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 Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Library of Medicine (NLM)
National Institute on Minority Health and Health Disparities (NIMHD)
Fogarty International Center (FIC)
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Advancing Translational Sciences (NCATS)
Office of Behavioral and Social Sciences Research (OBSSR)

Funding Opportunity Title

Centers of Excellence for Big Data Computing in the Biomedical Sciences (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

New

Related Notices

  • July 25, 2013 - See Notice NOT-OD-13-094. Notice of Participation of the Office of Behavioral and Social Sciences Research(OBSSR).
  • Funding Opportunity Announcement (FOA) Number

    RFA-HG-13-009

    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; 93.839; 93.866; 93.273; 93.855; 93.856; 93.846; 93.286; 93.865; 93.279; 93.173; 93.121; 93.847; 93.113; 93.859; 93.242; 93.307; 93.853; 93.361; 93.879; 93.351; 93.350; 93.213; 93.393; 93.394; 93.395; 93.396; 93.397; 93.399; 93.867; 93.233; 93.837; 93.838

    Funding Opportunity Purpose

    Biomedical research is becoming more data-intensive as researchers are generating and using increasingly large, complex, and diverse data sets. This era of "Big Data" taxes the ability of biomedical researchers to locate, analyze, and interact with these data (and more generally all biomedical data) and associated software due to the lack of tools, accessibility, and training.  In response to these new challenges in biomedical research, NIH has developed the Big Data to Knowledge (BD2K) Initiative. Under this FOA, BD2K Centers of Excellence are sought to conduct research to advance the science and utility of Big Data in the context of biomedical and behavioral research, and to create innovative new approaches, methods, software, tools, and related resources.  The Centers will advance the ability of the biomedical research enterprise to use Big Data by producing tools and resources from early-stage to mature development that will be broadly useful to the research community.

    Key Dates
    Posted Date

    July 22, 2013

    Letter of Intent Due Date(s)

    October 20, 2013

    Application Due Date(s)

    November 20, 2013   

    AIDS Application Due Date(s)

    November 20, 2013 

    Scientific Merit Review

    March 2014

    Advisory Council Review

    May 2014

    Earliest Start Date

    July 2014

    Expiration Date

    November 21, 2013  

    Due Dates for E.O. 12372

    Not Applicable

    Required Application Instructions

    It is critical that applicants follow the instructions in the PHS 398 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. While some links are provided, 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.

    Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

    Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of 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, 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, yet the ability to release data and to locate, integrate, and analyze data generated by others, as well as the software associated with the data, are often limited by the lack of tools, accessibility, and training.  (“Big Data” as addressed by the BD2K Initiative is defined in the Background Section.)  

    BD2K Centers of Excellence will address these issues by developing new approaches, methods, software, tools, and related resources and by providing training to advance Big Data science in the context of biomedical research.  BD2K Centers are expected to be large-scale efforts that take on challenges that are not feasible to address with the standard R01 grant. The Centers will form a BD2K Center Consortium, in which each is required to interact and collaborate with other centers in the consortium.  They are also encouraged to interact and collaborate with other domestic or international efforts in Big Data science.  The BD2K Centers will work in areas spanning Big Data science, producing tools and resources from early-stage to mature development for the biomedical research community.  BD2K Centers will not be supported to generate large sets of new data or to establish central comprehensive databases.  Although the research and the approaches, methods, software, tools, and related resources they develop will focus on specific biomedical research questions, the results and products of the BD2K Centers should be useful beyond those questions and be generalizable to meet the needs of the broader biomedical research community.

    Background

    The long-term goal of the BD2K Initiative is to support the advances in data science, other quantitative sciences, policy, and training that are needed for the effective use of Big Data in biomedical research.  (In this document, the term “biomedical” will be used in the broadest sense to include biological, biomedical, behavioral, social, environmental, and clinical studies that relate to understanding health and disease.)  While the biomedical research enterprise is producing increasingly large amounts of digital data, it has not yet fully capitalized on the transformative opportunities that these data provide.  As stated by the Data and Informatics Working Group (DIWG) of the Advisory Committee to the NIH Director, "Colossal changes in biomedical research technologies and methods have shifted the bottleneck in scientific productivity from data production to data management, communication, and interpretation." (http://acd.od.nih.gov/Data%20and%20Informatics%20Working%20Group%20Report.pdf).

    In this context, the term "Big Data" is meant to capture the opportunities and address the challenges facing all biomedical researchers in releasing, accessing, managing, analyzing, and integrating datasets of diverse data types.  Such data types may include imaging, phenotypic, molecular (including –omics), clinical, behavioral, environmental, and many other types of biological and biomedical data.  They may also include data generated for other purposes (e.g., social media, search histories, and cell phone data).  The datasets are increasingly larger and more complex, and exceed the abilities of currently-used approaches to manage and analyze them.  Biomedical Big Data primarily emanate from three sources: 1) a few groups that produce very large amounts of data, usually as part of projects specifically funded to produce important resources for the research community; 2) individual investigators who produce large datasets for their own projects, which might be broadly useful to the research community; and 3) an even greater number of investigators who each produce small datasets whose value can be amplified by aggregating or integrating them with other data.

    The major challenges to using biomedical Big Data include:

    Locating data and software tools:  Investigators need straightforward means of knowing what datasets and software tools are available and where to obtain them, along with descriptions of each dataset or tool.  Ideally, this would include all published and resource datasets and software tools, both basic and clinical, and, to the extent possible, even unpublished or proprietary data and software.

