National Institutes of Health (NIH)
National Cancer Institute (NCI)
Funding Opportunity Title
SBIR Phase IIB Bridge Awards to Accelerate the Development of Cancer Therapeutics, Imaging Technologies, Interventional Devices, Diagnostics, and Prognostics Toward Commercialization (R44)
R44 Small Business Innovation Research (SBIR) Grant - Phase II only
Reissue of RFA-CA-10-009
Funding Opportunity Announcement (FOA) Number
Catalog of Federal Domestic Assistance (CFDA) Number(s)
This Funding Opportunity Announcement (FOA) solicits Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that seek additional funding to support the next stage of development for projects that were previously funded by NIH SBIR Phase II awards. Projects proposed in response to this FOA must be applicable to one of the following areas: (1) cancer therapeutics; (2) cancer imaging technologies, interventional devices and in vivo diagnostics; or (3) in vitro and ex vivo cancer diagnostics and prognostics. The purpose of this FOA is to facilitate the transition of SBIR Phase II projects to the commercialization stage. This FOA is expected to promote partnerships between NIH’s SBIR Phase II awardees and third-party investors and/or strategic partners to facilitate and accelerate the capital-intensive steps that are required to commercialize new products and technologies. Consistent with the goals of this funding initiative and as required by the SF424 instructions for all Phase II SBIR applications, applicants must submit a Commercialization Plan, which should include details on any independent third-party investor funding that has already been secured or is anticipated during the Bridge Award project period. It is expected that the level of this independent third-party funding will equal or exceed the NCI funds being requested throughout the Phase IIB Bridge Award project period. Proposed projects may address preclinical and/or clinical stages of technology development. Clinical trials may be proposed as appropriate but are not required..
February 3, 2011
Open Date (Earliest Submission Date)
March 7, 2011
Letter of Intent Due Date
March 7, 2011
Application Due Date(s)
April 7, 2011 , by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Scientific Merit Review
Advisory Council Review
Earliest Start Date(s)
April 8, 2011
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The Small Business Innovation Research (SBIR) Program is an important mechanism by which the National Institutes of Health (NIH) helps bring innovative solutions to public health challenges. A major objective of the SBIR Program is to facilitate the commercialization of technologies developed by small business concerns (SBCs). Yet, the development of medical biotechnology products is often impeded by a significant funding gap, known as the “Valley of Death,” between the end of the SBIR Phase II award and the commercialization stage. This Funding Opportunity Announcement (FOA) solicits SBIR grant applications from SBCs to support later stage research and development (referred to as Phase IIB) for projects that were previously funded by NIH SBIR Phase II awards. The goal of this FOA and Phase IIB awards is to assist applicants in pursuing the next appropriate milestone(s) necessary to advance a product/technology along a promising commercialization pathway. A similar NCI SBIR Bridge award FOA was issued in 2010 (RFA-CA-10-009).
To be responsive to this FOA, proposed projects MUST be applicable to one of the following technical/scientific areas:
(1) Cancer Therapeutics;
(2) Cancer Imaging Technologies, Interventional Devices and In Vivo Diagnostics; or
(3) In Vitro and Ex Vivo Cancer Diagnostics and Prognostics.
SBIR Phase IIB Bridge Awards are designed to facilitate the continuation of promising SBIR Phase II projects in order to pursue the next appropriate milestone(s) toward ultimate commercialization. To achieve this goal, this FOA is designed to promote partnerships between NIH’s SBIR Phase II awardees and third-party investors and/or strategic partners. In particular, this FOA will give competitive preference and funding priority to applications deemed likely to result in a commercial product as indicated by the applicant’s ability to secure substantial independent third-party investor funds (i.e., third-party funds that equal or exceed the requested NCI funds). NCI support is thus intended to benefit cancer patients by accelerating the development of novel cancer-relevant products and technologies toward commercialization.
This FOA is specifically intended to provide additional support for products and technologies that require ultimate approval by a Federal regulatory agency; therefore, proposed projects may address preclinical and/or clinical stages of development (including clinical trials).
