- September 29, 2023
- 9:00 AM - 5:00 PM ET
On September 29, 2023, the U.S. Food and Drug Administration (FDA) is hosting a free hybrid public meeting entitled “Modernizing Food and Drug Administration Recalls Listening Session.”
This listening session provides an opportunity for stakeholders to share information and feedback about topics related to recall modernization, for FDA-regulated products. The FDA is inviting comments from all interested stakeholders and has identified the following examples of topic categories of the type of information the agency is interested in obtaining. Participants are encouraged to address these topics, or any other relevant topics related to recall modernization for FDA-regulated products:
- General recall preparations / contingency planning
- Creating successful recall strategies, including methods to reach underserved communities
- Initiating a recall
- Strategies for public warning, including press releases, social media, and other communication tools
- Increasing efficiency and effectiveness of recall information exchange
- Ensuring effective recalls
- Terminating a recall
- Strategies for reducing recall recurrence for similar situations
September 29, 2023, from 9:00 a.m. – 5:00 p.m. EDT
|September 1, 2023
(6 p.m. EDT)
Deadline to register to attend the listening session in person. Early registration is recommended if attending in person due to limited seating. The FDA may limit the number of in-person participants from each organization to ensure representation of diverse viewpoints.
|September 1, 2023
(6 p.m. EDT)
Deadline to register to speak at the listening session. The agency will do its best to accommodate these requests. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to speak. Each speaker will be limited to approximately 5 minutes, depending on the number of speakers. The FDA intends to select and notify speakers by September 8, 2023 and indicate the approximate time each presentation is to begin.
|September 15, 2023
(6 p.m. EDT)
|Deadline to email accompanying presentation materials (if any) for persons selected to speak at the listening session, must be in PPT format that conform with 508 compliancy (see https://tinyurl.com/457zmy8n), to FDAORAPublicMeetingRecalls@fda.hhs.gov. Accompanying presentation materials are optional. No commercial or promotional material will be permitted to be presented or distributed at the listening session.|
|September 29, 2023||Deadline to register to attend the listening session virtually. Registration may be performed at any time before or during the listening session. However, all requests to speak must be submitted by 6 p.m. EDT on September 1, 2023.|
|October 27, 2023
(11:59 p.m. EDT)
|Deadline to submit a public comment to the docket (FDA-2023-N-2393) for this listening session.|
Attending in person:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Rm. 1503A (the Great Room)
Silver Spring, MD 20993
Entry into the facility includes routine security check procedures. Please go to visitor information for FDA campus location, parking, security, and travel.
This listening session will also be webcast.
Registration is required to attend in person or virtually. Registrants will receive confirmation via email when they have been accepted.
Requests to Speak: During registration you may indicate if you wish to speak (virtually or in person) during the listening session, which topic(s) you wish to address, and whether you will have presentation slides. All requests to speak must be submitted by 6 p.m. EDT on September 1, 2023.
Attending in Person: Persons interested in attending in person must register by 6 p.m. EDT on September 1, 2023. During registration you may request special accommodations due to a disability.
Attending Virtually: Registration to attend virtually may be performed at any time before or during the listening session. However, all requests to speak must be submitted by 6 p.m. EDT on September 1, 2023.
A transcript of the listening session will be posted on FDA.gov as soon as it is available following the event.
COMMENTING TO THE DOCKET
FDA is establishing a public docket for this listening session. Please submit all public comments to the docket (FDA-2023-N-2393), available at Regulations.gov. The public comment period will end at 11:59 p.m. EDT on October 27, 2023
Linda Chasey, Office of Regulatory Affairs, FDA
For questions, email FDAORAPublicMeetingRecalls@fda.hhs.gov