2024-19323. Patient Engagement Advisory Committee; Notice of Meeting-Patient-Centered Informed Consent in Clinical Study

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Department of Health and Human Services

Food and Drug Administration

1. [Docket No. FDA-2024-N-0008]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

DATES:

The meeting will be held on October 30, 2024, from 10 a.m. to 5 p.m. Eastern Time.

ADDRESSES:

All meeting participants will be heard, viewed, captioned, and recorded for this advisory committee meeting via an online teleconferencing and/or video conferencing platform.

Answers to commonly asked questions about FDA advisory committee meetings may be accessed at: https://www.fda.gov/​AdvisoryCommittees/​AboutAdvisoryCommittees/​ucm408555.htm.

FOR FURTHER INFORMATION CONTACT:

Letise Williams, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5407, Silver Spring, MD 20993-0002, [e-mail], 301-796-8398, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last-minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's website at https://www.fda.gov/​AdvisoryCommittees/​default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before the meeting.

SUPPLEMENTARY INFORMATION:

Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. On October 30, 2024, the Committee will discuss and make recommendations on “Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products.” The individuals who volunteer to participate in clinical research play an integral role in advancing scientific knowledge and supporting the development of potentially life-saving therapies for patients in need. Informed consent is a key element in clinical studies and can be one of a patient's first interactions with the clinical community. Too often, however, informed consent forms are lengthy and difficult for potential research participants to understand. FDA has worked to improve informed consent over the years, including several recent activities such as developing a draft guidance in identifying key information in informed consent.

The Committee will provide recommendations on the informed consent process and the areas of focus of the informed consent. The Committee will also provide recommendations on factors to consider when communicating informed consent to clinical study participants to increase the likelihood of participants understanding the key elements of research.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA's website at the time of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material and the link to the online teleconference and/or video conference meeting will be available at https://www.fda.gov/​AdvisoryCommittees/​Calendar/​default.htm. Scroll down and select the appropriate advisory committee meeting link. The meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. Written submissions may be made to the contact person (see FOR FURTHER INFORMATION CONTACT ) on or before October 3, 2024. Oral presentations from the public will be scheduled between approximately 2 p.m. and 3 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT ) and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 25, 2024. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. If the number of registrants requesting to speak during the open public hearing is greater than can be reasonably accommodated during the scheduled open hearing portion of the advisory committee meeting, FDA may conduct a lottery to determine the speakers who will be invited to participate. The contact person will notify interested persons regarding their request to speak by September 26, 2024.

Virtual Breakout Session: Individuals interested in participating in the virtual breakout scenario discussions will need to sign up to participate on or before October 16, 2024. The signup sheet, as well as additional information pertaining to the virtual scenario discussions, will be available at https://www.fdalive.com/​peac. Everyone who signs up in advance and provides a valid email address will receive an ( print page 68909) email at least 2 days prior to the meeting with information on how to access the virtual platform that will host the virtual breakout scenario discussions. Please note due to limited technology capacity, participation in the virtual breakout scenario discussions will be limited to 150 participants. Once capacity reaches 150 participants, the breakout session will be closed to additional participants. Additional information regarding the virtual breakout scenario discussions will be provided at https://www.fdalive.com/​peac.

For press inquiries, please contact the Office of Media Affairs at [e-mail] or 301-796-4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact AnnMarie Williams at [e-mail], or 240-507-6496 at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/​AdvisoryCommittees/​AboutAdvisoryCommittees/​ucm111462.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 14.22(b), (f), and (g) relating to the location of advisory committee meetings are hereby waived to allow for this meeting to take place using an online meeting platform. This waiver is in the interest of allowing greater transparency and opportunities for public participation, in addition to convenience for advisory committee members, speakers, and guest speakers. The conditions for issuance of a waiver under 21 CFR 10.19 are met.

Dated: August 23, 2024.

Lauren K. Roth,

Associate Commissioner for Policy.