and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Heart, Lung, and Blood Institute (NHLBI) |
|
Funding Opportunity Title |
NHLBI SBIR Phase IIB Bridge Awards to Accelerate the Commercialization of Technologies for Heart, Lung, Blood, and Sleep Disorders and Diseases (R44) |
Activity Code |
R44 Small Business Innovation Research (SBIR) Grant - Phase II only |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-HL-13-016 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.837, 93.838, 83.839, 93.233 |
FOA Purpose |
The purpose of the NHLBI SBIR Phase IIB Bridge Award is to facilitate and accelerate the capital-intensive steps that are required to transition SBIR Phase II projects to the commercialization stage by promoting partnerships between SBIR Phase II awardees and third-party investors and/or strategic partners. Applicants must submit a Commercialization Plan, which should include details on any independent third-party 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 NHLBI funds being requested throughout the Phase IIB Bridge Award project period. Projects proposed in response to this FOA must relate to the NHLBI mission and require eventual Federal regulatory approval/clearance. 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 17, 2012 |
Open Date (Earliest Submission Date) |
May 19, 2012 |
Letter of Intent Due Date |
May 19, 2012; May 19, 2013; May 19, 2014 |
Application Due Date(s) |
June 19, 2012; June 19, 2013; June 19, 2014, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not Applicable. |
Scientific Merit Review |
November-December 2012, November-December 2013, November-December, 2014 |
Advisory Council Review |
January 2013, January 2014, January 2015 |
Earliest Start Date(s) |
April 2013, April 2014, April 2015 |
Expiration Date |
June 20, 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 funding mechanism that the National Institutes of Health (NIH) use to develop innovative solutions that address 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 between the end of the SBIR Phase II award and the commercialization stage. This Funding Opportunity Announcement (FOA) invites SBIR grant applications from SBCs to support later stage research and development (referred to as Phase IIB) for promising projects that were previously funded by SBIR Phase II awards and will require eventual Federal regulatory approval/clearance. The goal of this FOA and the resulting 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 by promoting partnerships between SBIR Phase II awardees and third-party investors and/or strategic partners.
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 independent third-party investor funds that equal or exceed the requested NHLBI funds (total costs).
This FOA is specifically intended to benefit clinical practice by accelerating the commercialization of novel products and technologies that are directly related to the NHLBI mission and that require ultimate approval/clearance by a Federal regulatory agency.
Proposed projects MUST be relevant to the NHLBI mission (see B. Scientific/Technical Scope).
Background
Since its inception in 1982, the NIH SBIR program has provided the small business community with seed funding to support the development of a broad array of commercial products to detect, diagnose, treat, and prevent disease. It provides an important funding mechanism for bringing new interventions to patients and clinicians. The SBIR program is structured in three phases. The objective in Phase I is to establish the technical merit and feasibility of a proposed research and development (R&D) effort, while in Phase II it is to continue the R&D effort for successful Phase I projects. The expectation is that in Phase III a SBC will be able to complete commercialization with non-SBIR funds.
However, many projects initiated with SBIR funding require considerable financing beyond the SBIR Phase II award to complete the necessary validation studies required to arrive at Phase III. In particular, the development of therapeutics, medical devices, and combined technologies often requires a number of years and substantial capital investments because of the costs associated with conducting clinical trials and/or other steps mandated by the federal regulatory approval process. Thus, despite the extensive R&D efforts during Phase II projects in these areas, the results are often insufficient to attract private investments needed for the eventual commercialization of a product and many small businesses become cash-starved before reaching the next critical milestone along the path toward commercialization. Hence, this FOA is designed to address this funding gap between the end of the SBIR Phase II award and the point at which non-SBIR financing can be secured for the subsequent stages of product development.
A number of public and private organizations have begun to recognize the challenges associated with this funding gap and are taking steps to provide additional resources to advance a greater number of promising early-stage technologies toward commercialization. Importantly, many of these organizations are not only providing financial support but are 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 development support, including 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. Such 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. It is anticipated that funding by third-party investors will be predicated on significant due diligence, thus encouraging awardees to formulate credible business plans for product commercialization. In addition, it is expected that third-party investors will maintain an active role in supporting the awardee during the product development phase and during pursuit of follow-on funding for the SBIR Phase III commercialization stage.
