Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)
National Institutes of Health (NIH)
Components of Participating Organizations

National Institute of Mental Health (NIMH)

Funding Opportunity Title
Laboratories to Optimize Digital Health (R01 Clinical Trial Required)
Activity Code
R01 Research Project Grant
Announcement Type

New

Related Notices
July 26, 2019- Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128

August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137

Funding Opportunity Announcement (FOA) Number
RFA-MH-20-510
Companion Funding Opportunity
none
Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.242

Funding Opportunity Purpose

NIMH seeks applications for innovative research projects to test strategies to increase the reach, efficiency, effectiveness, and quality of digital mental health interventions which may impact mental health outcomes, including suicide behaviors and serious mental illness. This Funding Opportunity Announcement (FOA) is intended to support the development of digital health test beds that leverage well-established digital mental health platforms and infrastructure to rapidly refine and optimize existing evidence-based digital health interventions and to conduct clinical trials testing digital mental health interventions that are statistically powered to provide a definitive answer regarding the intervention's effectiveness.

Key Dates

Posted Date

November 25, 2019

Open Date (Earliest Submission Date)
February 02, 2020
Letter of Intent Due Date(s)

February 2, 2020

Application Due Date(s)

March 2, 2020 and November 2, 2020 

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

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review
June 2020; February 2021
Advisory Council Review
August 2020; May 2021
Earliest Start Date
September 2020; June 2021
Expiration Date
November 03, 2020
Due Dates for E.O. 12372
Not Applicable
Required Application Instructions
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

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

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

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

    Part 2. Full Text of Announcement

    Section I. Funding Opportunity Description

    Purpose

    NIMH seeks applications for innovative research projects to test strategies to increase the reach, efficiency, effectiveness, and quality of digital mental health interventions which may impact mental health outcomes, including suicide behaviors and serious mental illness. This FOA is intended to support the development of digital health test beds that leverage well-established digital mental health platforms/infrastructure to rapidly refine and optimize existing evidence based digital health interventions and conduct clinical trials testing digital mental health interventions that are statistically powered to provide a definitive answer regarding the intervention's effectiveness.

    Background

    The healthcare landscape in the United States is constantly changing, creating new challenges to the delivery of high-quality treatments and services to children, youth, adults, and older adults with unmet or under-met mental health needs. Epidemiological findings suggest that approximately one half of the United States population meets lifetime criteria for a mental disorder, and approximately one quarter of the population meets criteria in any given year. However, only one half of people with any mental health disorder and only two thirds of people with a serious mental health disorder received mental health services in the previous year. Of those that find their way into mental health care, many fall out of care and/or do not receive guideline concordant treatment, including suicide risk assessment and evidence-based preventive interventions. Disparities in population status (e.g., members of racial, ethnic, sexual, and gender minority communities), a fragmented healthcare system, provider shortages, healthcare affordability, and other factors moderate these findings.

    Digital health incorporates mobile health (mHealth) and health information technology (smartphones, wearable sensors, internet platforms, and electronic health records) with biological, social, and behavioral data. Digital health technology offers unprecedented opportunities to help consumers, clinicians, and researchers measure, manage, and improve health and productivity. These tools also have the potential to improve our understanding of mental illness, to track the course of illnesses and recovery, and to provide and enhance mental health care. Digital mental health interventions are treatments that aim to improve mental health and deliver the treatment as a standalone intervention or as an adjunct to face-to-face interventions via a digital health platform (including mobile phone, website, virtual reality systems, and offline computer programs). Digital health interventions offer the potential to bridge the treatment gap and provide evidence-based interventions to the many individuals who currently are unable to access treatments.

