and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Neurological Disorders and Stroke (NINDS)) |
|
Funding Opportunity Title |
NINDS Competing Renewal Awards of SBIR Phase II Grants (Phase IIB) for Exploratory Clinical Trials (SBIR [R44]) |
Activity Code |
R44 Small Business Innovation Research (SBIR) Grant - Phase II only |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PAR-12-075 |
Companion FOA |
PAR-12-074, NINDS Competing Renewal Awards of STTR Phase II Grants (Phase IIB) for Exploratory Clinical Trials (R42) |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.853 |
FOA Purpose |
This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that seek additional funding to support exploratory clinical trials for projects that were previously funded by NIH SBIR Phase II awards. The trials must focus on products related to the mission and goals of the National Institute of Neurological Disorders and Stroke (NINDS) and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Since conducting the clinical trials needed for commercialization may be capital-intensive, the FOA aims to facilitate the transition of SBIR Phase II projects to the commercialization stage by promoting partnerships between NIH’s SBIR awardees and third-party investors and/or strategic partners. Consistent with the goals of this funding initiative and as required by the SF424 instructions for all SBIR Phase II 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 project period. It is expected that the level of this independent third-party funding will equal or exceed the NINDS funds being requested throughout the SBIR Phase IIB project period. |
Posted Date |
January 11, 2012 |
Open Date (Earliest Submission Date) |
July 5, 2012 |
Letter of Intent Due Date |
One month prior to application due date |
Application Due Date(s) |
August 5, 2012 and August 5, 2013, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
September 7, 2012 and September 7, 2013 by 5:00 PM local time of applicant organization. |
Scientific Merit Review |
October-November, 2012; October- November, 2013 |
Advisory Council Review |
January, 2013; January, 2014 |
Earliest Start Date(s) |
April, 2013; April, 2014 |
Expiration Date |
September 8, 2013 |
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 NINDS is committed to advancing treatments for people burdened by neurological diseases and the NINDS Small Business Innovation Research (SBIR) program has provided the small business community with critical seed funding to support the development of a wide variety of therapeutics for the treatment of neurological diseases. The SBIR Program is structured in three phases. The main objective in SBIR Phase I is to establish the technical merit and feasibility of the proposed research and development (R&D) efforts, whereas in SBIR Phase II it is to continue the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR Phase II, it is expected that the SBC will fully commercialize their product or technology using non-SBIR funds.
Some projects initiated with SBIR funding require considerable financing beyond the SBIR Phase II award to achieve commercialization. The development of medical biotechnology products is often impeded by a significant funding gap, known as the Valley of Death, between the end of the SBIR Phase II award and the commercialization stage. In particular, the development of therapeutics and medical devices often requires several years and substantial capital investments, due in part to the costs associated with conducting clinical trials. Traditionally, large pharmaceutical and biotechnology companies, as well as venture capital firms, have provided the resources needed to conduct the clinical studies required to fully develop and commercialize biomedical products and technologies initiated with SBIR funding. More recently, however, many investors in life science technologies have shown a bias toward financing the continued development of relatively mature technologies at established companies, rather than the higher-risk, emerging technologies under development at many small businesses.
This FOA supports SBIR Phase IIB applications from Small Business Concerns (SBCs) for exploratory clinical trials (i.e., Phase I and II clinical studies) of drugs, biologics, devices, or diagnostics as well as surgical, behavioral or rehabilitation therapies, that contribute to the justification for and provide the data required to design a future trial to confirm efficacy (i.e., a Phase III clinical trial). Applications must aim to generate data that inform a decision whether to continue further clinical development of the proposed intervention. Phase I clinical studies should be designed to provide important initial information regarding the intervention (e.g., safety, tolerability, dosing). Phase II clinical studies should yield data that allow a clear go/no-go decision regarding continued development. Applications to implement efficacy trials for interventions (i.e., Phase III trials) should be submitted to PAR-11-173, NINDS Phase III Investigator-Initiated Multi-Site Clinical Trials (U01). In addition, applicants are strongly encouraged to consider PAR-11-345, NeuroNEXT-Small Business Innovation in Clinical Trials, which also supports exploratory clinical trials. PAR-11-345 provides access to the Neurology Network of Excellence in Clinical Trials (NeuroNEXT) infrastructure, which will provide data management support and recruitment/retention support, as well as on-site implementation of the clinical protocol.
