NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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) will support Biomedical Technology Research Resources (BTRRs) in a variety of areas of biomedical science. (BTRR and Resource are used interchangeably throughout this FOA.) The program has recently been evaluated and the final report is available on the NIGMS BTRR home page (https://publications.nigms.nih.gov/btrrs/searchresults.asp). Several important changes have been made to simplify and clarify the application and review process, and to improve the flexibility of individual Resources and the program as a whole. The program continues to focus on two goals: the development of enabling technologies, and sustainable access to those technologies for the research community. These goals are addressed through three components of each center: Technology Research and Development (TR&D), Driving Biomedical Projects (DBPs), and Community Engagement (CE).

Technology Research and Development (TR&D) is the central activity of a BTRR. Research teams create critical, often unique, technologies at the forefront of their respective fields. In support of that mission, the Resources are structured to foster two kinds of collaborations: dynamic, short-term Technology Development Partnerships (Partnerships) with other technology developers, where appropriate, will enable the Resource to adopt and incorporate emerging capabilities in rapidly evolving fields. BTRR investigators must be able to recognize significant parallel contributions by other technology developers, determine whether collaboration is appropriate, and if so, establish mutually beneficial partnerships. While a BTRR is expected to operate at the leading edge of a technology area, it is important to recognize and exploit advances emerging from other academic research groups.

Similarly, Driving Biomedical Projects (DBPs) are biomedical research test-beds that allow BTRR investigators to test nascent technologies in the context of challenging problems in basic, translational, and clinical research, while providing biomedical researchers with the earliest possible access to these emerging tools. A deep understanding of needs and opportunities in the relevant areas of biomedical research is an essential prerequisite for all technology development. In a BTRR, this understanding is most clearly expressed through successful engagement of those researchers best positioned to benefit from early access to emerging tools.

BTRR investigators are expected to actively engage both researchers who are developing technologies relevant to the Resource’s mission, and the scientists in the community whose research may benefit from these emerging technologies. However, the BTRR should not merely integrate and offer access to technologies developed elsewhere. A BTRR is expected to develop leading technologies that will significantly impact a broad community of biomedical researchers, and through leadership within the relevant communities, support the integration of those technologies into the larger context of the relevant field. A successful BTRR will establish and maintain a leading role in the development and early application of important enabling technologies. NIGMS expects that most Research Resources will not be renewed beyond three cycles.

The relatively stable and substantial support of a BTRR allows researchers to address the full range of technology development, including early stage, high risk projects, iterative improvement in the context of challenging real-world problems, and the refinement and optimization of technologies to improve performance and promote the broadest possible dissemination and adoption. The success of BTRR-supported technology development is ultimately measured by adoption in the broader biomedical research community. It is essential that technology development be carried through to completion, including the optimization and dissemination of tools with strong potential for continued impact.

The technology development mission of a BTRR should be characterized by a focus on genuine completion of the development cycle for each promising technology, in a timely manner, and a drive toward obsolescence of the BTRR through ubiquity of the developed technology within the community.

Achieving sustainable community access to the technologies developed by a Resource is critical to the success of the BTRR program. The funding lifetime of a BTRR will in most cases not continue beyond fifteen years. Over that time, there should be multiple overlapping cycles of innovation, maturation, and dissemination of technologies that enable biomedical research in a continuing, sustained manner. In discussing the sustainability of Resource technologies, it is important to recognize that the goal of the program is to make the technology itself available on a sustainable basis, rather than making the Resource per se self-sustaining. The ultimate goal of a Resource should be to change the way researchers use and think of a technology that it is integrated into the relevant fields and spreads well beyond its origin. A successful resource can eventually make itself superfluous.

Resources promote the adoption and use of technologies through a robust program of Community Engagement (CE). Ultimately, the approach to community engagement is largely left to the discretion of the Resource Program Director/Principal Investigator (PD/PI). It is understood that some technologies are more readily shared, replicated, or commercialized than others, and unique constraints may dictate unique approaches. Further, BTRR investigators are encouraged to use novel, creative approaches to engage different segments of the biomedical research community. The phrase 'community engagement' describes a process, rather than the goals of that process. The process is emphasized because active engagement with the research community is central to achieving those goals, which are to provide the broadest possible access to emerging technologies, both within and beyond the Resource, moving those technologies out into the community as quickly and effectively as possible.

Active engagement of the relevant biomedical research community is essential for development of an informed, competent user base who can subsequently adopt the technology as it moves out of the Resource. This includes access to the technology as it matures within the BTRR, direct hands-on training in data acquisition and interpretation, and to the extent possible, availability of the technology outside the Resource. Technologies are moved out of the Resource quickly to promote the broadest and most sustainable availability possible.

Details concerning current BTRRs can be found at https://publications.nigms.nih.gov/btrrs/. The BTRR program is investigator-initiated. Applications in a wide range of biomedical technologies are welcome. New applicants are strongly encouraged to submit a pre-application (see PAR-17-315). The pre-application process provides feedback regarding appropriateness for this program and competitiveness of a potential application.

The National Institute of Biomedical Imaging and Bioengineering (http://www.nibib.nih.gov, NIBIB) has a similar program that supports Biomedical Technology Resource Resources. Details about that program can be found at https://www.nibib.nih.gov/research-funding/biomedical-technology-resource-centers. Applicants who are interested in submitting an application to the NIBIB program need to follow the NIBIB application procedures rather than those in this announcement. Applicants are encouraged to investigate both the NIGMS and NIBIB programs, and contact Institute staff, who can determine which program is a better fit for their proposed center.

Technology Research and Development: A BTRR may focus on advancement of a single technology area or the development of an integrated approach to a general class of problems. (See the NIGMS BTRR program web page for numerous examples of each type of Resource.) BTRRs may be developed in a specific technological area. For example, a Resource might focus on instrumentation and methods development for a specific instrument type. In contrast, a Resource may integrate multiple technologies to create transformative approaches to a class of research problems.

Regardless of the scope of the TR&D activities undertaken, a BTRR is an inherently multidisciplinary enterprise, requiring a range of specialized expertise to address complex technical and biomedical challenges. For example, these projects may involve development or significant modification of instruments and associated control and data analysis systems, development of new computer algorithms and related software, new physical or chemical methods to prepare samples for analysis, new reagents, or development of innovative applications through the integration of existing technologies.

