Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)
National Institute of Environmental Health Sciences (NIEHS)

Funding Opportunity Title

Research Network on Telomeres as Sentinels of Environmental Exposures, Psychosocial Stress, and Disease Susceptibility (U24 Clinical Trial Not Allowed)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AG-19-022

Companion Funding Opportunity

RFA-AG-19-023, U01 Research Project – Cooperative Agreements

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866, 93.113    

Funding Opportunity Purpose

This Funding Opportunity Announcement invites applications for a U24 Telomere Research Network/Collaboratory. This U24 will coordinate activities of a telomere length (TL) methods comparison study involving multiple labs supported under U01 awards made in response to FOA (RFA-AG-19-023) to address the need for cross-validation between protocols and samples for establishing best practices for population-based TL research. The U24 will serve as the central resource for the organization of meetings and other activities of this coordinated program, including support for the methods study, dissemination of its results, and resultant recommendations. It will also develop and foster an extended Telomere Research Network (TRN) connecting the broader field through a flexible range of activities that will advance an interdisciplinary research agenda on telomeres and activities directly associated with TL maintenance as sentinels of environmental exposures, psychosocial stress, and disease susceptibility. 

Please refer to the NIA website https://www.nia.nih.gov/research/dbsr/division-behavioral-and-social-research-funding-opportunities-and-applicant-resources regularly for frequently asked questions (FAQs), and other announcements related to this FOA and the companion FOA. 

Key Dates
Posted Date

August 15, 2018

Open Date (Earliest Submission Date)

November 3, 2018

Letter of Intent Due Date(s)

November 3, 2018

Application Due Date(s)

December 3, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

No late applications will be accepted for this Funding Opportunity Announcement.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May 2019

Advisory Council Review

August 2019

Earliest Start Date

September 2019

Expiration Date

December 4, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. Funding Opportunity Description
    Section II. Award Information
    Section III. Eligibility Information
    Section IV. Application and Submission Information
    Section V. Application Review Information
    Section VI. Award Administration Information
    Section VII. Agency Contacts
    Section VIII. Other Information

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    This U24 Cooperative Agreement Funding Opportunity Announcement (FOA) will support a Telomere Research Network/Collaboratory to serve three main functions: (1) to coordinate the activities among approximately 3-4 U01 Methods Comparison Projects (awarded in response to RFA-AG-19-023) working to determine the relationship between different telomere length (TL) assays, inter-assay variability, and the factors that influence results; (2) to incorporate input from the Methods Comparison Projects and experts across the telomere field to develop a set of recommendations for assay protocols for telomere measurement for different types of studies and especially for population-based TL research, including biological sample collection, storage, and processing; laboratory methods; data analysis; and reporting requirements; and (3) to develop and foster an extended Telomere Research Network (TRN) connecting the broader field through a flexible range of activities (meetings, pilot studies, collaboration across laboratories, commissioned analyses, outreach, etc.). This will include support of pilot projects using network-developed or optimized assays to develop preliminary data to advance interdisciplinary research on telomeres and activities directly associated with TL maintenance as sentinels of environmental exposures, psychosocial stress, and disease susceptibility. The TRN will facilitate continued dialogue and interdisciplinary collaborations between basic telomere biologists, exposure researchers, psychologists, population scientists, epidemiologists, biostatisticians, and others applying telomere assays, together with other biomarkers of environmental exposures, psychosocial stress, and disease susceptibility, in a variety of health-related research studies.  

    Please refer to the NIA website https://www.nia.nih.gov/research/dbsr/division-behavioral-and-social-research-funding-opportunities-and-applicant-resources regularly for frequently asked questions (FAQs), and other announcements related to this FOA and the companion FOA.

    Background

    A growing number of investigators across a range of scientific fields have become intrigued by the role of telomeres in health and aging, with respect to both their functional properties and predictive value. In addition to the direct role of telomere dysfunction in certain diseases, telomeres also appear to be “sentinels” for environmental exposures and psychosocial stress, potentially representing a readout of the accumulated life history of exposures of an individual. However, inconsistencies in epidemiological findings, concerns about comparability of telomere assessments across multiple studies, together with emerging findings that early life exposures may play an important role in setting TL, suggest that more research is needed to understand effects of environmental exposures and life stressors on telomere function and health outcomes.

    A recent NIEHS/NIA workshop brought together experts from basic telomere biology, medicine, biopsychology, epidemiology, and related fields to explore and discuss the potential use and value of TL as a biomarker for environmental exposures, psychosocial stress, and disease susceptibility in population-based research. A workshop summary is available here: https://www.nia.nih.gov/research/dbsr/telomeres-sentinels-environmental-exposures-psychosocial-stress-and-disease. Experts discussed how insights from basic biological science can advance epidemiological and clinical investigations and vice versa. Discussions also addressed additional factors that need to be measured alongside of telomeres (e.g., telomerase expression/activity), interactions between genes and the environment (including both the physical and the social environment) on health, tissue-specific effects, and the potential to use surrogate tissues in situations where the “target” tissue (e.g., the brain) is inaccessible. Building on this productive dialogue, attendees highlighted an immediate need to determine the comparability of results obtained using different assays and across different cell types; to set standards for sample preparation, DNA extraction, and reporting of assay protocols; and to make recommendations for conducting telomere assessments in different research contexts (e.g., lab-based vs. population-based). Continued dialogue across research disciplines will be essential to move this agenda forward. The participants reached consensus concerning the need for definitive studies on the methods and universal standards for laboratory protocols. This will involve multiple labs working together along with the appropriate biostatistics expertise. Participants also recommended that separate sets of recommendations be developed for laboratory, clinical, and population-based studies given that no single approach would meet the needs of all types of studies.

