Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
National Center for Advancing Translational Sciences (NCATS)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Funding Opportunity Title

Direct Phase II SBIR Grants to Support Extended Development, Hardening, and Dissemination of Technologies in Biomedical Computing, Informatics, and Big Data Science (R44)

Activity Code

R44 Small Business Innovation Research (SBIR) Grant - Phase II only

Announcement Type

New

Related Notices
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • NOT-OD-16-011 - Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number

PAR-15-288

Companion Funding Opportunity

PA-14-154, SBIR R43/R44-Phase I, Phase II, and Fast Track
PA-14-155, R01 Research Project Grant
PA-14-156, R01 Research Project Grant
PA-14-157, STTR R41/R42-Phase I, Phase II, and FastTrack

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.399; 93.396; 93.395; 93.394; 93.393; 93.172; 93.866; ; 93.351; 93.350; 93.856; 93.855; 93.113; 93.859; 93.279; 93.846; 93.853; 93286

Funding Opportunity Purpose

This funding opportunity announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose the extended development, maintenance, testing, evaluation, hardening and dissemination of existing biomedical software. This FOA is for applications that have completed the proof of concept Phase I stage-type of research through other (non-SBIR) funding sources. The NIH is interested in promoting a broad base of research and development of a broad base of innovative technologies in biomedical computing, informatics, and Big Data Science that will support rapid progress in areas of scientific opportunity in biomedical research. It is expected that this research and development is conducted in the context of important biomedical and behavioral research problems. As such, applications are intended to develop enabling technologies that could apply to the interests of most NIH Institutes and Centers and range from basic biomedicine to research in all relevant organ systems and diseases. Major themes of research include collaborative environments; data integration; analysis and modeling methodologies; and novel computer science and statistical approaches.  New opportunities are also emerging as large and complex data sets are becoming increasingly available to the research community. The proposed work should apply best practices and proven methods for software design, construction, and implementation to extend the applicability of existing technologies in biomedical computing, informatics and big data science to a broader biomedical research community.

Key Dates
Posted Date

June 30, 2015

Open Date (Earliest Submission Date)

August 5, 2015

Letter of Intent Due Date(s)

August 5, 2015 and 30 days prior to every subsequent Standard Due Date.

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

*** Note new SBIR/STTR Standard Due Dates.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

*** Note new SBIR/STTR Standard Due Dates.  SBIR/STTR Applications due on Standard Due dates will no longer be accepted on AIDS Due dates unless otherwise indicated.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date

April 6, 2017

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.

There are several options to submit your application to the agency through Grants.gov. You can use the ASSIST system to prepare, submit and track your application online. You can download an application package from Grants.gov, complete the forms offline, submit the completed forms to Grants.gov and track your application in eRA Commons. Or, you can use other institutional system-to-system solutions to prepare and submit your application to Grants.gov and track your application in eRA Commons. Learn more.

Problems accessing or using ASSIST should be directed to the eRA Service Desk.
Problems downloading forms should be directed to Grants.gov Customer Support.
Table of Contents

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

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

This Funding Opportunity Announcement (FOA) is aimed to encourage Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs),which ensure the availability, continued usefulness (through extended development), and software hardening of existing technologies in biomedical computing, informatics and big data science.

This FOA enables a small business that has accomplished the objectives of a Phase I SBIR grant through non-SBIR funds to initiate the Phase II SBIR stage of development, without needing to perform more early stage, Phase-I-SBIR-type research. This FOA will not accept ‘regular’ Phase II submissions from SBCs for projects that have completed the proof of concept Phase I stage-type of research through SBIR or STTR award from NIH or any other agency that participates in the SBIR/STTR programs.  For this FOA, it is expected that the technology, prototype, or method will have passed the proof of principle stage and that the product has demonstrated feasibility and supports a Phase II effort.  Data or evidence of the capability (including a statement of any Phase I-like quantitative milestones), completeness of design, and efficacy must be provided in the application, along with the rationale for selection of the criteria used to validate the technology, prototype, or method, similar to a Phase I final report required in standard Phase II applications.

