Quantitative Brain Amyloid Positron Emission Tomography Imaging in Patients With Alzheimer's Disease; Public Workshop; Request for Comments, 65069-65070 [2022-23380]

Download as PDF 65069 Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / Notices existing profiles into a comparable set of data elements across programs. These data will allow RTI International, a contractor to ACL, to develop an updated set of grantee profiles that are accessible, visually appealing, and consistent across programs. Specifically, the purpose of this data collection effort is to update the SHIP grantee profiles, which were last updated in 2016, and develop similar profiles for SMP and MIPPA. These profiles will be internal to ACL and will only be shared with grantees. A web-based questionnaire will be emailed to all 125 grant managers (representing 54 states and territories) electronically via Smartsheet. The collected data will be imported into a dataset and will be used to create program profiles accessible to ACL and grantees. The proposed data collection tools may be found on the ACL website for review at: https://www.acl.gov/aboutacl/public-input. Estimated Program Burden ACL estimates the burden of this collection of information as follows: A maximum of 125 grantees are expected to respond to the web-based data collection instrument. The approximate burden for pre-data collection preparation is 30 minutes per respondent and approximate burden for form completion is 20 minutes per respondent for a total annual estimate of 103.75 hours. The estimated completion burden includes time to review the instructions, read the questions and complete and responses. IC BURDEN CHART Number of respondents Respondent/data collection activity Hours per response Annual burden hours Pre-data collection preparation ...................................................................... Web-based data collection ............................................................................ 125 125 1 1 0.5 0.33 62.5 41.25 Total ........................................................................................................ 125 1 0.83 103.75 Dated: October 21, 2022. Alison Barkoff, Acting Administrator and Assistant Secretary for Aging. [FR Doc. 2022–23364 Filed 10–26–22; 8:45 am] BILLING CODE 4154–01–P 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. Notice of public workshop; request for comments. ACTION: 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 SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES Responses per respondent VerDate Sep<11>2014 16:55 Oct 26, 2022 Jkt 259001 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/visitorinformation. 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 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 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 E:\FR\FM\27OCN1.SGM 27OCN1 khammond on DSKJM1Z7X2PROD with NOTICES 65070 Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / Notices 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-201509-18/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, Kyong.Kang@fda.hhs.gov. 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 VerDate Sep<11>2014 16:55 Oct 26, 2022 Jkt 259001 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 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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-eventshuman-drugs/fda-cder-cdrh-snmmiand-mita-workshop-quantitative-brainamyloid-pet-imaging-patientsalzheimers. 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–N–1959] Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Postponement of Meeting AGENCY: Food and Drug Administration, HHS. Notice; postponement of meeting. ACTION: The Food and Drug Administration (FDA) is postponing the joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee scheduled for November 18, 2022. Future meeting dates will be announced in the Federal Register. FOR FURTHER INFORMATION CONTACT: Moon Choi, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–2894, NDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area). Please call the Information Line for up-to-date information on this meeting. SUPPLEMENTARY INFORMATION: The joint meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs SUMMARY: E:\FR\FM\27OCN1.SGM 27OCN1

Agencies

[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

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