    NIA and NIEHS extramural and intramural programs have longstanding and growing investments in exposure science assessing the impact of environmental exposures and psychosocial stress on premature aging and disease susceptibility, so establishing standards for the measurement of TL and other biomarkers is crucial. Resolving measurement issues for the field and setting standards for reporting on assay protocols in publications and grant applications will strengthen the foundations of this science. The network will both support this need and enable continued transdisciplinary dialogue among telomere scientists across multiple disciplines who, until the recent meeting, had not gathered in one place to discuss shared concerns and priorities for the field.

    Scope

    This FOA solicits applications for a Telomere Research Network/Collaboratory (TRN) that will address recommendations from a recent workshop through three sets of activities:

    1. To serve as a coordination and collaboration center for comparing methods developed or optimized through U01 projects funded under RFA-AG-19-023. This methods comparison study will support the development of guidelines for telomere length research feasible for population-based research;

    2. To coordinate development of and disseminate best practices based on results of the methods comparison studies and other Network activities, including developing recommended standards for the field for publishing and grant writing; and

    3. To conduct a range of activities to build an extended interdisciplinary telomere research network and support continued development of the field through activities including: dissemination of best practice guidelines; convening expert workshops and short-term education opportunities; and supporting pilot projects to develop a research agenda to deepen understanding of the role of telomeres (either alone or in conjunction with other biological indicators) as sentinels of environmental exposures, psychosocial stress, and disease susceptibility. This will include support of pilot projects using network-developed or optimized assays to develop preliminary data to advance interdisciplinary research on telomeres as sentinels of environmental exposures, psychosocial stress, and disease susceptibility.

    The TRN will facilitate continued dialogue and interdisciplinary collaborations between basic telomere biologists, exposure researchers, psychologists, population scientists, epidemiologists, biostatisticians, and others applying telomere assays together with biomarkers of environmental exposures, psychosocial stress, and disease susceptibility in a variety of health-related research studies.

    To effectively facilitate these roles, the TRN leadership should be interdisciplinary and include experts that span basic telomere biology, social science, clinical science, psychometrics, exposure science, biostatistics, and epidemiology. This interdisciplinary U24 allows for a flexible range of activities to foster continued dialogue among these fields and stimulate new research.

    Required Activity 1: Coordinate methods comparison study

    The first activity—intended to be completed in the first three years of the TRN—addresses the need to develop guidelines for telomere length (TL) measurement in population-based studies, in a transparent fashion through collaboration with the research community. This effort is intended to provide opportunities to improve existing techniques or develop new ones. This work will be done in conjunction with a coordinated set of Methods Comparison U01 studies funded under RFA-AG-19-023 designed to determine the relationship between different commonly used TL assays, inter-assay variability, and the factors that influence results. NIH intramural labs will produce and provide standard reference samples to be tested across the labs. The TRN will track and maintain a record of this distribution across the U01s. The TRN will support a consortium of 3-4 labs and link their output and activities to the broader telomere science field. The goal of this collaborative effort will be to develop best practice guidelines for TL research around biological sample collection, storage, and processing; laboratory methods; data analysis; reporting requirements; and other relevant parameters that may emerge from Methods Comparison Studies. Standards for measurement in archived or actively growing cells (including statistical analysis) will be developed.

    In coordinating these activities, it will be the responsibility of the TRN to ensure transparency of methods, sharing of data from the U01s, and input from the telomere research community. This effort will scale up rapidly and require an initial start-up meeting to set common parameters for the methods comparison study and regular meetings to achieve consensus on issues such as what cell types to collect; pre-analytical factors related to sample collection, DNA extraction methods, and sample storage; assay considerations, including assay reagent, analysis method, and selection of reference standard and controls; and issues related to batch analyses, standardization, and automation. The TRN will convene regular meetings of the Steering Committee (including U01 PDs/PIs, see below) to discuss progress and to evaluate and revise protocols as needed. In fulfilling this function, the TRN will serve a coordinating function, incorporating input from experts across the telomere field, to assist U01 partners in developing recommendations for assay protocols for telomere measurement for different types of studies. This will be achieved in part by establishment of an External Advisory Committee whose function will be to provide independent expert input on procedures for coordination and conduct of the measurement studies. Interactions between the advisory committee, the U01 Methods projects and the network hub are expected to be iterative and bidirectional as these standards are developed. These interactions will be facilitated through meetings organized by the network to share findings throughout the validation process, and to communicate progress with and give the larger community opportunity for input.

    In addition, in this phase the network will have the flexibility to support pilot projects to augment or enhance the methods comparison activity to address emerging needs across the projects or within individual projects as identified by the Steering Committee (including U01 PDs/PIs and NIH representatives). The TRN will also be required to develop a website for the project that includes a resource for sharing of data, protocols, and methods refinements across laboratories and with the broader telomere research community. Leveraging of existing data and protocol sharing resources is strongly encouraged, so that the resource will remain publicly available beyond the duration of the U24.

    Required Activity 2: Disseminate best practice guidelines

    The second activity addresses the need to share findings, integrate the recommendations and standards as they emerge across the consortium of labs, and make findings and network resources more widely available. It will be a responsibility of the TRN to promote dissemination of best practices to the field at large, through enabling the sharing of data, protocols, and results from the methods comparison studies on a public platform, and through coordinating outreach to relevant scientific groups about the procedures, outcomes, and recommendations resulting from these studies and from other network activities, as well as those emerging from the field at large. This will include standards for data collection, conduct of assays, and development of recommended standards for the field for publishing and grant writing. Collaborative network publications of these guidelines in peer-reviewed journals are strongly encouraged.

    In the service of this goal, and in parallel to the work conducted in the Methods Comparison projects, the TRN will also:

    1. Support an effort to collect unpublished knowledge on best practices for telomere length assays that would serve as a resource for the field;

    2. Compile and share information on existing studies that can provide data linking telomeres and companion biomarkers to environmental exposures and psychosocial stress;

    3. Support adoption of best practices for assay collection and storage;

    4. Solicit information about and review unpublished findings relating telomere assays to psychosocial stress and environmental exposures; and

    5. Incorporate this information, in collaboration with the broader network members, into recommendations for the field.

    The collective goal of this effort is to establish open dialogue about optimal methods for telomere assessment as a resource for the field and as a foundation for newly emerging approaches. It is anticipated and acknowledged that methods for measuring TL and other biomarkers of exposure are rapidly evolving. One primary role for the TRN is to serve as a clearinghouse for current knowledge and best practices, particularly for population-based, clinical, or epidemiological investigators wishing to incorporate telomere assays into studies of environmental exposures, psychosocial stress, and disease susceptibility.