    Gaining access to data and software tools:  Investigators need straightforward means for 1) releasing datasets and metadata in standard formats; 2) obtaining access to specific datasets or portions of datasets; 3) studying datasets with the appropriate software tools in suitable environments; and 4) obtaining analyzed datasets.

    Standardizing data and metadata:  Investigators need data to be in standard formats to facilitate interoperability, data sharing, and the use of tools to manage and analyze the data.  The datasets need to be described by standard metadata to allow novel uses as well as reuse and integration. 

    Extending policies and practices for data and software sharing:  While significant progress has been made, broad and rapid sharing of data and software is not yet the norm in all areas of biomedical research.  Establishing effective data- and software-sharing practices requires appropriate policies, changes in the research culture, recognition of the contributions made by data and software generators, and technical innovations.  Validation of software to ensure quality, reproducibility, provenance, and interoperability is essential.

    Organizing, managing, and processing biomedical Big Data:  Investigators need biomedical data to be organized and managed in a robust way that allows them to be fully used; currently, most data are not sufficiently well organized.  Barriers exist to releasing, transferring, storing, and retrieving large amounts of data.  Research is needed to design innovative approaches and effective software tools for organizing biomedical Big Data for data integration and sharing while protecting human subject privacy.

    Developing new methods for analyzing biomedical Big Data:  The size, complexity, and multidimensional nature of many datasets make data analysis extremely challenging.  Substantial research is needed for developing new methods and software tools for analyzing such large, complex, and multidimensional datasets.  User-friendly data workflow platforms and visualization tools are also needed to facilitate the analysis of Big Data.

    Training researchers for analyzing and for designing tools for analyzing biomedical Big Data effectively:  The challenges of biomedical Big Data are multifaceted.  Advances in biomedical sciences using Big Data will require more scientists with the appropriate data science expertise and skills, including those in many quantitative science areas such as computational biology, biomedical informatics, biostatistics, and related areas.  Users of Big Data software tools and resources must be trained to use them well.

    NIH is implementing the BD2K Initiative in the context of its broader activities in the areas of computational biology and biomedical informatics.  In the last decade, stimulated by the publication of the report on the Biomedical Information Science and Technology (BISTI) Initiative (Smarr and Botstein, 1999 [http://www.bisti.nih.gov/library/june_1999_Rpt.asp]), NIH has provided substantial funding in computational biology and biomedical informatics, ranging from individual research grants under the BISTI Program to the National Centers for Biomedical Computing [http://www.ncbcs.org], supported by individual NIH Institutes and Centers as well as by the NIH Common Fund.  Substantial resources have also been committed to training programs for the next generation of biomedical computational scientists.  The BD2K Initiative will not supplant, but rather will build on, ongoing efforts at NIH to support additional research in computational biology and biomedical informatics that specifically address the challenges and needs in Big Data science.  BD2K will implement new lines of research directed at gaining the full value of the Big Data that have been, and increasingly will be, generated in biomedical research.

    The following list, which is not intended to be comprehensive, describes examples of activities that this BD2K Center FOA aims to support to achieve the goal of facilitating the use of Big Data in biomedical research:

    As a result of BD2K and other efforts at NIH, it is envisaged that the future will be one in which 1) any biomedical research project is associated with the datasets it created for their useful lifetimes, and the data are findable and citable; 2) all of these data are organized, are described by appropriate metadata, and can be integrated with other data; and 3) essentially all of these data and the necessary software tools are available to and usable by the entire biomedical research community.

    Research Objectives of the BD2K Center Program

    A. Scientific Objectives 

    This FOA solicits applications for Centers of Excellence for Big Data Computing in the Biomedical Sciences (U54).  Each BD2K Center award will support a multi-investigator, interdisciplinary team working collaboratively to develop innovative approaches to address a major challenge to the effective use of Big Data for a broad and important biomedical research problem(s).  (As noted, the term “biomedical” is being used here in the broadest sense to include biological, biomedical, behavioral, social, environmental, and clinical studies that relate to understanding health and disease.)  The center grant activity code is being used for this FOA to solicit research projects that could not be achieved by smaller and more limited activity codes (other BD2K FOAs will be issued to solicit single investigator-initiated projects).  A BD2K Center application is expected to propose the development of specific and substantive “products” -- e.g., approaches, methods, software, tools, and other resources to analyze data -- and then distribute the products to the user community to dramatically enhance the research community's capabilities for using Big Data in biomedical research.  In addition, by training young and established investigators, the BD2K Centers will contribute, along with other BD2K programs, to the expansion of the pool of researchers who are able to use and develop methods to work with Big Data in biomedical research.

    The range of opportunities that is opened up by the growing capabilities for generating Big Data spans the gamut of biomedical sciences, and the challenges to making the benefits of Big Data available to all investigators are significant.  However, NIH is not expecting a single BD2K Center to address all areas and all needs of Big Data challenges. As noted by the Data and Informatics Working Group of the Advisory Committee to the NIH Director, there will be significant benefits from interactions among the BD2K Centers, since synergistic interactions among the Centers and between the Centers and the larger research community can result in an impact of the BD2K Center Program that is much broader than the sum of the individual Centers’ activities.  Therefore, BD2K Centers, once funded, will be expected to form a BD2K Center Consortium, within which each center is expected to interact and collaborate with other Centers in the consortium.  They are also encouraged to interact and collaborate with other domestic or international efforts in the science of Big Data outside the consortium.