This FOA is coordinated by the NIH Big Data Initiative (BD2K) and the Biomedical Information Science and Technology Initiative (BISTI) committees. Through this and related opportunities, Institutes and Centers of the NIH offer support for: fundamental research in biomedical computing, informatics, and Big Data Science; continued development, maintenance and hardening of software, tools and related resources; and applications of computational technologies to a particular domain area(s) in biomedical research. Information on these programs and related funding opportunities from participating Institutes and Centers of NIH can be found at http://www.bd2k.nih.gov and http://www/bisti.nih.gov. Note that in this document, the term “biomedical” will be used in the broadest sense to include biological, biomedical, behavioral, social, environmental, and clinical studies that relate to understanding health and disease. Applicants are reminded to carefully check that the proposed research lies in the mission of the participant Institutes and Centers of the initiative.

In addition to applications for funding in biomedical computing and informatics research that have been accepted under previous BISTI funding opportunity announcements, this announcement acknowledges new opportunities are also emerging as large and complex data sets are becoming increasingly available to the research community. While the biomedical research enterprise is producing increasingly large amounts of digital data, it has not yet fully capitalized on the transformative opportunities that these data provide.  As stated by the Data and Informatics Working Group (DIWG) of the Advisory Committee to the NIH Director, "Colossal changes in biomedical research technologies and methods have shifted the bottleneck in scientific productivity from data production to data management, communication, and interpretation." (http://acd.od.nih.gov/Data%20and%20Informatics%20Working%20Group%20Report.pdf).  In this context, the term "Big Data Science" is meant to capture the opportunities and address the challenges facing all biomedical researchers in releasing, accessing, managing, analyzing, and integrating datasets of diverse data types.  Such data types may include imaging, phenotypic, molecular (including –omics), physiological, anatomical, clinical, behavioral, environmental, and many other types of biological and biomedical data.  They may also include data generated for other purposes (e.g., social media, search histories, and cell phone data). 

Applications under this program announcement can seek support to continue development and maintenance of Big Data Science software.  A number of features of the improved software are listed below. Any of these improvements should benefit the existing user community and/or have potential for attracting more users.

First, contemporary software should be easy to modify and extend, and must be fully documented. Users who experience problems with software should be able to correct the problem with minimal effort and a mechanism must exist for incorporating these corrections into the software. As the needs of a community of users change, the software that supports their research efforts must be adaptable as well. The ability of software to be repaired and to evolve is particularly important because the scientific discovery process is open-ended and ever-changing.

Second, interoperability among different software packages or among software and existing databases is a major challenge. Applications with the goal of extending interoperability are welcomed under this FOA. Portability to different types of hardware is a related area of challenge. Applications with the goal of improving software so that it operates on a variety of platforms employing different operating systems are also encouraged.

Finally, an important goal of the BD2K and BISTI Initiatives is to promote a culture where a large body of annotated and shareable data is available online to the broad biomedical research community. The development and use of data and metadata standards are critical for achieving this goal. The NIH has a number of efforts to stimulate the creation and support of community-based approaches to develop such standards. Investigators may participate in the development of data standards, and may serve as early testers and adopters of community-developed standards.

In the context of the research and development to extend, harden and disseminate established software,investigators should target one or multiple of the following four themes of biomedical computing, informatics, and Big Data science that will enable progress in biomedical research.

1. Collaborative environments and technologies: An applicant addresses the issues of releasing Big Data and tools and gaining access to and using Big Data and tools. Examples include, but are not limited to:

  • Knowledge environments
  • Research commons
  • Scalable, extensible, and maintainable methods of data and metadata curation
  • Data security and privacy, and technical areas related to other ethical, legal, and social implications of Big Data

2. Data integration: An applicant may propose efficient and effective ways to create connections across data types (i.e., unimodal or multimodal data integration). Examples of data types that could be addressed include, but are not limited to:

