Key Dates

Related Announcements

PA-20-260 - PHS 2020 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

PA-20-265 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

PA-20-262 - PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

Issued by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

This NOSI intends to encourage small businesses to translate kidney precision medicine discoveries and technologies.

Background
Recent gains in access to kidney tissue and bio-samples and advances in multi-scale interrogation of human tissue and single cells have set the stage for precision medicine to be applied to kidney disease. Specifically, several cohort studies have included kidney biopsies [e.g., the Kidney Precision Medicine Project (KPMP) and the Nephrotic Syndrome Study Network (NEPTUNE)], and research consortia have advanced novel tools and technologies to interrogate bio-samples and released multi-omic data to the public. These bio-samples, technology, and data offer opportunities for technology development and translational research in the area of kidney precision medicine.

Objectives
Proposed technologies are expected to support efforts in kidney precision medicine. Example technologies include, but are not limited to:

Supporting kidney precision medicine

• Biopsy technologies, including better imaging methods, that improve the safety profile and accuracy of the kidney biopsy.
• Technologies that provide immediate feedback on the size, composition, or quality of kidney biopsy specimens.
• Instrumentation, methods, or reagents to preserve key analytes during collection and storage of kidney biopsy specimens and methods or reagents to extract these analytes from preserved specimens (i.e., frozen or formalin-fixed, paraffin-embedded archived tissue).
• Next-generation tissue interrogation technologies that probe the structural, functional, and molecular complexities of kidney tissue at a single-cell resolution, particularly in compartments that are difficult to study (e.g., interstitium).
• Innovative tools to expand the breadth and depth of longitudinal clinical phenotyping, including physiology, function, and imaging.
• Novel biomimetic “phantoms” that can support quality control efforts, serve as standards to normalize batch effects (ensure traceability, version control, rigor and reproducibility), and to enhance the ability of the research community to compare results from diverse tissue interrogation methods performed at different sites and at different times.

Translation of kidney precision medicine discoveries and technologies

• Assays or screens for drug discovery based on targets identified in precision medicine data sets.
• Technologies that improve the diagnosis, staging, grading, prognosis, subgroup stratification, and drug effect prediction in AKI and CKD; these could be based on tissue interrogation, circulating or excreted biomarkers, or imaging.
• Diagnostic or predictive tools based on automated analysis of digital pathology, multi-omic, and/or clinical data.
• Computational tools and software applications (“apps”) to analyze, integrate, display, and share complex data sets (derived from individual clinical, histological, tissue, cellular and molecular data).

Projects must be within the mission of the NIDDK: https://www.niddk.nih.gov/about-niddk/research-areas.

Application and Submission Information

This notice applies to due dates on or after January 5, 2021 and subsequent receipt dates through September 5, 2023. 

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-20-260 PHS 2020 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
• PA-20-265 PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
• PA-20-262 PHS 2020-2 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required)

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-DK-21-007” (without quotation marks) 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 not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

Daniel Gossett, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7723
Email: daniel.gossett@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Ms. Pamela Love
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-435-6198
Email: lovepa@mail.nih.gov