Request for Steering Committee Nominations, 23961-23962 [2013-09448]
Download as PDF
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]
BILLING CODE 4164–04–P
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
VerDate Mar<15>2010
comments on these and other potential
topics for future activities.
Jkt 229001
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
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
23961
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
E:\FR\FM\23APN1.SGM
23APN1
mstockstill on DSK4VPTVN1PROD with NOTICES
23962
Federal Register / Vol. 78, No. 78 / Tuesday, April 23, 2013 / Notices
Committee listed in this document. (The
IMEDS Steering Committee will also
have two members of FDA appointed by
FDA, and a liaison from the ReaganUdall Foundation Board of Directors
who will be appointed by the ReaganUdall Foundation Board of Directors;
these three individuals will be
nonvoting members).
1. Pharmaceutical Industry: Two
members
2. Academia/Research Institute: One
member
3. Provider (i.e., Clinician): One member
4. Data Partner: One member
5. Patient Advocate: One member
6. Consumer Advocate: One member
The following criteria will be used to
evaluate nominees for the IMEDS
Steering Committee.
1. Required Criteria for Each of Seven
Positions
a. Currently employed by/
volunteering for stakeholder field (e.g.,
pharmaceutical, academia, patient
advocate, provider, etc.) with several
years of relevant experience.
b. Leading expert in their relevant
field (based on position/title,
publications, or other experience).
2. Criteria across Steering Committee
(It is not a requirement that all
nominees meet all of these criteria, but
collectively, the Steering Committee
members should meet them.)
a. Ability to complete Steering
Committee responsibilities (which can
be accessed via the Reagan-Udall
Foundation Web site: https://
www.reaganudall.org/.)
b. Prior experience serving on a
related or similar governance body.
c. Understanding of postmarket
surveillance landscape and impact upon
stakeholder group represented by
Steering Committee seat, or
understanding of issues around use of
electronic health data for observational
purposes.
d. Individuals both with and without
past experience in Mini-Sentinel,
OMOP, and similar research/regulatory
science initiatives to ensure a diversity
of perspectives.
e. Individuals from both U.S.- and
international-based institutions.
3. The IMEDS Steering Committee
Chair must be able to complete the
additional responsibilities listed for this
position in the IMEDS Charter (section
2.3.6.2).
III. Terms of Service
• The IMEDS Steering Committee
meets in-person at least twice per year,
with bimonthly teleconferences in
between meetings (or monthly
teleconferences as deemed necessary by
the Chair).
VerDate Mar<15>2010
17:51 Apr 22, 2013
Jkt 229001
• Members serve 2-year terms, and a
maximum of two terms (based on
IMEDS fiscal calendar).
• Members do not receive
compensation from RUF.
• Members can be reimbursed by RUF
for actual and reasonable expenses
incurred in support of IMEDS in
accordance with applicable law and
their specific institutional policies.
• Members are subject to the IMEDS
Conflict of Interest policies.
IV. Nomination Instructions
• In 200 words or less, please
describe the relevant expertise and
experience the nominee would bring
while serving as the IMEDS Steering
Committee Chair and/or a Member and
to what extent they would meet the
criteria.
• Individuals may be nominated for
one or more of the seven voting
positions, and those making
nominations should specify for which of
the seven voting positions the nominee
is being nominated.
• Individuals may nominate
themselves.
Dated: April 17, 2013.
Jane Reese-Coulbourne,
Executive Director, Reagan-Udall Foundation
for the FDA.
[FR Doc. 2013–09448 Filed 4–22–13; 8:45 am]
BILLING CODE 4164–04–P
SECURITIES AND EXCHANGE
COMMISSION
Proposed Collection; Comment
Request
Upon Written Request, Copies Available
From: Securities and Exchange
Commission, Office of Investor
Education and Advocacy,
Washington, DC 20549–0213.
Extension:
Rule 10b–10.
SEC File No. 270–389, OMB Control No.
3235–0444.
Notice is hereby given that, pursuant
to the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.) (‘‘PRA’’), the
Securities and Exchange Commission
(‘‘Commission’’) is soliciting comments
on the existing collection of information
provided for in Rule 10b–10 (17 CFR
240.10b–10) under the Securities and
Exchange Act of 1934 (15 U.S.C. 78a et
seq.). The Commission plans to submit
this existing collection of information to
the Office of Management and Budget
(‘‘OMB’’) for extension and approval.
Rule 10b–10 requires broker-dealers
to convey basic trade information to
customers regarding their securities
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
transactions. This information includes:
the date and time of the transaction, the
identity and number of shares bought or
sold, and the trading capacity of the
broker-dealer. Depending on the trading
capacity of the broker-dealer, Rule 10b–
10 requires the disclosure of
commissions as well as mark-up and
mark-down information. For
transactions in debt securities, Rule
10b–10 requires the disclosure of
redemption and yield information. Rule
10b–10 potentially applies to all of the
approximately 5,178 firms registered
with the Commission that effect
transactions on behalf of customers.
Based on information provided by
registered broker-dealers to the
Commission in FOCUS Reports, the
Commission staff estimates that on
average, registered broker-dealers
process approximately 1.4 billion order
tickets per month for transactions on
behalf of customers. Each order ticket
representing a transaction effected on
behalf of a customer results in one
confirmation. Therefore, the
Commission staff estimates that
approximately 16.8 billion
confirmations are sent to customers
annually. The confirmations required by
Rule 10b–10 are generally processed
through automated systems. It takes
approximately 30 seconds to generate
and send a confirmation. Accordingly,
the Commission estimates that brokerdealers spend 140 million hours per
year complying with Rule 10b–10.
The amount of confirmations sent and
the cost of sending each confirmation
varies from firm to firm. Smaller firms
generally send fewer confirmations than
larger firms because they effect fewer
transactions. The Commission staff
estimates the costs of producing and
sending a paper confirmation, including
postage to be approximately 54 cents.
The Commission staff also estimates
that the cost of producing and sending
a wholly electronic confirmation is
approximately 39 cents. Based on
informal discussions with industry
participants as well as no-action
positions taken in this area, the staff
estimates that broker-dealers used
electronic confirmations for
approximately 35 percent of
transactions. Based on these
calculations, Commission staff estimates
that 10,920,000,000 paper confirmations
are mailed each year at a cost of
$5,896,800,000. Commission staff also
estimates that 5,880,000,000 wholly
electronic confirmations are sent each
year at a cost of $2,293,200,000.
Accordingly, Commission staff
estimates that total annual cost
associated with generating and
delivering to investors the information
E:\FR\FM\23APN1.SGM
23APN1
Agencies
- REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION
[Federal Register Volume 78, Number 78 (Tuesday, April 23, 2013)]
[Notices]
[Pages 23961-23962]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09448]
-----------------------------------------------------------------------
REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION
[BAC 416404]
Request for Steering Committee Nominations
ACTION: Request for nominations to the Steering Committee for the
Foundation's Innovation in Medical Evidence Development and
Surveillance program.
-----------------------------------------------------------------------
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 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 Reagan-Udall
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 Reagan-Udall 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:
I. Background
The Reagan-Udall Foundation for the FDA (the Foundation or RUF) 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 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 post-market
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
[[Page 23962]]
Committee listed in this document. (The IMEDS Steering Committee will
also have two members of FDA appointed by FDA, and a liaison from the
Reagan-Udall Foundation Board of Directors who will be appointed by the
Reagan-Udall Foundation Board of Directors; these three individuals
will be nonvoting members).
1. Pharmaceutical Industry: Two members
2. Academia/Research Institute: One member
3. Provider (i.e., Clinician): One member
4. Data Partner: One member
5. Patient Advocate: One member
6. Consumer Advocate: One member
The following criteria will be used to evaluate nominees for the
IMEDS Steering Committee.
1. Required Criteria for Each of Seven Positions
a. Currently employed by/volunteering for stakeholder field (e.g.,
pharmaceutical, academia, patient advocate, provider, etc.) with
several years of relevant experience.
b. Leading expert in their relevant field (based on position/title,
publications, or other experience).
2. Criteria across Steering Committee (It is not a requirement that
all nominees meet all of these criteria, but collectively, the Steering
Committee members should meet them.)
a. Ability to complete Steering Committee responsibilities (which
can be accessed via the Reagan-Udall Foundation Web site: https://www.reaganudall.org/.)
b. Prior experience serving on a related or similar governance
body.
c. Understanding of postmarket surveillance landscape and impact
upon stakeholder group represented by Steering Committee seat, or
understanding of issues around use of electronic health data for
observational purposes.
d. Individuals both with and without past experience in Mini-
Sentinel, OMOP, and similar research/regulatory science initiatives to
ensure a diversity of perspectives.
e. Individuals from both U.S.- and international-based
institutions.
3. The IMEDS Steering Committee Chair must be able to complete the
additional responsibilities listed for this position in the IMEDS
Charter (section 2.3.6.2).
III. Terms of Service
The IMEDS Steering Committee meets in-person at least
twice per year, with bimonthly teleconferences in between meetings (or
monthly teleconferences as deemed necessary by the Chair).
Members serve 2-year terms, and a maximum of two terms
(based on IMEDS fiscal calendar).
Members do not receive compensation from RUF.
Members can be reimbursed by RUF for actual and reasonable
expenses incurred in support of IMEDS in accordance with applicable law
and their specific institutional policies.
Members are subject to the IMEDS Conflict of Interest
policies.
IV. Nomination Instructions
In 200 words or less, please describe the relevant
expertise and experience the nominee would bring while serving as the
IMEDS Steering Committee Chair and/or a Member and to what extent they
would meet the criteria.
Individuals may be nominated for one or more of the seven
voting positions, and those making nominations should specify for which
of the seven voting positions the nominee is being nominated.
Individuals may nominate themselves.
Dated: April 17, 2013.
Jane Reese-Coulbourne,
Executive Director, Reagan-Udall Foundation for the FDA.
[FR Doc. 2013-09448 Filed 4-22-13; 8:45 am]
BILLING CODE 4164-04-P