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

National Institutes of Health (NIH)

Department of Veterans Affairs (VA)

Components of Participating Organizations
National Institute on Aging (NIA)
National Cancer Institute (NCI)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
Office of Behavioral and Social Sciences Research (OBSSR)
National Center for Advancing Translational Sciences (NCATS)
Funding Opportunity Title

Collaborative Aging (in Place) Research Using Technology (CART) (U2C)

Activity Code

U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

Announcement Type

New

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-AG-16-021

Companion Funding Opportunity

None

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

93.399, 93.866, 93.286, 93.853, 93.361, 93.350

Funding Opportunity Purpose

The purpose of this, Inter-Agency Funding Opportunity Announcement (FOA) is to develop and validate the infrastructure for rapid and effective conduct of future research utilizing technology to facilitate aging in place, with a special emphasis on people from underrepresented groups.

This FOA is designed to support Collaborative Aging (in Place) Research Using Technology (CART) by developing and validating a research infrastructure that has the capacity to integrate data across different projects, incorporates existing technologies, and can accommodate future technologies, designed to assess and intervene across a variety of observational and clinical research studies and settings, and for a range of measures, diseases and populations. The infrastructure development will include a demonstration project, to test feasibility for operating on a larger scale. The infrastructure and demonstration project accomplished by this FOA (Phase I) will serve as the foundation for the subsequent large-scale development project for technology research to help reduce hospitalizations, emergency room visits, and admissions to a nursing home for the older population (Phase II). Phase I is designed to be both disease and technology agnostic. Successful multidisciplinary applicants with strong partnerships in engineering, computer science, health and medical research (both public and private sector) are encouraged to apply.

Key Dates
Posted Date

October 21, 2015

Open Date (Earliest Submission Date)

December 28, 2015

Letter of Intent Due Date(s)

December 28, 2015

Application Due Date(s)

January 28, 2016, 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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2016

Advisory Council Review

August 2016

Earliest Start Date

September 2016

Expiration Date

New Date January 29, 2016 per issuance of NOT-AG-16-015. (Original Expiration Date: January 13, 2016)

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the 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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.


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

The purpose of this Inter-Agency FOA is to develop and validate the infrastructure for rapid and effective conduct of future research utilizing technology to facilitate aging in place, with a special emphasis on people from underrepresented groups.  “Aging in place” refers to a person living in a private home or community for as long as possible, while receiving support and services to help them to safely remain independent as they age.  This initiative grew out of a visioning workshop led by the National Heart, Lung, and Blood Institute and the Computing Community Consortium and funded by the National Science Foundation on the technology needed to enable successful aging in place: http://www.cra.org/ccc/visioning/visioning-activities/aging-in-place.

This FOA is designed to support Collaborative Aging (in Place) Research Using Technology (CART) by developing and validating a research infrastructure that integrates data, incorporates existing and can accommodate future technologies designed to assess, predict and intervene across a variety of observational and clinical research studies and settings, and for a range of measures, diseases and populations.  The infrastructure will be developed with iterative deployments as part of the final demonstration project, to test feasibility for operating at a larger scale. The infrastructure and demonstration project accomplished by this FOA (Phase I) will serve as the foundation for a subsequent large scale development project for technology research (Phase II).  Phase I is designed to be both disease and technology agnostic. Multidisciplinary teams with strong partnerships in engineering, computer science, health and medical research (both public and private sector), are encouraged to apply.

The data generated from the infrastructure development and demonstration project (Phase I) will be evaluated for the likelihood of achieving the stated objectives and specific aims in the application.  The data and findings from the demonstration project will be used to refine the system to support the project at full scale in Phase II.  This reduced-scale, path-building work requires significant economies of effort; it is anticipated that the basic organizational operations and execution responsibilities for the entire project will need to be shared.  All of the major organizational entities will be created with the necessary expertise and resources to test-drive the critical responsibilities.  The successful team will be expected to have collaborations and signed letters of support with outside organizations such as advocacy organizations (e.g., AARP) as well as health care systems, and industry (e.g., telecommunications, technology, large and small companies) with various areas of expertise, and develop the necessary platforms in collaboration with federal agencies.

Background and Rationale

The growth in our aging population, often called the “Silver Tsunami,” will have an enormous impact on health care systems and care providers over the next few decades, requiring the development of creative approaches to ensure effective treatment and management of chronic diseases in the elderly, both to improve the quality of life, and also to reduce hospitalizations. An approach receiving increasing attention is “aging-in-place,” in which new monitoring tools and technologies are provided to older persons to allow them and their family caregivers to monitor their health, communicate with healthcare providers, and manage their chronic conditions effectively and safely within their own homes.  However, in a healthcare environment where decision-making is increasingly evidence-based, the lack of published, quantitative information on the effectiveness of in-home technologies inhibits adoption among providers and patients.  Data from a smart home program instituted by the Department of Veterans Affairs (VA) for the care of older patients with common conditions such as diabetes, hypertension, and COPD demonstrated a 25% reduction in bed days and a 19% reduction in hospital admissions and re-admissions. The smart home intervention also led to substantial cost savings, and had an 86% patient satisfaction rate.  Despite numerous examples of successful use of monitoring technology, critical gaps exist in the large-scale validation and deployment of these technologies. Further, there are many commercial technologies available that lack systematic evaluation, making it difficult for physicians to recommend them, and payers to support them. Effective home management of chronic diseases such as heart failure, stroke, diabetes, hypertension, chronic obstructive airway disease (COPD), cognitive impairment, balance disorders, and arthritis could reduce hospitalizations, emergency department visits, and other healthcare costs and improve quality of life. As compared to a hospital, the home environment is a more appropriate environment for managing these chronic diseases as well as risk management (e.g., fall prevention), especially with the aid of proper tools and technology.

To support this emerging shift of care from inpatient settings to the home, there is also increasing demand for technology to support the virtual provider (i.e., both onsite and remote).  Virtual providers and interdisciplinary teams will be providing comprehensive care to older persons in their homes for the safe and effective management of their multiple serious chronic diseases and disabling conditions, these providers and teams will need point of care diagnostic, decisional, documentation and communication technologies based on evidence and experience. 

