[Federal Register Volume 84, Number 60 (Thursday, March 28, 2019)]
[Notices]
[Pages 11801-11802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05944]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1131]


Annual Public Meeting; Reagan-Udall Foundation for the Food and 
Drug Administration

AGENCY: Reagan-Udall Foundation, FDA, HHS.

ACTION: Notice of annual meeting.

-----------------------------------------------------------------------

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 they support FDA.

DATES: The public meeting will be held on May 2, 2019, from 10 a.m. 
until 12 noon. Registration to attend the meeting must be received by 
April 30, 2019, at 5 p.m. Eastern Time. Requests for oral presentation 
must be received before April 30, 2019, 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 Kelly Catterton (see FOR FURTHER INFORMATION 
CONTACT) before April 30, 2019, at 5 p.m. Eastern Time.

ADDRESSES: The public meeting will be held at the PEW Charitable 
Trusts, 901 E St. NW, Washington, DC 20004.

FOR FURTHER INFORMATION CONTACT: Kelly Catterton, Executive Assistant 
to the Executive Director, Reagan-Udall Foundation for 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.

[[Page 11802]]

II. Topics for Discussion at the Public Meeting

    FDA Center Directors will hold a panel discussion on pressing FDA 
initiatives suitable for Public-Private Partnerships. Panelists will 
include Drs. Janet Woodcock, Peter Marks, and Jeffrey Shuren. The panel 
moderator will be Michael McCaughan, Co-Founder of Prevision Policy. 
Find the meeting page at http://reaganudall.org/2019-annual-public-meeting-0.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the 
following website to register: https://reaganudall.salsalabs.org/2019AnnualMeeting/index.html. Persons interested in attending this 
public meeting must register online by April 30, 2019, at 5 p.m. 
Eastern Time.
    If you need special accommodations due to a disability, please 
contact Kelly Catterton (see FOR FURTHER INFORMATION CONTACT) no later 
than April 30, 2019, at 5 p.m. Eastern Time.
    Requests for Oral Presentations: Interested persons may present 
comments at the public meeting. Comments will be scheduled to begin 
approximately at 11:45 a.m. Time allotted for comments is limited to 3 
minutes per speaker. Those desiring to make oral comments should notify 
Kelly Catterton (see FOR FURTHER INFORMATION CONTACT) by April 30, 
2019, at 5 p.m. Eastern Time. 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 1, 
2019.

    Dated: March 22, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05944 Filed 3-27-19; 8:45 am]
 BILLING CODE 4164-01-P