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

Background

Down syndrome (DS) is the most common genetic cause of intellectual disability, the most common autosomal trisomy, and one of the most visible and universally recognized genetic syndromes. Each year there are approximately 5300 babies born in the United States with Down syndrome. Within the past 25 years, the average lifespan for a person with Down syndrome has doubled, from 30 to 60 years. Despite this increase in lifespan, individuals with Down syndrome and their families face significant and changing health challenges with age, and they have often been excluded from participation in research that could improve their health outcomes and quality of life. While all people with Down syndrome are connected by the common feature of a complete or partial copy of chromosome 21 (trisomy 21), there are significant physical and cognitive differences among them, indicating that inter-individual variability exists.

Down syndrome is associated with an increased prevalence of autism and epilepsy. About 75% of individuals experience cognitive decline in a syndrome that resembles Alzheimer’s disease but has its onset a decade or two earlier than typical Alzheimer’s disease. Individuals with Down syndrome also have high rates of hearing loss, eye abnormalities, congenital heart defects, sleep apnea, pulmonary hypertension, gastrointestinal malformations, thyroid disease, leukemia, and other autoimmune or immune dysregulation disorders including celiac disease. However, people with Down syndrome infrequently develop solid tumors such as breast or prostate cancer, and despite multiple risk factors for coronary artery disease and high rates of obesity, sleep apnea, and type 1 diabetes, they rarely develop atherosclerosis or have myocardial infarctions. Understanding this unique combination of risk and resiliencies will inform medical advances for individuals with Down syndrome, and for individuals who do not have Down syndrome but share these co-occurring conditions.

This NOFO is one of several NIH-wide research initiatives created in response to Fiscal Year 2018, 2019, 2020, 2021, 2022, and 2023 Omnibus Appropriations Reports, which encourage NIH to expand its current efforts on Down syndrome and common co-occurring conditions also seen in the general population, while increasing the number of Down syndrome investigators and the diversity of study populations and researchers. Together, the initiatives are called the INCLUDE Project (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE). Information about projects that were funded in prior years, as well as the NIH INCLUDE Down Syndrome Research Plan, are available on the INCLUDE Project website at https://www.nih.gov/include-project/. The INCLUDE Project has three components:

• Component 1: Targeted high risk - high reward basic science studies in areas highly relevant to Down syndrome
• Component 2: Assembly of a large cohort of individuals with Down syndrome across the lifespan to perform deep phenotyping and study co-existing conditions
• Component 3: Inclusive clinical trials of existing and future treatments and interventions for co-occurring conditions in individuals with Down syndrome

Purpose

The INCLUDE Project is soliciting applications for a federated biospecimen repository ("DS-Biorepository") for biological samples collected from INCLUDE-funded and other funded clinical studies, including but not limited to blood, plasma, skin, biopsy or surgical tissues, brain (whole or sections), spinal cord, cerebrospinal fluid, and/or amniotic fluid. The goal of the DS-Biorepository is to facilitate the collection, management, and rapid sharing of biological specimens to advance research and scientific discovery in co-occurring conditions in individuals with DS. In addition to collecting and storing biospecimens, the DS-Biorepository will develop a centralized system that links and/or connects, through a web-based user interface, distributed networks of existing biorepositories to facilitate the search of all publicly accessible biospecimens relevant to the study of DS.

It will also support biospecimen acquisition for the Down Syndrome Cohort Development Program (DS-CDP; RFA-OD-24-003 and RFA-OD-24-005 ). Applications from currently funded NIH-designated biospecimen repositories are encouraged to apply.

