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.

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - 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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Background

Longitudinal studies of early childhood development have contributed to a substantial body of evidence regarding the impact of socioenvironmental factors, defined as variables in one’s social and physical environment that interact with and influence brain and cognitive function. As recent examples, prospective longitudinal studies such as the Adolescent Brain and Cognitive Development (ABCD) study are integrating approaches informed by public health, developmental cognitive psychology, and neuroscience to examine socioenvironmental factors impacting neurocognitive development and the emergence of risk phenotypes for substance use disorders (SUD) and their comorbidities. Importantly, these and similar studies are providing data needed for the application of computational approaches to build and test predictive and explanatory models of relationships between early life socioenvironmental factors and the maturation of neurocognitive and social behavioral processes relevant to SUD. However, to fully elucidate brain developmental mechanisms linking early social environment to SUD risk, complementary studies designed a priori to test hypotheses generated by these cohort studies are needed. 

Studies in non-human species are necessary for revealing fundamental, conserved neurobiological and neurobehavioral processes underlying cognitive function. Moreover, as we have an increasing array of tools that allow for a priori control of neural and environmental variables that cannot be experimentally manipulated in humans, translational research in non-human species (i.e. “animal models”) can be a powerful means of testing hypotheses generated from research in humans. There have been major advances in tools for high resolution tracking of neural development, as well as cell- and circuit-specific imaging, recording and manipulation in multiple species including rodents and primates, and the pace of innovation is increasing. In parallel, the computational tools needed for harnessing dense, multidimensional data sets have also advanced. Together these tools have dramatically increased our potential for discovery and deeper understanding of fundamental neurodevelopmental and neurobehavioral processes.

Of relevance to the broad question of developmental factors and processes that influence risk for, or resilience to, SUD, there is a rich body of research in non-human species examining neurobiological processes and socioenvironmental factors in the development and maturation of cognitive and behavioral function. There is also a large body of research using rodent and non-human primate species modeling phenotypes and examining neurocognitive mechanisms relevant to SUD. Yet there are relatively few studies designed to examine the neurocognitive developmental mechanisms and trajectories that may link early life socioenvironmental factors to vulnerability for, or resilience against, SUD in adolescence and adulthood; and very few of those apply advanced tools for molecular, cellular and circuit monitoring and manipulation. Moreover, while computational modeling has proven to be a powerful approach for revealing relationships between early-life social factors and SUD risk in humans, there is currently no resource that can be leveraged to build complementary and cross-informative computational models from animal model data, i.e. to reveal potential causal relationships across early socioenvironmental manipulations, neurobehavioral developmental trajectories, and the emergence of SUD-relevant neurocognitive phenotypes.

Translating Socioenvironmental Influences on Neurocognitive Development and Addiction Risk (TranSINDA) was created to address these gaps by supporting a set of coordinated research projects in animal models, featuring the use of advanced neuroscience and developmental cognitive approaches and research designs that will integrate 1) early-life manipulations designed to model socioenvironmental risk factors for SUD and their comorbidities, 2) longitudinal assessments of neurocognitive development, and 3) characterization of SUD risk-relevant neurocognitive function in adolescence and/or adulthood. This research program will additionally support coordinated generation of a data set to be leveraged for building computational models aimed at elucidating meaningful relationships linking early socioenvironmental conditions, neurocognitive developmental trajectories, and the emergence of SUD risk-relevant neurobehavioral phenotypes. If successful, the TranSINDA research program and database will lead to increased understanding of developmental windows that may be most sensitive to the effects of socioenvironmental factors, and discovery of new potential neurobehavioral and socioenvironmental targets for interventions to prevent SUD.
 

