and Human Services (HHS)
EXPIRED
Participating Organization(s) |
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) |
Activity Code |
R44 Small Business Innovation Research (SBIR) Grant - Phase II only |
Announcement Type |
Reissue of RFA-CA-12-023 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-CA-14-002 |
Companion Funding Opportunity |
Not Applicable |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.394, 93.395 |
Funding Opportunity Purpose |
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 under SBIR or STTR Phase II awards from any Federal agency. 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 or STTR Phase II projects to the commercialization stage. This FOA is expected to promote partnerships between Federally-funded SBIR or STTR 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 services. 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 Phase IIB Bridge Award project period. It is expected that the level of this independent third-party funding will be equal to or greater than the 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. |
Posted Date |
February 12, 2014 |
Open Date (Earliest Submission Date) |
March 21, 2014 |
Letter of Intent Due Date(s) |
March 21, 2014 |
Application Due Date(s) |
April 21, 2014, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
AIDS Application Due Date(s) |
April 21, 2014, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
Scientific Merit Review |
June-July 2014 |
Advisory Council Review |
August 2014 |
Earliest Start Date |
September 2014 |
Expiration Date |
April 22, 2014 |
Due Dates for E.O. 12372 |
Not Applicable |
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
Purpose
The Small Business Innovation Research (SBIR) Program is an important mechanism by which the National Institutes of Health (NIH) and other Federal agencies help bring innovative solutions to public health challenges. A major objective of the Federal 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 or STTR 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 under SBIR or STTR Phase II awards from any Federal agency. 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 or service along a promising commercialization pathway.
To be responsive to this FOA, proposed projects MUST be applicable to at least one of the following technical/scientific areas:
(1) Cancer Therapeutics;
(2) Cancer Imaging Technologies, Interventional Devices, and In Vivo Diagnostics; and/or
(3) In Vitro and Ex Vivo Cancer Diagnostics and Prognostics.
These Bridge Awards are designed to facilitate the continuation of promising SBIR or STTR 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 Federally-funded SBIR or STTR Phase II awardees and third-party investors and/or strategic partners.
In particular, competitive preference and funding priority will be given to applications deemed likely to result in a commercial product or service 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 services toward commercialization.
This FOA is specifically intended to provide additional support for products and services 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 SBIR program at the NIH (and other Federal agencies) has provided the small business community with critical seed funding to support the development of a broad array of commercial products and services 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 service using non-SBIR funds. However, many of the early-stage projects initiated with SBIR or STTR funding require considerable financing beyond the SBIR or STTR 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 Federal 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 services initiated with Federal SBIR or STTR 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 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 service, 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 or STTR Phase II award and the point at which non-Federal financing can be secured for the subsequent stages of product development a phase often referred to as the Valley of Death.
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 peer review process at the NIH and other Federal agencies. As such, a major goal of this FOA is to provide a platform to incentivize partnerships between Federally-funded SBIR or STTR awardees and a broad range of potential third-party investors.
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 services initiated with Federal SBIR or STTR funding. In particular, applicants are expected to leverage their previous SBIR or STTR support, as well as the opportunity to compete for additional funding under this FOA, to negotiate and attract third-party financing needed to advance a product or service toward commercialization. The applicant’s ability to secure independent third-party investor funds that equal or exceed the total amount of the funds being requested over the entire Bridge Award project period will provide a measure of the commercial potential that is essential for the SBIR projects solicited under this FOA. This potential will be strongly considered in respective funding decisions. 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 applicants are strongly encouraged 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 under a previous Federally-funded SBIR or STTR Phase II award. It is essential that significant progress has been accomplished during the current/preceding SBIR or STTR Phase II project and also that the proposed product or service has significant commercial potential. Applicants should also demonstrate that the proposed product/service has a clear advantage over existing and/or competing products/services and should clearly define an appropriate path toward ultimate commercialization.
In particular, this FOA is specifically designed to provide additional support for products and services that require ultimate approval by a Federal regulatory agency.
