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)

Page Range		22233-22233
FR Document		2015-09072

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 Issue 76 (Tuesday, April 21, 2015)

[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.

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

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, Meetings@ReaganUdall.org.

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 Comments@ReaganUdall.org, 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

Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 22233

of compliance with 39 U.S.C. 3633(a), updates, panel discussion, and open development and review of tuberculosis
and an application for non-public Q & A. combination therapies. Additionally,
treatment of certain materials. It also DATES: The public meeting will be held the Foundation is establishing
filed supporting financial workpapers. on May 15, 2015, from 10 a.m. until 12 regulatory science fellowships as part of
noon. Registration to attend the meeting its broader education efforts aimed at
II. Notice of Commission Action
and requests for oral presentation must building capacity in regulatory science.
The Commission establishes Docket be received by May 8, 2015. See the
No. CP2015–59 for consideration of II. Meeting Attendance and
SUPPLEMENTARY INFORMATION section for
matters raised by the Notice. Participation
information on how to register for the
The Commission invites comments on meeting. A. Registration
whether the Postal Service’s filing is
ADDRESSES: The public meeting will be
consistent with 39 U.S.C. 3632, 3633, or If you wish to attend the meeting,
held The Pew Charitable Trusts
3642, 39 CFR part 3015, and 39 CFR visit: http://goo.gl/GX6ysw. Please
Conference Center, 901 E St. NW.,
part 3020, subpart B. Comments are due register for the meeting by May 8, 2015.
Washington, DC 20004. Entrance for the
no later than April 22, 2015. The public Seating may be limited, so early
meeting is located on 9th St. NW.,
portions of the filing can be accessed via registration is recommended.
between F St. NW. and E St. NW.
the Commission’s Web site (http:// Registration is free and will be on a first-
FOR FURTHER INFORMATION CONTACT: Jane
www.prc.gov). come, first-served basis. Onsite
The Commission appoints Curtis E. Reese-Coulbourne, Reagan-Udall registration on the day of the meeting
Kidd to serve as Public Representative Foundation for the FDA, 202–828–1205, will be based on space availability.
in this docket. Meetings@ReaganUdall.org.
SUPPLEMENTARY INFORMATION: B. Requests for Oral Comments
III. Ordering Paragraphs
I. Background Interested persons may present
It is ordered:
The Reagan-Udall Foundation for the comments at the public meeting.
1. The Commission establishes Docket
FDA (the Foundation) is an independent Comments will be scheduled to begin
No. CP2015–59 for consideration of the
501(c)(3) not-for-profit organization approximate at 11:40 a.m. Time allotted
matters raised by the Postal Service’s
created by Congress to advance the for comments may be limited to 3
Notice.
mission of FDA to modernize medical, minutes, dependent on number of
2. Pursuant to 39 U.S.C. 505, Curtis E.
veterinary, food, food ingredient, and requests received. Those desiring to
Kidd is appointed to serve as an officer
cosmetic product development; make oral comments should notify Jane
of the Commission to represent the
accelerate innovation; and enhance Reese-Coulbourne (see FOR FURTHER
interests of the general public in this
product safety. With the ultimate goal of INFORMATION CONTACT) by May 8, 2015.
proceeding (Public Representative).
improving public health, the Please include a brief statement of the
3. Comments are due no later than
Foundation provides a unique general nature of the comments they
April 22, 2015.
opportunity for different sectors (FDA, wish to present along with your name,
4. The Secretary shall arrange for
patient groups, academia, other address, telephone number, and email.
publication of this order in the Federal
Register. government entities, and industry) to The agenda for the public meeting
work together in a transparent way to will be posted on the event registration
By the Commission. create exciting new research projects to page: http://goo.gl/GX6ysw and the
Shoshana M. Grove, advance regulatory science. Reagan-Udall Web site: http://goo.gl/
Secretary. The Foundation acts as a neutral third aSVymH.
[FR Doc. 2015–09031 Filed 4–20–15; 8:45 am] party to establish novel, scientific
BILLING CODE 7710–FW–P collaborations. Much like any other C. Written Comments
independently developed information,
Interested persons may submit either
FDA evaluates the scientific information
electronic or written comments to the
REAGAN-UDALL FOUNDATION FOR from these collaborations to determine
Foundation at any time to Comments@
THE FOOD AND DRUG how Reagan-Udall Foundation projects
ReaganUdall.org, or by mail to the
ADMINISTRATION can help the Agency to fulfill its
Reagan-Udall Foundation for the FDA,
mission.
[BAC 416404] The Foundation’s programmatic 1025 Connecticut Ave. NW., Suite 1000,
efforts are designed to improve the Washington, DC 20036. Please include
Annual Public Meeting; Reagan-Udall your name, address, telephone number,
existing scientific tools (methods) used
Foundation for the Food and Drug and email when making comments.
to evaluate products as well as foster the
Administration
development of innovative tools and III. Post-Meeting Materials
ACTION: Notice of annual meeting. approaches. This is exemplified in the
Foundation’s projects including: The The Foundation plans to make
SUMMARY: The Reagan-Udall Foundation Innovation in Medical Evidence meeting materials and meeting
for the Food and Drug Administration Development and Surveillance Program, recording available to the public after
(FDA), which was created by Title VI of which develops and evaluates methods the meeting. Once available, these
the Food and Drug Administration for using observational electronic health materials will be posted at http://goo.gl/
Amendments Act of 2007, is care data for postmarket evidence aSVymH.
tkelley on DSK3SPTVN1PROD with NOTICES

announcing its annual public meeting. generation, including postmarket safety Dated: April 15, 2015.
The purpose of this meeting is to surveillance; the PredicTox Project,
Jane Reese-Coulbourne,
provide an opportunity for the which applies systems biology to
Foundation to engage with its develop mechanistic models to predict Executive Director, Reagan-Udall Foundation
for the FDA.
stakeholders and receive public input adverse events; and the Critical Path to
[FR Doc. 2015–09072 Filed 4–20–15; 8:45 am]
on its efforts. The meeting will include Tuberculosis Drug Regimens Project,
an organizational update, project which looks at novel approaches to BILLING CODE 4164–04–P

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Document Created: 2015-12-16 08:33:39
Document Modified: 2015-12-16 08:33:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of annual meeting.
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.
Contact		Jane Reese-Coulbourne, Reagan-Udall Foundation for the FDA, 202-828-1205, [email protected]
FR Citation		80 FR 22233