Participating Organization(s) |
National Institutes of Health (NIH) |
Division of Program Coordination, Planning and Strategic
Initiatives, Office of Research Infrastructure Programs (ORIP) |
|
Funding Opportunity Title |
Improvement of Animal Models and Development of Technologies for Stem Cell-Based Regenerative Medicine (SBIR)(R43/R44) |
Activity Code |
R43/R44 Small Business Innovation Research (SBIR) Grant - Phase I, Phase II, and Fast-Track |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PA-13-223 |
Companion Funding Opportunity |
|
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.351, 93.286, 93.859 |
Funding Opportunity Purpose |
This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to develop or improve technologies for obtaining, characterizing and testing animal and human stem cells and their derivatives as models for stem cell-based regenerative medicine using animal models. The program is intended to support projects devoted to the creation of informative animal models for regenerative medicine, which will facilitate testing the safety and therapeutic potential of animal and human stem cells and their derivatives for pre-clinical evaluation. The initiative focuses on the following areas: 1) comparative analysis of animal and human stem cells to provide information for selection of the most predictive and informative model systems; 2) development of new technologies for stem cells and their derivatives, including production, characterization and transplantation; and 3) improvement of animal disease models for stem cell-based therapeutic applications. The ultimate objective of these efforts should be to provide commercial products and technologies that can help develop future clinical therapies. |
Posted Date |
May 8, 2013 |
Open Date (Earliest Submission Date) |
July, 5, 2013 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
Standard dates apply, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Standard AIDS dates apply, by 5:00 PM local time of applicant organization. |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date |
Standard dates apply |
Expiration Date |
April 6, 2016 (Originally May 8, 2016) |
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
Regenerative Medicine aims to replace or regenerate human cells, tissues or organs to restore or establish normal function lost due to injury, toxicological/metabolic damage, congenital pathologies or ageing. Regenerative medicine has the potential to overcome the shortage of organs available for human transplants by replacing or stimulating the body's own repair mechanisms to heal or regrow damaged tissues or organs. The recent discovery of the reprogramming of adult cells to a pluripotent state provides opportunities to address a major problem of regenerative medicine, immune rejection of transplanted tissue. The ability to generate differentiated cells and tissues using cells from specific patients will facilitate individualized medicine and eventually will lead to specialized therapies. The field is moving toward translation to clinical practice and is becoming increasingly dependent on animal models. Generating the correct type and quantity of the specific cell types required for replacement therapy is a significant challenge, as are the problems associated with introducing these cells into the proper environment in vivo and overcoming immune reactions. Finding solutions to these problems will require extensive testing in experimental animal models.
Major advances have been made in the past several years in deriving pluripotent cells, such as embryonic stem cells (ESCs) and induced pluripotent cells (iPSCs) from both humans and animals. In parallel, other investigations have isolated and characterized multipotent somatic or adult stem cells from various tissues, including Mesenchymal Stem Cells (MSCs) and Germinal Stem Cells (GSCs).
The discovery of mouse ESCs in 1981 revolutionized the field of developmental biology and provided new capability for genome manipulation and investigations of gene function. Isolation of human ESCs created new possibilities for the field of regenerative medicine. ES-like cells have been derived from a number of animal species, including rats, fish, cows, pigs and non-human primates. Many characteristics of animal ES-like cells, including surface markers, growth factor requirements, ability to differentiate and others can be quite different from human ESCs.
The field of stem cell research experienced a dramatic new direction with the isolation of iPSCs, derived by reprogramming human or mouse somatic cells to a pluripotent state. Several studies on various animal systems suggest that the basic pluripotency network appears to be conserved among different species, allowing derivation of iPSCs from a variety of animals.
MSCs, a type of somatic stem cell, were originally identified as a subpopulation of bone marrow cells with osteogenic potential. The properties of MSCs have been examined extensively over the past decade. Studies using animal models have shown promising results following MSC therapy for induced injury in the musculoskeletal, cardiovascular, digestive and nervous systems. In addition, many clinical trials have demonstrated the efficacy of MSC infusion for treating various human diseases. Given the wide range of tissue sources, the recognition of subpopulations with specific properties, and the frequent production of genomic alterations upon expansion in cell culture, extensive characterization of MSCs and development of improved techniques are required. Most importantly, there is relatively limited understanding of the normal biological functions of MSCs and the mechanisms by which they participate in tissue repair.
Along with rodents, several other animal species are being developed as models for various studies in the field of regenerative medicine. Understanding the properties and capabilities of stem cells derived from animals such as rabbits, pigs, sheep, goats and monkeys will increase the potential for the use of the most appropriate systems for modeling particular human disease conditions or for other medical applications. Non-rodent mammalian species (often referred to as large animal models ) provide important advantages for transplantation studies, including large size, similarity to human physiology and pathology and longer life span, thus facilitating translation to studies in humans. The use of animal stem cells as a model for human cells in procedures related to regenerative medicine requires in-depth understanding of common regulatory pathways as well as species-specific properties and their impact on potential therapeutic applications.