  • Omics data (e.g., genomics, proteomics, metabolomics, etc.)
  • Image and physiological data (e.g., CT, PET/SPECT, sMRI, fMRI, rMRI, DTI, EEG, MEG, ultrasound, cellular level imaging, multi-electrode recording, etc.)
  • Behavioral, social, and environmental data
  • Clinical data (e.g., lab tests, pathology, imaging, diagnosis, electronic health records, etc.)
  • Data from nontraditional sources (e.g., social media, mobile devices, etc.)
  • Multiscale data (genomic, epigenomic, subcellular, cellular, network, organ, systems, organism, population levels)
  • Multiplatform data (desktop, cloud-based storage, etc.)
  • Data from multiple research areas and diseases (e.g., common inflammation pathways in cancer, obesity, immune diseases, and neurodegenerative diseases)
  • Data with special considerations (e.g., sparse data, heterogeneous data, or very large or very small datasets)
  • Human-computer interfaces and visualization

3. Analysis and modeling methodologies: An applicant may propose to develop approaches for modeling, simulation, or analysis to produce useful biomedical information in ways that current methods cannot provide. Examples include, but are not limited to:

  • Processing of data to allow more efficient analyses
  • Multidimensional statistical and computational methods for analyzing, inspecting, displaying, representing, parsing, and searching high-dimensional data
  • Intensive longitudinal data analyses
  • Spatio-temporal dynamical modeling and adaptive dynamical modeling (e.g., parameter fitting and optimization of complex time series data)
  • Mechanistic modeling
  • Agent-based, Ordinary Differential Equation (ODE), Partial Differential Equation (PDE), and stochastic methods
  • Clinical decision-making
  • Individualized therapies
  • Multi-scale modeling
  • Organ-based or whole-body-based modeling
  • Population-based modeling

4. Computer science and statistical approaches: An applicant may propose to develop enabling technologies in basic computer science such as:

  • Approaches for database development and management – ways to organize, store, and query Big Data
  • Technological approaches to distributing, sharing, and compressing Big Data
  • Crowdsourcing data annotation and data management
  • Approaches for efficient and novel uses of cloud platforms

The biomedical computing, informatics, and Big Data science research and development should take place in the context of biomedical and behavioral research that is of interest across most NIH Institutes and Centers from basic biomedicine to research in all relevant organ systems and diseases. 

Through separate funding opportunity announcements of similar scientific scope, participating Institutes and Centers invite applications for early stage development in biomedical computing, informatics, and Big Data science (R01) PA-14-155, extended development, hardening and dissemination of software technology (R01) PA-14-156, as well as early stage development in biomedical computing, informatics, and Big Data science through small business innovation research (SBIR) PA-14-154, and small business technology transfer (STTR) PA-14-157. Some NIH Institutes and Centers may have other grant mechanisms that could apply to biomedical computing projects. Applicants are encouraged to visit the BD2K and BISTI web sites for these and other relevant funding opportunities: http://www.bd2k.nih.gov/opportunities, and http://www.bisti.nih.gov/bistic_funding.cfm

Specific Areas of Interest

NIDA is interested in applications that promote the sharing and reuse of research data related to addiction.  These applications could include the sharing and discovery of basic and clinical addiction-related study data, the harmonization or standardization of addiction study ontologies, data visualization, technologies to communicate and summarize addiction-related study findings and increasing the ubiquity of high performance computing.

NCI is interested in supporting the enhancement and commercialization of informatics tools and technologies that are in high demand by cancer investigators. Products of proposed development should have clear applications in accelerating research in cancer biology, cancer treatment and diagnosis, cancer prevention, cancer control and epidemiology, and/or cancer health disparities.

Section II. Award Information
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 II – SBIR Direct Phase II Only)
Resubmission (for Phase II - SBIR Direct Phase II Only)

The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

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 $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% ($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 $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 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.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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;
    1. 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
    2. 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
    3. SBIR and STTR.  Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121.705(b) concerning registration and proposal requirements.
  3. 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 NIH STTR program.

