80_FR_26679 80 FR 26590 - Request for Steering Committee Nominations

80 FR 26590 - Request for Steering Committee Nominations

REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

Federal Register Volume 80, Issue 89 (May 8, 2015)

Page Range26590-26591
FR Document2015-11075

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.

Federal Register, Volume 80 Issue 89 (Friday, May 8, 2015) 
[Federal Register Volume 80, Number 89 (Friday, May 8, 2015)]
[Notices]
[Pages 26590-26591]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-11075]


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REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION


Request for Steering Committee Nominations

ACTION: Request for nominations to the Steering Committee for the 
Foundation's Innovation in Medical Evidence Development and 
Surveillance (IMEDS) program.

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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 May 24, 2015. IMEDS Steering Committee members will be 
selected by the Reagan-Udall Foundation for the FDA's Board of 
Directors by July 2015; those selected will be notified by July 30, 
2015 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: Nicole Spear, Reagan-Udall Foundation 
for the FDA, 202-828-1210. Nominations should be sent to 
[email protected]. Email subject line: SC Nomination.

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 Innovation in Medical Evidence Development and Surveillance 
(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 and the

[[Page 26591]]

Observational Medical Outcomes Partnership (OMOP).
    IMEDS's primary objective is to advance the science and tools 
necessary to support post-market evidence generation on regulated 
products, including safety surveillance and evaluations, and to 
facilitate utilization of a robust electronic healthcare 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 two (2) voting members of the IMEDS 
Steering Committee listed below.
    1. At Large (excluding Pharmaceutical representative): 1 member.
    2. Provider (i.e., Clinician): 1 member.
    The following criteria will be used to evaluate nominees for the 
IMEDS Steering Committee.
    1. Required Criteria for Each of 2 Positions
    a. Currently employed by/volunteering for stakeholder field (e.g., 
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 IMEDS Web site: http://imeds.reaganudall.org/governance.)
    b. Prior experience serving on a related or similar governance 
body.
    c. Understanding of post-market 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.

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 two-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

     To apply, please submit the nominee's CV and the 
nomination form that can be found on the IMEDS Web site: 
imeds.reaganudall.org, to [email protected] with ``SC Nomination'' 
in the subject line.
     Individuals may be nominated for one or more of the 2 
voting positions, and those making nominations should specify for which 
of the 2 voting positions the nominee is being nominated.
     Individuals may nominate themselves.

    Dated: May 4, 2015.
Jane Reese-Coulbourne,
Executive Director, Reagan-Udall Foundation for the FDA.
[FR Doc. 2015-11075 Filed 5-7-15; 8:45 am]
 BILLING CODE 4164-04-P