Since conducting the clinical trials needed for commercialization may be capital-intensive, the FOA aims to facilitate the transition of SBIR Phase II projects to the commercialization stage by encouraging business relationships between NIH’s SBIR awardees and third-party investors and/or strategic partners. In particular, this FOA will give competitive preference and funding priority to applicants deemed likely to result in a commercial product as indicated by an applicant's ability to secure substantial independent third-party funds (i.e. third-party funds that equal or exceed the NINDS funds being requested throughout the Phase IIB project period).
These funds can come from a variety of sources and a number of public and private organizations are taking steps to provide additional resources to advance a greater number of early-stage technologies toward commercialization. Importantly, many of these organizations are not only providing financial support but also establishing programs to provide commercialization guidance. For example, in the area of drug development, a number of major pharmaceutical firms have developed corporate venture funds focused on supporting projects in the pre-clinical stages of development, and some of these firms have established technology incubators to provide regulatory guidance. In addition, a growing number of universities are creating venture funds to support innovative technologies developed by their resident investigators, and numerous state-sponsored technology funds have also been created across the U.S. to support start-up companies. Taken together, these programs can provide additional financing and commercialization support for SBIR awardees that have received initial seed funding and a rigorous technical evaluation through the NIH peer review process. As such, a major goal of this FOA is to provide a platform to incentivize partnerships between NIH-funded SBIR awardees and a broad range of potential third-party investors.
Definitions
For this funding opportunity announcement Phase I and II clinical studies or trials refer to the common phases of a clinical trial. SBIR Phase I and II refer to the project phases of the SBIR program. SBIR Phase IIB awards must be based on a previously successful SBIR Phase II award.
Specific Objectives
Scientific/Technical Scope
The technical and commercial objectives described in the SBIR Phase IIB application MUST represent an extension of the development efforts that were pursued in a previously funded NIH SBIR Phase II grant.
Examples of appropriate studies under this FOA include, but are not limited to, those whose primary aim is to:
Applicants should make note of the following:
(1) This FOA is not intended to support the conduct of a clinical trial where the primary aim is to demonstrate efficacy. Efficacy should be evaluated in a Phase III trial.
(2) A trial will not be considered under this mechanism when its primary objective is to estimate intervention effect size to be used in power calculations for a future Phase III trial. Effect size estimates based on small or short-term studies are often unreliable. Power for a Phase III trial should be based on the smallest clinically meaningful effect size.
(3) Applications are encouraged that evaluate biological activity relative to clinical endpoints or that mechanistically test the activity of an intervention in terms of its presumed target(s).
(4) The use of innovative and efficient study designs are encouraged, such as adaptive dose-finding designs, designs incorporating plans for sample size recalculation, and futility designs.
(5) For a Phase II trial, specific plans for a future Phase III trial are required. Applicants should consider whether an adaptive, seamless Phase II/III design where data from subjects participating in the Phase II portion of the trial are used in the evaluation of Phase III trial might be more efficient in terms of study subjects and resources. Applications for seamless Phase II/III trials should be submitted under the above-referenced Multi-Site Clinical Trial FOA.
