Part 1. Overview Information

Key Dates

All applications are due 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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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 NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

The emergence of large-scale, complex data as well as high-performance computing and modern analytic technologies provides a unique opportunity to advance HIV research by forecasting the anticipated benefits and consequences of evidence-based practices, interventions, or strategies prior to implementation into healthcare, public health, and community-based settings. The promise of using “big data” to more precisely identify the prevention, diagnosis, treatment, and response needed to end the HIV epidemic in priority populations has been identified as a priority area by the U.S. Department of Health and Human Services, but these data-driven approaches must also consider the expertise of the population of interest, who can provide valuable insight about the complex social-environmental context in which they live, work, learn, and interact with others. Optimizing data-driven discoveries by engaging community members, end-users, and other interested/affected parties in the identification, development, and modeling of interventions and the use of data science methods to identify the implementation impacts of an intervention prior to implementation in real-world contexts is critical for delivering precision public health that will have a meaningful and sustained impact on the HIV epidemic.

Conventional data and implementation science research efforts have focused on identifying strategies for improving the uptake of evidence-based HIV interventions, but these efforts could be enhanced by capitalizing on the synergy between data and implementation science. Complex public health problems require collaborative and cross-disciplinary approaches to understand the interplay of complex, dynamic, and evolving individual, community, social, and structural factors that influence HIV outcomes and disparities over time and allow for a deeper understanding of the strategies that are most likely to improve HIV outcomes. Systems science approaches that include interested/affected parties are critical for ensuring that strategies for HIV prevention and treatment are rooted in the local context, can address local priorities, and are positioned for real-world impact. Collaborative, participatory, and team-based systems science research can leverage the strengths and expertise of a diverse group of interested/affected parties, implementing partners, and data and implementation scientists to accelerate efforts to end the HIV epidemic.

Objectives and Scope

The overarching objective of this NOFO is to accelerate the implementation of more targeted and sustainable interventions to improve HIV prevention, treatment, and care, which is closely aligned with the priorities of the NIMH Division of AIDS Research, the NIH Office of AIDS Research, and the U.S. Department of Health and Human Services. As such, this NOFO aims to support phased collaborative data science and implementation science research projects that uses a multi-stage participatory simulation modeling approach to more effectively address the HIV prevention and treatment needs of the population.

Research applications must propose a multiple Principal Investigator/Project Director (MPI) plan for collaborative data science and implementation science research with the goals of: 

• using data science methods to model complex systems, including the social and structural determinants of health, to identify more targeted HIV prevention, treatment, and care interventions and implementation strategies;
• identifying novel measurement approaches and using modern statistical methods to evaluate the implementation of data-driven discoveries; and
• integrating meaningful engagement of community and implementing partners at every stage, from problem definition and system conceptualization to development of the model, testing and evaluation, including simulating and evaluating implementation impacts prior to implementation, to intervention implementation, and finally evaluation and reflection.

Inherent in this NOFO is the need to integrate team science and systems science principles and practices to more clearly identify the prevention, diagnosis, treatment, and response required for a meaningful and sustained impact on the HIV epidemic. 

Applicants may propose any modeling approach appropriate for understanding complex, dynamic systems (e.g., system dynamics, agent-based modeling) impacting HIV prevention, treatment, or care. Investigators are strongly encouraged to also explore mental health as a factor impacting the effectiveness of evidence-based practices, interventions, and strategies across the HIV prevention and care continuum. The pilot implementation test of the strategy must include not only measures of effectiveness but also implementation process measures (e.g., adoption, reach) as appropriate to the research questions, population, and setting. An implementation framework or model (e.g., Consolidated Framework for Implementation Research [CFIR], Reach, Effectiveness, Adoption, Implementation, and Maintenance [RE-AIM]) must be identified to guide the study design and evaluation methods. Applicants should identify the NIH Office of AIDS Research Priority Area in which their research will address. 

Phased Innovation Award

This NOFO uses the Phased Innovation Award Mechanism (R21/R33) to provide up to 2 years of R21 support for initial activities and up to an additional 3 years of R33 support for expanded activities to support innovative participatory data science and implementation science research for the prevention, diagnosis, treatment, and response needed to end the HIV epidemic. The R21 phase may not exceed 2 years of support and the R33 phase may not exceed 3 years of support. Transition to the R33 phase is not guaranteed for all grants awarded under this NOFO. Continuation from the R21 phase to the R33 phase will be determined by the NIMH’s Division of AIDS Research (DAR) staff based on progress achieved in the R21 phase and other factors such as program priorities and availability of funds.

