Notice2023-03714
Patient-Focused Drug Development for Long COVID; Public Meeting; Request for Comments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 23, 2023
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 meeting entitled "Patient-Focused Drug Development for Long COVID." The purpose of the public meeting is to allow FDA to obtain patient perspectives on the impact of Long COVID on daily life, patient views on treatment approaches, and decision factors considered when selecting a treatment.
Full Text
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<title>Federal Register, Volume 88 Issue 36 (Thursday, February 23, 2023)</title>
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[Federal Register Volume 88, Number 36 (Thursday, February 23, 2023)]
[Notices]
[Pages 11447-11449]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03714]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0363]
Patient-Focused Drug Development for Long COVID; Public Meeting;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Patient-Focused Drug
Development for Long COVID.'' The purpose of the public meeting is to
allow FDA to obtain patient perspectives on the impact of Long COVID on
daily life, patient views on treatment approaches, and decision factors
considered when selecting a treatment.
DATES: The public meeting will be held virtually on April 25, 2023,
from 10 a.m. to 4 p.m. Eastern Time. Submit either electronic or
written comments on this public meeting by June 26, 2023. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public meeting will be hosted via a live webcast.
Please note that late, untimely filed comments will not be
considered. 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
26, 2023. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are received 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'').
[[Page 11448]]
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-2023-N-0363 for ``Patient-Focused Drug Development for Long COVID;
Public Meeting; 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.'' 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: Shannon Sparklin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6306, Silver Spring, MD 20993-0002, 301-
796-9208, <a href="/cdn-cgi/l/email-protection#461627322f2328320029253335232206202227682e2e3568212930"><span class="__cf_email__" data-cfemail="b9e9d8cdd0dcd7cdffd6dacccadcddf9dfddd897d1d1ca97ded6cf">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
This meeting will provide FDA with the opportunity to hear directly
from patients and patient representatives about their experiences with
Long COVID, including how Long COVID affects their daily life, the
symptoms that matter most to them, their current approaches to treating
Long COVID, and what they consider when determining whether or not to
participate in a clinical trial. Long COVID, also known as post-COVID
syndrome, post-acute sequalae of severe acute respiratory syndrome 2
coronavirus (SARS-CoV-2), long-haul COVID, or post-acute COVID-19
syndrome, is defined as persistence of COVID-19 symptoms 4 weeks beyond
SARS-CoV-2 infection. Literature has reported two categories of Long
COVID known as subacute or ongoing COVID-19 symptoms (4-12 weeks of
persistent symptoms post-infection), and chronic or post-COVID syndrome
(12 weeks or more of persistent symptoms post-infection). SARS-CoV-2
may cause cell damage to multiple organs in an infected person. The
most commonly reported symptoms include fatigue, brain fog, pain,
palpitations, shortness of breath, cough, insomnia, anxiety,
depression, constipation, and nausea. Since Long COVID was recently
recognized, there is currently no standardized framework for diagnosis
and treatment. While no medicines have been approved to treat Long
COVID, symptoms may be treated with medication, exercise, diet
modification, and meditation. FDA is interested in adult and pediatric
patients' perspectives on the following topics: (1) health effects and
daily impacts; (2) current approaches to treatment; and (3) clinical
trial participation.
For each topic, a brief discussion by a patient panel will begin
the dialogue. This discussion will be followed by a facilitated
discussion where FDA will invite patients and patient representatives
from the viewing audience to provide comments by calling into the
meeting via phone, or by submitting through the meeting platform live
comments which may be read during the meeting by the meeting
facilitator.
In addition to input generated through this public meeting, FDA is
interested in receiving patient and patient representative input
through written comments, which can be submitted to the public docket
(see ADDRESSES). FDA's questions will be available on the meeting
website and as part of the information provided in the public docket.
When submitting comments, if you are commenting on behalf of a patient,
please indicate that you are doing so, and answer the questions as much
as possible from the patient's perspective.
FDA will post the agenda and other meeting materials approximately
5 days before the meeting at: <a href="https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-patient-focused-drug-development-long-covid-04252023">https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-patient-focused-drug-development-long-covid-04252023</a>.
II. Topics for Discussion at the Public Meeting
On April 25, 2023, FDA is conducting a public meeting on Patient-
Focused Drug Development for Long COVID. FDA is interested in obtaining
patient perspectives on the impact of Long COVID on daily life and
patient views on treatment approaches, as well as clinical trial
participation.
III. Participating in the Public Meeting
Registration: To register for the public meeting, visit <a href="https://www.surveymonkey.com/r/LongCOVIDPFDD">https://www.surveymonkey.com/r/LongCOVIDPFDD</a>. Persons without access to the
internet can call 301-796-9208 to register.
If you need special accommodations due to a disability, please
contact Shannon Sparklin (see FOR FURTHER INFORMATION CONTACT) no later
than April 18, 2023.
Panelist Selection: Patients or patient representatives who are
interested in presenting comments as part of the initial panel
discussions will be asked to indicate in their registration which
topic(s) they wish to address. These patients or patient
representatives also will be asked to send <a href="/cdn-cgi/l/email-protection#1848796c717d766c5e777b6d6b7d7c587e7c793670706b367f776e"><span class="__cf_email__" data-cfemail="de8ebfaab7bbb0aa98b1bdabadbbba9eb8babff0b6b6adf0b9b1a8">[email protected]</span></a> a
brief summary of responses to the topic questions by April 4, 2023.
Panelists will be notified of their selection approximately 7 days
before the public meeting. We will try to accommodate all patients and
patient stakeholders who wish to speak, either through the panel
discussion or audience participation; however, the
[[Page 11449]]
duration of comments may be limited by time constraints.
Streaming Webcast of the Public Meeting: This public meeting will
be streamed via a webcast in both English and Spanish languages. Please
register for the webcast by visiting <a href="https://www.surveymonkey.com/r/LongCOVIDPFDD">https://www.surveymonkey.com/r/LongCOVIDPFDD</a>.
The English-language webcast can be accessed via: <a href="https://fda.yorkcast.com/webcast/Play/4eba453a2412474e98fff1fabcc63ac51d">https://fda.yorkcast.com/webcast/Play/4eba453a2412474e98fff1fabcc63ac51d</a>. The
Spanish-language webcast can be accessed via: <a href="https://fda.yorkcast.com/webcast/Play/0385884d5655420fabd3a55a237926691d">https://fda.yorkcast.com/webcast/Play/0385884d5655420fabd3a55a237926691d</a>. Simply click on the
link and hit the ``play'' button and it will start. A test signal will
be playing 30 minutes prior to the event, so you can click on the link
at any point during that time to start. You will hear music playing
during the test period and then the event will begin at 10 a.m. ET. If
you would like to check your system now, you can click on the link and
the page will open with a ``waiting'' statement showing.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible on the meeting
website at <a href="https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-patient-focused-drug-development-long-covid-04252023">https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-patient-focused-drug-development-long-covid-04252023</a>.
Dated: February 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03714 Filed 2-22-23; 8:45 am]
BILLING CODE 4164-01-P
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