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 Funding Opportunity Announcement (FOA), under the Big Data to Knowledge (BD2K) initiative, is to provide time-limited, catalytic support for standards-related activities in areas relevant to the NIH basic, translational, and clinical research mission.

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 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).

BD2K supports a variety of related efforts designed to enhance the utility of biomedical big data.

As part of that larger effort, this FOA focuses on making data more FAIR (Findable, Accessible, Interoperable and Reusable) by promoting and facilitating the use of data and metadata standards.

One of the goals of this program is to establish a repository of software developed under this program. Once implemented, funded individual projects are expected to deposit their software including the source codes and documentations at the repository, allowing centralized access and dissemination, consistent with achieving the goals of this program.For the purpose of this FOA, data and metadata standards are documented agreements on representation, format, definition, structuring, tagging, transmission, manipulation, use, and management of data. They can also be thought of as rules to describe how data are recorded. These include data exchange, data format, and data semantics. Throughout this FOA, the term data standard will be used to refer to all of these standard types.

All standards developed, extended or otherwise enhanced through BD2K grants are to be registered with a curated, searchable portal (e.g., BioPortal or BioSharing, or similar resource).

Data standards are essential to ensure high-quality data and to enable broad data sharing and reuse of data generated across the full spectrum of NIH-supported research, from single investigators conducting R01-driven research to large collaborative networks and consortia. As the following examples illustrate, data and metadata standards come in many different shapes and sizes, but all share the goal of enabling description, exchange, and sharing of data:

1) The epidemiologist who is conducting a collaborative analysis using data from several studies and needs data standards that were developed to harmonize collection and representation of risk factor data;

2) A clinical trials researcher who relies on a terminology data standard for representing information in the electronic health records of study participants, and needs a data exchange standard for sharing brain imaging data among collaborating sites;

3) A laboratory scientist who uses two chromatography instruments obtained from different vendors and could benefit from a technical data standard that enables communication and data interchange between these instruments;

4) Investigators using structured data from patient registries who need to rely on terminology standards to conduct natural history studies and other biomedical studies across different diseases.

NIH recognizes the importance of community engagement throughout the process of the standards lifecycle, from initial identification of the need for the standard to technical development or extension through dissemination, and evaluation of the utility of the standard in the research setting. Within this context, community encompasses a broad range of stakeholders who may be engaged at various points throughout the lifecycle, including technical developers, librarians, science domain experts, researchers, information scientists, vendors, funders, publishers, patient advocacy groups, and other end-users.

This FOA is intended to address important issues concerning, and gaps in, the lifecycle of data and metadata standards. Several important themes emerged from the issues raised by respondents to a Request for Information (RFI) and participants in two workshops, most of which identify social and technical challenges. The summaries from the Frameworks for Community-based Standards Efforts Workshop in 2013 can be found here and for the 2015 Community-based Data and Metadata Standards Workshop, here. Themes identified from responses to the RFI included that duplication and overlap in standards were the norm and not the exception, in part due to difficulties in discovering information about existing standards work. There were also concerns about long-term sustainability and maintenance of standards. Many who responded noted the critical ingredients of transparency, collaboration, and engaging diverse communities. The problems that arise associated with unpaid (and often unrecognized) volunteerism were cited multiple times, too. Finally, gaps in how the usefulness of standards is evaluated, was noted. Overall, the responses matched well with what has been learned in the past from individuals engaged in standards development.

Having evaluated the summaries from the workshops in 2013 and 2015, as well as the responses to the RFI, a list of standards-related development activities, for which additional effort is needed, was developed. The list follows, but is NOT exhaustive; applicants may propose other necessary activities:

1) Initiation, establishment of stakeholders/working group(s), establishment and refinement of technical requirements/use cases;
2) Harmonization or mapping of standards for use by a community or to bridge use by multiple communities;

3) Technical development, extension, and/or adaptation of the standard(s), including any tools to implement and/or facilitate use of the standard for example, adaptation or use of BD2K-supported CEDAR (Center for Data Annotation and Retrieval) tools to facilitate creating or harmonizing metadata standards in a new research domain;
4) Validation and 'fit for purpose' testing of the standard; iterative refinement of the standard based on end-user feedback; comparison of performance against other relevant standards;

5) Development of appropriate metrics and an overall evaluation plan to assess the impact of the data standard;

6) Development and implementation of dissemination strategies to maximize awareness, accessibility and uptake of the standard and associated tools;

7) Engagement with appropriate partners to develop a long-term plan for maintaining and sustaining the standard.