(6) Issues of study feasibility and refinement of study procedures may be addressed as secondary aims in an exploratory clinical trial, but not as the primary aim. Examples of such secondary aims include:
(7) Experimental Approach and Implementation:
The application must include a clear description of the outcome measures to be used in the proposed clinical trial; subject eligibility criteria; recruitment and retention strategies; procedures to avoid bias in allocation of subjects to treatment and in assessment of outcomes; the treatment regimen; and subject follow-up procedures. Statistical methods should be proposed that are appropriately matched to the study design. Consistent with achieving the goals of the program, it is expected that sample size, power calculations, and plans for analyses, data management, quality control, and data sharing will be included. If simulations were performed to aid in the design of this clinical trial, sufficient details about the simulations should be provided as an appendix to the trial protocol. Applicants are encouraged to concisely state the need, rationale, scientific relevance and potential impact of the proposed research. The approach should be summarized clearly in the application while the methodological details should be described in the protocol (see Appendix Materials under Section IV.6, below). The grant application should also include a proposed timeline for reaching important study milestones such as: (a) obtaining regulatory approval for the protocol; (b) establishing agreements with participating industry partners; (c) obtaining adequate supply of the investigational agent; (d) finalizing the study procedures and training participating clinical site staff; and (e) enrolling 25%, 50%, 75% and 100% of the sample size.
The application must include the status of all regulatory approvals necessary to conduct the proposed trial. Prior to the submission of an application, NINDS requires applicants to obtain authorization from the Food and Drug Administration (FDA) to use the proposed investigational drug, biologic product, or device in a clinical trial. More information about this policy can be found in NOT-NS-11-018. At the time of grant submission, applicants must provide documentation from the FDA providing information on one of the following three scenarios:
(A) The protocol has been submitted under an open IND/IDE and the IND/IDE is not under full or partial hold. Under this scenario, applicants must provide documentation such as a may proceed email or letter from the FDA.
(B) The protocol has been submitted under an IND/IDE and is on full or partial hold. Under this scenario applicants must provide full documentation from the FDA on the reasons for hold and the FDA recommendations.
(C) The protocol is exempt from an IND/IDE. Under this scenario applicants must provide a copy of the exemption letter from the FDA.
Prior to making an award, NINDS will also require documentation of the receipt of any other necessary regulatory approvals (e.g., Recombinant DNA Advisory Committee approval). IRB approval is not required at the time of application submission, but prior to funding. NINDS encourages investigators to begin these processes as early as possible. In addition, applicants should manage any conflict of interest issues that may be present in trials conducted by a for profit institution.
Applicants are strongly encouraged to consult with NINDS staff as plans for an application are being developed (see Agency Contacts, Section VIII). This early contact will provide an opportunity to clarify NINDS policies and guidelines as well as to discuss how to develop an appropriate project timeline and milestone plan, which are subject to peer review.
Plan for Full Commercialization
Applications considered under this FOA must outline a specific plan for future development in the case of a go decision. All applicants are expected to describe a realistic plan (extending beyond SBIR Phase IIB), which outlines how and when full commercialization can be accomplished. The long-term commercialization strategy should be presented as part of the 12-page Commercialization Plan. The full commercialization of the product/technology should be carried out with non-SBIR funds.
Independent Third-Party Investor Funds
This FOA is specifically intended to encourage business relationships between applicant SBCs and third-party investors/strategic partners who can provide substantial financing to help accelerate the commercialization of promising new products and technologies initiated with NIH SBIR funding. In particular, applicants are expected to leverage their previous NIH SBIR support, as well as the opportunity to compete for additional NINDS funding under this FOA, to negotiate and attract 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 NINDS funds being requested over the entire Bridge Award project period will provide a measure of the commercial potential that is essential for the SBIR applications submitted in response to this FOA. This potential will be strongly considered in 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 NINDS strongly encourages applicants to establish business relationships with investors and/or strategic partners that have appropriate prior experience in the commercialization of emerging biomedical technologies.
Funding Instrument |
Grant |
Application Types Allowed
|
Resubmission (Phase IIB) The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. |
Award Budget |
According to statutory guidelines, total funding support normally may not exceed $150,000 for Phase I awards and $1,000,000 for Phase II awards. Applicants are encouraged to propose a budget that is reasonable and appropriate for completion of the research project. Statutory guidelines may be exceeded based on the actual needs of the proposed project. . |
Award Project Period |
Durations up to 3 years for Phase II 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(s)/PI(s) 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 Program Director(s)/Principal Investigator(s) section of the SF424 (R&R) SBIR/STTR Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF424 (R&R) SBIR/STTR Application Guide.
