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 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

This is a non-competitive funding opportunity intended to fund a single award. The National Institute on Drug Abuse (NIDA) is announcing its intent to issue a single source cooperative agreement award to the University of Maryland Baltimore to 1. Coordinate all the data generated by the SCORCH consortium, 2. Analyze all the data generated by the SCORCH consortium, 3. Perform necessary SCORCH program scientific outreach activities, and 4. Support SCORCH consortium communication. The current SCORCH Data Center is integrated with the rest of the SCORCH consortium and is familiar with the current data, metadata, and data quality metric standards and data pipelines. They were involved in establishing these standards and have been/are working closely with key personnel on SCORCH data generation projects to ensure data and associated metadata are deposited. Continued support of the University of Maryland Baltimore SCORCH Data Center to complete the SCORCH Program activities will enable seamless SCORCH data coordination and archiving, will prevent disruption in data analysis, and will allow continued support of the currently existing SCORCH website which is the scientific face of the SCORCH program.

Background

Single Nucleus Assays: Molecular analysis of brain tissue typically relies on ensemble averaging of heterogenous mixtures of cell types within a specific brain region. However, technological advances enable molecular characterization of large numbers of individual cells. Single cell approaches can uncover effects on rarer cell types and have the potential to reveal cellular differences resulting from specific niche environments or transitory cellular states. Some single cell technologies in use include single cell RNA-sequencing (scRNA-seq), single nucleus RNA-sequencing (snRNA-seq), single nucleus assay for transposase-accessible chromatin-sequencing (snATAC-seq), single cell Hi-C, and spatial genomics approaches such as multiplexed fluorescence in situ hybridization (FISH). Individual researchers as well as large project teams including the Human Cell Atlas, Common Fund Human BioMolecular Atlas Program (HuBMAP), and NIH BRAIN Initiative Cell Atlas Network (BICAN) are exploiting these technologies to understand the diversity of cell types within the human body as well as their functions in human health and disease.

Addictive Substances. Chronic exposure to addictive substances can lead to long term changes in brain function and to substance use disorders (SUDs). Many known brain regions are involved in addictive processes including the prefrontal cortex, nucleus accumbens, ventral tegmental area, striatum, insula, amygdala, and hippocampus. Despite great advances in our understanding of molecular pathways and circuits involved in SUDs, there remains limited knowledge concerning 1. The specific types, numbers, and gene expression profiles of cells within these brain regions and 2. How exposures to addictive substances influence the states and functions of these cells.

HIV/ART. Antiretroviral therapy (ART) has, in large part, transformed the HIV epidemic into a chronic manageable disease in the United States. However, people living with HIV remain at higher risk for impaired cognitive functions (e.g. HIV-Associated Neurocognitive Disorder [HAND]). Use of addictive substances by HIV-infected individuals has the potential to further alter immune function and/or exacerbate HIV-related CNS impairment. However, little is known about 1. The effects of persistent HIV infection or HIV treatment regimens on gene expression in specific CNS cell types in key brain regions, or 2. How chronic addictive substance use might modify these effects.

SCORCH. The Single Cell Opioid Responses in the Context of HIV (SCORCH) consortium was formed to begin to address scientific questions about addiction and HIV/ART questions at the single cell level. Fifteen funded SCORCH data generation projects (NIDA SCORCH Program) have been generating brain snRNA-seq or snATAC-seq data. Four brain types are being assayed by all groups: control, drug-exposed/SUD, HIV+, and HIV+drug exposed/SUD. Emphasis is on individuals with chronic exposure to opioids, cocaine, methamphetamine, or cannabinoids. Four groups are generating data from non-human primate brain, four from rodent brain, and nine from human post-mortem brain with some data from human organoids as well. The SCORCH data coordination, analysis, and scientific outreach center was established to standardize and share the single cell molecular HIV/SUD data generated by this program by ensuring that the data is FAIR (Findable, Accessible, Interoperable, and Reusable). Harmonized molecular and single cell HIV/SUD data sets will enable data mining by the scientific community to uncover new HIV and/or SUD mechanisms and to identify candidate pathways for therapeutic intervention. The SCORCH Data Center will also enable future mining of these data sets as improved data science and information technology approaches are developed, maximizing NIDA ’s original investment in the data generating activities.

