Key Dates
- June 2, 2023 - Notice of Intent to Publish Notice of Funding Opportunity Announcements for a Down Syndrome Clinical Cohort Coordinating Center (DS-4C) for the INCLUDE Project. See Notice NOT-OD-23-135.
- June 2, 2023 - Notice of Intent to Publish Notice of Funding Opportunity Announcements for a Federated Biobanking resource for the Down Syndrome Cohort Study Program (DS-CDP) across the lifespan for the INCLUDE Project. See Notice NOT-OD-23-136.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The NIH INCLUDE Project seeks to improve health and quality-of-life for individuals with Down syndrome. The National Institutes of Health, Office of the Director, with other NIH Institutes and Centers (ICs) (NICHD, NHLBI, NIA, NIDCD, NIMH etc.), intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for Down Syndrome Cohort Research Sites (DS-CRS) to participate within a Down Syndrome Cohort Development Program (DS-CDP).
The DS-CDP will be a cooperative program committed to the assembly of a diverse cohort of people with Down syndrome (DS). The DS-CRS will serve to identify and enroll people with Down syndrome into a common diverse cohort. DS-CRS will work cooperatively with a Down Syndrome Clinical Cohort Coordinating Center (DS-4C) (NOT-OD-23-135) that will be responsible for overall management and oversight for the DS-CDP and assuring DS-CRS data is incorporated into the INCLUDE data repository maintained by the INCLUDE Data Coordinating Center (DCC). A related NOFO (NOT-OD-23-136) will support a federated biobanking system for the INCLUDE Project.
This NOFO will utilize the U01 activity code. The NOFO is expected to be published in Summer 2023 with an expected application due date in Fall 2023. Details of the planned NOFO are provided below.
Research proposed by the sites should focus on DS and its co-occurring conditions to study the epidemiology of Down syndrome, and the relationship of demographic factors to outcomes (e.g., race, ethnicity, gender, geographic location), and to address critical and co-occurring health conditions in individuals with DS across the lifespan.
The scientific scope of this NOFO is focused on specific areas of the INCLUDE Project that can lead to improved clinical care for individuals with Down syndrome; reduce morbidities associated with DS; expand our understanding of the safety, dosing and efficacy of therapeutics across the lifespan; and provide evidence to guide clinical practice in infants, toddlers, adolescents, young adults, and adults with Down syndrome. Projects focused on the transition periods of development (adolescents, 12-18 years of age; young adults, 18-26 years of age) will also be responsive and within scope.
The proposed research aims proposed by the clinical Down Syndrome Cohort Research Sites (DS-CRS) should be milestone driven. The total timeline for the project proposed by the research clinical site(s) in response to this NOFO may not exceed five years. The DS-CRS will work cooperatively with a Down Syndrome Clinical Cohort Coordinating Center (DS-4C) that will be funded through a U54 Specialized Center mechanism.
In addition, investigators proposing collaborative transdisciplinary investigations combining expertise in fields such as biochemistry, bioengineering, computational biology, molecular biology, health services, pharmacology, computer and data sciences, bioinformatics as well as bioethics will be encouraged to apply for this opportunity.
Partnering with low-resourced institutions such as Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and other Minority Serving Institutes (MSIs) will be strongly encouraged.
Applicants are strongly encouraged to contact INCLUDE staff to discuss the scientific scope and feasibility of the projects. The period of time from the estimated NOFO publication date until the estimated first application due date is designed to allow ample time for this discussion. If applying to this NOFO, the applicant is expected to work collaboratively with the respective team to jointly prepare a grant application in response to this funding opportunity that will undergo NIH peer review.
Funding Information
TBD
TBD
TBD
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization
Eligible Agencies of the Federal Government
Applications are not being solicited at this time.
Inquiries
Please direct all inquiries to:
Sujata Bardhan, Ph.D, M.S
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-0471
Email: [email protected]
Huiqing Li, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0554
Email: [email protected]
and Human Services (HHS)
