80 FR 22233 - Annual Public Meeting; Reagan-Udall Foundation for the Food and Drug Administration

REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

Federal Register Volume 80, Issue 76 (April 21, 2015)

The Reagan-Udall 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 purpose of this meeting is to provide an opportunity for the Foundation to engage with its stakeholders and receive public input on its efforts. The meeting will include an organizational update, project updates, panel discussion, and open Q & A.

[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Notices]
[Page 22233]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09072]


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REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

[BAC 416404]


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

ACTION: Notice of annual meeting.

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SUMMARY: The Reagan-Udall 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 purpose of this meeting is to provide an 
opportunity for the Foundation to engage with its stakeholders and 
receive public input on its efforts. The meeting will include an 
organizational update, project updates, panel discussion, and open Q & 
A.

DATES: The public meeting will be held on May 15, 2015, from 10 a.m. 
until 12 noon. Registration to attend the meeting and requests for oral 
presentation must be received by May 8, 2015. See the SUPPLEMENTARY 
INFORMATION section for information on how to register for the meeting.

ADDRESSES: The public meeting will be held The Pew Charitable Trusts 
Conference Center, 901 E St. NW., Washington, DC 20004. Entrance for 
the meeting is located on 9th St. NW., between F St. NW. and E St. NW.

FOR FURTHER INFORMATION CONTACT: Jane Reese-Coulbourne, Reagan-Udall 
Foundation for the FDA, 202-828-1205, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The Reagan-Udall Foundation for the FDA (the Foundation) 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 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 Reagan-Udall Foundation projects can 
help the Agency to fulfill its mission.
    The Foundation's programmatic efforts are designed to improve the 
existing scientific tools (methods) used to evaluate products as well 
as foster the development of innovative tools and approaches. This is 
exemplified in the Foundation's projects including: The Innovation in 
Medical Evidence Development and Surveillance Program, which develops 
and evaluates methods for using observational electronic health care 
data for postmarket evidence generation, including postmarket safety 
surveillance; the PredicTox Project, which applies systems biology to 
develop mechanistic models to predict adverse events; and the Critical 
Path to Tuberculosis Drug Regimens Project, which looks at novel 
approaches to development and review of tuberculosis combination 
therapies. Additionally, the Foundation is establishing regulatory 
science fellowships as part of its broader education efforts aimed at 
building capacity in regulatory science.

II. Meeting Attendance and Participation

A. Registration

    If you wish to attend the meeting, visit: http://goo.gl/GX6ysw. 
Please register for the meeting by May 8, 2015. Seating may be limited, 
so early registration is recommended. Registration is free and will be 
on a first-come, first-served basis. Onsite registration on the day of 
the meeting will be based on space availability.

B. Requests for Oral Comments

    Interested persons may present comments at the public meeting. 
Comments will be scheduled to begin approximate at 11:40 a.m. Time 
allotted for comments may be limited to 3 minutes, dependent on number 
of requests received. Those desiring to make oral comments should 
notify Jane Reese-Coulbourne (see FOR FURTHER INFORMATION CONTACT) by 
May 8, 2015. Please include a brief statement of the general nature of 
the comments they wish to present along with your name, address, 
telephone number, and email.
    The agenda for the public meeting will be posted on the event 
registration page: http://goo.gl/GX6ysw and the Reagan-Udall Web site: 
http://goo.gl/aSVymH.

C. Written Comments

    Interested persons may submit either electronic or written comments 
to the Foundation at any time to [email protected], or by mail 
to the Reagan-Udall Foundation for the FDA, 1025 Connecticut Ave. NW., 
Suite 1000, Washington, DC 20036. Please include your name, address, 
telephone number, and email when making comments.

III. Post-Meeting Materials

    The Foundation plans to make meeting materials and meeting 
recording available to the public after the meeting. Once available, 
these materials will be posted at http://goo.gl/aSVymH.

    Dated: April 15, 2015.
Jane Reese-Coulbourne,
Executive Director, Reagan-Udall Foundation for the FDA.
[FR Doc. 2015-09072 Filed 4-20-15; 8:45 am]
 BILLING CODE 4164-04-P