Specific Research Objectives

Innovative strategies are needed to develop an evidence-based health system for the aging population that integrates technologies for home-based health care. These could include, but are not limited to, continuous or frequent, real-time, non-invasive or minimally invasive monitors for health status in various medical conditions.  Along with novel sensing and measurement technologies, information technology tools will integrate data from multiple sources, create meaningful presentations and visualizations of information, and, eventually, embed relevant information into a patient’s health record.  Additionally, software and hardware tools will support synchronous or asynchronous communications between patients and a diverse care team including medical professionals and personal caregivers. Collectively, the “platform” including medical or consumer devices and sensors, communications technologies, wired or wireless data aggregators, scalable middleware or analytic systems, backend clinical or research data systems, along with older adults and care team-facing portals will be utilized to interact with the user remotely and respond to the data obtained from monitoring with timely interventions.

Awardees will develop and validate an infrastructure to support the development of aging in place technological research, in consultation with researchers, device and application industry experts, government agencies (e.g., Office of the National Coordinator for Health IT), and regulatory authorities (e.g., Food and Drug Administration). To address these needs, the following objectives should be met:

  • Establish and implement the basic governance, operational, and policy structures needed to develop and sustain a technology-based infrastructure that will enhance aging in place research;Establish and coordinate requirements, standards, specifications, and resources for aging in place research; 
  • Design the infrastructure and expected data models to be supported by the system by identifying and qualifying the equipment and software necessary to support the CART-equipped individuals and homes for the demonstration project. The infrastructure should be built with the flexibility to incorporate new and emerging technologies and support tailored deployment based on users care and monitoring requirements;
  • Design an illustrative study protocol for the final demonstration project which will recruit a moderate-scale (at least 200 homes) cohort of older adults (stratified by age to include a range of older adults with at least one existing medical condition) for the demonstration project;
  • Develop and refine the infrastructure based on initial design, study requirements, user-testing and iterative deployments of the system; ultimately building to an extended system test of at least 6 months for an initial or refined study protocol;
  • Assure usability and acceptability of hardware and software technology, communications and feedback interface(s) for older adults and members of the care team;
  • Support remote configuration and deployment of software and hardware tools based on factors such as health status, home environment, or user preference which support ability to scale deployments;
  • Develop and execute an iterative demonstration project to test the system. Compile results and assess study outcomes. 

Timeline: It is expected that applicants will carry out CART planning and development over the four years according to the following timeline.

  • Year 1: Careful and extensive expert planning, including focus groups with older adults;
  • Develop a framework for the CART system infrastructure which aims to optimize value for rapid evaluation, validation and development of empirical evidence for stand-alone or bundled technologies and services to support seniors aging in place;
  • Develop an iterative process for system development, installation and implementation of the software and hardware used for CART homes based on the requirements, standards, and specifications gathered, which will ultimately lead to successful implementation of the CART system in at least 200 homes.
  • Years 2 and 3: Platform development, user testing, iterative in-home deployments and refinement
  • Develop a working prototype of the CART system for the demonstration project, including major functional components of the technology for initial validation and testing of the system using different technologies in at least 200 homes;
  • Provide documentation and demonstrate that the working prototype of the CART system and the products used in it are ready for initial deployment, validation and testing.
  • Present evidence that appropriate testing (e.g., focus groups, interviews, cognitive or user-testing) with end-users (i.e., patients and care team members) of the system has been conducted to demonstrate the feasibility, acceptability, and usability of system components;
  • Provide evidence of appropriate iterative testing of the integration of data generated from the technology into the target clinical setting, health system or service, or other relevant software environment (e.g., Electronic Health Record) in preparation for scaling deployment and validation. Develop a timeline for problem mitigation.
  • Year 4: Extended deployment for demonstration project (minimum 6 months) geared to show feasibility for scaling across all platform components. Final enhancements and software documentation consistent with the stated resource sharing policy and integration of data into the Electronic Health Record (EHR) deployed.
  • Provide evidence that the fully-developed CART system, including all major functional components of the technology, is ready for formal validation or outcomes research on a larger scale (~10,000 homes);
  • Provide documentation of the CART system software dissemination plan, including system documentation and open-source dissemination of software source code repositories (as much as possible), for the final CART Phase I system to support further system development and validation in Phase II.

Success will be determined by evaluating the likelihood that the scaled up version (Phase II) will be deployable for continuous operations in up to 10,000 homes and useful for efficiently determining the utility of various measures/technologies for impact on outcomes such as reduced hospitalizations / transitions; better Quality of Life (QOL); delayed nursing home placement, etc.  This Phase I is not required to show significant results, but rather the strong likelihood that the infrastructure will provide clear processes to support efficient assessment of novel and innovative technologies that will help older adults remain independent in their homes safely.

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.

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

 Issuing IC and partner components intend to commit an estimated total of $7,000,000 to fund one award over four years. 

Award Budget

Application budgets are limited to $1,250,000 direct costs in any given year; these funds will be provided by the issuing IC and partner components.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 4 years.  

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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 not 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.

Individuals from institutions with co-located Clinical and Translational Science Award (CTSA) programs are encouraged to apply, particularly CTSAs with special expertise in mobile technologies or medical device development or with special access to or experience with geriatric patients or communities.

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

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

Nina Silverberg, Ph.D.
Telephone: 301-496-9350
Fax: 301-496-1494
Email: silverbergn@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

6

Admin Core

12

Core (Use for Resource Core and Data Core)

6

Project (Use for Demonstration Project)

12

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

  • Overall: required; min 1, max 1
  • Administrative Core: required; min 1, max 1
  • Resource Core: required; min 1, max 1
  • Data Core: required; min 1, max 1
  • Demonstration Project: required; min 1, max 1
Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.  