Animal experiments have historically made a significant contribution to understanding human disease. However, animal studies need to be improved in order to better predict the efficacy of treatment strategies in clinical trials. Several possible causes of the disparity between the results of animal studies and clinical trials have been identified, including failure to acknowledge the limitations of animal models, inadequate animal data and conclusions from them, less than optimal disease models and overestimation of treatment efficacy due to the preferred publishing of positive results. These problems should be addressed in the design and execution of preclinical, animal-based studies involving stem-cell based therapies.
The potential results of investigations must be applicable to the research interests of two or more of the categorical NIH Institutes and Centers. In addition, projects that predominantly address the research interests of one NIH Institute or Center, but that are peripherally related to the research interests of other Institutes and Centers, will not be considered appropriate for this FOA. An example of an inappropriate request is one exclusively involving an animal model of cancer or some other specific disease.
Research activities that are being sought to be supported under this FOA are intended to improve existing or create new animal models for regenerative medicine applications. Highly innovative projects are encouraged and can include, but are not limited to:
- Development and genetic, phenotypic and epigenetic characterization of animal stem cells as model systems for human stem cells and their application for regenerative medicine. Stem cells from rat as well as large animal species are of particular interest.
- Development and characterization of stable, well characterized pluripotent stem cell lines from large animal species, such as rabbits, dogs, pigs, sheep and monkeys. Development of stem cell lines from this type of animal model should be justified as having direct relevance to potential uses in the field of regenerative medicine. Further improvement of the technologies for safe genetic modification of pluripotent cells and their derivatives. Creation of biomarkers, standard protocols, reporter cell lines, species-specific reagents, proteomics, transcriptomics and genetic tools to assist the use of these cells for drug screening and disease modeling is also of interest.
- Improvement of methods for testing the efficacy and potency of MSCs in animals and for controlling the MSC secretome post-transplantation. Development of definitive markers for the multipotent state of the cells. Standardization of culture conditions for scale up of production. Improvement of the methods for creation of large batches of iPSCs-derived MSCs, that would allow in vivo testing in preclinical studies.
- Development of new techniques for non-invasive guiding and verifying cell injection, tracking cell migration, and monitoring long-term integration and survival of grafted stem cells and their derivatives (reporter genes, florescence probes, animal imaging). There is particular interest in the development of technologies for large animal species, addressing problems of tissue penetration and improving imaging sensitivity and resolution.
- Development of approaches to increase retention and survival of grafted cells, using such approaches as biomaterial carriers/nanomaterials and signaling molecules, which will prevent cell death and help to re-establish appropriate cell interactions and regulation.
- Development or improvement of existing humanized animal models. Preference will be given to studies involving species other than rodents. Develop humanized animals or bioreactors for in vivo generation of complex human tissues and organs using stem cells. Models may function as cell reservoir for cell differentiation, or cell propagation/expansion, ready for biomedical use.
- Develop high throughput technologies for genetic, phenotypic and therapeutic screens to study stem cell biology and to use for drug discovery, disease modeling and pre-clinical testing in appropriate animal species, such as zebrafish. Improvement and distribution of the reagents, protocols, stem cell lines, vectors, genetically altered animal strains and disease models, suitable for such screening.
- Development of technologies to increase mammalian stem cell reprograming and somatic cell transdifferentiation efficiencies, using reproducible methods addressing safety concerns. These technologies might include, for example, the use of removable vectors and vector systems with temporal expression of transcription factors, RNA or small molecules. Large scale production of defined populations of stem-cell derived differentiated cells. Development of techniques for improving standardization and quality of stem cells and their derivatives. Decreasing the risk of contaminants and transmissible diseases. Increasing the reliability of cryopreservation and long term storage. Novel approaches for activation of endogenous stem and progenitor cells and re-programing of somatic cells in situ.
- Development of approaches for rigorous evaluation and resolving challenges associated with stem cell therapy, such as: risk of cellular genetic and epigenetic instability, high mutation rate during in vitro manipulations, epigenetic memory of differentiated iPSCs and immune responses induced after stem cell transplantation. Improvement and testing tolerance induction regimes and elucidation of the underlying mechanisms of the induction, maintenance and/or loss of tolerance to transplantation in appropriate animal species, such as nonhuman primates. Of particular interest is the development of methods for sensitive detection and elimination of tumorigenic cells, and functional assays and high-throughput techniques that will predict the potential immunogenicity of transplants and the tumorigenicity or metastatic potential of different populations of stem cell derivatives.
