Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI) National Library of Medicine (NLM)
Funding Opportunity Title	Innovative Health Information Technology for Broad Adoption by Healthcare Systems and Consumers (SBIR) (R44)
Activity Code	R44 Small Business Innovation Research (SBIR) Grant - Phase II for previously funded Phase I grants, and R44 Fast-Track grants
Announcement Type	New
Related Notices	June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
Funding Opportunity Announcement (FOA) Number	PA-12-196
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.393, 93.394, 93.395, 93.399, 93.879
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) invites Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that propose to develop and disseminate evidence-based health information technology (health IT) products that have the potential to 1) prevent or reduce the risk of cancer , 2) facilitate patient-provider communication, and/or 3) improve disease outcomes. The SBC must have received a prior Phase I award or may apply for a Fast-Track (Phase I/Phase II) under this FOA. The purpose of this FOA is to facilitate the transition of SBIR-funded projects to the commercialization stage and to achieve broad scale dissemination of the products. This FOA is expected to promote partnerships between SBC's and large businesses or health-related organizations with the capacity to fully commercialize and disseminate the product. Consistent with the goals of the SBIR funding initiatives, Phase II and Fast-Track SBIR applications must submit a Commercialization Plan, which should include details on how large business or health-related organization(s) will partner with the small business applicant for commercialization and dissemination of the proposed product.

Posted Date	June 5, 2012
Open Date (Earliest Submission Date)	July 5, 2012
Letter of Intent Due Date	30 days before the due date.
Application Due Date(s)	Standard dates apply, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	January 8, 2015
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) SBIR/STTR Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This Funding Opportunity Announcement (FOA) invites Small Business Innovation Research (SBIR) applications from small business concerns (SBCs) that propose to develop and disseminate user-centered designs for health information technology (health IT) products that have the potential to 1) prevent or reduce the risk of cancer, 2) facilitate patient-provider communication, and/or 3) improve disease outcomes. The SBC must have received a prior Phase I award from any participating agency or other NIH Institutes/Centers (ICs) or may apply for a Fast-Track (Phase I/Phase II) under this FOA. The purpose of this FOA is to facilitate the transition of SBIR-funded projects to the commercialization stage and to achieve broad scale dissemination of the products. This FOA is expected to promote partnerships between SBC's and large businesses or health-related organizations with the capacity to fully commercialize and disseminate the product. Consistent with the goals of the SBIR funding initiatives, Phase II and Fast-Track SBIR applicants must submit a Commercialization Plan, which should include details on how the large business or health-related organization(s) will partner with the small business applicant for commercialization and dissemination of the proposed product. Applications intended for ICs must be relevant to the objectives of the respective institutes.

Achieving a 21st Century Health care system. In the landmark 2001 report, Crossing the Quality Chasm, the Institute of Medicine (IOM) highlighted six markers of a transformed 21st-century healthcare system that recognize the potential of health information technology (health IT) to improve the health of all Americans: safe, effective, patient-centered, timely, efficient, and equitable. Building on this vision, the Office of the National Coordinator for Health Information Technology (ONC) is leading the Federal Health IT Strategic Plan which focuses on improving the quality, efficiency, safety, and patient-centeredness of health care. In collaboration with federal partners, the ONC’s plan addresses IOM recommendations by promoting the adoption of electronic health records (EHRs), supporting the meaningful use of EHRs and health IT, and the electronic exchange of health information for public and population health.

In this context the President's Council of Advisors on Science and Technology (PCAST) note that Improvements in health and quality of life, particularly as we age, depend upon knowledge and information that can drive appropriate actions .Advances are needed in the modeling of interpersonal interaction and in the understanding of human behavior and motivation to allow both physicians and patients to gain maximum advantage from tools that facilitate personalized healthcare. The restructuring of the health services environment is creating new decisional architectures for health promotion and disease prevention that can address the IOM recommendations by leveraging data for improved communication and decision support between healthcare providers, patients, and caregivers.