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims:  Comprehensively address the goals of this FOA which are to create a sustainable infrastructure for the aging in place research community, allowing them to efficiently recruit participants, identify and qualify equipment and software, conduct studies and collect and pool data using a rapid and reliable system.  

Research Strategy:  Applicants should describe how they will develop and validate an infrastructure to support the development of aging-in-place technological research in consultation with researchers and device and application industry experts, and regulatory authorities (e.g., Food and Drug Administration). In the Overall section, applicants should address how the various cores will be coordinated in order to create the demonstration of a sustainable system that can be scaled up for Phase II of the CART program.

Focusing on the project as a whole address, describe (i) the importance of the problem or critical barrier to progress in the field that the proposed project is focused on; (ii) how the resources developed in the proposed project will improve scientific knowledge, technical capability, and/or clinical practice; (iii) how the concepts, methods, technologies, treatments, services, or preventive interventions that drive understanding of aging in place will be changed if the proposed aims are achieved.

Additionally, show how the project will:

  • Enhance the performance of innovative research on aging in place through use of novel concepts, approaches, methodologies, instrumentation, or interventions;
  • Provide an environment and resources to enhance cutting edge research by bringing together investigators from various fields to study aging;
  • Foster the development of new lines of research;

Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts or consultants. For program activities to be conducted off-site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application. Only letters relevant to the entire application should be submitted in this component. Letters specific to a core or project should be submitted in the relevant component.

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 present a Data Sharing Plan.

    The CART Program encourages sharing of resources with broad availability of policies, practices, materials, protocols and tools to facilitate collaboration, reuse, and replication by a range of researchers. In addition, the CART Program expects the sharing of study data from the system in a timely manner, and with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Thus, the CART Program expects awardees to implement a Resources and Data Sharing Plan consistent with achieving these program goals.  The final Resources and Data Sharing plan is expected to be developed by the CART Program steering committee post award.

    Software-dissemination plan: Applications are expected to include a software-dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. However, the software-dissemination plan should address, as appropriate, the following goals:

    Software source code and documentation from the final CART Phase I system should be made available in order to continue future, large scale development.
    The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
    To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources:  Demonstrate how the existing hardware and software capacity (servers, web-based portals) are adequate for continued support and expansion of the resource. The resources should provide adequate privacy and security protections. Describe the sufficient commitments of facilities, infrastructure, and other resources to allow for the full scale operation under reduced NIH support in Phase II and ultimately foster resource sustainability.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)
  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Admin Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
  • One or more VA investigators should be involved as Senior/Key Personnel on one or more components. A VA-affiliated investigator needs to be part of the research team to access and use VA resources.
  • Investigators, collaborators, or other researchers on the project should have sufficient software and hardware expertise to support the development of the proposed platform.
Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.

  • The budget should include funds sufficient to provide meeting support for weekly/monthly teleconferences for the multiple CORES and for twice-yearly in person CART Steering Committee meetings in the Bethesda, MD area.
  • The applicant's request for funding from VA is limited to $250,000 total costs per year. Though VA funding will be handled separately by the awardee and VA, a separate section of the budget justification for VA expenses should be prepared and submitted by the applicant.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: Identify general objectives planned for the Administrative Core along with the main benchmarks that would indicate the accomplishment of these objectives.        

Research Strategy: The Administrative Core will provide overall administrative and organizational oversight and management of the CART Cores and Project. It will also serve as the primary interface between CART Program and the research and policy community.

As part of this section, the applicant should address the following: 

  • How the Core will establish and implement the basic governance, operational, and policy structures.  This involves setting up committees and coordinating the execution of their respective charters.
  • How the Core will work with Resource Core to build and coordinate requirements, standards, specifications, and resources.
  • Describe how the Administrative, Operations, Logistic, Business and/or Legal staff will support the CART program as a whole.
  • Describe internal evaluations, self-assessment processes, and progress reporting that have the ability to assess and anticipate both researcher and participant needs.
  • Describe how the program will focus on policy, standards and ethics.
  • Describe the program's ability to prioritize and incorporate improvements into operations and software that enhance its utility for research.
  • Address anticipated challenges/obstacles and alternative strategies to surmount potentials obstacles.

Letters of Support:  Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off-site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.

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 CART Program encourages sharing of resources with broad availability of policies, practices, materials, protocols and tools to facilitate collaboration, reuse, and replication by a range of researchers. In addition, the CART Program expects the sharing of study data from the system in a timely manner, and with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Thus, the CART Program expects awardees to implement a Resources and Data Sharing Plan consistent with achieving these program goals.  The final Resources and Data Sharing plan is expected to be developed by the CART Program steering committee post award.

  • Software-dissemination plan: Applications are expected to include a software-dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. However, the software-dissemination plan should address, as appropriate, the following goals:
  • Software source code and documentation from the final CART Phase I system should be made available in order to continue future, large scale development;
  • The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages;
  • To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Administrative Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Resource Core

When preparing your application in ASSIST, use Component Type ‘Core.’

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

SF424 (R&R) Cover (Resource Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Resource Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Resource Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources:  Demonstrate how the existing hardware and software capacity (servers, web-based portals) are adequate for continued support and expansion of the resource. The resources should provide adequate privacy and security protections. Describe the sufficient commitments of facilities, infrastructure, and other resources to allow for the full scale operation under reduced NIH support in Phase II and ultimately foster resource sustainability.

Project /Performance Site Location(s) (Resource Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Resource Core)
  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Resource Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used. 
  • One or more VA investigators should be involved as Senior/Key Personnel on one or more components. A VA-affiliated investigator needs to be part of the research team to access and use VA resources.
  • Investigators, collaborators, or other researchers on the project should have sufficient software and hardware expertise to support the development of the proposed platform.
  • Personnel should include but is not limited to the following: programmers, data analysts, network and software engineers, computing-support staff, data privacy and security experts, bioethicists, human factors engineering, behavioral scientists, standards logistics manager, and other staff required to support the needs of the Resource Core and without whom CART would be unsuccessful;
  • Operations management should have the ability to ensure efficient and effective day-to-day administrative operations; and coordination with other components of the Resource Core including investigators funded through a different funding source.
Budget (Resource Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

  • The applicant's request for funding from VA is limited to $250,000 total costs per year. Though VA funding will be handled separately by the awardee and VA, a separate budget justification for VA expenses should be prepared and submitted by the applicant.
PHS 398 Research Plan (Resource Core)

Specific Aims:  Identify general objectives planned for the development and functioning of the Resource Core along with the main benchmarks that would indicate the accomplishment of these objectives.  