    The primary research focus of a BD2K Center will be research and development in one or more areas that may include approaches, methods, software, tools, and other resources that enable data release, acquisition, storage, distribution, management (e.g., approaches for developing databases, data and metadata formats and standards, ontologies, and interoperability, etc.), processing, annotation, visualization, statistical and computational analysis, integration, simulation, and modeling.  The BD2K Centers should include diverse expertise and could involve investigators not only from the biomedical sciences, but also from the physical, quantitative, and related science disciplines that have developed cutting-edge approaches to address Big Data challenges.

    The methods and scientific results should be published, and the software, tools, and resources should be made available to the community.  Since the BD2K Centers will be NIH-funded through the current mechanism for a finite duration, the Centers should propose plans to ensure the continued distribution of the methods and software after the end of the NIH funding period.

    NIH would like the overall BD2K Center program to cover the following four areas of Big Data science, and encourages applicants to focus on one or more of them:

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

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

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

    4. Computer science and statistical approaches:  An applicant may propose a Center to explore research areas in the basic computational science of biomedical Big Data.  Examples include, but are not limited to:

    Examples:  A proposed Center should have one or more specific areas of focus, which it uses to develop approaches, methods, tools, and other resources to obtain new knowledge from Big Data datasets.  Examples of focus areas might include, but are not limited to:

    This list of examples is to emphasize that the BD2K Initiative, and the BD2K Center program within it, need to address scientific areas of interest across the entire NIH.

    BD2K Center Consortium:  The BD2K Centers will be funded as cooperative agreements to allow NIH to organize a BD2K Center Consortium within which all BD2K Centers will be expected to contribute and cooperate.  The Consortium will explore the possibilities for concerted action among a subset or all of the Centers that will contribute to the advancement of data science beyond the individual Centers.  For example, the Consortium could identify common issues, explore opportunities for synergy among the Centers, and identify areas of possible consensus that could form the basis for policy recommendations within the Consortium or in the broader use of Big Data.  All Centers will be expected to be early adopters of BD2K policies and practices (http://www.bd2k.nih.gov).

    B. Implementation of the Objectives of the BD2K Center Program

    A BD2K Center must engage in data science research in the context of biomedical research, dissemination, and training.  NIH is not specifying a particular organizational structure for a BD2K Center; each applicant should develop the structure that would best accomplish the proposed research and other center activities.  The application should describe a well-integrated plan to accomplish all of these goals successfully.

    A major feature of a BD2K Center is the integration of the overall Center -- its "centerness".  The research plan should be cohesive, and all of the parts of a Center should be integrated to address its Big Data focus, so that the whole Center is greater than the sum of its parts.

    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 staff will assist, guide, coordinate, or participate in project activities.

    Application Types Allowed

    New

    The OER Glossary and the PHS 398 Application Guide provide details on these application types.

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

    NIH intends to fund six to eight awards, corresponding to a total of up to $24 million, in Fiscal Year 2014.  Future year amounts will depend on annual appropriations.

    Award Budget

    The application budget may be up to $2 million direct costs per year, not including the F&A costs of subcontracts.

    Award Project Period

    The total project period for an application submitted in response to this funding opportunity may be up to four 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 not eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are  allowed.

    Required Registrations

    Applicant organizations must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

    All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least6 weeks prior to the application due date.

    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 PIs/PDs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 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. Address to Request Application Package

    Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

    2. Content and Form of Application Submission

    It is critical that applicants follow the instructions in the PHS 398 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.

    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 e-mail to:

    Ajay Pillai, Ph.D.
    Division of Genome Sciences
    National Human Genome Research Institute (NHGRI)
    301-496-7531
    Email: BD2KCenterRFA@mail.nih.gov

    Application Submission

    Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

    Center for Scientific Review
    National Institutes of Health
    6701 Rockledge Drive, Room 1040, MSC 7710
    Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
    Bethesda, MD 20817 (for express/courier service; non-USPS service)

    Page Limitations

    All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations for the Research Strategy section of each component of the application.

    Instructions for the Submission of Multi-Component Applications

    The following section supplements the instructions found in the PHS398 Application Guide, and should be used for preparing a multi-component application.

    The application must include all of the following components:

    Overall Component

    All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

    Face Page (Overall)

    All instructions in the PHS 398 Application Guide must be followed.

    Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Overall)

    All instructions in the PHS 398 Application Guide must be followed.

    Table of Contents (Overall)

    All instructions in the PHS 398 Application Guide must be followed.

    Detailed Budget for Initial Budget Period (Overall)

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions: Provide the total budget for the initial budget period for the entire Center application, by summing the individual budgets of each of the components (DSR, Training, Administration, and Consortium Activities, including sub-contracts); i.e., the budget presented in the Overall Component should be the cumulative budget for the entire BD2K Center.

    Budget for Entire Proposed Period of Support (Overall)

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  Provide the total budget for the entire proposed period of support for the entire Center application, by summing the individual budgets of each of the components (DSR, Training, Administration, and Consortium Activities, including sub-contracts); i.e., the budget presented in the Overall Component should be the cumulative budget for the entire BD2K Center.

    Biographical Sketch (Overall)

    All instructions in the PHS 398 Application Guide must be followed.