With the rapid evolution of health IT devices, standards, and platforms, there is an urgent need for translating the behavioral and communication science evidence-base for the prevention and control of cancer into the development of health IT tools and applications (i.e., products) that are compatible with these emerging platforms for consumer and clinical health. This includes alleviating the burden of cancer through prevention and reduced risk, improvements to screening and diagnosis, efficacy of therapy, and end of treatment transitions. Examples of such platforms include electronic medical records (EMRs) and personal health records (PHRs), the patient-centered medical home, and mobile technologies for health (mHealth). This FOA s emphasis on translational science expands the use of health IT to meet the priorities of NCI and NLM as aligned with Subtitle A of the HITECH Act.

Proposed projects for this FOA must utilize established principles of user-centered design. Potential products should be designed for consumers, patients, health providers, and/or their caregivers. The development of these products should be informed by existing research on how such technologies can help improve health-related behaviors, patient-physician communication, patient engagement, and care coordination. Funding is expected to lead to the design of products that can be integrated into existing EMR and PHR systems, mobile, and other emerging technology platforms that are suitable for a variety of clinical and home-based settings.

1. Defining a Partnership:

This FOA strongly recommends applicants develop partnerships between small business concerns and large business or health-related organizations. In this FOA, these non-SBIR partners are called "entities" and are defined as US-based for-profit or not-for-profit organizations with more than 500 employees.

Examples of entities include but are not limited to: large healthcare delivery systems; clinical settings (HMOs, hospitals, clinics, private practices); insurers; health departments; EMR vendors; pharmaceutical companies; health IT companies that produce applications, systems and tools for consumers and providers; health care companies; employers with health IT interests; and wellness advocacy groups.

2. Partnership Expectations:

• SBCs: the SBC is responsible 1) for the planning, execution and evaluation of the scientific content, which includes conducting the research and evaluating end-product in the environment for which it will be used; 2) for securing a commitment from an entity to participate in the feasibility testing of the proposed project in the Phase I portion of a Fast-Track and/or to work with the "entity" to obtain feedback regarding further development that will be conducted in the Phase II portion of the project; 3) for developing a working relationship with the entity and developing a formal partnership for Phase II applications.
• Entity: it is anticipated that the entity will possess appropriate prior experience in implementing applications and technologies in consumer and/or clinical settings, and will be responsible for 1) providing resources such as consultation, focus group participants, large-scale study participants, technology platforms, distribution networks and/or financing to help accelerate the commercialization/dissemination of products developed by the SBC, 2) advising the SBC on utility and commercial viability, 3) assisting with integration of the proposed product with existing technology platforms/user bases, and 4) assisting in the commercialization or distribution of the final product.
• Budgets must adhere to current SBIR guidelines regarding subcontracting in Phase I/Phase II portions of awards.

3. Documenting Partnerships: If an application has scientific merit and is selected for funding, both the SBC and the entity need to have a partnership agreement in place prior to an award being made. A sample Model Agreement , referred to as the NIH SBIR Sample Partnership Agreement document, can be accessed at: http://sbir-dev.cancer.gov/resource/hit/ . This document provides one example of allocating the rights to intellectual property, additional research, development, profit sharing and commercialization.

Programmatic funding priority will be given to SBCs that arrange a partnership prior to the application submission deadlines.

Negotiating third-party partnerships, e.g. Venture Capital (VC) funding, other corporate partners, academic institutions, etc. to advance commercialization is at the discretion of the SBC and entity.

Applicants are encouraged to:

• Develop, implement and evaluate innovative tools and applications for consumers, patients, their caregivers, and/or healthcare providers that effectively translate the behavioral and communication science evidence base while addressing one or more topics in the following categories: Applications that improve healthcare quality, reduce medical errors, reduce health disparities, and/or advance the delivery of patient-centered care through shared care planning and/or care coordination that can also potentially impact population health as outlined in Subtitle A, Section 3001 of the HITECH Act.
• Address the objectives for the meaningful use of health IT as described in the Federal Health IT Strategic Plan.
• Target 1) Care coordination, 2) Patient-centered medical home, 3) Shared care and treatment planning tools, 4) Chronic care management tools, 5) Remote monitoring systems for patients, 6) Home health care devices, 7) Augmented reality/virtual environments for patient engagement, and 8) Mobile health applications.
• Integrate resulting products with existing EMR, PHR, mobile, or other technology platforms, as well as existing community and clinical resources to support individual and population health.