Scope

The objectives of the DS-Biorepository are to:

1. Serve as the primary biorepository for biospecimens generated from INCLUDE-funded research and related DS projects for which clinical and other data will and/or are being shared, unless there is a compelling reason to use another existing biorepository. This would include specimens generated by the new longitudinal Down Syndrome Cohort Development Program (DS-CDP) under development (RFA-OD-24-003 and RFA-OD-24-005 ). The DS-Biorepository will be responsible for identifying and sending biospecimen collection kits to the Cohort Research Sites (DS-CRS). The DS-Biorepository will pay for the assembly, distribution and tracking of these biosample kits, including any shipping costs for submission of samples.

2. Coordinate the implementation of standard processes, protocols, and practices for biospecimens relevant to the study of DS.

3. Develop a new web-based user interface to facilitate the search of all publicly-accessible biospecimens relevant to the study of DS. In addition, the DS-Biorepository will coordinate with existing biorepositories and the INCLUDE Data Coordinating Center (DCC; includedcc.org) to extract, curate, standardize, and display, via public web services and the user interface, associated biospecimen metadata using NIH-relevant data standards.

This funding opportunity will support an existing biospecimen repository that has demonstrated experience with receiving, processing, storing, and distributing various types of specimens, including but not limited to: blood, plasma, skin, biopsy or surgical tissues, brain (whole or sections), spinal cord, cerebrospinal fluid, and/or amniotic fluid.

Data Sharing

The NIH Policy for Data Management and Sharing (Policy) expects researchers to maximize the sharing of scientific data and make data accessible as soon as possible: no later than the time of an associated publication or the end of the award period, whichever comes first. Additionally, rapid data sharing is a critical component of INCLUDE’s goal to accelerate discovery of etiology and biologic pathways underlying co-occurring conditions of Down syndrome. NIH requires all applications submitted in response to this NOFO to include a Data Management and Sharing Plan (Plan) outlining how scientific data and any accompanying metadata will be managed and shared. It is expected that all de-identified human data coordinated and generated by this project will be submitted to the INCLUDE Data Hub (portal.includedcc.org) in coordination with the INCLUDE Data Coordinating Center (DCC). The INCLUDE Data Hub is a centralized data resource that allows access to large-scale clinical and multi-omics datasets specific to Down syndrome and supports collaborative, cloud-based analysis to accelerate scientific discoveries related to Down syndrome and its co-occurring conditions. The Data Management and Sharing Plan will be considered by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program as well as the NIH Policy for Data Management and Sharing.

Notice of NIH's Interest in Diversity

Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission. Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust. In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences. See NOT-OD-20-031 and 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 details.

To support the best science, the INCLUDE project encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

• Transdisciplinary research projects and collaborations among neuroscientists and researchers from fields such as biochemistry, bioengineering, computational biology, molecular biology, health services, pharmacology, computer and data sciences, bioinformatics as well as bioethics
• Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-colleges).
• Individual applications and partnerships that enhance geographic and regional heterogeneity.
• Investigators and teams composed of researchers at different career stages.
• Participation of individuals from diverse backgrounds, including groups historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.

For the purposes of this NOFO, diverse refers to diversity of the scientific workforce supporting this resource as well as diversity of participants contributing samples to the biorepository.

Plan for Enhancing Diverse Perspectives (PEDP)

• 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.

Pre-Application Webinar and Frequently Asked Questions

A Pre-Application Webinar for all interested prospective applicants will be hosted by INCLUDE Program staff. Webinar date and other details will be posted on the INCLUDE website: https://www.nih.gov/include-project/. Frequently Asked Questions (FAQs) will also be posted and updated on the INCLUDE website: https://www.nih.gov/include-project/frequently-asked-questions.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

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

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

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH 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 registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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 SF424 (R&R) Application Guide.

The PD/PI is strongly encouraged to devote a minimum of 4.2 person-months to this resource. For applications with multiple PDs/PIs, a minimum effort of 2.2 person-months is required of the contact PD/PI, and 1.2 person-months of effort per additional PD/PI is required.

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).

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:

Erika D. Tarver, MSM, MPH
Telephone: 301-827 -2617
Email: [email protected]

Page Limitations

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed. The additional instructions apply:

Facilities and Other Resources: Applications must describe the facilities and resources available. Applicants should especially focus on the unique resources at their institution and any sub-contracts which lend themselves to the completion of the project.

Other Attachments: The following items should be included as other attachments:

Project Management Plan: Applications must provide a Project Management Plan submitted as a single pdf attachment, with the title Project Management Plan that includes the following information. Provide a plan detailing the measures that will be taken to ensure cross-disciplinary communication and integration across the team (i.e., the collaborating laboratories) and addressing the division of labor across the team. The plan must provide a detailed description of how different elements of the project would operate in a synergistic and integrated manner. Teams must carefully address how their individual contributions converge on a project that spans the relevant areas of the Center's responsibilities including tissue procurement, processing, quality control, biobanking, data management, and issues around ethical, legal and social implications (ELSI).

Existing Tissue samples and Data Plan: In this attachment, applications must provide detailed description of any available tissue sample and data collections that will be leveraged for this project, including amounts, quality, type, and location.

Standard Operating Procedure: In this attachment, applications must provide a detailed explanation for the process for receiving, testing and storing procured samples.

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 historically 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 the purposes of this NOFO, diverse refers to diversity of the scientific workforce supporting this resource as well as diversity of participants contributing samples to the biorepository.

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

SF424(R&R) Senior/Key Person Profile

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

Key personnel are strongly encouraged to highlight in their biosketch experience managing biobanks, overseeing specimen processing, establishing web-based infrastructures to facilitate sharing of samples and metadata, interacting with a distributed research network, and coordinating ethical, legal and social implications of the use of biospecimens for research.

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.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: Briefly describe how the project will meet the overall scientific goals of the INCLUDE Project and the anticipated impact of the project should the goals be met. Specifically, the goal of the DS-Biorepository is to facilitate the collection, management, and rapid sharing of biological specimens to advance research and scientific discovery in co-occurring conditions in individuals with Down syndrome (DS). Refer to the following objectives of the DS-Biorepository when developing aims.

Objective 1. Serve as the primary biorepository for biospecimens generated from INCLUDE-funded clinical research and related Down syndrome projects for which clinical and other data will and/or are being publicly shared, unless there is a compelling reason to use another existing biorepository. This would include specimens generated by the new longitudinal Down Syndrome Cohort Development Project (DS-CDP) under development (RFA-OD-24-003 andRFA-OD-24-005 ).

For Objective 1, applicants should describe how they will:

• Ensure that biorepository facility complies with safety and biohazard containment guidelines and regulations, as well as applicable federal, state, and local laws for handling biosamples and current best practices. In addition, ensure that all work is carried out with rigorous quality control and quality assurance.
• Create or leverage high quality, robust, flexible, and secure web-based information systems for biospecimen request, review, approval, and distribution, of biospecimens hosted by this biorepository. Provide security and back-up systems, as needed.

Objective 2. Coordinate the implementation of standard processes, protocols, and practices for biospecimens relevant to the study of DS.

For Objective 2, applicants should describe how they will:

• Promote the implementation of standard protocols for collection and storage of new biospecimens from individuals with Down syndrome.
• Create or harmonize standardized documentation of the processing and quality control of biospecimens held by the biorepository(ies), to ensure high-quality materials are available for subsequent analysis, including but not limited to material transfer agreements and data use agreements.

Objective 3. Develop a new web-based user interface to facilitate the search of all publicly accessible biospecimens relevant to the study of Down syndrome. Coordinate with existing biorepositories and the INCLUDE DCC to extract, curate, standardize, and display, via public web services and the user interface, associated biospecimen metadata using NIH relevant data standards.

