[Federal Register Volume 89, Number 121 (Monday, June 24, 2024)]
[Notices]
[Pages 52471-52473]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-13776]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2561]


Best Practices for Meeting Management; Public Workshop; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``Best Practices for 
Meeting Management.'' This workshop is being conducted to fulfill a 
commitment to hold a public meeting to discuss best practices for 
meeting management in the seventh authorization of the Prescription 
Drug User Fee Act (PDUFA VII). The purpose of the public workshop is to 
discuss issues related to submission of meeting requests, efficient 
time management, finalizing meeting agenda, development and submission 
of meeting background packages, and lessons learned from the 
Coronavirus Disease 2019 (COVID-19) pandemic including the use of 
virtual meeting platforms. The public workshop will also discuss and 
share experience and metrics related to specific PDUFA meeting 
activities associated with the Center for Biologics Evaluation and 
Research (CBER) and Center for Drug Evaluation and Research (CDER) 
meetings in fiscal years (FYs) 2021 through 2023. This will include 
Type D and Initial Targeted Engagement for Regulatory Advice on CBER/
CDER Products (INTERACT) meetings, which began with PDUFA VII in FY 
2023. Learnings from the public meeting could inform FDA's internal 
process improvement efforts and, as appropriate, be reflected in an 
update to the ``Best Practices for Communication Between IND 
[Investigational New Drug Application] Sponsors and FDA During Drug 
Development'' guidance.

DATES: The public workshop will be held in person and virtually on July 
22, 2024, from 9 a.m. to 2 p.m., Eastern Time. Either electronic or 
written comments on this public workshop must be submitted by August 
22, 2024. See the SUPPLEMENTARY INFORMATION section for registration 
date and information.

ADDRESSES: The public workshop will be held in person at the FDA White 
Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the 
Great Room, Silver Spring, MD 20993-0002 and virtually using the Zoom 
platform. Entrance for the public workshop participants (non-FDA 
employees) is through Building 1 where routine security check 
procedures will be performed. For parking and security information, 
please refer to https://www.fda.gov/about-fda/visitor-information.
    You may submit comments as follows. 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 August 22, 2024. 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

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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-2024-N-2561 for ``Best Practices for Meeting Management; Public 
Workshop; 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: Danielle Villata, Center for Drug 
Evaluation and Research, Food and Drug Administration, 301-796-3800, 
[email protected] or Sonday Kelly, Center for Biologics 
Evaluation and Research Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 240-402-8410, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Timely and effective interactive communications with sponsors 
during drug development is a core Agency activity to help achieve the 
Agency's mission to facilitate the conduct of efficient and effective 
drug development programs, which can enhance public health by making 
new, safe, and effective drugs available to the American public. 
Through PDUFA, FDA has established numerous meeting opportunities with 
sponsors such as Type A, B, and C meetings in addition to 
communications that take place during the review of certain marketing 
applications such as mid-cycle telecons and late-cycle meetings. PDUFA 
VII added two new meeting types, the INTERACT and Type D meetings.
    Due to the significant volume of FDA and sponsor interactions over 
the years, the addition of multiple new meeting/communication types, 
and format changes to interactions (e.g., extended use of virtual 
meetings) due to the COVID-19 pandemic, updating FDA's and Industry's 
standards for meeting management best practices has become more 
important.
    Best practices for meeting management are the responsibility of 
Industry and FDA and efforts from both are needed to continue 
advancement and improvement of these communications. To that end, FDA 
hired a contractor to gather and analyze FDA meeting metrics and 
feedback for discussion at a public workshop to identify best practices 
for effective FDA-sponsor meeting management. This public workshop is 
intended to fulfill a commitment FDA agreed to under the FDA User Fee 
Reauthorization Act of 2022, in accordance with the PDUFA 
Reauthorization Performance Goals and Procedures Fiscal Years 2023 
Through 2027 letter (PDUFA VII letter), which is available at https://www.fda.gov/media/151712/download. Specifically, section I.K.1 of the 
PDUFA VII letter outlines efforts to enhance communication between FDA 
and sponsors during drug development, and the Agency's intent to hold a 
public workshop to discuss best practices for meeting management by 
July 30, 2024.

II. Public Workshop Topics for Discussion

    The public workshop will facilitate discussion on issues related to 
submission of meeting requests, efficient time management, finalizing 
meeting agenda, development and submission of meeting background 
packages to enable effective communication and lessons learned from the 
COVID-19 pandemic including virtual meeting platforms. Based on an 
analysis of meeting management practices prepared by the contractor, 
this public workshop will provide a forum to discuss and share 
experiences related to specific PDUFA meeting activities associated 
with CBER and CDER meetings in FYs 2021 through 2023. This will include 
Type D and INTERACT meetings, which began with PDUFA VII in FY 2023. 
FDA will discuss the number of meeting requests granted and denied for 
INTERACT meetings and provide a summary of rationales for denied 
meeting requests. Reported metrics will include the number of requests 
granted and denied for in-person pre-IND, Type C, Type D, and INTERACT 
meetings.
    Workshop updates, agenda, and background materials (if any) will be 
made available at https://www.fda.gov/drugs/news-events-human-drugs/public-workshop-best-practices-meeting-management-under-pdufa-vii-07222024 prior to the workshop.

III. Participating in the Public Workshop

    Registration: To register for this hybrid public workshop, please 
visit the following website: https://fda.zoomgov.com/webinar/register/WN_2im_5zChQ8WvhX_kfS3CdQ. Please provide complete contact information 
for each attendee, including attendance format (in-person or virtual), 
name, title, affiliation, and email. You will be asked to indicate in 
your registration if you plan to attend in person or via the Zoom 
webinar.
    Registration for in-person attendance will close on July 8, 2024, 
11:59 p.m. Eastern Time. Registration for the webinar will remain open 
until the day

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of the workshop. Registration is free and in-person attendance is based 
on space availability, with priority given to early registrants. Early 
registration is recommended because seating is limited; therefore, FDA 
may limit the number of participants from each organization. 
Registrants will receive confirmation when they have been accepted. 
Onsite registration on the day of the workshop will be based on space 
availability.
    If you need special accommodations due to a disability, please 
contact Danielle Villata (see FOR FURTHER INFORMATION CONTACT) no later 
than July 8, 2024, 11:59 p.m. Eastern Time.
    Requests for Oral Presentations: During online registration you may 
indicate if you wish to present during a public comment session. You 
must register online to present comments during the public workshop. 
All requests to make oral presentations must be received by the close 
of registration on July 8, 2024, 11:59 p.m. Eastern Time. We will do 
our best to accommodate requests to make public comments. 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 
participate in the focused sessions. Following the close of 
registration, we will determine the amount of time allotted to each 
presenter and the approximate time each oral presentation is to begin, 
and will select and notify participants by July 15, 2024. If selected 
for presentation, any presentation materials must be emailed to 
Danielle Villata (see FOR FURTHER INFORMATION CONTACT) no later than 
July 18, 2024, 11:59 p.m. Eastern Time. No commercial or promotional 
material will be permitted to be presented or distributed at the public 
workshop.
    Streaming of the Public Workshop: This public workshop will also be 
available via Zoom webinar to registered attendees. To view the Zoom 
webinar of this public workshop, please register at https://fda.zoomgov.com/webinar/register/WN_2im_5zChQ8WvhX_kfS3CdQ. For more 
information about Zoom, please visit https://support.zoom.us/hc/en-us/articles/206175806-Frequently-asked-questions.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may also be viewed at the Dockets Management 
Staff (see ADDRESSES).

    Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13776 Filed 6-21-24; 8:45 am]
BILLING CODE 4164-01-P