Applicants are strongly encouraged to consult with NCI and NLM Program Staff as plans for an application are being developed. This early contact will provide an opportunity to clarify the applicant's understanding of program goals and guidelines, including the scope of projects within the program and the requirement that project objectives be milestone-driven. These discussions also provide important information and guidance on how to develop an appropriate milestone plan, which is subject to peer review under this program.

For this FOA, the SBC has the primary responsibility of:

• Defining objectives and approaches;
• Conducting user-centered design and usability testing during the research and development process;
• Planning and conducting research;
• Meeting specified milestones throughout the project;
• Product development, implementation, and evaluation;
• Analyzing outcome data and publishing results;
• Sharing appropriate information, data, and research materials with NCI staff as necessary; and
• Addressing how the proposed partnership between the SBC and the entity will promote the commercialization and dissemination of their product.

In addition to meeting measureable milestones, progress will be monitored to determine if the applicant has described how their product(s) will:

• Improve healthcare delivery;
• Improve patient-provider communication related to health promotion, disease prevention, care management, etc.;
• Improve health-related decision making;
• Promote actual positive behavior changes;
• Improve health outcomes and quality of life; and/or
• Improve adherence to chronic disease prevention, detection, and treatment guidelines.

For this FOA, the Entity has the primary responsibility of:

• Participating with the SBC throughout the Phase I and Phase II as described in the proposal with regard to meeting their milestones;
• Providing guidance on developing a product that is appropriate to the consumer and/or clinical setting relevant to the entity; and
• Assisting in commercializing and/or disseminating the final product.

In particular, this FOA will give competitive preference and funding priority to applications deemed likely to result in a commercial product.

Milestones

The short-term objective of this FOA is the development of a collaboration between an SBC and an entity to: a) drive development of evidence-based, scalable, consumer and/or clinical applications to reduce death and suffering from cancer ; and b) assist in the commercialization of products created for users in consumer and/or clinical settings.

The long-term objective of this FOA is to translate and disseminate evidence-based applications and technologies that help enable the delivery of timely, tailored, and scalable health solutions to a broad range of users in consumer and clinical settings.

To achieve these goals applicants are expected to:

• Address all the requirements of this announcement;
• Provide a focused and comprehensive proposal and describe its scientific and technical merit;
• Describe the proposed product, how it will help to meet stated objectives; and its commercial viability;
• Include the qualifications, experience and prior accomplishments of the principal investigators, research team, and consultants;
• Describe the adequacy of facilities to conduct research;
• Establish an advisory group for product development purposes;
• Define the user population(s) and include sample size, gender, age, race, culture, and other relevant demographic information;
• Describe the appropriateness of the population and user setting(s) for testing and evaluation, data collection methods, barriers to product use, and appeal to potential users;
• Use appropriate theory, evaluation, and outcome methods; measure and evaluate the short and potential long-term effectiveness of the product with end-users in consumer and/or clinical settings;
• Conduct appropriate user-centered design and usability testing methodologies for product prototype development in Phase I, and further development and refinement in Phase II (either at NCI's User-Centered Informatics Resource Lab or comparable facilities).
• Assess changes in end-user knowledge, attitudes, risk reduction, and behaviors as relevant to the product;
• Provide a line item budget justification; and
• Adhere to NIH Data and Safety Monitoring Guidelines for Clinical Trials when conducting NIH defined clinical trials;
• Contact FDA if the final product will require regulatory approval.

Phase I Milestones: Applicants are expected to include a Research Strategy citing specific aims and feasibility milestones that would justify transition from the Phase I to the Phase II. The milestones should be well described, quantifiable, scientifically justified, and relevant to the progress of the Phase I application for successful transition to Phase II.

Phase II Milestones. SBCs are encouraged to collaborate with their partnering entities in the development of the Phase II application to set relevant milestones that will allow for tracking the development, implementation and evaluation of the described product as described above. Achievement of proposed milestones will be evaluated by NIH staff prior to releasing funding for each year of the award.

Plan for Full Commercialization (all applications).

