Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Human Genome Research Institute (NHGRI))
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Library of Medicine (NLM)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Office of Strategic Coordination (Common Fund)
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)

Funding Opportunity Title

Development of Software and Analysis Methods for Biomedical Big Data in Targeted Areas of High Need (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

  • March 26, 2014 - See Notice NOT-HL-14-220. Notice of National Heart, Lung, and Blood Institute (NHLBI) Participation.
  • March 26, 2014 - See Notice NOT-HD-14-011. Notice of NICHD's Participation.
  • March 12, 2014 - See Notice NOT-CA-14-038. Notice of National Cancer Institute (NCI) Participation.
  • March 5, 2014 - See Notice NOT-DA-14-008. Notice of Participation of the National Institute on Drug Abuse.
  • March 5, 2014 - See Notice NOT-EB-14-004. Notice of NIBIB's Participation.
  • February 27, 2014 - See Notice NOT-RM-14-009. Notice of Participation of the Office of Strategic Coordination.

Funding Opportunity Announcement (FOA) Number

RFA-HG-14-020

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.172; 93.846; 93.242; 93.853; 93.173; 93.856; 93.855; 93.879; 93.310; 93.286; 93.279; 93.393; 93.394; 93.395; 93.396; 93.399; 93.865; 93.233

Funding Opportunity Purpose

In response to the spectacular opportunities and immense challenges presented by the dawning era of "Big Data" in biomedical research, NIH has developed the Big Data to Knowledge (BD2K) initiative with the mission of enabling the biomedical research community to use the various types of Big Data for research. The purpose of this Funding Opportunity Announcement (FOA) is to solicit development of analysis methods and software in the four topic areas of data compression/reduction, data visualization, data provenance, and data wrangling as part of the overall BD2K initiative.

Key Dates
Posted Date

February 19, 2014

Open Date (Earliest Submission Date)

May 19, 2014

Letter of Intent Due Date(s)

May 19, 2014

Application Due Date(s)

June 19, 2014, by 5:00 PM local time of applicant organization.

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2014

Advisory Council Review

January 2015

Earliest Start Date

March 2015

Expiration Date

June 20, 2014  

Due Dates for E.O. 12372

Not Applicable

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.


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Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

In response to the spectacular opportunities and immense challenges presented by the dawning era of "Big Data" in biomedical research, the NIH has developed the Big Data to Knowledge (BD2K) initiative. The mission of BD2K is to enable the biomedical research community to use the various types of Big Data for research. Biomedical research is rapidly becoming data-intensive as investigators are generating and using increasingly large, complex, multidimensional, and diverse datasets. However, the ability to release data, to locate, integrate, and analyze data generated by others, and to utilize the data is often limited by the lack of tools, accessibility, and training. The purpose of this BD2K U01 Funding Opportunity Announcement (FOA) is to solicit development of software tools and analysis methods in the four topic areas of data compression/reduction, data visualization, data provenance, and data wrangling as part of the overall BD2K initiative. While this FOA is intended to foster new development, submissions consisting of significant adaptations of existing methods & software are also invited.

Background

Biomedical research is becoming more data-intensive as researchers are generating and using increasingly large, complex, 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 (http://bd2k.nih.gov/about_bd2k.html).

NIH recognizes that a number of areas of high need exist within biomedical Big Data research communities. Therefore, NIH solicited input from these communities via a Request for Information (RFI) on four of these targeted topic areas: data compression/reduction, data visualization, data provenance, and data wrangling (http://grants.nih.gov/grants/guide/notice-files/NOT-HG-13-014.html). Responses were received from across the scientific community, industry, and academia that broadly covered the four targeted areas in the RFI.  

Research Objectives and Scope

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 four topic areas listed below. This FOA aims to support the development of innovative 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 Compression/Reduction

Data Compression refers to the algorithm-based conversion of large data sets into alternative representations that require less space in memory. Data Reduction refers to the reduction of data volume via the systematic removal of unnecessary data bulk. The area of data compression is important in Big Data science primarily for its role in helping to reduce resource usage. Compression algorithms must consider the degree of compression desired, the amount of distortion allowable, and/or the computational resources available for compressing and decompressing data, among other factors. Additionally, the complementary area of data reduction aims to dramatically reduce the data volume, and in the meantime reduce the complexity/dimensionality of data for easier analysis. This usually involves processing and/or reorganization of data to minimize redundancy, eliminate noise, and preserve signal and data integrity. 

