Notice of Intent to Publish a Funding Opportunity Announcement for Limited Competition for the Continuation of Clinical Sites for the Undiagnosed Diseases Network (U01 - Clinical Trial Not Allowed)
July 13, 2022
Estimated Publication Date of Funding Opportunity Announcement:
August 01, 2022
First Estimated Application Due Date:
September 02, 2022
Earliest Estimated Award Date:
April 03, 2023
Earliest Estimated Start Date:
April 03, 2023
RFA-NS-22-051 - Data Management Coordinating Center for Diagnostic Centers of Excellence (U2C Clinical Trial Not Allowed)
National Institute of Neurological Disorders and
National Human Genome Research Institute (NHGRI)
This Notice informs the research community that the participating NIH Institutes and Centers intend to publish a Funding Opportunity Announcement (FOA) limited to those institutions and Program Directors/Principal Investigators (PD/PI) of Undiagnosed Diseases Network (UDN) Clinical Sites who received an NIH award under the NIH Common Fund UDN program through RFA-RM-17-019. The purpose of this Limited Competition FOA is to allow these UDN Clinical Sites an opportunity to compete for one additional year of NIH funding to: continue their participation in the UDN; establish collaborations and efficient processes with the next phase Data Management and Coordinating Center (DMCC; see: RFA-NS-22-051); enroll and evaluate new participants; and further develop their sustainability plans as the network transitions to a sustainable national resource.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The FOA is expected to be published in August, 2022 with an expected application due date in September, 2022.
This FOA will utilize the U01 activity code. Only Renewal applications will be allowed.
Research Initiative Details
The overarching goals of the UDN are to:
- Facilitate research into the etiology of undiagnosed diseases by collecting and sharing standardized, high-quality clinical and laboratory data including genotyping, phenotyping, and documentation of environmental exposures.
- Demonstrate means to improve the clinical evaluation of difficult-to-diagnose patients using a collaborative team approach and investigating and validating promising new diagnostic technologies.
- Promote an integrated and collaborative community across multiple Clinical Sites and among laboratory and clinical investigators prepared to investigate the pathophysiology, cell biologic, and molecular mechanisms underpinning these difficult-to-diagnose condtitions.
Objectives of this Research Program
The research goals and objectives of this FOA are the same as those described in RFA-RM-17-019, with the following modifications:
- Enrollment projections are commensurate with prior experience and success of the Clinical Site, and should be reflected in the budget. However, at a minimum, applicants must recruit, select, evaluate, and follow at least 15 participants in this project period, and participant evaluations must be completed by the project end date of the grant.
- Clinical Sites are still encouraged to recruit, select, evaluate, and follow participants with disorders in any clinical specialty. However, in the transition of the UDN to a larger network that serves diverse undiagnosed patient populations in the US (see: RFA-NS-22-051), applicants have the option to specialize in one or more areas of clinical practice including but not limited to pediatrics, neurology, cardiology, gastroenterology, immunology, metabolism, environmentally-linked or infectious diseases, etc.
- Applicants may propose streamlined and more efficient, cost-effective diagnostic approaches (e.g., remote visits, tiered evaluation strategies, use of innovative tools or strategies for record review, etc.), while still providing a comprehensive and expeditious clinical evaluation of participants.
- The funds provided under this Limited Competition FOA are intended to augment the sustainability plans established by Clinical Sites in Phase II of the UDN (see: RFA-RM-17-019). Applicants should implement the sustainability plans developed at their site and, when possible, seek reimbursement from non-NIH sources for all or part of the clinical evaluation and sequencing costs (e.g., by billing insurance, utilizing support from outside partnerships).
- UDN Clinical Sites are encouraged to recruit and enroll participants from health disparity populations, including those from racially/ethnically minority populations, from urban and rural areas who are economically disadvantaged, medically underserved, and/or those with limited English proficiency. In this application, Clinical Sites should prioritize patient costs for under/uninsured UDN participants and other costs that cannot be reimbursed through billing insurance or supported by outside partnerships.
- Costs associated with research-grade testing or sequencing and other research activities (e.g., RNA sequencing, gene function studies in model organisms, metabolomics, immunologic profiling etc.), specifically those that are deemed “investigational” and not reimbursed by insurance or outside partnerships, will be supported through subawards issued by the DMCC (RFA-NS-22-051) to be awarded in FY2023. Applicants have the option to budget some of the costs associated with the evaluation (e.g., whole genome sequencing) in this application, if non-reimbursable and justified.
- To develop further UDN sustainability plans as the network transitions to a sustainable national resource.
Estimated Total Funding
Issuing IC and partner components intend to commit an estimated total of $6,500,000 total costs to fund up to 11 awards, contingent upon available funds and submission of meritorious applications.
Expected Number of Awards
Estimated Award Ceiling
Application budgets are limited to $400,000 direct costs and need to reflect the actual needs of the proposed project; the maximum project period is 1 year (FY2023).
Primary Assistance Listing Number(s)
Anticipated Eligible Organizations
Applications are not being solicited at this time.
Please direct all inquiries to:
National Institute of Neurological Disorders and Stroke (NINDS)