The ultimate goal of this FOA is to facilitate commercialization of Phase II products developed under this FOA. All applicants, in conjunction with the partnering entity, are expected to describe a realistic plan that includes how full commercialization of the product is expected to be achieved and should be presented as part of the 12-page Commercialization Plan. The actual commercialization of the final product is expected to be carried out with non-SBIR funds.

Securing funds from third-party investors and/or strategic partners, in addition to SBIR funds, is at the discretion of the SBC and entity involved in this FOA. Applicants are strongly encouraged to establish business relationships with partners (and investors) that have appropriate prior experience in implementing applications and technologies in consumer and/or clinical settings. The entity must 1) provide a detailed overview of their history and utilization of applications and technologies in consumer and clinical settings, and 2) a strategic marketing plan to commercialize and disseminate the SBC’s product. Programmatic funding priority will be given to SBCs that have made partnership arrangements with an entity prior to submitting the application.

Applicants are highly encouraged to access: http://sbir-dev.cancer.gov/resource/hit/ for a non-inclusive list of examples of products relevant to this FOA.

Funding Instrument	Grant
Application Types Allowed	Phase II or Fast-Track Resubmission allowed The OER Glossary and the SF424 (R&R) SBIR/STTR Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	According to statutory guidelines, total funding support normally may not exceed $1,000,000 for Phase II awards or $1,150,000 for Fast-Track (Phase I plus 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 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,or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;

4. Has, including its affiliates, not more than 500 employees.

SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both. Business concerns include, but are not limited to, any individual (sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R) SBIR/STTR Application Guide should be referenced for detailed eligibility information.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations must complete the following registrations as described in the SF424 (R&R) SBIR/STTR Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. For projects with multiple PD(s)/PI(s), at least one PD/PI must meet the primary employment requirement. Occasionally, deviations from this requirement may occur.

The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements. For institutions/organizations proposing multiple PD(s)/PI(s), see Multiple Principal Investigators section of the SF424 (R&R) SBIR/STTR Application Guide.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS funding opportunity, including the SBIR and STTR Parent announcements.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF424 (R&R) SBIR/STTR Application Guide.

A Phase I awardee may submit a Phase II application either before or after expiration of the Phase I budget period, unless the awardee elects to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I awardee should submit a Phase II application within the first six due dates following the expiration of the Phase I budget period.

In Phase 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research
• Name, address, and telephone number of the PD(s)/PI(s)
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

The letter of intent should be sent to:

Patricia Weber, DrPH
SBIR Development Center
National Cancer Institute (NCI)
6116 Executive Blvd, Suite 402
Bethesda, MD 20892-8332 (for U.S. Postal Service regular or express mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: 301-594-8106
Fax: (301) 480-0482
Email: [email protected]

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) SBIR/STTR Application Guide to ensure you complete all appropriate optional components.

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

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

Resource Sharing Plans

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) SBIR/STTR Application Guide.

Appendix

Do not use the Appendix to circumvent page limits. 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 Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) SBIR/STTR Application Instructions. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/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 Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the proposed project have commercial potential to lead to a marketable product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?)

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangement?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Phase IIB Competing Renewals

Not Applicable

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/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) , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• 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/priority 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.

After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.

• Expenditure data portion of the Federal Financial Report
• Final Progress Report
• Final Invention Statement and Certification (HHS 568)
• Annual Invention Utilization Reports
• Final Cash Transaction Report (PSC 272)
• Phase II Data Collection Requirement for Government Tech-Net Database

Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.

For details about each specific required report, see the section on Award Guidelines, Reporting Requirements, and Other Considerations, in the SF424 (R&R) SBIR/STTR Application Guide.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Patricia Weber, DrPH
SBIR Development Center
National Cancer Institute (NCI)
Telephone: 240-276-5240
Email: [email protected]

Bradford Hesse, PhD
Health Communication and Informatics Research Branch
National Cancer Institute (NCI)
telephone: 240-276-6721
Email: [email protected]

Jane Ye, PhD
Division of Extramural Programs
National Library of Medicine (NLM)
Telephone: 301-594-4882
Email: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Jacquelyn Boudjeda
Office of Grants Administration
National Cancer Institute (NCI)
Telephone: 301-496-1204
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.

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