81 FR 22132 - Annual Public Meeting

REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

Federal Register Volume 81, Issue 72 (April 14, 2016)

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, open Q & A and the opportunity for public commentary.

[Federal Register Volume 81, Number 72 (Thursday, April 14, 2016)]
[Notices]
[Page 22132]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08656]


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REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

[BAC 416404]


Annual Public Meeting

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, open Q & A and the opportunity 
for public commentary.

DATES: The public meeting will be held on May 26, 2016, from 10 a.m. 
until 12 noon. Registration to attend the meeting and requests for oral 
presentation must be received by May 18, 2016. See the SUPPLEMENTARY 
INFORMATION section for information on how to register for the meeting.

ADDRESSES: The public meeting will be held at 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: Dr. Nancy Beck, 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 (IMEDS) Program, which 
develops and evaluates methods for using observational electronic 
health care data for postmarket evidence generation, including 
postmarket safety surveillance; the Big Data for Patients (BD4P) 
Program, which is a data science training program for patient advocates 
in the science, concepts, uses, and impact of big data on patients; and 
the Critical Path to Tuberculosis Drug Regimens Project, which looks at 
novel approaches to development and review of tuberculosis combination 
therapies, including strategies for engaging communities in the 
research process. The Foundation is currently exploring potential new 
projects as well. One of those projects is the Food Safety Innovation 
Consortium, to advance regulatory science in the food safety arena. 
Another area under development involves examining ways to improve the 
availability and clarity of information on the request process for 
individual expanded access (compassionate use) for drugs that have not 
yet been approved by the FDA.

II. Meeting Attendance and Participation

A. Registration

    If you wish to attend the meeting, visit: http://bit.ly/1RRSqjp. 
Please register for the meeting by May 18, 2016. Seating is limited and 
registration will be on a first-come, first-served basis. Onsite 
registration will be available if space permits. There is no fee to 
attend this workshop.

B. Requests for Oral Comments

    Interested persons are welcome to present comments at the public 
meeting, provided they are submitted by May 18, 2016. Comments are 
scheduled to begin approximately at 11:40 a.m. Time allotted for 
comments may be limited to 3 minutes, dependent upon the number of 
requests received. Submissions must include: Your name, organization, 
address, telephone number, email, and a brief statement on the general 
nature of your comments. All submissions should be sent to: 
[email protected], please specify ``RUF Public Meeting 
Comments'' in the subject line.
    The agenda for the public meeting will be posted on the event page 
on the Reagan-Udall Web site: http://bit.ly/1UZnfcb.

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, 
organization, 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 on the Reagan-Udall Web site: http://bit.ly/1UZnfcb.

    Dated: April 11, 2016.
Nancy Beck,
Acting Deputy Director, Reagan-Udall Foundation for the FDA.
[FR Doc. 2016-08656 Filed 4-13-16; 8:45 am]
 BILLING CODE 4164-04-P