While the historical focus of the program has been the invention, development, and adaptation of technologies rooted in the physical and mathematical sciences, such as major instrument platforms or data visualization and analysis software, technology rooted in biological and molecular sciences are also appropriate. Regardless of the specific technologies involved, the essential common feature of a BTRR is the assembly of a critical mass of both technological and intellectual resources with the intent of developing and exploiting advances in technology and methods for biomedical research.

These Resources create tools that can substantially improve present approaches to a wide variety of problems in the biomedical sciences. A successful BTRR will drive a virtuous cycle in which technological advances facilitate biomedical inquiry, leading to new questions which in turn motivate further technical innovation. This is accomplished through a synergistic interaction of technical and biomedical expertise, both within the Resources and through intensive collaborations with other leading laboratories. Ideally, these Resources identify opportunities for transformative technological advances that open new lines of biomedical inquiry. They also should be uniquely positioned to recognize biomedical research problems that are solvable by the creation of new tools. This intense synergy between technology development and community-driven biomedical problem-solving defines the Resources as fundamentally different in character from laboratories engaged in research projects that may have more narrowly defined, inwardly-focused goals.

Driving Biomedical Projects: Development of new biomedical research tools is most effective when pursued in the context of challenging problems. A BTRR, by virtue of its latitude to pursue the full spectrum of technology development, can fully exploit the benefits of test-bed biomedical projects as nascent technologies evolve. The Driving Biomedical Projects (DBPs) of a BTRR are a set of biomedical research projects that will be pursued by the Resource in collaboration with outside investigators to provide a context for the demonstration, integration, and refinement of Resource technologies. This collection of projects is an essential aspect of a BTRR's mission, and a significant investment of time and effort by the Resource.

DBPs are collaborative projects. Resource personnel are expected to work jointly with investigators outside the Resource who have expertise in a particular biomedical discipline, and have reached a point in their research where the availability of new technologies offers significant benefits. The BTRR should support the work done in the Resource. However, the collaborating investigators may not receive financial support from the Resource for the work that they do in their laboratory.

DBPs should be selected on the basis of both their potential for significant biomedical impact and their appropriateness as test beds for new technology. A DBP should either: (a) present an opportunity to clearly demonstrate the significant impact of technologies under development in the Resource, or (b) represent a research problem hindered by a significant technical challenge that motivates the Resource’s technology development, driving it forward. Realistically, in most cases, DBPs will function in both of these roles: if not simultaneously, then at different stages in the virtuous cycle between technology development and biomedical inquiry. The selected biomedical research projects should present substantial technical challenges providing the opportunity for an iterative push-pull relationship to develop between TR&D and the DBPs, advancing both. Such efforts are expected to lead to joint publications. For new Resources in particular, it is sometimes difficult to envision short-term impact of technology development on DBPs because the new tools are still being developed. DBPs are test-bed projects, and will often require substantial iterative feedback between the Resource and collaborators, even to establish sample requirements and experimental parameters. Impact of technologies will generally evolve gradually as these parameters are clarified and the complexity of experiments increases. DBP collaborators are characterized by a willingness to persevere through early failures in order to benefit as early as possible from the successful application of emerging technologies.

Community Engagement: A BTRR is expected to serve as a resource for the biomedical research community and must have a national impact. Leadership of a Resource must include a clear vision for the relevance and potential impact of the technologies under development, and a strong desire to realize that vision through active engagement of the biomedical research community. This intense focus on Community Engagement (CE) activities sets the BTRR program apart from other NIH research centers. For a BTRR to be successful, Resource staff must actively work with researchers who need access to technology and expertise, including hands-on training for outside investigators. The Resource must also invest effort in achieving genuine dissemination of the technology and methods it has developed. These efforts require the commitment of significant financial and personnel resources to activities outside of their primary research focus. Providing other investigators with ready access to Resource tools and expertise has a substantial impact on the administration and daily operation of the laboratory.

Substantive, ongoing efforts to disseminate technologies and train non-specialists in their use require a fundamentally outward-looking philosophy, as well as enthusiasm for engaging the research community. The goal of these efforts is, so far as is possible, to export the technology and expertise of the Resource into the community, achieving a broader impact on biomedical research than would be possible through the projects in which the Resource can participate directly. Industrial partnerships are not required, but they are welcome when appropriate. Ultimately, the CE elements of the Resource should aim for the widespread and routine application of the technologies being actively disseminated. An extended technology development cycle might require a Renewal application for full feasibility, maturation and community adoption. However, it is expected that most Research Resources will not be renewed beyond three cycles and all Renewal applications will require a sustainability plan.

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

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

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).

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (use for Administration and Management)	6
Tech R and D (use for each Technology Research and Development Project)	6
Driving Bio Proj (use for Driving Biomedical Projects Portfolio)	6
Comm Engag (use for Community Engagement)	12

Additional page limits 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 a multi-component application.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

• Overall: required
• Administration and Management: required
• Technology Research and Development Projects: required, maximum 5
• Driving Biomedical Projects Portfolio: required, maximum 1
• Community Engagement: required, maximum 1

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the overall aims of the proposed Resource.

Research Strategy: Provide an overview of the proposed BTRR. Describe the rationale for the Resource and its anticipated impact on biomedical research. Discuss the technological theme(s) at the heart of the Resource that are intended to address those opportunities. Describe the complementary roles of the various Technology Research and Development (TR&D) projects in advancing technical capabilities. Discuss the Driving Biomedical Projects (DBPs), as well as broader strategies for Community Engagement (CE), explaining why the projects and plans presented in detail in the corresponding components of the application will position the BTRR to bring the subject technologies into broad use. This section should include an explicit discussion of the integration of all of the BTRR components to form a coherent whole which will effectively develop and share enabling technologies.

The Overall Research Strategy should present the rationale for the proposed BTRR. This includes the needs and opportunities in the research community that will be addressed by the Resource, the overall technical approach for meeting those needs, and why the proposed work is timely and potentially effective. The value of the proposed Resource should be discussed in the context of currently available technologies as well as other ongoing technology development efforts.

The projected arc of the Resource’s technology development program should be presented, placing the Research Strategy in that context and referencing plans for sustainability of the technologies, including how the proposed technology development plan will result in technologies that can be adopted beyond the Resource. This section should describe the complementary nature of the TR&D projects, including the rationale for inclusion of Technology Development Partnerships, if any.

