Notice of Availability of Competitive Supplements/Revisions for the INCLUDE (Investigation of Co-occurring Conditions across the Lifespan to Understand Down syndromE) Project (Competitive Supplement/Revision Clinical Trial Optional)

Notice Number: NOT-OD-19-071

Key Dates
Release Date : February 05, 2019

Related Announcements

RFA-OD-19-015

RFA-OD-19-016

RFA-OD-19-018

Issued by
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 on Dental and Craniofacial Research (NIDCR)

National Institute of Mental Health (NIMH)

National Institute of Neurological Disorders and Stroke (NINDS)

National Institute of Nursing Research (NINR)

National Center for Complementary and Integrative Health (NCCIH)

National Center for Advancing Translational Sciences (NCATS)

National Institute of Environmental Health Sciences (NIEHS)

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Office of Strategic Coordination (Common Fund)

Purpose

The National Institutes of Health Office of the Director announces the opportunity for investigators with relevant active NIH-supported research project grants from the participating Institutes listed above to submit competitive revision 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 competitive revision supplements for the following mechanisms: research project grants (R01, R03, R21) and cooperative agreements (U01 only).  A limited number of administrative supplement proposals may be allowed under a future Notice, to be published at a later date, for some mechanisms not included in this announcement.  Applications for Competitive Revisions will be routed directly to the NIH awarding component listed on the Notice of Award of the most recent parent award, but they will be reviewed by one or more Special Emphasis Panel(s) convened for the INCLUDE Project. Applications from individuals with diverse backgrounds and in topics relevant to Down syndrome research are welcome. Projects must clearly demonstrate the potential to produce a significant impact in research related to Down syndrome on a topic of priority for the INCLUDE initiative (https://www.nih.gov/include-project).

FOAs for applicants proposing competitive revisions (supplements) are below:

Activity code of parent award

FOA number to apply to

Title

Supplement (Revision) Due date

R01 (BESH)

PA-19-091

NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)

March 5, 2019

R01 (Clinical Trial)

PA-19-055

Research Project Grant (Parent R01 Clinical Trial Required)

March 5, 2019

R01 (No clinical trial)

PA-19-056

Research Project Grant (Parent R01 Clinical Trial Not Allowed)

March 5, 2019

Parent R21 (BESH)

PA-19-092

NIH Exploratory/ Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)

March 16, 2019

R21 (Clinical Trial)

PA-19-054

NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)

March 16, 2019

R21 (No clinical trial)

PA-19-053

NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

March 16, 2019

R03

PA-19-052

NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)

March 16, 2019

U01

PAR-18-550

Analytical Validation of a Candidate Biomarker for Neurological Disease (U01) (Clinical Trial Optional)

March 14, 2019

Scope

This initiative will encompass research on all three domains of INCLUDE and will support Competitive Revision applications to supplement existing funded NIH projects that propose to add a new component related to the goals of the INCLUDE project. The purpose is to support new but related projects or aims that will add an element related to Down syndrome in order to accelerate scientific progress in the field. Only applications submitted in response to this Notice will be allowed to apply for this funding. Competitive Revision applications will be considered eligible for funding if they address one or more of the following components related to the INCLUDE Project research objectives. See Frequently Asked Questions (FAQs) listed on the INCLUDE website for information about specific interests of the NIH participating ICs (https://www.nih.gov/include-project).

Component 1: Targeted, high risk-high reward, basic science studies in Down syndrome: For basic science studies, supplements should target areas of science of highest impact and that are likely to translate into new therapeutic approaches. Topics of emphasis may include: chromosome silencing, immune system dysregulation, epigenetic/metabolomic/transcriptomic profiling in model organisms/iPSCs/brain organoids, development of novel model systems, and development of a molecular atlas for cardiac and other specimens. Supplements could also support research that will inform the other two components of the INCLUDE project, namely a cohort study and/or a clinical trials network.

Component 2: Molecular snapshot of Down syndrome through a cohort study: The goal is to add to or expand an existing Down syndrome cohort, with data collected in a shared database using common data elements and building on the DS-Connect® patient registry. Supplements could add comprehensive molecular (i.e., pan-‘omics) analyses to existing Down syndrome cohorts or support existing infrastructure for sample and neuroimaging collection in the Down syndrome population.

Component 3: Inclusive clinical research for individuals with Down syndrome: Supplement requests could leverage existing clinical trials infrastructure to expand or extend an existing Down syndrome cohort or module in a currently funded trial. Of particular interest are ongoing clinical trials testing therapies for common conditions such as asthma or sleep apnea that occur in people with and without Down syndrome.

We encourage projects that:

  • Are broadly related to the scope of the active parent award
  • Are not currently focused on Down syndrome but could add a Down syndrome cohort, module, or model system of great relevance to Down syndrome
  • Extend, expand, or enhance an existing Down syndrome project in a novel direction
  • Propose to address one of the components listed under the Down syndrome research objectives
  • Are likely to stimulate additional activity leading to progress on Down syndrome
  • Address a priority for the IC that issued the parent award (if applicable)

Supplements to existing clinical trials are allowed, but addition of a new clinical trial that was not a part of the parent award is not allowed. If an applicant is interested in proposing a new clinical trial, please see these FOAs: [Link to RFA-OD-19-018 and RFA-OD-19-015. Supplement requests addressing components 2 or 3 should strongly encourage participants with Down syndrome or their caregivers to register in DS-Connect®: The Down Syndrome Registry (https://DSConnect.nih.gov). In addition, investigators can propose to use DS-Connect to help with recruitment for this proposed research; to do so, register a professional account with DS-Connect and/or contact the registry coordinator at DSConnect@ nih.gov.