A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I awardee should submit a Phase II application within the first six due dates following the expiration of the Phase I budget period.
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:
Stephanie Fertig
6001 Executive Blvd., Room 2228
Bethesda, MD 20892-9527
For FedEx: Rockville, MD 20852
Telephone: 301-496-1779
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:
Specific Aims
The hypotheses and specific aims of the trial must be clearly and concisely stated. The primary and secondary endpoints to be measured must be clearly defined. The inclusion of secondary endpoints should be justified by stating the need for the supportive or explanatory data they are likely to yield. Applicants are encouraged to concisely state the potential impact of the proposed research.
Research Strategy
Significance and Biological Relevance
Applicants are encouraged to concisely state the need, rationale, and scientific relevance of the proposed research. It is particularly important that there be a discussion of how the trial will test the hypothesis proposed and how results of the trial (positive or negative) may be explained based on the biological action of the proposed intervention. The application should explain why the proposed study is necessary before implementing a Phase III trial. The application must present an overview of the state of the science, current status of therapeutics for the disease, and relevance of the trial for treatment of the disease.
Prior Studies and Rationale for Development
The major findings of the pre-clinical and clinical studies that led to the proposed clinical trial should be presented. Data from pre-clinical and pilot studies demonstrating the need for and the feasibility of the trial should also be presented. To evaluate preclinical research, sufficient information must be available about pre-clinical study design, execution, analysis, and interpretation. NINDS urges applicants to consider these elements when describing supporting data and designing the proposed studies. Applicants are also encouraged to discuss these issues with program staff prior to submission. Conceptualization and planning must have progressed to a stage sufficient to allow for an overall assessment of the likelihood of trial success. Applications should address patient perspectives on acceptability of the proposed intervention.
Study Organization and Administration
Human Subjects:
Applicants should refer to Part II of the PHS398 Application Instructions Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan. Assurances of the protection of human participants and the biohazard safety of employees (if applicable) must be provided both for the overall study and for individual clinical sites. NIH policy requires education on the protection of human research participants for all key personnel. The applicant must discuss any issues which might lead to concern for the welfare of participants. Master templates of the forms to be used to obtain informed consent at each site must be included in an appendix. At a minimum, the human subjects sections of data coordinating center applications must address data security measures and confidentiality.
Data and Safety Monitoring Plan:
Applicants must include a Data and Safety Monitoring (DSM) Plan for all clinical trials that is commensurate with the risk level of the proposed clinical research. All applications or study protocols must include a general description of the monitoring plan, policies, procedures, responsible entities, and approaches to identifying, managing and reporting reportable events (adverse events and unanticipated problems), to the applicable regulatory agencies (e.g., Institutional Review Board (IRB), the NINDS/NIH, the Office of Biotechnology Activities, Office of Human Research Protections, the Food and Drug Administration, and the Data and Safety Monitoring Board (if one is used) Therefore, the DSM Plan must address the following areas:
NIH requires the establishment of Data and Safety Monitoring Boards (DSMBs) for multi-site clinical trials involving interventions that entail potential risk to participants (http://grants.nih.gov/grants/guide/notice-files/not98-084.html). The purpose of this board is to provide independent advice to NINDS concerning scientific issues pertaining to subject safety, data quality, study conduct and study continuation. In monitoring safety in the trial, the board also may recommend termination in the event of early significance of findings or futility, or the determination of unacceptable adverse effects. The DSMB is appointed by the NINDS and consists of individuals who are not associated with the institutions participating in the trial (http://www.ninds.nih.gov/research/clinical_research/policies/data_safety_monitoring.htm). Potential members of this board should NOT be named in the application, although the areas of expertise needed for the board should be indicated.
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.
