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

This FOA, which uses the NIH conference cooperative agreement program (U13), is part of the NIH-wide initiative, Big Data to Knowledge (BD2K). Data science related organizations have a critical role in advancing biomedical data science but often depend on meetings to carry out the work that will foster greater cooperation of efforts with the NIH. Therefore, the purpose of this Funding Opportunity Announcement (FOA) is to support high quality and impactful conferences/meetings that are convened by data science related organizations whose missions focus on biomedical data science.

For this announcement, a conference is defined as a gathering, such as in the form of a symposium, seminar, scientific meeting, workshop, or any other organized and formal meeting where persons assemble to coordinate, exchange, and disseminate information, or to explore or clarify a defined subject, problem, or area of knowledge.

Applicants representing data science related organizations may request support for one or a series of meetings over multiple years that address areas of data science aligned with the goals of the NIH BD2K program.

Biomedical research is rapidly becoming more data-intensive as investigators are generating and using increasingly large, complex, multidimensional, and diverse datasets. This era of big data in biomedical research taxes the ability of many researchers to release, locate, analyze, and interact with these data and associated software due to the lack of tools, accessibility, and training. In response to these new challenges in biomedical research, and in response to the recommendations of the Data and Informatics Working Group (DIWG) of the Advisory Committee to the National Institutes of Health (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).

Over the past several years, several not-for-profit data science-related organizations have arisen to bring together interested parties to address emerging issues in biomedical data science (e.g., data accessibility, sharing, and interoperability; digital publishing). These groups are defined by a mission focus on one or more areas of biomedical data science and operational characteristics of transparency, open participation and bottom-up priority setting and governance. In keeping with the highly participatory, grass-roots nature of these organizations, much of their work is accomplished through convening of various stakeholder groups. This occurs in many ways, from large conferences and plenaries to seminars, webinars, workshops and web-supported, regular interactions of working groups.

This FOA targets not-for-profit data science-related organizations, whose work aligns with, and is complementary to, the overall mission of BD2K. Specifically, this FOA solicits applications from organizations requesting support for high quality and impactful conferences/meetings focused on emerging issues in biomedical data science. A "conference" may be based on a formal meeting where people assemble in person or other formats such as meeting online via web conferencing and/or videoconferencing applications.

Conferences that would be appropriate for support under this FOA may be in diverse areas of the field of biomedical data science, as long as they are relevant to BD2K mission. Examples of such areas include, but are not limited to, the following aspects:

• Digital resource discovery, citation and access;
• Data and metadata standards;
• Ethical Legal and Social Implications (ELSI) of biomedical data science;
• Data management, transformation, and analysis tools; and

Permission to Submit Application. Support of conferences under this FOA is contingent on the fiscal and programmatic interests and priorities of the NIH BD2K Program. Therefore, the PD(s)/PI(s) of a conference cooperative agreement application is required to obtain a permission-to-submit letter (for respective contact, see Section VII. Agency Contacts.).

Applicants are urged to initiate contact well in advance of the chosen application receipt date to discuss the proposed meetings and ensure they address current BD2K programmatic priorities. This initial contact should occur no later than 6 weeks before that due date. Please note that agreement to accept an application does not guarantee funding.

The NIH website on NIH Support for Conferences and Scientific Meetings centralizes information regarding grants and cooperative agreements for scientific conferences. The Contacts and Special Interests website includes contact information for the participating ICs as well as information about each IC’s specific interests and funding parameters. This website and related links are updated frequently, so interested parties should check periodically for the most current information.

Applicants responding to this FOA may request support for a single meeting or series of meetings. The proposed meeting(s) must address one or more aspects identified in the NIH BD2K Mission Statement. Successful applicants will work with NIH staff post-award to ensure that the meeting goals are well aligned with the BD2K interests.