Revision applications can support a significant expansion of the scope or research protocol approved and funded for the “parent” award on which the revision application is based. Prospective investigators are encouraged to consult the Program Officials listed on this announcement to ensure that the projects will considerably contribute to achieving the goal of this Notice. Revision applications must be sent in response to an FOA with the same activity as the parent grant (i.e., if a grantee seeks a revision to an R01, the revision application must be sent in response to an FOA for R01s) and that allows revision applications. The FOA does not need to be the one to which the parent grant was submitted. Please see the table above which lists the existing FOAs to use when submitting a supplement based on the activity code of the parent award.

Award Budget

Applicants may request support for up to 2 years, not to exceed the remaining years on the parent grant.  Supplement budget requests are not capped. However, budget requests with annual budgets greater than the annual total direct costs of the parent award in the current year, exclusive of Facilities and Administrative costs on subcontracts, must be highly justified. Application budgets must reflect the actual needs of the proposed project. 

Budget requests are limited to up to 2 years of funding, not to exceed the remaining years on the parent grant (see below). Two-year requests must provide a two-year research timeline. Projects cannot be dependent on a no cost extension of the parent award to complete the proposed project. Modular and categorical budgets are permitted.

Supplement budget requests that exceed $500,000 in direct costs (exclusive of Facilities and Administrative costs on sub-contracts), must receive prior written permission from the program officer for the parent award and IC Contact listed on this Notice prior to submission.

Award Project Period

The supplement project and budget periods must be within the currently approved project period for the existing parent award. The proposed project may be for one or two years, not to exceed the remaining number of years on the parent grant. The parent award must receive funds in FY19 (Oct. 1, 2018-Sept. 30, 2019) and not be in an extension period during the period of the proposed supplement. In other words, all supplement applications must request an end date that does not exceed the current end date of the parent award.

Submitting an Application

For R01 competitive revision supplements submitted in response to this notice, please submit all applications by March 7, not the standard due date referenced in the FOA.

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

Applicants should begin the Introduction to the Revision Application section by stating: “This application is being submitted in response to NOT-OD-19- MMM ".

Applicants MUST insert the unique identifier "INCLUDE19-" in the beginning of the Project Title of their application. [Note: NIH limits the Project Title to 200 characters (including spaces and punctuation)].

In addition, applications should enter the following in Box 4b of the application package"INCLUDE19"

See Frequently Asked Questions (FAQs) listed on the INCLUDE website for information about specific scientific priorities and program contacts at the NIH participating ICs (https://www.nih.gov/include-project).

Inquiries

Please direct all inquiries to the contact at the Institute, Center or Office supporting the parent award, as per below.

Anna E. Mazzucco, PhD
National Institutes of Health (
NIH)
Telephone: 301-451-1220
Email: anna.mazzucco@nih.gov 

Malcolm A. Smith, MD, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6087
Email: Malcolm.Smith@nih.gov 

Houmam Araj, PhD
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: arajh@nei.nih.gov

Charlene Schramm, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-402-3793
Email: SchrammC@nhlbi.nih.gov 

Joy T. Boyer, BA
National Human Genome Research Institute (NHGRI)
Telephone: 301-480-2247
Email: jb40m@nih.gov 

Laurie M. Ryan, PhD
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: ryanl@mail.nih.gov 

Frosso Voulgaropoulou, PhD
National Institute of Allergy and Infectious Diseases (NIAID
Telephone: 240-627-3205
Email: fvoulgaropoulou@niaid.nih.gov 

Marie Mancini, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
Email: mancinim2@mail.nih.gov

Melissa A. Parisi, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6880
Email: parisima@mail.nih.gov

Kelly King, PhD 
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-3458
Email: kingke@nidcd.nih.gov

Jason Wan, PhD
National Institute of Dental and Craniofacial Research (NIDCR
Telephone: 301-594-9898
Email: JasonWan@nidcr.nih.gov 

Ellen Leschek, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-402-8291
Email: LeschekE@EXTRA.NIDDK.NIH.GOV 

Jonathan A. Hollander, PhD
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3269
Email: jonathan.hollander@nih.gov

Lisa Gilotty, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-443-3825
Email: gilottyl@mail.nih.gov

Robert Riddle, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-5745
Email: rr260c@nih.gov 

Rebekah S. Rasooly, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-827-2599
Email: rr185i@nih.gov 

Nathan Stinson, Jr., PhD, MD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8704
Email: stinsonn@mail.nih.gov

Holli Hamilton, MD, MPH, RAC
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-838-5926
Email: hamiltonho@mail.nih.gov

Jane C. Atkinson, DDS
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-827-6031
Email: jatkinso@mail.nih.gov

Robin Boineau, MD, MA
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-435-6286
Email: Robin.Boineau@nih.gov

Sige Zou, PhD
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0749
Email: sige.zou@nih.gov

Concepcion (Marie) Nierras, PhD
Office of Strategic Coordination (Common Fund)
Telephone: 301-435-5840
Email: concepcion.nierras@nih.gov