Information Regarding the Use of NINDS Common Data Elements. The NINDS encourages investigators to utilize the NINDS Common Data Elements (CDE) resource when constructing data collection forms (see: http://www.commondataelements.ninds.nih.gov).
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 modifications:
Clinical Protocol
The study protocol (required and formatted using the NINDS protocol template, http://www.ninds.nih.gov/research/clinical_research/toolkit/protocol.htm), Clinical Investigator’s Brochure or equivalent, as well as any of the other items relevant to the protocol (e.g., the consent form, documentation to access the study population, etc.), are to be submitted as appendices.
The proposed clinical trial protocol research plan must include:
If investigators choose to incorporate patient reported outcomes in the study, it is suggested that they review the following FDA guidance to assist in their planning: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf.
If the applicant proposes a drug, biologic, or device as an intervention, the application must include documents showing the evaluation of the intervention by the FDA, specifically an active IND/IDE, an exemption letter from the FDA, or a compelling explanation why FDA approval is not applicable. Prior to making an award, NINDS will require documentation of the receipt of any other necessary regulatory approvals (e.g., Recombinant DNA Advisory Committee approval). NINDS requires FDA and IRB approvals prior to award, and encourages investigators to seek regulatory and ethics approvals as early as possible prior to submission.
Third-Party Support
Applicants are expected to provide detailed, verifiable documentation of any third-party support to corroborate the Fundraising Plan. Documentation other than letters of support (e.g., term sheets, redacted bank statements, etc.), should be submitted as Appendix materials.
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.
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, NIH. Applications that are incomplete will not be reviewed.
Commercialization Plan
The following subsections should be included within the Commercialization Plan (within the 12-page limit), in addition to the requirements listed in the SF424 Application Guide
1) SBIR/STTR Commercialization History
Applicants should provide an SBIR/STTR Commercialization History that addresses the questions listed below. The following questions should be addressed for all SBIR/STTR awards received from ANY Federal agency:
2) Fundraising Plan
Applicants are expectedto provide a Fundraising Plan. This plan is expected to include the following information:
The NINDS considers the raising of independent third-party investor funds to be an important means to facilitate and accelerate the capital-intensive steps that are required to commercialize new products/technologies emerging from NIH-funded SBIR Phase II projects. As such, the NINDS expects that applicants for the SBIR Phase IIB 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 NINDS expects that the third-party portion of the total investment received in any given year will represent a substantial portion of the total investment, generally at least $250,000 in any given year. In all cases, it is expected that the level of this independent third-party funding will equal or exceed the NINDS funds being requested throughout the 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.
SBIR-eligible public companies may include as part of their fundraising plan the issuance of stock. In such a case, the preferred documentation is a letter of commitment, signed by the Chairman of the Board of Directors, which stipulates the following: (1) the amount of capital raised from the issuance of stock; (2) the amount of capital that will be dedicated to the proposed project under this FOA; (3) sufficient information regarding the use of the dedicated capital to demonstrate a substantial, value-added contribution toward the development and commercialization of the product/technology to be developed under this FOA (see instructions below under, Use of Third-Party Investment Funds ).
It is likely that several months will have elapsed between the time an application is submitted and the time it is peer reviewed and subsequently considered for possible funding. Accordingly, applicants should present a detailed summary of all past and/or planned (i.e., future/expected) third-party investor funds which clearly shows, relative to the estimated award date, when these funds have been and/or will be secured. For example, if the fundraising efforts of the SBC are in progress, and/or if the third-party investment is contingent upon NIH selecting the application for funding, then such plans should be clearly described in the Fundraising Plan.
At the time of application, applicants should provide detailed, verifiable documentation (e.g., redacted bank statement or other documentation) of any independent third-party investor support that has been secured up to one year prior to the application receipt date. Applicants should also provide detailed, verifiable documentation of any independent third-party investor support that will be provided to the SBC during the proposed 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 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. 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:
4) Use of Third-Party Investment Funds
The Federal funds provided by a SBIR Phase IIB award can only be used for advancing the research-related elements of the project. The use of any third-party investor funds will be at the discretion of the SBC. Applicants should provide sufficient information regarding the use of any third-party support to demonstrate a substantial, value-added contribution toward the development and commercialization of the product/technology. In particular, applicants are expected to address the following questions regarding the use of third-party funds.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, with the following modifications:
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?)
