[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Notices]
[Pages 15844-15845]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07544]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0001]
Annual Public Meeting; Reagan-Udall Foundation for the Food and
Drug Administration
AGENCY: Reagan-Udall Foundation for the Food and Drug Administration.
ACTION: Notice of annual meeting.
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SUMMARY: The Reagan-Udall Foundation (the Foundation) for the Food and
Drug Administration (FDA), which was created by Title VI of the Food
and Drug Administration Amendments Act of 2007, is announcing its
annual public meeting. The Foundation will discuss its activities and
how it supports FDA.
DATES: The public meeting will be held on May 4, 2018, from 10 a.m.
until 12 noon. Registration to attend the meeting must be received by
May 3, 2018, at 5 p.m. Eastern Time. Requests for oral presentations
must be received before May 2, 2018, at 5 p.m. Eastern Time. See the
SUPPLEMENTARY INFORMATION section for registration date and
information. The public is also invited to submit written comments by
sending them via email to Elisabeth Shaefer (see FOR FURTHER
INFORMATION CONTACT) before May 3, 2018, at 5 p.m. Eastern Time.
ADDRESSES: The public meeting will be held at Alston & Bird, 950 F St.
NW, Washington, DC 20006.
FOR FURTHER INFORMATION CONTACT: Elisabeth Shaefer, Executive Assistant
to the Executive Director, Reagan-Udall Foundation for the FDA, 202-
849-2255, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Reagan-Udall Foundation for the FDA is an independent 501(c)(3)
not-for-profit, organization created by Congress to advance the mission
of FDA to modernize medical, veterinary, food, food ingredient, and
cosmetic product development; accelerate innovation, and enhance
product safety. With the ultimate goal of improving public health, the
Foundation provides a unique opportunity for different sectors (FDA,
patient groups, academia, other government entities, and industry) to
work together in a transparent way to create exciting new research and
engagement projects to advance regulatory science.
The Foundation acts as a neutral third party to establish novel,
scientific collaborations. Much like any other independently developed
information, FDA evaluates the scientific information from these
collaborations to determine how the Foundation projects can help the
Agency to fulfill its mission.
Foundation projects currently include: Innovation in Medical
Evidence Development and Surveillance, a public-private partnership
that allows researchers to study drug safety concerns of interest to
public health; an Expanded Access Navigator that offers instructional
material and resources for physicians, patients, and their caregivers
on how to access investigational drugs outside of clinical trials; and
a new joint Foundation and FDA regulatory science fellowship program.
II. Topics for Discussion at the Public Meeting
FDA Commissioner, Dr. Scott Gottlieb, will deliver a keynote
address, followed by a panel discussion on the ``Evolution of FDA
Science and Engagement'' and the role of the Foundation. Panelists will
include the current FDA Commissioner, Dr. Scott Gottlieb, and former
FDA Commissioners Drs. Robert Califf and Andrew C. von Eschenbach. The
panel moderator will be Susan Dentzer, President and Chief Executive
Officer of the Network for Excellence in Health Innovation. Find the
meeting agenda at https://reaganudall.org/public-meeting.
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following website to register: https://reaganudall.org/public-meeting.
Persons interested in attending this public meeting must register
online by May 3, 2018, at 5 p.m. Eastern Time.
If you need special accommodations due to a disability, please
contact Elisabeth Shaefer (see FOR FURTHER INFORMATION CONTACT) no
later than May 1, 2018.
Requests for Oral Presentations: Interested persons may present
comments at the public meeting. Comments will be scheduled to begin
approximately at 11:30 a.m. Time allotted for comments may be limited
to 3 minutes, dependent on the number of requests received. Those
desiring to make oral comments should notify Elisabeth Shaefer (see FOR
FURTHER INFORMATION CONTACT) by May 2, 2018. Please include a brief
statement of the general nature of the comments you wish to present
along with your name, address, telephone number, and email address. The
contact person will notify individuals regarding their request to speak
by May 3, 2018.
[[Page 15845]]
Dated: April 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07544 Filed 4-11-18; 8:45 am]
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