- Develop new methods and animal models to evaluate the safety of animal and human stem cell-derived progenitor and differentiated cell transplantation in animal species, including studies of adsorption, distribution, differentiation, survival, metabolism, and toxicity of stem cell-based biomedical procedures. These models should take into account properties of the specific cell populations and should mimic the intended use of the cells in humans.
- Development of animal models for human disease conditions, which can be used for validation of stem cell-mediated therapy for regenerative medicine. Applications should not be focused on specific disease conditions. However, a specific disease can be used as a proof of principle, if also applicable to other disease conditions. Preference will be given to disease models that best emulate physiological, cellular and molecular manifestations seen in humans. Demonstration of the functionality of specific stem cells and their derivatives and effectiveness of achieving predictive results in improved animal models.
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed
|
New (Phase I, Fast-Track) |
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 (direct costs, indirect costs, fee) normally may not exceed $150,000 for Phase I awards and $1,000,000 for Phase II awards. With appropriate justification from the applicant, Congress will allow awards to exceed these amounts by up to 50% ($225,000 for Phase I and $1,500,000 for Phase II). As written in the statute and under appropriate circumstances, NIH can apply for a waiver from SBA to issue an award exceeding $225,000 for Phase I or $1,500,000 for Phase II, if this cap will interfere with NIH’s ability to meet its mission. Award waivers from the SBA are not guaranteed and may delay the release of funds. Applicants are strongly encouraged to contact NIH program officials prior to submitting any application in excess of the guidelines. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project. |
Award Project Period |
According to statutory guidelines, award periods normally may not exceed 6 months for Phase I and 2 years for Phase II. Applicants are encouraged to propose a project duration period that is reasonable and appropriate for completion of the research project. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:
1. Is organized for profit, with a place of business located
in the United States, which operates primarily within the United States or
which makes a significant contribution to the United States economy through
payment of taxes or use of American products, materials or labor;
2. Is in the legal form of an individual proprietorship, partnership, limited
liability company, corporation, joint venture, association, trust or
cooperative, except that where the form is a joint venture, there must be less
than 50 percent participation by foreign business entities in the joint
venture;
3. (i) SBIR and STTR. Be a concern which is more than 50%
directly owned and controlled by one or more individuals (who are citizens or
permanent resident aliens of the United States), other business concerns (each
of which is more than 50% directly owned and controlled by individuals who are
citizens or permanent resident aliens of the United States), or any combination
of these; OR
(ii) SBIR-only. Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; OR
(iii) SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and application requirements.
4. Has, including its affiliates, not more than 500 employees.
If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.
If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner.
If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner.
Definitions:
- Hedge fund has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
- Portfolio company means any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm.
- Private equity firm has the meaning given the term private equity fund in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
- Venture capital operating company means an entity described in 121.103(b)(5)(i), (v), or (vi). The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.
Small business concerns that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the STTR program.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, may be allowed.
Applicant organizations 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.
- System for Award Management (SAM) must maintain an active entity registration(formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
- SBA Company Registry New requirement. See Section IV. Application and Submission Information, SF424(R&R) Other Project Information Component for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a DUNS number to complete this registration. SBA Company registration is NOT required before SAM, Grants.gov or eRA Commons registration.
- Grants.gov
- eRA Commons
All Program Directors/Principal Investigators (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 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 PDs/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.
The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
- To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
- Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
- Of an application with a changed grant activity code.
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 I, normally, a minimum of two-thirds or 67% of the
research or analytical effort must be carried out by the small business
concern. The total amount of all consultant and contractual arrangements to
third parties for portions of the scientific and technical effort generally may
not exceed 33% of the total amount requested (direct, F&A/indirect, and
fee).
In Phase II, normally, a minimum of one-half or 50% of the research or
analytical effort must be carried out by the small business concern. The total
amount of consultant and contractual arrangements to third parties for portions
of the scientific and technical effort generally may not exceed 50% of the
total Phase II amount requested (direct, F&A/indirect, and fee).
A small business concern may subcontract a portion of its SBIR or STTR award to a Federal laboratory within the limits above. A Federal laboratory, as defined in 15 U.S.C. 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.
The basis for determining the percentage of work to be
performed by each of the cooperative parties in Phase I or Phase II will be the
total of the requested costs attributable to each party, unless otherwise
described and justified in Consortium/Contractual Arrangements of the PHS 398
Research Plan component of SF424 (R&R) application forms.
Additional details are contained in the SF424 (R&R) SBIR/STTR
Application Guide.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.
