Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Heart, Lung, and Blood Institute (NHLBI) National Human Genome Research Institute (NHGRI) 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) National Institute on Deafness and Other Communication Disorders (NIDCD) 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 Neurological Disorders and Stroke (NINDS) National Institute on Minority Health and Health Disparities (NIMHD) National Library of Medicine (NLM) Office of Strategic Coordination (Common Fund) National Cancer Institute (NCI)
Funding Opportunity Title	Development of an NIH BD2K Data Discovery Index Coordination Consortium (U24)
Activity Code	U24 Resource-Related Research Projects Cooperative Agreements
Announcement Type	New
Related Notices	February 21, 2014 - See Notice NOT-HG-14-024. The purpose of this Notice is to inform the scientific community of new FAQs. January 10, 2014 - See Notice NOT-GM-14-101. Notice of National Institute of General Medical Sciences (NIGMS) Participation. January 2, 2014 - See Notice NOT-CA-14-019. Notice of National Cancer Institute (NCI) Participation.
Funding Opportunity Announcement (FOA) Number	RFA-HL-14-031
Companion Funding Opportunity	none
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.837; 93.172; 93.855; 93.856; 93.273; 93.846; 93.847; 93.310; 93.279; 93.113; 93.173; 93.307; 93.853; 93.879; 93.286; 93.393
Funding Opportunity Purpose	The purpose of this Funding Opportunity Announcement (FOA) is to create a consortium to begin development of an NIH Data Discovery Index (DDI) to allow discovery, access, and citation of biomedical data. As part of the NIH Big Data to Knowledge (BD2K) initiative, the DDI seeks to fulfill the recommendation from the Data and Informatics Working Group (DIWG) report to the Advisory Council of the Director (http://acd.od.nih.gov/06142012_DIWG_ExecSummary.pdf) to "Promote Data Sharing Through Central and Federated Catalogues." The awardee in response to this FOA will constitute a DDI Coordination Consortium (DDICC, U24) to conduct outreach, fund small pilot projects, manage communication with stakeholders, constitute and coordinate Task Forces to study relevant questions related to access, discoverability, citation for all biomedical data and assure community engagement in the development, testing and validation of an NIH DDI. Part of this effort will be to assemble a user interface (website) through which the results of development and testing of models for an NIH DDI may be communicated. It is anticipated that a successful DDICC will work with the NIH to overcome obstacles in the way of better use and application of biomedical big data by developing a working concept for a DDI.

Posted Date	December 13, 2013
Open Date (Earliest Submission Date)	February 6, 2014
Letter of Intent Due Date(s)	February 6, 2014
Application Due Date(s)	March 6, 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	June 2014
Advisory Council Review	August 2014
Earliest Start Date	September 2014
Expiration Date	March 7, 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.

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

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 software associated with the data is often limited by the lack of tools, accessibility, and training.

(http://acd.od.nih.gov/Data%20and%20Informatics%20Working%20Group%20Report.pdf)

The mission of the National Institutes of Health (NIH) is to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce illness and disability. NIH was founded on the enduring premise that public investment in biomedical science yields new knowledge that benefits the public. To assure this outcome publicly-funded science should generate data that is publicly available whenever feasible and that greater sharing of data will accelerate scientific inquiry and discovery. Thus, society receives a great benefit from its investment in research. Biomedical research is witnessing a very large increase in the amounts of data generated from measurements on living systems. Ever-increasing quantities of data in many forms, from multi-'omics, to phenotypic, imaging, behavioral, and clinical research projects and trials, are emerging from NIH funded research. Despite our great efficiency at generating new data, effective sharing of the data is constrained by challenges in data discovery and annotation. However, effective use of these data has the potential to revolutionize biomedical research and discovery and improve the next generation health care in the U.S. if we can effectively address the challenges of finding, accessing, and converting into knowledge.