    Over the last decade, NIMH has supported the development and testing of digital health technology, with a focus on establishing the efficacy of digital health assessments and digital health interventions. This research has demonstrated that digital health technology can be used to passively monitor clinical states and as a means for reducing symptoms. However, with few exceptions, the majority of NIMH funded research of digital health interventions has not moved into or beyond the effectiveness stage of research. In contrast to federally funded mental health research, the pace of commercial technology development has progressed rapidly. Over the last 5 years commercially available digital health platforms for mental health have gained considerable traction in the marketplace. Current estimates suggest that greater than 25% of commercially available digital health apps focus on mental health and a significant cross section of consumers are regularly utilizing digital health technology to access treatment for mental health. As digital health technology for mental health is being increasingly used to provide standalone self-managed interventions and/or to supplement in-person treatment, well-designed pragmatic research is necessary to evaluate the effectiveness of existing digital health technology, optimize existing digital health interventions, and examine factors related to uptake and engagement.

    Research Scope and Objectives

    This FOA uses the R01 mechanism and is intended promote partnerships between software developers and academic researchers and leverage existing digital mental health platform infrastructure. It is expected that the proposed digital mental health platforms will be well established, provide evidence-based interventions and have a substantial existing user base. It is also expected that these partnerships will enable applicants to conduct research both to rapidly test ideas and conduct exploratory research as well as large cost-effective pragmatic effectiveness trials. While this FOA will support testing of evidence-based digital health intervention approaches, it is not intended to support the translation of existing face-to-face treatments into technology-based applications.

    Investigators are strongly encouraged to review NOT-MH-18-031 for guidance concerning the NIMH high priority topics in digital mental health. For this FOA, NIMH requires investigators to develop and leverage partnerships with digital health developers and existing well-established digital health delivery platforms, so that the research follows a deployment-focused model of services design and testing. Deployment-focused studies take into account the perspective of relevant stakeholders and key characteristics of settings intended to implement optimized digital mental health interventions. Potential stakeholders include, but are not limited to, federal agencies (e.g., Centers for Medicare and Medicaid Services, Substance Abuse and Mental Health Services Administration, Health Resources and Services Administration, Department of Defense, Department of Veterans Affairs); commercial health insurers/funders; public and commercial disability insurers; employers and other payers; delivery systems; professional/trade associations; accrediting and licensing organizations; medical education and other training programs; clinicians; vendors of information technology and other relevant products/services; service users; family members; and community organizations. The applicant should identify key stakeholders based on the characteristics of the proposed intervention and how the intervention will be deployed within service systems. Such communication and collaboration will ensure findings are relevant and practical, create opportunities for research that is not otherwise feasible, and enable stakeholders to anticipate relevant research initiatives in their planning and activities. Where appropriate, it is strongly encouraged that applicants seek consultation from the Food and Drug Administration for guidance related to regulatory approval/certification of the digital mental health interventions that are being tested.

    Consistent with the NIMH Experimental Therapeutics approach to intervention development and testing, this FOA is intended to support studies that not only examine the intervention effects on outcomes of interest, but also inform understanding of the intervention’s mechanisms of action. As such, the scope of work must include specification of intervention target(s)/mechanism(s) and assessment and analysis of intervention-induced changes in the presumed target(s)/mechanism(s) that are hypothesized to account for the intervention outcomes (see the NIMH Clinical Trials web page for additional information ).

    Proposed studies should capitalize on existing infrastructure (e.g., existing evidence based digital mental health platforms) to increase the efficiency of participant recruitment, and data collection and management. Platforms should be well established with a sufficient existing user base to support nimble intervention refinement and testing with appropriate sample size to achieve adequate statistical power.

    Of note, the goal of this funding announcement is not just to conduct pragmatic trials on digital health platforms. Rather, applicants are also expected to propose additional research beyond the primary effectiveness trial that capitalize on the unique features of the proposed digital health platform. Such additional research might include but is not limited to: analyses of baseline characteristics of users to develop treatment matching algorithms, analyses of existing data to determine the optimal sequence and dose of the digital intervention, development and testing of real time adaptive customized interventions that augment the base digital intervention

    Examples of responsive applications  include, but are not limited to, studies that:

    • Test strategies to rapidly identify and enroll participants, and parametrically refine intervention content, dose, and delivery parameters to optimize the digital health intervention’s therapeutic benefit and efficiency.
    • Test the effectiveness of digital health platforms to optimize the benefit of in-person treatment and bridge therapy sessions and promote between-session skill practice/acquisition.
    • Develop and test adaptive interventions and just-in-time interventions that can be ‘pushed out’ via mobile technology based on information regarding the individual’s current state. For example, interventions that prompt users to complete an assessment at specific times during the day or passive ascertainment of changes in clinical status, immediately followed by provision of behavioral support, such as self-management strategies.
    • Test strategies to deliver digital mental health interventions designed to overcome well-documented uptake and adherence challenges with digital health interventions (e.g., using research-informed approaches to enhance motivation and promote continued engagement).
    • Test digital health technology-driven approaches to improve access to and promote engagement with and continuity of care during known periods of heightened risk, such as care transitions between systems (e.g., handoffs between emergency departments and inpatient psychiatric or substance abuse treatment; transitions between outpatient mental health/substance abuse programs and primary care settings).
    • Leverage patterns of use to identify subcategories of users (i.e., brief users, social users, persistent users) and develop and test strategies to encourage continued engagement.
    • Within digital health platforms that connect users with paraprofessionals and clinicians, test flexible patient matching algorithms and strategies to increase treatment fidelity to Evidence Based Practices (EBPs).
    • Test whether digital interventions can mitigate racial/ethnic/gender disparities in access, service utilization, and mental health outcomes.
    • Utilize electronic health record data in conjunction with digital health interventions to examine the clinical epidemiology, service utilization, response to treatment, within or across large systems responsible for mental health service delivery in order to inform timing and targets for intervening.
    • Use big data and commensurate analytic approaches (e.g., predictive analytics, machine learning, etc.) for the purposes of understanding concentrations of risk and optimizing mental health care within the digital health ecosystem.

    Areas of High Program Priority

    • Digital mental health interventions being tested should be based on existing social and behavioral science theories.
    • Interventions should take advantage of the unique functionality of mobile and wireless devices. Utilization of real-time data collection and feedback is encouraged where appropriate.
    • Studies designed to test if the proposed digital mental health intervention yields significant reductions in symptoms in individuals who exhibit clinically significant symptoms and/or functional impairment at baseline.
    • Applications that propose digital mental health interventions that focus on treating serious mental illness (SMI).
    • Studies that utilize software, devices, and systems that are interoperable with existing infrastructure such that resulting data is interoperable with relevant health information systems where applicable.
    • Applications that test generalizable principles or approaches to using technology to improve the accuracy and efficiency of assessment and the effectiveness and quality of intervention and service delivery.
    • Studies that address known challenges with uptake and adherence/sustained use of technology-based approaches and attention to privacy and other safety/ethical considerations associated with the use of technology for research and clinical purpose.

    Areas of Low Program Priority    

    • Applications that leverage digital mental health interventions that are not empirically based.
    • Testing of digital mental health interventions that do not focus on reducing the severity of clinically significant mental health symptoms and/or functional impairments.
    • Proposed studies that do not plan to enroll participants with baseline levels of measurable clinically significant symptoms and/or functional impairment.
    • Proposing the use of digital mental health platforms with insufficient users to conduct rapid, appropriately powered studies.
    • Applications that propose the translation of existing face-to-face treatments into digital health interventions.
    • Applications that propose clinical trials with a non-active comparator.

    Scale and Scope of Studies Covered Under this Announcement This FOA encourages studies that utilize well-established digital MH platforms to conduct statistically powered trials testing strategies to optimize existing evidence-based digital health interventions. Applicants pursuing other stages of research (e.g., intervention development, pilot testing, clinical trials outside of existing well-established platforms) are encouraged to visit the Support for Clinical Trials at NIMH webpage for a list of alternative FOAs for other stages of intervention development and testing. Applicants are strongly encouraged to consult with NIMH staff when developing plans for an application (see Agency Contacts, Section VII). This early contact will provide an opportunity to clarify NIMH policies and guidelines, and discuss whether the proposed project is consistent with NIMH program priorities

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

    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. Only those application types listed here are allowed for this FOA.

    Clinical Trial?
    Required: Only accepting applications that propose clinical trial(s)

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    NIMH intends to commit a total of $2,250,000 in FY 2020  to fund 3 awards.

    Award Budget
    Application budgets are not limited but need to reflect the actual needs of the proposed project.
    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 from this FOA.

    Section III. Eligibility Information

    1. Eligible Applicants

    Eligible Organizations

    Higher Education Institutions

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

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

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

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Governments

    • State Governments
    • County Governments
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • 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 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) – 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but all registrations must be in place by time of submission. 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

     

    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

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

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

     

    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:

    nimhpeerreview@mail.nih.gov

    Page Limitations
    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
    Instructions for Application Submission
    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
    SF424(R&R) Cover
    All instructions in the SF424 (R&R) Application Guide must be followed.
    SF424(R&R) Project/Performance Site Locations
    All instructions in the SF424 (R&R) Application Guide must be followed.
    SF424(R&R) Other Project Information
    All instructions in the SF424 (R&R) Application Guide must be followed.
    SF424(R&R) Senior/Key Person Profile
    All instructions in the SF424 (R&R) Application Guide must be followed.
    R&R or Modular Budget
    All instructions in the SF424 (R&R) Application Guide must be followed.
    R&R Subaward Budget
    All instructions in the SF424 (R&R) Application Guide must be followed.
    PHS 398 Cover Page Supplement
    All instructions in the SF424 (R&R) Application Guide must be followed.
    PHS 398 Research Plan
    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

    Research Strategy:

    Significance

    • Justify the practical effect of the digital mental health intervention in terms of the estimated hypothesized effect size (e.g., in terms of remediation of symptoms or functional impairment, sustained skill use, improved adherence), compared with already available approaches. Address the potential impact of the digital mental health intervention in terms of both (1) the empirical basis for the anticipated effect size (e.g., citing data regarding the magnitude of the association between the target and the clinical endpoint of interest and/or effect sizes obtained in prior efficacy studies), and (2) the clinical meaningfulness of the anticipated increment in effects compared to existing approaches.
    • Address the degree to which the proposed digital mental health intervention is scalable and could be disseminated into practice, given typically available resources (e.g., trained, skilled providers), typical service structures (including mental health care financing), and typical service use patterns.
    • Detail how the proposed research will generate data that will lead to a firm conclusion about the digital mental health intervention and provide information about the anticipated scope and goals of intended future work

    Investigator(s)

    • Describe plans to involve collaborations and/or input from community practice partners/providers, consumers, and relevant policy makers in a manner that informs the research (e.g., to help ensure the interventions/service delivery approaches are acceptable, feasible, and scalable) and helps to ensure the results will have utility for end-users.

    Innovation

    • Highlight how innovative research strategies and design/analytic elements are incorporated, as appropriate, to enhance the study's potential for yielding practice-relevant information, and enable the research to be conducted within a rapid time frame.
    • Highlight how the digital health platform capitalizes on the unique functionality of mobile and wireless devices, utilizes real-time data collection, incorporates regular software updates that are informed by the research and user feedback.

