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
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