As a research sponsor, a steward of the peer-review process for awarding research funding, and the major public library for access to research publications and data, the NIH has a unique opportunity to create a pathway for improved access to biomedical data as the agency has done for access to the journal publications themselves. Facilitating easier discovery and access to existing data should help researchers determine when new data must be generated and when data exists and may be re-used in the same or different contexts (when possible and appropriate). Currently, even with the vast riches of available data, life scientists typically approach a new project by determining how to procure their samples, collecting discrete new data around a narrow focus, and largely analyzing those data in isolation. Data discovery remains challenging despite the burgeoning number of biomedical databases (e.g. the annual Nucleic Acids Research (Journal) update lists over 1500 databases). Even well-established databases, such as the NCBI’s Gene Expression Omnibus (GEO) that has nearly one million datasets freely available, are underutilized (http://nar.oxfordjournals.org/content/41/D1/D1.abstract). The obstacles to finding data resources paradoxically makes it easier for researchers to obtain scientific funding to re-collect data rather than to use existing data to develop a well-reasoned hypothesis that can be tested with targeted follow-up experiments. In times of constrained research funding, enabling data discovery could help keep research and discovery active and thriving, avoid duplication of effort, and ensure that research funding is maximally useful, in terms of new discoveries, useful data sets, and publications.

This FOA is an attempt to address the problems of discoverability and citability of data, which were identified in the 2012 report of the Data and Informatics Working Group (DIWG) of the NIH Advisory Committee to the Director as fundamental challenges that impede the dramatic potential of data re-use (http://acd.od.nih.gov/06142012_DIWG_ExecSummary.pdf). First and foremost there is no easy query or search infrastructure that can help identify the presence and availability of relevant data sets. Currently data may be found in an increasing number and variety of different repositories or web sites, when it is available at all. Journal publications present primary results and knowledge derived from these data measurements, but rarely allow for an easily searchable means for identification of and access to the underlying data. Second, the value of data sets derives in part from their continued usefulness, which is difficult to ascertain if there is not a reliable method for researchers to cite data that they re-use. Improved data citation may help incentivize data sharing, as it could enable researchers getting professional recognition for data sharing as well as for journal publications. As noted in the 2012 DIWG report, not only is there a lack of technical infrastructure for NIH-funded researchers to easily submit datasets associated with their work, there is a lack of incentives to do so. "There is little motivation to share data, since the most common current unit of academic credit is co-authorship in the peer-reviewed literature. Moreover, promotion and tenure in academic health centers seldom includes specific recognition of data sharing outside of the construct of co-authorship on scientific publications."

Among the actions recommended by the DIWG was the creation of a new technical infrastructure in the form of catalogs and tools to facilitate data sharing (Recommendation 1b): "The NIH should create and maintain a centralized catalog for data sharing. The catalog should include data appendices to facilitate searches, be linked to the published literature from NIH-funded research, and include the associated minimal metadata as defined in the metadata framework to be established." A recent NIH BD2K workshop (NIH Data Catalog Workshop, August 21-22, 2013; http://bd2k.nih.gov/pdf/DDI_Workshop_summary.pdf) to consider the concept of a data catalog concluded that there is need to enhance discoverability of data through (e.g.) the development of pointers to relevant data, employing simplified vocabularies to access data by means of basic metadata. An NIH Data Discovery Index (DDI) was proposed to promote more effective data sharing and collaboration, support a more diverse approach to acknowledge scientific value of biomedical data, and assess whether such a DDI concept could enable additional measures of academic achievement and might increase transparency and accountability of the results of government funding of science.

The intent of establishing an NIH DDI is to help researchers find and cite relevant publicly available datasets related to their scientific question of interest. Such a DDI would provide minimal metadata and would support links to the data themselves, to associated publications, and to NIH grants that supported the data collection. Coordination of the development of an NIH DDI through a DDICC will be the mechanism by which community engagement, testing, and validation of the DDI concept would be accomplished and will inform subsequent DDI deployment. Whereas the DDI will address discovery and citation of data, other parallel initiatives within the BD2K program and future developments will more directly address the usability of such datasets, which may include detailed annotation, detailed data and metadata standards, or software and associated data processing pipelines, which will help address the question of ensuring data are usable and converting such data to knowledge.