For Objective 3, applicants should describe how they will:

• Build and maintain an up-to-date searchable inventory of biospecimens through a user interface to enable researchers to search for available samples and associated metadata. Integrate the user interface with the INCLUDE Data Coordinating Center Data Hub to enable users to identify datasets associated with linked biospecimens.
• Work closely with the INCLUDE DCC to create standards for unique identifiers and for linking the biospecimens with the metadata associated with data that are available through the INCLUDE Data Hub
• Retrieve, curate, and standardize metadata from relevant partner biorepositories for indexing in the user interface to enable researchers and members of the public to easily identify available biospecimens relevant to the study of Down syndrome and co-occurring conditions.
• Coordinate with the partner biorepositories, the INCLUDE DCC, and NIH to establish a common metadata schema for structuring and exposing all relevant biospecimen metadata, leveraging relevant NIH data standards.
• Establish a public application programming interface (API) to enable other systems to consume all metadata to improve the findability of Down syndrome biospecimens. Anticipated client systems include but are not limited to the INCLUDE Data Hub Portal developed by the INCLUDE DCC.
• Document all software code and data standardization methods in a publicly accessible repository, such as GitHub. It is expected that all aspects of software and data processing will be well-documented and shared with the wider scientific community, in a timely manner that would enable other researchers to replicate and build on for future research efforts, aligned with the open-source regime used to distribute software.

Research Strategy: Applicants should propose an organizational structure and a project management plan for the DS-Biorepository. The project management plan should include a timeline and yearly milestones with clear, quantitative objective criteria for success of the biorepository. The plan should also include an explicit strategy for increasing the diversity of samples included in the biorepository to reflect the diversity of the population with Down syndrome.

Propose a plan to arrange coordinated receipt and distribution of biospecimens, from current and/or past studies, to facilitate research in DS and DS co-occurring conditions for INCLUDE-funded projects and independent projects with a focus on DS.

Applicants should also propose a plan for collaborating or partnering with existing biorepositories that collect, store, and/or disseminate samples from individuals with DS.

Letters of Support:

An Institutional Letter of Support should be provided stating the institutional support for the proposed center. Applicants are encouraged to reach out to the INCLUDE DCC (https://includedcc.org/) for guidance and a letter of support for their proposal. Letters of support from any partner organizations or biorepositories that will be collaborating with the DS-Biorepository are encouraged.

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.
• The plan must include information about how all documentation (i.e., standard operating procedures, laboratory manuals, and other procedural documents, etc.) will be made freely and publicly available, in order to allow harmonization across studies and in order to have full transparency regarding laboratory procedures, thus limiting the risk of batch effect in biomarkers research findings.
• It is expected that all de-identified human data coordinated and generated by this project will be submitted to the INCLUDE Data Hub (portal.includedcc.org) in coordination with the INCLUDE Data Coordinating Center (DCC). The INCLUDE Data Hub is a centralized data resource that allows access to large-scale clinical and multi-omics datasets specific to Down syndrome and supports collaborative, cloud-based analysis to accelerate scientific discoveries related to Down syndrome and its co-occurring conditions.

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

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

• Applications must include the standard operating procedures for equipment monitoring and maintenance; laboratory protocols, including QA/QC activities; and blank questionnaires/surveys for procurement of samples and clinical information about donors and other metadata.

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

In order to expedite review, applicants are requested to notify the CSR Referral Office by email at [email protected] when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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

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

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

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

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), 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 appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Compliance with resource-sharing expectations.

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

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

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 (DHHS) grant administration regulations at 45 CFR Part 75, 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 awardees 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 award 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below. Independent Program Consultants (PCs), appointed by the NIH and funded through other mechanisms, will review the progress of the program annually and as needed to provide advice to the NIH about scientific direction.

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

The awardee PD(s)/PI(s) will coordinate project activities scientifically and administratively at the awardee institution and will have primary responsibility for performing all scientific and fee-for-service activities. The PI agrees to accept the close coordination, cooperation, and participation of the NIH Project Scientist and an authorized NIH-established Steering Committee (SC) in those aspects of scientific and technical management of the project as described below.

