It is critical that applicants follow the instructions in the Research Instructions for 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

Big Data to Knowledge (BD2K) is a trans-NIH initiative established to enable biomedical research as a digital research enterprise, to facilitate discovery, support the generation of new knowledge, and maximize community engagement in implementing data management practices that lead to findable, accessible, interoperable, reusable digital data.

The ability to harvest the wealth of information contained in biomedical Big Data has the potential to advance our understanding of human health and disease and to accelerate discoveries of therapies and treatments. However, the scope, scale and heterogeneity of Biomedical Big Data create major organizational and analytical impediments to the ability of researchers to clearly describe, easily share and broadly use those data. As biomedical datasets become increasingly large, diverse, and complex, they tax conventional methods for sharing, managing, integrating and analyzing existing and new data.

This FOA directly addresses two of the four major aims of BD2K: 1) to facilitate broad use of biomedical digital assets by making them discoverable, accessible, interoperable and reusable; and 2) to enable a data ecosystem that accelerates both basic and translational discovery as part of a digital enterprise.

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

The global biomedical research community generates large volumes of digital data of different kinds, of different modalities, and in different formats. For researchers to take full advantage of existing research data, they must be findable, accessible, interoperable and reusable (FAIR). The ability to re-use, integrate or add to existing data sets will open new avenues of opportunity and can speed discoveries that will improve health. While there are many successful examples of well-curated digital research data that are available to all researchers, NIH wishes to accelerate the availability and re-use of biomedical research data, whose generation it supports, by transforming the processes used to curate digital data assets that are the product of biomedical research.

Digital curation involves annotating, managing, and preserving digital assets. A digital asset is a binary file that can be stored on a computer and re-used. Proficient curation of digital data assets maximizes their reuse potential, mitigates risk of obsolescence, reduces the likelihood that their long-term value will diminish or be lost, and helps assure reproducibility of research. However, there are costs associated with curation. Resources available to support the long-term availability of digital data are unlikely to grow at the same rate as data volumes. As the costs of managing digital data continue to climb, there is an increasing realization that the processes of curation for biomedical research data must become more efficient (less costly) and more effective (meeting quality and completeness standards and supporting research reproducibility). This Funding Opportunity Announcement is focused on curation of biomedical digital data assets.

Today’s curation processes are a mix of computational and manual activities, involving specialized technical and professional staff. Successful examples of semi-automated digital curation already exist, employing processes that require less or minimal human intervention to annotate the digital asset. However, to achieve FAIR access to biomedical digital data, new or improved approaches for automated curation and management of digital assets must be explored, validated, and widely adopted, including effective, automated curation being applied earlier in the data life cycle, at the time data are generated.

Generation and curation of biomedical data sets can be viewed as a single process, one that involves a mix of people at different steps, including scientists at all career levels, technical support staff, IT specialists, curators, and librarians. Methods and tools are needed that can be used by this workforce throughout the entire data life cycle, to monitor and assess the accuracy, completeness, quality and efficiency of the curation process. Proposed approaches should identify the process step, intended user and expected improvements to be achieved.

Applications may propose development of new tools and approaches, or build upon existing open-source tools and pipelines in order to enhance efficiency, control costs and improve quality. Whether a new tool or enhancement of an existing tool is proposed, the improvements over comparable existing curation approaches or comparable tools must be documented through a comparative study. During the project period, applicants are expected to test the approach with one or more target audiences in the curation process outlined above, and to disseminate the results of their research.

Potential topics to be addressed include:

• Approaches that drive curation to become more standardized. For example, interfaces to assist in the assignment of metadata by proposing terms from accepted ontologies.
• Tools and templates to facilitate consistent use of community-defined standards such as common data elements and standards used by archival resources such as GenBank, SRA, Biosample, etc.
• Automated or semi-automated approaches to merging (harmonizing) disparate or heterogeneous data sets for purposes of new research.
• Approaches that improve the speed and accuracy of extracting metadata information from text or other digital sources, and linking the information to a data set or other digital asset.
• Approaches that support data annotation at points throughout the research lifecycle (data gathering, preparation of data for sharing, public sharing of data sets, submission or review of articles supported by data sets, etc.).
• Approaches for distributed approaches to curation processes that increase the efficiency, completeness, accuracy or quality of the digital asset.
• Approaches that apply curation earlier in the data generation life cycle, such as tools that ensure metadata for high through-put research data sets are accurately and consistently captured and transmitted with the data files.
• Approaches that can be applied in more than one subject domain.

The following topics are non-responsive to this FOA:

• Do not focus on tools and approaches for making curation more efficient and effective
• Do not address the curation and management of biomedical big data
• Have a primary focus on data generation, data storage, database development, or data analytics other than in the context of a proof of concept experiment to improve curation
• Focus only on describing or improving manual methods of curation
• Applications that do not include comparative testing and active outreach and dissemination to one or more target audiences.
• Focus on hardware development or the curation of software, standards or other digital assets other than data.

See Section VIII. Other Information for award authorities and regulations.

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 not allowed.

Applicant Organizations

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

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

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

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

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

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

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

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

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

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

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

The letter of intent should be sent to:

Valerie Florance, PhD
Telephone: 301-496-4621
Fax: 301-402-2952
Email: NLMEPINFO_BD2K@mail.nih.gov

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

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

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

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

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

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

Applications should include a team with expertise in information science or informatics, biomedical curation and biomedical domain expertise. Leadership may come from any of the above as PD/PI or MPD/MPI.

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) and key personnel to participate in a required annual BD2K Consortium meeting held within the United States, at a location to be determined by NIH staff.

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

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

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

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

1. Identify the curation process(es) and domain of interest being addressed and how the proposed approach will make digital data assets more findable, accessible, interoperable or reusable.