    Resources (Overall)

    All instructions in the PHS 398 Application Guide must be followed.

    Research Plan (Overall)

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

    Specific Aims: The Specific Aims for the Overall Component should be the overall vision for the Center.  These Specific Aims should not be the same as the specific aims of the other components, but should be overarching and at a high level.    

    Research Strategy: The Overall Component should provide a concise vision and proposed plan for the Center.  What Big Data problems are being addressed, what approaches, methods, software, and tools will be generated, who are the users, and how will the Center be useful?  The Overall Component should also include a concise description of the structure of the Center, including a brief management plan and organization chart.

    The Overall Component should explain how the components of the organization, including key personnel, will interact, why each is essential for accomplishing the overall Center goals, and how the organization of the components into a Center will create an entity that is greater than the sum of its parts in terms of generating results that will be important for the greater biomedical research community.

    Protection of Human Subjects: Any sections relating to Human Subjectsfor the entire application should be placed here. 

    Vertebrate Animals: Any sections relating to Vertebrate Animals for the entire application should be placed here. 

    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 PHS 398 Application Guide .  Applicants are instructed  to place the Resource Sharing Plan only in the Data Science Research Component.

    Data Science Research (DSR)

    All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

    Face Page (Data Science Research (DSR))

    All instructions in the PHS 398 Application Guide must be followed.

    Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Data Science Research (DSR))

    All instructions in the PHS 398 Application Guide must be followed.

    Table of Contents (Data Science Research (DSR))

    All instructions in the PHS 398 Application Guide must be followed.

    Detailed Budget for Initial Budget Period (Data Science Research (DSR))

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  Provide a budget that includes funds for the DSR activities.  Travel for scientific meetings and conferences, as well as DSR-specific travel, should be requested in this section.  A Center application may not request funds for large-scale data production or acquisition; however, a limited amount of funds may be requested for the production or acquisition of test datasets that are necessary for the proposed research and development.  Such test datasets may also be obtained from publicly available sources or collaborations.    

    Budget for Entire Proposed Period of Support (Data Science Research (DSR))

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  Provide a budget that includes funds for the DSR activities.  Travel for scientific meetings and conferences, as well as DSR-specific travel, should be requested in this section.  A Center application may not request funds for large-scale data production or acquisition; however, a limited amount of funds may be requested for the production or acquisition of test datasets that are necessary for the proposed research and development.  Such test datasets may also be obtained from publicly available sources or collaborations.

    Biographical Sketch (Data Science Research (DSR))

    All instructions in the PHS 398 Application Guide must be followed.  Include the biographical sketches for the DSR component lead(s) as well as others involved in the DSR activities.

    Resources (Data Science Research (DSR))

    All instructions in the PHS 398 Application Guide must be followed.  Describe all resources available for the DSR activities.

    Research Plan (Data Science Research (DSR))

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

    Specific Aims: This section should include the DSR Specific Aims.

    Research Strategy: Data science research is the major activity of a BD2K Center and should be the major part of the budget.  Projects should focus on innovative and high-impact computational and informatics approaches to advancing research in the use of Big Data in the context of biomedical research, as discussed in the Scientific Objectives section above.  The applicant should identify the research questions s/he proposes to address, and how these questions are related to important biomedical, translational, or clinical research problems. 

    Each application should contain a plan for validation of the scientific methods, approaches, software, tools, and related resources.  This plan should provide the organizing principles by which scientific validation will be conducted.  If appropriate, descriptions of software should also be accompanied by plans for hardening to enable widespread use.  The application should describe the different kinds of interfaces and functionality that apply to different stakeholder and user communities.

    The products of the Center are expected to be generalizable beyond the specific datasets used in development and, ideally, beyond the particular biomedical research area addressed by the Center’s research.  Thus, the applicant should discuss the generalizability of the proposed products of the Center and how they could be relevant to other datasets and Big Data opportunities.

    A major product of the Centers will be the software that they develop.  The software and tools should be freely available, appropriately documented, and developed in such a way that they can be turned into professional-grade software and tools.  The Centers should (i) provide tools and resources to users, and (ii) as appropriate, provide software environments where users/developers can contribute their own software, ontologies, and standards.  As appropriate, applicants should also describe data and software management and provenance, software development and testing practices, software toolkit development and deployment, application programming interfaces (APIs), and human subject data privacy and security protections.

    Applications are expected to contain plans, as appropriate, to include user feedback in the development of tools, to train intended users to use the tools, and to assess the impact of their use.  Centers should plan to accept improvements to their software from the community.  Users may be basic, translational, or clinical biomedical researchers, experimental scientists, behavioral scientists, social scientists, clinicians, software developers, or computational scientists.

    Databases and Software:  Development of comprehensive central databases for particular data types is not within the scope of this FOA, although an applicant may propose the development of one or more limited databases for research and validation of the approaches, methods, software, tools, or related resources being developed in the project.  Putting existing databases in a newly proposed knowledge/research commons, or extending existing knowledge/research commons to data types beyond currently supported databases would be within scope.  Research groups may develop their own local databases to meet their computational needs.  As appropriate, Centers may develop professional-grade software development environments and repositories.

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

    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 PHS 398 Application Guide, with the following modifications: 

    The resource sharing plan for the DSR Component should cover all the activities of the Center.  .  Program staff may negotiate modifications to these plans prior to funding.

