Best Practices for Meeting Management; Public Workshop; Request for Comments, 52471-52473 [2024-13776]
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Federal Register / Vol. 89, No. 121 / Monday, June 24, 2024 / Notices
Medicine (HFV–147), Food and Drug
Administration, 7500 Standish Place,
Rockville MD 20855, 240–402–0651,
Heather.Longstaff@fda.hhs.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA is announcing the
availability of a draft GFI #292 entitled
‘‘Chemistry, Manufacturing, and
Controls Considerations for Type A
Medicated Articles.’’ This draft
guidance provides recommendations to
sponsors submitting CMC information
for Type A medicated articles. Type A
medicated articles contain new animal
drugs and provide for administration of
these drugs in animal feed. Type A
medicated articles are intended solely
for use in the manufacture of another
Type A medicated article or in the
manufacture of a Type B or Type C
medicated feed. Because Type A
medicated articles are not directly
administered to the animal, there are
some issues specific to Type A
medicated articles that do not apply to
other new animal drug dosage forms.
These unique considerations are
highlighted in this guidance under the
relevant Common Technical
Document—Quality section headings.
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on ‘‘Chemistry,
Manufacturing, and Controls
Considerations for Type A Medicated
Articles.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
lotter on DSK11XQN23PROD with NOTICES1
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 514 have
been approved under OMB control
numbers 0910–0032; the collections of
information in 21 CFR 511.1 have been
approved under OMB control number
0910–0117; and the collections of
information in sections 512(b) and
512(n) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(b) and
360b(n)) have been approved under
OMB control number 0910–0669.
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III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidance-industry,
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://
www.regulations.gov.
Dated: June 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13796 Filed 6–21–24; 8:45 am]
BILLING CODE 4164–01–P
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.
Notice of public workshop;
request for comments.
ACTION:
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
SUMMARY:
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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.
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/visitorinformation.
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.
ADDRESSES:
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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Federal Register / Vol. 89, No. 121 / Monday, June 24, 2024 / Notices
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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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-201509-18/pdf/2015-23389.pdf.
VerDate Sep<11>2014
18:55 Jun 21, 2024
Jkt 262001
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,
Danielle.Villata@fda.hhs.gov or Sonday
Kelly, Center for Biologics Evaluation
and Research Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 240–
402–8410, Sonday.Kelly@fda.hhs.gov.
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 FDAsponsor 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
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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/publicworkshop-best-practices-meetingmanagement-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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Federal Register / Vol. 89, No. 121 / Monday, June 24, 2024 / Notices
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).
VerDate Sep<11>2014
18:55 Jun 21, 2024
Jkt 262001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
062
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing a publication containing
modifications the Agency is making to
the list of standards FDA recognizes for
use in premarket reviews (FDA
Recognized Consensus Standards). This
publication, entitled ‘‘Modifications to
the List of Recognized Standards,
Recognition List Number: 062’’
(Recognition List Number: 062), will
assist manufacturers who elect to
declare conformity with consensus
standards to meet certain requirements
for medical devices.
DATES: Submit either electronic or
written comments on the notice at any
time. These modifications to the list of
recognized standards are applicable
June 24, 2024.
ADDRESSES: You may submit comments
on the current list of FDA Recognized
Consensus Standards at any time as
follows:
SUMMARY:
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
PO 00000
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52473
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
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–
2004–N–0451 for ‘‘Food and Drug
Administration Modernization Act of
1997: Modifications to the List of
Recognized Standards, Recognition List
Number: 062.’’ Received comments 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. FDA will
consider any comments received in
determining whether to amend the
current listing of modifications to the
list of recognized standards, Recognition
List Number: 062.
• 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
E:\FR\FM\24JNN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 52472]]
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