Purpose

The goal of this notice of funding opportunity (NOFO) is to support a multidisciplinary team to create the TranSINDA Data Coordination Center (DCC). The TranSINDA DCC will serve as the organizational hub for the management and sharing of data from TranSINDA Research Projects supported under RFA-DA-24-019 and RFA-DA-25-037 (and related notices) and, with the PIs/PDs of these research projects, establish the TranSINDA Consortium. The DCC will build a modern data ecosystem that integrates the data repository under common data standards and serves as a resource for software tools for large scale data query, analysis, visualization, and integration.  Although the DCC is not required to generate data, secondary data analysis may be performed.  

The TranSINDA DCC will direct activities in four essential areas: 1) Data Standards, 2) Data Management and Ecosystem, 3) Statistical and Modeling Support, and 4) Coordination, Dissemination and Education. Each application in response to this NOFO must address all four of these essential areas, according to the purpose and guidelines below:

1. Data Standards 
   • Guided by input from the TranSINDA Consortium, the DCC will establish a catalog of standards for TranSINDA research. This includes standards for data and metadata, along with data dictionaries and controlled vocabularies. This also includes domain-specific ontologies that capture various components of brain-behavior knowledge. This, in addition, includes standard operational procedures (SOPs) or best practices for data collection, processing, and analysis. The DCC is expected to leverage existing standards, ontologies, common data elements, well-established data collection approaches, data processing pipelines, and other tools which are suitable for TranSINDA studies. 
   • The DCC will coordinate implementation of the standards across TranSINDA research activities. This process will necessarily involve close collaboration and coordination with the TranSINDA Consortium. 
2. Data Management and Ecosystem
   • The DCC will work collaboratively with the TranSINDA Research Projects to manage data workflows. In the workflows, TranSINDA Research Projects will submit raw and/or processed data to the DCC. The DCC will curate and process the data, conduct necessary quality assurance (QA)/quality control (QC), and then coordinate with appropriate data repositories to ingest and deposit the data into the archive. The DCC will further validate, index, and harmonize the data, and make the data available for use by the scientific community. In this way, the DCC will serve as the organizational hub for rapid and seamless data management and sharing. 
   • The DCC will develop a cloud-based access and analysis platform that is integrated with the TranSINDA data archive and data standards. The platform will be implemented with a series of uniform data processing pipelines and cutting-edge software tools for data processing, analysis, visualization, harmonization, and integration. Future integration of cloud-based ML/AI tools for advanced modeling with TranSINDA data will be considered in the design of the data ecosystem.
   • The DCC is expected to consult or collaborate with informatics infrastructure projects relevant to the data produced by the TranSINDA Research Projects.
3.  Statistical and Modeling Support
   • The DCC, with input from the TranSINDA Consortium, will identify experts in statistics, formal theory and computational modeling who will provide input on design of TranSINDA experiments to assure creation of a database that integrates multimodal data from the TranSINDA Research Projects and is amenable to analysis with advanced statistical approaches and application of ML/AI tools for building and testing models.  
4. Coordination, Dissemination and Education
   • The DCC will work with NIH Staff and the PIs/PDs of the TranSINDA Research Projects to coordinate activities of the TranSINDA Consortium.  The coordination will include (but is not limited to) organizing meetings or/and working groups and maintaining consortium-relevant workflows, protocols, and documents. 
   • The DCC will make available to the TranSINDA Research Projects tools and resources for accessing and analyzing TranSINDA data, and will promote their dissemination to the broader research community. This includes (but is not limited to) developing, compiling and disseminating tutorials, detailed walkthroughs and other materials about TranSINDA studies, and developing best practices on the use of the TranSINDA dataset.
   • The DCC will organize training activities that serve the needs of TranSINDA investigators and can be extended to the broader research community. The topics of training include (but are not limited to) data processing, curation and analysis, data standards, computing on the cloud, and using the TranSINDA data ecosystem.
   • The DCC will develop and maintain the TranSINDA Web Portal, which will constitute the main entry point to consortium information, resources, and the TranSINDA Data Ecosystem to serve as the central site for internal and external communication, dissemination and training activities. 
   • In consultation with NIH Staff, the DCC will provide guidance on policy and ethics related to data sharing and use.
   • The TranSINDA DCC will coordinate, monitor and assist with implementation of the Data Management and Sharing Plans of the TranSINDA Research Projects.

