[Federal Register Volume 87, Number 207 (Thursday, October 27, 2022)]
[Notices]
[Pages 65069-65070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23380]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 https://www.fda.gov/about-fda/visitor-information.
    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 https://www.regulations.gov 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:
     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-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 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.'' 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 https://www.regulations.gov. 
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: 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: Kyong ``Kaye'' Kang, Center for Drug 
Evaluation and Research, Food and Drug Administration, 301-796-1970, 
[email protected].

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 https://fda.zoomgov.com/webinar/register/WN_ezA-_Y94QMSaT0SHBdlS5g.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. 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 https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
internet at https://www.fda.gov/drugs/news-events-human-drugs/fda-cder-cdrh-snmmi-and-mita-workshop-quantitative-brain-amyloid-pet-imaging-patients-alzheimers.

    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