Proposed projects must include both an R21 phase, with milestone-driven development activities, and an R33 phase, with expanded activities that will extend the initial model development, testing, and simulation phase (Phase I) for implementation and evaluation (Phase II) with the end goal of achieving the aims of the entire award. The transition from the R21 to the R33 phase will be based on successful completion of established milestones for the R21 phase and other factors such as program priorities and availability of funds. Applications proposing only R21 or R33 activities will not be accepted under this NOFO.

Preliminary data is not required for this mechanism but may be included if available. 

R21 Activities

Priority activities of the R21 phase include, but are not limited to, the following:

1. Establish (a) partnerships with community and implementing partners and other interested/affected parties to identify, describe, and understand the problem and (b) expectations with participants about the importance of integrating diverse perspectives to achieve a greater understanding of the problem to be addressed. Interested/affected parties include, but are not limited to, individuals with lived experience, end-users and/or the beneficiaries of the HIV prevention, treatment, or care practices, interventions, or strategies that will be implemented.
2. In collaboration with data and implementation scientists, community and implementing partners, and other interested/affected parties, clearly define the problem, identify, define, and prioritize key variables, conceptualize the problem (i.e., reference modes), collaboratively reflect on the reference modes to gain insights, and generate a dynamic hypothesis (i.e., reference modes and causal loops) reflecting the problem. Multiple opportunities should be offered for active participation to ensure that the concerns of the partners and interested/affected parties are reflected throughout the process. 
3. Design the model, test, and evaluate using evidence (i.e., data and expertise of the community partners, implementing partners, and others); identify relevant data sources to parameterize the model and any relevant population characteristics (e.g., race/ethnicity, sex/gender) in collaboration with relevant parties.
4. Use the model to simulate alternative scenarios to forecast the potential impact of implementing one or more strategy(ies), alone or in combination, to be piloted in the R33 phase; using a participatory team science approach, evaluate the trade-offs among competing strategies and establish a consensus for recommended HIV prevention, treatment, or care practices, interventions, or strategies that will be implemented.

R33 Activities

Activities of the R33 phase include, but are not limited to, the following:

1. Identify, select, and operationalize novel measurement approaches (e.g., observational methods; geospatial data) and metrics to evaluate the implementation processes and HIV-related outcomes (e.g., HIV testing, PrEP uptake); refine measures as appropriate.
2. Carry out a pilot study to evaluate implementation of one or more strategies identified in the R21 phase. Both implementation and HIV-relevant clinical or behavioral outcomes should be evaluated during the pilot phase. Applicants are encouraged to select implementation and/or HIV-related outcomes at two or more levels of influence (e.g., individual, provider, clinic, health system, etc.).
3. Compare model simulations with data obtained through the pilot study; engage partners and interested/affected parties in model evaluation, reflections, and insights. 
4. Use innovative methods and strategies to communicate critical insights from the research to inform a future implementation trial.

Transition from the R21 to the R33 phase:

• An initial award will be made for the R21 phase. Successful completion of established milestones will be used to assess potential transition from the R21 to the R33 phase.
• Prior to the end of the R21 phase, grantees must submit a transition package. The transition package must include a progress report describing activities during the R21 phase, completion of the established milestones, and updated plans for the R33 phase based on insights from the R21 phase.
• Transition packages will be reviewed by NIMH DAR staff. The transition from the R21 to the R33 phase will be based on successful completion of established R21 milestones and other factors, such as program priorities and availability of funds. If approved, the R33 will be awarded without the need to submit a new grant application.

Transition Criteria

Criteria to determine whether the award will transition from the R21 phase to the R33 phase will include the following:

1. Have the investigators built and meaningfully engaged a coalition of community partners, implementing partners, and interested/affected parties across all stages of the model development? Is there any evidence (e.g., acknowledgment, visibility, and recognition; documented attendance and retention rates; qualitative feedback) of participant engagement and mutually shared expectations about the importance of integrating diverse perspectives to achieve a greater understanding of the problem(s) addressed? 
2. Is there evidence of best practices used in problem identification, model conceptualization, formulation, calibration, simulation, and evaluation? Has the validity of the model (e.g., structural, behavioral) been established? If applicable, were model variables stratified by relevant population or other characteristics? Does the model reflect the documented concerns of the partners and interested/affected parties? How?
3. Is the evidence-based intervention and implementation strategy(ies) identified appropriate in the proposed setting? Is there group consensus on these proposed approaches? Were any concerns raised and, if yes, what strategies will be used to mitigate those concerns? Will it be feasible to carry out the implementation pilot study?

