Request for Scientific Advisory Committee Nominations, 26589-26590 [2015-11077]

Download as PDF Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Notices I. Introduction In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30 et seq., the Postal Service filed a formal request and associated supporting information to add Priority Mail Express & Priority Mail Contract 18 to the competitive product list.1 The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Id. Attachment B. To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors’ Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers. asabaliauskas on DSK5VPTVN1PROD with NOTICES II. Notice of Commission Action The Commission establishes Docket Nos. MC2015–49 and CP2015–61 to consider the Request pertaining to the proposed Priority Mail Express & Priority Mail Contract 18 product and the related contract, respectively. The Commission invites comments on whether the Postal Service’s filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than May 11, 2015. The public portions of these filings can be accessed via the Commission’s Web site (https://www.prc.gov). The Commission appoints Kenneth R. Moeller to serve as Public Representative in these dockets. III. Ordering Paragraphs It is ordered: 1. The Commission establishes Docket Nos. MC2015–49 and CP2015–61 to consider the matters raised in each docket. 2. Pursuant to 39 U.S.C. 505, Kenneth R. Moeller is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative). 3. Comments are due no later than May 11, 2015. 4. The Secretary shall arrange for publication of this order in the Federal Register. 1 Request of the United States Postal Service to Add Priority Mail Express & Priority Mail Contract 18 to Competitive Product List and Notice of Filing (Under Seal) of Unredacted Governors’ Decision, Contract, and Supporting Data, May 1, 2015 (Request). VerDate Sep<11>2014 16:38 May 07, 2015 Jkt 235001 By the Commission. Shoshana M. Grove, Secretary. [FR Doc. 2015–11079 Filed 5–7–15; 8:45 am] BILLING CODE 7710–FW–P POSTAL SERVICE Product Change—Priority Mail Express and Priority Mail Negotiated Service Agreement Postal ServiceTM. Notice. AGENCY: ACTION: The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule’s Competitive Products List. DATES: Effective date: May 8, 2015. FOR FURTHER INFORMATION CONTACT: Elizabeth A. Reed, 202–268–3179. SUPPLEMENTARY INFORMATION: The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on May 1, 2015, it filed with the Postal Regulatory Commission a Request of the United States Postal Service to Add Priority Mail Express & Priority Mail Contract 18 to Competitive Product List. Documents are available at www.prc.gov, Docket Nos. MC2015–49, CP2015–61. SUMMARY: Stanley F. Mires, Attorney, Federal Requirements. [FR Doc. 2015–11067 Filed 5–7–15; 8:45 am] BILLING CODE 7710–12–P REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION [BAC 416404] Request for Scientific Advisory Committee Nominations Request for nominations to the Scientific Advisory Committee for the Foundation’s Innovation in Medical Evidence Development and Surveillance (IMEDS) program. ACTION: 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) Scientific Advisory Committee. The IMEDS Scientific Advisory Committee will provide scientific oversight and SUMMARY: PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 26589 guidance of the IMEDS Program, and will report to the Reagan-Udall Foundation for the FDA’s Board of Directors. Instructions on submitting 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 Scientific Advisory Committee members will be selected by the IMEDS Steering Committee before July 15, 2015; those selected will be notified by July 30, 2015 regarding the Steering Committee’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 IMEDS@ ReaganUdall.org. Email subject line: SAC 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 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 E:\FR\FM\08MYN1.SGM 08MYN1 26590 Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Notices asabaliauskas on DSK5VPTVN1PROD with NOTICES evaluations, and to facilitate utilization of a robust electronic healthcare 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 Scientific Advisory Committee has oversight of all IMEDS projects. II. IMEDS Scientific Advisory Committee Positions and Selection Criteria RUF is seeking nominations for four (4) voting members of the IMEDS Scientific Advisory Committee listed below. 1. At Large (excluding Pharmaceutical representative): 2 members. 2. Regulated Industry Representative: 2 members. The following criteria will be used to evaluate nominees for the IMEDS Scientific Advisory Committee. 1. Required Criteria for Each of 4 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 Scientific Advisory Committee (It is not a requirement that all nominees meet all of these criteria, but collectively, the Scientific Advisory Committee members should meet them.) a. Ability to complete Scientific Advisory Committee responsibilities (which can be accessed via the IMEDS Web site: https://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 Scientific Advisory Committee seat, or VerDate Sep<11>2014 16:38 May 07, 2015 Jkt 235001 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 Scientific Advisory 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 IMEDS@ reaganudall.org with ‘‘SAC Nomination’’ in the subject line. • Individuals may be nominated for one or more of the 4 voting positions, and those making nominations should specify for which of the 4 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. 2015–11077 Filed 5–7–15; 8:45 am] BILLING CODE 4164–04–P REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION Request for Steering Committee Nominations Request for nominations to the Steering Committee for the Foundation’s Innovation in Medical Evidence Development and Surveillance (IMEDS) program. ACTION: The Reagan-Udall Foundation for the Food and Drug Administration SUMMARY: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 (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 May 24, 2015. IMEDS Steering Committee members will be selected by the ReaganUdall 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 IMEDS@ ReaganUdall.org. 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 E:\FR\FM\08MYN1.SGM 08MYN1

Agencies

  • REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION
[Federal Register Volume 80, Number 89 (Friday, May 8, 2015)]
[Notices]
[Pages 26589-26590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11077]


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REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION

[BAC 416404]


Request for Scientific Advisory Committee Nominations

ACTION: Request for nominations to the Scientific Advisory Committee 
for the Foundation's Innovation in Medical Evidence Development and 
Surveillance (IMEDS) 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) Scientific 
Advisory Committee. The IMEDS Scientific Advisory Committee will 
provide scientific oversight and guidance of the IMEDS Program, and 
will report to the Reagan-Udall Foundation for the FDA's Board of 
Directors. Instructions on submitting 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 Scientific Advisory Committee 
members will be selected by the IMEDS Steering Committee before July 
15, 2015; those selected will be notified by July 30, 2015 regarding 
the Steering Committee'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 
IMEDS@ReaganUdall.org. Email subject line: SAC 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 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

[[Page 26590]]

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 Scientific Advisory Committee has oversight of all IMEDS 
projects.

II. IMEDS Scientific Advisory Committee Positions and Selection 
Criteria

    RUF is seeking nominations for four (4) voting members of the IMEDS 
Scientific Advisory Committee listed below.
    1. At Large (excluding Pharmaceutical representative): 2 members.
    2. Regulated Industry Representative: 2 members.
    The following criteria will be used to evaluate nominees for the 
IMEDS Scientific Advisory Committee.
    1. Required Criteria for Each of 4 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 Scientific Advisory Committee (It is not a 
requirement that all nominees meet all of these criteria, but 
collectively, the Scientific Advisory Committee members should meet 
them.)
    a. Ability to complete Scientific Advisory Committee 
responsibilities (which can be accessed via the IMEDS Web site: https://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 Scientific Advisory 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 Scientific Advisory 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 IMEDS@reaganudall.org with ``SAC Nomination'' 
in the subject line.
     Individuals may be nominated for one or more of the 4 
voting positions, and those making nominations should specify for which 
of the 4 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. 2015-11077 Filed 5-7-15; 8:45 am]
 BILLING CODE 4164-04-P
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