Appropriate Representation and Conference Environment. A critical part of the application for NIH conference support is the documentation of appropriate representation of women, racial/ethnic minorities, persons with disabilities, and other individuals who have been traditionally underrepresented in science in the planning and implementation of, and participation in, the proposed conference. Appropriate representation means representation based on the availability of these scientists from these groups known to be working in a field of biomedical or behavioral research. If appropriate representation is not apparent, no award will be issued until program staff members are assured of concerted recruitment efforts.

Consistent with Federal civil rights laws, and the Guidelines for Inclusion of Women, Minorities, and Persons with Disabilities in NIH-Supported Conference Grants policy,, it is expected that organizers of NIH-supported conferences and scientific meetings take steps to maintain a safe and respectful environment for all attendees by providing an environment free from discrimination and harassment, sexual or otherwise.

Efficient Spending Requirements. The NIH Policy on Promoting Efficient Spending: Use of Appropriated Funds for Conferences and Meeting Space, Food, Promotional Items, and Printing and Publications requires advance approvals prior to any obligation of funds (i.e., issuance of a Notice of Grant Award). The approval process, which does not begin until after an application has been peer reviewed, undergoes a second-level review by an NIH Advisory Council and if selected for funding, can take 2-3 months. To facilitate the approval process, each applicant organization identified for funding will need to work closely with the NIH to provide additional details regarding the funds requested. Applicants are encouraged to consider this extended timeline in conference planning. For applications requesting multiple years of support, a separate approval process is needed each year. For conference grant and efficient spending guidance, please click here.

Please visit the BD2K site Frequently Asked Questions (FAQs) site (https://datascience.nih.gov/bd2k/faqs/u13#CommunityMtgs ) for answers to questions related to this announcement.

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)

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

Eligibility is restricted to data science related organizations that are not-for-profit organizations with a mission focus on one or more areas of biomedical data science, operational characteristics of open participation, and bottom-up priority setting and governance, and who regularly bring together interested parties to work on emerging issues in biomedical data science (e.g., data sharing and interoperability, digital publishing).

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

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.

PD(s)/PI(s) must have expertise in one or more areas of biomedical data science and skills and experience needed for promoting/facilitating open interactions among scientists, bottom-up priority setting and governance, and ability to bring together interested parties to work on emerging issues in biomedical data science (e.g., data sharing and interoperability, digital publishing).

If multiple PDs/PIs are designated, at least the Contact PD/PI must be from the application-submitting not-for-profit organization with a mission relevant to biomedical data science.

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 and proposes a different meeting or meeting series.

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.

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.

Descriptive Title of Applicant’s Project: Enter the title of the scientific conference.

Cover Letter: Contacting NIH for information on eligibility is encouraged and advance permission to submit an application is required. Advance permission to submit an application should be requested early in the process and must be requested no later than six weeks before the application due date. All applicants must include the permission-to-submit letter from the BD2K permission letter contact person (see Section VII. Agency Contacts), who has agreed to accept assignment of the application. Applications that do not include the permission-to-submit letter will not be accepted for review. Note that advance permission to submit an application does not guarantee funding. Please see Section I. Funding Opportunity Description for further details.

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. with the following additional instructions:

The person listed as Financial/Grants Management Contact in Section VII should be consulted for guidance regarding any specific budget requirements. Enter the direct costs requested. Facilities and Administrative (F&A) costs are not allowed. Provide a narrative justification for each proposed personnel position, including the role of the individual in the conference and the proposed level of effort. Include information regarding efforts to obtain funding for this conference from other sources.

Allowable Costs include: Salary (in proportion to the time or effort spent directly on the conference); rental of necessary equipment; travel and per diem or subsistence allowances; supplies needed for conduct of the conference (only if received for use during the budget period); conference services; publication costs; funds to help defray registration costs for some select attendees (for example, women, racial/ethnic minorities, persons with disabilities, other individuals who have been traditionally underrepresented in science, graduate students); speakers fees.

Non-allowable costs: Meals/food and beverages; purchase of equipment; transportation costs exceeding U.S. carrier coach class fares; visas; passports; entertainment; tips; bar charges; personal telephone calls; laundry charges; dues; honoraria or other payments for conferring distinction or communicating respect, esteem or admiration; patient care; alterations or renovations; facilities and administrative costs/indirect costs.

