Key Dates

Related Announcements

None

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

Purpose

The purpose of this Notice is to inform applicants in response to NOT-OD-20-024, "Notice of Special Interest (NOSI): Availability of Administrative Supplements for the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) Project" of a change to the Purpose, changes to the Research Objectives, a change to the Award Project Period, and changes to the Application and Submission Information.

The NOT has been modified as follows:

Purpose:

Original language:

The Office of the Director of the National Institutes of Health (NIH) announces the opportunity for investigators with relevant active NIH-supported grants from the participating Institutes listed above to submit administrative supplement applications for funded projects to meet new NIH Down syndrome research objectives related to the NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project. This Notice is soliciting administrative supplements for the following mechanisms ONLY: R03,R21,R24,P01, P30,P40,P50,P51,U01,U10,U19,U24,U42,U54,UG1,UG3,UL1,U2C,K12, and T32.

The following new language is being added to this FOA (in bold italics)

The Office of the Director of the National Institutes of Health (NIH) announces the opportunity for investigators with relevant active NIH-supported grants from the participating Institutes listed above to submit administrative supplement applications for funded projects to meet new NIH Down syndrome research objectives related to the NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project. This Notice is soliciting administrative supplements for the following mechanisms ONLY: R01,R03,R21,R24,P01,P20, P30,P40,P50,P51,U01,U10,U19,U24,U42,U54,UG1,UG3,UL1,U2C,K12, and T32.

Research Objectives

Original language:

This Notice of Special Interest (NOSI) announces NIH support for the professional development of early career scientists aiming to establish a career in DS-related research. By providing these scientists with training, resources, and mentorship, the NIH intends to foster a pipeline of investigators in DS and other intellectual disabilities who will lead future research to improve the understanding of the biology of DS and support development of new treatments for health conditions experienced by those with DS. Sharing of resources and effective communication of outputs to the broader communities are a high priority of the INCLUDE Project. Applicants responding to this NOSI are strongly encouraged to describe plans for rapid sharing of data and results as well as innovative data analytics approaches (see Goal 3, NIH Strategic Plan For Data Science).

The following language replaces the prior language in this FOA (in bold italics):

This Notice of Special Interest (NOSI) announces NIH support for administrative supplement applications for funded projects to meet NIH Down syndrome research objectives related to the NIH INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project as listed below. Sharing of resources and effective communication of outputs to the broader communities are a high priority of the INCLUDE Project. Applicants responding to this NOSI are strongly encouraged to describe plans for rapid sharing of data and results as well as innovative data analytics approaches (see Goal 3, NIH Strategic Plan For Data Science).

Supplement applications will be eligible for funding if they address one or more of the following components related to the INCLUDE Project research objectives:

• Component 1: Targeted, high risk-high reward, basic science studies in areas highly relevant to Down syndrome
• Component 2: Cohort Study to connect existing resources and expand to inclusion of individuals with Down Syndrome
• Component 3: Inclusive clinical trials research for co-occurring conditions in individuals with Down syndrome

Applications will be considered eligible for funding if they:

• Are within the scope of the active parent award
• Are focused on DS
• Propose to address one of the three components listed above
• Are likely to stimulate additional activity leading to progress on DS
• Address a priority for the IC that issued the parent award (see below for more information)

Supplements to existing clinical trials are allowed. The proposed research must be within the scope of the parent clinical trial and the parent clinical trial award must have two or more budget years remaining in the current project period. The addition of a new clinical trial that was not a part of the parent award is not allowed. Supplement requests addressing INCLUDE Components 2 or 3 should encourage participants with DS or their caregivers to register in DS-Connect : The Down Syndrome Registry.

The following new language is being added to this FOA (in bold italics):

For those applications that generate clinical data, it is expected that the data sharing plan will include the INCLUDE Data Coordinating Center (DCC). Applications generating clinical data should describe the anticipated timelines, formats, and approach to submitting data to the INCLUDE DCC.

Award Project Period

Original Language:

To be eligible, the parent award must be active in the current fiscal year (i.e., the parent award received funds in the current fiscal year and is not in an extension period), and the research proposed in the supplement should be requested for one year. The awarding institute may consider a no-cost extension of up to an additional year at the conclusion of the first year. The earliest anticipated start date is August 2020, August 2021 and August 2022.

New Language:

To be eligible, the parent award must be active in the current fiscal year (i.e. is not in an extension period), and the research proposed in the supplement should be requested for one year. The awarding institute may consider a no-cost extension of up to an additional year at the conclusion of the first year.

Application and Submission Information:

The following new language is being added to this FOA (in italics):

Applications in response to this NOSI must be submitted to PA-20-272 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional) or its subsequent reissued equivalent. All instructions in theSF424 (R&R) Application Guideand PA-20-272 must be followed, with the following additions:

In order to ensure identification, tracking, and appropriate review of their applications, all applicants MUST follow these special instructions:

• Application Due Date(s) May 12, 2021, July 23, 2021, November 23, 2021 , March 23, 2022, July 23, 2022
• Applications must include NOT-OD-20-024 in the Agency Routing Identified field (Box 4b) of the SF424 R&R form. Applications without the identifier NOT-OD-20-024 () in Box 4b will not be considered for this initiative.
• Use the form package for the existing NIH Grants and/or Cooperative Agreements.
• Applicants are strongly encouraged to notify the program contact at the Institute supporting the parent award that a request has been submitted in response to NOT-OD-20-024 n order to facilitate efficient processing of the request.
• Applicant organizations may submit more than one application to this NOSI. Use unique project titles for each application to ensure our systems treat each application as a distinct submission.
• Application budgets must reflect the actual needs of the proposed project. Supplement budget requests that exceed $500,000 in direct costs or 50% of the direct costs of the current year of the parent award (exclusive of Facilities and Administrative costs on sub-contracts) must receive permission from the project officer and IC Contact prior to submission.
• The application Abstract section should describe the proposed supplement, and the Research Strategy section should include a summary or abstract of the funded parent award or project. The Research Strategy should state the relevance to the parent award and the INCLUDE project, and articulate the component(s) and any IC-specific priorities that the supplement is addressing.

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with a Program Officer from the appropriate Institute or Center listed on this NOSI well in advance of the grant receipt date to better determine appropriateness and interest of the awarding ICO.

Please direct all inquiries to the contact at the Institute, Center or Office supporting the parent award as indicated on the funding page of the INCLUDE Project website.