Since its inception in 1982, the NIH SBIR program has provided the small business community with critical seed funding to support the development of a broad array of commercial products for the detection, diagnosis, treatment, and prevention of disease. The SBIR Program is structured in three phases. The main objective in Phase I is to establish the technical merit and feasibility of the proposed research and development (R&D) efforts, whereas in Phase II it is to continue the R&D efforts to advance the technology toward ultimate commercialization. The objective in Phase III is for the small business to fully commercialize their product or technology using non-SBIR funds. However, many of the early-stage projects initiated with SBIR funding require considerable financing beyond the SBIR Phase II award to achieve commercialization. In particular, the development of therapeutics and medical devices often requires several years and substantial capital investments, due in large part to the costs associated with conducting clinical trials and/or other steps mandated by the Federal regulatory approval process.
Among the areas of R&D supported by the NCI’s SBIR Program, cancer therapeutics, imaging technologies, interventional devices, diagnostics and prognostics typically require substantial levels of additional financing beyond the SBIR Phase I and Phase II funding. Moreover, a number of emerging products in these areas are becoming increasingly complex due to the technological advances in multi-disciplinary fields. For example, new products may involve measurements of both physical and molecular signatures, combine device(s) and molecular probe(s), or perform dual functions of diagnosis and therapy. These products are referred to as “combined technologies” by the Food and Drug Administration (FDA), and examples in oncology include those related to genomics, proteomics, certain approaches to imaging, image-guided diagnosis and therapy, and other therapeutics. Importantly, the developers of such technologies often face additional challenges during the regulatory approval process, requiring even more time and effort to commercialize such technologies.
Large pharmaceutical and biotechnology companies, as well as venture capital firms, have traditionally provided the resources needed to fully develop and commercialize biomedical products and technologies initiated with NIH SBIR funding. More recently, however, many investors in life science technologies have shown a bias toward financing the continued development of relatively mature technologies at established companies, rather than the higher-risk, emerging technologies under development at many small businesses. Consequently, a number of NIH-funded SBIR awardees are successfully completing their Phase II activities, yet they are still unable to attract sufficient investment (by the end of the Phase II award) to continue the development of their product or technology, thus exhausting their financial resources at a critical stage. The purpose of this FOA is to address this funding gap between the end of the SBIR Phase II award and the point at which non-NIH financing can be secured for the subsequent stages of product development – a phase often referred to as the “Valley of De ath.”
A number of public and private organizations have begun to recognize the challenges associated with the “Valley of Death” and are taking steps to provide additional resources to advance a greater number of early-stage technologies toward commercialization. Importantly, many of these organizations are not only providing financial support but also establishing programs to provide commercialization guidance. For example, in the area of drug development, a number of major pharmaceutical firms have developed corporate venture funds focused on supporting projects in the pre-clinical stages of development, and some of these firms have established technology incubators to provide regulatory guidance. In addition, a growing number of universities are creating venture funds to support innovative technologies developed by their resident investigators, and numerous state-sponsored technology funds have also been created across the U.S. to support start-up companies. Taken together, these programs can provide additional financing and commercialization support for SBIR awardees that have received initial seed funding and a rigorous technical evaluation through the NIH peer review process. As such, a major goal of this FOA is to provide a platform to incentivize partnerships between NIH-funded SBIR awardees and a broad range of potential third-party investors.
Specific Objectives for SBIR Phase IIB Bridge Award Applications
A. Independent Third-Party Investor Funds
This FOA is specifically intended to encourage business relationships between applicant SBCs and third-party investors/strategic partners who can provide substantial financing to help accelerate the commercialization of promising new products and technologies initiated with NIH SBIR funding. In particular, applicants are expected to leverage their previous NIH SBIR support, as well as the opportunity to compete for additional NCI funding under this FOA, to negotiate and attract third-party financing needed to advance a product or technology toward commercialization. Therefore, competitive preference and funding priority will be given to projects deemed likely to result in a commercial product as evidenced by the applicant’s ability to secure independent third-party investor funds that equal or exceed the total amount of the NCI funds being requested over the entire Bridge Award project period. It is anticipated that many of the partnerships between applicant SBCs and third-party investors will involve a considerable level of project due diligence by the private sector, thereby increasing the likelihood of commercial success for the funded projects. In light of these goals, the NCI strongly encourages applicants to establish business relationships with investors and/or strategic partners that have appropriate prior experience in the commercialization of emerging biomedical technologies.