All applicants are expected to collect Common Data Elements (CDEs) for HIV-related human subjects research funded by the NIMH consistent with the NIMH Common Data Elements for HIV-Funded Research Policy (NOT-MH-23-105). The NIMH CDEs for HIV-funded research should be briefly described in the Data Management and Sharing Plan. All data, models, and related tools, software, and/or code, and findings from the awarded studies are expected to be shared using the NIMH Data Archives (NDA) consistent with the NIMH Data Management and Sharing Policy. 

Annual Meeting of the R21/R33 Awardees

All grantees are required to participate in two meetings during the R21 phase: (1) a virtual half-day kick-off meeting to provide an overview of the nature and purpose of each project and to foster collaborations among the PI/PDs, scientific staff, and other project personnel and (2) a one-day programmatic meeting to discuss project progress, challenges, and opportunities. The virtual kick-off meeting will take place during the first quarter of Year 1; the one-day in-person programmatic meeting will take place during the first quarter of Year 2. Applications must include a budget for the MPIs to travel to Bethesda, Maryland for the in-person meeting. The meetings are open to all investigators supported under this NOFO and to the Division of AIDS Research at the NIMH.

Pre-application Webinar

NIMH will host a webinar for all prospective applicants to provide an opportunity to ask questions related to the scientific scope of this NOFO and technical details for applying. Prospective applicants are encouraged to submit their questions regarding the NOFO in advance of the webinar. Further details on where and when to submit the questions will be provided once the webinar has been scheduled. Participants must register for the event but participation in the webinar is optional. Please visit the NIMH website for pre-application information and further details regarding the webinar for this specific NOFO.

Applications Not Responsive to the NOFO

An application will be considered non-responsive to this NOFO and will not be reviewed if it: 

• Does not include a MPI leadership plan that includes both a data scientist and an implementation scientist as principal investigators.
• Does not propose a modeling approach appropriate for understanding complex, dynamic systems.
• Does not include implementation science theories, models, and/or frameworks.
• Does not include a plan for meaningful engagement with community and/or implementing partners and other interested/affected parties.
• Does not propose a novel measurement approach for evaluating the relevant implementation and HIV outcomes.

Prospective applicants are urged to consult with the scientific contacts (jointly) listed in Section VII of this NOFO early in the pre-submission process to ensure that applications are responsive to the NOFO. Non-responsive applications will not be reviewed. 

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

Local 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)

Federal Governments

• 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)

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. 

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.

• 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; 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 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.

Research applications must propose a multiple Principal Investigator/Project Director (MPI) plan that includes a data scientist and an implementation scientist. 

Individuals with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigators) (PDs/PIs) are invited to work with their organization to develop an application in response to this NOFO. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support (see Notice of Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities).

The Multiple Program Director/Principal Investigator Policy and submission details can be found in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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 NOFO. 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 notice of funding opportunity 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.

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:

Email: [email protected]

Page Limitations

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

The biosketch should highlight PD/PI expertise and experience in data science and implementation science.

R&R Budget

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

Applications must include a budget for the MPIs to travel to Bethesda, Maryland for the one-day programmatic meeting to be held in-person at NIH during the first quarter of Year 2.

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:

Applications should clearly detail the following in the corresponding sections:

Specific Aims: 

• Describe and clearly identify the specific aims and provide an overview of the milestones for both the R21 and R33 phases of the proposed project. Proposed milestones should not be a restatement of the specific aims.

Research Strategy:

The Research Strategy must include a description of both the R21 and R33 phases as a single Research Strategy section. 

Significance (all of the following are required):

• Identify the NIH Office of AIDS Research Priority Area in which their research will address.
• Provide an overview of evidence-based HIV interventions in the setting and priority population of interest, gaps the project is intended to fill, and how partners and interested/affected parties will meaningfully contribute to the research.
• Describe the potential impact of the proposed project on advancing HIV intervention research by integrating data science and implementation science principles, methods, and approaches.

Investigators (all of the following are required):

• Provide evidence of the expertise of the members of the research team in HIV prevention and treatment research, data science, systems science, implementation science, community engagement, social determinants of health, or other relevant areas or disciplines, and how each member will contribute to the overarching goals of the project. 
• Delineate the role, activities, and engagement of the community and implementing partners and other interested/affected parties on the research team.