With these and other efforts, the DCC will facilitate and promote open science approaches to TranSINDA data.

The PD(s)/PI(s) of the TranSINDA must have expertise in the coordination and management of multiple projects. Because TranSINDA Research Projects require longitudinal designs to interrogate neurobehavioral development, the DCC team must include expertise in longitudinal research designs.  Inclusion of expertise in creating standards and metadata for integrating data from different species is highly encouraged. 
 

Potential applicants are strongly encouraged to contact the Scientific/Research Contact identified in Section VII (Agency Contacts) of this NOFO early in the process of the application development.

Special Considerations

National Institute on Drug Abuse (NIDA) applicants are strongly encouraged to review the guidelines and adhere to the requirements applicable to their research listed in the Special Considerations for NIDA Funding Opportunities and Awards. Upon award, these considerations will be included in the Notice of Grant Award.

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

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation.  Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions.  Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

The PEDP will be submitted as Other Project Information as an attachment (see Section IV).  Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance materials.

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

All organizations administering an eligible parent award may apply for a supplement under this NOFO.

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 Government

• 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 (Organizations)

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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 How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information. 

• 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 registration; 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.

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - 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: NIDALetterofIntent@mail.nih.gov

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Plan for Enhancing Diverse Perspectives (PEDP)

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. 
• Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application.
• The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.
• The PEDP may be no more than 2 pages in length and should include:
  • Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project;
  • Description of how the PEDP will advance the scientific and technical merit of the proposed project;
  • Anticipated timeline of proposed PEDP activities;
  • Evaluation methods for assessing the progress and success of PEDP activities.

Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:

• Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).
• Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds.
• Description of planned partnerships that may enhance geographic and regional diversity.
• Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers.
• Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

Examples of items that are not appropriate in a PEDP include, but are not limited to:

• Selection or hiring of personnel for a research team based on their race, ethnicity, or sex.
• A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP guidance materials.

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

A detailed budget for the DCC covering the four essential areas of activities described in Section I, Purpose, must be presented.

PEDP implementation costs:

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7): https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Research Plan

The application must establish the expertise of the DCC PD(s)/PI(s) in the coordination and management of multiple projects, cloud-based data analysis, and data and resources dissemination. The team must include expertise in longitudinal research designs with multimodal data. Inclusion of expertise in building computational models with data from multiple species is highly encouraged.

The Research Strategy must include overall strategy, operational plan, and organizational structure appropriate for accomplishing the goals in the four essential areas of DCC activities: 1) Data Standards; 2) Data Management and Ecosystem; 3) Statistical and Modeling Support, and 4) Coordination, Dissemination, and Education.

The Research Strategy must include, but is not limited to:

• A strategy by which the DCC will support TranSINDA Research Projects and the TranSINDA Consortium. This strategy must address the leadership structure of the DCC. 
• Development and implementation of data standards, ontologies, and best practices for TranSINDA, including but not limited to standards for:
  • Data and metadata, along with data dictionaries and controlled vocabularies; and
  • Domain-specific ontologies that capture aspects of the scientific fields contributing to TranSINDA research.
• Data Management and Ecosystem activities including:
  • Developing and implementing data quality metrics and informatics tools or pipelines to assure data management and archiving with implementation of FAIR standards;
  • Conducting data processing, QA/QC evaluation, harmonization, ingestion, and submission of a TranSINDA data archive to a well-documented central repository with processes in place to assure access to the entire TranSINDA database by the research community;
  • Tracking TranSINDA data workflows and provenance and monitoring data use statistics and data users’ experience;
  • Establishing a cloud-based access and analysis platform and data ecosystem;
  • Establishing milestones of data submission by individual projects; and
  • Monitoring and reporting to NIH the submission and release status of data generated by TranSINDA Research Projects and otherwise assisting with the implementation of the Data Management and Sharing Plans of the TranSINDA Research Projects. 
• Statistical and Modeling Support including:
  • Making the appropriate statistical and computational expertise available to the TranSINDA consortium; and
  • Coordinating TranSINDA Consortium activities aimed at collaborative development and evaluation of research designs and data structures to assure potential to link data across modalities, scales, and species within and across different studies and to apply advanced statistical or computational models.
• Coordination, Dissemination, and Education activities through which TranSINDA DCC will curate, evaluate and implement broad dissemination of tools for accessing and analyzing TranSINDA data, including (but limited to):
  • Coordination of the TranSINDA Consortium, including organization of  meetings or/and working groups, planning for publications, and maintaining consortium-relevant workflows, protocols, and documents in a single location.
  • Developing, compiling and disseminating tutorials, walkthroughs and other materials about TranSINDA studies;
  • Developing training activities for TranSINDA and the broader research community;
  • Developing and maintaining a TranSINDA Web Portal, which will constitute the main entry point to consortium information, resources, and data ecosystem for internal and external users;
  • Assisisting with implementation of the Data Management and Sharing Plans of the TranSINDA Research Projects.

The proposed plan must address how the DCC will leverage future innovations and other changes in informatics and computational methods and tools, and innovations in best practices. Leveraging appropriate established standards, ontologies, common data elements, data processing pipelines, and open-access data repositories and informatics tools, is encouraged. 

The DCC is not required to generate scientific data. However, if the Research Plan of the proposed DCC includes secondary data analysis, the management and sharing of the derived data must be addressed in the Data Management and Sharing Plan of the DCC. 

The application must include a timeline for carrying out the research activities of the DCC that includes quantifiable milestones addressing the four required areas of DCC activities.

Potential applicants are strongly encouraged to contact the Scientific/Research Contact identified in Section VII of this NOFO as they develop the proposed planning activities. 

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide. 

Other Plan(s):

All instructions in the How to Apply - 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. 

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

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 How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

Foreign Organizations

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

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

See Part 2. 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

Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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 Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply - 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 How to Apply - Application Guide.

See more tips for avoiding common errors.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

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

Applications must include annual milestones for PEDP. Applications that fail to include annual milestones will be considered incomplete and will be withdrawn. Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be withdrawn before review. 

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov. 

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 NOFO, it is important to consider the following: 

The TranSINDA Program is built around the TranSINDA Research Projects, a set of research projects that will develop and test new animal models designed to elucidate mechanisms underlying the impact of early socioenvironmental conditions on neurocognitive development and the emergence of SUD risk-relevant neurobehavioral phenotypes in adolescence and adulthood. Each TranSINDA Research Project will develop and implement a study design integrating 1) early-life manipulations designed to model socioenvironmental risk factors for SUD and their comorbidities, 2) longitudinal assessments of neurocognitive development appropriate to the model species, and 3) characterization of SUD risk-relevant neurocognitive function in adolescence and/or adulthood. A major goal of the TranSINDA Program is to establish a consortium with the purpose of coordinating research designs, data generation and data management across the TranSINDA Research Projects, and to produce a data set to be leveraged by the research community for secondary analyses and building computational models.

The purpose of the TranSINDA Data Coordination Center (DCC) is to coordinate activities of the TranSINDA Consortium and serve as the organizational hub for the management and sharing of TranSINDA data. The DCC will be responsible for building a modern data ecosystem that integrates TranSINDA data under common data standards into a centralized data archive and serves as a resource for software tools for large scale data query, analysis, visualization, and integration.  The TranSINDA DCC will direct activities in four essential areas: 1) Data Standards, 2) Data Management and Ecosystem, 3) Statistical and Modeling Support, and 4) Coordination, Dissemination and Education.
 

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).

As part of the overall impact score, reviewers should consider and indicate how the Plan to Enhance Diverse Perspectives affects the scientific merit of the project.