Is there compelling justification for the development of the proposed intervention in terms of potential advances in clinical practice, public health, and/or patient quality of life? Is there a sufficient body of preclinical or clinical research to support the study rationale? Is there convincing evidence that there is equipoise in the medical and patient communities and the intervention is ready for clinical development? Is it clear why the proposed exploratory trial is essential to inform the design and implementation of a subsequent Phase III trial, or enable a go/no-go decision regarding further clinical development of the intervention? Is the proposed project likely to yield clear answers needed to justify proceeding to Phase III (go/no-go decision)?
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?
What is the project team members prior experience in leading clinical trials and what is their expertise in the content area of the trial? Is the right multidisciplinary team (clinician, statistician, data manager, study coordinator, etc.) assembled to conduct this clinical trial?
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?
Are there adequate plans for management and quality control of data collected at clinical sites or measured at central laboratories and reading centers? Does the data collection process utilize the NINDS Common Data Elements (CDE) to the extent possible, or are the data elements compatible with the NINDS CDE? Does the budget provide for attending DSMB meetings, contracting an Independent Medical Monitor, and/or supporting the work of a Study Monitoring Committee (as appropriate)? Is the statistical design efficient? Is there adequate consultation with patients and other stakeholders in study design (e.g., inclusion of a patient representative on the Steering Committee)? Has the applicant proposed clear milestones that provide objective, quantitative outcomes that will justify continuing the project?
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?
Is there evidence that the study drug, biologic or device will be available in sufficient quantities? Is there evidence that all regulatory approvals have been obtained as specified in NOT-NS-11-018? Are the proposed project milestones (particularly regarding subject accrual goals) and timeline feasible and appropriate for the timely completion of the trial? Does the information provided in the application give reasonable assurance that the target sample size can be enrolled in the timeframe proposed?
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.
Market, Customer, and Competition
How compelling is the value proposition, and to what extent does the application demonstrate a substantial market-pull for the technology under development? How well has the applicant described the market niche(s) for the product/ technology, and how urgent is the unmet need(s) being addressed? To what extent has the applicant identified realistic, market-based milestones that can be achieved over the next five years?
How well has the applicant demonstrated an understanding of the competitive environment in which they plan to sell their product? To what extent has the applicant identified their customers and demonstrated a clear understanding of their needs? How well has the company addressed potential hurdles that may delay or prevent acceptance of their product? How reasonable are the applicant’s plans for generating a revenue stream, and how realistic are the revenue projections?
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/technology? For example, how successful have the PD(s)/PI(s) been in commercializing other 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 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 NINDS 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?
Phase IIB
How promising are the outcomes of the previously-funded NIH SBIR Phase II project upon which the proposed SBIR Phase IIB is predicated? To what extent does the progress justify the continuation of the development efforts? How appropriate are the proposed milestones for the SBIR Phase IIB in determining whether the awardee has successfully reached the specified goals?
Phase II Applications
For Phase II Applications, how well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity?
Phase I/Phase II Fast-Track Applications
For Phase I/Phase II Fast-Track Applications,
reviewers will consider the following:
1. Does the Phase I application specify clear, appropriate, measurable goals
(milestones) that should be achieved prior to initiating Phase II?
2. To what extent was the applicant able to obtain letters of interest,
additional funding commitments, and/or resources from the private sector or
non-SBIR/STTR funding sources that would enhance the likelihood for
commercialization?
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
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
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 Center for Scientific Review, 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:
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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.
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]
Stephanie Fertig
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Tijuanna E. DeCoster, MPA
National Institute of Neurological Disorders and Stroke
Telephone: 301-496-9231
Email: [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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