88 FR 36 pgs. 11447-11449 - Patient-Focused Drug Development for Long COVID; Public Meeting; Request for Comments
Type: NOTICEVolume: 88Number: 36Pages: 11447 - 11449
Pages: 11447, 11448, 11449Docket number: [Docket No. FDA-2023-N-0363]
FR document: [FR Doc. 2023-03714 Filed 2-22-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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.
[top] • 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-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, PatientFocused@fda.hhs.gov.
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.
[top] 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 PatientFocused@fda.hhs.gov 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
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