[Federal Register Volume 88, Number 36 (Thursday, February 23, 2023)]
[Notices]
[Pages 11447-11449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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'').

[[Page 11448]]

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-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 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: 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, [email protected].

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: https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-patient-focused-drug-development-long-covid-04252023.

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 https://www.surveymonkey.com/r/LongCOVIDPFDD. 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 [email protected] 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 https://www.surveymonkey.com/r/LongCOVIDPFDD.
    The English-language webcast can be accessed via: https://fda.yorkcast.com/webcast/Play/4eba453a2412474e98fff1fabcc63ac51d. The 
Spanish-language webcast can be accessed via: https://fda.yorkcast.com/webcast/Play/0385884d5655420fabd3a55a237926691d. 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 https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-patient-focused-drug-development-long-covid-04252023.

    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