Scored Review Criteria

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

Significance

Does the proposed Data Coordination Center address the needs of the research program that it will serve? Is the scope of activities proposed for the Data Coordination Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research program?  

Specific to this NOFO:

• How effectively will the proposed DCC coordinate the multiple research projects contributing to the TranSINDA Program and establish a data ecosystem that assures access and use of TranSINDA data?
• How likely is the proposed DCC to enhance the impact of the TranSINDA program by serving as an organizational hub for the management and sharing of data from the TranSINDA Research Projects and establishing a modern data ecosystem that serves as a resource for software tools for large scale data query, analysis, visualization, and integration?

Investigator(s

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

Specific to this NOFO:

• How well does the investigators’ expertise assure coordination of multiple projects and management of multimodal data generated from longitudinal research designs using animal models? How strong is the expertise in developing cloud-based platforms for accessing data and related analytic tools?
• How will the proposed leadership structure of the DCC contribute to the goal of the development and execution of an organizational hub for the management and sharing of TranSINDA data?

Innovation

Does the application propose novel organizational concepts or management strategies in coordinating the research resources of the program the Data Coordination Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Specific to this NOFO:

• To what degree does the proposed plan position the DCC for leveraging or driving innovations in informatic and computational approaches and best practices for data dissemination?

Approach

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

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?

Specific to this NOFO:

• How feasible and functional are the proposed practices and tools for the following required functions of the DCC:
  • Development and implementation of data standards, ontologies and best practices for managing data from the TranSINDA Research Projects.
  • Development of a data ecosystem that:
    • Performs quality assurance/quality checking evaluation of data;
    • Manages harmonization, ingestion and submission of data to well-documented repositories with practices that assure broad access by the research community;
    • Tracks data workflows, provenance, and use;
    • Establishes a cloud-based platform for access and analysis; and
    • Establishes milestones of data submission by individual projects and monitors and reports the submission and release status of data generated by TranSINDA Research Projects. 
  • Statistical and Modeling Support, including but not limited to coordination of data structures across TranSINDA Research Projects to assure the potential to link data across modalities, scales, and species, within and across different studies, using advanced statistical or computational models.
  • Coordination, Dissemination, and Education activities through which TranSINDA DCC will curate, evaluate and implement broad dissemination of tools for accessing and analyzing TranSINDA data, including but not limited to:
    • Coordinating activities of the TranSINDA Consortium including meetings, consortium-relevant workflows, protocols and documents;
    • Developing training activities and compiling and disseminating tutorials, walkthroughs and other materials about TranSINDA studies;
    • Developing and maintaining a web portal which will constitute the main entry point to consortium information, resources, and data ecosystem for internal and external users; and
    • Coordinating with NIH staff to provide guidance on policy and ethics related to data sharing and use.
• How feasible and measurable are the proposed timeline and milestones for the DCC?
   

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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

Applications from Foreign Organizations

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.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIDA 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 Council on Drug Abuse. 

The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project, including the PEDP, as determined by scientific peer review
• Availability of funds.
• Relevance of the proposed project to program priorities.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• Provide scientific and administrative leadership of the DCC.
• Develop and implement the strategy by which the DCC will coordinate, disseminate, and support analysis of the data generated by the TranSINDA Research Projects. The DCC PDs/PIs will develop the strategy according to the requirements described in Part 2. Section IV, Research Plan of this NOFO, specifically addressing: 1) development and implementation of data standards, ontologies, and best practices for TranSINDA Research Projects; 2) development of a data management ecosystem; 3) providing statistical and modeling support; and 4) coordination, dissemination and education activities to support use of TranSINDA data.
• Serve as a member of the DCC Steering Committee and attend meetings.
• Implement common guidelines and procedures approved by the DCC Steering Committee and NIH.
• Coordinate the TranSINDA Consortium, including coordinating and attending consortium meetings. The DCC PI(s)/PD(s) will also represent the DCC as a voting member of the Consortium.
• Adhere to NIH policies regarding intellectual property and other policies that might be established during the course of the study.
• Keep confidential information obtained from other members of the consortium.
• Accept close coordination, cooperation and participation of NIH program staff in the scientific, technical and administrative management of the DCC.
• Inform the NIH program official of all major interactions with the rest of the community.
• Provide updates at least annually on progress in PEDP implementation. 
• Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