Phase I to Phase II Transition Rate Benchmark

In accordance with guidance from the SBA, the HHS SBIR/STTR Program is implementing the Phase I to Phase II Transition Rate benchmark required by the SBIR/STTR Reauthorization Act of 2011.   This Transition Rate requirement applies to SBIR and STTR Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years, excluding the most recently-completed fiscal year.  For these companies, the benchmark establishes a minimum number of Phase II awards the company must have received for a given number of Phase I awards received during the 5-year time period in order to be eligible to receive a new Phase I award.  This requirement does not apply to companies that have received 20 or fewer Phase I awards over the 5 year period. 

Companies that apply for a Phase I award and do not meet or exceed the benchmark rate will not be eligible for a Phase I award for a period of one year from the date of the application submission.  The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently-completed year.  The benchmark minimum Transition Rate is 0.25.   

SBA calculates individual company Phase I to Phase II Transition Rates daily using SBIR and STTR award information across all federal agencies.  For those companies that have received more than 20 Phase I awards over the past 5 years, SBA posts the company transition rates on the Company Registry at SBIR.gov.   Information on the Phase I to Phase II Transition Rate requirement is available at SBIR.gov. 

Applicants to this FOA that may have received more than 20 Phase I awards across all federal SBIR/STTR agencies over the past five (5) years should, prior to application preparation, verify that their company’s Transition Rate on the Company Registry at SBIR.gov meets or exceeds the minimum benchmark rate of 0.25. 

Phase II to Phase III Commercialization Benchmark

In accordance with guidance from the SBA, HHS, including NIH, SBIR/STTR Programs are implementing the Phase II to Phase III Commercialization Rate benchmark for Phase I applicants, as required by the SBIR/STTR Reauthorization Act of 2011. The Commercialization Rate Benchmark was published in a Federal Register notice on August 8, 2013 (78 FR 48537).

This requirement applies to companies that have received more than 15 Phase II awards from all agencies over the past 10 years, excluding the two most recently-completed Fiscal Years. Companies that meet this criterion must show an average of at least $100,000 in revenues and/or investments per Phase II award or at least 0.15 (15%) patents per Phase II award resulting from these awards. This requirement does not apply to companies that have received 15 or fewer Phase II awards over the 10 year period, excluding the two most recently-completed Fiscal Years.

Information on the Phase II to Phase III Commercialization Benchmark is available at SBIR.gov. 

Applicants to this FOA that may have received more than 15 Phase II awards across all federal SBIR/STTR agencies over the past ten (10) years should, prior to application preparation, verify that their company’s Commercialization Benchmark on the Company Registry at SBIR.gov meets or exceeds the benchmark rate listed above.

Applicants that fail this benchmark will be notified by SBA annually and will not be eligible to receive New Phase I, Fast-track or Direct Phase II awards for a period of one year. 

Foreign Institutions

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.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM, SBA Company registry, and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • SBA Company RegistryNew 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.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

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.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility
Number of Applications

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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 or IIB support, a Phase I awardee should submit a Phase II application, and a Phase II awardee should submit a Phase IIB application, within the first six due dates following the expiration of the Phase I or II budget period, respectively.

Contractual/Consortium Arrangements

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.

Section IV. Application and Submission Information
1. Requesting an Application Package

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR Application Guide, including Supplemental Grant Application Instructions 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.

Letter of Intent

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 activity
  • Name(s), address (es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Vinay Pai, Ph.D.
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4781
Email: paiv@mail.nih.gov

Page Limitations

All page limitations described in the SF424 (R&R) SBIR/STTR Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF 424 (R&R) SBIR/STTR Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.  

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.  

SF424(R&R) Other Project Information

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 of the Other Attachments field on the “Research and Related Other Project Information” form.

For questions and for technical assistance concerning the SBA Company Registry, please contact the SBA at http://sbir.gov/feedback?type=reg.

2. SBIR Application Certification for small business concerns majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms

Applicant small business concerns that are majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms (e.g. majority VCOC-owned) are required to submit a Certification at time of their application submission per the SBIR Policy Directive.  Follow the instructions below. 

