Required Application Instructions

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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The purpose of this BD2K Funding Opportunity Announcement (FOA) is to solicit development of software tools and methods in the three topic areas of Data Privacy, Data Repurposing, and Applying Metadata, all as part of the overall BD2K initiative. While this FOA is intended to foster new development, submissions consisting of significant adaptations of existing methods and software are also invited.

Biomedical research is rapidly becoming more data-intensive as investigators are generating and using increasingly large, complex, multidimensional, and diverse datasets. This era of big data in biomedical research taxes the ability of many researchers to release, locate, analyze, and interact with these data and associated software due to the lack of tools, accessibility, and training. In response to these new challenges in biomedical research, and in response to the recommendations of the Data and Informatics Working Group (DIWG) of the Advisory Committee to the NIH Director (http://acd.od.nih.gov/diwg.htm), NIH has launched the trans-NIH Big Data to Knowledge Initiative (https://datascience.nih.gov/bd2k).

NIH recognizes that a number of areas of high need exist within the various biomedical research communities for software that enable researchers to make better use of big data. This funding opportunity announcement solicits the development of software tools and methods in the three topic areas of Data Privacy, Data Repurposing, and Applying Metadata.

This FOA solicits development of innovative analytical methods and software tools with the objective of addressing critical current and emerging needs of the biomedical research community for using, managing, and analyzing the larger and more complex data sets inherent to biomedical big data, focusing on the three topic areas listed below. This FOA aims to support the development of innovative tools and approaches to tough problems, as opposed to having fully fledged software tools developed for less-daunting problems. It is not expected that software and methods developed under this FOA will be fully hardened, but rather that investigators show a novel approach to a difficult problem and show some proof-of-concept for this new approach using relevant biomedical big data. While this FOA is intended to foster new development, submissions consisting of significant adaptations of existing methods and software are also invited.

1. Data Privacy

Data privacy and information privacy refer to the challenges of collecting, analyzing, and sharing data while ensuring that any personably identifiable information contained within or associated with the data is not improperly disclosed. As biomedical researchers work to extract increasing amounts of knowledge from the growing amount of data available from a variety of sources, many without privacy protections in place, the possibility of identification is increased in an era where huge amounts of information can be synthesized from public data. For example, de-identification has been shown to be ineffective under certain conditions due to linkage attacks, and this problem will grow if new tools and approaches are not developed. Loss of privacy within biomedical big data can affect large swathes of the population, and there are smaller vulnerable subpopulations whose data and medical records may have additional privacy risks. In addition to the need to protect data provided by human participants, there are also privacy challenges to how separate datasets are combined and to how information content is stored on device systems. The data that is being generated through mobile-health, social networking, wearable devices, etc., can be integrated with more traditional health related data to build novel insights into improving people’s health. This introduces a specific challenge for biomedical research, namely, integrating such data while preserving privacy.

Examples of submissions that will be considered responsive include, but are not limited to:

• Software packages that recognize and adapt to different levels of privacy and confidentiality for different data types.
• Software that identifies sensitive information in large heterogeneous biomedical datasets.
• Software systems that can inform when privacy protections on datasets are infringed or when identity can be compromised.
• Software that can inform when combinations of separately de-identified datasets will reintroduce personally identifiable information (PII).
• Software that determines the level of privacy that needs to be established for standardized datasets.
• Reusable privacy-compliant software that will enable plug-and-play approaches to biomedical research software development.
• Developing open source simulation environments for studying privacy questions in biomedical data.
• Development of encryption methods for human participant data, including homomorphic encryption.

Note: Applications focusing primarily on bioethics or policy research will not be considered responsive to the Data Privacy topic area.

2. Data Repurposing

Data repurposing refers to the biomedical research use and application of data that was not originally created for research purposes. This could include biomedical and health-relevant data collected for purposes of medical care, environmental monitoring data, or quantified-self data. This could also include data types generated outside of a biomedical context, such as data collected for business purposes (including search queries, shopping behavior and economic trend data) or more emerging data types generated through social media, mobile devices and wearable technology use. Additionally, publically available data sources unrelated to the biomedical fields may still contain useful information relevant to human health and health outcomes. Such resources may include weather data, agricultural and land use data, air & water quality measures, and plant & animal maps.

