Notice2022-08022
Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
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Published
April 14, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue and Gene Therapies Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on scientific issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Full Text
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<title>Federal Register, Volume 87 Issue 72 (Thursday, April 14, 2022)</title>
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[Federal Register Volume 87, Number 72 (Thursday, April 14, 2022)]
[Notices]
[Pages 22215-22217]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08022]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0470]
Cellular, Tissue and Gene Therapies 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 Cellular, Tissue and Gene
Therapies Advisory Committee. The general function of the committee is
to provide advice and recommendations to FDA on scientific 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 June 9, 2022, from 10 a.m. to 6 p.m.
and June 10, 2022, from 10 a.m. to 4 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of the COVID-19 pandemic,
all meeting participants will be joining this advisory committee
meeting via an online teleconferencing platform. Answers to commonly
asked questions about FDA advisory committee meetings may be accessed
at: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
The online web conference meeting will be available at the
following link on the day of the meeting: Day 1 June 9 link: <a href="https://youtu.be/RvtTK3KNl5g">https://youtu.be/RvtTK3KNl5g</a> and Day 2 June 10 link: <a href="https://youtu.be/Eo2BXnGienc">https://youtu.be/Eo2BXnGienc</a>.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2022-N-0470. The docket will close on June 8,
2022. Submit either electronic or written comments on this public
meeting on or before June 8, 2022. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before June 8, 2022. The <a href="https://www.regulations.gov">https://www.regulations.gov</a>
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of June 8, 2022. 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 2, 2022, 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the
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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:
<bullet> 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.
<bullet> 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-2022-N-0470 for ``Cellular, Tissue and Gene Therapies 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Christina Vert or Tonica Burke, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 1244, Silver Spring, MD 20993-
0002, <a href="/cdn-cgi/l/email-protection#ed8e998a998c8ead8b898cc385859ec38a829b"><span class="__cf_email__" data-cfemail="11726576657072517775703f7979623f767e67">[email protected]</span></a>, 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 <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> 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 meeting presentations will be
heard, viewed, captioned, and recorded through an online
teleconferencing platform. The committee will discuss two biologics
license applications (BLAs) from bluebird bio, Inc.: (1) BLA 125755 for
elivaldogene autotemcel (autologous CD34+ stem cells genetically
modified with a lentiviral vector to contain an adenosine triphosphate-
binding cassette, sub-family D, member 1 gene that encodes a functional
adrenoleukodystrophy protein); the applicant has requested an
indication for the treatment of patients younger than 18 years of age
with early cerebral adrenoleukodystrophy who do not have an available
and willing human leukocyte antigen-matched sibling hematopoietic stem
cell donor and (2) BLA 125717 for betibeglogene autotemcel (autologous
CD34+ stem cells genetically modified with a lentiviral vector to
contain a gene encoding functional beta-globin); the applicant has
requested an indication for the treatment of patients with [beta]-
thalassemia who require regular red blood cell transfusions.
The morning session of June 9, 2022, will include presentations of
the effectiveness and product-specific safety results from the clinical
trials in BLA 125755. The afternoon session will include presentations
of safety concerns relevant to both products, followed by committee
discussion of BLA 125755. On June 10, 2022, the morning session will
include presentations of the effectiveness and product-specific safety
results from the clinical trials in BLA 125717. The afternoon session
will include committee discussion of BLA 125717.
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 meeting room will be available at
<a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. Scroll
down to the appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials 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 submitted to the Docket (see
ADDRESSES) on or before June 2, 2022, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Eastern Time on June 9, 2022, and
between approximately 1 p.m. and 2 p.m. Eastern Time on June 10, 2022.
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 May
25, 2022. 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 May 26, 2022.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#422426232d2f23022426236c2a2a316c252d34"><span class="__cf_email__" data-cfemail="a6c0c2c7c9cbc7e6c0c2c788ceced588c1c9d0">[email protected]</span></a> or 301-796-4540.
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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 Christina Vert at <a href="/cdn-cgi/l/email-protection#eb889f8c9f8a88ab8d8f8ac5838398c58c849d"><span class="__cf_email__" data-cfemail="20435447544143604644410e4848530e474f56">[email protected]</span></a> (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 <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> 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: April 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08022 Filed 4-13-22; 8:45 am]
BILLING CODE 4164-01-P
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