Annual Public Meeting, 23960-23961 [2013-09441]
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23960
Federal Register / Vol. 78, No. 78 / Tuesday, April 23, 2013 / Notices
Schedule
Drug
JWH–250 (6250) ..........................
SR–18 also known as RCS–8
(7008).
JWH–019 (7019) ..........................
JWH–081 (7081) ..........................
SR–19 also known as RCS–4
(7104).
JWH–122 (7122) ..........................
AM–2201 (7201) ...........................
JWH–203 (7203) ..........................
2C–T–2 (7385) .............................
JWH–398 (7398) ..........................
Psilocybin (7437) ..........................
Psilocyn (7438) .............................
2C–D (7508) .................................
2C–E (7509) .................................
2C–H (7517) .................................
2C–I (7518) ..................................
2C–C (7519) .................................
2C–N (7521) .................................
2C–P (7524) .................................
2C–T–4 (7532) .............................
AM–694 (7694) .............................
Phenylacetone (8501) ..................
NUCLEAR REGULATORY
COMMISSION
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[NRC–2013–0001]
Sunshine Act Meetings
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AGENCY HOLDING THE MEETINGS: Nuclear
Regulatory Commission.
DATES: Weeks of April 22, 29, May 6, 13,
20, 27, 2013.
PLACE: Commissioners’ Conference
Room, 11555 Rockville Pike, Rockville,
Maryland.
STATUS: Public and Closed.
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Week of April 22, 2013
Monday April 22, 2013
9:00 a.m. Meeting with the Department
of Energy Office of Nuclear Energy
(Public Meeting) (Contact: Brett
Rini, 301–251–7615).
This meeting will be webcast live at
the Web address—www.nrc.gov.
2:30 p.m. Discussion of Management
and Personnel Issues (Closed—Ex. 2
and 6).
mstockstill on DSK4VPTVN1PROD with NOTICES
The company plans to manufacture
the listed controlled substances for
distribution to their research and
forensic customers conducting drug
testing and analysis.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and
determined that the registration of
Cayman Chemical Company to
manufacture the listed basic classes of
controlled substances is consistent with
the public interest at this time. DEA has
investigated Cayman Chemical
Company to ensure that the company’s
registration is consistent with the public
interest. The investigation has included
inspection and testing of the company’s
physical security systems, verification
of the company’s compliance with state
and local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C.
823(a), and in accordance with 21 CFR
1301.33, the above named company is
granted registration as a bulk
manufacturer of the basic classes of
controlled substances listed.
Dated: April 16, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. 2013–09530 Filed 4–22–13; 8:45 am]
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Tuesday April 23, 2013
9:00 a.m. Briefing on the Status of
Lessons Learned from the
Fukushima Dai’ichi Accident
(Public Meeting) (Contact: William
D. Reckley, 301–415–7490).
This meeting will be webcast live at
the Web address—www.nrc.gov.
Week of April 29, 2013—Tentative
There are no meetings scheduled for
the week of April 29, 2013.
Week of May 6, 2013—Tentative
There are no meetings scheduled for
the week of May 6, 2013.
* The schedule for Commission
meetings is subject to change on short
notice. To verify the status of meetings,
call (recording)—301–415–1292.
Contact person for more information:
Rochelle Bavol, 301–415–1651.
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The NRC Commission Meeting
Schedule can be found on the Internet
at: https://www.nrc.gov/public-involve/
public-meetings/schedule.html.
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The NRC provides reasonable
accommodation to individuals with
disabilities where appropriate. If you
need a reasonable accommodation to
participate in these public meetings, or
need this meeting notice or the
transcript or other information from the
public meetings in another format (e.g.,
Braille, large print), please notify
Kimberly Meyer, NRC Disability
Program Manager, at 301–287–0727, or
by email at kimberly.meyerchambers@nrc.gov. Determinations on
requests for reasonable accommodation
will be made on a case-by-case basis.
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This notice is distributed
electronically to subscribers. If you no
longer wish to receive it, or would like
to be added to the distribution, please
contact the Office of the Secretary,
Washington, DC 20555 (301–415–1969),
or send an email to
darlene.wright@nrc.gov.
Dated: April 18, 2013.
Rochelle C. Bavol,
Policy Coordinator, Office of the Secretary.
[FR Doc. 2013–09652 Filed 4–19–13; 4:15 pm]
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Week of May 13, 2013—Tentative
There are no meetings scheduled for
the week of May 13, 2013.
REAGAN-UDALL FOUNDATION FOR
THE FOOD AND DRUG
ADMINISTRATION
Week of May 20, 2013—Tentative
[BAC 416404]
Monday, May 20, 2013
9:30 a.m. Briefing on Human Capital
and Equal Employment
Opportunity (EEO) (Public Meeting)
(Contact: Kristin Davis, 301–287–
0707).
This meeting will be webcast live at
the Web address—www.nrc.gov.
Annual Public Meeting
Week of May 27, 2013—Tentative
Wednesday, May 29, 2013
9:00 a.m. Briefing on Results of the
Agency Action Review Meeting
(AARM) (Public Meeting) (Contact:
Rani Franovich, 301–415–1868).
This meeting will be webcast live at
the Web address—www.nrc.gov.