The overall objective of this Funding Opportunity Announcement (FOA) is to create a consortium to address critical issues relevant to development of an NIH Data Discovery Index (DDI) that would support discovery, access, and citation of biomedical big data. The awardee will develop a DDI Coordination Consortium (DDICC) that will work with NIH and community stakeholders to conduct outreach; promote communication; constitute and coordinate Task Forces to study relevant questions related to biomedical data discovery, access, and citation; and fund small pilot projects to collaboratively test possible solutions. Community engagement is a key feature of DDICC approach, and the DDICC will be expected to foster the wide-scale collaborations and partnerships between and among key stakeholders to demonstrate feasibility of the concept. By the end of the three-year award, the DDICC should identify key features and approaches to inform subsequent deployment of an NIH DDI, which will include demonstration of the feasibility of a data index that enables data discovery and access while contributing to increased citability of biomedical data. Clear lessons learned and potential paths forward for implementation of a fully functional NIH DDI should be made apparent. NIH expects that the research undertaken through this FOA will converge on a data-driven solution that identifies effective solutions to solving the data discovery challenge. It will also tell the NIH what is the exact nature and meaning of such an index. Options that are readily apparent include establishing a structure along the lines of PubMed, or developing a distributed solution, like the Internet, with required controlled metadata that can be indexed by suitable web crawlers.

The NIH DDI will be expected to serve as the source for access to publicly available biomedical data and associated metadata that will allow researchers to easily discover data of potential interest and will support citation of such data when it is re-used. The DDI will provide a means for researchers to identify, access, and cite relevant biomedical big data and that will encourage data re-analysis and re-use that may catalyze scientific progress, reduce duplication of experimental data collection, and reward the data provider using direct data-level citations.

The NIH Data Catalog Workshop report concluded that a DDI should have features such as:

• Have a website that can provide information at all levels (both human and machine-readable interfaces)
• Support an extensible and scalable approach to indexing shared datasets
• Utilize pointers to relevant resources in a distributed system, including the data sets, publications, and grant funding.
• Promote the use of minimal metadata to support discovery across data resources

The DDICC is expected to engage key stakeholders. These stakeholders include: users wishing to find data to answer questions (i.e. basic and clinical investigators, patient groups, and others), biomedical data generators, the data science community, informatics experts, the library sciences community, data repositories, journal publishers, professional societies, the NIH and other federal agencies, and international science agencies/funders. By creating an NIH DDI coordinating consortium the intent is to effect coordination between/among the NIH and sources of data whether in large repositories, with publishers, or other distributed sites. The DDICC will need to develop, test, and validate concepts that increase communication, access, discoverability, and citation of biomedical big data and that will help inform the development of a DDI. Activities of the DDI will be governed by quantifiable milestones and realistic timelines. The DDICC will provide a white paper to the community summarizing the findings.

The DDICC will:

• Foster exploration of the different ways in which data discovery can be enabled and assist the biomedical community in finding effective approaches that can adapt to evolving data discovery and sharing needs.
• Conduct outreach, promote communication, and engage the community of stakeholders interested in addressing critical issues associated with DDI development and testing possible solutions. Such activities would include use of the DDI as data consumers or producers.
• Constitute and coordinate Task Forces to study critical issues associated with approaches to developing or implementing a DDI. For instance, these may include (but are not limited to) data access, discoverability, citation, linking across DDI and other resources, or metrics for evaluation of effectiveness. It is expected that Task Forces will help assure community engagement and facilitate coalescence of community activities around specific, critical issues related to the DDI.
• Support collaborative research through pilot projects that address possible solutions to critical issues identified by Task Forces. These pilot projects are expected to be short-term, nimble, and informative, so that the DDI can learn through both associated failures and successes. The DDICC is expected to help identify, coordinate, and possibly fund such pilot projects, but not necessarily conduct them.
• Anticipate and take advantage of other BD2K initiatives that include development of a software catalog, frameworks for development of standards, training, and use of clinical research data (http://bd2k.nih.gov/#sthash.dQYXlX4g.dpbs).
• Evaluate the results of these development efforts through discussions held with a consortium steering committee, NIH staff, community engagement, and an External Scientific Panel that will provide scientific input all BD2K activities associated with a Data Discovery Index, including the DDICC.

In addition to sponsoring and coordinating meetings, task forces, and pilot projects, the DDICC will develop and deploy a simplified user interface (web portal) to assist in accomplishing these objectives. The web portal will serve to as a major means for communicating activity across the DDI consortium, within each of the task forces, and progress and findings from individual pilot projects. These will help inform the concept of a data discovery index. In the final year, the DDICC will provide a white paper to the NIH and the community, summarizing activities of the consortium and identifying lessons learned. This white paper will help inform the subsequent development of a DDI.