B. Scientific/Technical Scope
The technical and commercial objectives described in the SBIR Phase IIB Bridge Award application MUST represent an extension of the development efforts that were pursued in a previously funded NIH SBIR Phase II grant. In particular, this FOA is specifically designed to provide additional support for products/technologies that require ultimate approval by a Federal regulatory agency.
Applications received under this FOA must fall within one of three technical/scientific areas: (1) Cancer Therapeutics; (2) Cancer Imaging Technologies, Interventional Devices, and In Vivo Diagnostics; or (3) In Vitro and Ex Vivo Cancer Diagnostics and Prognostics. The following descriptions provide additional details on each of these areas, as well as appropriate development activities to be proposed under this FOA.
Area 1: Cancer Therapeutics
Projects proposed under Area 1 may include (but are not necessarily limited to) the development of the following categories of cancer therapeutics:
Therapeutic modalities other than those listed above may also be considered.
Applicants proposing projects under Area 1 are generally expected to have completed most of the following steps in the development process (as appropriate for the specific project):
For projects pertaining to Area 1, applicants are expected to propose activities that will lead to the successful filing of an Investigational New Drug (IND) application, as well as clinical studies to support the filing of a New Drug Application (NDA) and/or Biological License Application (BLA).
Specific activities to be proposed will vary among applications. Appropriate activities that may be proposed for Area 1 include (but are not necessarily limited to) the following examples:
Other R&D activities needed to meet the requirements and expectations of relevant regulatory agencies may also be proposed, as necessary and required for commercialization.
Area 2: Cancer Imaging Technologies, Interventional Devices & In Vivo Diagnostics
Projects proposed under Area 2 may include (but are not necessarily limited to) the development of the following categories of cancer imaging technologies, interventional devices and in vivo diagnostics:
Cancer imaging modalities and interventional devices/technologies other than those listed above may also be considered.
Applicants proposing projects under Area 2 are generally expected to have completed the following steps in the development process (as appropriate for the specific project):
For projects pertaining to Area 2, applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, Investigational Device Exemption (IDE) application, and/or the successful approval of a study protocol by the Radioactive Drug Research Committee (RDRC).
Specific activities to be proposed will vary among applications. Appropriate activities that may be proposed for Area 2 include (but are not necessarily limited to) the following examples:
Other R&D activities needed to meet the requirements and expectations of relevant regulatory agencies may also be proposed, as necessary and required for commercialization of the technology.
Area 3: In Vitro and Ex Vivo Cancer Diagnostics and Prognostics
Projects proposed under Area 3 may include (but are not necessarily limited to) the development of the following categories of in vitro and ex vivo cancer diagnostics and prognostics:
In vitro and ex vivo cancer diagnostic and prognostic technologies other than those listed above may also be considered. Prognostic technologies may be focused on (predicting) disease progression, response to therapy, or both.
Applicants proposing projects under Area 3 are generally expected to have completed the following steps in the development process (as appropriate for the specific project):
For projects pertaining to scientific Area 3, applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, and/or Investigational Device Exemption (IDE) application, as needed for the specific technology/system/assay. Thus, activities to be pursued under this FOA should address any relevant requirements for clinical validation and regulatory approval, as necessary and required for commercialization of the technology.
C. Plan for Full Commercialization (all applications)
The goal of the SBIR Phase IIB Bridge Award is to advance SBIR Phase II projects toward ultimate commercialization. All applicants are expected to describe a realistic plan (extending beyond the SBIR Phase IIB Bridge Award project period), which outlines how and when full commercialization can be accomplished. The long-term commercialization strategy should be presented as part of the 12-page Commercialization Plan. The full commercialization of the product/technology should be carried out with non-SBIR funds.