This section should also describe the overall themes of the DBPs, the motivation for selection of the projects included in the application, and the expected interaction of the DBPs with the TR&D projects.

Provide an overview of the general approach to CE, and how the complementary elements of Collaboration & Service, Training, and Dissemination will be integrated to maximize the impact of the Resource. Describe in broad terms the special constraints or opportunities for CE that are presented by the nature of the technology being developed. This section should describe, in light of those factors, the overall philosophy and broad plans to accomplish the elements of CE.

The Overall Research Strategy should include an annotated timeline that describes how the various projects relate to one another and the target dates for availability of technologies. This is intended only to describe the research plan and should not be interpreted by applicants or reviewers as a series of milestones. Challenging technology development projects are not always predictable.

This section should include preliminary data that is broadly supportive of the technological approach, if appropriate. In Renewal applications, this component should also include a progress report describing the major advances and national impact achieved in the previous performance period. However, specific progress in each of the component areas (TR&D, DBPs, CE) should be included in those components when appropriate.

Progress Report Publication List: For renewal applications, the title and complete references to all publications, manuscripts accepted for publication, patents, and other referenceable materials that have resulted from the BTRR since it was last reviewed competitively must be included in the publication list. All publications directly resulting from BTRR funded effort must explicitly acknowledge support from the BTRR award, and be included in the publication list. These publications should be distinguished from those that do not benefit directly from BTRR funding. See Appendix instructions below.

Letters of Support: All letters of support should be included in the most relevant component, and should not be duplicated. Letters applicable to the entire application, such as those expressing institutional support, should be included in the Overall component. Letters of support from investigators specifically collaborating with Resource investigators on any TR&D, DBP, or other projects described specifically in the application should be included in the respective component. The purpose of letters of support is to describe the nature of the collaborative relationship, including its scope, and any special circumstances (e.g. materials or technology transfer, or intellectual property agreements). Do not include letters of support from resource users whose interactions are limited to activities described in the CE component.

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 a Data Sharing Plan. Detailed plans for active recruitment of collaborators and sharing of intellectual and technological resources is a fundamental aspect of any BTRR. Plans should be briefly described here, referring the reader to the salient Components of the application.

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 with the following modification.

The application may include a list of publications indirectly resulting from effort in the Resource. This is not required. Indirectly-supported publications include work that benefited from the existence of resources developed by the BTRR, but involved no active engagement or effort by the Resource. An indirectly-supported publication might, for example, cite the use of Resource-developed software downloaded and used independently by a non-Resource investigator. These publications may be listed as evidence of the secondary impact of the BTRR, beyond the investigators actively working with the Resource. This is a measure of the effectiveness of the center’s Community Engagement efforts and the value of Resource technologies in the broader community.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

When preparing your application in ASSIST, use Component Type Admin Core.

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

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field. The PD/PI must serve as the Project Lead of the Administration and Management component'
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

The PD/PI is required to dedicate a minimum of 3 person months effort to this program.

Funds should be requested in the Consultant Costs category of the budget for support of External Advisory Committee (EAC) member travel expenses for the annual EAC meeting. The funds will be restricted for this purpose, and may not be re-budgeted without prior approval by program staff.

Equipment that will be applicable beyond a single project should be requested in the Administration and Management component. A justification should be supplied for the equipment requested for the Resource. Price quotes should be included for major items of equipment costing more than $25,000. The budget justification section should include an evaluation of alternative instruments or manufacturers along with a discussion of the proposed procurement plan.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the aims of the Administration and Management functions of the proposed center.

Research Strategy: This section should be broken down into: Organizational Structure and Staff Responsibilities, Resource Operating Procedures, the External Advisory Committee (EAC) and Sustainability Plan.

Organizational Structure and Staff Responsibilities: Describe the organizational structure of the BTRR. Indicate the relationship of the Resource to the administrative structure of the applicant institution. Describe how the PD/PI and the proposed Resource staff will be organized with respect to the Resource components: each of the TR&D projects, DBPs, CE, and Administration and Management functions.

Describe specific plans to ensure that the BTRR functions as a well-integrated multidisciplinary team, rather than a collection of separate laboratories or projects linked by a common thematic interest. It is expected that the PD(s)/PI(s) will provide leadership and direction to the key components of the Resource. This includes directing and coordinating the TR&D project leaders, overseeing the progress and turnover of DBP projects, and ensuring proper access to Resource resources through Collaboration and Service, Training and Dissemination activities. PD(s)/PI(s) are expected to be fully engaged in all of these activities.

If multiple PDs/PIs are proposed, the application must describe in detail the structural and procedural elements that will ensure this integration and prevent fragmentation of the center. Funds and personnel effort should not simply be divided among PDs/PIs who pursue their respective aims independently. It should not be presumed that the best way to organize Resource projects is along organizational boundaries, or the boundaries between the research activities of the individual PDs/PIs. The organizational structure of the Resource, particularly the TR&D projects, should be carefully justified. This is distinct from the mPD/PI Leadership Plan because the focus here is on the rationale for the organization of the research projects independent of the individual leaders involved. That is, this section should address the scientific rationale for the organization of the projects themselves and why it is justified on a basis other than the boundaries between research groups.

Resource Operating Procedure: Describe operating procedures and policies planned for the Resource. Include criteria and mechanisms to review requests for the use of the equipment and facilities in the Resource and to schedule that use once it has been approved. Describe criteria and process for prioritizing and selecting any collaborative projects, such as Technology Partnerships, DBPs, or if applicable, Collaboration and Service projects. Include instructions on how users are to acknowledge support provided by the Resource in any resulting publications.

External Advisory Committee: Each BTRR must have an External Advisory Committee (EAC). The EAC is appointed by the PD(s)/PI(s) and advises the PD(s)/PI(s) on future directions for the Resource, particularly in planning additional grant applications and in setting priorities for allocation of Resource facilities. The committee chair should be knowledgeable about the Resource's technology and the science it serves, but should not be a member of the Resource staff or a major user of the Resource. Other committee membership should be balanced among scientists knowledgeable about the Resource s technology, experts in its application to biomedical research problems and users of the technology.

EAC members and the chair should be from outside the host institution. NIGMS encourages the inclusion of scientists who are not affiliated with the Resource; however, inclusion of collaborators on the EAC is not prohibited. Membership should be rotated periodically. The EAC should meet at least annually and prepare a written report of its recommendations, addressed to the PDs/PIs.

