Expired PAR-14-119: Design and Development of Novel Technologies for Healthy Independent Living (R21)

Part 1. Overview Information

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Biomedical Imaging and Bioengineering (NIBIB) National Heart, Lung, and Blood Institute (NHLBI) National Institute on Aging (NIA) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Nursing Research (NINR) Office of Behavioral and Social Sciences Research (OBSSR)
Funding Opportunity Title	Design and Development of Novel Technologies for Healthy Independent Living (R21)
Activity Code	R21 Exploratory/Developmental Research Grant
Announcement Type	Reissue of PAR-11-021
Related Notices	NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015) June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number	PAR-14-119
Companion Funding Opportunity	PAR-14-118, R01 Research Project Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.286, 93.866, 93.865, 93.361, 93.837
Funding Opportunity Purpose	This FOA encourages Exploratory/ Developmental Research Project (R21) applications for design and development of novel technologies to monitor health or deliver care in a real-time, accessible, effective, and minimally obtrusive way. These may be novel sensor or monitoring systems, home-use point-of-care devices, home or mobile therapy or rehabilitation tools, or information systems and should have the goal of fostering healthy and independent living. The development of such technologies has the potential to significantly improve the quality of life for people with disabilities, people aging with mild impairments, as well as individuals with chronic conditions.

Key Dates

Posted Date	February 26, 2014
Open Date (Earliest Submission Date)	August 23, 2014
Letter of Intent Due Date(s)	30 days before the application due date
Application Due Date(s)	September 23, 2014; September 23, 2015; September 23, 2016, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	January 7, 2015; January 7, 2016; January 7, 2017 by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Scientific Merit Review	February-March 2015, February-March 2016, February-March 2017
Advisory Council Review	May 2015, May 2016, May 2017
Earliest Start Date	July 2015, July 2016, July 2017
Expiration Date	January 8, 2017
Due Dates for E.O. 12372	Not Applicable

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). 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

Purpose

The average age of Americans is increasing and chronic conditions are becoming more prevalent. There is a need to improve the effectiveness of disease prevention, to improve access to healthcare, and to sustain healthy independent living. At the same time, there is an increased availability of new technologies and an ever-improving health information technology infrastructure. Advances in bioengineering coupled with the aforementioned needs of society suggest a ripe opportunity for the design and development of home or mobile technologies that enable functional independence and can improve quality of life for people with disabilities, chronic conditions, or mild impairments associated with aging. Home-health and mobile-health technologies are expected to function not only as monitoring devices, but as essential components in the delivery of healthcare.

This FOA encourages Exploratory/Developmental Research Project Grant (R21) applications for research and development of novel technologies that monitor health, inform clinical decisions, or deliver therapies in a real-time and minimally obtrusive way. These are technologies that enable monitoring of personal motion, vital signs, and physiological measures in a manner that minimizes disruption to an individual’s daily routine and at all times protects their privacy, dignity and comfort. These systems are expected to integrate, process, analyze, communicate, and present data so that the individuals are engaged and empowered in their own healthcare with reduced burden to care providers. Effective application of home-based and mobile technologies has the potential to increase adherence to rehabilitation and medical regimens, reduce incidence of avoidable post-acute complications, and improve self-care management of chronic conditions. Applications to refine or enhance existing systems or to evaluate them in particular settings are referred to the companion FOA for R01s [Technologies for Healthy Independent Living (R01)].

Health care and medicine rely on effective detection and characterization of a person's physical and mental states and of significant changes to those states. Current methods to assess these indicators of well-being are performed at the convenience of the care provider and usually assume that observations during an office visit represent typical function. Furthermore, these methods may involve contrived or burdensome tests or depend heavily on recall. Thus, current methods may miss significant acute events or important signals of declining function or may poorly characterize detected events.

Technologies designed for home and mobile monitoring are intended to overcome these limitations. They have the potential to capture rare, irregular, or transient events; symptoms that are difficult for a patient to report; and changes in condition that evolve slowly over time. These improvements, in turn, could yield more accurate and earlier detection of changes that may interfere with healthy and independent living.