Discoverability: The central function of the DDI will be to enable discovery of data relevant to the interests and needs of any interested stakeholder. Example topics related to data discovery may include:

• Working with stakeholders to identify and implement minimal common metadata for the DDI. Some aspects might include the identity of the data author/owner, what type of data it is, when it was produced, where it is located, and how it should be cited.
• Testing effective approaches to support data discovery within and across disciplines. This may include linkages to enriched metadata, in addition to the basic DDI metadata, or other resources to facilitate enriched discovery. This might include partnering with data repositories to test feasibility of such approaches.
• Exploring how to best ensure that researchers make their data available through policy, incentives, or other activities that may minimize barriers to sharing.
• Exploring approaches to a flexible, adaptive DDI approach that will allow it to continue to adapt to the changing needs of the stakeholders.
• Providing an effective system that will support both biomedical researchers and non-experts to identify and locate existing data sources.
• Exploring approaches of how to support data discovery while accounting for updates in the data themselves (this may include corrected data, new data releases, or versions). This may affect data citation and tracking re-use history of the data.

Access: Data indexed in the DDI should be available and accessible. The DDICC will:

• Hold workshops, meeting, and consultations with stakeholders to overcome limitations in the sharing of data as it pertains to access.
• Work with stakeholders, including NIH, data repositories, journals, and societies, to identify data sources and facilitate open access.
• Establish relevant Task Forces and pilot projects to test and validate approaches to make data access.
• Design the DDI structure to support user-friendly access, such as prioritizing links to live (accessible) or verified high-quality (and frequently used) datasets.

Citation: Data will require a unique and readily identifiable tag that can serve as a unique identifier that can itself be cited in appropriate journals, publications, and online references (e.g. Wiki pages). Such a citation should give its provenance. The applicant should indicate that web sites generated by the DDICC will be equally accessible to people with disabilities (compliance with Section 508). The DDICC will:

• Explore models for assigning universal and citable unique data identifiers for data sets, such as a DOI (Digital Object Identifier) or ways to fingerprint based on metadata.
• Determine the best means for assigning credit. This may require partnerships with the library sciences community, biomedical journal publishers, funders, and bio-repositories to identify strategies to support consistent data citation.
• Explore approaches to support linkage between scientific publications and underlying data sets.
• Work with stakeholders to facilitate data citation through supply of sufficient information to allow for provenance of the data.
• Develop metrics of data publication and citation that can be used by NIH and the academic communities to assess scholarly activity related to the citation of datasets.

Outreach: The DDICC will have a coordination role that is expected to engage the broader population of stakeholders. While it is expected that applicants will include individuals with key expertise in the application, it is envisioned that the DDICC will carry out many of its activities through broader community engagement, focused by interests into specific task forces and pilot projects. Thus applicants should identify communities and individuals they would engage and how they would do so, with the goal of establishing a vibrant and collaborative consortium. A successful DDICC will support self-sustaining activities and interactions that extend past the funding of the DDICC itself.

Task Forces: The purpose of the DDICC is to engage the community, identify critical topics or features of a DDI, and pilot the feasibility and effectiveness of potential solutions to address these areas. These task forces will organize DDI and community efforts around specific critical issues, with the intent of identifying and testing possible solutions. It is expected that task forces may be of variable duration, depending upon the nature of the activities, and that new task forces may develop. The DDICC will therefore need to present a plan to manage each task force as well as manage the life cycle of task forces as well. The DDICC is expected to coordinate and facilitate task forces and their associated pilot projects, as well as to coordinate activities across the DDI consortium, including activities with the NIH.

Examples of possible task forces may include, but are not limited to:

• Approaches to link publications with data.
• DDI data discovery that balances requirements of cross-repository searches with support of enriched data discovery in field-specific data repositories.
• Development of data citation and access metrics.
• Approaches to index data that lacks an existing repository.
• Outreach and Dissemination to data repositories to facilitate engagement and participation.
• Identification of useful tools to support DDI-compliant data annotation by investigators.

