Notice of Special Interest (NOSI): Development of Functional Assay Sites to Evaluate Candidate -Omics Variants Associated with Heart, Lung, Blood, or Sleep Disease NOT-HL-19-731

Key Dates

Related Announcements

PA-19-056 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PA-19-270 PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed

PA-19-272 PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

Issued by

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

Large-scale high-throughput sequencing studies, such as the NHLBI’s Trans-Omics for Precision Medicine (TOPMed) program and the NHGRI’s Genome Sequencing Program, have identified hundreds of millions of genetic variants potentially associated with numerous heart, lung, blood and sleep (HLBS) clinical phenotypes. The challenge now is to distinguish which are pathogenic and clinically significant, and at a level of scale capable of generating a knowledge base of annotated variants with sufficient breadth and depth to inform clinical care.

Biological functional assays are one approach to validating candidate disease variants. However, these assays are highly specific for the physiology of the target disease, require specialized expertise, and may be difficult or expensive to replicate in multiple research labs. Therefore, the NHLBI solicits research applications from academic and small business entities proposing to design and conduct biological functional assays. Broad systems-level approaches are encouraged over single gene or single gene variant assessments.

The NHLBI is issuing this Notice of Special Interest (NOSI) to highlight interest in receiving grant applications focused on HLBS disorders in the following area(s):

• Development and/or application of moderate- or high-throughput functional assays to provide biological validation of candidate human variants associated with HLBS disorders

Examples of potential research include, but are not limited to:

• Massively parallel reporter assays to screen thousands of regulatory elements in cell culture to identify variants that influence gene expression related to a specific HLBS endpoint.
• Gene editing of human variants into iPS cells followed by differentiation into HLBS cell type(s) that can be assayed for HLBS endpoints or drug responses.
• Generation of Drosophila avatars of human variants to assay for system s-level disruptions of HLBS molecular networks.
• Functional characterization of new Sickle Cell Disease-associated -omics candidates.

Application and Submission Information

This Notice applies to due dates on or after February 5, 2020 and subsequent receipt dates through September 7, 2022.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

• PA-19-056 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• PA-19-270 PHS 2019-02 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• PA-19-272 PHS 2019-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For funding consideration, applicants must include NOT-HL-19-731 in the Agency Routing Identifier field (box 4b) of the SF424 R&R form. Applications without this information in box 4b will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will be not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

Charlene Schramm, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-402-3793
Email: schrammc@nih.gov