    Required Activity 3: Support an extended network and stimulate new research

    Finally, throughout all five years of the project, the TRN will have the function of building bridges between disciplines and stimulating new research through pilot funding, expert meetings, short term education opportunities, and outreach. To effectively facilitate these roles, the TRN leadership should be interdisciplinary and include experts that span basic telomere biology, social science, clinical science, psychometrics, exposure science, biostatistics, and population health research. The U24 allows for a flexible range of activities to foster continued dialogue among these fields and stimulate new research.

    Increased levels of funding in the last two years will allow the TRN to support additional pilot work, expanding on accomplishments of the first three years, around key questions facing the field, with priorities to be determined by discussion at expert meetings and with input from the field at large. This will include support of pilot projects using network-developed assays to develop preliminary data to advance interdisciplinary research on telomeres as sentinels of environmental exposures, psychosocial stress, and disease susceptibility. Applications for pilot funding should be solicited from both within the U01 consortium and the field at large.

    The TRN will employ these tools to facilitate continued dialogue and interdisciplinary collaborations between basic telomere biologists, exposure researchers, psychologists, population scientists, epidemiologists, biostatisticians, and others applying telomere assays together with biomarkers of environmental exposures, psychosocial stress, and disease susceptibility in a variety of health-related research studies. Such continued transdisciplinary dialogue can support a more coordinated research strategy to address pressing questions for the field identified at the recent NIEHS/NIA workshop, including, but not limited to:

    1. Whether TL and other telomere functional markers are early sentinels of cumulative adverse exposures, premature aging, or early disease processes because they encapsulate the life history of the individuals. What studies are necessary to enhance the quality of data that permit tests of this hypothesis? Is the telomere a marker of the exposures or is it a cumulative index of overall health status? If the telomere is a marker of cumulative exposure, what are the likely mechanisms?

    2. Developing strategies for new research designs on TL dynamics, including studies that take advantage of natural experiments, include repeated measures, and investigate interactions between multiple variables.

    3. Understanding early life determinants of TL and attrition, including mechanistic and cross-tissue studies. Given accumulating evidence that exposures in early development play important roles in predicting long-term outcomes and likely affect the initial setting of TL as early as birth, major questions to be addressed include: What governs the fast rate of shortening early in life and why is there a window of susceptibility? Is there a set-point during early development and is this universal? What are the reasons for race and sex differences observable already early in life? What are the best times/conditions to measure telomeres?

    4.Promote widespread incorporation of state-of-the-art measures of psychosocial stress exposure and experience, including both composite measures and differentiated measures of specific types of stress to ensure comparability and better understanding of timing of exposure, duration, and dose effects.

    5. Promote appropriate standards for reporting on environmental exposures in telomere studies to insure comparability and better understanding of timing of exposure, duration, and dose effects.

    6. Promote dialogue and research into the bigger question as to how we should think of telomeres as an integrative marker, either alone or in combination with other markers, or through a deeper understanding of telomere dynamics. This includes consideration of what is the most important set of assays for determining premature biological aging in healthy humans? What other markers can be combined? Should we examine TL in addition to other indices of cellular aging, such as inflammation, SASP, genetic index, epigenetic aging, and mitochondrial function? In what contexts do replicative senescence and TL matter most? Does focusing on telomeres have advantages/disadvantages relative to other biomarkers related to aging or exposures?  

    7. Given that longitudinal data in well-characterized cohorts will be necessary to advance this agenda to determine the impact of a range of stress and environmental exposures on health and aging, what are the next steps for this field? Existing longitudinal cohort studies with rich early life data and stored biospecimens may present an especially attractive opportunity for addressing these issues.

    Telomere Research Network (TRN) Organization Overview

    The TRN will provide interdisciplinary leadership to coordinate the collaborative activities of the telomere methods comparison projects, to engage with the field at large to promote participation in and advancement of the broad network goals and activities, and to ensure transparency of all activities. Initially, the TRN will be collaborating with between 3-4 U01 awardees whose goal is to conduct the methods comparison studies described in RFA-AG-19-023. The TRN will engage domain expertise to facilitate work being performed and coordinate parallel activities performed across projects. The TRN will:

    1. Develop and manage a centralized process for coordinating and tracking sample distribution (which will be directly implemented by NIH intramural labs), protocol registration, coordinated methods, and data sharing;

    2. Serve as the central resource for the organization of the meetings and other activities of the network, including convening a start-up meeting and regular meetings of the Steering Committee, including PDs/PIs from the Methods Comparison Projects, and an Expert Advisory Committee to establish parameters for the collaborative measurement project and to share progress and modify protocols for the methods;

    3. Support and oversee the process for development, adaptation, and establishment of technical guidelines and best practices for conducting assays of TL that can be incorporated into population-based studies linking those measures to environmental exposures, psychosocial stress, and disease susceptibility in collaboration with a Steering Committee;

    4. Engage in dissemination activities related to the registry that could include, but are not limited to, publication in peer-reviewed journals, presentations at scientific meetings, development of training modules and/or curricula, and partnerships with professional organizations or other institutions to further the goals of the Network; and

    5. Maintain a publicly available registry of assay protocols, methods guidelines, and data resources from the network for advancing telomere and exposure biology research.

    The TRN will also survey the field for unpublished information on best practices, unpublished findings, available data, and other resources that the network can draw upon in developing guidelines for the field. It will make available pilot funds to investigators of the U01 projects and the field at large to support activities that will advance network goals. It will serve as a hub to coordinate activities of the methods projects, external advisory committee, pilot awardees, and experts in the field at large.

    Building on advances in the first three years of the program, and upon the completion of the Methods Comparison studies, the TRN will coordinate activities to support an extended interdisciplinary network and stimulate new research. This will include support of pilot projects using network-developed assays to develop preliminary data to advance interdisciplinary research on telomeres as sentinels of environmental exposures, psychosocial stress, and disease susceptibility. Applications for pilot funding should be solicited from both within the U01 consortium and the field at large.

    This staged approach has the potential to speed availability of initial comparative results while serving as a platform to answer broader questions, such as the relationship between TL and certain exposures and health outcomes.

    NOTE: Participation in network activities, including presentation at workshops, or serving as faculty on summer institutes, or receiving pilot funding, will not constitute formal collaboration from the perspective of NIH, with the exception of those key personnel listed on the application. Network activities are intended to advance the field at large. An important consideration in developing a network is the potential to grow the field substantially through recruitment of new investigators rather than sustaining only the original team.

    Resources for Applicants

    Information about the NIEHS/NIA Workshop on Telomeres as Sentinels for Environmental Exposures, Psychosocial Stress, and Disease Susceptibility is available at the following links:

    Meeting book: https://www.niehs.nih.gov/about/events/pastmtg/2017/telomeres/meeting_book_508.pdf  

    Bibliography:  https://www.niehs.nih.gov/about/events/pastmtg/2017/telomeres/telomere_bibliography_508.pdf  

    Workshop report: https://www.niehs.nih.gov/about/events/pastmtg/2017/telomeres/telomere_meeting_report_508.pdf

    See Section VIII. Other Information for award authorities and regulations.

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIA and NIEHS intend to commit a combined total of $1.417 million across RFA-AG-19-022 and RFA-AG-19-023 to fund 3-4 U01 awards and one U24 award. NIA and NIEHS intend to commit a combined total of $1.417 million across RFA-AG-19-022 and RFA-AG-19-023 to fund 3-4 U01 awards and one U24 award.

    RFA with multiple ICs/components (choice 2, not preferred; use if ICs/components are not showing each contribution in the FOA)

    Award Budget

    Application budgets are limited to $345,000 in direct costs per year in years 1-3 and $500,000 in direct costs per year in years 4-5.

    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is 5 years.   

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education

    The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

    • Hispanic-serving Institutions
    • Historically Black Colleges and Universities (HBCUs)
    • Tribally Controlled Colleges and Universities (TCCUs)
    • Alaska Native and Native Hawaiian Serving Institutions
    • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

    • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

    For-Profit Organizations

    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    Other

    • Independent School Districts
    • Public Housing Authorities/Indian Housing Authorities
    • Native American Tribal Organizations (other than Federally recognized tribal governments)
    • Faith-based or Community-based Organizations
    • Regional Organizations
    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are  allowed.

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
    • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
    • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

    Program Directors/Principal Investigators (PD(s)/PI(s))

    All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

    For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

    2. Cost Sharing

    This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

    3. Additional Information on Eligibility
    Number of Applications

    Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

    The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

    Letter of Intent

    Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

    By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

    • Descriptive title of proposed activity
    • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
    • Names of other key personnel
    • Participating institution(s)
    • Number and title of this funding opportunity

    The letter of intent should be sent to:

    Lis Nielsen, Ph.D., National Institute on Aging (NIA)
    Michelle Heacock, Ph.D., National Institute of Environmental Health Sciences (NIEHS)
    Email: NIATelomeresFOAs@nih.gov

    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    SF424(R&R) Project/Performance Site Locations

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    SF424(R&R) Other Project Information

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    SF424(R&R) Senior/Key Person Profile

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    The contact PD/PI of the U24 will be the lead Director of the Telomere Research Network (TRN) and is the person responsible for the overall management of the TRN; if there are multiple PDs/PIs of the TRN, they will serve as co-directors. The relationship between the TRN and the Methods Comparison Projects should be one of equal and substantial partners in all joint activities.

    The TRN leadership should be interdisciplinary and include experts that can integrate across basic telomere biology, social science, clinical science, psychometrics, exposure science, biostatistics, and population health research.

    Network activities are intended to advance the field at large. Participation in network activities, including presentation at workshops, or serving as faculty on summer institutes, or receiving pilot funding, will not constitute formal collaboration from the perspective of NIH, with the exception of those key personnel listed on the application. An important consideration in developing a network is the potential to grow the field substantially through recruitment of new investigators rather than sustaining only the original team.

    The TRN is expected to have significant experience and knowledge in the following areas; the biosketch should highlight the depth of relevant experience and how it will be provided by the proposed team and structure, in areas including:

    • Conducting systematic reviews and meta-analyses of existing research on telomeres as sentinels of environmental exposures, psychosocial stress, and disease susceptibility.
    • Facilitating cooperation between basic, clinical, and population-based scientists studying working in this field.
    • Helping to take research questions from hypothesis to implementation and the ability to document these processes.
    • Study design and statistics, particularly with novel designs and methods that could enhance the efficiency of validation studies and of population-based research on the role of telomeres (either alone or in conjunction with other biological indicators) as sentinels of environmental exposures, psychosocial stress, and disease susceptibility.
    • Creativity and innovation in solving technical and project challenges as well as coordinating efforts among disparate research communities.

    Note that the contact PD/PI of the U24 TRN will serve as chair of the Steering Committee for the first award year. Thereafter, other Steering Committee members may serve as chair on a rotating basis, as agreed by the Steering Committee.

    R&R Budget

    All instructions in the SF424 (R&R) Application Guide must be followed.

    The TRN Director must devote at least 20 percent (2.4 person months) effort to this program. In cases for which Multiple PDs/PIs serve as co-directors of the TRN, the Directors must devote a combined effort of at least 2.4 person-months. The TRN application budget should include funds for TRM PD(s)/PI(s) and key personnel to travel to a kick-off meeting for the Telomere Research Network that will be organized by NIH staff and held in the Washington, DC area in the fall of 2019, within 2 months of the TRN and Methods Comparison Project awards.