Pilot Projects: To demonstrate feasibility of the DDI and to test usefulness of different possible approaches to address issues identified by task forces, the DDICC will implement a series of use cases as defined through pilot projects. These pilot projects will be funded out of the DDICC as small budget/short duration experiments with defined milestones and will be implemented by key collaborating stakeholders through subcontracts. These pilot projects will test concepts needed to develop a long-term solution to data discoverability, access, and citation and pilot projects should work in the context of the specific DDI task forces. Pilot projects will be the learning environment for testing concepts needed to implement a DDI and are to be nimble, high risk, and short duration to better engage stakeholders in experiments to find the right mix of approaches for an effective DDI. There may be multiple such projects addressing different potential solutions to given questions. All such pilot projects must be designed with specific, quantitative, and achievable milestones to allow the DDI stakeholder community and the relevant task forces to learn what has and has not worked. The applicant should identify how they will manage and coordinate pilot projects, and how they will ensure that the pilot projects inform the associated task force, and their proposed process to solicit and assess new potential pilot projects. While the DDICC may provide funding for pilot projects, the level of funding and the duration may differ between projects, depending on the scientific need. However, all pilot projects should result in the DDICC and the community in learning how the success or failure of each pilot project will help inform future development and deployment of a DDI.

Several use cases as potential pilot projects were suggested by the Data Catalog Workshop (see: report), but applicants are encouraged to identify useful and meaningful pilot projects that have the potential to substantially inform how a DDI might be successfully deployed.

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 $3,000,000 for fiscal year 2014 to fund one award.
Award Budget	Budgets are limited to $2,000,000 in direct costs per year but must reflect the actual needs of the proposed project.
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.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

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

Applicant Organizations

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

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

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

All PD(s)/PI(s) must have an eRA Commons account 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.

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

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

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

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

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:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

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

The letter of intent should be sent to:

Director, Office of Scientific Review
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924 (Express zip 20817)
Telephone: 301-435-0270
Fax: 301-480-0730
Email: [email protected]

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

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.

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

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

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

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

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

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 meeting with the BD2K Data Discovery Index External Scientific Panel (ESP) in the United States, at a location to be determined by NIH staff.

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

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

Specific Aims: The Specific Aims should be the overall vision for the proposed DDICC, including community engagement, identification of key topics, formulation and management of task forces and associated pilot projects, and administration of these activities.

Research Strategy: Responsive applications will address each of the following elements. Page numbers indicated below are provided only as guidelines within the page limitations of a U24 application.

1. DDICC Overview - 1-2 pages

2. DDICC Community Engagement Capabilities - 1-4 pages

3. DDICC Task Forces and Pilot Projects - 1-6 pages

4. DDICC Administrative Coordination and Management - 1-4 pages

DDICC Overview:

The Overview should include background information regarding the overall DDICC approach to working cooperatively to serve as a national resource to the scientific community engaged in identifying, developing, and testing approaches to implement and use a DDI. The applicant should provide a concise description of the vision and proposed plan for the DDICC, identify issues of relevance to the DDI addressed by the application, and identify approaches, methods, software, and tools that would be generated, and how these activities will inform development of a useful DDI. The applicant will provide (1) management expertise to ensure effective management and oversight of the overall consortium as well as task forces and their associated pilot projects; (2) community engagement and communications expertise to develop the DDI consortium beyond the funded investigators; (3) data, metadata, and informatics expertise; and (4) scientific expertise in biomedical research.

DDICC Community Engagement Capabilities:

The applicant should provide a plan and proven capability for outreach activities and community engagement. These will include:

• Identifying key stakeholders and providing a plan to further identify, engage, and inform stakeholders.
• Engaging with stakeholders to evaluate the success or otherwise of the tested solutions using surveys or other methods to check if different groups have been successful at discovering relevant data.
• Providing a simple web site with a user interface that allows for simple and rapid navigation and information distribution.
• Proposing additional methods that allow for community contributions, education, or engagement by the DDICC as a whole or in particular task forces.
• Organizing, promoting, and supporting open public meetings, working groups, and task forces to engage the broader community of stakeholders, so that the DDICC may benefit from their diverse knowledge and expertise, and which would allow them to focus on areas of particular interest.

DDICC Task Forces and Pilot Projects:

The applicant should provide a plan and proven capability to establish and manage multiple task forces and associated pilot projects within the DDICC. This section should:

• Detail how the experimental nature of the pilot projects will contribute to the determination of feasibility and implications for implementation of an NIH DDI.
• Identify initial topics for task forces to focus activities in the first year, including initial stakeholders for each topic, and indicate how the DDICC would support these task forces and solicit further participation from the community to help address each topic.
• Propose initial pilot projects for each task force that would help test useful approaches to address its topic. These pilot projects are expected to be supported through collaborations with key stakeholders, so key collaborators should be identified for initial pilot projects and a plan for identifying and engaging future collaborators should be included.
• Detail how pilot projects will be assessed, including approval of pilot project milestones and goals prior to the start and assessment of lessons learned upon completion.
• Provide detail on management of task forces, how task forces goals and outcomes will be assessed, and whether it has completed its mission. They will indicate how the outcomes of each task force are presented to NIH and the research community.
• Identify the process for allocating effort and resources between task forces and pilot projects, if more proposals arise than can be supported through this funding mechanism.
• Provide plans for collaborations and/or partnerships, where applicable.

DDICC Administrative Coordination and Management:

This section should include a concise description of the structure of the DDICC, including a brief management plan and organization chart with administrative details defined. The applicant should explain how the constituent parts of the DDICC, including key personnel, will interact, how their activities will contribute to the accomplishment of the overall goals, and how the organization will create an entity that will result in a community resource useful and important for the greater biomedical research community. Describe plans and activities to meet and fulfill the activities and goals of the DDICC, which include:

• Enabling the DDICC to support multiple task forces and pilot projects, the DDICC Steering Committee, and the DDI ESP.
• Ensuring logistical support and management to fulfill the DDICC tasks including, but not limited to: conducting monthly teleconferences of the Steering Committee (SC) and work groups, writing, organizing and distributing DDICC-related reports including regular conference calls of the SC, annual meetings of the SC, other work groups and reports that may be requested by the NIH Project Scientist and NIH Program Staff; coordinating and archiving information regarding DDICC activities; and producing any DDICC-related resource reports.
• Serving as an information conduit between the consortium members, scientific community being served, and layman public audiences by producing appropriate public-relations materials on behalf of the DDICC. This includes updating, and advertising a public DDI website, and actively promoting broad utilization of DDICC resources by outside investigators.
• Providing a plan for managing the life cycle of task forces and pilot projects; identifying and assessing new such activities; managing and funding approved ones (as necessary); and evaluating outcomes and findings from such task forces and pilot projects to ensure they inform subsequent DDI implementation.
• Describing how NIH officials will be involved in decision-making processes of the DDICC (e.g. through a Steering Committee).

Letters of Support: Given the need to develop wide-scale collaborations and partnerships, including potentially with the private sector and international leaders in the data science, letters of support from collaborative individuals/entities should be provided. However, applicants may include a maximum of 15 letters of support within the application. Do not submit letters of support as an appendix. If letters of support are included they should directly address how the proposed U24 project will help develop or enhance a DDICC, as described in the Research Objectives sections of this FOA.

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:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

The resource sharing plan for the application should cover all the activities of the U24. NIH Program Staff may negotiate modifications to these plans prior to funding. Plans are expected for sharing software (see below).

Consistent with achieving the goals of the program, NIH expects that the project procedures, documents, and software be shared with the community, as much as possible. The BD2K DDICC awardee is expected to release to the research community data, models, and software in a timely fashion through an informatics platform and other standard mechanisms. The development of policies, methods, and standards for such sharing are critically important for BD2K. The NIH expects that the DDICC awardee will develop such policies, methods, and standards in concert with the NIH and the DDI External Scientific Panel. These policies, methods, and standards will remain consistent with NIH-wide policies on data and resource sharing.

Specific Plan for Sharing Software: A software dissemination plan, with appropriate timelines, is expected to be included 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. Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan. A dissemination plan guided by the following principles is thought to promote the largest impact:

• 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.
• 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. 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.
• 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.
• 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.

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 application 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.

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

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

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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 NHLBI, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed. Applications that do not include a plan for community engagement, that do not include identification of task force areas and a plan on how to identify and manage task forces and pilot projects will be deemed non-responsive.

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

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

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

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

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? How will the DDICC contribute to the development of an effective DDI system, as part of the overall objectives of the NIH BD2K initiative?

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? Do the PD(s)/PI(s), collaborators, and other researchers have the expertise and background necessary to conceptualize, develop, and test a biomedical DDICC, including data curation (including metadata and data annotation), knowledge management, web site development, community outreach, project management, and knowledge of biomedical research?