Specific Objectives for SBIR Phase IIB Bridge Award Applications
A. Independent Third-Party Investor Funds
This FOA specifically encourages 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 that were initiated with SBIR funding. In particular, applicants are expected to leverage their previous SBIR support, as well as the opportunity to compete for additional NHLBI funding under this FOA, to attract and negotiate third-party financing needed to advance a product or technology toward commercialization. The applicant’s ability to secure independent third-party investor funds that equal or exceed the total amount of the NHLBI funds being requested over the entire Phase IIB Bridge Award project period will help to validate the commercial potential that is essential for the SBIR projects solicited under this FOA. This potential will be strongly considered in review (refer to Section V. Application Review Information) and making 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 NHLBI strongly encourages applicants to establish business relationships with investors and/or strategic partners that have appropriate prior experience in commercializing 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 SBIR Phase II award. It is essential that significant progress was accomplished during the current/preceding SBIR Phase II project and also that the proposed product/technology has significant commercial potential. Applicants should also be able to demonstrate that the proposed product/technology has a clear advantage over existing and/or competing products/technologies and should clearly define an appropriate path toward ultimate product commercialization.
This FOA is specifically designed to provide additional support for products/technologies that require ultimate approval/clearance by a Federal regulatory agency.
Although projects previously funded by another NIH Institute/Center or another Federal agency are eligible to apply under this FOA, proposed projects MUST be relevant to the NHLBI mission. Applicants are strongly encouraged to contact the NHLBI to discuss whether their proposed project meets this criterion. The NHLBI supports development of technologies to detect, prevent, or treat cardiovascular, lung, blood and sleep disorders. It also supports research on the clinical use of blood and all aspects of the management and safety of blood resources. The NHLBI SBIR/STTR program fosters basic, applied, and clinical research on all product and service development related to the mission of the NHLBI. The NHLBI program priority areas for technology development research include:
Cardiovascular Diseases areas: heart failure, atherothrombosis, heart attack, high blood pressure, atrial fibrillation along with other atrial and ventricular arrhythmias, sudden cardiac death, adult and pediatric congenital heart disease, cardiovascular complications of diabetes and obesity, acquired valve disease, cardiomyopathies, and peripheral vascular diseases.
Lung Diseases areas: asthma, bronchopulmonary dysplasia, chronic obstructive pulmonary disease, cystic fibrosis, respiratory neurobiology, sleep-disordered breathing, critical care and acute lung injury, developmental biology and pediatric pulmonary diseases, immunologic and fibrotic pulmonary disease, rare lung disorders, pulmonary vascular disease, and pulmonary complications of AIDS and tuberculosis.
Blood Diseases and Resources areas: sickle cell disease (SCD), the thalassemias, Fanconi anemia, Diamond-Blackfan anemia and other bone marrow failure syndromes, iron chelation, fetal hemoglobin production, white blood cell disorders, myeloproliferative and myelodysplastic syndromes, hematopoietic stem cell transplantation and novel cell-based therapies, transfusion medicine (red blood cells, platelets, and plasma) and blood banking including technologies to store, process, and screen blood, thrombosis and hemostatic disorders including but not limited to idiopathic thrombocytopenic Purpura (ITP), thrombotic thrombocytopenic purpura (TTP), hemophilia, and coagulation factor deficiencies and disorders.
The following guidelines provide examples of appropriate development activities to be proposed under this FOA. Responsive proposals are not limited to the following areas.
For projects pertaining to the development of therapeutics, 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).
For projects pertaining to imaging technologies, interventional devices, and in vivo diagnostics, applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, or an Investigational Device Exemption (IDE) application.
For projects pertaining to ex vivo or in vitro diagnostics, prognostics, and screening tests, applicants are expected to propose activities that will lead to the successful filing of a 510(k) application, Premarket Approval (PMA) application, an Investigational New Drug (IND) application, and/or Investigational Device Exemption (IDE) application, as needed for the specific technology/system/assay.
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. Specific activities to be proposed will vary among applications.
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) that 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 plan for the product/technology should extend beyond the period of SBIR funding.
Funding Instrument |
Grant |
Application Types Allowed
|
Resubmission (Phase IIB previously submitted under this
FOA only) 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 |
NHLBI intends to commit $5,000,000, and up to 5 awards in FY 2013. |
Award Budget |
Budgets up to $1,000,000 total costs per year may be requested. Fixed fee is included in this threshold. |
Award Project Period |
Durations up to 3 years for SBIR Phase IIB Bridge Award 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 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.
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, are not allowed.
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 Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 4-6 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 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 PD(s)/PI(s), 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 PD(s)/PI(s), 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.