In this section of the application, the role of the EAC should be described. The committee's role in advising on instrument purchases, Technology Partnerships, reviewing DBP and other collaborative and service projects for merit and appropriateness, allocating instrument time, and on the research plans for the BTRR should be presented. In Renewal applications, names of current committee members and a brief description of their qualifications should be included. For applications for new centers, potential EAC members must not be contacted or appointed prior to completion of the submission, review, and funding process, and should not be named in the application; however, the scientific disciplines of anticipated committee members that would be represented on the EAC should be described. If an EAC was already constituted before the applicant began preparation of the application, the membership of that committee must be disclosed in the application.

A local executive committee or other local committee appointed to deal with specialized topics may be proposed as an adjunct to the EAC. The function and meeting schedule for these committees should be described in this section.

Sustainability Plan: Bearing in mind that NIGMS expects that most Research Resources will not be renewed beyond three cycles, for both New and Renewal applications, this section of the application should address the long-term plans for achieving sustainable community access to Resource-developed technologies and metrics for determining success of these plans. Sustainability in the context of this program refers to continuing, long-term access to and adoption of technologies and related resources beyond the life of the BTRR. Many specific details of sustainability are addressed elsewhere. This Sustainability Plan should deal directly with the anticipated lifetime of the BTRR and the sustainability of the technology beyond that point. If there are insurmountable obstacles to sustainability beyond the BTRR, a rationale for continuation of the Resource may be presented here.

Letters of Support: All letters of support should be included in the most relevant component, and should not be duplicated. Letters applicable to the entire application, such as those expressing institutional support, should be included in the Overall component. Letters of support from investigators specifically collaborating with Resource investigators on any TR&D, DBP, or other projects described specifically in the application should be included in the respective component. The purpose of letters of support is to describe the nature of the collaborative relationship, including its scope, and any special circumstances (e.g. materials or technology transfer, or intellectual property agreements). Do not include letters of support from resource users whose interactions are limited to activities described in the CE component.

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.

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.

PHS Inclusion Enrollment Report (Administration and Management)

Not Applicable.

When preparing your application in ASSIST, use Component Type Tech R and D.

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

SF424 (R&R) Cover (Technology Research and Development Project)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Technology Research and Development Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Technology Research and Development Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Technology Research and Development Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Technology Research and Development Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Technology Research and Development Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Support should be requested for all research and project management activities related to the project. If one or more Technology Development Partnerships is anticipated, and activities conducted outside of the BTRR in the collaborating laboratories or personnel associated with the collaborating laboratories will be supported by the BTRR grant, funds should be requested through a consortium subcontract.

PHS 398 Research Plan (Technology Research and Development Project)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the specific aims of this Technology Research and Development Project.

Research Strategy: Describe the goals of the Technology Research and Development (TR&D) project. Together, the TR&D projects are the central focus of the BTRR application and serve as the foundation for all other Resource activities. Present the Research Strategy in sufficient detail for critical evaluation of the both the quality of the research and the role of the project in the overall Resource. Describe why the TR&D project is at the cutting edge of the technological field, with a goal of increasing the technology’s impact on biomedical research.

The Research Strategy should address the background and rationale for the project, its significance, and methods. All related DBP(s) should be listed for each TR&D project. It is expected that the TR&D projects will be related to each other and that the description of these projects will show synergy among them. This synergy may be related to multiple applications of a common underlying technology, or complementary approaches supporting a common goal. The application should describe the relationship and complementarity among these projects, and their support of the overall goals of the BTRR. The inclusion of any TR&D should be clearly supported by the overall rationale for the center.

Justify the approach proposed in light of potential impact, and present alternative approaches to solving technological problems in the event that the main conceptual thrust should prove unfeasible. Provide a rationale for the risk balance proposed. The nature and scope of a BTRR support the full spectrum of technology development, including early stage high-risk projects, iterative improvements to evolving technologies in the context of DBPs, and the refinement and optimization of technologies to foster their dissemination. As a group, the TR&D projects proposed for a BTRR should address all of these aspects. Elements of high risk (and potentially high payoff) are appropriate in the TR&D projects, but so are more straightforward optimization efforts.

For Renewal applications, new activities should be specifically identified. The development of new, innovative technologies and strong rationale for significant impact of technological R&D are important considerations in reviewing renewal applications. Long-term support of a Resource depends strongly on demonstrated commitment to the introduction and application of new technologies and to serving biomedical investigators on a national basis. However, it is expected that most Research Resources will not be renewed beyond three cycles.

A TR&D project may include, if warranted, plans for one or more Technology Development Partnership subprojects. A Partnership is appropriate if adopting an innovative technology being developed in another research group will significantly advance the TR&D program of the Resource. Explain plans for the Partnership and provide the supporting rationale. Partnership subprojects should be brief, generally one to two years, conducted as funding-neutral collaborations analogous to DBPs. Alternatively, Partnerships may be supported through redeployment of Resource funds as consortium subcontracts.

Partnerships anticipated at the time an application is submitted should be described. However, Partnerships may be initiated at any time during the grant period at the discretion of the PD/PI(s), consistent with NIH grant policy. It should not be expected that Partnerships will be supported through supplements to either laboratory, except under extraordinary circumstances. BTRRs have a long record of collaboration with industrial partners. In general, industrial partnerships are funding neutral, characterized by in-kind contributions of effort and equipment. The introduction of Partnerships as an optional element of the TR&D program of a BTRR should not be interpreted to suggest a change in the nature or implementation of industrial partnerships.

BTRR components must be integrated to form a coherent program. The two sections below must be included as specific subheadings in the Research Strategy section of each TR&D project.

Technology Development Integration: Describe the relationship of this TR&D project to the overall technology development program of the BTRR. Discuss the complementarity between this TR&D project and the other proposed TR&Ds.

Interaction with DBPs: Describe how the TR&D project is responsive to the emerging needs of the biomedical research community. To encourage synergistic interaction, DBPs serving as test beds for TR&D projects must be included in the application (see below). The relationship between TR&D projects and DBPs must be described explicitly for each TR&D project. Provide a brief discussion of which DBPs are enabled by the TR&D project. Note that a more detailed discussion of the entire TR&D program's impact on the DBPs as a whole is required in the DBP component of the application.