NOTE: Commercial merit and viability of the proposed R&D. Competitive preference and funding priority will be given to projects deemed likely to result in a commercial product as indicated by the applicant’s ability to secure appropriate independent third-party investor funds that equal or exceed the total amount of the NCI funds being requested over the entire project period.
Application Types Allowed
Phase IIB Competing Renewal (Phase IIB, formerly Phase II Competing Renewal)
Resubmission (only for those previously submitted in response to RFA-CA-08-021 and RFA-CA-10-009)
The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
The following NIH components intend to commit the following amounts in FY 2011:
NCI/SBIR Development Center, $10,000,000, up to 10 awards.
Budgets up to $1,000,000 total costs per year may be requested.
Award Project Period
Durations up to 3 years for the SBIR Phase IIB Bridge Award (Phase IIB) may be requested. Project periods MUST not exceed 3 years under this FOA.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:
1. Is organized for profit, with a place of business
located in the United States, which operates primarily within the United States
or which makes a significant contribution to the United States economy through
payment of taxes or use of American products, materials or labor;
2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;
3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;
4. Has, including its affiliates, not more than 500 employees.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) SBIR/STTR Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PD/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur. Provided these conditions are met, applications submitted in response to this FOA may have the same or different PDs/PIs as the original Phase II grants on which the current applications are predicated.
The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed . Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF424 (R&R) SBIR/STTR Application Guide. Resubmission applications will be accepted only for applications that were originally submitted in response to the previous SBIR Phase IIB Bridge Award FOAs (RFA-CA-08-021 and RFA-CA-10-009).
The SBIR Phase IIB Bridge Award application must represent a continuation of the R&D efforts performed under a previously funded NIH SBIR Phase II award. Applications may be predicated on a previously funded SBIR Phase II grant or contract award. NOTE: Applicants who intend to submit a Phase IIB Bridge Award application that is predicated on an SBIR Phase II contract MUST contact the SBIR Development Center prior to submission, so that the NCI can properly arrange for such applications to be accepted. Applicants must demonstrate in their application that significant progress has been accomplished during the current/preceding NIH SBIR Phase II project, and also that the product/technology has significant commercial potential. Applicants must also demonstrate that the proposed product/technology has a clear advantage over existing and/or competing products/technologies and must clearly define an appropriate path toward ultimate product commercialization. Only one Phase IIB Bridge Award is allowed per each prior, qualifying NIH SBIR Phase II award. Following the award period under this FOA (i.e., up to 3 years), recipient SBCs are expected to pursue the full commercialization of these SBIR-funded projects using non-SBIR funds.
To qualify for renewal under the Phase IIB Bridge Award, the prior Phase II award could have been funded in response to any NIH SBIR solicitation and could have been funded by the NCI or by another NIH Institute/Center. However, the proposed objectives must fall within the technical scope of this solicitation as described under Section I (Specific Objectives for SBIR Phase IIB Bridge Award Applications). SBCs that previously received an NIH SBIR Phase IIB Competing Renewal (formerly Phase II Competing Continuation) should NOT submit a Bridge Award application under this FOA that is predicated on the same Phase II project as the Competing Renewal award.
This FOA is only open to NIH SBIR Phase II projects nearing completion and those that have recently ended. To be eligible under the current FOA, current Phase II projects MUST end on or before August 31, 2011. In general, past Phase II projects should have ended within 24 months of the application receipt date. The NCI will consider longer periods of hiatus on a case-by-case basis. In all cases, the Phase II project period must end before a Phase IIB Bridge Award can be issued.
In Phase II, normally, a minimum of one-half or 50% of the
research or analytical effort must be carried out by the small business
concern. The total amount of consultant and contractual arrangements to third
parties for portions of the scientific and technical effort generally may not
exceed 50% of the total Phase II amount requested (direct, F&A/indirect,
The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of the requested costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS398 Research Plan component of SF424 (R&R) application forms. Additional details are contained in the SF424 (R&R) SBIR/STTR Application Guide..
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Number and title of this funding opportunity
The letter of intent should be sent to:
Andrew J. Kurtz, Ph.D.