Specifically, the PD(s)/PI(s) will:

• Develop guidelines and procedures related to the DS-Biorepository operations and seek approval from the SC.
• Design protocols, oversee the provision of services and research resources to the scientific community, and work cooperatively to set project milestones, in consultation with NIH program staff and the SC.
• Collaborate with members of the INCLUDE DS-CDP on design of a common protocol for longitudinal cohort development, biospecimen acquisition, and omics evaluation, including assembly, distribution, shipping and tracking of biospecimen collection kits to the DS-CRS for submission of samples.
• Receive biomaterials and data files from INCLUDE-funded or DS-focused grants, the INCLUDE DCC, and other scientists; ascertain that proper informed consent exists for all samples; develop a unique coding system for each sample that de-identifies patient data; and distribute biomaterials and data files to qualified researchers granted access by criteria set up by the SC and consistent with NIH data and biomaterials sharing policies.
• Provide DNA extraction and banking for all NIH INCLUDE-funded projects.
• Collaborate with the INCLUDE DCC to define a protocol detailing the requirements for sharing of genotypic data to a central data bank from scientists using cells and DNA obtained from the DS-Biorepository.
• Maintain a log of usage that records the products and services provided and the fees charged.
• For each non-competing renewal, submit progress reports in the standard format, as required by NIH. The progress report will describe the activities and accomplishments of the DS-Biorepository for the preceding award period and the goals to be accomplished during the renewal period. The progress report will include the log of usage. The contents of the progress report will be used by the NIH program officer, along with other information, to determine the amount of funding the DS-Biorepository will receive for the renewal period.
• Organize and set the agenda for at least one meeting of the SC, with additional advisors as appropriate, each year, along with teleconferences as needed. The awardee will have one vote on the SC and will accept any modification, deletion, or addition of activities approved by the SC. The PI will be responsible for preparing, within 30 days, a concise summary of each SC meeting or teleconference for distribution to participants.
• Attend and participate in an annual INCLUDE Investigators' Meeting and any other meetings as recommended by NIH Program Staff.

Awardees 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 DHHS, PHS, and NIH policies.

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

The designated NIH Project Scientist will serve as a member of the SC and have substantial scientific involvement during the conduct of this activity through technical assistance, advice, and coordination above and beyond normal stewardship. This includes facilitating the partnership relationship between the NIH and the DS-Biorepository, helping to maintain the overall scientific balance in the program commensurate with emerging research opportunities, and ensuring that the activities of the biorepository are consistent with the scientific mission of the NIH INCLUDE Project. Access to research resources maintained in the DS-Biorepository will be determined by the SC with input from NIH and consistent with NIH sharing policies. The NIH Project Scientist shall be a voting member of the SC. The Program Official and other NIH staff involved with the INCLUDE Project may also attend meetings of the SC as observers but will not have voting privileges.

Specifically, the NIH Project Scientist will:

• Serve as a member of the SC
• Provide relevant scientific expertise and overall knowledge.
• Advise the director of the DS-Biorepository regarding recruitment of members and replacement of existing members of the SC, should any choose to leave.
• Attend SC meetings and assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action.
• Participate with other SC members in the group process of setting priorities and milestones, deciding optimal approaches and protocol designs, and contributing to the adjustment of protocols or approaches as warranted.
• Serve as administrative liaison to the INCLUDE DCC to help coordinate biorepository activities with those complimentary programs. The NIH Project Scientist will coordinate the DS-Biorepository's activities with the scientific mission and evolving goals of the NIH INCLUDE Project and the DS-CDP, with input as required from the SC and other NIH staff. The NIH Project Scientist will also coordinate the DS-Biorepository's activities with other US and international efforts that focus on sharing research resources for genetic analyses of complex diseases in individuals with DS.