Describe plans for the optimization of technologies to a point where dissemination is realistic. Such plans should be incorporated in every TR&D project, across the entire TR&D program of the Resource. As appropriate, relate TR&D optimization plans to dissemination plans for the technologies.

A TR&D project should not focus on data collection. However, in some cases, modest sub-projects designed to generate data for use in technology development or testing may be included as a part of a TR&D project. Such projects should be included only when data to test tools, devices, or software are not available elsewhere, and they do not substitute for DBPs.

Letters of Support: All letters of support should be included in the most relevant component, and should not be duplicated. Letters applicable to the entire application, such as those expressing institutional support, should be included in the Overall component. Letters of support from investigators specifically collaborating with Resource investigators on any TR&D, DBP, or other projects described specifically in the application should be included in the respective component. The purpose of letters of support is to describe the nature of the collaborative relationship, including its scope, and any special circumstances (e.g. materials or technology transfer, or intellectual property agreements). Do not include letters of support from resource users whose interactions are limited to activities described in the CE component.

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.

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.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

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

PHS Inclusion Enrollment Report (Technology Research and Development Project)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

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

When preparing your application in ASSIST, use Component Type Driving Bio Proj.

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

SF424 (R&R) Cover (Driving Biomedical Projects Portfolio)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Driving Biomedical Projects Portfolio)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Driving Biomedical Projects Portfolio)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Other Attachments: The application must include a table of every DBP being pursued. For Renewal applications, DBPs from the previous funding period that are not continued in the Renewal application must also be included. Each entry in the table must include:

• The name of the primary collaborating investigator for the DBP
• The institution of the PD/PI
• The title of the project
• The name(s) of BTRR personnel involved with the project
• The TR&D project(s) with which the DBP interacts
• A concise statement of how the DBP acts as a driver or test bed for the BTRR’s TR&D program: provide rationale for the proposed approach to the problem and impact of the expertise of the BTRR investigators and technology on the project.
• Innovation: A concise statement of the technological innovations that will result from the DBP interaction with Resource TR&D and their implications beyond this project.
• Start and end (if applicable) dates for the DBP
• The external funding source and status of the project, including NIH grant number where applicable.
• For renewal applications only: publications that have resulted from the DBP

Project /Performance Site Location(s) (Driving Biomedical Projects Portfolio)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Driving Biomedical Projects Portfolio)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Driving Biomedical Projects Portfolio)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

The BTRR budget should support the work done in the Resource by BTRR personnel. However, the collaborating DBP investigators may not receive financial support from the Resource for the work that they do in their own laboratory.

PHS 398 Research Plan (Driving Biomedical Projects Portfolio)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the aims addressed by inclusion of the Driving Biomedical Projects and their rationale.

Research Strategy: This component of a BTRR should describe a set of biomedical research projects that will be pursued by the Resource in collaboration with outside investigators, including the overall themes of the biomedical research projects that constitute the basis for the DBPs, their driving relationship to the Resource technology development program, and the anticipated benefits of the collaborative interactions. The overarching purpose of a collection of DBPs is to provide a context for the demonstration, integration, and refinement of Resource technologies. This section of the application should describe how the DBPs together address that broad goal. The potential impact of the proposed technology development on these individual scientific problems should also be clear. The Research Strategy should focus on a broad discussion of the DBPs, their relationship to the TR&D projects, their selection, monitoring, and turnover, and the impact of the BTRR on these projects. Individual DBP projects must be listed in a table included in the Other Attachments section (see above).

It is expected that turnover in DBPs will occur during the project period. The rationale for selection of the DBPs included in the application, and a process for recruiting, selecting, and terminating DBPs should be presented in this section of the application. DBPs should be selected on the basis of both their potential for significant biomedical impact and their appropriateness as test beds for new technology. A DBP should either: (a) present an opportunity to clearly demonstrate the significant impact of technologies under development in the Resource, or (b) represent a research problem hindered by a significant technical challenge that motivates the Resource’s technology development, driving it forward. Realistically, in most cases, DBPs will function in both of these roles: if not simultaneously, then at different stages in the virtuous cycle between technology development and biomedical inquiry. The selected biomedical research projects should present substantial technical challenges providing the opportunity for an iterative push-pull relationship to develop between TR&D and the DBPs, advancing both. The Research Strategy should treat the DBPs as a whole, discussing the major biomedical research themes represented by the projects, the rationale for anticipated Resource impact in those areas, and in the case of renewal applications, demonstrated impact.

DBPs are collaborative projects. Describe plans for Resource personnel to work jointly with DBP investigators outside the Resource. For new Resources in particular, it is sometimes difficult to envision short-term impact of technology development on DBPs because the new tools are still being developed. DBPs are test-bed projects, and will often require substantial iterative feedback between the Resource and collaborators, even to establish sample requirements and experimental parameters. Impact of technologies will generally evolve gradually as these parameters are clarified and the complexity of experiments increases. DBP collaborators are characterized by a willingness to persevere through early failures in order to benefit as early as possible from the successful application of emerging technologies. Describe the planned approach to establishing and strengthening collaborative relationships with DBP investigators. For renewal applications, explain what has made these relationships successful.

Tripartite Driving Biomedical Projects: In some cases, a DBP may involve, in addition to the biomedical collaborators, additional technology partners. For example, a BTRR might develop software for data interpretation, in collaboration with both a laboratory gathering data and a biomedical investigator whose research problem forms the basis for the experiments. This is acceptable. In these cases, the role of each participant and the nature of the collaborations among them should be described in the context of the biomedical research problem that is serving as the DBP, and should be noted in the table listing the projects. However, details of collaborative technology development should be described in the relevant TR&D project components(s).

Purely technical collaborations focused on advancing some aspect of TR&D are not considered DBPs and should be included within the relevant TR&D project, either as a fundamental, ongoing element of that project, or, if transient, as a Technology Development Partnership. Collaborations with biomedical researchers that make use of the technology and expertise of the BTRR but are not intended to serve as either a primary driver or test bed for technology development should be included in the CE section (see below).

Describe the breadth and scope of the portfolio of DBPs engaged by the Resource. The DBPs should be broad in scope and involve a variety of biomedical research areas. The Resource is expected to be highly responsive to a national user community whose members are primarily grantees and contractors of other NIH programs. It is the Resource’s responsibility to identify user communities that both need and will use the research capabilities to be provided by the Resource. The scope of a BTRR’s portfolio of DBPs should be reflective of the breadth of the technology’s potential impact.