SBIR Development Center
National Cancer Institute
31 Center Drive, Building 31, Room 10A19
Bethesda, MD 20892-2580
Telephone: (301) 594-6846
Fax: (301) 480-0482
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) SBIR/STTR Application Guide to ensure you complete all appropriate “optional” components.
All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed., with the following additional instructions:
Do not use the appendix to circumvent page limits. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide, with the following modifications:
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) SBIR/STTR Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
The Federal funds provided by a Phase IIB Bridge Award should only be used for advancing the research-related elements of the project..
Applications must be submitted electronically following the instructions described in the SF424 (R&R) SBIR/STTR Application Instructions. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF
424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the
successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) SBIR/STTR Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the NCI , NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Evaluation of Responsiveness
Prior to the peer review process, program staff in the NCI SBIR Development Center will determine whether applications are responsive to this FOA. All applications will be administratively evaluated to determine whether:
In general, applications submitted in response to this FOA should be predicated on SBIR Phase II grants that ended not more than 24 months prior to the application receipt date. In exceptional situations, applications predicated on older SBIR Phase II grants will be considered, but only after a careful administrative evaluation to determine whether the proposed R&D activities are responsive to this FOA in terms of reflecting a current, scientifically-relevant problem approached as a commercially-viable opportunity.
Other Submission Information for SBIR Phase IIB Bridge Award Applications
All applicants are strongly encouraged to contact NCI program staff prior to submitting an SBIR Phase IIB Bridge award application.
Commercialization Plan: The following subsections should be included within the Commercialization Plan (within the 12-page limit), in addition to the requirements listed in the SF424 Application Guide
1) SBIR/STTR Commercialization History
Applicants should provide an SBIR/STTR Commercialization History that addresses the questions listed below. The following questions should be addressed for all SBIR/STTR awards received from ANY Federal agency:
2) Fundraising Plan
Applicants must provide a Fundraising Plan. This plan is expected to include the following information:
The NCI considers the raising of independent third-party investor funds to be an important means to facilitate and accelerate the capital-intensive steps that are required to commercialize new products/technologies emerging from NIH-funded SBIR Phase II projects. As such, the NCI expects that applicants for the Phase IIB Bridge Award will secure substantial independent third-party investor funds, generally at least $750,000 in total third-party investor funds over the entire project period. If the project period spans multiple years, the NCI expects that the third-party tranche (i.e., portion of the total investment) received in any given year will represent a substantial portion of the total investment, generally at least $250,000 in any given year. In all cases, it is expected that the level of this independent third-party funding will equal or exceed the NCI funds being requested throughout the Phase IIB Bridge Award project period.
Examples of third-party investors include, but are not necessarily limited to, another company, a venture capital firm, an individual “angel” investor, a foundation, a university, a research institution, a State or local government, or any combination of the above. Third-party investors generally should not include owners of the applicant SBC, their family members, and/or “affiliates” of the applicant SBC. Preferred independent third-party investor funds under this FOA include cash, liquid assets, and/or convertible debt. Independent third-party investor funds generally should not include in-kind support, intangible assets, self-funding, and/or other debt.
SBIR-eligible public companies may include as part of their fundraising plan the issuance of stock. In such a case, the preferred documentation is a letter of commitment, signed by the Chairman of the Board of Directors, which stipulates the following: (1) the amount of capital raised from the issuance of stock; (2) the amount of capital that will be dedicated to the proposed project under this FOA; (3) sufficient information regarding the use of the dedicated capital to demonstrate a substantial, value-added contribution toward the development and commercialization of the product/technology to be developed under this FOA (see instructions below under, “Use of Third-Party Investment Funds”).
It is likely that several months will have elapsed between the time an application is submitted and the time it is peer reviewed and subsequently considered for possible funding. Accordingly, applicants should present a detailed summary of all past and/or planned (i.e., future/expected) third-party investor funds which clearly shows, relative to the estimated award date, when these funds have been and/or will be secured. For example, if the fundraising efforts of the SBC are in progress, and/or if the third-party investment is contingent upon NIH selecting the application for funding, then such plans should be clearly described in the Fundraising Plan.
