2012-10767. Annual Public Meeting

ACTION:

Notice of annual meeting.

SUMMARY:

The Reagan-Udall Foundation for the Food and Drug Administration (FDA), which was created by Title VI of the Food and Drug Amendments of 2007, is announcing an annual open public meeting. The Foundation will provide an overview of its history, project updates, as well as projected activities going forward.

DATES:

The open public meeting will be held on May 23, 2012, from 10 a.m. until 12 noon. Interested persons may sign up to attend in person and/or make comments at the meeting or submit written comments by visiting http://www.ReaganUdall.org on or before May 17, 2012. Oral comments from the public will be scheduled between approximately 11 a.m. and 12 p.m. Time allotted for each registrant will be 3 minutes. The contact person will notify interested persons regarding their request to speak by May 23, 2012. Written comments are encouraged. Those individuals interested in making formal comments should notify the contact person and submit a brief statement of the general nature of the comments they wish to present. Written comments are encouraged through May 25, 2012.

Location: West Policy Center, 1909 K St. NW., Suite 730, Washington, DC 20006.

FOR FURTHER INFORMATION CONTACT:

Jane Reese-Coulbourne, Reagan-Udall Foundation for the FDA, 202 828-1205, [e-mail].

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 has announced initial projects including: An evaluation of a systems biology approach to preclinical safety testing; new ways to develop tuberculosis (TB) multi-drug regimens; and pilot fellowship programs in the areas of safety surveillance, large scale data analysis, and toxicology. The Foundation seeks comments on these and other potential topics for future activities.

II. Agenda

The Foundation will be providing an overview of its history, project updates, as well as projected activities going forward. Find the Meeting Agenda at http://www.ReaganUdall.org.

Dated: April 30, 2012.

Jane Reese-Coulbourne,

Executive Director, Reagan-Udall Foundation for the FDA.