Applications received under this FOA must fall within at least 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.
Responsiveness
To be responsive to this FOA, the development activities completed under the previous SBIR or STTR Phase II award MUST provide the appropriate technical foundation to justify continued development of the technology for a cancer-relevant indication/use. Platform technologies that were initially developed for a non-cancer indication/use (e.g., SBIR or STTR Phase II projects funded by an NIH Institute/Center other than the NCI, or SBIR or STTR Phase II projects funded by a Federal agency other than the NIH) may be responsive only if the earlier data demonstrates technical proof-of-concept that is scientifically relevant to the cancer indication/use. To be responsive under this FOA, the aims of the project must focus on a cancer-relevant indication/use as the primary product or service.
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed
|
Phase IIB Competing Renewal (Phase IIB) Resubmission (only for Phase IIB applications previously submitted in response to RFA-CA-12-001 or RFA-CA-12-023 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 |
NCI intends to commit $10,000,000 in FY 2014 to fund up to 10 awards. |
Award Budget |
Budgets up to $1,000,000 total costs per year may be requested. |
Award Project Period |
Project periods up to 3 years may be requested. |
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 must be less
than 50 percent participation by foreign business entities in the joint
venture;
3. (i) SBIR and
STTR. Be a concern which is more than 50% directly owned
and controlled by one or more individuals (who are citizens or permanent
resident aliens of the United States), other business concerns (each of which
is more than 50% directly owned and controlled by individuals who are citizens
or permanent resident aliens of the United States), or any combination of
these; OR
(ii) SBIR-only. Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; OR
(iii) SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements.
4. Has, including its affiliates, not more than 500 employees.
If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.
If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner.
If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner.
Definitions:
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.
Small business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the NIH STTR program.
Phase I to Phase II Transition Rate Benchmark
In accordance with guidance from the SBA, the HHS SBIR/STTR Program is implementing the Phase I to Phase II Transition Rate benchmark required by the SBIR/STTR Reauthorization Act of 2011. This Transition Rate requirement applies to SBIR and STTR Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years, excluding the most recently-completed fiscal year. For these companies, the benchmark establishes a minimum number of Phase II awards the company must have received for a given number of Phase I awards received during the 5-year time period in order to be eligible to receive a new Phase I award. This requirement does not apply to companies that have received 20 or fewer Phase I awards over the 5 year period.
Companies that apply for a Phase I award and do not meet or exceed the benchmark rate will not be eligible for a Phase I award for a period of one year from the date of the application submission. The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently-completed year. The benchmark minimum Transition Rate is 0.25.
SBA calculates individual company Phase I to Phase II Transition Rates daily using SBIR and STTR award information across all federal agencies. For those companies that have received more than 20 Phase I awards over the past 5 years, SBA posts the company transition rates on the Company Registry at SBIR.gov. Information on the Phase I to Phase II Transition Rate requirement is available at SBIR.gov.
Applicants to this FOA that may have received more than 20 Phase I awards across all federal SBIR/STTR agencies over the past five (5) years should, prior to application preparation, verify that their company’s Transition Rate on the Company Registry at SBIR.gov meets or exceeds the minimum benchmark rate of 0.25.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, may be allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 PDs/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.
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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
General Requirements
The Phase IIB Bridge Award application must represent a continuation of the R&D efforts performed under a previous Federally-funded SBIR or STTR Phase II award. Phase IIB Bridge Award applications may be predicated on the following categories of prior Phase II awards:
NOTE: Applicants who intend to submit a Phase IIB Bridge Award application that is predicated on a Phase II award funded by a Federal agency other than the NIH or a previous Phase II contract award MUST contact the SBIR Development Center prior to submission, so that the NCI can properly arrange for such applications to be accepted.
The qualifying parent SBIR or STTR Phase II project may be renewed only once through the Phase IIB Bridge Award under this FOA. Following the Phase II Bridge Award period (i.e., up to 3 years), recipient SBCs are expected to pursue the full commercialization of these SBIR-funded projects using non-SBIR funds.