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: Note that this section will be called Conference Plan in the system-generated Table of Contents.

In the Conference Plan section of the application (uploaded as the Research Strategy attachment), describe the organization and the community(-ies) it represents. Identify the role of the PD(s)/PI(s) in the organization. Describe the organization's mission, history and focus on biomedical data science. Describe the organizational characteristics and prior activities that support its community-based nature (e.g., open participation and broad outreach to relevant stakeholders, bottom-up priority setting and governance). Describe the alignment of the organization's mission with the broad objectives of the NIH Big Data to Knowledge (BD2K) program.

Describe the objectives, specific program, and logistical arrangements for the conference(s). Describe the format and list the agenda and speakers, including the principal topics to be covered, problems to be addressed, and developments or contributions the conference(s) might stimulate. Provide a detailed justification for the conference(s), including the scientific need, timeliness, and usefulness of the conference(s) to the scientific community.

Describe the composition and role of the organizing committee, and provide the names and credentials of key participants (i.e. speakers, presenters, session moderators) in the conference, including the basis for their selection and documentation of their agreement to participate.

Estimate the expected size and composition of the audience, as well as the method of selection. Address plans to seek appropriately balanced representation among invited participants and plans to encourage attendance by women, minorities, and persons with disabilities.

Identify resources for child care and other types of family care at the conference site to allow individuals with family care responsibilities to attend.

Describe plans for publicizing the conference to all interested participants and for publishing the proceedings (with the latter plan not being required). Identify related conferences held on the subject during the past 3 years and how the proposed conference is similar to and/or different from these, and why it is still necessary and useful. If this is one in a series of periodic conferences held by a permanent sponsoring organization, briefly describe and evaluate the last conference in the series.

Applications requesting multiple years of support must provide the following additional information for each future year requested, in as much detail as possible:

• Conference topic(s);
• Tentative dates, locations, and participants; and
• Contingency plans for future conferences dependent upon, for example, the outcome of the first year’s conference or developments in the field.

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:

• All applications, regardless of the amount of direct costs requested for any one year, should address how relevant resources (e.g., reports, white papers, draft standards) resulting from the conference will be shared with the public.

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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow our Post Submission Application Materials policy.

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 this conference address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these endeavors on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: If the aims of the application are achieved, how will the activities advance the mission of the BD2K program? How well do the goals of the conference/scientific meeting align with those of the BD2K program? To what extent will the meeting enable cross fertilization with BD2K activities?

Investigator(s)

Is(are) the PD(s)/PI(s) well suited for organizing and fulfilling the goals of this conference? Are the qualifications and past performance of the PD(s)/PI(s) appropriate, and are they well suited for their described roles in the conference? Are the key personnel and selected speakers appropriate and well suited for their described roles in the conference?

Specific to this FOA: How appropriate are the PD(s)/PI(s) roles and involvement with the data science-related organization for ensuring that the meeting will reflect the goals and governance principles of that organization?

Innovation

Does the conference employ novel approaches or methods to fulfill its purpose? Does the conference draw together appropriate experts who may otherwise not have an opportunity to meet?

Approach

Are the format and agenda for the conference appropriate for achieving the specified goals? Is the conference timely for the subject matter? For applications designating multiple PDs/PIs, is the Leadership Plan approach, including the designated roles and responsibilities, governance and organizational structure consistent with and justified by the topics of the conference and the expertise of each of the PDs/PIs?

Specific to this FOA: How strong are the plans for publicizing the conference to all interested participants and/or for publishing the proceedings (if applicable)? How well does the application identify related conferences held on the subject during the past 3 years and justify the need for the proposed conference? How appropriate are the proposed types of speakers for their described roles in the conference/scientific meeting?

Environment

Is the conference site appropriate? Does the applicant organization have the ability to contribute to the probability of success? Do the proposed meetings, exhibits, interactions, etc., take advantage of unique features of the environment or employ useful collaborative arrangements? Is institutional support evident?

