National Institutes of Health (NIH)
National Human Genome Research Institute (NHGRI)
Funding Opportunity Title
Informatics Tools for High-Throughput Sequence Data Analysis (SBIR) (R43/R44)
Funding Opportunity Announcement (FOA) Number
RFA-HG-10-018, Informatics Tools for High-Throughput Sequence Data Analysis U01
Catalog of Federal Domestics Assistance (CFDA) Number(s)
This FOA is intended to fund the further development of existing computational software tools for use with contemporary DNA sequencing technology in order to make those tools sufficiently robust, reliable, well-documented, and well-supported that they can be readily adopted by any biological or biomedical research laboratory.
Potential applications for such tools include determination of sequence quality, alignment, assembly, variant calling, interpretation of variants, or any other application for which there is existing or likely future demand by many investigators or clinicians who work with large amounts of data from contemporary sequencing instruments. Applications for producing stand-alone tools or integrated suites of programs for data processing or analysis will be responsive to this FOA.
Applications responsive to this FOA will describe the further development of software tools (algorithms or programs) that have already been shown to be useful in the sequencing setting, but which are not readily transferable to others. Applications for the initial stages of software development will be considered non-responsive. Applicants may propose the further development of tools they have initially developed on their own, or that have been obtained from others.
Because a major goal of this funding initiative is to develop widely useful and broadly disseminated tools for furthering research across the scientific community, NHGRI expects that applications will include information about how any tools developed will be disseminated, and made as readily available as possible, to the broader community.
December 13, 2010
Open Date (Earliest Submission Date)
February 3, 2011
Letter of Intent Due Date
February 3, 2011
Application Due Date(s)
March 3, 2011, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Scientific Merit Review
Advisory Council Review
Earliest Start Date(s)
March 4, 2011
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The DNA sequencing landscape has changed dramatically in the last few years. A new generation of genome sequencing platforms that produce high throughput genome sequence data has now made it possible for laboratories outside of large sequencing centers to generate enormous amounts of sequence data in their experiments. Often, however, such laboratories face a serious challenge because they do not have access to readily usable software tools or the informatics expertise necessary to take best advantage of the new sequencing capabilities. There is thus a need for robust, well-documented, and well-supported software tools for processing and analyzing the data that individual labs can now generate, and the demand for such software tools will only grow, with the increasing uptake of large-scale sequencing, and the development of new applications for sequence data.
Large sequencing centers, such as those supported by the NHGRI and similar efforts in the U.S. and abroad have faced similar software needs as they have converted their production efforts to the new sequencing technologies. The informatics components of those centers have, accordingly, been able to develop a large number of tools to manage, process, analyze, and interpret the large nucleic acid sequence data sets produced to address a number of scientific questions, including identifying human variants underlying disease, and comparative and functional genomic analyses. While the sequence analysis informatics tools they have developed are technically available to others, there are significant practical barriers to their use by the wider community. Most of the "in-house" informatics tools developed so far are optimized only for local applications. Furthermore, the software may not be well-documented, and it does not generally have adequate documentation or user support. It may only run on large, local computational clusters (something many researchers do not have), and may not, for example be useful for cloud applications, or operate on multiple platforms. It may require a dedicated group of local bioinformatics experts to maintain or update. In general, the centers have not been supported to develop their tools to make them readily transferrable to other groups, especially groups operating at a smaller scale and/or that do not have extensive dedicated local bioinformatics support. This situation has the potential to create a bottleneck to the ability of the growing number of investigators who wish to analyze sequence data that they have generated in pursuit of their own projects. The issue promises to become even more serious because the costs of producing sequence data continue to drop rapidly, and will soon be exceeded by the costs of analysis.
The NHGRI therefore seeks to support efforts to address this gap, and this FOA has been issued to solicit applications to take existing software for management, analysis, or interpretation of large-scale DNA or RNA sequence data and make it into a robust, readily transferable software tool for wider use. The purpose of the FOA is to support the further development of existing tools to give them high utility in terms of the potential number of users and/or ease of use, high significance in terms of the specific capabilities they enable, and to make them readily transferrable, with excellent documentation for installation and use, and appropriate user support. Access to the tools and underlying code should be high as well, for example through deposition in a suitable repository (e.g. SourceForge).
The existing "in-house" software from which applications for this FOA should start can come from any appropriate source, including software developed at existing sequencing centers (which NHGRI regards as a resource when developed through the NHGRI large-scale sequencing program), or from companies or academic laboratories that work with sequence data.
Investigators funded under this FOA will undertake activities that are substantially complementary to those carried out by the NHGRI Large-Scale Sequencing research network, which will include large-scale sequencing activities and informatics tools development funded by cooperative agreements (please see RFA-HG-10-018 Informatics Tools for High-Throughput Sequence Data Analysis U01). NHGRI anticipates that awardees will cooperate to the extent possible on resolving some common questions, for example:
In addition, NHGRI has received advice that it is unclear whether the kind of software tool development requested in this FOA is best done through funding academic groups, or by companies. NHGRI expects to evaluate this question through this program in an ongoing manner during the award.
