[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]
 BILLING CODE 4161-01-P