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.  The file must be named “SBIR Application VCOC Certification.pdf”.  DO NOT CHANGE OR ALTER THE FILE NAME.  Changing the file name may cause delays in the processing of your application.

e.   When you are completing the application package, attach this certification as a separate file by clicking "Add Attachments" located to the right of Other Attachments field on the “Research and Related Other Project Information” form.

SF424(R&R) Senior/Key Person Profile Expanded

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.  

R&R Budget

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.  

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.  

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed.  

PHS 398 Research Plan

All instructions in the SF424 (R&R) SBIR/STTR Application Guide must be followed, with the following additional instructions:

Research Strategy: Summarize the preliminary work that forms the basis for this direct to Phase II application, quantitative milestones (a quantitative definition of success) achieved, the importance of the findings, and emphasize the progress made toward their achievement.  Describe the technology developed, its intended use and who will use it.  Provide data or evidence of the capability, completeness of design, and efficacy along with the rationale for selection of the criteria used to validate the technology, prototype, or method. Describe the current status of the product (e.g., under development, commercialized, in use, discontinued). 

The applicant should address the intended use of the technology, identify the technology development needs that the project will address, and how these needs are related to important biomedical, translational, or clinical research problems. Applicants will be expected to demonstrate fundamental understanding and adequate expertise in the relevant areas of both biomedical research and computational science and technology.

Applications will be expected to address the generalizability of the software, scientific validation of implementations, and self-evaluation according to the following guidelines:

Generalizable, scalable, extensible, and interoperable: Given the expanding needs in biomedical research for advances in a variety of areas of biomedical computing and informatics, the technologies proposed under this announcement should address a significant biocomputational research question and, as appropriate, should be generalizable, scalable, extensible, and interoperable. The applicant should also provide plans for the dissemination of products of the project, including software, tools and related resources, to the relevant research and user communities. The extended development work proposed should be forward-thinking, fill a critical gap, address an area of need or projected need, and seek to exceed the current state of the art.

Scientific Validation: Each application should contain a brief plan for validation of the scientific software, tools and related resources.  This plan should provide the organizing principles by which scientific validation will be conducted. 

User input: Projects should include plans for how end user input will be obtained. Users may be basic or translational biomedical researchers, experimental scientists, behavioral scientists, social scientists, clinicians, software developers, or computational scientists.

Evaluation: The application should include a plan for evaluating the quality and utility of the software, tools and related resources being developed through this initiative. Criteria for evaluation of products may include adequacy, trustworthiness, authenticity, integrity, availability, documentation, and transparency. Specific examples of evaluative information could include, as appropriate, the quality of publications citing uses, tracking the number of users, background/training of the users, requests for services, successful use of the products, number of students, use of training materials, the ability to extend the utility of tools through collaborations with other investigators, etc. The research community being served will have expectations that could be documented through mechanisms such as user feedback, letters of support, etc. Quantifiable measures of results and success are important and should be built in as:

  • Short-term internal metrics (for ongoing improvement);
  • Long-term objective metrics (to gauge impact of use on the scientific field).

Methods for assessment, such as user registration, should not be so onerous that they compromise the use of the investigator’s resources.

Data and metadata standards: An important goal of the BD2K and BISTI Initiatives is to promote a culture where a large body of annotated and shareable data is available online to the broad biomedical research community. The development and use of data and metadata standards are critical for achieving this goal. The NIH has a number of efforts to stimulate the creation and support of community-based approaches to develop such standards. Investigators may participate in the development of data standards, and may serve as early testers and adopters of community-developed standards. The application should include a plan for how the proposed SBIR grant will manage data and metadata standards and formats.  Applicants should, as appropriate, i) engage with community-based standard and format development activities, and ii) apply community-based standards and formats to the data and metadata that the SBIR grant is using for its research.