There is no specific number of DBPs expected in this component, but at least one must be included. Every TR&D project must have a driving relationship with at least one DBP. It is preferred that a DBP drive more than one TR&D project. In Renewals, the number and breadth (both scientific and geographic) of DBPs are expected to be richer than in new applications. Because BTRRs must demonstrate a national scope and impact, applicants are encouraged to seek out a significant number of DBPs outside their home institutions. However, it is understood that in many instances there are significant technical and logistical obstacles associated with distant collaborations (e.g., access to patient populations, or the need for repeated ready access to biological materials). In exceptional cases where a majority of DBPs are local, the applicant should provide justification and rationalize this with respect to the overall mission to achieve a national impact.

DBPs are expected in most cases to stem from ongoing biomedical research projects that have already been peer reviewed. DBPs are expected to be significant biomedical research problems.

Details of the biomedical project not relevant to the technology development relationship should not be the focus of the Research Strategy. Because this program does not provide direct support for the collaborating biomedical investigator, the discussion in the BTRR application should not focus on the approach or feasibility of a specific biomedical project. It should focus on the aspects of the proposed DBPs that requires the technology under development.

Letters of Support: All letters of support should be included in the most relevant component, and should not be duplicated. Letters applicable to the entire application, such as those expressing institutional support, should be included in the Overall component. Letters of support from investigators specifically collaborating with Resource investigators on any TR&D, DBP, or other projects described specifically in the application should be included in the respective component. The purpose of letters of support is to describe the nature of the collaborative relationship, including its scope, and any special circumstances (e.g. materials or technology transfer, or intellectual property agreements). Do not include letters of support from resource users whose interactions are limited to activities described in the CE component.

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.

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.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

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

PHS Inclusion Enrollment Report (Driving Biomedical Projects Portfolio)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

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

When preparing your application in ASSIST, use Component Type Comm Engag.

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

SF424 (R&R) Cover (Community Engagement)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Community Engagement)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community Engagement)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Community Engagement)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Community Engagement)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Community Engagement)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Support should be requested for all research, outreach, user training, technology dissemination and project management activities related to the CE component of the BTRR. This includes personnel and all other materials and associated expenses. No support may be requested in the application for CE activities conducted outside of the BTRR, such as laboratory work undertaken by any Collaboration and Service (C&S) collaborators, or for personnel associated with the collaborating laboratories. No funds may be requested to support travel or accommodations for training course registrants.

PHS 398 Research Plan (Community Engagement)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: Describe the aims of the Community Engagement component of the proposed center.

Research Strategy: Describe plans for Community Engagement (CE). Plans should focus on active engagement with the research community to provide the broadest possible access to Resource technologies, moving those technologies out into the community as quickly and effectively as possible. In addition to details discussed below, the CE plan should address the following overarching themes:

Expected Life of the Center: Explain the anticipated arc of the technology development program over the expected lifetime of the Resource, which should inform plans for the progression from Resource access to widespread dissemination of the technology. Rather than a Resource becoming essential to the research community because of the technologies developed there, and then maintaining that high level of technical capability in order to remain essential, successful development and dissemination of technologies should in most cases eventually make the Resource obsolete, generally by year 15. Present plans consonant with this expectation. Substantial resources, with respect to both effort and funds, should be devoted to promoting and disseminating robust technologies and training the research community in their use.

Sustainability Plan: Substantive plans working toward sustainable community access to the technology should be developed, with a strong rationale for the approach taken. It is anticipated that in most instances, technologies will be widely disseminated beyond the Resource within, at most, five years of their development. This will allow for multiple successive rounds of technology development and dissemination during the life of the Resource. The optimization of technologies to a point where dissemination is practical should be included in the TR&D program of the Resource. A strategy for engaging the community to promote adoption of new technologies and to achieve sustainability should be addressed in an integrated manner in the CE component.

Unique considerations of the subject technologies and the affected research communities may present issues for technology promotion and adoption. Innovative plans to mitigate these obstacles should be presented. For example, if replication of a technology outside the Resource is not feasible, consideration should be given to how this might be overcome to make the technology truly portable, and if not, how to ensure widespread access.

The primary purpose of this component of a BTRR is to promote the widespread sustainable application of technologies developed by the Resource. Historically, BTRRs have been required to include three components that represented essential elements of the Community Engagement mission: Collaboration and Service, Training and Dissemination. Moving forward, the decision of which specific approaches to the community engagement process will be employed is left to the discretion of the Resource PD/PI(s). However, all of the elements described below must be addressed in some form, and applicants are strongly encouraged to include specific plans for Collaboration and Service, User Training, and Dissemination. In the absence of such plans, a specific rationale for their absence must be provided. It is understood that some technologies are more readily shared, replicated, or commercialized than others, and unique constraints may dictate unique approaches. Further, BTRR investigators are encouraged to use novel, creative approaches to engage different segments of the biomedical research community.

At a minimum, the CE component must include detailed plans to provide access to technologies in the Resource as they mature, and to develop an informed, competent user base in the research community that is prepared to adopt these technologies as they emerge from the Resource. Plans should be presented for direct hands-on training in data acquisition and interpretation. To the extent possible, technologies are expected to become available outside the Resource. Plans must be presented to move technologies out of the Resource as quickly as possible, in a manner that will promote the broadest and most sustainable availability possible.

Each of these elements must be addressed, and should be integrated, along with any additional elements deemed appropriate by the applicant, to form a coherent program of Community Engagement.

Collaboration and Service: Present plans to provide access to the advanced technologies created in the Resource. The concentration of instrumentation, software, methods, and expertise developed in a BTRR represents an important resource for biomedical and clinical researchers. Explain how the BTRR will actively engage the research community to collaborate and provide broad access to Resource capabilities. Note that this program is not intended for support of a Resource that is predominately focused on routine service.

Describe the overall range of C&S projects to be supported by the Resource. Describe plans for the selection and evaluation of C&S projects. Note that C&S projects are distinct from DBPs. These projects may make extensive use of Resource technologies and expertise, but are distinguished from Driving Biomedical Projects in that they do not serve as primary drivers or as test beds for the new technologies in the early stages of development. C&S projects generally exploit the more mature capabilities of the Resource.