Scope. The proposed project should be framed to answer one or more vexing questions about persistent HIV infection in the brain. In addition, the major thrust of the proposed project MUST:

• Propose to coordinate and analyze single cell and other molecular data sets generated by SCORCH and other NIDA-funded HIV and substance use disorder projects.
• Propose to make this data findable, accessible, interoperable, and reusable (FAIR) to enable secondary analyses by the scientific community.

Applicants are encouraged to contact NIDA program staff to answer any questions. Key activities of the SCORCH Data Center will be to:

• Work with SCORCH consortium members to ensure that all data and metadata have standardized formats and associated quality metrics and have been processed through standardized pipelines.
• Associate new SCORCH data with clinical metadata from the appropriate brain banks or tissue sources.
• Work closely with the SCORCH consortium PD(s)/PI(s) to analyze the data generated, to develop analysis strategies to integrate the datasets in synergistic ways with other relevant datasets, and to share useful information and insights about these data with the broader biomedical research community. It is anticipated that the SCORCH Data Center will lead an integrative analysis of all the SCORCH single cell data in a capstone publication.
• Develop strategies to enable and improve coordination, analysis, and sharing of spatial genomics and related data types.
• Develop strategies to enable and improve coordination, analysis, and sharing of data types from spatially and/or functionally resolved cellular assemblies relevant to HIV or addiction. Examples include but are not limited to anatomical structures, functional networks and ensembles characterized under PAR-20-241/ RFA-DA-22-011/ RFA-DA-23-035 Large Scale Integrated Mapping and Molecular Profiling of Cell Ensembles and/or Cell-Types Mediating Opioid Action in the Rodent Brain and RFA-DA-23-036 Investigating the Effects of Addictive Substances on Brain Developmental Trajectories Using Innovative Scalable Methods for Quantification of Cell Identity, Lineage and Connectivity.
• Archive raw and processed datasets generated by the SCORCH consortium in appropriate NIH-supported archives.
• Maintain, and improve a website to serve as a community-wide nexus for SCORCH protocols, assay and data standards, raw and processed data, data pipelines, and other resources generated by the consortium.
• Facilitate SCORCH data use by the scientific community for data mining to identify candidates for SUD and/or HIV therapeutic targets or to investigate SUD or HIV mechanisms. Provide user-friendly access to consortium data and by identifying or generating robust tools to enable both naive and experienced investigators to query, integrate, analyze, and model the data.
• Develop workshops and implement a community outreach strategy to inform the research community of the accomplishments of the SCORCH program and disseminate information about the community resources and data generated by the program.
• Coordinate SCORCH consortium activities by organizing steering committee meetings, workgroup meetings, external program consultant logistics, and other awardee meetings as needed.

Plan for Enhancing Diverse Perspectives :

• This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310, 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 material. The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions.

Special Considerations

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.

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

Only the following applicant may apply for this single source funding: University of Maryland Baltimore. Please refer to Section I. Notice of Funding Opportunity for more details.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted 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 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.

Only the PI/PDs associated with the award issued under RFA-DA-19-038 to the University of Maryland Baltimore are eligible to apply for this single source funding. Please refer to Section I. Notice of Funding Opportunity information for more details.

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 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).

Only a single award will be issued to the University of Maryland Baltimore under this single source funding opportunity. Please refer to Section I. Notice of Funding Opportunity Information for more details.

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 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 protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed with the following exceptions:

Overall Project Specific Aims: 1 page limit

Data Coordination Component: 6 page limit

Data Integration and Analysis Component: 6 page limit

Scientific Outreach Component: 6 page limit

Consortium Logistics Component: 6 page limit

Research Management Component: 6 page limit

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.

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

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

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

Other Attachments:

Plan for Enhancing Diverse Perspectives

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity
• The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate.
• Where possible, applicant(s) should align their description with these required elements within the research strategy section
• 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 1-page in length and should include a timeline and milestones for relevant components that will be considered as part of the review

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

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp

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

R&R Budget

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

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 SF424 (R&R) Application Guide must be followed.

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

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

Specific Aims: The overall programmatic goal is to continue SCORCH Data Center efforts to coordinate, curate, analyze, and provide public access to single cell SCORCH datasets and other NIDA-generated molecular HIV/SUD data. The SCORCH Data Center will also be responsible for integrating the efforts of all funded components of the NIDA SCORCH program and serve as a community-wide nexus for single cell protocols, data, assay and data standards, and other resources generated by the program. The application should be framed to answer one or more vexing questions about persistent HIV infection in the CNS in each proposed aim. Describe the specific aims of the UM1 for the performance period of this project.

Research Strategy: The research strategy should address the following items and in particular describe: 1. SCORCH Data Center activities in each area to date, 2. The proposed goals for the upcoming SCORCH Data Center project period and how they are aligned with the actual needs of the SCORCH consortium, and 3. The activities proposed to achieve these goals.

Data Coordination Component

The SCORCH Data Center will develop an overall data coordination plan that maximizes data transportability and data interoperability, given the rapidly changing landscapes for data access and data integration. We anticipate that the datasets handled by the Scorch Data Center will consist of single nucleus and other molecular data. However, the Center should indicate how it can be nimble and shift to coordination of other data types as needed. Applicants should describe any experience in successfully leading the coordination of data intensive activities and high-throughput datasets and should describe their plans for addressing some of the anticipated activities of the Center which include:

• Leading the consortium to establish the exact types and formats of data that will be transferred to the SCORCH Data Center and develop data verification, validation, and quality metrics pipelines.
• Leading the consortium to develop and define required single nucleus data and metadata standards for the assays included in the study, including common data elements using well-defined formats and associated controlled vocabularies. Include plans for de-identification of any data.
• Maintaining a user-friendly web-based system to enable secure upload of metadata and data from the consortium to the SCORCH Data Center.
• Working with consortium members to establish regular data freezes to quantify productivity and facilitate analysis activities.
• Making all data and metadata submitted to the Center rapidly available through the portal to the data generators, the SCORCH consortium, and ultimately to the scientific community.
• Working with SCORCH data generators and NIH staff to deposit and make human SCORCH genomic data through dbGaP.
• Maintaining a process for accepting or incorporating other relevant data types/sets that may facilitate our understanding of single cell HIV/SUD data that are produced outside the consortium. This should include assessing and improving data pipeline development and maximizing the value of the datasets generated.
• Planning to work with NIH staff to identify around 30 NIDA-funded high value HIV/SUD datasets (e.g. transcriptomic, epigenomic, gene variant, other omics) and work to reverse engineer common data and metadata standards to facilitate use by the scientific community.
• Maintaining an export pipeline to permit timely transfer of data from consortium data freezes or publications to appropriate public repositories and community databases. Regardless of where datasets are deposited, the SCORCH Data Center will provide access to SCORCH data and metadata for the duration of the consortium. Data and metadata must be available in standard formats to facilitate additional analysis by members of the consortium and the broader scientific community.
• Developing strategies to enable and/or improve coordination of spatial genomics and related data types as well as data from spatially and/or functionally resolved cellular assemblies relevant to HIV or addiction.