This FOA is only open to SBIR or STTR 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, 2014. 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 provided that the applicants can demonstrate the readiness of the proposed project for commercialization and the ability to secure substantial third-party investor funds. 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,
and fee).
A small business concern may subcontract a portion of its
SBIR or STTR award to a Federal laboratory within the limits above. A Federal
laboratory, as defined in 15 U.S.C. 3703, means any laboratory, any federally
funded research and development center, or any center established under 15
U.S.C. 3705 & 3707 that is owned, leased, or otherwise used by a Federal
agency and funded by the Federal Government, whether operated by the Government
or by a contractor.
The basis for determining the percentage of work to be performed
by each of the cooperative parties in Phase I or Phase II will be the total of
the requested costs attributable to each party, unless otherwise described and
justified in Consortium/Contractual Arrangements of the PHS 398 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.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
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:
The letter of intent should be sent to:
Andrew J. Kurtz, Ph.D.
SBIR Development Center
National Cancer Institute
9609 Medical Center Drive, 1W540
Bethesda, MD 20892-9706 (for U.S. Postal Service regular or express mail)
Rockville, MD 20850 (for non-USPS delivery)
Telephone: 240-276-5228
Fax: 240-276-5236
Email: kurtza@mail.nih.gov
All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.
The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) SBIR/STTR Application Guide to ensure you complete all appropriate optional components.
Instructions for Application Submission
The following section supplements the instructions found in the SF 424 (R&R) SBIR/STTR Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed, with the following additional instructions:
Project Summary/Abstract: Provide the name of awarding agency and identification/serial number of the Phase II award (grant or contract) upon which the application is predicated (for NIH awards, use the full standard format for grant number, e.g., 5R44CA123456-04 ).
Other Attachments:
1. SBA Company registry
All applicants to the SBIR and STTR programs are required to register at the SBA Company Registry prior to application submission and attach proof of registration. Completed registrations will receive a unique SBC Control ID and .pdf file. If applicants have previously registered, you are still required to attach proof of registration. The SBA Company Registry recommends verification with SAM, but a SAM account is not required to complete the registration. In order to be verified with SAM, your email address must match one of the contacts in SAM. If you are unsure what is listed in SAM for your company, you may verify the information on the SAM site. Confirmation of your company's DUNS is necessary to verify your email address in SAM. Follow these steps listed below to register and attach proof of registration to your application.
a. Navigate to the SBA Company Registry.
b. If you are a previous SBIR/STTR awardee from any agency, search for your small business by Company Name, EIN/Tax ID, DUNS, or Existing SBIR/STTR Contract/Grant Number in the search fields provided. Identify your company and click Proceed to Registration .
c. If you are a first time applicant, click the "New to the SBIR Program?" link on lower right of registry screen.
d. Fill out the required information on the Basic Information and Eligibility Statement screens.
e. Press Complete Registration on the lower right of the Eligibility Statement screen and follow all instructions.
f. Download and save your SBA registry PDF locally. The name will be in the format of SBC_123456789.pdf, where SBC_123456789 (9 digit number) is your firm’s SBC Control ID. DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application.
g. When you are completing the application package, attach this SBA registry PDF as a separate file by clicking "Add Attachments" located to the right of the Other Attachments field on the Research and Related Other Project Information form.
For questions and for technical assistance concerning the SBA Company Registry, please contact the SBA at http://sbir.gov/feedback?type=reg.
2. SBIR Application Certification for small business concerns majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms
Applicant small business concerns that are majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms (e.g. majority VCOC-owned) are required to submit a Certification at time of their application submission per the SBIR Policy Directive. Follow the instructions below.
Applicant small business concerns who are more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these (i.e. NOT majority VCOC-owned) should NOT fill out this certification and should NOT attach it to their application package.
a. Download the SBIR Application VCOC Certification.pdf at the NIH SBIR Forms webpage.
b. Answer the 3 questions and check the certification boxes.
c. The authorized business official must sign the certification.
d. Save the certification using the original file name. The file must be named SBIR Application VCOC Certification.pdf . DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application.
e. When you are completing the application package, attach this certification as a separate file by clicking "Add Attachments" located to the right of Other Attachments field on the Research and Related Other Project Information form.