Specific to this FOA: How well does the data science-related organization's mission and history support a focus on biomedical data science? How well does the applicant organization focus on community driven processes (e.g., open participation and broad outreach to relevant stakeholders, bottom-up priority setting and governance)? How does the organization's mission align with the broad objectives of the NIH Big Data to Knowledge (BD2K) program?

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.

Appropriate Representation

How well do the plans for inclusion of women, racial/ethnic minorities, persons with disabilities, and other individuals who traditionally have been underrepresented in science provide for their appropriate representation in the planning, organization, and execution of the proposed conference? For more information, visit Inclusion of Women, Minorities and Persons with Disabilities in NIH-Supported Conference Grants.

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Children

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

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.

Provision of Family Care Facilities

Are the plans to inform attendees about family care resources adequate?

Not Applicable

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

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)

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.

All applications will be assigned to NCI. 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 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. 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. All awards will be administered by NCI on behalf of BD2K.

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

• Defining objectives of the conference and approaches to its development;
• Planning the conference organization, including, as appropriate, inviting scientific leaders;
• Providing administrative and organizational support to scientific leaders of the conference, invited speakers, and other conference participants; and
• Overseeing or participating (as appropriate) in analyzing conference impact, preparing conference reports, summarizing the results/interpretations/conclusions, and/or facilitating the publication of such information if desirable.

Awardees will retain the primary rights to information and other resources developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

Awardees are responsible for identifying specific milestones for conferences that will be supported during the project period, when multi-year conferences are supported.

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

The NIH Program staff members from respective Institutes/Centers will be assigned to awards resulting from this FOA as "Project Scientists". These Project Scientists will have substantial scientific and programmatic involvement during the conduct of this activity through technical assistance, advice and coordination that is above and beyond the normal stewardship role in awards.

The Project Scientists will be expected to assist the awardees in various aspects relevant to the award, such as:

• Serving on Working Group of the U13 award BD2K Program;
• Serving as liaisons, as needed, to additional expertise, resources, etc., that might be needed;
• Assisting the awardees in various scientific and organizational aspects of the conference as appropriate:
• Helping optimize the content of the meeting and planning the agenda;
• Suggesting potential speakers;
• Participating in the assessment/acceptance of submitted conference presentations; and/or
• Assisting the awardees, conference organizers, invited speakers, and conference attendees in other ways as needed for the goals of the initiative.

Note: Project Scientists will not serve as invited speakers at the conferences to be supported under this FOA.

Additionally, an NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the U13 award. The Program Official will be named in the award notice.

Areas of Joint Responsibility include:

The PDs/PIs of the U13 awards under this FOA will form, together with the NIH Project Scientists involved, a Working Group for the program of "BD2K Support for Meetings of Data Science Related Organizations". Other related NIH-BD2K staff members may also participate in this group as appropriate. The NIH Project Scientist(s) will initiate the formation of the Working Group and will facilitate its activities.

The primary roles of the Working Group will be to:

• Serve as an interface between the individual U13 awardees funded under this FOA and appropriate NIH (and, more specifically, BD2K) staff, programs, and resources;
• Assess scientific progress of the entire meeting support program, identify new opportunities, priorities, etc.;
• Discuss policy recommendations for areas applicable to all conferences supported (e.g., regarding guidelines for publication of conference materials); and
• Harmonize other activities relevant to all individual projects (conferences) collectively.

The meetings of the Working Group will take place as needed (in person, virtually, or by teleconference).

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 arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Coordinating Group 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 arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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: http://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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)

Telephone: 301-945-7573

To request permission to submit, all prospective applicants must contact:

David Contois
National Cancer Institute (NCI)
Telephone: 240-276-6447
Email: [email protected]

Steven Cole
National Cancer Institute (NCI)
Telephone: 301-496-1045
Email: [email protected]

Mark Caprara, Ph.D.
Center for Scientific Review (CSR)
Telephone: (301) 613-5228
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

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

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