Tools and methods that enable biomedical researchers to enrich their research by incorporating and analyzing information from such NIH-relevant data sources can lead to new insights including connecting behavior to adverse outcomes, revealing important subpopulations, and identifying novel health markers and associations. This topic area supports the development of methods and software tools that address biomedical researchers ease of access to, inclusion of, and challenges of use of NIH-relevant sharable data not originally captured for research use, as appropriate.

Examples of submissions that will be considered responsive include, but are not limited to:

• Software for enabling access to repurposable data that is broadly disbursed, including methods for aggregation and integration of data across multiple platforms and sources.
• Software and methods for collecting and reformatting heterogeneous unaggregated data from public sources.
• Software for discovery of repurposable data, such as methods for finding related data or other public data that can broaden or enrich a held dataset.
• Software and methods for quality assessment and trust in repurposed data, including addressing issues of self-reported data and data collection under imperfect conditions (such as the variability in use of wearable technology or intermittent wireless or GPS connections).
• Software and methods for assessing context and informative value of repurposed data, such as identifying data context dependency and usable health-relevant content.
• Software and methods for real-time and dynamic repurposed data, such as weather data and other locally-resolved data.
• Software and methods for addressing missing data, biases, and unmeasured confounders in repurposed data (e.g., clinical EHR data, self-reported data, etc.).

Note: Applications focusing primarily on secondary data analyses of research-collected data will not be considered responsive to the Data Repurposing topic area.

3. Applying Metadata

Software for applying metadata refers to tools and methods that improve the ability of researchers to submit data and materials to databases, journals, and other common resources shared by the community by helping them annotate their data and apply metadata. This software should help users transform metadata and other information about the data in ways that support and enable data interoperability and exchange of information. This is distinct from transformations on the data for the purpose of extracting knowledge, data reduction, or harmonization of existing metadata catalogs for data mining.

It is well-recognized that researchers find it labor-intensive and confusing to meet the standards of repositories that must formally process and manage data resources and to submit their results to journals and other resources in optimal ways. Software for applying metadata should strive to make it easier for researchers to share their data with the community and promote an outward-looking focus with "their" data so that it can broadly benefit the community. Software for applying metadata includes tools and methods that both lower the effort required for, as well as incentivize the process of applying metadata.

The NIH BD2K initiative seeks to develop an interactive data ecosystem. This necessitates multiple approaches to any one topic, including metadata, and instilling productive relationships among various approaches. Applicants should be aware of ongoing BD2K metadata efforts, such as the Center for Expanded Data Annotation and Retrieval (http://med.stanford.edu/cedar/our-solution.html) and bioCADDIE (https://biocaddie.org/publications/biocaddie-white-paper), and applications to this topic area should describe how their activities under this FOA can be complementary or synergistic.

Examples of submissions that will be considered responsive include, but are not limited to, development of:

• Software platforms to facilitate the use of controlled vocabularies and ontologies.
• Open software toolkits that integrate with industry standards and widely used APIs.
• Software tools to merge and integrate sources to generate metadata in standard formats.
• Ways to address major challenges with metadata with direct benefit to the community.
• Software and tools for crowdsourcing metadata tasks and tagging data attributes, including distributed microtasking platforms that reduce the user-interactive burden of applying metadata.
• Machine learning methods for automating the application of metadata.
• Automated methods for capturing and applying metadata in research workflows.
• Mobile, rapid-interaction tools for data annotation and applying metadata.
• Software that applies metadata sufficient to maintain provenance of data.

Note: The following applications will not be considered responsive to the Applying Metadata topic area:

• Software tools primarily focused on data integration and data mining
• Software tools primarily focused on workflows
• Software tools primarily focused on database and database infrastructure development

Additional Notes:

1. It is anticipated that a single application will have a primary focus on one of the three topic areas. Applicants can submit multiple independent applications, each addressing a separate topic area.

2. This FOA will not support applications that:

• do not address the topic areas identified in the FOA.
• do not address the topic areas in the context of biomedical big data.
• have a primary focus on software use or training, data generation, data storage & database development, or computational modeling and simulation.
• encompass tools developed in the normal procession of basic science research that are not purposefully built specifically to address one of the three topic areas.
• focus on hardware development.

3. Supplemental Project Funding (subject to availability of supplemental funds)

This FOA is intended to support the development of innovative analytical methods and software tools with the objective of addressing critical current and emerging needs of the biomedical research community for using, managing, and analyzing the larger and more complex data sets inherent to biomedical big data in the three defined topic areas. However, it is recognized that some projects may reach a stage beyond proof of concept that might warrant further development into a hardened, well-documented software tool useful to the larger biomedical big data community. In such cases, NIH may choose to supplement projects awarded under this FOA, subject to availability of funds.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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

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 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.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• 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.