Specific Areas of Research Interest
Applications are solicited to develop transferrable tools in any area related to the management, analysis or interpretation of large volumes of DNA or RNA sequence, from the point of data production through at least publication including, but not limited to, the following areas: sequencing pipeline management, basecalling, assignment of data quality values, alignment, assembly, variant calling, validation, visualization of data, functional interpretation of variants, etc. Applicants may propose to develop software tools that can be used in the study of any biomedical question that can be addressed through high-throughput sequencing, including for example RNA expression, metagenomics, and epigenomics.
Applications are sought that propose either to develop stand-alone tools, or to bundle software tools into a coherent suite or package. Applications that run in a cloud environment are encouraged.
Applicants must justify their selection of project and approach based on the existing or likely future demand for the proposed software tools by a breadth of investigators who work with large-scale sequence data.
Software tools to be further developed include those that are working in one or a few laboratories but are not readily transferable, or those that are at some advanced stage of development in the applicant's research group. Applications that propose development from the beginning of new tools, algorithms, etc., and which do not devote the majority of the effort to making them widely transferable and usable within the period of the award, will not be considered responsive.
NHGRI seeks development of software that has both high utility and sustainability for example software products that are: interoperable with other software products relevant to sequence analysis especially with software that is already in wide use or of particular relevance to the topic of analysis; supported through both original release and subsequent updates; able to be customized by users; rights can be transferred or otherwise sustained in the event that the original investigators are unable to continue development and support.
Application Types Allowed
Funds Available and Anticipated Number of Awards
Issuing IC intends to commit an estimated total of $2M per year total costs, and anticipates up to five awards.
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.
Award Project Period
According to statutory guidelines, award periods normally may not exceed 6 months (SBIR)/1 year (STTR) 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 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, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;
4. Has, including its affiliates, not more than 500 employees.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.
Applicant organizations must complete the following registrations as described in the SF424 (R&R) SBIR/STTR Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PD/PIs, at least one must meet the primary employment requirement. Occasionally, deviations from this requirement may occur
The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
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).
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.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Number and title of this funding opportunity
The letter of intent should be sent to:
Adam L. Felsenfeld
5635 Fishers Lane
Suite 4076, MSC 9305
Bethesda, MD 20892
The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) SBIR/STTR Application Guide to ensure you complete all appropriate “optional” components.
All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed, with the following additional instructions:
Resource Sharing Plan
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) Application Guide.
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. The instructions for the Appendix of the Research Plan are described in the SF424 (R&R) Application Guide
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) SBIR/STTR Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) SBIR/STTR Application Instructions. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
All PD/PIs must include their eRA Commons ID in the
Credential field of the Senior/Key Person Profile Component of the SF
424(R&R) Application Package. Failure to register in the Commons and
to include a valid PD/PI Commons ID in the credential field will prevent the
successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) SBIR/STTR Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Reviewand responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Guidance for Applicants
Because this initiative seeks to foster the creation of robust, transferable software tools that will be useful to the community, applicants should address several points:
A software development and distribution plan with appropriate timelines, is expected to be included in the Phase 2 portion of the application. Reviewers will be asked to evaluate the plan based on its likely impact towards producing a successful product. In this context, applicants should consider points related to the sustainability and utility of the software, including plans for making available original and subsequent updated/improved versions of software products; ability for the user to customize; interoperability with current widely-used sequencing analysis software; operation on multiple platforms; and plans for transferability in the event that the original developer is unable to continue develop0ing or maintaining the software product.
Applications that propose to develop wholly new software tools as a sole or majority component will not be considered to be responsive.
In order to expedite review, applicants are requested to notify the NHGRI Referral Office by email at email@example.com when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, and Fast-Track, , does the Commercialization Plan demonstrate a high probability of commercialization?)
If the proposed software tool development is successful, is it likely to be widely adopted and used?
Is the proposed software tool likely to be an improvement over existing similar tools that may be available, for example by superior technical performance or ease of use?
Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Are the investigators sufficiently familiar with the state of the art in large-scale DNA sequencing informatics tools, and community needs? Do they have sufficient access to existing tools in order to have a basis for their further development?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
One significant goal of this RFA is to encourage the development of tools that are reliable, sustainable, and able to be widely used by the community in analyzing sequence data. Is the plan adequate for ongoing support of the software? Are there adequate plans for making available original and subsequent updated/improved versions of software products; for the user to customize; interoperability with current widely-used sequencing analysis software; operation on multiple platforms? Are there plans for transferability in the event that the original developer is unable to continue developing or maintaining the software product?
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/priority 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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Renewals, the committee will consider the progress made in the last funding period.
Phase IIB Applications
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 NHGRI. (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.
As part of the scientific peer review, all applications will:
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Human Genome Research . The following will be considered in making funding decisions:
After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
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.
Cooperative Agreement Terms and Conditions of Award
NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.
Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.
For details about each specific required report, see the section on “Award Guidelines, Reporting Requirements, and Other Considerations,” in the SF424 (R&R) SBIR/STTR Application Guide.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Adam L. Felsenfeld, Ph.D.
National Human Genome Research Institute (NHGRI)
Rudy Pozzatti, Ph.D.
National Human Genome Research Institute (NHGRI)
Grants Management Branch
National Human Genome Research Institute (NHGRI) ()
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.
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