Notice Number: NOT-DK-19-027
Key Dates
Release Date: October 9, 2019
First Available Due Date: January 5, 2020
Expiration Date: January 7, 2023
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 Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Center for Advancing Translational Sciences (NCATS)
Purpose
This NOSI aims to support the development of innovative approaches to renal replacement therapy and address critical accompanying challenges such as vascular access and fluid management during dialysis.
Background
Chronic Kidney Disease (CKD) and Acute Kidney Injury (AKI) are interconnected syndromes which pose a substantial public health burden. Even with the best available medical therapies, the progressive loss of kidney function can lead to the need for dialysis or kidney transplantation. Hemodialysis and peritoneal dialysis are life-sustaining treatments for kidney failure, but they have substantial limitations and have not significantly improved in decades. Whereas living donor kidney transplantation is preferred, the selection process is complex and lengthy, not all patients are candidates, and organs are in short supply. Unlike dialysis, kidney transplantation cannot be offered emergently. Alternative therapies and technological advances to enhance existing therapies are needed.
Objectives
It is anticipated that the funded applications will propose to develop and test in appropriate models and/or research participants novel technologies related to renal replacement therapy. The applications must be directly related to the mission of the NIDDK, NIBIB, or NCATS. Example areas include, but are not limited to:
- Novel filters or sorbents that will enable new forms of renal replacement therapies
- Wearable, portable, or implantable dialysis systems
- Bioengineered, functional tissue or bioreactors that restore or replace kidney function
- Dialysis-related technologies and bioengineered surfaces that address issues of filtration, connection to the vasculature and urinary system, microbubbles, thrombosis, infection, or bleeding
- Biosensors that monitor key patient variables that are being modulated by therapy
- Accurate, non-invasive methods to assess volume status to enable self-management of volume
- Hemodialysis vascular access devices that can be rapidly cannulated, self-cannulated, prevent infection, and remain patent for prolonged periods
- Tools to improve access and support of treatment modalities that can be used at home
- Therapeutic stimulation of productive kidney repair/regeneration pathways, or connectivity in vivo
- Tools to improve assessment or preservation of organs for transplant and reduce the organ discard rate
Applications are also encouraged that include combinations of technologies that distribute electrolyte homeostasis, toxin removal, and volume regulation across different technologies (for example, a gastrointestinal sorbent and a complementary device), or closed loop technologies that respond to feedback from integrated sensors.
Applications are encouraged from researchers and innovators engaged in major initiatives such as the (Re)Building a Kidney Consortium and the Kidney Innovation Accelerator (KidneyX). Applicants are encouraged to consult the Kidney Health Initiative (KHI) Technology Roadmap For Innovative Alternatives To Renal Replacement Therapy: https://khi.asn-online.org/pages/?ID=8
Applicants who are also participating in KidneyX should be aware of sections of the NIH Grants Policy Statement (GPS) that may apply when a NIH grantee wins a Federal prize competition. Specifically, under Section 8.3.2 of the NIH GPS, the treatment of Program Income in the Notice of Award is usually “Additional Costs.” Program income is gross income--earned by a recipient, a consortium participant, or a contractor under a grant--that was directly generated by the grant-supported activity or earned as a result of the award. If Program Income is generated under this grant award, instructions must be followed for Reporting Program Income, which can be found in Section 8.3.2.1 of the NIH GPS: https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.3.2_program_income.htm
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is interested in supporting applications in all areas described in this NOSI, provided they fall within the mission of the NIDDK. Applicants are strongly encouraged to discuss potential applications with NIDDK's SBIR/STTR Scientific/Research Contacts.
National Center for Advancing Translational Sciences (NCATS)
The National Center for Advancing Translational Sciences (NCATS) is interested in supporting applications under this funding announcement that meet its mission and research priorities. For a description of the NCATS SBIR/STTR research priorities, please refer to http://ncats.nih.gov/smallbusiness/priorities on the NCATS website. Applicants are strongly encouraged to contact Scientific/Research staff about anticipated activities under this announcement prior to submission.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is interested in supporting applications under this funding announcement that meet its mission and research priorities. Applicants are strongly encouraged to discuss potential applications with the Scientific/Research Contacts.
Application and Submission Information
This notice applies to due dates on or after January 5, 2020 and subsequent receipt dates through January 5, 2023 . The following funding opportunity announcements (FOAs) or their reissued equivalents must be used for submissions for this initiative.
| Activity Code | FOA and FOA Title | First Available Due Date |
| R41/R42 | 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) | January 5, 2020 |
| R43/R44 | 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) | January 5, 2020 |
Submit applications for this initiative through one of the following funding opportunity announcements (FOAs) or any reissues of these announcements through the expiration date of this notice.
All instructions in the SF424 (R&R) Application Guide and the listed funding opportunity announcements must be followed, with the following additions:
For funding consideration, applicants must include "NOT-DK-19-027" (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
Please direct all inquiries to:
Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with one of the SBIR/STTR Scientific/Research Contact(s) from one of the Institutes or Centers participating in this NOSI well in advance of the grant receipt date: https://sbir.nih.gov/engage/ic-contacts.
and Human Services (HHS)