    The TRN will be responsible for organizing and attending several face-to-face meetings. These meetings are meant to facilitate coordination among Methods Comparison Teams and any subcommittees in which they participate. The TRN application budget should include funds for organizing and traveling the TRN PD(s)/PI(s) and key personnel to the following:

    • Annual 1.5-day TRN Steering Committee and External Advisory Committee (EAC) meetings in the Washington, DC or Raleigh, NC areas, including funds for traveling the EAC members (Note: Methods Comparison Project PD(s)/PI(s) will budget for their own travel) in the first three years of the award.
    • Annual 1.5-day TRN meetings in the Washington, DC or Raleigh, NC areas in years 4-5, including funds for traveling all invited participants, including as appropriate, representatives from the U01 projects, which will be complete after year 3, pilot investigators supported by the network, and other scientists as appropriate.

    The TRN will be responsible for supporting pilot research to augment, as needed, the Methods Comparison Study in years 1-3, and to stimulate new research using the Network-recommended assays in years 3-5.  Additional pilot funding that serves the broader network goals is permitted throughout all five years of the program.

    R&R Subaward Budget

    All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS 398 Cover Page Supplement

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    PHS 398 Research Plan

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

    Research Strategy

    Describe plans for accomplishing the three objectives of the TRN:

    1) To serve as a coordination and collaboration center for a set of U01 projects funded under RFA-AG-19-023 to conduct a methods comparison study for TL assays feasible for population-based studies.  U24 applications should describe procedures to support a consortium of 3-4 labs in their efforts to compare assay methods and develop best practice guidelines around biological sample collection, storage, and processing; laboratory methods; data analysis; and reporting requirements and link their output and activities to the broader telomere science field. Applications should describe plans for tracking and maintaining a record of distribution of standard reference samples across the U01s; convening regular meetings of the TRN Steering Committee and External Advisory Committee; insuring transparency of methods, sharing of data from the U01s, and input from community; supporting pilot projects to augment or enhance the methods comparison activity to address emerging needs across the projects or within individual projects as identified by the Steering Committee (including U01 PDs/PIs and NIH representatives); and developing a website for the project that includes a resource  for sharing of data, protocols, and methods refinements across laboratories and with the broader research community.

    2) To coordinate development of and disseminate best practices around biological sample collection, storage, and processing; laboratory methods; data analysis; and reporting requirements for TL assays feasible for population-based studies. Applications should describe plans for coordinating and disseminating best practice recommendations for telomere assays for population-based research, including for publishing and grant writing, based on results of the methods comparison studies and other Network activities. Applications should describe plans to promote dissemination of best practices to the field at large, through enabling the sharing of data, protocols, and results from the methods comparison studies on a public platform, and through coordinating outreach to relevant scientific groups about the procedures, outcomes, and recommendations resulting from these studies and from other network activities, as well as those emerging from the field at large. Applications should also describe plans to serve as a clearinghouse for current knowledge and best practices, particularly for population-based, clinical, or epidemiological investigators wishing to incorporate telomere assays into studies of environmental exposures, psychosocial stress, and disease susceptibility. This must involve:

    1. Collecting unpublished knowledge on best practices for TL assays that would serve as a resource for the field;

    2. Compiling and sharing information on existing studies that can provide data linking telomeres and companion biomarkers to environmental exposures and psychosocial stress;

    3. Supporting adoption of best practices for assay collection and storage;

    4. Soliciting information about and reviewing unpublished findings relating telomere assays to psychosocial stress and environmental exposures;

    5. Incorporating this information, in collaboration with the broader network members, into recommendations for the field.

    3) To conduct a range of activities to build an extended interdisciplinary telomere research network to advance research on telomeres as sentinels of environmental exposures, psychosocial stress, and disease susceptibility. Applications should describe plans to support continued development of the field through a flexible range of activities including, as appropriate: dissemination of best practice guidelines; convening expert workshops and short-term education opportunities; and supporting pilot projects to develop a research agenda to deepen understanding of the role of telomeres (either alone or in conjunction with other biological indicators) as sentinels of environmental exposures, psychosocial stress, and disease susceptibility. This must include support of pilot projects using network-developed or optimized assays to develop preliminary data to advance interdisciplinary research on telomeres as sentinels of environmental exposures, psychosocial stress, and disease susceptibility. Applications should describe a plan for the solicitation, review, selection, and management of pilot projects.

    In addition to the above, the application should also describe specific plans for the organization of the meetings and other activities of the TRN program detailed above.

    It is also expected that the TRN will engage nationally with other organizations and projects working in similar areas and stay abreast of emerging basic, clinical, and population-based science that could be integrated into the other projects supported by the TRN Program.

    The exact boundaries of the activities of the TRN, the Methods Comparison Projects, and NIH are not possible to predict at this time and will depend in large part on the capacities and experience of the Methods Comparison teams awarded. Some of these responsibilities will, therefore, need to be negotiated once the program is funded and started. Applicants should describe their willingness to be flexible in determining areas of responsibility in this collaborative program. The TRN will not be responsible for data coordination within the Methods Comparison Projects. Each Methods Comparison Project will have its own assay protocols, data quality control, and biostatistical staff. However, TRN applicants should describe how they envision facilitating interactions among the various Methods Comparison Project teams.

    Applicants should describe their plans for providing administrative support for the activities of the TRN Program, including but not limited to:

    • Develop and manage a centralized process for coordinating and tracking sample distribution (which will be directly implemented by NIH intramural labs), protocol registration, coordinated methods, and data sharing;
    • Serve as the central resource for the organization of the meetings and other activities of the network, including convening a start-up meeting and regular meetings of the Steering Committee including PDs/PIs from the Methods Comparison Projects and an Expert Advisory Committee to establish parameters for the collaborative measurement project and to share progress and modify protocols for the methods;
    • Support and oversee the process for development, adaptation, and establishment of technical guidelines and best practices for conducting assays of TL that can be incorporated into population-based studies linking those measures to environmental exposures, psychosocial stress, and disease susceptibility in collaboration with a Steering Committee;
    • Engage in dissemination activities related to the registry that could include, but are not limited to, publication in peer-reviewed journals, presentations at scientific meetings, development of training modules and/or curricula, and partnerships with professional organizations or other institutions to further the goals of the Network; and
    • Maintain a publicly available registry of assay protocols, methods guidelines, and data resources from the network for advancing telomere and exposure biology research. The TRN will maintain a website that includes or connects to a registry and archive that allows public access to the data and other data products produced over the course of the program.

    Telomere Research Network Public Resources Transition Plan

    The application should describe a plan to ensure continued public availability of TRN resources at the end of the project period. Inclusion of approaches and activities that will facilitate the transition of the resources of the TRN, including content of the public website, at the end of the award period is required. Continuation of the TRN beyond 5 years is not guaranteed.

    Timeline for Achieving Objectives

    As noted above, applications are encouraged to be creative and flexible in the approach to achieving the five objectives for the TRN outlined above but should include a timeline that describes when and how the PD(s)/PI(s) will complete the activities proposed to achieve the TRN objectives. Applicants should also keep in mind that actual activities and completion dates may change following consultation with NIH staff and the TRN Steering Committee.

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    • The TRN will also be required to develop a website for the project that includes a resource for sharing of data, protocols, and methods refinements across laboratories and with the broader research community. Leveraging of existing data and protocol sharing resources is strongly encouraged, so that the resource will remain publicly available beyond the duration of the U24.
    • NIH expects the sharing of study data from both the TRN and the Methods Comparison Projects in a timely manner, and with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Awardees will be expected to implement a Resources and Data Sharing Plan consistent with achieving these program goals.
    • In addition, NIH encourages sharing of software and code that are developed or modified to accomplish aims of this program. The goals of software sharing under this program include 1) broad availability to biobehavioral, biosocial, and biomedical researchers, research institutions, and government health care systems; 2) terms that permit the dissemination and/or commercialization of enhanced or customized versions of the software, or incorporation of the software or components of it into other software packages; and 3) terms of software availability that include the ability of individuals outside the applicant institution and its collaborating organizations to modify the source code and to share modifications with others. If software is developed with support from this program, awardees and their sub-contractors are expected to implement software sharing plans consistent with achieving the goals of this program.
    • The application is expected to describe plans for ensuring that data accumulated at the TRN are distributed to other relevant informatics resources in a standard data format; and ensuring that the data accumulated under the TRN are made publicly available and can be retrieved from the TRN through multiple methods of querying, including simple web interfaces for common standard queries and tools to allow the downloading of large datasets.

    Appendix:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    PHS Human Subjects and Clinical Trials Information

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed.

    Delayed Onset Study

    All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS Assignment Request Form

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    3. Unique Entity Identifier and System for Award Management (SAM)

    See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

    Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

    7. Other Submission Requirements and Information

    Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

    For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

    All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

    Overall Impact

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

    Significance

    Overall, does the application present a research strategy that will allow the TRN to: (1) serve as a coordination and collaboration center for a set of U01 projects funded under RFA-AG-19-023 to conduct a methods comparison study for TL assays feasible for population-based studies; (2) coordinate development of and disseminate best practices around biological sample collection, storage, and processing; laboratory methods; data analysis; and reporting requirements for TL assays feasible for population-based studies; and (3) conduct a range of activities to build an extended interdisciplinary telomere research network to advance research on telomeres as sentinels of environmental exposures, psychosocial stress, and disease susceptibility?

    Investigator(s)

    Are the PD(s)/PI(s) and other personnel well suited to their roles in the Network? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing transdisciplinary research projects and coordinating collaborative research? If the Network is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Network? Does the applicant have experience overseeing selection and management of subawards, if needed?

    Will the investigative team proposed by the U24 be able to facilitate cooperation between basic, clinical, and population-based scientists studying the role of telomeres in relation to environmental exposures, psychosocial stress, and disease susceptibility? Does the investigative team have relevant experience and expertise in project management required for this U24? Does the investigative team have relevant expertise in the conduct of systematic reviews, the development of technical guidelines and best practices, and the dissemination of research results and materials? Does the investigative team include expertise in study design and statistics, particularly with novel designs and methods that could enhance the efficiency of validation studies and of population-based research on the role of telomeres (either alone or in conjunction with other biological indicators) as sentinels of environmental exposures, psychosocial stress, and disease susceptibility? Does the team have a record of creativity and innovation in solving technical and project challenges, as well as coordinating efforts among disparate research communities?  

    Innovation

    Does the application propose novel approaches to advancing interdisciplinary research on the role of telomeres in relation to environmental exposures, psychosocial stress, and disease susceptibility and in coordinating the methods comparison projects the Network will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Does the application address how the proposed network activities will advance the field? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, management strategies or instrumentation proposed?     

    Approach

    Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network and the methods comparison projects the network will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Is an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects? 

    Are the proposed network activities likely to serve the broader community of researchers engaged in the study of telomeres in relation to environmental exposures, psychosocial stress, and disease susceptibility? For applications that span multiple institutions, are appropriate procedures in place for coordination across institutions and for effectively engaging with other relevant activities at participating institutions?

    Will the plan described for the management and coordination of the Telomere Research Network (TRN) enhance the efficacy Methods Comparison Projects being coordinated? Will the plan for the development, adaptation, and dissemination of project-related materials enhance their usability by other members of the TRN and the larger research community? Is there an appropriate plan to engage nationally with other organizations and projects working in similar areas and stay abreast of emerging basic, clinical, and population-based science that could be integrated into the other projects supported by the TRN Program? Does the proposed TRN have a detailed plan for meeting the objectives in a timely fashion? The three objectives are: (1) to serve as a coordination and collaboration center a set of U01 projects funded under RFA-AG-19-023 to conduct a methods comparison study for TL assays feasible for population-based studies; (2) to coordinate development of and disseminate best practices around biological sample collection, storage, and processing; laboratory methods; data analysis; and reporting requirements for TL assays feasible for population-based studies; and (3) to conduct a range of activities to build an extended interdisciplinary telomere research network to advance research on telomeres as sentinels of environmental exposures, psychosocial stress, and disease susceptibility.