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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) 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.

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).

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) 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.

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:

David J. Miller, Ph.D.
Telephone: 240-276-6210
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

All instructions in the SF424 (R&R) Application Guide must be followed. Biographical sketches should convey how the proposed staffing (including PD/PI(s), research staff, consultants, and collaborators) combine the domain-relevant expertise with the data science expertise critical to address the research question within the chosen topic area.

All instructions in the SF424 (R&R) Application Guide must be followed. The annual budget must include funds for travel by the PD/PI(s) to participate in a required BD2K Consortium meeting held within the United States, at a location to be determined by NIH staff.

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

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

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

Research Strategy: As part of the Research Strategy Section, applications should clearly address the following aspects:

1. Identify which of the three topic areas the application proposes to address.

2. Define the challenging problem for biomedical big data research within the chosen topic area that the application proposes to address, giving particular emphasis to how the problem currently exists for the biomedical big data research community, the specific aspects of the problem that create the challenge, and the shortcomings of existing approaches.

3. Explain how the proposed software tools or method will address the challenging problem and the specific aspects of the problem that create the challenge. Describe how the proposed software tools or methods will have impact for researchers working with biomedical big data.

4. For applications that incorporate the aggregation of public or non-controlled-access data, applicants are expected to address methods for mitigating privacy concerns that may arise from such aggregated data.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

A software dissemination plan, with appropriate timelines, is expected to be included in the application. There is no prescribed single license for software produced through grants responding to this announcement. However, NIH does have goals for software dissemination, and reviewers will be instructed to evaluate the dissemination plan relative to these goals:

1. The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.

2. The terms of software availability should permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

3. To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

4. The terms of software availability should include the ability of researchers to modify the source code and to share modifications with other colleagues. An applicant should take responsibility for creating the original and subsequent official versions of a piece of software.

5. To further enhance the potential impact of their software, applicants may consider proposing a plan to manage and disseminate the improvements or customizations of their tools and resources by others.

Any software dissemination plans by the institution (and its subcontractors as applicable) represent a commitment to support and abide by the plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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) 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) Application Guide. 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. See Section III of this FOA for information on registration requirements.

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. Additional information may be found in the SF424 (R&R) 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, and for responsiveness by the NIH BD2K Targeted Software Development Subcommittee. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

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

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

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

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?

In addition, specific to this FOA: Does the proposed research address a current critical barrier or challenge for using, managing, or analyzing biomedical big data within the chosen topic area? If the proposed project is successful, will it have a significant influence on biomedical researchers' capabilities for working with biomedical big data?

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?

In addition, specific to this FOA: Does the proposed staffing (including PD/PIs, research staff, consultants, and collaborators) combine the domain-relevant expertise with the data science expertise critical to address the research question within the chosen topic area?

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?

In addition, specific to this FOA: Is there innovation either in the method/tool developed or in how the method/tool is taken from one field and applied in another? Does the proposed research constitute a novel/innovative software tool or analytical method within the chosen topic area, a new direction for methods research within the chosen topic area, or a significant adaptation of prior software or methods?

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?

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 arrangements?

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.

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.

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.

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

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

Not Applicable

Not Applicable

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

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).

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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review (CSR), 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 selection 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory 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/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

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

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

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

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.

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The BD2K Initiative: This is the set of programs developed by NIH to deal with the special opportunities for and challenges to the use of big data in biomedical research (http://www.bd2k.nih.gov).

The BD2K Consortium: This includes the PIs of funded BD2K awards and NIH staff.

The BD2K Targeted Software Development Program: This is the opportunity for cooperative agreement awards described in this FOA. This may also include additional opportunities described in future BD2K targeted software development FOAs.

The BD2K Targeted Software Development Coordinating Group: If formed, this would serve as an interface between the individual projects funded under this FOA and other appropriate NIH programs.