    Consistent with achieving the goals of the program, NIH expects that the project datasets (genotypic, molecular, phenotypic, behavioral, environmental, covariate, and other relevant data) will be widely shared with the scientific community for research, as much as possible.  At the same time, since data privacy is particularly important for the BD2K Initiative, applicants should carefully observe standards of patient privacy, confidentiality, and management of health information.  One of the major objectives of the BD2K Initiative is to address both data sharing and subject privacy. 

    Specific Plan for Sharing Software:  A software dissemination plan, with appropriate timelines, is expected in the application.  There is no prescribed single license for software produced in this project; however, reviewers will be asked to evaluate the software sharing and dissemination plan based on its likely impact. A dissemination plan guided by the following principles is thought to promote the largest impact:

    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 should also 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 outside the Center and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with the Center.  An applicant should take responsibility for creating the original and subsequent “official” versions of a piece of software.

    5.  Given the long-term goals of this initiative to create software and tools for data science research that will serve as a resource to biomedical researchers across the nation, applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others.  This proposal may include a plan to incorporate the enhancements into the “official” core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

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

    Training

    All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

    Face Page (Training)

    All instructions in the PHS 398 Application Guide must be followed.

    Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Core or Project)

    All instructions in the PHS 398 Application Guide must be followed.

    Table of Contents (Training)

    All instructions in the PHS 398 Application Guide must be followed.

    Detailed Budget for Initial Budget Period (Training)

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  Provide a budget that includes funds for the Training activities.  Travel for training meetings, as well as Training-specific travel, should be requested in this section.

    Budget for Entire Proposed Period of Support (Training)

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  Provide a budget that includes funds for the Training activities.  Travel for training meetings, as well as Training-specific travel, should be requested in this section.

    Biographical Sketch (Training)

    All instructions in the PHS 398 Application Guide must be followed.  Include the biographical sketches for the Training component lead(s) as well as others involved in the Training activities.

    Resources (Training)

    All instructions in the PHS 398 Application Guide must be followed.  Describe all resources available for the Training activities.

    Research Plan (Training)

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

    Specific Aims: This section should include the Specific Aims of the Training component.

    Research Strategy: As a major component of the BD2K Initiative, the BD2K Center Program is expected to contribute to the initiative’s training objectives by taking advantage of the unique environment of each Center.  Each Center is expected to propose training activities in the skills and approaches needed for Big Data research.  Training may be tailored to 1) data scientists (including informaticians and computational and quantitative scientists) who wish to apply their skills and knowledge in the biomedical sciences, or 2) biomedical scientists who wish to gain the requisite knowledge and skills to access, organize, analyze, and integrate large and complex datasets. 

    BD2K Centers are expected to promote training through the broad, effective dissemination of the approaches, methods, software, tools, and related resources they develop.  Any of a variety of approaches to the training of the user communities may be proposed.  Examples of acceptable training activities include short courses offered at the Center, workshops and demonstrations at scientific meetings, on-line tutorials, development and sharing of Big Data use cases, integration of Big Data skills into core curricula, and standard or innovative uses of the Center’s web site.  The application should explain the plans for dissemination of the approaches, methods, software, tools, related resources, and associated documentation.

    In addition, applicants may propose any of a variety of training activities for all professional levels from graduate student training at the Master’s or Ph.D. levels to established-investigator level.  Opportunities are encouraged to promote the careers of new and early-stage investigators and the careers of computational professionals who may choose not to be independent biomedical science investigators.  Both the use and adaptation of existing training programs, as well as the development of innovative approaches to training in the skills necessary to do research in the area of Big Data science or in the use of Big Data, are encouraged.  Investigators are encouraged to share training methods and materials with other Centers as well as the broader community.

    The BD2K Initiative will also have separate announcements of special programs for other training activities; interested applicants are encouraged to visit the portal for updates (http://www.bd2k.nih.gov).

    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 PHS 398 Application Guide.  Applicants are instructed to place the Resource Sharing Plan only in the Data Science Researach Component.

    Administration

    All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

    Face Page (Administration)

    All instructions in the PHS 398 Application Guide must be followed.

    Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Administration)

    All instructions in the PHS 398 Application Guide must be followed.

    Table of Contents (Administration)

    All instructions in the PHS 398 Application Guide must be followed.

    Detailed Budget for Initial Budget Period (Administration)

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  Provide a budget that includes funds for the Administration activities.  Travel for Administration-specific activities should be requested in this section. 

    Budget for Entire Proposed Period of Support (Administration)

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  Provide a budget that includes funds for the Administration activities.  Travel for Administration-specific activities should be requested in this section.

    Center Director’s effort:  The Center Director (PD/PI) should be the overall lead of the Administration component. The scientific and managerial complexity of a BD2K Center will require a substantial amount of the PD/PI's effort to be successful. The Center Director may participate in multiple center awards under this FOA, but cannot serve as PD/PI on more than one active BD2K Center award.  The PD/PI of a Center grant must commit a minimum effort of 3.6 months per year to the overall Center distributed across all components; if there are multiple PDs/PIs, then one must commit at least 3.6 months per year and the others must commit at least 2.4 months per year to the Center distributed across all components.

    Biographical Sketch (Administration)

    All instructions in the PHS 398 Application Guide must be followed.  Include the biographical sketches for the PI(s)/PD(s) as well as others involved in the Administration activities.

