Notice2022-23380
Quantitative Brain Amyloid Positron Emission Tomography Imaging in Patients With Alzheimer's Disease; Public Workshop; Request for Comments
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Published
October 27, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Quantitative Brain Amyloid PET Imaging in Patients with Alzheimer's Disease." The purpose of the public workshop is to evaluate the role of quantitative positron emission tomography (PET) measures of amyloid deposition in the brain in clinical trials and clinical use in patients with suspected or confirmed Alzheimer's disease.
Full Text
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<title>Federal Register, Volume 87 Issue 207 (Thursday, October 27, 2022)</title>
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[Federal Register Volume 87, Number 207 (Thursday, October 27, 2022)]
[Notices]
[Pages 65069-65070]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23380]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2588]
Quantitative Brain Amyloid Positron Emission Tomography Imaging
in Patients With Alzheimer's Disease; Public Workshop; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Quantitative Brain
Amyloid PET Imaging in Patients with Alzheimer's Disease.'' The purpose
of the public workshop is to evaluate the role of quantitative positron
emission tomography (PET) measures of amyloid deposition in the brain
in clinical trials and clinical use in patients with suspected or
confirmed Alzheimer's disease.
DATES: The public workshop will be held on November 17, 2022, from 8:30
a.m. to 5 p.m. Eastern Time. Submit either electronic or written
comments on this public workshop by December 19, 2022. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public workshop will be held at FDA White Oak Campus
Great Room. Entrance for the public workshop participants (non-FDA
employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to <a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</a>.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before December 19, 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 December 19, 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.
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 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-2588 for ``Quantitative Brain Amyloid PET Imaging in
Patients with Alzheimer's Disease.'' Received comments, those filed in
a timely manner (see ADDRESSES), will be placed
[[Page 65070]]
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.'' The Agency 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 to 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 this 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: Kyong ``Kaye'' Kang, Center for Drug
Evaluation and Research, Food and Drug Administration, 301-796-1970,
<a href="/cdn-cgi/l/email-protection#dd96a4b2b3baf396bcb3ba9dbbb9bcf3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="0e457761606920456f60694e686a6f2066667d20696178">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Alzheimer's disease (AD) is a major public health concern worldwide
and its accurate diagnosis and staging is critical for the optimal
management of patients at risk for or afflicted with this devastating
disorder. The accuracy of clinical diagnosis of AD by dementia experts
is modest when compared to postmortem diagnosis. Amyloid burden is one
of the pathological hallmarks of the disease, and in patients
presenting with cognitive and memory disturbances, quantitative imaging
of brain amyloid offers the potential to enhance the assessment and
management of patients with suspected or confirmed AD. This workshop
aims to evaluate the role of quantitative PET measures of amyloid
deposition in the brain in clinical trials and as well as in clinical
use in patients with suspected or confirmed AD.
II. Topics for Discussion at the Public Workshop
The workshop will provide an overview of clinical and
investigational uses of brain amyloid PET imaging, the regulatory
history of marketed imaging drug products and devices for amyloid
quantitation, clinical pharmacology of tracers, quantitation
methodology, metrics and analytical validity, and use of quantitative
amyloid in clinical trials with perspectives from industry, trade and
professional organizations, academic investigators, and patient
advocacy group.
III. Participating in the Public Workshop
Registration: To register for the public workshop, persons
interested in attending this public workshop virtually or in-person
must register online by November 16, 2022, 11:59 p.m. Eastern Time.
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone. No
same-day registration will be available.
Registration is free and in-person participation is limited due to
space availability constraints; therefore, FDA may limit the number of
onsite participants from each organization. Registrants will receive
confirmation when they have been accepted. If there are COVID-19
restrictions in place at the time of the event, this conference will
move to an all-virtual event.
If you need special accommodations due to a disability, please
contact Kyong ``Kaye'' Kang no later than November 16, 2022.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast at <a href="https://fda.zoomgov.com/webinar/register/WN_ezA-_Y94QMSaT0SHBdlS5g">https://fda.zoomgov.com/webinar/register/WN_ezA-_Y94QMSaT0SHBdlS5g</a>.
If you have never attended a Connect Pro event before, test your
connection at <a href="https://collaboration.fda.gov/common/help/en/support/meeting_test.htm">https://collaboration.fda.gov/common/help/en/support/meeting_test.htm</a>. To get a quick overview of the Connect Pro program,
visit <a href="https://www.adobe.com/go/connectpro_overview">https://www.adobe.com/go/connectpro_overview</a>. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at <a href="https://www.fda.gov/drugs/news-events-human-drugs/fda-cder-cdrh-snmmi-and-mita-workshop-quantitative-brain-amyloid-pet-imaging-patients-alzheimers">https://www.fda.gov/drugs/news-events-human-drugs/fda-cder-cdrh-snmmi-and-mita-workshop-quantitative-brain-amyloid-pet-imaging-patients-alzheimers</a>.
Dated: October 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23380 Filed 10-26-22; 8:45 am]
BILLING CODE 4164-01-P
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