General Requirements
The SBIR Phase IIB Bridge Award application must represent a continuation of the R&D efforts performed under a previously funded 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 or a Phase II award from a non-NIH Federal agency MUST contact the NHLBI prior to submission, so that the NHLBI can properly arrange for such applications to be accepted. Applicants should demonstrate in their application that significant progress has been accomplished during the parent SBIR Phase II project, and also that the product/technology has significant commercial potential. Applicants should also demonstrate that the proposed product/technology has a clear advantage over existing and/or competing products/technologies and should clearly define an appropriate path toward ultimate product commercialization. Qualifying parent SBIR Phase II projects 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.
To qualify for renewal under the Phase IIB Bridge Award, the prior Phase II award could have been funded in response to any Federal SBIR solicitation and could have been funded by the NHLBI, by another NIH Institute/Center, or by another Federal agency. However, the proposed objectives must fall within the technical scope required for this FOA as defined in Section I (under Specific Objectives for SBIR Phase IIB Bridge Award Applications ). In addition, the development activities completed under the previous Phase II award MUST provide the appropriate technical foundation to justify continued development of the technology for an NHLBI mission-related indication/use. Platform technologies that were initially developed for a non-NHLBI mission-related indication/use (i.e., certain Phase II projects funded by another NIH Institute/Center or another Federal agency) may be eligible for continued support under this FOA only if the earlier data demonstrate technical proof-of-concept that is scientifically relevant to the NHLBI mission-related indication/use. For all projects supported under this FOA, the aims of the project should focus on an NHLBI mission-relevant indication/use as the primary product or service. SBIR Phase IIB Bridge awards are non-renewable.
In general, past Phase II SBIR projects should have ended within 24 months of the application receipt date. The NHLBI 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,
and fee).
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 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.
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:
Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express mail zip: 20817)
Telephone: (301) 435-0270
FAX: (301) 480-0730
Email: [email protected]
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 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.
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:
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. Note that Phase I SBIR/STTR Appendix materials are not permitted, unless requested specifically by NIH (and specified in this paragraph). The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide, with the following modification:
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 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 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.
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
SF 424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD(s)/PI(s) 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 NHLBI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Evaluation of Responsiveness
Prior to the peer review process, program staff at the NHLBI will determine whether applications are responsive to this FOA. All applications will be administratively evaluated to determine whether:
The proposed R&D represents the continuation of work conducted under a previously-funded SBIR Phase II award (grant or contract);
The prior SBIR Phase II grants or contracts have ended not more than 24 months prior to the application receipt date (or application qualifies for exception from that rule as defined above in Section III.3. Additional Information on Eligibility).
The proposed R&D falls within the technical scope of this FOA as described under, Section I (Specific Objectives for SBIR Phase IIB Bridge Award Applications);
The budget amounts and project period conform to the limits stipulated under this FOA, as described under Section II ("Award Budget" and "Award Project Period");
The application includes a Commercialization Plan addressing all five points as described below under "Other Submission Requirements and Information" and includes letters of support and/or documentation of support from third-party investors.
Other Submission Requirements and Information
Commercialization Plan
The following subsections should be included within the 12 page limit of the Commercialization Plan ( Question 7 of the SBIR/STTR Information form), 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:
Has the company gone through any name changes within the past five years? If so, list all previous company names in the application.
Is the company a subsidiary or a spin-off? If so, provide the name of the parent company.
What percentage of the company’s revenue was derived from SBIR/STTR funding during each of the past 5 years, including both Phase I and Phase II awards? Report a percentage value for each year individually.
What is the total number of SBIR/STTR Phase II awards that the company has received from the Federal government? For each award, provide (as a table):
1) the award number, the award amount, project duration, and the name of the awarding agency
2) the product name resulting from the award project
3) the current status of the project (Pre-clinical development, Clinical development, Commercially available, Discontinued)
4) FDA approval status of award project (PMA, IND, NDA, etc; Not yet submitted, Submitted, Approved, Not approved)
5) follow-on funding (amount and investor name), strategic partnership (name of partner), or out-licensing (name of licensee)
6) the total revenues generated to date as a result of commercialization of the award project
What are the total revenues that have been generated to date as a result of the commercialization of the SBIR/STTR projects funded in the past 5 years?
2) Fundraising Plan
Consistent with achieving the goals of this program, applicants must provide a Fundraising Plan. This plan must include the following information:
The NHLBI 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 SBIR Phase II projects. As such, the NHLBI expects that applicants for the Phase IIB Bridge Award will secure substantial independent third-party investor funds. In all cases, it is expected that the level of this independent third-party funding will equal or exceed the NHLBI funds (total costs) being requested for the entire project period of the Phase IIB Bridge Award. If the project period spans multiple years, the NHLBI 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.