    Approach

    • Detail the rationale and empirical basis for the digital mental health intervention approach in terms of the intended target population, stage of intervention (e.g., acute care, continuation or maintenance treatment, transition to independent care management), corresponding goals and focus of the intervention (e.g., remediating symptoms or impairments; promoting sustained adherence), potential scalability, key window or timeframe over which the digital mental health intervention should be administered.
    • Consistent with NIMH's experimental therapeutics approach, include a plan that explicitly addresses whether the digital mental health intervention engages the mechanism that is presumed to underlie the intervention effects (the mechanism that accounts for changes in clinical/ functional outcomes, changes in patient or provider behavior, etc.). Specifically, include a conceptual framework that clearly identifies the target mechanisms and the empirical evidence linking the mechanisms to the study outcomes, plans for assessing engagement of the target mechanisms, and analytic strategies that will examine target engagement and associations with clinical benefit. In the case of multi-component interventions, the application should specify the conceptual basis, assessment plan, and analytic strategy for the target mechanisms corresponding to each intervention component, as appropriate in the effectiveness context.
    • Provide a clear justification for the type of experimental design chosen.
    • Include a rationale for the choice of methods proposed and describe how the results will inform the next stages of research or deployment.
    • Include a clear description of the digital mental health platform and documentation describing the current number of daily users of the platform.
    • Provide an enrollment plan that documents how current users will be recruited, consented and randomized. Ensure the enrollment plan aligns with the proposed sample size and power analysis.
    • Describe the assessment and monitoring of the fidelity of intervention delivery via procedures that are feasible and valid.
    • Include outcome measures that are validated and generally accepted by the field, including stakeholder-relevant outcomes (e.g., individual functioning, health services use), as appropriate.
    • ?Justify the proposed period of observation (i.e., timing of assessments and length of follow-up), given the intent of the intervention (e.g., acute care, continuation therapy, skill generalization, maintenance of gains, adherence promotion).
    • Include the assessment of symptoms and related outcomes using strategies that can facilitate sharing of data as appropriate (see NOT-MH-19- 033) 
    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.

    The following modifications also apply:

    • Sharing Data via the NIMH Data Archive: To advance research through widespread data sharing among researchers, investigators funded under this FOA are encouraged to share human subjects data via the NIMH Data Archive (NDA) (See (NOT-MH-19-033) Notice of Data Sharing Policy for the National Institute of Mental Health). Established by the NIMH, and supported by other NIH Institutes, the NDA is a secure informatics platform for scientific collaboration and data-sharing that enables the effective communication of detailed research data, results, tools, and supporting documentation.

      Where possible, investigators funded under this FOA are expected to use NDA technologies to submit data in accordance with the NDA Data Sharing Terms and Conditions, incorporated by reference, which can be found at https://nda.nih.gov/contribute/sharing-regimen.html. A resource sharing plan, formulated in accordance with these NDA Data Sharing Terms and Conditions, should be included in the grant application. The NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technologies. Investigators funded under this FOA should use these technologies to submit and share their research data and results at the appropriate times. The NDA Cost Estimation Tool is a customizable Excel worksheet that can be used to calculate an estimate of the resources needed to submit and share data with the NDA. This resource estimate should be submitted as part of the application budget (http://nda.nih.gov/contribute_cost_estimation.html).

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS Assignment Request Form
    All instructions in the SF424 (R&R) Application Guide must be followed.  

    Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

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

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

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

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

    For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    Important reminders:

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

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

    See more tips for avoiding common errors.

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

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

    Section V. Application Review Information

    1. Criteria

    Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

    A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

    Overall Impact
    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
    Scored Review Criteria
    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

     

    Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?

    How well does the application justify the practical effect of the digital mental health intervention in terms of the estimated hypothesized effect size (e.g., in terms of remediation of symptoms or functional impairment, reduced likelihood of relapse or re-hospitalization, improved adherence), compared with already available approaches? How well does the application address both (1) the empirical basis for the anticipated effect size (e.g., citing data regarding the magnitude of the association between the target and the clinical endpoint of interest and/or effect sizes obtained in prior efficacy studies), and (2) the clinical meaningfulness of the anticipated increment in effects compared to existing approaches?

    If the approach is successful, what are the potential scalability and potential for dissemination into practice given typically available resources (e.g., trained, skilled providers), typical service structures (including health care financing), and typical service use patterns?

    How likely is the proposed research to generate data that will lead to a firm conclusion about the digital mental health intervention and provide information about the anticipated scope and goals of intended future work?

    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

     

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

    How well does the trial involve collaborations and/or input from community practice partners/providers, consumers, and relevant policy makers in a manner that informs the research (e.g., to help ensure that the intervention/service delivery approach is acceptable, practical, and scalable) and helps to ensure the results will have utility for end-users?

    With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial that is conducted on a digital health platform and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

     

    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?

    How well does the application leverage mobile health and health information technology (smartphones, wearable sensors, internet platforms, and electronic health records) with biological, social, and behavioral data?

    Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

    Does the application include innovative research strategies and design/analytic elements to enhance the study's potential for yielding practice-relevant information, and enable the research to be conducted within a rapid time frame?

    Does the proposed research capitalize on the unique functionality of mobile and wireless devices, utilize real-time data collection, and incorporate regular software updates that are informed by the research and user feedback?

     

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project ? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    • Does the application clearly describe the digital mental health intervention, the rationale and empirical basis for the intervention approach in terms of the intended target population, stage of intervention (e.g., acute care, continuation or maintenance treatment, transition to independent care management), corresponding goals and focus of the intervention (e.g., remediating symptoms or impairments; promoting sustained adherence), potential scalability, key window or timeframe over which the digital mental health intervention should be administered?
    • Do the proposed plans explicitly address whether the digital mental health intervention engages the mechanism that is presumed to underlie the intervention effects (the mechanism that accounts for changes in clinical/ functional outcomes, changes in patient or provider behavior, etc.)? Does the application include a conceptual framework that clearly identifies the target mechanisms and the empirical evidence linking the mechanisms to the study outcomes, plans for assessing engagement of the target mechanisms, and analytic strategies that will examine target engagement and associations with clinical benefit? In the case of multi-component interventions, does the application address the target mechanisms corresponding to each intervention component, as appropriate in the effectiveness context?
    • Does the application provide a clear justification for the type of experimental design chosen?
    • Does the application include a clear description of the digital mental health platform and documentation describing the number of daily users of the platform?
    • Do the applicants provide an enrollment plan that documents how current users will be recruited, consented and randomized? Is the enrollment plan aligned with the proposed sample size and power analysis?
    • Does the application provide a clear rationale for the choice of methods proposed and describe how the results will inform the next stages of research or deployment?
    • How well does the application describe the assessment and monitoring of the fidelity of intervention delivery via procedures that are feasible and valid?
    • Does the application include outcome measures that are validated and generally accepted by the field, including stakeholder-relevant outcomes (e.g., individual functioning, health services use), as appropriate?
    • Does the application justify the proposed period of observation (i.e., timing of assessments and length of follow-up), given the intent of the intervention (e.g., acute care, continuation therapy, skill generalization, maintenance of gains, adherence promotion)?
    • Does the application include the assessment of symptoms and related outcomes using strategies that can facilitate sharing of data as appropriate (see NOT-MH-19-033)?

    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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

    Does the application adequately address the following, if applicable

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

    Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

     

    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?

    Does the application clearly describe the proposed digital health platform including a clear description of the digital health intervention, the number of currently active daily users, and the necessary infrastructure to remotely administer and record assessments?

    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

    Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

    If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

    If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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

    Study Timeline

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

    Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

     

    For research that involves human subjects but does not involve one of the 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 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.

     

    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 individuals of all ages (including children and older adults) 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.

     

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

     

    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.

     

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

     

    Not Applicable

     

    Not Applicable  

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

     

    Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

     

    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).

     

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

     

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

     

    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 NIMH, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:
    • May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
    • Will receive a written critique.
    Appeals of initial peer review will not be accepted for applications submitted in response to this FOA. Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.

    3. Anticipated Announcement and Award Dates

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

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

    Section VI. Award Administration Information

    1. Award Notices

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

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

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

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

    Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

    ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety

    Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

    Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

    2. Administrative and National Policy Requirements

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

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

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

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    Cooperative Agreement Terms and Conditions of Award
    Not Applicable

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
    Application Submission Contacts
    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

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

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

    Scientific/Research Contact(s)

    Adam Haim, Ph.D.
    National Institute of Mental Health (NIMH)
    Telephone: 301-435-3593
    Email: Haima@mail.nih.gov

    Peer Review Contact(s)

    Nick Gaiano Ph.D.
    National Institute of Mental Health (NIMH)
    Telephone: 301-827-3420
    Email: nick.gaiano@nih.gov  

    Financial/Grants Management Contact(s)

    Tamara Kees
    National Institute of Mental Health (NIMH)
    Telephone: 301-443-8811
    Email: tkees@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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