Use of Common Data Elements in NIH-funded Research: NIH encourages the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies.  CDEs are data elements that have been identified and defined for use in multiple data sets across different studies.  Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.  NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository).  NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection.  The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.  Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

Resource Sharing Plans: Individuals are required to comply with the instructions for the Resource Sharing Plans 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,

3. Submission Dates and Times

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.  

Section V. Application Review Information

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.

1. Criteria

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.

Overall Impact

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).

Scored Review Criteria

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 human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?   

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?        

Additional Review Criteria

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

How well did the applicant demonstrate feasibility of the methodology or technology equivalent to meeting Phase I-level objectives, and providing a solid foundation for the proposed Phase II activity?

Phase I/Phase II Fast-Track Applications

Not Applicable

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Phase IIB Competing Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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) /Genomic Data Sharing Plan.

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.

2. Review and Selection Process

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 submitted in response to this FOA. 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:

  • 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.
3. Anticipated Announcement and Award Dates

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.

Section VI. Award Administration Information
1. Award Notices

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.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

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.

Report fraud, waste and abuse

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

3. Reporting

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. When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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 Part III. Section 5, "SBIR/STTR Award Guidelines, Reporting Requirements, and Other Considerations,” in the Supplement Grant Applications For All Competing Applications and Progress Reports.

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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

Scientific/Research Contact(s)

Valentina di Francesco, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-451-8276
Email: vdifrancesco@mail.nih.gov

Mary Chelsea Lane Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3741
Email: mary.lane@nih.gov

Jonathan Franca-Koh, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7622
Email: jonathan.franca-koh@nih.gov

Xibin Wang, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-3511
Email: wangx1@mail.nih.gov

Stephanie Fertig, MBA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: fertigs@ninds.nih.gov

Mary Ann Wu, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email: maryann.wu@nih.gov

Vinay Pai, Ph.D.
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4781
Email: paiv@mail.nih.gov

Thomas Radman, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-0298
Email: thomas.radman@nih.gov

Daniel Shaughnessy, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-2506
Email: shaughn1@niehs.nih.gov

Lili Portilla, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-217-2589
Email: Lilip@nih.gov

Michael-David Kerns
National Institute on Aging (NIA)
Telephone: 301-402-7713
Email: michael-david.kerns@nih.hhs.gov

Julia Berzhanskaya, PhD
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301.451.2569
Email: julia.berzhanskaya@nih.gov

Miguel Contreras
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-594-9410
Email: miguel.contreras@nih.gov

Peer Review Contact(s)

Ray Jacobson
Center for Scientific Review (CSR)
Telephone: 301-996-7702
Email: jacobsonrh@csr.nih.gov

Financial/Grants Management Contact(s)

Carol Alderson
National Institute on Drug Abuse (NIDA)
Telephone: 301-933-6196
Email: aldersoc@nida.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@gab.nci.nih.gov

Shelly Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301.594.3788
Email: carows@mail.nih.gov  

Monika Christman
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7860
Email: christmm@exchange.nih.gov

Tijuanna DeCoster, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@mail.nih.gov

Deanna Ingersoll
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone:  240-669-2989
Email: ingersolld@niaid.nih.gov

Artisha Eatmon
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone:240-669-2953
Email: artisha.eatmon@nih.gov

James Huff
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4786
Email: huffj@mail.nih.gov

Patrice Molnar
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-5136
Email: molnarp@nigms.nih.gov

Melinda B. Nelson
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-435-5278
Email: melinda.nelson@nih.gov

Pamela B. Clark
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-7629
Email: evans3@niehs.nih.gov

Long Nguyen
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301 402-6737
Email:  nguyen1@mail.nih.gov

Linda Whipp
National Institute on Aging (NIA)
Telephone: 301-402-7731
Email: WhippL@nia.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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 Part 75.

The SBIR Program is mandated by the Small Business Innovation Development Act of 1982 (P.L. 97-219), reauthorizing legislation (P.L. 99-443) P.L. 102-564, and P.L. 112-81 (SBIR/STTR Reauthorization Act of 2011). The basic design of the NIH SBIR Program is in accordance with the Small Business Administration (SBA) SBIR Policy Directive.

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