The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs at the National Cancer Institute (NCI) is issuing this Notice of Special Interest (NOSI) to highlight the urgent need for the development of prophylactic, therapeutic and diagnostic for Coronavirus Disease 2019 (COVID-19). To accelerate the development of promising technologies, the NCI encourages applications from small businesses with NCI-funded active SBIR/STTR awards for technologies that have a strong potential to be adapted/repurposed for use as a prophylactic, therapeutic or diagnostic tool for SARS-CoV-2 (COVID-19).

Background

The COVID-19 pandemic is an urgent health emergency (as defined by the CDC and WHO). Innovative technologies to diagnose the virus and/or infection rapidly at the point of care setting, vaccines and other technologies to prevent and protect from infections, and therapeutics to treat the disease and manage symptoms are urgently needed.

The SBIR/STTR programs fund and support small businesses developing innovative technologies to improve health and well-being. There is an opportunity to adapt and retool a number of these innovative technologies that SBIR/STTR-funded small businesses are already developing to diagnose, prevent, and treat novel coronavirus and COVID-19. Through this NOSI, NCI encourages small businesses with NCI-funded active SBIR/STTR awards with promising technologies to submit applications to PA-18-935, Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement Clinical Trial Optional).

Research Objectives & National Cancer Institute Areas of Interest

The NCI Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs encourage applications from small businesses with NCI-funded active NCI SBIR/STTR awards that have a strong potential to be adapted/repurposed for use as a prophylactic, therapeutic or diagnostic tool for SARS-CoV-2 (COVID-19) in cancer patients, cancer survivors, and in the general population. A compelling rationale should be presented and linked to an appropriate research plan to generate data in support of the new proposed use. Areas of interest include but not limited to:

• Adapting the use of cancer diagnostics and diagnostic technologies and platforms for diagnosing the virus, infection, and potential immunity against the virus rapidly at the point of care setting;
• Repurposing or expanding use of cancer vaccines, vaccine candidates, and other technologies for prevention of, and/or protection from SARS-CoV-2 infection;
• Repurposing or expanding the use of cancer therapeutics and therapeutic candidates for the treatment of COVID-19 and the management of severe symptoms.

Applicants are strongly encouraged to contact the NCI Program Director of the parent award to discuss potential applications and whether urgent competitive revision applications or administrative supplement requests are more appropriate for the proposed research.

Application and Submission Information

Applications in response to this NOSI must be submitted using the following target funding opportunity announcement or its subsequent reissued equivalent.

• PA-18-935 - Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional)

Applications that involve a change in scope must apply through PA-18-935 Urgent Competitive Revision to Existing NIH Grants and Cooperative Agreements (Urgent Supplement - Clinical Trial Optional).

To be eligible for a supplement through this NOSI, the parent award on which the revision application is based must:

• be an NCI-funded active SBIR/STTR (R41, R42, R43, R44 mechanisms) award (i.e., not be in an extension period) at the time the revision/supplement application is submitted.

All instructions in the SF424 (R&R) Application Guide and in the target funding opportunity announcement (PA-18-935) must be followed, with the following additions:

• The Research Strategy section of the application is limited to:
  • 6 pages for R41 and R43 awards; and
  • 12 pages for R42 and R44 awards.

Award Project Period: The project period will generally be limited to 1 year.

Award Budget: The NCI SBIR program will consider awards of up to $250,000 in total cost for phase I (R43), and $1,000,000 in total cost for phase II (R44). The NCI STTR program will consider awards of up to $250,000 for phase I (R41) and $500,000 for phase II (R42).

Application Deadlines: Applications will be accepted on a rolling basis from April 14, 2020, through June 25, 2020, by 5:00 PM local time of the applicant organization. This NOSI expires on June 26, 2020. An application submitted in response to this NOSI that is received on June 26, 2020, or later will be withdrawn.

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, all applicants must designate "NOT-CA-20-043" 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.
• All applications (including those for multi-project activity codes) must be submitted electronically using a single-project application form package

Urgent competitive revision applications through this NOSI to PA-18-935 must use the application form package with the Competition ID of NOT-CA-20-043-FORMS-E." This FOA will be reissued with a NOT-CA-20-043-FORMS-F package on May 25, 2020. Submissions to PA-18-935 must be completed by June 25, 2020 (see NOT-OD-20-026 for details). Submissions to the reissued FOA will be accepted on or after May 25, 2020, through the expiration date of this Notice.

• Applications should include a data sharing plan and should state if the application falls under the NIH Genomic Data Sharing Policy.
• Applications must specifically address issues of potential biohazards, and all research must be conducted in compliance with the health and safety requirements found in the NIH Grants Policy Statement.

Investigators planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with Program Directors of the parent award before writing and submitting their competitive revision and/or administrative supplement applications to allow for the determination of appropriateness and interest of the institute in any related proposed research.

Ashim Subedee, PhD.
Program Director, NCI, NIH
Telephone: 240-276-7601
Email: ashim.subedee@nih.gov

Please direct financial/budgetary inquiries to:

Crystal Wolfrey
Chief Grants Management Officer, NCI, NIH
Email: wolfreyc@mail.nih.gov

Please direct scientific/programmatic inquiries to:

The NCI Program Director who has stewardship of the parent award for which you would like to submit a competitive revision application.