Notice Number: NOT-OD-19-051

Key Dates

Issued by
National Institutes of Health (NIH)

Purpose

TheOffice of the Director of theNational Institutes of Health (NIH) intends to publish four Funding Opportunity Announcements (FOAs) for the INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) project (https://www.nih.gov/include-project).Individuals with Down syndrome (DS) face significant and changing health challenges but have often been excluded from participation in research that could improve their health outcomes and quality of life. This population is understudied even though DS is the most common genetic cause of intellectual and developmental disabilities (IDD) and, in the past 25 years, the average lifespan has doubled, from 30 to 60 years.

The Fiscal Year (FY) 18 Budget appropriation directed the NIH “to develop a new trans-NIH Down syndrome initiative to study trisomy 21 [and] to improve the health and neurodevelopment of individuals with Down syndrome and typical individuals at risk for Alzheimer's disease, cancer, cardiovascular disease, immune system dysregulation, and autism, among others.” The INCLUDE initiative aims to address these issues by advancing research on DS in 3 domains: (1) targeted, high-risk, high-reward basic science studies of trisomy 21; (2) assembly of a large clinical cohort of individuals with DS across the lifespan; and (3) inclusive clinical trials research oncurrent and future therapies for co-occurring conditions in DS.

NIH Institutes and Centers likely to participate include some or all of the following:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)

This Notice is announcing that there will be four competitions in FY19. The FOAs are expected to be published in late January 2019 with an expected application due date in March 2019. These are planned as Requests for Applications (RFAs). The goal will be to make awards by the end of the fiscal year in September 2019.

This Notice is being provided to allow potential applicants sufficient time to develop responsive applications.

Research Initiative Details

The four FOAs that will be issued are outlined below:

1. INCLUDE Project Transformative Research Award
   This initiative will focus on research in the targeted, high risk, high reward basic science domain and will support unusually innovative research projects, which, if successful, would have a major impact in understanding the biology of DS or potential to lead to the development of new treatments for health conditions experienced by individuals with DS. Projects may be considered transformative if they address or overturn fundamental scientific paradigms through novel approaches, transform the way research is conducted through the development of novel tools or technologies, or lead to major improvements in health through the development of highly innovative therapies, diagnostic tools, or preventive strategies. This RFA will utilize the Transformative Research Award (R01 Clinical Trial Not Allowed) activity code.
   
2. INCLUDE Project Clinical Trial Readiness Award
   This initiative will support clinical projects that address critical needs for clinical trial readiness in DS. Projects may facilitate DS research by enabling efficient and effective movement of candidate therapeutics or diagnostics towards clinical trials for DS and its co-occurring conditions, or may increase their likelihood of success through development and testing of biomarkers and clinical outcome assessment measures, development and testing of novel trial methods and recruitment strategies, or by defining the presentation and course of the co-occurring conditions in individuals with DS to enable the design of future clinical trials. This RFA will utilize the Exploratory/Developmental Research Grant Award (R21 - Clinical Trial Not Allowed) activity code.
3. INCLUDE Project Clinical Trials for Co-Occurring Conditions in Down Syndrome
   This initiative will support development of clinical trials to treat critical and co-occurring health conditions in individuals with DS. Research is needed to develop or test new and innovative adaptations of current drugs, interventions, and therapies for the treatment and management of co-occurring conditions in DS. Projects will be encouraged that focus on delivering better healthcare outcomes and should seek solutions that are effective, deliverable, and sustainable in clinical settings beyond the research environment. Projects may address a particular co-occurring condition at a particular stage of development or across the lifespan in people with DS. Outcomes research and health services research related to DS will also be encouraged in addition to testing new, enhanced, or tailored therapies for treating DS. Because some aspects of this research area may be new for the trans-NIH scientific community, there will likely be a need to obtain preliminary data or conduct early-stage clinical trial preparatory activities before moving to a full-scale project in this domain. This RFA will utilize the R61/R33 Phased Exploratory/Developmental Grant Award (R61/R33 - Clinical Trial Required) activity code.
4. INCLUDE Project Competitive Supplements for Research in Down Syndrome
   This initiative will encompass research on all three domains of INCLUDE and will support competitive supplement applications to existing funded NIH projects that propose to add a new component related to the goals of the INCLUDE project. The goal is to support new but related projects or aims that will add a DS element in order to accelerate scientific progress on the INCLUDE project. . This RFA will utilize the Competitive Revision (Supplement) mechanism to an existing funded award, and supplements will be limited to no more than two years of support, depending on the duration of the funded “parent” award.
   For a list of Institute- and Center-specific research interests related to the INCLUDE initiative, see the Frequently Asked Questions page to be listed on the INCLUDE website (https://www.nih.gov/include-project).

Funding Information

Estimated Total Funding TBD
Expected Number of Awards TBD
Estimated Award Ceiling TBD
Primary CFDA Numbers TBD

Anticipated Eligible Organizations

Inquiries

Please direct all inquiries to: