The National Cancer Institute (NCI) SBIR Development Center recognizes that early-stage proof of concept studies can evolve rapidly, necessitating supplementary experiments and/or follow-on experiments for accelerated progress to position promising projects for stronger SBIR Phase II applications and to generate interest from follow-on investors and strategic partners. To accelerate the development of promising technologies, the NCI announces the opportunity for current NCI-funded SBIR Phase I grantees (R43 grant mechanism only) to seek supplemental project funding via the Administrative Supplement mechanism. The funds from these Administrative Supplements are intended to support research activities that are aimed at:

1. Achieving next critical milestones in the technology development pathway to make the applicants more competitive for Phase II applications and/or for raising private-sector capital; and
2. Accelerating the development of the SBIR product to advance it towards commercialization.

Scientific/Technical Scope

The funding can be used to cover additional costs that are associated with achieving new research objectives as long as they are within the original scope of the parent award. The supplement request must be for costs that result from adding a limited number of activities to advance the project to the next critical milestone(s) consistent with its originally approved aims and objectives. It is important to note that while the additional research and development funded by the supplement should advance the project forward, the scope is limited to the same product/technology, disease indication and overall goals as the parent award.

The technical objectives must represent activities that would advance the project to the next critical milestone in technology development. Specific activities to be proposed will vary depending on technical areas and stage of product development. Examples of activities that may be proposed include (but are not limited to):

• Lead optimization
• In vivo efficacy studies in relevant animal models
• PK/PD studies
• Toxicity studies
• Other IND-enabling studies
• Assay development and optimization
• Drug product scale-up and manufacturing
• Defining assay performance and analytic validation
• Sensitivity, specificity and reproducibility testing
• Validation studies using clinical samples
• Software development
• Validation in phantoms and/or animal models
• Biocompatibility/safety/sterility
• Prototype testing prior to IDE/510(K)/PMA submission

Activities that are not supported include:

1. Activities outside the scope of the parent award
2. Studies designed to evaluate a different indication than originally proposed
3. Research activities aimed at developing a different technology or product than originally proposed
4. Non-R&D activities, such as regulatory and reimbursement activities.

Application and Submission Information

Applications in response to this NOSI must be submitted using the following funding opportunity or its reissued equivalent:

• PA-18-591 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-18-591 must be followed, with the following additions:

• Application Due Date The first Application Due Date is March 18, 2020, by 5:00 PM local time of applicant organization. Applications can be submitted on a rolling basis. This administrative supplement program is a two-year pilot that will end March 18, 2022. Please note that the current parent administrative supplement funding opportunity that this NOSI relates to (PA-18-591) expires on January 26, 2021. This NOSI will relate to the reissue of the parent supplement funding opportunity after January 26, 2021, until March 18, 2022.
• For funding consideration, applicants must include “NOT-CA-20-012” (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.
• Applicants should begin the supplement application abstract by stating “This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-CA-20-012.”
• The process for Streamlined Submissions using the eRA Commons cannot be used for this initiative.
• Requests may be for up to one (1) year of support only.
• To be eligible, the applicant must be a current NCI-funded SBIR Phase I (R43 Small Business Innovation Research Grants only) awardee.

• Budget: Grantees with currently active NCI Phase I SBIR awards may propose Administrative Supplement budgets up to $150K direct costs.

• Project Period: At the time of the supplement application, the grantees should have completed a substantial portion of the work proposed in the existing parent award and should have at least 3 months remaining in their parent award. The award must not be in no-cost extension at the time of application. The project period requested for all Administrative Supplements should be adequate to complete the proposed supplemental work but should not exceed one year from the proposed start date of the supplement.

• The Research Strategy section of the application is limited to 6 pages.
• Applicants must incorporate all of the following elements in their Research Strategy:
• Brief description summarizing the merit of the proposed technology including:
  • Significance
  • Value proposition
  • Commercial potential
  • Innovation

• Milestones achieved and progress made during the current award period
• Address the need for the supplement and how the supplement will fit into the commercial development plan
  • Detailed scope of work including goals, tasks, milestones, and timeline.

• Discuss briefly how the proposed supplement addresses the goals of this program as described in this Notice:
  • Achieving the next critical milestones in the technology development pathway to make the applicants more competitive for a Phase II application;
  • Accelerating the development of the SBIR product to advance it towards commercialization
• Letters of Interest: Letters that demonstrate interest from potential private sector partners are encouraged.

Note: You are strongly encouraged to discuss your Administrative Supplement request in advance with the NCI SBIR Program Director listed on your NCI Phase I grant Notice of Award. The purpose is to receive pre-submission feedback on the proposed supplement work scope and its fit with this program.

Administrative Evaluation Criteria

NCI SBIR Program staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. Additionally, Program staff will evaluate applications using the following selection factors:

• The relevance of the proposed activities to the parent grant and original work scope;
• Satisfactory progress toward achieving the aims of the parent grant, as appropriate to the current stage of the project;
• Impact of the proposed work to advance the technology forward to meet the next key development milestones;
• Impact of the proposed work to make the applicant more competitive for phase II application and to move the technology towards commercialization;
• Appropriate and well-described plan to accomplish the goals within the timeframe proposed.

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

Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed funding opportunity announcements.

Please contact your NCI SBIR Program Director with any questions you may have regarding the NCI SBIR Administrative Supplement application requirements and process.

For all other questions, please contact:

Ashim Subedee, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7601
Email: ashim.subedee@nih.gov

Financial/Grants Management Contact

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: woodwars@mail.nih.gov