2. Describe who would use this approach curator, data manager, scientist, for example -- and describe when use of the proposed approach is most helpful, e.g., data generation, data deposition in the research/data lifecycle.

3. Define the challenging problem for biomedical big data curation within the chosen area of use, giving particular emphasis to the specific aspects of the problem that create the challenge and the shortcomings of existing approaches.

4. Describe current tools and approaches available to address this problem area and how the proposed approach differs.

5. Describe the proposed approach (e.g., what tools/methods will be developed, what the basis of comparison will be, how the proposed approach will be tested). Applicants should make clear whether the proposed work is improvement of an existing tool or new development, and should include a timeline that lays out steps for design, testing and dissemination.

6. For a new tool, the applicant should justify the need for it, and must provide baseline data and compare it to the new approach. For improvements to an existing tool, the applicant should describe the innovation, and undertake comparative testing to show the benefits of changes made to the original tool. Describe the metrics that will be used to assess the proposed approach (e.g., efficiency, effectiveness, accuracy, quality). The final tool or approach should include appropriate metrics for tracking curation work, such as completeness, accuracy, production time, quality of metadata, utility for re-use or integration, and similar factors.

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

8. Describe the approach for dissemination and testing by the user community.

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

In addition to the dissemination and testing plan outlined above, applicants are expected to include a general plan for sharing the resource widely, with appropriate timelines, as appropriate and consistent with achieving the goals of the program. A software dissemination plan, with appropriate timelines, is expected to be included to meet the goals of this initiative.

There is no prescribed single license for software produced through grants responding to this announcement. However, reviewers will be instructed to evaluate the dissemination plans relative to these goals:

• Any developed software should be freely available to biomedical researchers, curators, 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 outside researchers to modify the source code and to share modifications with other colleagues as well as with the investigators. 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.
• Applicants are expected to propose a plan to manage and disseminate the improvements or customization of their tools and resources that are contributed 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 PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the BD2K Sustainability Work Group, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

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

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

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

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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? Is the proposed work likely to improve the efficiency or effectiveness of digital curation processes in a measurable way? If the aims of the application are achieved, is it likely that the approach will be widely adopted?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does project leadership include expertise in digital curation and data management? If the project focuses on a biomedical domain or audience, does the investigative team include representation from that audience?

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? If the applicant proposes to develop a new tool, is there a strong justification of need? If the applicant proposes to enhance an existing tool or approach, does the enhancement constitute a novel addition or modification to the existing tool, such as adding embedded intelligence?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects? Are members of the target audience involved in design and testing? Is there a clear timeline and milestones for the comparative study, and building, testing and implementing the proposed tool or approach? Is there discussion of sustainability of the new or improved resource?

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

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

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

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Not Applicable

Not Applicable

Not Applicable

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

Not Applicable.

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Does the data sharing plan support open access to the results?

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NIH Multi-Council Working Group, the Board of Regents of the National Library of Medicine and councils of other NIH Institutes as appropriate. 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.
• The adequacy of software sharing plans

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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.

Prior to funding, program staff may negotiate modifications of software sharing plans with the applicant. Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan. The final version of any accepted software sharing plans will become a condition of the award.

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

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

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

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

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

The BD2K Innovations in Curation of Biomedical Big Data: This is the opportunity for cooperative agreement awards described in this RFA.

The BD2K Digital Curation Group: This committee, which will include members of the Sustainability Work Group, and program officers and science officers assigned to each award, will serve as a coordinating committee for the individual projects funded under this FOA.

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

The Program Director(s)/Principal Investigator(s)/Multi-PIs will have the primary responsibility for defining the details for the projects within the guidelines of this RFA and for performing all scientific activities. The contact PD/PI will agree to accept the close coordination, cooperation, and participation of the NIH staff on the BD2K Digital Curation Group in aspects of scientific and technical management of the projects as described below. Specifically, the PD/PI/MPIs supported by a Big Data to Knowledge (BD2K) Enhancing the Efficiency and Effectiveness of Digital Curation for Biomedical Big Data grant award will:

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

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

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

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

• Provide technical assistance and advice to the individual BD2K Digital Curation awardee as appropriate to achieve the aims of the cooperative agreement.
• Coordinate and facilitate the interactions among the BD2K Digital Curation awardees.
• Promote and help coordinate collaborative research efforts that involve interactions with other members of the BD2K Consortium, as well as with other NIH-sponsored programs, projects, and centers where appropriate.

To help carry out these duties, the Project Scientist may consult with NIH experts in the field. As needed, additional Project Scientists could be appointed to work with the lead Project Scientist.

Additionally, an NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice. The Program Official may also have substantial programmatic involvement to coordinate and facilitate collaborations with other awardees and ensure the activities of the project are consistent with BD2K and the goals of this RFA. The Program Official may be the same person as Project Scientist, in which case, the individual involved will seek NIH waiver according to the NIH procedures for management of conflict of interest as needed.

Areas of Joint Responsibility Include:

The NIH Project Scientist(s) and the PDs/PIs of the BD2K, constituted as the BD2K Digital Curation Group, will be jointly responsible for the coordination of intra-program activities and the scientific integration of individual projects with other appropriate NIH programs. Joint responsibilities include:

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

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

Dispute Resolution:

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

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

The effectiveness of software sharing may be evaluated as part of the administrative review of each RPPR.

https://grants.nih.gov/grants/policy/myf.htmA 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Valerie Florance, Ph.D.
National Library of Medicine (NLM))
Telephone: 301-496-4621
Email: NLMEPINFO_BD2K@mail.nih.gov

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

Dwight Mowery
National Library of Medicine (NLM)
Telephone: 301-496-4221
Email: moweryd@mail.nlm.nih.gov

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.