Research Strategy: Describe the development of the CART Program, including selection of the technologies to be initially deployed, the capacity to address system standards and upgrades, selection and integration of Electronic Health Records, user training and outreach, strategic planning, and development of a public-private partnership model of sustainability.

Applications should describe the following:

  • The overall vision of the CART Resource Core and its components, and how this meets the CART objectives;
  • Overall approach and methods to establish a technology-based aging in place system that can intensively measure multiple domains of functioning in a valid and reliable format and grow to accommodate additional technologies as the system moves to Phase II;
  • Overall approach to developing and utilizing the appropriate expertise from the scientific, participant and policy communities (e.g., Office of the National Coordinator for Health IT); 
  • Process for installing and monitoring the technology installed for CART homes including interactive communications systems, relevant data-based risk stratification processes, call center or related response capabilities and actions for indicated medical alerts and alarms;
  • Ability to develop a data portal for user-friendly access to data (both raw and processed datasets), metadata, and visualization tools. This Web-based interface should provide controlled access to both CART participants and the broader scientific community, enable federation to relevant external databases and data resources, including the Electronic Health Records (see also the Data Core);
  • Ability to generate participant and researcher portals that are created using user-centered design principles. Portals should contain wikis for reporting research findings and updates;
  • Description of server maintenance, software maintenance and upgrades, and security and backup processes;

Technical capabilities and strategies for designing the data repository and management systems in such a way to maximize sustainable functioning in the future, even under limited or no funding;

  • Ability to devise, implement, and adapt business plans on a quarterly basis;
  • In collaboration with Administrative Core, describe how the Core will build and coordinate requirements, standards, specifications, and resources.  Given the lack of current standards among medical, wireless, and mobile devices, describe how they will work together with the community and industry to generate standards for the infrastructure system. It is expected that these standards will make use of existing standards (e.g., those developed by HL7, Continua, etc.). Standards also include the development of an ethics and regulatory policy framework for the infrastructure; and
  • How they will identify and qualify equipment and software necessary to successfully implement the demonstration project.

Customer support capacity that may include the following:

  • Basic technical support for participants participating in CART;
  • Communication channels (phone, email, web-based content such as frequently asked questions, and other appropriate mechanisms); and
  • Ability to refer to more technical staff for issues requiring more detailed knowledge of programming, databases, statistical or bioinformatics approaches, etc.

Letters of Support: Include signed letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.

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 and Software Sharing Plan.
  • The CART Program encourages sharing of resources with broad availability of policies, practices, materials, protocols and tools to facilitate collaboration, reuse, and replication by a range of researchers. In addition, the CART Program expects the sharing of study data from the system in a timely manner, and with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Thus, the CART Program expects awardees to implement a Resources and Data Sharing Plan consistent with achieving these program goals.  The final Resources and Data Sharing plan is expected to be developed by the CART Program steering committee post award.
  • Software-dissemination plan: Applications are expected to include a software-dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. However, the software-dissemination plan should address, as appropriate, the following goals:
  • Software source code and documentation from the final CART Phase I system should be made available in order to continue future, large scale development;
  • The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages;
  • To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Resource Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Resource Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Data Core

When preparing your application in ASSIST, use Component Type ‘Core.’

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

SF424 (R&R) Cover (Data Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Data Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Data Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources:  Demonstrate how the existing hardware and software capacity (servers, web-based portals) are adequate for continued support and expansion of the resource. The resources should provide adequate privacy and security protections. Describe the sufficient commitments of facilities, infrastructure, and other resources to allow for the full scale operation under reduced NIH support in Phase II and ultimately foster resource sustainability.

Project /Performance Site Location(s) (Data Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Data Core)
  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Data Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
  • One or more VA investigators should be involved as Senior/Key Personnel on one or more components. A VA-affiliated investigator needs to be part of the research team to access and use VA resources.
  • Investigators, collaborators, or other researchers on the project should have sufficient software and hardware expertise to support the development of the proposed platform.
Budget (Data Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

  • The applicant's request for funding from VA is limited to $250,000 total costs per year. Though VA funding will be handled separately by the awardee and VA, a separate budget justification for VA expenses should be prepared and submitted by the applicant.
PHS 398 Research Plan (Data Core)

Specific Aims:  Identify general objectives planned for the development and functioning of the Data Core. Objectives should target development of standards, data interoperability, data access and security and privacy, along with the main benchmarks that would indicate the accomplishment of these objectives.  

Research Strategy: The CART program Data Core should develop a central data and software resource for integrating and facilitating access, analysis, and dissemination of data and software generated within the CART program.

Applications should describe the following:

  • The overall vision of the Data Core and how this meets the CART program objectives;
  • The proposed process for creating data standards for the CART program that utilize existing standards whenever possible (for example, see http://csrc.nist.gov/groups/SMA/fisma/index.html  for FISMA standards, Hl7, Continua, etc.) and develop those that are needed with input from the research and industry communities including the VHA Health System;
  • The proposed process for creating a data repository with the capability to store/aggregate all primary and processed data and associated metadata generated by the CART program including VA data requirements; (see http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=56&FType=2 and http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=1851 for examples of VA requirements);
  • Plans to establish a data-submission pipeline, quality-control metrics, provenance checking, and minimal metadata elements required to deposit CART data into the repository;
  • Plans to combine and analyze various formats of data made available from the CART program, including sensors data (both targeting health and those found in the Internet of Things), self-report, medical data from electronic health records, etc.;
  • Ability to store and report participant data to the researcher or clinician via a secure, password-protected system compliant with applicable federal data-security standards including VA requirements (for example, see http://www.hhs.gov/ocr/privacy/hipaa/understanding/srsummary.html for HIPAA standards);
  • Ability to export data consistent with data interoperability standards, including HL7 capability for integration into electronic health records;
  • Plans to establish a software clearinghouse which will collect software developed within the CART program and make them available to the broader community;
  • Ability to ensure data security and maintain confidentiality of personally-identifiable information at the highest level;
  • Specific processes and methods for integration of data generated by outside sources;
  • Technical capabilities to provide interoperability of the CART data with other databases through federation (e.g., linkage to Big Data to Knowledge [BD2K]) including VA requirements;
  • Public dissemination of software and data capabilities available within the CART program;
  • Technical capabilities and strategies for designing the data repository and management systems in such a way to maximize sustainable functioning in the future, even under limited or no funding; and
  • Description of server maintenance, software maintenance and upgrades, security, backup processes, and data recovery plan.

Letters of Support: Include signed letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off-site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application.

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 and Software Sharing Plan.

  • The CART Program encourages sharing of resources with broad availability of policies, practices, materials, protocols and tools to facilitate collaboration, reuse, and replication by a range of researchers. In addition, the CART Program expects the sharing of study data from the system in a timely manner, and with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Thus, the CART Program expects awardees to implement a Resources and Data Sharing Plan consistent with achieving these program goals.  The final Resources and Data Sharing plan is expected to be developed by the CART Program steering committee post award.
  • Software-dissemination plan: Applications are expected to include a software-dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. However, the software-dissemination plan should address, as appropriate, the following goals:
  • Software source code and documentation from the final CART Phase I system should be made available in order to continue future, large scale development;
  • The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages;
  • To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Data Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Data Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

Demonstration Project

When preparing your application in ASSIST, use Component Type ‘Project.’

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

SF424 (R&R) Cover (Demonstration Project)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Demonstration Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Demonstration Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Demonstration Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Demonstration Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Demonstration Project)
  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
  • One or more VA investigators should be involved as Senior/Key Personnel on one or more components. A VA-affiliated investigator needs to be part of the research team to access and use VA resources.
  • Investigators, collaborators, or other researchers on the project should have sufficient software and hardware expertise to support the development of the proposed platform.
Budget (Demonstration Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

  • The applicant's request for funding from VA is limited to $250,000 total costs per year. Though VA funding will be handled separately by the awardee and VA, a separate budget justification for VA expenses should be prepared and submitted by the applicant.
PHS 398 Research Plan (Demonstration Project)

Specific Aims:  Describe a demonstration project using the CART system that validly and reliably collects longitudinal real-time or frequent data on a minimum of three areas of health function (e.g., cardiovascular, mobility and cognitive) in a sample of at least 200 CART homes.  

Research Strategy: Applicants should describe the process for developing and deploying a demonstration project using the CART system in at least 200 CART homes that will enhance aging in place, for the purpose of demonstrating the feasibility and utility of the system and the value of moving to Phase II. Iterative system deployment of increasing complexity should be planned to occur in years 2 and 3 to evaluate, enhance and refine the system. The plans for iterative development cycles and final number and distribution of homes should be clearly described and justified. Participants must be stratified by age to include a range of older adults (65 years and above) and have at least one medical condition (either chronic or post-acute). Applicants should clearly justify their sample size, selection of participants and how they are stratified and should focus on the question of whether technology can help people live in their homes longer with a better quality of life.

Participants may live alone or with one or more other residents. If including participants with multiple household members, information must be provided in the application regarding how individuals will be distinguished in the measurements. The sample should include the participation of people living in at least 200 homes from racially/ethnically diverse communities, including representatives from low socioeconomic status and medically underserved areas as well as those cared for in different health systems -- including the Veteran's Health Administration (VHA) -- and those in Housing and Urban Development housing. Preferred partners should include an owner of a multifamily property funded by the US Department of Housing and Urban Development’s 202 Supportive Housing for the Elderly Program with rental assisted units. For more information about HUD’s 202 program, please see: http://portal.hud.gov/hudportal/HUD?src=/program_offices/housing/mfh/progdesc/eld202. For a partial Inventory of Units, which is sorted by state, please see: http://portal.hud.gov/hudportal/HUD?src=/program_offices/housing/mfh/hto/inventorysurvey. Preferred property/resident characteristics include: 202 building of at least 50 HUD-assisted and age restricted units; owner provides an on-site Service Coordinator; residential units are “internet-ready”. Partnering with CTSAs that are known for strength and expertise in engaging diverse communities is encouraged. In accordance with the Draft NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research, applicants are encouraged to plan for single IRB review by engaging resources such as the National CTSA Reliance IRB Project.

The demonstration project should include the following two sections:

1. A core set of measures, selected and clearly described by the applicant, that are collected in all settings using technology that has been validated and has safety data (where applicable). Support risk-stratification measures that could indicate a life threatening situation, alerts should be provided to someone in a position to act on them and in a format that facilitates comprehension and action. The measures should address high-impact conditions across the continuum of care in domains that are person-centered and longitudinal or measured over time and may also include technology for care planning and care management. Examples include, but are not limited to the following:

  • Cardiovascular function (e.g., heart rate including arrhythmias, blood pressure, biomarkers correlated with severity of prognosis of heart failure; but not weight alone);
  • Mobility function (e.g., gait speed, turning, but not steps alone);
  • Cognitive function (e.g., computer games but not a test score; technology-based cognitive assessment; communication skills, etc.);
  • Completion of Instrumental Activities of Daily Living (IADLs);
  • Promoting healthy lifestyle and behavior (e.g., nutrition, physical and cognitive exercise, social interaction, and stress reduction; health coaching; patient self-management skill-building principles & strategies);
  • Management for chronic condition(s) (e.g., medication pick-up/refill, medication dose adjustment and optimization, consultation with healthcare staff regarding changes in disease status and determining whether a clinic visit is needed);