Approach (all of the following are required):

• Describe the research approach, including milestones, for both phases of the proposed project and distinguish clearly between the two phases.
• Identify milestones that will be reached by the end of the R21 phase with metrics to assess achievement of those milestones to enable the transition to the R33 phase. 
• Describe plans for meaningful engagement with community partners, implementing partners, and other interested/affected parties, including a discussion of the specific ways that participation will inform the model development process, and a description of the activities or processes that will facilitate equitable and engaged decision-making and/or consensus building.
• Specify the modeling approach and describe how it will be used to define and conceptualize the problem, build, test, and evaluate the model. Describe how the model will be calibrated and validated.
• Describe the relevant data source(s) expected to be used and available variables.
• Specify the implementation science theory(ies), model(s), or framework(s) being used and how it/they will guide model development, intervention and/or strategy selection, and pilot testing.
• Delineate the expected study design, study setting, and population, as well as plans for recruitment, measurement, data collection, and analysis for the pilot phase based on prior formative work and/or anticipated findings from the R21 phase. It is understood that the specifics of these components may change based on the actual findings of the R21 phase.

Letters of Support: Applications should include letters of support that provide evidence of a commitment from the community and/or implementing partners to actively participate in all stages of model development and implementation.

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.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

To advance the goal of advancing research through widespread data sharing among researchers, investigators funded under this NOFO are expected to share those data via the National Institute of Mental Health Data Archive (NDA; see NOT-MH-23-100). Established by the NIH, the NDA is a secure informatics platform for scientific collaboration and data sharing that enables the effective communication of detailed research data, tools, and supporting documentation. NDA links data across research projects through its Global Unique Identifier (GUID) and Data Dictionary technology. Investigators funded under this NOFO are expected to use these technologies to submit data to the NDA.

To accomplish this objective, it will be important to formulate a) an enrollment strategy that will obtain the information necessary to generate a GUID for each participant, and b) a budget strategy that will cover the costs of data submission. The NDA website provides two tools to help investigators develop appropriate strategies: 1) the NDA Data Submission Cost Model which offers a customizable Excel worksheet that includes tasks and hours for the Program Director/Principal Investigator and Data Manager to budget for data sharing; and 2) plain language text to be considered in your informed consent available from the NDA's Data Contribution page. Investigators are expected to certify the quality of all data generated by grants funded under this NOFO prior to submission to NDA and review their data for accuracy after submission. Submission of descriptive/raw data is expected semi-annually (every January 15 and July 15); submission of all other data is expected at the time of publication, or prior to the end of the grant, whichever occurs first (see NDA Sharing Regimen for more information); Investigators are expected to share results, positive and negative, specific to the cohorts and outcome measures studied. For more guidance on submitting data to NDA, refer to the NDA Data Sharing Plan on the NDA website. NDA staff will work with investigators to help them submit data types not yet defined in the NDA Data Dictionary.

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

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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 Institutions

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.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

NIMH expects investigators for this funding announcement to collect Common Data Elements (CDEs) for HIV-related human subjects research funded by NIMH. Unless NIMH stipulates otherwise during the negotiation of the terms and conditions of a grant award, this Notice applies to all grant applications involving human research participants. The necessary funds for collecting and submitting these CDE data from all research participants to the NIMH Data Archive (NDA) should be included in the requested budget. A cost estimator (https://nda.nih.gov/ndarpublicweb/Documents/NDA_Data_Submission_Costs.xlsx) is available to facilitate the calculation of these costs. NIMH may seek further information regarding CDEs prior to award. Details for HIV-funded NIMH research can be found at NOT-MH-23-105 and the NIMH webpage on Data Sharing for Applicants and Awardees.

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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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 NIMH, 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

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.

For this particular announcement, note the following:
 

The R21/R33 phased innovation grant supports investigation of novel scientific ideas or new interventions, model systems, tools, or technologies that have the potential for significant impact on biomedical or behavioral and social sciences research. An R21/R33 grant application need not have preliminary data, extensive background material or preliminary information; however, they may be included if available. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.  Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.  Reviewers will assign a single impact score for the entire application, which includes both the R21 and R33 phases.

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).

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.

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.

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.

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 will receive a written critique.

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.

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

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Mental Health Council. 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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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.

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

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, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients 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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 – Award Term and Condition 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.

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: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Please send all inquiries to BOTH contacts listed below: 

Lori A.J. Scott-Sheldon, Ph.D.
Division of AIDS Research
National Institute of Mental Health
Telephone: 301-792-2309
Email: [email protected]

Suzanne L. Pollard, Ph.D.
Division of AIDS Research
National Institute of Mental Health
Telephone: 301-761-6869
Email: [email protected]
 

Nicholas Gaiano, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-827-3420
Email: [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email:[email protected]

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.

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 and 2 CFR Part 200.