, in 
addition to convenience for advisory committee members, speakers, and 
guest speakers. The conditions for issuance of a waiver under 21 CFR 
10.19 are met.

    Dated: August 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17926 Filed 8-9-24; 8:45 am]
BILLING CODE 4164-01-P