Pain management;

2. Evaluate novel technologies and/or measures. These should measure domains that are important, prevalent, predictive of health status, require frequent measurement and can change rapidly. This piece should demonstrate the ability of the infrastructure to carry out this type of evaluation. Examples include, but are not limited to, the following:

  • Activity-monitoring devices or sensors to detect personal care needs;
  • Activity-monitoring devices or sensors to detect acute medical events;
  • Devices to ensure adherence to rehabilitation and medical regimens;
  • Real-time monitoring and management of chronic conditions;
  • Monitoring systems to detect trajectory of change in physical and cognitive abilities;
  • Therapeutic or management systems to address physical or cognitive decline;
  • Fall-detection or fall-prevention systems;
  • Devices to monitor and facilitate sleep health;
  • Technologies aimed at helping the lay caregiver or professional provider;
  • Research and development for improved human-computer interfaces for home-use technologies;
  • Novel sensor or monitoring systems (e.g., devices or sensors to detect acute myocardial infarction or heart failure); and
  • Home-use point-of-care devices, home or mobile therapy or rehabilitation tools, or information systems.

In addition, evidence of outside resources such as access to food and transportation should be collected and part of the data available for analysis.

At the conclusion of the demonstration project, a report should be completed, describing the results, assessing the study design and sharing insights and knowledge gained to be applied to future project (Phase II) scaling efforts.  The data and findings from the demonstration project will be used to refine the operation and establish statistical power for results that can be expected from the operation of the project at full scale.

Priority on Sustainability. The NIH plans to support CART only for a limited time to facilitate its transition to sustainability. Accordingly, it is expected that CART and the awardee institution will plan research and development with sustainability in mind.

Plans and resource designs should assume that there will be limited NIH support for CART after the end of the funding period indicated in this FOA. Therefore, the ultimate financial sustainability of CART is of high priority. Applicants should provide vigorous, credible, and well-documented steps that lead to sustainability.

Letters of Support: Include signed letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. For program activities to be conducted off-site, i.e., at an institution other than the applicant institution, a letter of assurance or comparable documentation, signed by the collaborator as well as the off-site institutional officials, must be submitted with the application

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 and Software Sharing Plan.

The CART Program encourages sharing of resources with broad availability of policies, practices, materials, protocols and tools to facilitate collaboration, reuse, and replication by a range of researchers. In addition, the CART Program expects the sharing of study data from the system in a timely manner, and with appropriate privacy and confidentiality protections to facilitate further research, reuse of data, and replication. Thus, the CART Program expects awardees to implement a Resources and Data Sharing Plan consistent with achieving these program goals.  The final Resources and Data Sharing plan is expected to be developed by the CART Program steering committee post award.

  • Software-dissemination plan: Applications are expected to include a software-dissemination plan if support for development, maintenance, or enhancement of software is requested in the application. However, the software-dissemination plan should address, as appropriate, the following goals:
  • Software source code and documentation from the final CART Phase I system should be made available in order to continue future, large scale development;

The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages;

  • To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

Planned Enrollment Report  (Demonstration Project)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report (Demonstration Project)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

3. Submission Dates and Times

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. 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.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. 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.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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.

Important reminders:

All PD(s)/PI(s) and component Project Leads 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.

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 (SAM). 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 the National Institute on Aging (NIA), 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 NOT-OD-13-030.

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 - Overall

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 - Overall

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

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed plan provide for a resource that will allow accessibility of these measurement systems by researchers examining health outcomes across multiple populations and disease conditions? Will the proposed plan increase uptake of the measurement systems for use in trials and clinical settings? Are future directions and needs of the research field addressed with appropriate consideration to adapting, modifying, replacing, or adding tools? Does the project address an important problem or a critical barrier to progress in the aging in place field especially for the lower socioeconomic aging population?     

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI , do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the investigators, collaborators, or other researchers on the project have sufficient software and hardware expertise to support the development of the proposed platform?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? What novel approaches will be used by the investigators to capture relevant information for research purposes (e.g., from clinical settings or integration into electronic health records)? Does the proposed plan allow for technological advances (e.g., upgrades to relevant software or development of new software) during the project period?     

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?   

Is there a clear plan to include underserved individuals, including those living in a rural environment and those with disabling conditions for whom access to care is arduous? Is the range of ages appropriate? Are participants with a range of medical conditions, and co-occurring conditions included? Is the plan for number of homes and stratification clearly described, feasible and likely to lead to a successful platform for research on aging in place? 

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is the existing hardware and software capacity (servers, web-based portals) adequate for continued support and expansion of the resource? Does the proposed plan include adequate privacy and security protections? Are there sufficient commitments of facilities, infrastructure, and other resources to allow for the full scale operation under reduced NIH support in Phase II and ultimately foster resource sustainability?     

Review Criteria - Administrative Core

As applicable for the core 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.

Significance

Do the proposed activities described allow for successful interface between the CART program and the research and policy community? How will the core contribute to achieving the overall goals of the CART program?

Investigators

Are the Core Lead(s), collaborators, and other researchers well suited to the core? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the core?  Are the leadership and administrative staff of the core qualified in leading the operations of the proposed CART program?

Innovation

Does the core challenge and seek to shift current research and technology by utilizing novel theoretical concepts, approaches or methodologies, technologies, or interventions? Are the concepts, approaches or methodologies, technologies, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, technologies, or interventions proposed? How effectively will the core facilitate novel multidisciplinary and interdisciplinary research strategies?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?  Will the strategy lead to the ultimate financial sustainability of the program? How well will the core staff lead the proposed program and interact with other program components and other organizational components within and outside the institution? Are the plans adequate for the establishment and functioning of the proposed advisory panels?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Will the resources and environment of the core adequately contribute to the leadership of the program and to achieving its goals? Will the resources and environment prioritize and incorporate improvements into operations and software that enhances its utility for research?

 
Review Criteria - Resource Core

As applicable for the core 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.