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Is a plan for the solicitation, award, and evaluation of task forces and pilot projects well defined? Will this project result in methods and strategies that can be adopted by the biomedical research community to support data sharing? Are the approaches tailored to specific portions of the community or more broadly applicable?

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? Has the applicant established alliances/collaborative partnerships where appropriate or needed to facilitate achievement of the research goals? Does the project take advantage of the best available tools and resources available to the scientific community to-date? Do the letters of collaboration and institutional support show strong commitment to the project?

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.

Task Forces

Does the application identify an initial set of task forces and identify appropriate initial participants? Are the plans to further develop these task forces appropriate and do they include plans for associated plans for community engagement? Do they identify key expertise to be included in each task force? Are task force management and oversight plans appropriate and do they include how findings from each will be identified and shared with the NIH and the community? Is there a plan to manage identification and support of new task forces and the end support for task forces that have completed their objectives?

Pilot Projects

Does the application identify an initial set of pilot project(s) associated with each proposed initial task force? Are the plans for soliciting, assessing, and supporting additional pilot projects for each task force appropriate? Are pilot project management and coordination plans appropriate and do they include how goals and milestones for each pilot will be assessed prior to its initiation and how its findings will be shared with the task force, the NIH, and the community? Is there a plan to manage identification and support of new pilot projects and the end support for pilot projects that have completed their objectives?

Community Engagement

Does the application include a cohesive plan for community engagement that is likely to result in identification and engagement of key stakeholders? Are proposed methods for community engagement innovative and effective? Since a user interface (website) will be required to support community access to DDICC activities, does the application indicate that necessary expertise and prior experience are available to successfully execute and implement the proposed user interface including (where appropriate) partnering and collaborating with other scientists or organizations? How well does the proposed plan of the web site align with the anticipated critical activities of the project? Will the web site integrate the DDICC-related efforts and serve as a community-wide resource for developing a DDI?

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

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

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

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

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

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

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

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

Cooperative Agreement Terms and Conditions of Award

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

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

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

• Agreeing to the governance of the DDICC consortium through the Steering Committee (see below), the NIH (NIH Program Staff and NIH Project Scientist(s)), and accepting recommendations from an NIH DDI External Scientific Panel (ESP).
• Actively participating in the DDICC Steering Committee (DDICC SC), including attending both in-person and teleconference meetings, and participating in collaborative activities. The DDICC SC will meet in person at least once a year and will recommend the frequency with which other in-person and teleconference meetings will be held.
• Updating goals and milestones at the time of award and providing summaries of progress toward those goals at least yearly, as requested by NIH. The milestones will be reviewed annually (and at other times, if necessary), and new milestones will be negotiated with the NIH and the DDICC investigators, as needed.
• Working with the NIH and other PD(s)/PI(s) on DDICC milestones and goals.
• Ensuring that data and software are deposited in a timely manner in the appropriate public databases as agreed upon by the DDICC SC. Ensuring that software and other tools and resources developed as part of this project are made publicly available according to DDICC policies, and publishing results of the projects in a timely manner.
• Agreeing to abide by any policies -- including those regarding intellectual property, data and software release, publication of DDI papers, as modified by recommendation of the DDICC SC and approved by the NIH.
• Be prepared for annual administrative site visits by NIH staff and an annual meeting in the Bethesda area.
• Agreeing to participate in the collaborative activities of the network, and agreeing not to disclose confidential information obtained from other members of the DDICC SC.
• 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 has substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• An NIH Program Officer will provide the standard programmatic overview and stewardship of the projects, including review of pre-award and award documents/requirements, review of progress reports and budgets, facilitating budget recommendations to grants management, and any other programmatic issues that may arise.
• One or more NIH Program Staff will serve as Project Scientist(s), however the NIH Program Officer and the NIH Project Scientist will be separate individuals. The Project Scientist(s) will serve as the scientific representative of the NIH to the investigators in accordance with policies and procedures of the cooperative agreement mechanism. One Project Scientist will represent the NIH as a voting member of the Steering Committee. If there is more than one Project Scientist, one of them will be designated as the Lead Project Scientist. The Project Scientist(s) will provide the substantial NIH scientific programmatic involvement with the awardee that is anticipated during the performance of the activities supported by this Cooperative Agreement, including review of milestones.
• The NIH Project Scientist(s) will perform the initial analysis of awardee milestones and will work with the Program Officer on any milestone renegotiations. The NIH Project Team is comprised of program staff representing several Institutes and Centers, will provide final assessment, review, and approval of Center milestones and any renegotiation.
• In addition, the NIH Program Officer will:
  • Have the option to recommend, following consultation with the NIH Project Scientist(s), and the ESP, the withholding or reduction of support from any project that substantially fails to achieve its goals according to the milestones agreed to at the time of the award.
  • Participate in the DDICC SC meetings as an ex officio member
  • Other NIH Staff may serve on sub-committees, working groups, or task forces of the DDICC, as needed. The Staff will assist the DDICC SC in developing operating guidelines and consistent policies for dealing with situations that require coordinated actions.
  • The NIH Project Scientist(s) will help the DDICC SC members to coordinate the group process of exchanging information about research approaches and protocol designs and of developing additional DDICC policies.
  • The NIH will review and approve, in consultation with the ESP, recommendations and plans provided by the DDICC SC for collaborative activities.
  • NIH reserves the right to withhold funding or curtail an award in the event of:
  • Substantive changes in the project, or failure to make sufficient progress toward the work scope with which NIH concurred, or
  • Ethical or conflict of interest issues.
• Collectively the NIH will have 1 vote on the DDICC SC.
• The NIH staff representation to the DDICC Steering Committee, together with the External Scientific Panel (below) will help to determine whether DDICC plans will further the aims of the NIH Big Data To Knowledge (BD2K) initiative (http://bd2k.nih.gov/#sthash.9aZVqdPU.dpbs).