Data Integration and Analysis Component

The SCORCH Data Center PD(s)/PI(s) will work closely with the rest of the consortium PD(s)/PI(s) to facilitate analysis of the data obtained by PD(s)/PI(s) within the project. The PD(s)/PI(s) will establish the overall data integration and analysis priorities for the consortium. The Center should plan to provide substantial support for consortium-wide integrative analysis efforts. We anticipate that the datasets to be integrated will consist of single nucleus and other sequencing-based data. Applicants should describe prior experience in successfully leading the analysis of large sequencing-based datasets and describe their plans to address some of the anticipated activities of the SCORCH Data Center which include:

• Leading an Analysis Work Group (AWG) made up of members of the SCORCH Data Center and other consortium members with appropriate statistical expertise to integrate and analyze all data sets generated by the consortium. Machine learning, artificial intelligence, and other novel analysis methods are encouraged.
• Leading the consortium in publishing a capstone integrative analysis of all SCORCH-generated data.
• Providing user-friendly data analysis tools to help members of the scientific community analyze data generated by the consortium.
• Developing uniform data processing pipelines to standardize the single nucleus analyses, access the quality of consortium data, and integrate and analyze relevant HIV/SUD and other datasets and data types.
• Analysis of environmental effects on single nucleus data sets which will be challenging. The SCORCH Data Center should propose to develop strategies or tools to identify rare but significant effects from the high dimensional data that will be obtained.
• Developing strategies to enable and/or improve analysis and sharing of spatial genomics and related data types as well as data from spatially and/or functionally resolved cellular assemblies relevant to HIV or addiction.

Scientific Outreach Component

The SCORCH Data Center PD(s)/PI(s) will work closely with the rest of the consortium to obtain protocols, data, etc. to: 1. Provide the scientific community with user-friendly, publicly accessible SCORCH consortium information, and 2. Make the scientific community aware that this information is available for their use. Applicants should describe any prior experience in successfully communicating scientific information to experts and non-experts and should describe their plans to address some of the anticipated activities of the Scientific Outreach Component. Major anticipated activities include the following areas.

Area 1: Maintain and improve a publicly accessible SCORCH website or portal. The website or portal will provide access to:

• Public items such as information on study design, protocols, data and metadata standards, data pipelines, data sharing and publication policies, etc.
• A summary of all available datasets generated by the SCORCH consortium. The website or portal should strive to incorporate data visualization tools to create intuitive and user-friendly datasets.
• Metadata-enabled common data element querying to identify available data subsets of interest. Links should provide a description of the data and any associated metadata. The website or portal should, to the extent possible, provide access to a method to easily download large datasets so that users can acquire and analyze all or large parts of the data. The website or portal should support data retrieval for any data deposited in the consortium database or other public databases.
• A secure consortium intranet to enable consortium members to access materials or data not yet released to the public.
• The website or portal should contain links to any social media sites that will be used by the consortium. Appropriate social media activities to promote the consortium are encouraged.
• Identification of key use cases for HIV/SUD single cell and other molecular data sets by the scientific community and implementation of plans to address these use cases.

Area 2: Develop an outreach strategy to disseminate available SCORCH consortium protocols, standards, data, and other resources to the scientific community. The outreach should include:

• Plans for sponsorship of workshops or sessions at scientific meetings to facilitate use of datasets by scientists beyond the consortium.
• Plans for publishing white papers on best practices and considerations for data collection, pre-processing, analysis, etc.
• Working with the SCORCH consortium to implement a public data release policy and publication policy congruent with that of a community resource project while simultaneously protecting human subjects.

Consortium Logistics Component

The SCORCH Data Center will dedicate some effort to logistical activities and will collaborate closely with NIH staff, and consortium PD(s)/PI(s). Applicants should describe their plans to address some of the anticipated critical activities of the Consortium Logistics Component which include:

• Facilitating communication and interaction between the various SCORCH Data Center components and across the SCORCH consortium, including providing call-in numbers, setting up teleconferences, and providing internet-based resources such as mailing lists, a wiki, file sharing, and/or social media tools to share data and enable discussions within the consortium.
• Serving as a central hub to organize recurring face-to-face and virtual consortium meetings. The Consortium Logistics Component should provide logistical support for a yearly in-person meeting of the consortium. At some point, this meeting might be expanded to include attendees beyond the consortium to maximize scientific outreach. The SCORCH Data Center should budget for in person meeting logistics and AV support. The SCORCH Data Center should also budget for travel of its own staff, as well as travel and honoraria for occasional keynote speakers or other relevant extramural attendees including external program consultants (no more than 7 per in person meeting). All other meeting attendees will pay for travel and lodging via their own funds.
• Providing NIH staff with real time (or as needed) quantitative updates on data deposition, data quality, and data usage statistics.

Research Management Component

SCORCH Data Center key personnel/consultants should demonstrate strong scientific expertise in the areas of single nucleus technologies, analysis of these data types, as well as the effects of persistent HIV and chronic opioid exposure on the brain.

• The effective management of the SCORCH Data Center requires a significant commitment by the PD(s)/PI(s) and the leaders of the individual Data Center components. Applicants should describe how s/he will manage the proposed project, who will oversee the day-to-day activities (e.g. a project manager if not the PD(s)/PI(s)), and how the management structure will support achievement of the proposed goals and milestones. Any experience coordinating large projects should be described.
• If selected for funding, applicants will work with NIH staff to develop granular milestones for each year of funding.
• It will be difficult to predict the exact volume and types of data that will be submitted over the lifetime of the SCORCH consortium. Potential changes in technology platforms or the assessments being performed by the consortium may dramatically alter the type and volume of data. Applicants should describe how they will prioritize their activities to ensure that the main goal of the SCORCH consortium, the generation and analysis of snRNA-seq datasets for at least one brain region relevant to persistent HIV infection and opioid use disorder, will be achieved.
• As the data storage, analysis, and dissemination needs of the consortium change with time, components of the SCORCH Data Center may be asked to implement modifications to their workflows as agreed upon by the consortium. All components of the SCORCH Data Center should indicate their willingness to be flexible in their implementation of data coordination, analysis, and outreach workflows.

After award selection but prior to funding, the prospective awardee(s) for the SCORCH Data Center components will be asked to submit revised budgets and research plans for all proposed Data Center components and the administrative core.

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.

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

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

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

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 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 SF424 (R&R) 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.

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 NIDA, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications must include annual milestones. 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.

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.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this NOFO:

• If the proposed SCORCH Data Center is fully successful in carrying out its plans, how will it have a transformative effect on the scientific field?
• How well will the proposed work transform our ability to assess the effects of persistent HIV and chronic addictive substance exposure on the brain at the single cell level?
• To what extent do the efforts described in the Plan for Enhancing Diverse Perspectives further the significance of the project?

Investigator(s)

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

Specific to this NOFO:

• How do SCORCH Data Center key personnel/co-investigators/consultants demonstrate strong scientific expertise in persistent HIV and chronic addictive substance exposure on the brain?
• To what extent are the leadership plans, experience, and levels of effort appropriate for managing a project of this magnitude?
• To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives strengthen and enhance the expertise required for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this NOFO:

• To what extent are machine learning, artificial intelligence, or other novel methods proposed?
• To what extent will the efforts described in the Plan for Enhancing Diverse Perspectives meaningfully contribute to innovation?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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 well have the applicants carried out SCORCH Data Center activities to date?
• How well are the proposed goals for the upcoming SCORCH Data Center project period aligned with the actual needs of the SCORCH consortium?
• How appropriate and achievable are the activities proposed to achieve these goals?
• How well will the approach proposed by the applicant enable the SCORCH Data Center components to integrate the efforts of the funded components of the program and serve as a community-wide resource?
• How does the Data Center overall plan allow for data transportability and data interoperability in the future?
• How suitable is the applicant's plan for enabling and/or improving analysis of spatial genomics and related data types as well as data from spatially and/or functionally resolved cellular assemblies relevant to HIV or addiction?
• Are the timeline and milestones associated with the Plan for Enhancing Diverse Perspectives well-developed and feasible?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this NOFO:

• To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

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

For Renewals, the committee will consider the progress made in the last funding period.