Significance

Do the proposed activities describe the selection of the technologies to be deployed? How will the core contribute to achieving the overall goals of the CART program? Is there a feasible development of public-private partnerships to provide sustainability?

Investigators

Are the Core Lead(s), collaborators, and other researchers well suited to the core? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the core?  Are the leadership and administrative staff of the core qualified in leading the operations of the core?

Innovation

Does the core challenge and seek to shift current research and technology by utilizing novel theoretical concepts, approaches or methodologies, technologies, or interventions? Are the concepts, approaches or methodologies, technologies, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, technologies, or interventions proposed? How effectively will the core facilitate novel multidisciplinary and interdisciplinary research strategies?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?  Will the strategy lead to the ultimate financial sustainability of the program? How well will the core staff lead the proposed program and interact with other program components and other organizational components within and outside the institution? How well is the deployment described and how successful will the program be meeting objectives?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Will the resources and environment of the core adequately contribute to the leadership of the program and to achieving its goals? Will the resources and environment prioritize and incorporate improvements into operations and software that enhances its utility for research?

Review Criteria - Data Core

As applicable for the core 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.

Significance

Do the proposed activities successfully develop a central data and software resource? How will the core contribute to achieving the overall goals of the CART program? Are there plans to establish a software clearinghouse and make data available to a broader community?

Investigators

Are the Core Lead(s), collaborators, and other researchers well suited to the core? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the core?  Are the leadership and administrative staff of the core qualified in leading the operations of the core?

Innovation

Does the core challenge and seek to shift current research and technology by utilizing novel theoretical concepts, approaches or methodologies, technologies, or interventions? Are the concepts, approaches or methodologies, technologies, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, technologies, or interventions proposed? How effectively will the core facilitate novel multidisciplinary and interdisciplinary research strategies?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?  Will the strategy lead to the ultimate financial sustainability of the program? How well will the core staff lead the proposed program and interact with other program components and other organizational components within and outside the institution?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Will the resources and environment of the core adequately contribute to the leadership of the program and to achieving its goals? Will the resources and environment prioritize and incorporate improvements into operations and software that enhances its utility for research?

Review Criteria - Demonstration Project

As applicable for the component 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.

Significance

Can the proposed activities successfully collect longitudinal, real time or frequent data on a minimum of three areas of health function? How will the project contribute to achieving the overall goals of the CART program? Are the plans to establish the system in at least 200 homes feasible, realistic and possible?

Investigators

Are the Project Lead(s), collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? Do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  Are the leadership and administrative staff of the project qualified in leading the operations of the project?

Innovation

Does the project challenge and seek to shift current research and technology by utilizing novel theoretical concepts, approaches or methodologies, technologies, or interventions? Are the concepts, approaches or methodologies, technologies, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, technologies, or interventions proposed? How effectively will the project facilitate novel multidisciplinary and interdisciplinary research strategies?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?  Will the strategy establish feasibility and will particularly risky aspects be managed?  Will the strategy lead to the ultimate financial sustainability of the program? How well will the project staff lead the proposed program and interact with other program components and other organizational components within and outside the institution? Are there clear plans for development cycles and justification and plans for the distribution of homes involved in the project? Do the homes represent a diverse population?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Will the resources and environment of the project adequately contribute to the leadership of the program and to achieving its goals? Will the resources and environment prioritize and incorporate improvements into operations and software that enhances its utility for research?

Additional Review Criteria - Overall

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.

Building Partnerships

Are collaborations or partnerships well-described including ease of technology transfer and interoperability between devices and/or health systems?  Is the geographic diversity inclusive such as rural, urban, single vs. multi-family homes for the CART homes?

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 five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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 - Overall

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 .

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 on Aging 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 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 National Advisory Council on Aging. 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

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.

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 Part75 and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program 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 recipient’s activities by involvement in and otherwise working jointly with the award recipient 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.

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

  • Defining objectives and approaches for CART and its components, in collaboration with the steering committee (do not list the names of committee members);
  • Overseeing the planning and conducting of all CART scientific, organizational, and administrative activities;
  • Promoting and coordinating scientific collaborations across CART and between CART and external investigators as well as outside collaborators;
  • Overseeing initial formation as well as improvements/adjustments in CART infrastructure;
  • Overseeing the adherence of CART to the approved plans for timely sharing of resources and data;
  • Participating as voting member(s) in the activities of the CART Steering Committee and interacting with any sub-committee(s);
  • Accepting and implementing all scientific, organizational, administrative, and policy recommendations approved by the CART Steering Committee to the extent consistent with applicable grant regulations;
  • Organizing and participating in the periodic CART Steering Committee Meetings and other activities of the CART as relevant;
  • Cooperating in the program evaluation process and interacting with NIH representatives coordinating this process;
  • Overseeing the timely preparation and submission to the NIH of annual progress reports and other information as needed;
  • Conducting periodic self-evaluation of the resource; and
  • Being prepared for administrative site visits by NIH staff members.

Intellectual Property Considerations

Awardees will be responsible for relevant intellectual property oversight that will include:

  • Ensuring the ability to maintain, manage, modify, and distribute data by securing appropriate permissions from other parties involved;
  • Developing criteria for making decisions to include or remove outcome measures and various technology as needed to address intellectual property constraints while ensuring minimal burden to users of these instruments;
  • Notifying users of the existence of third party ownership or reach-through, as appropriate;
  • Ensuring that infrastructure, items, and instruments developed with NIH grant support are made available to users in a manner consistent with NIH sharing policies (see http://sharing.nih.gov), including the NIH research systems policy and the NIH data sharing policy as applicable;
  • Ensuring that agreements with any party, including users, do not  unreasonably limit access by other parties to the CART infrastructure and/or items or instruments; and
  • Establishing appropriate agreements between/among stakeholders for the appropriate sharing of data and appropriate protection of intellectual property

The PD(s)/PI(s) assumes responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of research conducted with or through CART in accordance with terms and conditions of the award.

CART will be subject to external evaluation (coordinated by the NIH). The CART awardee will be expected to participate in such evaluations.