The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) SBIR/STTR Application Guide to ensure you complete all appropriate optional components.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed, with the following additional instructions:
Other Attachments:
1. SBA Company registry
All applicants to the SBIR and STTR programs are required to register at the SBA Company Registry prior to application submission and attach proof of registration. Completed registrations will receive a unique SBC Control ID and .pdf file. If applicants have previously registered, you are still required to attach proof of registration. The SBA Company Registry recommends verification with SAM, but a SAM account is not required to complete the registration. In order to be verified with SAM, your email address must match one of the contacts in SAM. If you are unsure what is listed in SAM for your company, you may verify the information on the SAM site. Confirmation of your company's DUNS is necessary to verify your email address in SAM. Follow these steps listed below to register and attach proof of registration to your application.
a. Navigate to the SBA Company Registry.
b. If you are a previous SBIR/STTR awardee from any agency, search for your small business by Company Name, EIN/Tax ID, DUNS, or Existing SBIR/STTR Contract/Grant Number in the search fields provided. Identify your company and click Proceed to Registration .
c. If you are a first time applicant, click the New to the SBIR Program? link on lower right of registry screen.
d. Fill out the required information on the Basic Information and Eligibility Statement screens.
e. Press Complete Registration on the lower right of the Eligibility Statement screen and follow all instructions.
f. Download and save your SBA registry PDF locally. The name will be in the format of SBC_123456789.pdf, where SBC_123456789 (9 digit number) is your firm’s SBC Control ID. DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application.
g. When you are completing the application package, attach this SBA registry PDF as a separate file by clicking Add Attachments located to the right Other Attachments on the Research and Related Other Project Information form.
For questions and for technical assistance concerning the SBA Company Registry, please contact the SBA at http://sbir.gov/feedback?type=reg.
2. SBIR Application Certification for small business concerns majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms
Applicant small business concerns that are majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms (e.g. majority VCOC-owned) are required to submit a Certification at time of their application submission per the SBIR Policy Directive. Follow the instructions below.
Applicants small business concerns who are more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these (i.e. NOT majority VCOC-owned) should NOT fill out this certification and should NOT attach it their application package.
a. Download the SBIR Application VCOC Certification.pdf at the NIH SBIR Forms webpage.
b. Answer the 3 questions and check the certification boxes.
c. The authorized business official must sign the certification.
d. Save the certification using the original file name. Convert the file to a PDF. The file must be named SBIR Application VCOC Certification.pdf . DO NOT CHANGE OR ALTER THE FILE NAME. Changing the file name may cause delays in the processing of your application.
e. When you are completing the application package, attach this certification as a separate file by clicking Add Attachments located to the right of Other Attachments on the Research and Related Other Project Information form.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed, with the following additional instructions:
Resource Sharing Plans
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) SBIR/STTR Application Guide.
Appendix
Do not use the Appendix to circumvent page limits. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide, with the following modification:
- Note that Phase I SBIR/STTR Appendix materials are not permitted.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants
administration.
Applicants are responsible
for viewing their application before the due date in the eRA Commons to ensure accurate
and successful submission.
Information on the submission process and a definition of on-time
submission are provided in the SF424 (R&R) SBIR/STTR Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants
Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants
Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) SBIR/STTR Application Instructions. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in
the Credential field of the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) SBIR/STTR Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Important Update: See
NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves 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?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangement?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
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
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.
As part of the scientific peer review, all applications:
- May undergo a committee process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
- Will receive a written critique.
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 NIH Council of Councils. The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review.
- Availability of funds.
- Relevance of the proposed project to program priorities.
After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.
Information regarding the disposition of applications is available in the NIH Grants
Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
The Office of Inspector General Hotline accepts tips from all sources about potential fraud, waste, abuse and mismanagement in Department of Health & Human Services programs. The reporting individual should indicate that the fraud, waste and/or abuse concerns an SBIR/STTR grant or contract, if relevant. Report Fraud.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
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.
- Final Progress Report (requirements have recently changed - please see the NOT-OD-12-152)
- Final Invention Statement and Certification (HHS 568)
- Annual Invention Utilization Reports
- Federal Financial Report (FFR) replaced the Final Cash Transaction Report (PSC 272)
- Phase II Data Collection Requirement for Government Tech-Net Database
Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.
For details about each specific required report, see the section on Award Guidelines, Reporting Requirements, and Other Considerations, in the SF424 (R&R) SBIR/STTR Application Guide.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov
SBA Company Registry (Questions regarding required registration at the SBA Company Registry and for technical questions or issues)
Website to Email: http://sbir.gov/feedback?type=reg.
Miguel Contreras, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-594-9410
Email: contre1@mail.nih.gov
Rosemarie Hunziker, Ph.D.
National Institute of Biomedical Imaging and Bioengineering
(NIBIB)
Telephone: 301- 451-1609
Email: hunzikerr@mail.nih.gov
Stefan Maas, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0943
Email: maassw@mail.nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Jean Richelsen
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-9446
Email: richelsj@mail.nih.gov
James Huff
National Institute of Biomedical Imaging and Bioengineering
(NIBIB)
Telephone: 301- 451-4782
Email: huffj@mail.nih.gov
Nicole Fleisher
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3923
Email: nf58e@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) P.L. 102-564, and P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011). The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.