Present plans for the Resource to provide community access to expertise in the Resource for consultation and data interpretation, access to software and associated technical support, and access to instrumentation for routine work by outside users. These plans may include assistance provided to other laboratories or institutions to help them build their own independent resources for user access. It is expected that BTRR support will be acknowledged in papers resulting from all CE support of research, regardless of whether BTRR staff are listed as authors. That acknowledgement should use the NIGMS grant number. Present plans for ensuring and tracking this acknowledgement.

The application should include a description of the overall goals of the C&S functions of the Resource. The Resource’s approach to, and plans for, C&S activities should be described, as well as the manner in which service will be provided. This section should make clear the impact of the C&S functions of the Resource on the research community, rather than concentrating on the scientific aspects of the specific C&S projects that are included. The BTRR should strive to conduct the majority of its C&S projects with researchers who are outside the applicant institution, broadening the scope of the Resource’s impact as technologies mature.

If a charge back system that results in program income is planned, a description of how costs are to be shared by the users should be included. Additionally, special administrative requirements that apply to program income must be observed. See the NIH Grants Policy Statement Section 8.3.2.

Technology Training for the User Community: Informing the scientific community about the technical capabilities and accomplishments of the subject technologies developed in a BTRR, and how these tools can be applied to their problems, is critical. The technologies, methods, and software developed in BTRRs are frequently sophisticated and conceptually novel. User training generally is necessary to facilitate adoption by scientists outside the BTRR. Technology user training for the research community should be planned and provided by the BTRR. A BTRR must allocate sufficient resources for training both specialists and non-specialists to make the best possible use of the new tools. The approaches to user training do not need to be novel. The user training should simply be well thought out, accessible, and effective. The Resource’s Training plan should aim to build technical competence in the broader community of researchers.

The overall goal of the user training element of BTRR Community Engagement is expected to be twofold: to improve the general understanding of the Resource’s technologies in the appropriate research communities and to create a cadre of biomedical researchers from other fields who are now trained in the use of the technology so that they can effectively apply it in their own research.

Well-defined plans for user training should be presented in the application. Specific methods or activities are not prescribed. The choice of approaches should be informed by the special constraints and opportunities presented by the circumstances of the BTRR in question. A defining feature of BTRR user training activities is the direct interaction between Resource personnel and the user. Note that while web-based, self-service tutorials are highly laudable, and encouraged, this does not represent an adequate replacement for hands-on training. Plans for tracking the demand for and utilization of user training resources should be described.

Successful user training activities will enable researchers to fully utilize the technologies and resources developed by the BTRR. Examples of appropriate approaches to user training include hands-on laboratory experience such as visits in the BTRR laboratories for researchers from other laboratories or reciprocal visits by BTRR personnel; seminars and lectures; short courses or symposia offered independently or in conjunction with society meetings attended by the user community; workshops on relevant topics that bring together researchers in multidisciplinary areas from academic institutions, hospitals and industry for discussions on the use of the BTRRs technology in biomedical research. Because of the increasing importance of translational and clinical research, plans for training researchers involved in those efforts are encouraged where appropriate.

If on-site user training and collaborative work will be supported, describe plans to make workspace available for visiting scientists.

Academic courses that are offered as part of the curriculum of the Resource’s institution, and not available to those outside the institution, should not be considered an element of the Resource’s user training mission and should not be included in this section. Individuals benefiting from the user training experiences may not be paid a salary in conjunction with the experience, nor may the experience be a requirement for receipt of an academic degree.

Formal pedagogy and direct responsibility for training of students and post-doctoral fellows are important elements of the academic research enterprise, and it is expected that students and post-doctoral fellows within the BTRR will play major roles in the TR&D components of the Resource. However, those educational activities are not considered relevant to the user training element of a BTRR, which is focused on the external research community.

For renewal applications, a progress report on user training activities from the previous project period should be included in this section, including data collected as part of the aforementioned demand/utilization tracking plans.

Technology Dissemination: A fundamental motivation for the BTRR program is to bring cutting-edge technology to bear on biomedical research problems. A critical step to meeting this objective is to share new technologies and methods as broadly as possible in order to bring them into routine use. The DBP and CE aspects of a BTRR all build toward this overall goal of broad dissemination.

Dissemination activities should have one objective. Resources must promote and enable the broader use of technologies beyond the BTRR. Informing the scientific community about the technical capabilities and accomplishments of the subject technologies developed in a BTRR is also critical, but it is not dissemination of the actual technology. A variety of approaches can be proposed to meet these goals. These approaches can include, but are not limited to: distributing and supporting software products; transferring technologies to other laboratories directly; patenting inventions, and licensing technologies to industry, including partnerships with small businesses and support from the SBIR and STTR programs. Publishing articles, books, newsletters, annual reports, or special issues of technical journals, issuing press releases, presenting research results at meetings; conducting workshops and conferences, and web-based training modules and tutorials are all helpful ancillary activities that bridge training and dissemination. All BTRR Dissemination activities must acknowledge NIGMS grant support, and cite the NIGMS grant number.

A robust web presence is required for every BTRR. Support from NIGMS should be acknowledged on that web site. The web site should provide information about:

• The Resource’s research focus and capabilities
• A section of plain language information for the general public about the technologies being developed and those presently available to users
• Contact information
• How to establish Driving Biomedical Projects or other collaborations
• How Resource collaborators and users should cite the BTRR grant
• A section on current newsworthy items directed to the general public
• An image gallery that features data and results
• Links to online tutorials
• The availability of software, reagents, and other resources, as applicable.
• Links to other related NIH funded resources including other BTRRs, the NIH BTRR Portal page (http://www.btrportal.org), and the NIGMS BTRR program web page.

In addition to the BTRR web page, each Resource is required to maintain an up-to-date presence on the Biomedical Technology Research Resources Portal (http://www.btrportal.org/). This site presents information on all Resources in the NIGMS and NIBIB BTRR programs, with links to each Resource’s web page.

In Resources that are developing software, emphasis should be placed on producing portable, well-documented, user-friendly software, making it readily available to the user community and providing user support. NIGMS encourages sharing of source code, consistent with the NIH data-sharing policy. Although software is not required to be open source, if a restrictive license will be used to distribute the software, written justification is required in the application.

Use of Common Data Elements in NIH-funded Research: NIH encourages the use of the FAIR (Findable, Accessible, Interoperable and Reusable) principles and common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects

Plans should be described for measuring the success of Dissemination efforts, as well as tracking the demand for and utilization of resources provided directly by the BTRR.