    In addition to the above, does the plan include appropriate approaches to achieve the following steps?

    • ·    Collect unpublished knowledge on best practices for TL assays that would serve as a resource for the field;
    • ·    Compile and share information on existing studies that can provide data linking telomeres and companion biomarkers to environmental exposures and psychosocial stress;
    • ·    Supporting adoption of best practices for assay collection and storage;
    • ·    Soliciting information about and reviewing unpublished findings relating telomere assays to psychosocial stress and environmental exposures;
    • ·    Incorporating this information, in collaboration with the broader network members, into recommendations for the field.

    Are plans for the following activities included and are they appropriate and feasible?

    • ·    Develop and manage a centralized process for coordinating and tracking sample distribution (which will be directly implemented by NIH intramural labs), protocol registration, coordinated methods, data sharing;
    • ·    Serve as the central resource for the organization of the meetings and other activities of the network, including convening a start-up meeting and regular meetings of the Steering Committee including PDs/PIs from the Methods Comparison Projects and an Expert Advisory Committee to establish parameters for the collaborative measurement project and to share progress and modify protocols for the methods;
    • ·    Support and oversee the process for development, adaptation, and establishment of technical guidelines and best practices for conducting assays of TL that can be incorporated into population-based studies linking those measures to environmental exposures, psychosocial stress, and disease susceptibility in collaboration with a Steering Committee;
    • ·    Engage in dissemination activities related to the registry that could include, but are not limited to, publication in peer-reviewed journals, presentations at scientific meetings, development of training modules and/or curricula, and partnerships with professional organizations or other institutions to further the goals of the Network; and
    • ·    Maintain a publicly available registry of assay protocols, methods guidelines, and data resources from the network for advancing telomere and exposure biology research. The TRN will maintain a website that includes or connects to a registry and archive that allows public access to the data and other data products produced over the course of the program.
    Environment

    Will the institutional environment in which the Network will operate contribute to the probability of success in facilitating the research consortium it serves and the broader telomere field? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Network proposed? Will the Network benefit from unique features of the institutional environment, infrastructure, or personnel?  Are resources available within the scientific environment to support electronic information handling?

    Additional Review Criteria

    As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Children 

    When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    Resubmissions

    Not Applicable

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Additional Review Considerations

    As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

    Applications from Foreign Organizations

    Not Applicable

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    For networks involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    Budget and Period of Support

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Environmental Health Sciences, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:

    • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
    • Will receive a written critique.

    Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

    Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.
    3. Anticipated Announcement and Award Dates

    After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

    Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

    Section VI. Award Administration Information
    1. Award Notices

    If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

    A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

    Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 75, and other HHS, PHS, and NIH grant administration policies.

    The administrative and funding instrument used for the TL Methods Comparison Projects will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below. Awardee will retain custody of and have primary rights to the data and software developed under this award, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

    Definitions

    Methods Comparison Project: One of the U01 awards funded under RFA-AG-19-023 working on the Methods Comparison Study.

    Telomere Research Network (TRN): The U24 award funded under RFA-AG-19-022 and all participants in activities supported by the U24. TRN is expected to expand to engage and include other investigators in the broader field over time, through participation in workshops, pilot research programs, and other activities.

    Methods Collaboratory: The total collection of projects and staff that encompass the two companion FOAs: RFA-AG-19-022 and RFA-AG-19-023.

    Steering Committee: The main governing board of the Telomere Research Network comprised of PDs/PIs and NIH Project Scientists from each U01 award and the U24 award as well as additional investigators and NIH staff as appropriate. The Steering Committee may establish subcommittees as deemed appropriate.

    External Advisory Committee (EAC): A panel of four to six senior scientists with relevant expertise who are not PD(s)/PI(s) of a project involved in the Telomere Research Network that will provide expert input to the Steering Committee about the design and conduct of the methods comparison study.

    Network Governance

    The awards funded under this FOA and the companion FOA will be cooperative agreements (see Section VI.2 Cooperative Agreement Terms and Conditions of Award). Close interaction with the NIH and with the Methods Comparison Project awardees will be required to accomplish the goals of this program.

    A Telomere Research Network Steering Committee will be established to address issues that span the TRN and all Methods Comparison Projects, including providing input into the processes of the projects, and assisting in dissemination of all of the deliverables named above. Principles of governance will be established at the initial meeting.

    Areas of Responsibility

    The U24 PD(s)/PI(s) will have the primary responsibility for:

    • Defining objectives and approaches and coordinating activities of the Methods Collaboratory and other activities of the broader TRN.
    • Assuming accountability to the applicant organization officials and to the NIH for the performance and proper conduct of TRN research in accordance with terms and conditions of the award.

    All Program Director(s)/Principal Investigator(s) of the TRN will have the primary responsibility for:

    • Overseeing the budget and activities of the award, as detailed, above.
    • Cooperating with U01 investigators and NIH Staff, as appropriate, in the coordination of collaborative activities undertaken by the Methods Collaboratory and broader TRN.  This includes, but is not limited to:
    • Serving as a coordination and collaboration center for the methods comparison study. 
    • Coordinating development of and disseminating best practices around biological sample collection, storage, and processing; laboratory methods; data analysis; and reporting requirements for TL assays feasible for population-based studies. 
    • Conducting a range of activities to build an extended interdisciplinary telomere research network to advance research on telomeres as sentinels of environmental exposures, psychosocial stress, and disease susceptibility.
    • Facilitating the formation of and participating in appropriate Working Groups to promote exchange of preliminary findings, inconsistencies/or validation of protocols, and ideas across the Methods Collaboratory and broader TRN.
    • Interacting and complying with requests for information from the Steering Committee and other sub-committees as appropriate.
    • Organizing and participating in annual PD/PI scientific meetings, and monthly committee calls.
    • Accepting and implementing all scientific, practical, and policy decisions approved by the Steering Committee to the extent consistent with applicable grant regulations.
    • Serving on the Steering Committee (for details, see "Areas of Joint Responsibility" below).
    • Providing information to the NIH Program Directors and Project Scientists concerning progress by submitting annual progress reports in a standard format.
    • Complying with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.

    NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

    One or more NIA/NIEHS Program Directors will be substantially involved in the TRN and Methods Collaboratory as NIH Project Scientists. NIH Project Scientists will have scientific and programmatic involvement that is above and beyond the normal stewardship role in awards.  NIA/NIEHS Project Scientist(s) will have the following responsibilities to all Methods Collaboratory awardees:

    • Have substantial involvement to guide, coordinate, and participate in the conduct of the TRN and Methods Collaboratory activities.
    • Attend and participate in all Steering Committee and subcommittee meetings.
    • Coordinate and facilitate the interactions between the this U24 cooperative agreement and awardees for the U01 Methods Comparison Projects.
    • Serve as a liaison between the Steering Committee, the Methods Collaboratory, the Methods Comparison Projects, the TRN, the NIH and other federal agencies as needed.
    • Facilitate and coordinate the exchange of information and interactions between Methods Collaboratory awardees to support collaborative efforts.
    • Participate in organizing and coordinating TRN Scientific meetings as required.
    • Advise on the design of research activities, availability of resources, and/or management and technical performance of projects, as appropriate.
    • Participate as collaborators to the U24 investigators in some shared activities, if appropriate.
    • Assist in avoiding unwarranted duplications of effort across the Methods Collaboratory and TRN.

    Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The NIH reserves the right to adjust funding, withhold, suspend, or terminate the support to those TRN awardee institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance. The NIH Program Official will be responsible for monitoring the level of performance and making recommendations for any corrective actions.

    Areas of Joint Responsibility include:
    A Steering Committee will serve as the governing board for the Methods Collaboratory.

    The Steering Committee will have primary responsibility for:

    • Overseeing the overall organization of the Methods Collaboratory initiative and for reviewing its research goals. Evaluating the adherence of U01 awardees to any approved data sharing plans or intellectual property plans.
    • Developing the appropriate structure of Working Groups to promote the exchange of experiences, protocols, novel research findings, etc. across the Methods Collaboratory.
    • Establishing advisory committees and subcommittees, as necessary, to serve the Steering Committee and the U01 awardees.
    • Making recommendations for re-directing the Methods Collaboratory's focus in order to accommodate new scientific opportunities and directions.
    • Sharing and reviewing annual progress among the components of the Methods Collaboratory.
    • At a minimum, the Steering Committee will be composed of one Principal Investigator from each of the Methods Comparison Projects, the NIH Project Scientist for each Methods Comparison Project, the Director (contact PD/PI) of the TRN, the NIH Project Scientist for the TRN and other representatives from NIA and NIEHS, as necessary. All members are expected to actively participate in all Steering Committee activities. Principles of governance will be established at the initial meeting. The PI for each of the U01 projects and the PI for the TRN will each have a vote.  NIH staff will have one vote. Other NIH staff members may participate in Steering Committee meetings as non-voting members.
    • The PD/PI of the U24 TRN will serve as chair of the Steering Committee for the first award year. Thereafter, a Steering Committee Chair will be elected every twelve months from amongst the Steering Committee members by the committee. An individual may continue serving as Chair for more than one year if all committee members agree. NIH staff cannot serve as Steering Committee Chair. NIH staff will serve as ex-officio Secretary of the Steering Committee.  
    • The Steering Committee may establish subcommittees as needed to advance Methods Collaboratory goals.
    • In the event that PD(s)/PI(s) cannot agree on critical aspects of the Methods Collaboratory, such as common protocols, then the Steering Committee, in consultation with NIH Program Staff, will vote on a recommendation for how to proceed. NIA/NIEHS Staff will have final authority to implement proposed recommendations.  All activities must comply with NIH, DHHS, and Federal Guidelines.
    • Other guidelines for the Steering Committee, such as a quorum and frequency and type of meetings (in-person, remote), will be determined at its initial meeting. It is anticipated that the Steering Committee will meet at least once per month by teleconference.
    External Advisory Committee (EAC)

    An External Advisory Committee will be established for years 1-3, to provide expert input to the Network and NIH partners about the design and conduct of the collaborative Methods Comparison study. The members with relevant expertise will be nominated by the U24 and U01 PDs/PIs, NIH staff, and will be selected and invited by the Steering Committee. The EAC is expected to have 4-6 members; however, the membership may be enlarged on an ad hoc basis as needed. The EAC will meet with all project leads at the kick-off meeting, to be scheduled in the fall of 2019, and again once a year in conjunction with an annual in-person Steering Committee meeting coordinated by the TRN. The function of the EAC will be to provide external input on the design, conduct and progress of the methods comparison study and development of recommendations for the field, including changes, if any, which would benefit the program. After each meeting, the EAC can meet in closed session and make a confidential report to the Steering Committee.

    Dispute Resolution:
    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

    A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application processes and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Lis Nielsen, Ph.D.
    National Institute on Aging (NIA)
    Telephone: 301-496-3136
    Email: nielsenli@nia.nih.gov

    Michelle Heacock, Ph.D.
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3267
    Email: heacockm@niehs.nih.gov

    Peer Review Contact(s)

    Leroy Worth, Ph.D.
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3340
    Email: worth@niehs.nih.gov

    Financial/Grants Management Contact(s)

    Karen Molina
    National Institute on Aging (NIA)
    Telephone: 301-827-8226
    Email: karen.molina@nih.gov

    Lisa Archer Edwards
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3258
    Email: archer@niehs.nih.gov

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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