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

One or more designated NIH Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. Additional NIH scientific staff members with relevant expertise may also become substantially involved in CART activities as Projects Scientists or Coordinators.

The NIH Project Scientist(s) and other substantially involved NIH program staff members will assist CART by:

  • Monitoring the operations of CART components and activities;
  • Making recommendations to the CART Steering Committee on strategic directions and improvements to CART components and activities;
  • If appropriate, collaborating scientifically on research projects involving CART investigators;
  • Serving as a liaison to facilitate and/or coordinate interactions between CART and other entities that may be mutually beneficial;
  • Using the NIH channels to disseminate knowledge about the CART to scientific community;
  • Facilitate contacts between CART and non-CART-affiliated researchers interested in potential collaborations with CART and/or the use of CART as a resource; and
  • Coordinating an external evaluation of the CART Program.

NIH staff members who are substantially involved in the scientific activities (e.g., publications) of CART will not attend peer review meetings of renewal and/or supplemental applications.

In addition, an NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award, including reviewing progress, and will be named in the award notice. If this individual becomes substantially involved in the CART activities, he/she will not attend peer review meetings of renewal and/or supplemental applications or will seek NIH waiver if such participation is essential.

The NIH reserves the right to adjust funding, withhold, suspend, or terminate the support to the CART awardee and/or member 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.

Areas of Joint Responsibility include:

CART Steering Committee. The CART Steering Committee will serve as the main governing board for the CART Initiative. The Steering Committee will consist of the following voting members:

  • CART PD(s)/PI(s), one of whom is expected to chair the Steering Committee;
  • Three to five other PD(s)/PIs and/or senior scientific staff from CART, with at least one representative from each core;
  • Scientific staff, one representing each of the funding agencies (including individual NIH Institutes, Centers or Offices);
  • Advisory staff, at least one from each participating agency (these will include: VA, ONC, CMS, NSF and FDA). Committee membership will not be comprised of more than 1/3 federal staff.

NOTE: Each voting member noted above representing CART will have one vote (including those individuals who may have multiple responsibilities).

Additional individuals may be added to the CART Steering Committee as non-voting members by a decision of the existing voting members. These additional non-voting members may include, for example, other NIH Program Staff members, and/or Program Staff members from other Federal Agencies (e.g., Centers for Medicare and Medicaid Services, U.S. Food and Drug Administration).

The CART Steering Committee will meet twice per year in person and monthly via phone conference. Applicants should budget for in-person meetings to occur in the Washington, D.C., metropolitan area.

The CART Steering Committee will have primary responsibility for:

  • Overseeing the overall functioning of the CART;
  • Establishing advisory committees and subcommittees, as needed;
  • Reviewing CART strategic goals for its evolution as a research resource (in consultation with Scientific Consulting Panel, see below);
  • Ensuring goals for sustainability are prioritized;
  • Ensuring that the CART takes advantage of existing NIH resources and programs and;
  • Ensuring that CART meets the missions/needs of funding agencies, to the extent possible.

The CART Steering Committee will also form subcommittees, each with a specific functional area of oversight as defined in the application. Whether a business sub-committee exists, the awardee must include an expert in business management to either the CART Steering Committee or the Scientific Consulting Panel.

Scientific Consulting Panel: A Scientific Consulting Panel will operate as a subcommittee to the Steering Committee, advising the Steering Committee and providing technical expertise to the entire CART. This panel will comprise scientific experts not affiliated with CART institutions and may include scientists from academic and other research institutions as well as from NIH, clinicians and clinical staff, and relevant stakeholders for non-traditional research methods. Members of the Scientific Consulting Panel will be selected by the Steering Committee in consultation with the NIH Project Scientist. The Scientific Consulting Panel will be charged with the following activities:

  • Reviewing the overall progress of CART and making appropriate recommendations to strengthen activities in certain areas once per year;
  • Participating in the semi-annual CART Scientific Meetings;
  • Providing additional consultations to the Steering Committee and CART investigators as needed (responding to inquiries via e-mail and/or telephone); and
  • Providing linkages to investigators not funded by CART but conducting, or interested in conducting, related research.

Members of the Scientific Consulting Panel should NOT be appointed prior to the submission of the application and should not be listed in the application as this will limit the potential pool of reviewers unnecessarily.

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 composed of three members 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 progress report, 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. 

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-435-0714

Scientific/Research Contact(s)

Nina Silverberg, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: silverbergn@mail.nih.gov

William Riley, Ph.D.
Office of Behavioral and Social Science Research (OBSSR)
Telephone: 301-496-0979
Email: wriley@mail.nih.gov

D. Elizabeth McNeil, M.D., M.Sc
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: mcneilde@mail.nih.gov

Vinay Pai, Ph.D.
National Institute on Biomedical and Bioengineering (NIBIB)
Telephone: 301-451-4781
Email: paiv@mail.nih.gov

Augie Diana, Ph.D.
National Institute of Nursing Research (NINR)
Telephone: 301-402-6423
Email: dianaa@mail.nih.gov

James McClain, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6804
Email: mcclainjj@mail.nih.gov  

Mary Purucker, MD, PhD
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0741
Email:  puruckerm@mail.nih.gov

Peer Review Contact(s)

Ramesh Vemuri, PhD
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: VemuriR@mail.nih.gov

Financial/Grants Management Contact(s)

John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: jbladen@mail.nih.gov

Tijuanna Decoster
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@mail.nih.gov

Angelos Bacas
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4785
Email: bacasa@mail.nih.gov

Judy Lee Sint
National Institute of Nursing Research (NINR)
Telephone: 301-402-6959
Email: sintj@mail.nih.gov

Silvia Torres
National Cancer Institute (NCI)
Telephone: 240-276-6322
Email: torressp@mail.nih.gov

Stacia H. Fleisher, M.P.P.
National Center for Advancing Translational Sciences (NCATS)
Telephone:  301-435-0851
Email:  fleishersh@mail.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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