Notice2024-13776
Best Practices for Meeting Management; Public Workshop; Request for Comments
Primary source
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Published
June 24, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 121 (Monday, June 24, 2024)</title>
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[Federal Register Volume 89, Number 121 (Monday, June 24, 2024)]
[Notices]
[Pages 52471-52473]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</a>.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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
[[Page 52472]]
manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#266247484f434a4a4308704f4a4a47524766404247084e4e5508414950"><span class="__cf_email__" data-cfemail="5c183d323539303039720a3530303d283d1c3a383d7234342f723b332a">[email protected]</span></a> or Sonday Kelly, Center for Biologics
Evaluation and Research Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993, 240-402-8410,
<a href="/cdn-cgi/l/email-protection#31625e5f5550481f7a545d5d48715755501f5959421f565e47"><span class="__cf_email__" data-cfemail="580b37363c392176133d343421183e3c397630302b763f372e">[email protected]</span></a>.
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 <a href="https://www.fda.gov/media/151712/download">https://www.fda.gov/media/151712/download</a>. 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 <a href="https://www.fda.gov/drugs/news-events-human-drugs/public-workshop-best-practices-meeting-management-under-pdufa-vii-07222024">https://www.fda.gov/drugs/news-events-human-drugs/public-workshop-best-practices-meeting-management-under-pdufa-vii-07222024</a> prior to the workshop.
III. Participating in the Public Workshop
Registration: To register for this hybrid public workshop, please
visit the following website: <a href="https://fda.zoomgov.com/webinar/register/WN_2im_5zChQ8WvhX_kfS3CdQ">https://fda.zoomgov.com/webinar/register/WN_2im_5zChQ8WvhX_kfS3CdQ</a>. 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 <a href="https://fda.zoomgov.com/webinar/register/WN_2im_5zChQ8WvhX_kfS3CdQ">https://fda.zoomgov.com/webinar/register/WN_2im_5zChQ8WvhX_kfS3CdQ</a>. For more
information about Zoom, please visit <a href="https://support.zoom.us/hc/en-us/articles/206175806-Frequently-asked-questions">https://support.zoom.us/hc/en-us/articles/206175806-Frequently-asked-questions</a>.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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
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