The PD(s)/PI(s) Authorities and Responsibilities

The Program Director(s)/Principal Investigator(s) will have the primary responsibility for defining the details for the projects within the guidelines of this FOA and for performing all scientific activities. The PD/PI will agree to accept the close coordination, cooperation, and participation of the NIH staff (Project Scientists and other appropriate BD2K Program Staff) in those aspects of scientific and technical management of the projects as described below. Specifically, the PD/PI supported by this BD2K Targeted Software Development Program award will:

• Retain the primary authority and responsibility for the project as a whole, including defining the research objectives, conducting specific studies, analysis and interpretation of research data, and preparation of publications.
• Provide, in addition to standard annual progress reports (see Section VI.3. Reporting), other relevant information to the NIH Project Scientist or Program Officer, and coordinate and cooperate with NIH staff and other members of appropriate collaborating NIH programs.
• Be expected to work directly with the NIH Project Scientist on the coordination of intra-program activities and the scientific integration of individual projects within the BD2K Consortium as well as with other relevant NIH programs.
• Join the BD2K Consortium, participate in person, and budget for travel to joint meetings held once annually at a rotating location, along with other critical staff.
• Participate in the appropriate coordinating meetings and/or working groups, and/or teleconferences as needed.
• Agree not to disclose confidential information obtained from other members of the BD2K Consortium and extended network.
• Accept and implement all scientific, practical and policy decisions approved by the BD2K Targeted Software Development Coordinating Group in addition to applicable NIH policies, laws, and regulations.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

NIH Staff Responsibilities

A designated NIH Program Staff member, acting as Project Scientist, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The role of the Project Scientist will be to facilitate and not to direct. This includes facilitating the partnership relationship between NIH, the BD2K Consortium, and the BD2K Targeted Software Development Program awardees. The Project Scientist’s role includes helping to maintain the overall scientific balance in the program commensurate with new research and emerging research opportunities, facilitating communication and coordination among the awardees, and ensuring that the activities of the awardees are consistent with the mission of BD2K. Specifically, the NIH Project Scientist will:

• Provide technical assistance and advice to the individual BD2K Targeted Software Development Program awardee as appropriate to achieve the aims of the cooperative agreement.
• Work directly with the awardee to facilitate their collaborations with other awardees.
• Coordinate and facilitate the interactions among the BD2K Targeted Software Development Program awardees.
• Promote and help coordinate collaborative research efforts that involve interactions with other members of the BD2K Consortium, as well as with other NIH-sponsored programs, projects, and centers where appropriate.
• Assist in the interaction between the awardee and investigators at other institutions, as appropriate for the program.
• Assist in avoiding unwarranted duplication of effort.

To help carry out these duties, Project Scientists may consult with non-NIH experts in the field.

Additionally, an NIH Program Officer will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice. The Program Officer may also have substantial programmatic involvement to coordinate and facilitate collaborations with other awardees and ensure the activities of the project are consistent with BD2K and the goals of this FOA. The Program Officer may be the same person as Project Scientist, in which case, the individual involved will not attend peer review meetings, or will seek NIH waiver according to the NIH procedures for management of conflict of interest.

Areas of Joint Responsibility

The NIH Project Scientist(s) and the PDs/PIs of the BD2K Targeted Software Development Program will be jointly responsible for the coordination of intra-program activities and the scientific integration of individual projects with other appropriate NIH programs. Joint responsibilities include:

• Developing working groups and trans-project efforts as needed.
• Organizing and conducting regular meetings to share progress and foster collaborations between the awardees, either by teleconference, videoconference, or face-to-face, as needed.

Although the BD2K Targeted Software Development Program will not have any separate formal governing body, the awardees' activities may involve the formation of a Coordinating Group. The primary role of the Coordinating Group will be to serve as an interface between the individual projects funded under this FOA and appropriate NIH programs. Such a Coordinating Group, if formed, will:

• Consist of the PD/PI and the NIH Project Scientist from each project.
• Convene to assess scientific progress, identify new research opportunities, establish priorities, consider policy recommendations, propose publication guidelines and discuss strategies.
• Meet in person, virtual, or by teleconference, with additional project staff and/or NIH staff, as needed.

The NIH Project Scientist(s) will initiate the formation of the Coordinating Group and will facilitate its activities.

The NIH Project Scientist(s) may additionally form an External Scientific Panel (ESP) composed of senior non-federal scientists who are not directly involved in the activities of the BD2K Initiative. The ESP would advise NIH on the progress of the BD2K Targeted Software Development Program, on the contributions of individual projects and/or project collaborations within the consortium, and on the progress and effectiveness of the consortium as a whole.

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three academic members who are not involved in the study will be convened. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

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.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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.

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David J. Miller, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6210
Email: [email protected]

Raymond Jacobson, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-996-7702
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
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 Part 75.