The NIH Program Officer is responsible for normal stewardship of the Cooperative Agreement and will:

• Serve as program liaison between the DS-Biorepository and other NIH staff involved in the INCLUDE Project and the DS-CDP.
• Assist in promoting and encouraging the sharing of unique research resources for co-occurring conditions in individuals with Down syndrome by the scientific community at large.
• Retain the option to recommend re-allocating NIH support provided to the DS-Biorepository as scientific goals evolve.
• Determine the amount of support that will be awarded to the DS-Biorepository as a non-competing renewal. The progress report received from the biorepository, along with other information, will be used to make this determination. The criteria used for this decision will include, but not be limited to number of samples banked and distributed, customer satisfaction, and successful performance of the DS-Biorepository in providing services to the Down syndrome research community.

Scientific Oversight - Steering Committee (SC):

The SC will meet at least once each year and will oversee DS-Biorepository activities to assure that the needs of the broader scientific community for research resources necessary for the genetic analysis of co-occurring conditions in individuals with Down syndrome are being met. The SC will provide oversight of the DS-Biorepository and scientific advice to NIH. SC members will provide scientific and operational oversight concerning both long-term developments and distribution activities at the DS-Biorepository.

The SC will consist of leaders in the field, including the MPIs of the INCLUDE DCC and the NIH Project Scientist. SC members will be selected by the director of the DS-Biorepository after consultation with NIH. Members will be selected for their broad expertise in relevant topics such as molecular biology, molecular genetics, genomics, pharmacogenomics, statistical genetics, epidemiology, bioinformatics, cell and DNA banking of samples from individuals with DS.

Additional SC members may be added with agreement between the SC and NIH. The NIH Project Scientist (voting member) and Program Official (non-voting member) will attend SC meetings and will act as representatives of NIH. Other NIH staff involved with the INCLUDE Project may attend SC meetings to help facilitate specific discussions.

Data Sharing:

Providing access to protocols, data and biomaterials collected in DS-focused studies for qualified investigators in the wider scientific community addresses is an interest and priority of the government. NIH expects that the information to be shared will include clinical, diagnostic, and pedigree structure information, in addition to cell lines and DNA. Oversight for this process will be provided by the SC and NIH.

More specifically, when requested, the DS-Biorepository is expected to: (1) establish cell lines, from which DNA will be extracted and stored; (2) provide data to qualified investigators related to the clinical phenotype, diagnostic criteria, and pedigree structure for cell lines, DNA, and other specimens; and (3) set up mechanisms by which data and biomaterials can be made easily available to qualified investigators in the scientific community.

Areas of Joint Responsibility include:

None. All responsibilities are divided between awardees and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between awardees and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the DS-Biorepository 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 awardee. This special dispute resolution procedure does not alter the awardee'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. 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.

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.

Areas of Joint Responsibility include:

None; all responsibilities are divided between recipients and NIH staff as described above.

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

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

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

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

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

The primary point of contact for this NOFO should be:

Laurie Ryan, Ph.D.
NATIONAL INSTITUTE ON AGING (NIA)
Division of Neuroscience
Phone: 301.496.9350
E-mail: [email protected]

Sujata Bardhan, PhD

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Telephone: 301-435-0471

Email: [email protected]

Melissa Parisi, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6880
Email: [email protected]

Jyoti Dayal
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301.480.2307
E-mail: [email protected]

Robert C Rivers, PhD
NIDDK - NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Phone: 301-443-8415
E-mail: [email protected]

Laurie Ryan, Ph.D.
NATIONAL INSTITUTE ON AGING (NIA)
Division of Neuroscience
Phone: 301.496.9350
E-mail: [email protected]

Katherine Malinda, Ph.D.

Center for Scientific Review (CSR)

Email: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Elizabeth Gutierrez
NIDDK - NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
Phone: 301-594-8844
E-mail: [email protected]

Philip E. Smith
NATIONAL INSTITUTE ON AGING (NIA)
Phone: 301-555-1212
E-mail: [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.