Software and methods proposed in response to this topic must target a data compression and/or reduction challenge important to biomedical Big Data. These methods may additionally be more generally applicable to non-biomedical data types and may be adapted from other fields. Some examples of data compression/reduction software and methods that would be considered responsive to this FOA might include, but are not limited to:

2. Data Visualization

Data Visualization refers broadly to human-centric data representation that aids information presentation, exploration, and manipulation. This is typically performed via the use of visual and graphical techniques; however, these can be augmented with sound and other sensory cues to create deeper experiences. Effective data visualization permits researchers to communicate information through graphical and interactive means and enables them to intuitively delve into and explore within the data, gaining both insight into a dataset’s structure and interrelationships and extracting knowledge from the data. One of the primary challenges in the Big Data era is on interpreting complex, high-dimensional, high-throughput data, especially in the context of other relevant and often orthogonal data. As such, intuitive software tools and methods for data visualization can serve as unique conduits for discovery and furthering understanding of data, beyond what can be conveyed in presenting the data in machine-oriented formats and tables.

Software and methods proposed in response to this topic must target a data visualization challenge important to biomedical Big Data. These methods may additionally be more generally applicable to non-biomedical data types and may be adapted from other fields. Some examples of data visualization software and methods that would be considered responsive to this FOA might include, but are not limited to:

3. Data Provenance

Data Provenance refers to the chronology or record of transfer, use, and alteration of data that documents the reverse path from a particular set of data back to the initial creation of a source dataset. Provenance of digital scientific data is useful for determining attribution, enabling data citation, identifying relationships between objects, tracking back differences in similar results, guaranteeing the reliability of the data, and to allow researchers to determine whether a particular dataset can be used in their research by providing lineage information about the data. Moreover, effective data provenance software, methods, and practices should ensure that any given biomedical research project remains associated with the datasets it created throughout the useful lifetimes of the data.

Software and methods proposed in response to this topic must target a data provenance challenge important to biomedical Big Data. These methods may additionally be more generally applicable to non-biomedical data types and may be adapted from other fields. Some examples of data provenance software and methods that would be considered responsive to this FOA might include, but are not limited to:

4. Data Wrangling

Data Wrangling is a term that is applied to activities that make data more usable by changing their form but not their meaning.  Data wrangling may involve reformatting data, mapping data from one data model to another, and/or converting data into more consumable forms. Such data wrangling activities make it easier to submit data to a database or repository, load data into analysis software, publish to the Internet, compare datasets, or otherwise make data more accessible, usable, and shareable in different settings. Data wrangling is distinct from data mining, which refers to activities that extract information content from data. Researchers who generate datasets that become Big Data in aggregate often find it difficult to share their data, even when standards are well-established. Specialized skills are often needed to format data, apply metadata, use ontologies, capture attributes, annotate features, and apply other functions to reformat, manipulate, transform, or process data. Software supported under this topic should assist biomedical researchers in making their own data more usable to others.

Software and methods proposed in response to this topic must target a data wrangling challenge important to biomedical Big Data. These methods may additionally be more generally applicable to non-biomedical data types and may be adapted from other fields. Some examples of data wrangling software and methods that would be considered responsive to this FOA might include, but are not limited to:

Notes:

1. It is anticipated that a single application will focus on one of the four topic areas, and applicants must identify which topic area is being addressed. While an application may contain components that address more than a single topic area, the application should identify the single topic area that is the primary focus of the proposed work. Applicants can submit multiple independent applications, each addressing a separate topic area.

2. This FOA will not support applications that:

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 four 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.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

NIH intends to commit $6.5 million to fund 10-15 awards in fiscal year 2015.

Award Budget

Direct costs are limited to a maximum of $300K in each year.

Award Project Period

The maximum project period is 3 years.  

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) 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.

Letter of Intent

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

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

The letter of intent should be sent by email to:

David J. Miller, Ph.D.
Division of Cancer Biology
National Cancer Institute (NCI)
Telephone: 240-276-6210
Email: BD2K_targeted@mail.nih.gov

Page Limitations

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

Required and Optional Components

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

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.   In addition, address how 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.

R&R or Modular Budget

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.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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 four 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.

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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.

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 by the Center for Scientific Review and responsiveness by the NIH BD2K targeted software development subcommittee. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

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

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Does the proposed 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?

Investigator(s)    

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

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?   Is there innovation either in the method/tool developed or in the 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?  

Approach

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

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

Environment

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

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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:

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 Advisory Council for Human Genome Research. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

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:

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:  

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:

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:

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.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-435-0714
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

David J. Miller, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6210
Email: BD2K_targeted@mail.nih.gov

Peer Review Contact(s)

Mark G. Caprara, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-613-5228
Email: capraramg@mail.nih.gov

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

Authority and Regulations

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


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