Specific Areas of Research Interest

Projects that address a specific and well-characterized clinical need will be considered of high potential impact. In designing technology solutions, applicants are advised to consider the context in which their technology will be used and the needs of the expected users. In many cases this will mean involving the end-users -- whether people with disabilities, elderly people with mild impairments, or people with chronic medical conditions -- in the research and development process. It is expected that many of these projects will be collaborations between engineers and computer scientists; and nurses, physical therapists, doctors, and other clinicians. Behavioral scientists may also be involved in identifying the best approaches to ensure adoption of the approach and patient engagement and motivation. Projects should include the appropriate outcome measures, particularly those that are clinically meaningful to the patient population of interest.

The technologies developed with funding through this FOA are expected to interoperate with other home-based or mobile technologies and communicate with existing health information technology systems, as appropriate. Some other technical features that are expected to lead to successful systems are: reliability, robustness (i.e. ability to function in a variety of operating environments), safety, simplicity, reliance on the appropriate baseline information, contextual awareness, inclusion of software to support decision-making, and consideration of power consumption. Furthermore, systems will ideally integrate information from multiple sensors, appropriate clinical information, and ambient data such as temperature or global position. Proposed systems should incorporate existing standards and consider the regulatory environment where appropriate.

Furthermore, successful technologies that are likely to achieve wide-spread dissemination must consider human factors. That is, they should: be reliable, robust, safe, and simple (four traits also found as technical features); be aesthetically acceptable and unobtrusive; uphold patient’s privacy preferences; be easy to use and have intuitive user interfaces with consideration for user disability or impairment; provide feedback in meaningful forms, whether auditory, visual, or tactile; maintain or promote social engagement; and address a heterogeneous population where one size does not fit all. Perhaps most importantly, a system for healthy independent living should engage, empower, and motivate the individual with respect to his/her own healthcare.

The objective of any home-based or mobile monitoring system that includes an alarm or alert feature is that it be sensitive (avoid false-negatives) and specific (avoid false-positives) as appropriate to the situation and how the system is used. Ideally, the alerts or cueing of the system will be customized to the needs and preferences of the user.

Some examples of appropriate topics for this FOA include but are not limited to:

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 progressive decline in physical and cognitive abilities
Therapeutic or management systems to address physical or cognitive decline
Fall detection or prevention systems
Devices to monitor and facilitate sleep health
Technologies aimed at helping the lay care-giver 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), home-use point-of-care devices, home or mobile therapy or rehabilitation tools, or information systems that have the goal of fostering healthy and independent living for people with cardiovascular disease(s).

Applicants are encouraged to collaborate with federally funded programs such as the NCATS Clinical and Translational Science Awards (CTSAs), the NIBIB Point-of-Care Technologies Network (POCTRN), the NICHD Medical Rehabilitation Research Infrastructure Network, the NIH Basic and Behavioral & Social Science Opportunity Network (OppNet), the NIH National Centers for Biomedical Computing (NCBC), the Agency for Healthcare Research and Quality (AHRQ) Practice Based Research Networks (PBRNs), the AHRQ Patient Safety Network (PSNet), the AHRQ Evidence-based Practice Centers (EPC), and the AHRQ Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Network. If collaborating with such a program, applicants should describe how the collaboration would enhance performance and productivity to explore, develop, and integrate novel technologies for supporting healthy independent living. Applicants are advised to provide a letter of agreement that identifies the level of support from the Program Director/Principal Investigator of those centers.

Applicants may also consider consulting the above programs or other publicly-available resources to benefit from prior efforts to identify and characterize clinical and health-related needs. The available information may provide valuable input into the development of technical solutions. For example, AHRQ's EPC program and DEcIDE Network release evidence reports, research gap report, and technical briefs that summarize published findings on health care delivery issues. These can be found via the Effective Health Care Program site.

The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.

The R21 mechanism is intended to encourage new exploratory and developmental research projects. For example, such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.

Section II. Award Information

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New Resubmission The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Award Budget	Direct costs are limited to $275,000 over the two years of the R21 award, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period.
Award Project Period	2 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
Non-domestic (non-U.S.) Entities (Foreign Institutions)

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download 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.

2. Content and Form of Application Submission

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

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Mary Rodgers, PhD, PT
National Institute of Biomedical Imaging & Bioengineering/NIH/DHHS
6707 Democracy Blvd., Suite 200
Bethesda, MD 20892-5477
Telephone: 301-402-1337
Fax: 301-480-1614
Email: [email protected]

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Instructions for Application Submission

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

SF424(R&R) Cover