    Resources (Administration)

    All instructions in the PHS 398 Application Guide must be followed.  Describe all resources available for the Administration activities.

    Institutional commitment:  A strong institutional commitment is encouraged, and should be described if provided.  The commitment may include faculty appointments, partial salary support for investigators, purchase of research equipment, and assignment of research space to support the research and facilitate collaboration and interdisciplinary interaction. 

    Research Plan (Administration)

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

    Specific Aims: This section should include the Specific Aims of the Administration component.

    Research Strategy: The Research Strategy of the Administration component should include the following information.

    Administrative Plan: The application should describe the management and integration of activities in the Center. Applicants should specify appropriate administrative/business management staff, as well as the oversight mechanisms that will be used by the Center Director (PD/PI), any Center Co-Directors, and any other relevant key personnel.  If multiple geographic sites are involved in the proposed Center, the Administrative Plan should describe the leadership and communication plans to manage the multiple sites.  The applicant should describe the proposed Center structure and the application may include an organizational chart.

    External advisory committee:  The applicant may request funds to support an external advisory committee that will advise the PD/PI about the Center’s activities and monitor progress. If included, the Administrative Plan should describe the types of expertise that would be on this committee, although the application should not name specific individuals. The application should describe how the committee would function, and how its advice would be implemented.

    Assessment of Progress:  The Administrative Plan should describe a set of milestones or defined objectives that the PD/PI and NIH staff can use for annual assessments of whether the proposed research and other activities of the Center are progressing appropriately toward the goals of the Center.  NIH recognizes that some basic research accomplishments may not be easily quantifiable; thus, the PD/PI should propose appropriate criteria to measure the progress of the research.  The proposed milestones or objectives for the out-years may be less detailed than those for the first year of the project.  Since the award uses the Cooperative Agreement mechanism, a set of Center milestones or objectives will be negotiated with program staff prior to the award.  Similarly, a set of consortium milestones or objectives will be negotiated after the award.  Progress toward the milestones or objectives should be reported annually, and the milestones will be reconsidered, and renegotiated if necessary, as part of the annual non-competing continuation application (Type 5) process.  The list of Center milestones or objectives should be limited to two pages.

    Evaluation:  The Administrative Plan should include a plan for evaluating the quality and utility of the Center products and training.  Criteria of evaluation for Center products may include adequacy, trustworthiness, authenticity, integrity, availability, documentation, and transparency.  Specific examples of evaluative information could include tracking the number of users, background/training of the users, requests for services, successful use of the Center products, publications citing uses, number of students, use of training materials, the ability to extend the utility of tools through collaborations with other Centers, etc.  The research community being served will have expectations that could be documented through mechanisms such as user feedback, letters of support, etc.  There should be evaluative measures for both short-term and long-term outcomes.  Quantifiable measures of intermediate results and success are important and should be built in as:

    Infrastructure:  Big Data research requires the appropriate computer, data storage, and networking infrastructure resources.  The application should describe the infrastructure resources that are available, to be obtained, or will be developed during the award, and justify how these resources will be used to support the research at the host institution as well as the biomedical research community. 

    Core facilities or shared resources are not required, but if requested, they should be described and justified adequately, particularly their management and service to the research project as well as to the biomedical research community.

    Sustained distribution of Center products:  The application should describe a plan for the continued maintenance and distribution of the software and tools beyond the funding period.

    Website: The application should describe the plans to establish and maintain a website to communicate the Center’s mission, describe the availability of resources and other products of the Center, and disseminate training information.  One of the initial Consortium activities will be creating a BD2K Center Consortium website/portal to disseminate the products and activities of all the BD2K Centers.  This will be the main portal to communicate with the wider community.  Each Center should plan to contribute to the development and maintenance of this resource.

    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 PHS 398 Application Guide.  Applicants are instructed to place the Resource Sharing Plan only in the Data Science Researach Component.

    BD2K Center Consortium Activities

    All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

    Face Page (BD2K Center Consortium Activities)

    All instructions in the PHS 398 Application Guide must be followed.

    Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (BD2K Center Consortium Activities)

    All instructions in the PHS 398 Application Guide must be followed.

    Table of Contents (BD2K Center Consortium Activities)

    All instructions in the PHS 398 Application Guide must be followed.

    Detailed Budget for Initial Budget Period (BD2K Center Consortium Activities)

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:   Provide a budget that includes funds for the Consortium activities.  Travel for Consortium-specific activities should be requested in this section.  For planning, the travel budget should include funds for the PD(s)/PI(s) and other personnel (up to five travelers total) to attend one BD2K Center Consortium meeting in Bethesda, and for the PD(s)/PI(s) and other personnel (up to two travelers total per meeting) to attend two additional Steering Committee meetings, one on the East Coast and one on the West Coast. Applicants should include a plan for collaborative activities within the BD2K Center program, and may request up to $200,000 direct costs per year for this purpose.  Some staff may need to visit other Centers for collaborative activities, and such travel should be in the budget request.   