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 must clearly indicate within their third-party fundraising plan the total amount of funding that will be secured from the preferred sources listed above.
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 must present a detailed summary of all past and/or planned (i.e., future/expected) third-party investor funds that 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 must be clearly described in the Fundraising Plan.
At the time of application, applicants must 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 must also provide detailed, verifiable documentation of any independent third-party investor support that will be provided to the SBC during the proposed Phase IIB Bridge Award project period. Include letters of support in Item 14, Letters of Support in the PHS 398 Research Plan Component. Place other documentation, such as term sheets or redacted bank statements in the Appendix materials.) Documentation of support from third-party investors should corroborate the Fundraising Plan.
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.
Note: Applicants are expected to document their third-party funds (or plans for raising them) as concretely as possible. For example, plans to raise additional funds from venture capital firms and/or other pharmaceutical companies should name specific partners and investors. Also, letters of support from institutional partners should indicate any actual or planned/conditional financial commitment (as a specific dollar figure or range).
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:
What is the perceived funding gap for the product/technology under development?
Why is additional government funding critically needed to accelerate the development of the product or technology toward commercialization? Specifically, what activities are being proposed under this FOA that would not otherwise be possible through independent third-party investments OR would be significantly delayed without additional NIH support?
To what extent would a possible award under this FOA advance the product or technology far enough to attract sufficient, independent third-party financing and/or strategic partnerships to carry out full commercialization?
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 must 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.
What are the specific activities that the third-party investor funds will support?
Have the investors attached any restrictions/triggers/milestones to future payments (i.e., tranches)? If so, what are they?
5) Regulatory Plan
Applicants must provide a regulatory plan describing the regulatory pathway that is being or will be pursued and a timeline for achieving regulatory approval with discrete milestones. Applicants must also submit evidence that they have contacted the appropriate regulatory authority and that their research plan and objectives follow the relevant requirements or guidance of that authority. Examples that provide evidence of appropriate interactions are letters or emails between the company and the appropriate FDA Center personnel or meeting minutes concerning a presubmission meeting or regarding a 510(k), IDE, PMA, HDE, BLA, IND, or NDA application. Copies of these letters, emails or minutes should be attached in the Letters of Support section in the PHS398 Research Plan Component. Applicants may also provide details of their interaction with the regulatory authority in the description of their Regulatory Plan. This should include the regulatory authority contact and date of interaction. Applicants should describe any outside assistance they have obtained or plan to obtain for developing and achieving the proposed Regulatory Plan.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, with the following modification:
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/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.
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?)
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(s)/PI(s), 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 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?
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? If the technology proposed for development is a platform technology that was initially developed for a non-NHLBI mission-relevant 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 NHLBI mission-relevant indication/use?
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?
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?
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.
Specific to this FOA: How promising are the outcomes of the previously-funded 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)?
Commercialization Potential
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 medical 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?
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, if the PD(s)/PI(s) have had previous Phase II awards, how successful have they been in commercializing those technologies and discoveries?
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?
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 NHLBI 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.
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 (formerly called Phase II Competing Renewals), 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/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(s) convened by the NHLBI, in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments 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 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 Heart, Lung, and Blood Advisory Council . The following will be considered in making funding decisions:
After the peer review of the application is completed, the
PD(s)/PI(s) 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.
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 NHLBI 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 Office of Translational Alliances and Coordination and the NHLBI Office of Grants Management prior to award. In such a case, the revised Fundraising Plan supersedes the original plan and becomes a term of award.
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 NHLBI), becomes a term of award. Throughout the Phase IIB 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.
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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
Cooperative Agreement Terms and Conditions of Award
Not Applicable.
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(s)/PI(s).
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 or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
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)
TTY: 301-451-5939
Email: [email protected]
Kurt W. Marek, Ph.D.
Office of Translational Alliances and Coordination
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7114
Bethesda, MD 20892-7922
Telephone: 301-443-8778
Email: [email protected]
Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express mail zip: 20817)
Telephone: 301-435-0270
FAX: 301-480-0730
Email: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Robert L. Tarwater
Lead Grants Management Specialist
Office of Grants Management
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7150
Bethesda MD 20892-7926
Telephone: 301-402-6090
E-mail: [email protected]
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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NIH Funding Opportunities and Notices
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