3. Supplemental Information: documents related to third-party-investors and their commitment (to be included in support of the Commercialization Plan)
Include documentation of support from third-party investors, such as term sheets or redacted bank statements or other appropriate documents (other than letters of support). Collate all such documents in one file (with the list of attached documents at the beginning). Use filename "Third-Party Investors". (Note that this filename will become a bookmark in the application.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed, with the following additional instructions:
Research Strategy
In addition to standard content of Research Strategy, the applicants must address the following items.
Commercialization Readiness and Competitive Advantage. Applicants should demonstrate in their application that significant progress has been accomplished during the parent SBIR or STTR Phase II project, and also that the product or service has significant commercial potential. Applicants should also demonstrate that the proposed product/service has a clear advantage over existing and/or competing products/services and should clearly define an appropriate path toward ultimate commercialization.
Milestones. In addition to standard sub-sections of Research Strategy (and within its standard page limits), applicants should describe appropriate milestones to be achieved during the proposed project period toward accomplishing the stated aims of the project. For multi-year awards, applicants should indicate specific milestones for each year of the award. Milestones proposed should be specific and quantitative, if possible. If applicable, proposed milestones should include meeting specific regulatory requirements [e.g., Investigational New Drug (IND) filing].
Letters of Support
In addition to standard letters of support documenting collaborations, access to expertise, or to unique research resources, etc, include letters of support documenting commitments from third-party investors. Letters of support from these institutional partners should indicate any actual or planned/conditional financial commitment as a specific dollar figure or range, consistent with the instructions provided under Section IV.2, Other Attachments, Fundraising Plan . Appropriate documentation of third-party investor commitment(s) may include a conditional letter of support stating that the third-party funding is contingent upon NIH selecting the application for an award.
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 support, 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 or service to be developed under this FOA (see additional instructions under Section IV.2, Other Attachments, Use of Third-Party Investment Funds ).
Resource Sharing Plans
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) SBIR/STTR Application Guide.
Appendix
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.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed, with the following additional instructions:
Commercialization Plan: All applicants must propose a realistic plan (extending beyond the SBIR Phase IIB Bridge Award project period), which outlines how and when full commercialization can be accomplished and reflects appropriate third-party commitments. The full commercialization of the product or service should be carried out with non-SBIR funds.
The following subsections with the headings a-d should be included within the Commercialization Plan, in addition to the requirements listed in the SF424 Application Guide:
a. Statement of Need
Applicants must provide a concise Statement of Need . This statement is expected to provide answers to the questions listed below:
b. Fundraising Plan
Consistent with achieving the goals of this program, applicants are expected to provide a Fundraising Plan. This plan is expected to include the following information:
A detailed and specific plan for securing substantial, independent third-party investor funds. Any third-party investment support received up to one (1) year prior to the application receipt date may be counted toward the total.
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 or services emerging from Federally-funded SBIR or STTR 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 portion of the total third-party 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. Applicants should clearly indicate within their third-party fundraising plan the total amount of funding that will be secured from the preferred sources listed above.
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.
Evidence of a firm third-party commitment at the time of application submission would be considered optimal and is strongly encouraged (if possible), but will not be required. For any third-party commitment (firm, conditional, or tentative), at the time of application submission, applicants must obtain detailed, verifiable documentation of any independent third-party investor support that will be provided to the SBC during the proposed Bridge Award project period. Applicants should also obtain 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, which may be counted toward the third-party funding that is expected under this FOA. Documentation of support from third-party investors should corroborate the Fundraising Plan.
Note: Applicants are expected to describe their matching funds (or plans for raising them) as concretely as possible. For example, plans to raise additional funds from venture capital companies and/or other pharmaceutical companies should name specific partners and investors. The description of any commitments in this section must be properly supported by specific documentation (following instructions under "Other Attachments" and "Letters of Support").