This overall program is intended to provide time-limited and catalytic support for a diverse array of standards development activities that address unmet needs. It is expected that the need to develop a standard de novo will be extremely rare and that most projects will adapt/refine/extend existing standard(s). The support provided through this FOA is not intended to replace existing standards resources and infrastructure available to facilitate standards efforts over the lifecycle. Rather, projects funded through this FOA should capitalize on existing public and/or private resources and identify organizational partners and support mechanisms that may be available to enable continued development and maintenance of the standard. The project will need to have in place a plan for evaluating the intermediate and longer-term product(s) of the standards development activities and the short and long-term impact of the standard.

This FOA supports both short-term and longer-term projects. For example, a high-impact project to extend an existing terminology in a particular subdomain to adapt it for use in a new community might be accomplished in four months with a relatively modest level of effort. Similarly, establishment or refinement of technical requirements or use-cases might be accomplished in 6 months. On the other hand, a project to implement, deploy, test and get community feedback/validation for a tool to facilitate mapping research data elements for use in aggregating data from multiple studies might be considerably larger and require more than 1 year’s funding

Please visit the Frequently Asked Questions (FAQ) site for answers to questions that might arise.

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

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 not 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)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Mark Caprara
Telephone: 301.613.5228
Email: [email protected]

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.

All instructions in the SF424 (R&R) Application Guide must be followed. The PD/PI and a limited number of key collaborators should allocate travel funds in the budget for participation in a yearly BD2K All-Hands Meeting. Awardees will also be expected to participate in BD2K-related teleconferences and/or working groups that align with their projects.

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: Applicants must address each of the following elements:

Summary of benefit. Outline the need for and impact of the proposed work to the community in a purpose statement. Describe methods used to identify existing standards resources for the targeted data type, including efforts currently under development. Include the basis for determining deficiencies in existing resources, or efforts, for meeting the stated purpose. Describe specific impacts and benefits of the work (short and long-term and how the project will progress through the lifecycle). How will this work help to promote FAIR principles, i.e., make research data Findable, Accessible, Interoperable, and Reusable?' Describe if the application builds on an existing standard. If not, is there a need for a new standard? Describe and justify how the proposed effort does not duplicate currently funded work.

Action plan. Describe the overall standards-related effort that is proposed during the project period, the component activities, their relationships to one another. Provide a timeline of proposed activities. The proposed project should describe progress along the standards development lifecycle, from the start of funding to the end of funding. Describe how the project funded through this FOA would capitalize on existing public and/or private resources and identify organizational partners and support mechanisms that may be available to enable continued development and maintenance of the standard. If the project described does not adapt/refine/extend existing standard(s), please justify the need to develop a standard de novo. Describe how any standards developed, extended or otherwise enhanced through grants awarded through this FOA will be registered with a curated, searchable portal (e.g., BioPortal or BioSharing, or similar standard resource).

Harmonization and alignment. As appropriate, list existing and/or developing resources relevant to the proposed work. Identify relationship/interactions with other relevant standards resources and alignment of proposed work to these resources.

Community engagement. Identify the various stakeholder groups, (considering both standards groups and related research fields/data types) their specific roles in the proposed standards development activities and overall approach that will be used to sustain community involvement throughout the project period.

Governance plans. Describe the governance model for the proposed activities, including roles, responsibilities and processes for communication, policy development, decision making, and oversight.

Metrics and dependencies. Describe metrics for measuring progress for each proposed activity and the quality of interim products. Highlight known risks and any dependencies that may impact successful completion of the proposed project/program.