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ACTION:
Notice of annual meeting.
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, 2013, 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 https://
SUMMARY:
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Federal Register / Vol. 78, No. 78 / Tuesday, April 23, 2013 / Notices
www.ReaganUdall.org on or before May
17, 2013. 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, 2013.
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
22, 2013.
Location: West Policy Center, 1909 K
St. NW., Suite 730, Washington, DC
20006.
Jane
Reese-Coulbourne, Reagan-Udall
Foundation for the FDA, 202–828–1206,
Meetings@ReaganUdall.org.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
mstockstill on DSK4VPTVN1PROD with NOTICES
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 projects include:
The Innovation in Medical Evidence
Development and Surveillance (IMEDS)
Program, methods for using
observational electronic health care data
for postmarket evidence generation,
including postmarket safety
surveillance; the Systems Toxicology
Project, an evaluation of a systems
biology approach to preclinical safety
testing; and the Critical Path to
Tuberculosis Multidrug Regimens
(CPTR) Project, looking at new ways to
develop tuberculosis combination
therapies. The Foundation seeks
17:51 Apr 22, 2013
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
https://www.ReaganUdall.org.
Dated: April 17, 2013.
Jane Reese-Coulbourne,
Executive Director, Reagan-Udall Foundation
for the FDA.
[FR Doc. 2013–09441 Filed 4–22–13; 8:45 am]
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REAGAN-UDALL FOUNDATION FOR
THE FOOD AND DRUG
ADMINISTRATION
[BAC 416404]
Request for Steering Committee
Nominations
Request for nominations to the
Steering Committee for the Foundation’s
Innovation in Medical Evidence
Development and Surveillance program.
ACTION:
I. Background
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comments on these and other potential
topics for future activities.
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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 requesting nominations for its
Innovation in Medical Evidence
Development and Surveillance (IMEDS)
Steering Committee. The IMEDS
Steering Committee will provide
oversight and guidance of the IMEDS
Program, and will report to the ReaganUdall Foundation for the FDA’s Board
of Directors. Instructions on making
nominations are listed in the
‘‘Background’’ section.
DATES: All nominations must be
submitted to the Reagan-Udall
Foundation for the FDA by April 30,
2013. IMEDS Steering Committee
members will be selected by the ReaganUdall Foundation for the FDA’s Board
of Directors on May 23, 2013; those
selected will be notified by May 30
regarding the Board’s decision.
Location: The Reagan-Udall
Foundation for the FDA is located at
1025 Connecticut Ave. NW., Suite 1000,
Washington, DC 20036.
FOR FURTHER INFORMATION CONTACT: Jane
Reese-Coulbourne, Reagan-Udall
Foundation for the FDA, 202–828–1206.
Nominations should be sent to
IMEDS@ReaganUdall.org.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
The Reagan-Udall Foundation for the
FDA (the Foundation or RUF) is an
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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 IMEDS program is offered by the
Foundation. IMEDS is a public-private
partnership created to build upon the
significant progress made on research
methodology by the Sentinel Initiative,
including its Mini-Sentinel pilot and the
Observational Medical Outcomes
Partnership (OMOP).
IMEDS’s primary objective is to
advance the science and tools necessary
to support postmarket evidence
generation on regulated products,
including safety surveillance and
evaluations, and to facilitate utilization
of a robust electronic health care data
platform for generating better evidence
on regulated products in the postmarket settings. To accomplish this
objective, the IMEDS program includes
three projects:
1. IMEDS-Methods: Supports the
development of a methods research
agenda and coordination of methods
research in support of using electronic
health data for safety surveillance
conducted by FDA as well as the
broader community of researchers.
2. IMEDS-Education: Offers
educational opportunities in areas
related to medical product safety
surveillance, and methods research and
application for scientific professionals.
3. IMEDS-Evaluation: Applies
Methods and Education lessons learned
for medical product assessments to
facilitate leveraging Sentinel tools and
capabilities toward a national resource
for evidence generation.
The IMEDS Steering Committee will
have oversight of all IMEDS projects.
II. IMEDS Steering Committee Positions
and Selection Criteria
RUF is seeking nominations for seven
voting members of the IMEDS Steering
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Agencies
- REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION
[Federal Register Volume 78, Number 78 (Tuesday, April 23, 2013)]
[Notices]
[Pages 23960-23961]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09441]
=======================================================================
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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 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, 2013, 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 https://
[[Page 23961]]
www.ReaganUdall.org on or before May 17, 2013. 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,
2013. 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 22, 2013.
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, 202-828-1206, 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 projects include: The Innovation in Medical
Evidence Development and Surveillance (IMEDS) Program, methods for
using observational electronic health care data for postmarket evidence
generation, including postmarket safety surveillance; the Systems
Toxicology Project, an evaluation of a systems biology approach to
preclinical safety testing; and the Critical Path to Tuberculosis
Multidrug Regimens (CPTR) Project, looking at new ways to develop
tuberculosis combination therapies. 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 https://www.ReaganUdall.org.
Dated: April 17, 2013.
Jane Reese-Coulbourne,
Executive Director, Reagan-Udall Foundation for the FDA.
[FR Doc. 2013-09441 Filed 4-22-13; 8:45 am]
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