81 FR 22132 - Annual Public Meeting

REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

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

Page Range		22132-22132
FR Document		2016-08656

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 Issue 72 (Thursday, April 14, 2016)

[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]


=======================================================================
-----------------------------------------------------------------------

REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

[BAC 416404]


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 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

22132 Federal Register / Vol. 81, No. 72 / Thursday, April 14, 2016 / Notices

available for ordinary letter post items located on 9th St. NW., between F St. on the request process for individual
absent a special arrangement with the NW. and E St. NW. expanded access (compassionate use)
destination postal operator. This change FOR FURTHER INFORMATION CONTACT: Dr. for drugs that have not yet been
will increase delivery costs since foreign Nancy Beck, Reagan-Udall Foundation approved by the FDA.
postal operators charge higher rates for for the FDA, 202–828–1205, Meetings@
delivery of parcels as compared to letter II. Meeting Attendance and
ReaganUdall.org.
post pieces; however, this change will Participation
SUPPLEMENTARY INFORMATION:
improve the market features of PMI A. Registration
FREs and PMI SFRBs. We have I. Background
evaluated the classification changes in The Reagan-Udall Foundation for the If you wish to attend the meeting,
this context in accordance with 39 FDA (the Foundation) is an independent visit: http://bit.ly/1RRSqjp. Please
U.S.C. 3632–3633 and 39 CFR 3015.5 501(c)(3) not-for-profit organization register for the meeting by May 18,
and 3015.7. We approve the changes, created by Congress to advance the 2016. Seating is limited and registration
finding that they are appropriate, and mission of FDA to modernize medical, will be on a first-come, first-served
are consistent with the regulatory veterinary, food, food ingredient, and basis. Onsite registration will be
criteria, as indicated by management. cosmetic product development; available if space permits. There is no
Order accelerate innovation; and enhance fee to attend this workshop.
product safety. With the ultimate goal of
We direct management to file with the improving public health, the B. Requests for Oral Comments
Postal Regulatory Commission Foundation provides a unique
appropriate notice of these classification opportunity for different sectors (FDA, Interested persons are welcome to
changes. The changes in classification present comments at the public meeting,
patient groups, academia, other provided they are submitted by May 18,
set forth herein shall be effective on government entities, and industry) to
June 3, 2016. 2016. Comments are scheduled to begin
work together in a transparent way to approximately at 11:40 a.m. Time
By The Governors: create exciting new research projects to allotted for comments may be limited to
lllllllllllllllllll advance regulatory science. 3 minutes, dependent upon the number
James H. Bilbray The Foundation acts as a neutral third
of requests received. Submissions must
Chairman, Temporary Emergency party to establish novel, scientific
include: Your name, organization,
Committee of the Board of Governors collaborations. Much like any other
address, telephone number, email, and
independently developed information,
[FR Doc. 2016–08583 Filed 4–13–16; 8:45 am]
FDA evaluates the scientific information a brief statement on the general nature
BILLING CODE 7710–12–P
from these collaborations to determine of your comments. All submissions
how Reagan-Udall Foundation projects should be sent to: comments@
can help the Agency to fulfill its reaganudall.org, please specify ‘‘RUF
REAGAN-UDALL FOUNDATION FOR mission. Public Meeting Comments’’ in the
THE FOOD AND DRUG The Foundation’s programmatic subject line.
ADMINISTRATION efforts are designed to improve the The agenda for the public meeting
[BAC 416404] existing scientific tools (methods) used will be posted on the event page on the
to evaluate products as well as foster the Reagan-Udall Web site: http://bit.ly/
Annual Public Meeting development of innovative tools and 1UZnfcb.
approaches. This is exemplified in the
ACTION: Notice of annual meeting. Foundation’s projects including: The C. Written Comments
SUMMARY: The Reagan-Udall Foundation
Innovation in Medical Evidence
Interested persons may submit either
for the Food and Drug Administration Development and Surveillance (IMEDS)
electronic or written comments to the
(FDA), which was created by Title VI of Program, which develops and evaluates Foundation at any time to comments@
the Food and Drug Administration methods for using observational
reaganudall.org, or by mail to the
Amendments Act of 2007, is electronic health care data for
Reagan-Udall Foundation for the FDA,
announcing its annual public meeting. postmarket evidence generation,
including postmarket safety 1025 Connecticut Ave. NW., Suite 1000,
The purpose of this meeting is to Washington, DC 20036. Please include
provide an opportunity for the surveillance; the Big Data for Patients
(BD4P) Program, which is a data science your name, organization, address,
Foundation to engage with its telephone number, and email when
stakeholders and receive public input training program for patient advocates
in the science, concepts, uses, and making comments.
on its efforts. The meeting will include
an organizational update, project impact of big data on patients; and the III. Post-Meeting Materials
updates, open Q & A and the Critical Path to Tuberculosis Drug
Regimens Project, which looks at novel The Foundation plans to make
opportunity for public commentary.
approaches to development and review meeting materials and meeting
DATES: The public meeting will be held
of tuberculosis combination therapies, recording available to the public after
on May 26, 2016, from 10 a.m. until 12 including strategies for engaging the meeting. Once available, these
noon. Registration to attend the meeting communities in the research process. materials will be posted on the Reagan-
and requests for oral presentation must
mstockstill on DSK4VPTVN1PROD with NOTICES

The Foundation is currently exploring Udall Web site: http://bit.ly/1UZnfcb.
be received by May 18, 2016. See the potential new projects as well. One of
SUPPLEMENTARY INFORMATION section for Dated: April 11, 2016.
those projects is the Food Safety
information on how to register for the Innovation Consortium, to advance Nancy Beck,
meeting. regulatory science in the food safety Acting Deputy Director, Reagan-Udall
ADDRESSES: The public meeting will be arena. Another area under development Foundation for the FDA.
held at 901 E St. NW., Washington, DC involves examining ways to improve the [FR Doc. 2016–08656 Filed 4–13–16; 8:45 am]
20004. Entrance for the meeting is availability and clarity of information BILLING CODE 4164–04–P

VerDate Sep<11>2014 17:56 Apr 13, 2016 Jkt 238001 PO 00000 Frm 00085 Fmt 4703 Sfmt 9990 E:\FR\FM\14APN1.SGM 14APN1

Document Created: 2018-02-07 13:48:12
Document Modified: 2018-02-07 13:48:12

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 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.
Contact		Dr. Nancy Beck, Reagan-Udall Foundation for the FDA, 202-828-1205, [email protected]
FR Citation		81 FR 22132