Areas of Joint Responsibility include:

• The NIH jointly with the DDICC investigators will evaluate and modify, as needed, task forces, their goals, and milestones. Membership of the DDICC SC will include the PI, co-PI(s) and other key personnel with each having one vote. Awardees of pilot projects and task force leads will attend DDICC SC meetings, as well. The DDICC SC Chair will be appointed by the NIH and drawn from the individual project PIs/coPIs. The DDICC SC may add additional, non-voting, members, as needed. Other government staff may attend the steering committee meetings, if their expertise is required for specific discussions. The SC may set up subcommittees or task forces, as needed. Task Force leads will coordinate task force activities and communication, including providing proposals for pilot projects to the DDICC SC. There will be periodic teleconferences at an agreed upon schedule to coordinate activities of the DDICC SC. There will be one in-person Investigator’s meeting which will involve the ESP and include an DDICC SC meeting. Travel to attend such meetings will be included in the DDICC budget. The DDICC will be responsible for convening steering committee meetings.

Together the members of the DDICC SC will:

• Identify scientific and policy issues that need to be, or can benefit by being, addressed at the DDI NIH staff level.
• Assure that progress on meeting milestones and timelines is being met. Develop recommendations to the NIH for addressing such issues.
• Assess and recommend proposed task force topics and identify leads.
• Coordinate the findings and recommendations for joint and collaborative projects.
• Discuss progress in meeting the overall goals of the DDICC as well as possible areas of synergy that may benefit the DDI or BD2K as a whole.
• Develop operational guidelines, including frequency of meetings, items requiring voting, number or proportion of votes required to pass any initiatives, etc.
• Coordinate any issues of joint relevance to the DDI investigators relating to project milestones between the PI(s)/PD(s) and the NIH.

External Scientific Panel (ESP):

An ESP will be constituted to provide advice to the investigators and the NIH on issues related to the DDI. The ESP will be responsible for reviewing the progress of the DDICC. This shall include the DDICC, per se, as well as task forces and the pilot projects. The ESP will be composed of 4-6 senior, non-federal scientific experts who are not directly involved in the activities of the DDI activities. NIH will appoint members to the ESP and select one member as chair. The role of the ESP will be to advise the investigators and the NIH on issues relevant to achieving the goals of the DDICC.

The ESP will meet at least once a year, in conjunction with a meeting of the DDICC SC, to allow the ESP members to interact directly with the awardees, and by phone or email, at other times as needed.

Annually, the ESP will advise the NIH about the progress of the DDICC, and, as necessary will present recommendations regarding any changes in the DDICC program. The assessments and recommendations will be provided to the Director of the Office of Strategic Coordination, NIH.

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 members 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.

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.

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

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

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