    Budget for Entire Proposed Period of Support (BD2K Center Consortium Activities)

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:  Provide a budget that includes funds for the Consortium activities.  Travel for Consortium-specific activities should be requested in this section.  For planning, the travel budget should include funds for the PD(s)/PI(s) and other personnel (up to five travelers total) to attend one BD2K Center Consortium meeting a year in Bethesda, and for the PD(s)/PI(s) and other personnel (up to two travelers total per meeting) to attend two additional Steering Committee meetings per year, one on the East Coast and one on the West Coast.  Applicants should include a plan for collaborative activities within the BD2K Center program, and may request up to $200,000 direct costs per year for this purpose.  Some staff may need to visit other Centers for collaborative activities, and such travel should be in the budget reques

    Biographical Sketch (BD2K Center Consortium Activities)

    All instructions in the PHS 398 Application Guide must be followed.  Include the biographical sketches for the PI(s)/PD(s) as well as others involved in the Consortium activities.

    Resources (BD2K Center Consortium Activities)

    All instructions in the PHS 398 Application Guide must be followed.  Describe all resources available for the Consortium activities.

    Research Plan (BD2K Center Consortium Activities)

    All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

    Specific Aims: This section should include of the Specific Aims of the BD2K Center Consortium component.

    Research Strategy: The applicant should state his/her willingness to participate in the BD2K Center Consortium and to agree to any policies that the Consortium Steering Committee may decide on, consistent with NIH policies, laws, and regulations.

    The Consortium is a major component of the BD2K Center program, and success in this component will be important for achieving the goals of the overall BD2K Initiative.  Since the members of the Consortium will not be known when the application is written, NIH understands that the applicant may not be able to provide collaborative activity plans in detail.  Instead, the applicant should discuss the general approaches s/he would take in intra-Consortium projects, including suggestions for efforts that would be valuable for the overall goals of the BD2K Initiative.  The final plan for Consortium collaborative activity may be modified, after funding, from the proposed plan.  In addition, it is expected that Consortium milestones or objectives will be negotiated after the award is made.  Some collaborative activities can be adjusted or added after the Consortium is established.  NIH program staff will provide approval for collaborative activities in consultation with the Steering Committee and the Independent Experts Committee.

    Investigators may propose interaction and collaboration with industry as appropriate for their research plan, as long as there is no constraint on access to data and tools for the academic research community.

    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 PHS 398 Application Guide.  Applicants are instructed to place the Resource Sharing Plan only in the Data Science Researach Component.

    Appendix for the Entire Application

    Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide, with the following modification:

    Applicants may submit CDs or DVDs as appendix material to illustrate dynamic imaging or computational programs that do not convey well on paper.

    Foreign Institutions

    Foreign (non-U.S.) Institutions (as subcontracts) must follow policies described in the NIH Grants Policy Statement and procedures for foreign institutions described throughout the PHS 398 Application Guide.

    3. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates. 

    Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

    Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

    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 received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

    Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the NIH BD2K Project Team.  Applications that are incomplete or nonresponsive will not be reviewed.  

    Applicant Information Webinar

    An Applicant Information Webinar will be held on Thursday, September 12, 2013, from 3 – 4:30 pm EDT, to provide information about the FOA to prospective applicants.  NIH staff will provide an overview of the FOA and answer questions.  The webinar is open to all prospective applicants.  Participation in the teleconference is not a prerequisite for applying, and is not required for a successful application.  Information about how to participate in the webinar will be posted at http://www.bd2k.nih.gov.  Potential applicants are encouraged to submit their questions or comments to BD2KCenterRFA@mail.nih.gov prior to the meeting.  Afterwards, the webinar slides and a summary of the questions and answers will be posted on the same site.  NIH will also post a list of Frequently Asked Questions (FAQs) and answers; this information may be updated without additional notice.

    Post-Submission Materials

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

    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.

    Reviewers will provide an impact score for each component of the Center (Overall, Data Science Research (DSR), Training, Administration, and BD2K Center Consortium Activities).  The impact score of the Overall Component is the impact score of the entire application.  Reviewers will  provide individual criterion scores for the Overall Component, but not for the other components.  They will also provide written critiques for all the components of the application.

    The Overall Component impact score will reflect a) the overall effectiveness and innovativeness of the approaches, methods, software, tools, and related resources in enabling basic and translational research using Big Data; b) the scientific merit of the specific DSR projects, including the potential generalizability of the results of the research program to other areas of biomedical research; c) the merit of the training plans; d) the qualifications of the Center Director and other staff; e) the quality of the plans for management and oversight of the Center; f) the adequacy of plans for the release of data, methods, software, tools, related resources, and associated documentation; g) the synergy among the components; h) the proposed contribution to the Consortium activities; and i) the overall impact of the Center.  The overall impact score for the Center application may be higher or lower than the average of the individual components based on assessment of whether the whole is greater than the sum of its components.

    Overall Impact - Overall

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center proposed).

    Scored Review Criteria - Overall

    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.

    Significance

    Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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?  Has the applicant proposed research and development that will improve the application of the science of Big Data beyond the specific areas studied?

    Investigator(s)

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

    Innovation

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

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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 Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  Do the new approaches, methods, software, tools, and related resources have the potential to be further developed for broader applicability?  Has the applicant provided appropriate plans for scientific validation of the research, software, and tools?  Has the applicant provided a viable approach to engaging user feedback on the development and hardening of software and tools?  Are the plans for the use of standards for data and metadata appropriate for this field? Are the plans for training adequate?  Are the plans for participation in the BD2K Center Consortium adequate?

    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?    

    Integration of the U54 Center (Overall)

    Will the program function as a true integrated “Center” rather than as a collection of unrelated research projects and support services?  Will the whole Center be greater than the sum of its individual components? Do coordination and integration among the proposed components reflect a cohesive research program?