Sustainability and succession plans. Describe how the standards effort will continue after the project period (e.g., updating, curating, and evolving). As appropriate, identify entities and mechanisms of sustainability. Identify where standards will be found and accessed.

Evaluation. As part of good program management, NIH assesses the implementation, effectiveness, and diversity of its programs using evaluation tools and techniques. Grantees may be asked to provide information (e.g., respond to survey questions) for program evaluation purposes, both locally and at the national level. Such information may be used in evaluations of the projects and BD2K Standards Program. As stated earlier, the project should also have in place a plan for evaluating the intermediate and longer-term product(s) of the standards development activities, and the short and long-term impact of the standard.

Letters of Support: If appropriate, provide letters of support documenting community interest in participating in the project.

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 modifications.

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

Dissemination/outreach plan. Describe strategies for raising awareness of the project and engaging a diverse group of stakeholders in the relevant research communities. How will the standards be shared and publically available? Acknowledge the need to ensure coordination and leveraging of relevant standards resources along with NIH efforts, by attending a yearly BD2K All-Hands Meeting. Awardees will be expected to participate in BD2K-related teleconferences and/or working groups that align with their projects.

All standards developed, extended or otherwise enhanced through grants awarded through this FOA must be registered with a curated, searchable portal (e.g., BioPortal or BioSharing, or similar standard resource.

Software Dissemination Plan

A software dissemination plan, with appropriate timelines, is expected to be included in the Resource Sharing Plan(s) in the PHS398 Specific Research Plan Component to meet the goals of this initiative. Grantees are entitled to limited software copyright protections and institutional software licensing agreements.

There is no prescribed single license for software produced under this FOA; however reviewers will be instructed to evaluate dissemination plans which should be consistent with the following guidelines:

• The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
• The terms of software availability should include the ability of 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 customizations of their tools and resources that are contributed by others. This proposal may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

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.

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? Will this work help to promote FAIR principles, i.e., make research data Findable, Accessible, Interoperable, and Reusable?' Is there a compelling benefit for this standards-related effort? Does the application describe how the project funded through this FOA would capitalize on existing public and/or private resources and identify organizational partners and support mechanisms that may be available to enable continued development and maintenance of the standard, tool, or resource? Is this effort likely to have a significant effect on the field or on the data type? Does the purpose of the standard effort meet a need in the scientific community? How will this effort relate to other standards resources in an ongoing way?

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? Are appropriate relationships/interactions with standards resources defined?

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? Note: For the purposes of this initiative, innovation is defined as applying to the purpose of the effort and not necessarily the methods applied. The approach to moving the standard along its lifecycle (e.g., through extending, promoting adoption, helping harmonize, or evaluating a standard or set of standards) can be based on existing approaches and methods.

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? Does the overall standards-related effort proposed include the component activities and their relationships to one another, a timeline, and the key individuals' activities-related expertise? Is a convincing case presented for the insufficiency of existing standards or efforts for the purposes for which this effort is intended? Does the proposed project progress along the standards development lifecycle, from the start of their funding to the end of funding? Has a list of existing/developing resources relevant to the proposed work been provided? If so, are the relationships and interactions described? Is a diverse group of stakeholders identified and plans for engagement of stakeholders appropriate? Is the scientific community interest documented? Are plans for governance of the standards effort appropriate? Are the metrics identified for measuring success appropriate? Are the risks and dependencies described? Are plans for dissemination and outreach of the standards effort appropriate? Are plans for assessing the impact of the effort appropriate? Are sustainability and succession beyond the project period addressed sufficiently (i.e., are the entities and mechanisms of sustainability identified)? Is there an evaluation plan?

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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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).

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 Research, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Environmental Health Sciences Council. 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 will be considered by Program staff when making funding recommendations.

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.

In making such considerations, 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

Not Applicable

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: 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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-435-0714

Cindy Lawler
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919.316.4671
Email: [email protected]

Mark Caprara
Center for Scientific Review (CSR)
Telephone: 301.613.5228
Email: [email protected]

Barbara Gittleman
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0585
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.