At the time of application, applicants should provide detailed, verifiable documentation (e.g., redacted bank statement or other documentation) of any independent third-party investor support that has been secured up to one year prior to the application receipt date. Applicants should also provide detailed, verifiable documentation of any independent third-party investor support that will be provided to the SBC during the proposed Bridge Award project period. Documentation of support from third-party investors should corroborate the Fundraising Plan. (See Section IV.2 for more information about the use of appendices to include supporting documention.)
Examples of adequate documentation of planned (i.e., future/expected) third-party funding include a term sheet and/or letter of commitment from the third party (or parties) stipulating the terms of the proposed investment, although other forms of documentation may be considered. At the time of application, evidence of a firm third-party commitment is ideal, but not required. Appropriate documentation of third-party investor support may include a conditional letter of commitment stating that the third-party funding is contingent upon NIH selecting the application for an award.
Applicants seeking further information regarding preferred sources and/or types of support that would demonstrate a third-party investor commitment are strongly encouraged to communicate with the Scientific/Research Contact(s) listed under Section VII.
3) Statement of Need
Applicants must provide a concise “Statement of Need”. This statement is expected to provide answers to the questions listed below:
4) Use of Third-Party Investment Funds
The Federal funds provided by a Phase IIB Bridge Award can only be used for advancing the research-related elements of the project. The use of any third-party investor funds will be at the discretion of the SBC. Applicants should provide sufficient information regarding the use of any third-party support to demonstrate a substantial, value-added contribution toward the development and commercialization of the product/technology. In particular, applicants are expected to address the following questions regarding the use of third-party funds.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115 with the following exceptions:
Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase IIB Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)
Specific to this FOA: How compelling is the value proposition, and to what extent does the application demonstrate a substantial market-pull for the technology under development? How well has the applicant described the market niche(s) for the product/ technology, and how urgent is the unmet need(s) being addressed? To what extent has the applicant identified realistic, market-based milestones that can be achieved over the next five years? How well has the applicant demonstrated an understanding of the competitive environment in which they plan to sell their product? To what extent has the applicant identified their customers and demonstrated a clear understanding of their needs? How well has the company addressed potential hurdles that may delay or prevent acceptance of their product? How reasonable are the applicant’s plans for generating a revenue stream, and how realistic are the revenue projections? How strong is the applicant’s intellectual property (IP) portfolio/position (pertinent to the proposed project), and to what extent does the company have a reasonable strategy to protect its IP going forward?
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific to this FOA: To what extent do the prior experience and qualifications of the project team members lend confidence that the team will be successful in commercializing the proposed product/technology? For example, how successful have the PD(s)/PI(s) been in commercializing other SBIR/STTR supported technologies and discoveries in the past?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Specific to this FOA: How promising are the outcomes of the previously-funded NIH SBIR Phase II project upon which the proposed Phase IIB Bridge Award is predicated? To what extent does the progress justify the continuation of the development efforts? How appropriate are the proposed milestones for the Phase IIB Bridge Award in determining whether the awardee has successfully reached the specified goals (e.g., IND filing)? If the proposed project involves advancing the product/technology through the Federal regulatory approval process, how sound is the proposed plan to meet these requirements?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangement?
Specific to this FOA: To what extent does the applicant SBC have the ability to address regulatory issues, either through their own staff members or through appropriate arrangements with external regulatory consultants? To what extent is the applicant SBC concentrating on its core competencies in order to maximize its chances of success? How well can the applicant SBC sustain itself and grow as a business? To what extent will the applicant's business alliances and/or corporate partnerships help in facilitating commercialization? For example, will the third-party investors play an active role in facilitating the commercialization of the product/technology, and if so to what extent? If the SBC has received previous SBIR/STTR funding from ANY Federal agency, then how successful is the company’s track record in commercializing prior SBIR/STTR projects?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.