    Additional Review Criteria - Overall

    As applicable for the Center 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 Human Subjects Protection and Inclusion Guidelines.

    Inclusion of Women, Minorities, and Children 

    When the proposed Center involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

    Not Applicable

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Additional Review Considerations - Overall

    As applicable for the Center 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; 3) Genome Wide Association Studies (GWAS), and 4) Software Sharing Plan.

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) 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 and 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 Center Consortium

    Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2 "Award Administration Information".

    The BD2K Initiative:  This is the set of programs developed by NIH to deal with the special opportunities related to Big Data.  The BD2K Center Program is the specific opportunity for cooperative agreement Center awards.  The BD2K Initiative is described in the portal http://www.bd2k.nih.gov.

    The BD2K Centers Consortium:  This includes the set of funded Center awards and NIH BD2K Project Team staff.

    Steering Committee (SC):  This is the primary forum of the BD2K Center Consortium.  The PI(s)/PD(s) of the awards and the NIH Lead Science Officers serve on the Steering Committee.  See further details about the Steering Committee under Terms and Conditions Section VI.2.

    Independent Experts Committee (IEC): This will be composed of senior scientists with relevant expertise who are not PI(s)/PD(s) or supported by an award in the BD2K Initiative.  NIH will appoint the members.  The IEC will be responsible for evaluating the progress of the BD2K Initiative, including the BD2K Center Program.  See more about the IEC under the Terms and Conditions Section VI.2.

    NIH BD2K Project Team (BPT):  This will serve as the trans-NIH group that provides coordination for, and management and oversight of, the BD2K Initiative.  The Project Team membership will include representatives from NIH Institute and Center program staff.  The Project Team will receive recommendations from the Steering Committee and the Independent Experts Committee.  Project Team approval will be required for adoption of Steering Committee recommendations and for the initiation of collaborative projects within the Consortium.  The Project Team will report to the NIH Associate Director for Data Science.

    The BD2K Center Consortium will rely on collegial and cooperative interactions among its members, and with other initiatives that may emerge. 

    Each year there will be a BD2K Center Consortium Meeting, which will be held back-to-back with a meeting of the Independent Experts Committee.  Each Center will present its research findings at this meeting.  There will also be two Steering Committee meetings per year.

    The PD(s)/PI(s) will have the primary responsibility for:

    NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

    Areas of Joint Responsibility include:

    The Steering Committee is responsible for coordinating the activities of the BD2K Centers and is the committee through which the BD2K Project Team formally interacts with the BD2K Center Consortium.  Steering Committee membership will include the PI of each Center (limited to one person for a Center with multiple PIs) and the NIH Lead Scientific Officer for each Center award.  Each member will have one vote.  The Steering Committee Chair will not be an NIH staff member but will be appointed by the NIH BD2K Project Team.  The Steering Committee may add additional members.  NIH BD2K Project Team members may attend SC meetings as non-voting members.  Other government staff may attend the SC meetings, if their expertise is required for specific discussions.  The Steering Committee may set up subcommittees, including BD2K Center staff, NIH Program Staff, and other appropriate experts as needed.

    The Steering Committee will:

    The Independent Experts Committee (IEC) will be responsible for reviewing and evaluating the progress of the BD2K Initiative, including the BD2K Center Consortium.  The IEC will report to the NIH BD2K Project Team.  The IEC will also, as appropriate and at the Project Team’s request, advise NIH about the progress of the individual BD2K Centers in meeting their individual and consortium goals and milestones or objectives.  The IEC will be composed of 6-8 senior non-federal scientists who are not directly involved in the activities of the BD2K Initiative.  NIH will appoint members to the IEC and select one member as chair.  The BD2K Program Officers, Science Officers, Project Team, and other NIH Program Staff may attend the IEC meetings as non-voting participants.

    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 will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. 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 DHHS regulation 45 CFR Part 16.

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.  In addition to the usual progress report, investigators are asked to provide two-page descriptions of two science highlights, including graphics that describe outstanding achievments of the Center in the past year. Progress toward the milestones or objectives should be reported annually, and the milestones will be reconsidered, and renegotiated if necessary, as part of the annual non-competing continuation process.

    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

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

    eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
    TTY: 301-451-5939
    Email: commons@od.nih.gov

    Scientific/Research Contact(s)

    Peter Lyster, Ph.D.
    Division of Biomedical Technology, Bioinformatics, and Computational Biology
    National Institute of General Medical Sciences (NIGMS)
    Telephone: 301-594-3928
    Email:  BD2KCenterRFA@mail.nih.gov 

    Lisa Brooks, Ph.D.
    Division of Genome Sciences
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-435-5544
    Email: BD2KCenterRFA@mail.nih.gov 

    Peer Review Contact(s)

    Raymond Jacobson  
    Division of Basic and Integrative Biological Sciences
    Center for Scientific Review (CSR)
    Telephone: 301-996-7702
    Email: BD2KCenterRFA@mail.nih.gov 

    Financial/Grants Management Contact(s)

    Ms. Lori Burge
    Grants Management Officer
    National Institute of General Medical Sciences (NIGMS)
    Telephone: 301-451-3781
    Email:  BD2KCenterRFA@mail.nih.gov  v

    Ms. Cheryl Chick
    Grants Administration Branch
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-435-7858
    Email: BD2KCenterRFA@mail.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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