• A Project Scientist will also be assigned to this award. The Project Scientist will interact scientifically with the PD(s)/PI(s) and other personnel of the DCC as a partner in the research, and provide technical assistance and advice, to facilitate coordination of the DCC and TranSINDA Consortium. The Project Scientist will be a member of the TranSINDA Consortiumand participate in the meetings of the Consortium, as well as other meetings of the DCC.
•  A Program Officer will be assigned to this award. The Program Officer will be responsible for routine scientific and programmatic stewardship and guidance for the entire project. The Program Officer will also negotiate milestones with the DCC PD(s)/PI(s) and ensure that the milestones are being met. The Program Officer will moreover be responsible for monitoring the resource sharing plans of the DCC. The Program Officer may, as needed, attend TranSINDA Consortium meetings and other relevant meetings of the DCC.

Areas of Joint Responsibility include:

• A TranSINDA Consortium will be created by, and consist of, the PI(s)/PD(s) of the DCC (this award), the PI(s)/PD(s) of the TranSINDA Research Projects, and the NIH Project Scientists for the DCC and Research Projects.  The DCC PI(s)/PD(s) will co-chair and coordinate the meetings of the TranSINDA Consortium. At the inaugural meeting of the Consortium, the DCC PI(s)/PD(s) will oversee election of the additional co-chair(s) from the PI(s)/PD(s) of the TranSINDA Research Projects. The Consortium Co-Chairs will establish the governance structure of the Consortium and oversee meeting frequency and protocols. The DCC and Research Project PI(s)/PD(s) will serve as members with one vote per award; NIH Project Scientists will have one collective vote.  NIH Program Officers may participate in Committee meetings as non-voting members.  
• A Steering Committee will be established for this award to provide guidance on DCC activities, including establishment of DCC policies and protocols, research priorities, optimal research designs, and coordination of the TranSINDA Consortium; and to advise on milestones and progress of the DCC.  The Committee will also help in establishing working groups as needed to address particular issues and interests of the TranSINDA DCC and Research Projects. The Steering Committee will be assembled by the DCC PI(s)/PD(s) and be composed of the DCC PI(s)/PD(s), key investigators from the TranSINDA Research Projects selected by the TranSINDA Consortium, and the NIH Project Scientist for the DCC. As necessary, and with approval of the NIH Program Officer, the Steering Committee may invite external experts to participate in Committee activities. The Committee will be chaired by the PD(s)/PI(s) of the DCC and may be co-chaired by other TranSINDA Research Project PD(s)/PI(s) as designated by the Committee. The structure and governance of the Steering Committee, including meeting frequency and protocol, will be determined by the Chair(s) with input of the Committee.  The PI(s)/PD(s) of the DCC and Research Projects will serve as voting members with the DCC and each Research Project holding one vote; NIH Project Scientists will participate as voting members with one collective vote. NIH Program Officers may participate in Committee meetings as non-voting members.  

Dispute Resolution:

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

3. Data Management and Sharing

Consistent with the 2023 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 Section 8.4.1 Reporting.  To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

• Awardees will provide updates at least annually on implementation of the PEDP.

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 Section 8.6 Closeout. 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 2 CFR Part 200.301.

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: GrantsInfo@nih.gov (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: support@grants.gov

Holly Moore, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-7376
Email: holly.moore@nih.gov

Dharmendar Rathore, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6965
Email: dharmendar.rathore@nih.gov

 Garlin Hallas
National Institute on Drug Abuse (NIDA)
Telephone: 301-827- 4507
Email: garlin.hallas@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.

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 2 CFR Part 200.