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.
c. 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 or service. In particular, applicants are expected to address the following questions regarding the use of third-party funds.
d. 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:
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.
Organizations must submit applications to 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 before the due date 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 Statement.
Pre-award costs are allowable only as described in the NIH Grants
Policy Statement.
The Federal funds provided by a Phase IIB Bridge Award must 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.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in
the Credential field of the Senior/Key Person Profile Component of the
SF424(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 System for Award Management (SAM). 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 NCI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Prior to the peer review process, program staff members in the NCI SBIR Development Center will determine whether applications are responsive to this FOA. All applications will be administratively evaluated to determine whether:
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
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
review system.
Reviewers will provide an overall impact 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.
Significance
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 II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)
Specific to this FOA: Is the project ready for commercialization activities based on the outcomes of the previously-funded SBIR or STTR Phase II project upon which the proposed Phase IIB Bridge Award is predicated? If the technology proposed for development is a platform technology that was initially developed for a non-cancer indication/use, then to what extent have the Phase II activities provided a solid foundation (i.e., relevant proof-of-concept) to support continued development of the technology for the proposed cancer indication/use? Is there compelling justification for the continued development of the proposed product or service in terms of potential advances in clinical practice, public health, and/or patient quality of life?
Investigator(s)
Are the PD(s)/PI(s), 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?
Innovation
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?
Approach
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 managed?
If the project involves human subjects and/or
NIH-defined clinical research, are the plans to address 1) the protection of
human subjects from research risks, and 2) inclusion (or exclusion) of
individuals on the basis of sex/gender, race, and ethnicity, as well as the
inclusion or exclusion of children, justified in terms of the scientific goals
and research strategy proposed?
Specific to this FOA: How appropriate are the proposed milestones for the Phase IIB Bridge Award in determining whether the awardee has successfully reached the specified goals? If the proposed project involves advancing the product or service through the Federal regulatory approval process, how sound is the proposed plan to meet these requirements?
Environment
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?
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 score, but will not give separate scores for these items.
Commercialization Plan
Market, Customers, and Competition. To what extent is the project focused on a cancer-relevant indication/use as the primary product or service? 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 or service, 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 during the project period and in the years beyond? How well has the applicant demonstrated an understanding of the competitive environment in which they plan to sell their product or service? 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 or service? How reasonable are the applicant’s plans for generating a revenue stream, and how realistic are the revenue projections?
Intellectual Property (IP). 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?
Company. 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 or service? For example, how successful have the PD(s)/PI(s) been in commercializing other SBIR/STTR-supported technologies and discoveries in the past? 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 or service, and if so to what extent?
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 or service? 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?
Phase II Applications
Not Applicable
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 Guidelines
for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
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.
Biohazards
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.
Resubmissions
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.
Phase IIB Competing Renewals
For Phase IIB Applications, the committee will consider the progress made in the last funding period.
Revisions
Not Applicable
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 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(s) , in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned 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 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
Commons.
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
Policy Statement.
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’s 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.
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.
Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
The Office of Inspector General Hotline accepts tips from all sources about potential fraud, waste, abuse and mismanagement in Department of Health & Human Services programs. The reporting individual should indicate that the fraud, waste and/or abuse concerns an SBIR/STTR grant or contract, if relevant. Report Fraud.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
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; and (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 authorized person(s) in the NCI Office of Grants Administration prior to award. In such a case, the revised Fundraising Plan supersedes the original plan and becomes a term of award.
SBIR or STTR 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.
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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: GrantsInfo@nih.gov
eRA Commons Help Desk (Questions regarding eRA Commons
registration, submitting and tracking an application , documenting system
problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov
SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg.
Andrew J. Kurtz, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5228
Email: kurtza@mail.nih.gov
Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov.
Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: woodwars@mail.nih.gov
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) P.L. 102-564, and P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011). The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.
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