Fundraising Plan. How well does the application support the ability of the SBC to secure substantial independent third-party investor funds (i.e., third-party funds that equal or exceed the requested NCI funds), including the preferred types of liquid, third-party investor funds (i.e., cash, liquid assets, and/or convertible debt), as expected under this FOA? How detailed is the documentation (e.g., term sheet) that has been provided by the applicant to corroborate the Fundraising Plan? To what extent has the applicant demonstrated that the third-party investor support will provide a substantial, value-added contribution toward the development and commercialization of the product/technology? For example, has the applicant described the specific activities that the third-party investor funds will support? If the third-party investors have attached restrictions and/or triggers and/or milestones to future payments, then to what extent have these restrictions been clearly stipulated in the application? In general, have the terms of the future investment rounds been sufficiently described, thus demonstrating a high level of confidence in the SBC’s ability to execute the overall fundraising plan?
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Phase IIB Competing Renewal Applications (formerly called Phase II Competing Renewals), the committee will consider the progress made in the last Phase II funding period.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by an appropriate Scientific Review Group convened by the NCI (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board . The following will be considered in making funding decisions:
After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
SBIR Phase IIB Bridge Award Terms and Conditions
If a Phase IIB Bridge Award application is selected for funding, the applicant’s plan for securing independent third-party investor funds (i.e., the Fundraising Plan submitted as part of application) will become a term of award. Prior to the issuance of an award, NIH will request “Just-In-Time” information from the applicant to verify compliance with the Fundraising Plan. Once the NCI grants management official has notified the SBC that their application is being considered for funding, the SBC is encouraged to submit all of the requested “Just-In-Time” information as soon as possible. Just-In-Time information related to the Fundraising Plan may include, but is not limited to, the following:
Prior to the issuance of an award, any substantive change to the applicant’s original Fundraising Plan (as reviewed by the Special Emphasis Panel) must be discussed with the assigned Program Director during the administrative review process. Substantive changes to the original Fundraising Plan may include, but are not necessarily limited to the following: (1) one or more of the original investors has withdrawn or substantially reduced their committed level of support; (2) the financing mechanism or instrument, or other terms associated with the third-party investment, have been significantly altered relative to the originally proposed plan. Prior to the issuance of award, if the applicant proposes to modify the Fundraising Plan, the assigned Program Director must verify that the updated type(s), source(s), total amount(s), and anticipated schedule(s) for receiving funds represent an equivalent or superior plan as compared to the originally evaluated Fundraising Plan.
All substantive changes to the original Fundraising Plan (i.e., the plan evaluated by the Special Emphasis Panel) will be evaluated on a case-by-case basis. All substantive changes to the applicant’s original Fundraising Plan must be appropriately addressed in a revised fundraising plan. If a revised Fundraising Plan is proposed, it must be approved by the Director of the SBIR Development Center and the NCI Office of Grants Administration prior to award. In such a case, the revised Fundraising Plan supercedes the original plan and becomes a term of award.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Agreement Terms and Conditions of Award
NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.
Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.
For details about each specific required report, see the section on “Award Guidelines, Reporting Requirements, and Other Considerations,” in the SF424 (R&R) SBIR/STTR Application Guide.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
SBIR Phase IIB Bridge Award: Compliance with the Fundraising Plan (Reporting)
As described above, the applicant’s Fundraising Plan submitted at the time of application (or the revised Fundraising Plan approved by the NCI), becomes a term of award. Throughout the Bridge Award project period, grantees will be expected to provide detailed, verifiable documentation (e.g., redacted bank statement or other documentation) of independent third-party investor support that is planned/expected, according to the schedule that is stipulated in the Fundraising Plan.
A grantee’s failure to comply with the terms of award may cause NIH to take one or more enforcement actions, including suspension of the grant, withholding of support, or termination, depending on the severity and duration of the non-compliance. NIH will undertake any such action in accordance with applicable statutes, regulations, and policies.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Andrew J. Kurtz, Ph.D.
Small Business Innovation Research Development Center
National Cancer Institute
31 Center Drive, Building 31, Room 10A19
Bethesda, MD 20892-2580.
National Cancer Institute (NCI)
Division of Extramural Activities
National Cancer Institute
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
FAX: (301) 402-0275
National Cancer Institute (NCI)
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) and P.L. 102-564 (Small Business Research and Development Act). The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.
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