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

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

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 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 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 2.4.4 Disposition of Applications.

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 Standard Terms and Conditions for Research Grants
• 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 Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer 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. 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.

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 for:

• 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.
• Determining research approaches, designing protocols, setting project milestones, and conducting research.
• Participating in group activities, including a Consortium-wide SCORCH Program Steering Committee and subcommittees as needed.
• The SCORCH Consortium will meet virtually or in person yearly and the SCORCH Program Steering Committee will recommend the frequency of other in-person and teleconference meetings as needed.
• Providing reports and data in a timely fashion as agreed upon by the SCORCH Program Steering Committee.
• Abiding by common definitions, protocols, and procedures, as chosen by majority vote of the SCORCH Program Steering Committee.
• Submitting periodic progress reports in a standard format, as agreed upon by the SCORCH Program Steering Committee and NIH SCORCH Working Group.
• Attending and participating in SCORCH Program Steering Committee meetings and accepting and implementing decisions by the NIH SCORCH Working Group, as appropriate.

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

• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
• The NIH SCORCH Working Group will consist of program staff from NIDA and possibly other NIH institutes.
• The NIH Project Scientist(s) will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination. However, the role of NIH staff will be to facilitate and not to direct the activities. The Project Scientist(s) will participate as members of the SCORCH Program Steering Committee and, the Project Scientists together will have a single vote. The Project Scientist(s) will have the following substantial involvement:
• Participating with the other SCORCH Program Steering Committee members in addressing issues that arise with SCORCH planning, operation, assessment, and data analysis. The Project Scientist(s) will assist and facilitate the group process and not direct it.
• Serving as a liaison, helping to coordinate activities, including acting as a liaison to other NIH Institutes/Centers, and as an information resource for the award recipients. The Project Scientist(s) will also help coordinate the efforts of the SCORCH Consortium with other groups conducting similar efforts.
• Attending all SCORCH Program Steering Committee meetings as a voting member, assisting in developing standard operating procedures, and consistent policies for dealing with situations that require coordinated action. The Project Scientist(s) will be responsible for working with the grantees as needed to manage the logistic aspects of the SCORCH program.
• Reporting periodically on SCORCH progress to the NIH SCORCH Working Group.
• Serving on subcommittees of the SCORCH Program Steering Committee as appropriate.
• Assisting award recipients in the development, if needed, of policies for dealing with situations that require coordinated action.
• Providing advice in the management and technical performance of the award.
• Assisting in promoting the availability of the data and related resources developed by the SCORCH program to the scientific community at large.
• Participating in data analyses, interpretations, and where warranted, co-authorship of the publication of results of studies conducted through the program.
• Other NIH SCORCH Working Group staff may assist the award recipient as designated by the Program Official.

Areas of Joint Responsibility include:

Close interaction among the participating investigators will be required, as well as significant involvement from the NIH, to manage and assess the SCORCH program. The award recipients and the Project Scientist(s) will meet in person with the SCORCH Program Steering Committee yearly and on conference calls as needed to share information on methodologies, analytical tools, and preliminary results. PDs/PIs, key co-investigators and pre- and post-doctoral trainees from diverse backgrounds, including those from underrepresented groups or those from different but related disciplines, are encouraged to attend these meetings.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The three members will be: a designee of the SCORCH Program 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 DHHS regulation 45 CFR Part 16.

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.

• 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. 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 $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

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]

Susan Wright, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6683
Email: [email protected]

Dharmendar Rathore, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-402-6965
Email: [email protected]

Ericka Wells
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6705
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.