26590 Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Notices evaluations, and to facilitate utilization understanding of issues around use of (FDA), which was created by Title VI of of a robust electronic healthcare data electronic health data for observational the Food and Drug Amendments of platform for generating better evidence purposes. 2007, is requesting nominations for its on regulated products in the post- d. Individuals both with and without Innovation in Medical Evidence market settings. To accomplish this past experience in Mini-Sentinel, Development and Surveillance (IMEDS) objective, the IMEDS program includes OMOP, and similar research/regulatory Steering Committee. The IMEDS three projects: science initiatives to ensure a diversity Steering Committee will provide 1. IMEDS-Methods: Supports the of perspectives. oversight and guidance of the IMEDS development of a methods research e. Individuals from both U.S.- and Program, and will report to the Reagan- agenda and coordination of methods international-based institutions. Udall Foundation for the FDA’s Board research in support of using electronic of Directors. Instructions on making III. Terms of Service health data for safety surveillance nominations are listed in the conducted by FDA as well as the • The IMEDS Scientific Advisory ‘‘Background’’ section. broader community of researchers. Committee meets in-person at least DATES: All nominations must be 2. IMEDS-Education: Offers twice per year, with bimonthly submitted to the Reagan-Udall educational opportunities in areas teleconferences in between meetings (or Foundation for the FDA by May 24, related to medical product safety monthly teleconferences as deemed 2015. IMEDS Steering Committee surveillance, and methods research and necessary by the Chair). members will be selected by the Reagan- application for scientific professionals. • Members serve two-year terms, and Udall Foundation for the FDA’s Board 3. IMEDS-Evaluation: Applies a maximum of two terms (based on of Directors by July 2015; those selected Methods and Education lessons learned IMEDS fiscal calendar). will be notified by July 30, 2015 for medical product assessments to • Members do not receive regarding the Board’s decision. facilitate leveraging Sentinel tools and compensation from RUF. Location: The Reagan-Udall capabilities toward a national resource • Members can be reimbursed by RUF Foundation for the FDA is located at for evidence generation. for actual and reasonable expenses 1025 Connecticut Ave. NW., Suite 1000, The IMEDS Scientific Advisory incurred in support of IMEDS in Washington, DC 20036. Committee has oversight of all IMEDS accordance with applicable law and FOR FURTHER INFORMATION CONTACT: projects. their specific institutional policies. • Members are subject to the IMEDS Nicole Spear, Reagan-Udall Foundation II. IMEDS Scientific Advisory Conflict of Interest policies. for the FDA, 202–828–1210. Committee Positions and Selection Nominations should be sent to IMEDS@ Criteria IV. Nomination Instructions ReaganUdall.org. Email subject line: SC RUF is seeking nominations for four • To apply, please submit the Nomination. (4) voting members of the IMEDS nominee’s CV and the nomination form SUPPLEMENTARY INFORMATION: Scientific Advisory Committee listed that can be found on the IMEDS Web I. Background below. site: imeds.reaganudall.org, to IMEDS@ 1. At Large (excluding Pharmaceutical reaganudall.org with ‘‘SAC The Reagan-Udall Foundation for the representative): 2 members. Nomination’’ in the subject line. FDA (the Foundation) is an independent 2. Regulated Industry Representative: • Individuals may be nominated for 501(c)(3) not-for-profit, organization 2 members. one or more of the 4 voting positions, created by Congress to advance the The following criteria will be used to and those making nominations should mission of FDA to modernize medical, evaluate nominees for the IMEDS specify for which of the 4 voting veterinary, food, food ingredient, and Scientific Advisory Committee. positions the nominee is being cosmetic product development; 1. Required Criteria for Each of 4 nominated. accelerate innovation, and enhance Positions. • Individuals may nominate product safety. With the ultimate goal of a. Currently employed by/ themselves. improving public health, the volunteering for stakeholder field (e.g., Foundation provides a unique Dated: May 4, 2015. academia, patient advocate, provider opportunity for different sectors (FDA, Jane Reese-Coulbourne, patient groups, academia, other etc.) with several years of relevant Executive Director, Reagan-Udall Foundation government entities, and industry) to experience. for the FDA. work together in a transparent way to b. Leading expert in their relevant [FR Doc. 2015–11077 Filed 5–7–15; 8:45 am] create exciting new research projects to field (based on position/title, publications, or other experience). BILLING CODE 4164–04–P advance regulatory science. 2. Criteria across Scientific Advisory The Foundation acts as a neutral third Committee (It is not a requirement that party to establish novel, scientific all nominees meet all of these criteria, REAGAN-UDALL FOUNDATION FOR collaborations. Much like any other but collectively, the Scientific Advisory THE FOOD AND DRUG independently developed information, Committee members should meet them.) ADMINISTRATION FDA evaluates the scientific information a. Ability to complete Scientific from these collaborations to determine Request for Steering Committee Advisory Committee responsibilities how Reagan-Udall Foundation projects Nominations (which can be accessed via the IMEDS can help the agency to fulfill its asabaliauskas on DSK5VPTVN1PROD with NOTICES Web site: http://imeds.reaganudall.org/ ACTION: Request for nominations to the mission. governance.) Steering Committee for the Foundation’s The Innovation in Medical Evidence b. Prior experience serving on a Innovation in Medical Evidence Development and Surveillance (IMEDS) related or similar governance body. Development and Surveillance (IMEDS) program is offered by the Foundation. c. Understanding of post-market program. IMEDS is a public-private partnership surveillance landscape and impact upon created to build upon the significant stakeholder group represented by SUMMARY: The Reagan-Udall Foundation progress made on research methodology Scientific Advisory Committee seat, or for the Food and Drug Administration by the Sentinel Initiative and the VerDate Sep<11>2014 16:38 May 07, 2015 Jkt 235001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\08MYN1.SGM 08MYN1

Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Notices 26591 Observational Medical Outcomes stakeholder group represented by SECURITIES AND EXCHANGE Partnership (OMOP). Steering Committee seat, or COMMISSION IMEDS’s primary objective is to understanding of issues around use of advance the science and tools necessary [Release No. 34–74863; File No. SR– electronic health data for observational NYSEArca–2015–01] to support post-market evidence purposes. generation on regulated products, Self-Regulatory Organizations; NYSE including safety surveillance and d. Individuals both with and without past experience in Mini-Sentinel, Arca, Inc.; Order Instituting evaluations, and to facilitate utilization Proceedings To Determine Whether To of a robust electronic healthcare data OMOP, and similar research/regulatory science initiatives to ensure a diversity Approve or Disapprove Proposed Rule platform for generating better evidence Change Amending NYSE Arca Equities on regulated products in the post- of perspectives. Rule 5.2(j)(3), Commentary .02 Relating market settings. To accomplish this e. Individuals from both U.S.- and to the Listing of Investment Company objective, the IMEDS program includes international-based institutions. Units Based on Municipal Bond three projects: Indexes 1. IMEDS-Methods: Supports the III. Terms of Service development of a methods research May 4, 2015. agenda and coordination of methods • The IMEDS Steering Committee On January 16, 2015, NYSE Arca, Inc. research in support of using electronic meets in-person at least twice per year, (‘‘Exchange’’) filed with the Securities health data for safety surveillance with bimonthly teleconferences in and Exchange Commission conducted by FDA as well as the between meetings (or monthly (‘‘Commission’’), pursuant to Section broader community of researchers. teleconferences as deemed necessary by 19(b)(1) of the Securities Exchange Act 2. IMEDS-Education: Offers the Chair). of 1934 (‘‘Act’’) 1 and Rule 19b–4 educational opportunities in areas • Members serve two-year terms, and thereunder,2 a proposed rule change to related to medical product safety a maximum of two terms (based on amend NYSE Arca Equities Rule surveillance, and methods research and IMEDS fiscal calendar). 5.2(j)(3), Commentary .02 to application for scientific professionals. accommodate the listing of certain 3. IMEDS-Evaluation: Applies • Members do not receive Investment Company Units based on Methods and Education lessons learned compensation from RUF. municipal bond indexes. The proposed for medical product assessments to • Members can be reimbursed by RUF rule change was published for comment facilitate leveraging Sentinel tools and for actual and reasonable expenses in the Federal Register on February 4, capabilities toward a national resource incurred in support of IMEDS in 2015.3 On March 19, 2015, pursuant to for evidence generation. accordance with applicable law and Section 19(b)(2) of the Act,4 the The IMEDS Steering Committee will their specific institutional policies. Commission designated a longer period have oversight of all IMEDS projects. • Members are subject to the IMEDS within which to approve the proposed II. IMEDS Steering Committee Positions Conflict of Interest policies. rule change, disapprove the proposed and Selection Criteria rule change, or institute proceedings to RUF is seeking nominations for two IV. Nomination Instructions determine whether to disapprove the (2) voting members of the IMEDS proposed rule change.5 The Commission • To apply, please submit the received no comment letters on the Steering Committee listed below. nominee’s CV and the nomination form 1. At Large (excluding Pharmaceutical proposed rule change. This order that can be found on the IMEDS Web institutes proceedings under Section representative): 1 member. 2. Provider (i.e., Clinician): 1 member. site: imeds.reaganudall.org, to IMEDS@ 19(b)(2)(B) of the Act 6 to determine The following criteria will be used to reaganudall.org with ‘‘SC Nomination’’ whether to approve or disapprove the evaluate nominees for the IMEDS in the subject line. proposed rule change. Steering Committee. • Individuals may be nominated for I. Description of the Exchange’s 1. Required Criteria for Each of 2 one or more of the 2 voting positions, Positions Proposal 7 and those making nominations should a. Currently employed by/ specify for which of the 2 voting NYSE Arca Equities Rule 5.2(j)(3) volunteering for stakeholder field (e.g., permits the listing and trading of positions the nominee is being academia, patient advocate, provider Investment Company Units (‘‘Units’’).8 nominated. etc.) with several years of relevant experience. • Individuals may nominate 1 15 U.S.C. 78s(b)(1). b. Leading expert in their relevant themselves. 2 17 CFR 240.19b–4. 3 See Securities Exchange Act Release No. 74175 field (based on position/title, Dated: May 4, 2015. (Jan. 29, 2015), 80 FR 6150 (‘‘Notice’’). publications, or other experience). 2. Criteria across Steering Committee Jane Reese-Coulbourne, 4 15 U.S.C. 78s(b)(2). 5 See Securities Exchange Act Release No. 74534, (It is not a requirement that all Executive Director, Reagan-Udall Foundation 80 FR 15834 (Mar. 25, 2015). The Commission nominees meet all of these criteria, but for the FDA. designated a longer period within which to take collectively, the Steering Committee [FR Doc. 2015–11075 Filed 5–7–15; 8:45 am] action on the proposed rule change and designated members should meet them.) BILLING CODE 4164–04–P May 5, 2015, as the date by which it should approve, disapprove, or institute proceedings to asabaliauskas on DSK5VPTVN1PROD with NOTICES a. Ability to complete Steering determine whether to disapprove the proposed rule Committee responsibilities (which can change. be accessed via the IMEDS Web site: 6 15 U.S.C. 78s(b)(2)(B). http://imeds.reaganudall.org/ 7 A complete description of the proposal can be governance.) found in the Notice. See Notice, supra note 3. 8 An ‘‘Investment Company Unit’’ is a security b. Prior experience serving on a that represents an interest in a registered related or similar governance body. investment company that holds securities c. Understanding of post-market comprising, or otherwise based on or representing surveillance landscape and impact upon Continued VerDate Sep<11>2014 16:38 May 07, 2015 Jkt 235001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\08MYN1.SGM 08MYN1


Document Created: 2018-02-21 10:24:44
Document Modified: 2018-02-21 10:24:44
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionRequest for nominations to the Steering Committee for the Foundation's Innovation in Medical Evidence Development and Surveillance (IMEDS) program.
DatesAll nominations must be submitted to the Reagan-Udall Foundation for the FDA by May 24, 2015. IMEDS Steering Committee members will be selected by the Reagan-Udall Foundation for the FDA's Board of Directors by July 2015; those selected will be notified by July 30, 2015 regarding the Board's decision.
ContactNicole Spear, Reagan-Udall Foundation for the FDA, 202-828-1210. Nominations should be sent to [email protected] Email subject line: SC Nomination.
FR Citation80 FR 26590 
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