A progress report of Dissemination activities from the previous project period should be included in this section for renewal applications.

Letters of Support: All letters of support should be included in the most relevant component, and should not be duplicated. Letters applicable to the entire application, such as those expressing institutional support, should be included in the Overall component. Letters of support from investigators specifically collaborating with Resource investigators on any TR&D, DBP, or other projects described specifically in the application should be included in the respective component. The purpose of letters of support is to describe the nature of the collaborative relationship, including its scope, and any special circumstances (e.g. materials or technology transfer, or intellectual property agreements). Do not include letters of support from resource users whose interactions are limited to activities described in the CE component.

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.

Applicants should note the requirement described above, to describe specific plans for sustainable community access to resources developed in the BTRR.

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, with the following modifications.

The following attachments are required in the Community Engagement component if Collaboration and Service (C&S) is proposed as an element of Community Engagement.

Table of Collaboration and Service Projects

Collaboration and Service projects are not required. If present, there is no limit to the number of C&S projects that may be proposed. If applicable, a table of all C&S projects should be provided. For renewal applications, C&S projects from the previous funding period should be included in the table following the listing of current and proposed activities. Each entry in the table should include:

• The collaborating investigator for the Collaboration/Service project
• The institution of the PD/PI
• The title of the project
• The name(s) of Resource personnel involved with the project
• Start and finish dates for the project
• The external funding status of the project
• A brief description of the biomedical research problem that will form the basis of the C&S project.
• The rationale for and impact of the proposed BTRR effort on the project.
• Publications that have resulted from the project

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

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

PHS Inclusion Enrollment Report (Community Engagement)

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

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

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) using ASSIST or other electronic submission systems. 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.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 (SAM). 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Important Update: See NOT-OD-18-228 for updated inclusion and human subjects review language for due dates on or after January 25, 2019.

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

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

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

Significance

Does the proposed Center address the needs of the research community that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research community?

Will the proposed BTRR develop technical capabilities likely to substantially enable biomedical research? Is the BTRR likely to become an important resource for researchers?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing technology development research? Do the investigators demonstrate significant experience with coordinating collaborative basic research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?

Are the scientific and managerial credentials of the PD/PI(s) and the credentials of other key professional and technical staff appropriate for the needs of a BTRR? If multiple PD/PI(s) are proposed, do they each operate in a leadership capacity regarding all components of the BTRR?

Innovation

Does the application propose novel technologies, including methods and instrumentation in coordinating the research projects the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of technologies proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research community the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the community, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

In Renewals, is the role of the External Advisory Committee or in new applications plans for the committee and types of committee members appropriate? Do the members of this committee have sufficient breadth and ability to take an effective role in the review and guidance of the Resource operations? In renewal applications, is there evidence that the EAC is active? Are there plans for rotation of the members of this committee?

If other committees such as a local executive committee are proposed, are the composition and organizational plans for these committees adequately described? How will they benefit the Resource?

Is the research program described appropriate for the BTRR program? Are the technology development, biomedical test-bed, and community engagement components of the BTRR necessary and sufficient to address the stated need? Is there synergy among all of the BTRR components?

Given the rationale motivating the overall technology development program, is the chosen strategic direction the appropriate one to address the defined need? Do the proposed TR&D projects constitute a potentially effective, integrated approach to the technical goals of the Resource? Is there synergy among the TR&D projects?

Is the organizational structure of the BTRR conducive to its development and operation as a well-integrated multidisciplinary team? Are the structural and procedural elements of the BTRR adequate to ensure against fragmentation of the technology development program?

Is the sustainability plan appropriate?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research projects it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Are the space and resources for the BTRR, including those for visiting scientists, appropriate and adequate? In the case of a renewal application, is the usage of the technologies developed and supported by the Resource appropriate and adequate? Are technologies in place and operational, and are staff members currently on site?

As applicable for the resource 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 resource 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.

For Renewals, the committee will consider the progress made in the last funding period.

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

Not Applicable

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

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

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.

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each of the Technology Research and Development Projects, and for the Driving Biomedical Projects and Community Engagement components.

Technology Research and Development Projects

Is the Resource technology dynamically evolving, state of the art, an important area for research and development in its own right, and likely to advance the frontiers of biomedical research? Are alternative approaches to solving technological problems presented?

Are the TR&D projects complementary and synergistic? Does the overall TR&D program of the BTRR represent the expression of a coherent vision?

Is there synergy between a TR&D project and the DBP(s) in advancing the focal technology?

Is the entire arc of the technology development process addressed in the TR&D projects? Is it clear that technology development will be carried through to completion, including optimization for use by non-specialists where appropriate?

What is the potential for achievement of the BTRR's technological goals to enable biomedical research? How is this Resource unique and useful to the community in the technological goals it is pursuing as well as in the cluster of DBPs to which the advanced technology is being applied?

Is the Resource technology already broadly available?

Are Resource TR&D personnel suitably qualified to lead these technically complex and specialized projects?

If Technology Development Partnerships are proposed, are they justified? Are planned partnerships likely to result in successful integration of partner technologies into the Resource?

In Renewal applications, is evidence provided of new meritorious efforts and significant progress during the past grant period?

Driving Biomedical Projects

Are plans presented for the Resource staff to continuously develop new, significant applications of the Resource technology in the biomedical sciences through recruitment of high quality Driving Biomedical Projects? Will the proposed DBPs serve as test beds and/or drivers for the specific associated TR&D project(s)?

Will the DBPs advance and motivate further technological research and development in the Resource? Is the technology appropriate for the proposed DBPs and will it have high impact on the science being explored in them?

Will proposed DBPs drive and/or provide test beds for TR&D research? Are the described relationships between DBPs and TR&Ds meaningful? In renewal applications, are DBPs making good use of the technological advances? In renewals, is the balance right between continuing DBPs, DBPs that have finished, and DBPs that have turned into C&S projects? Are new DBPs in important biomedical fields being actively sought to invigorate the Resource?

Community Engagement

Are plans for Community Engagement (CE) responsive to community needs? Are the plans reasonable? Are the different aspects of the CE plan integrated? Do these plans consider any unique constraints associated with the subject technology? Are plans for technology access sustainable?

Does the CE component include detailed plans to provide access to technologies in the Resource as they mature? If present, do C&S projects have a national geographical distribution? For Resources that do a substantial amount of service, are the plans for sharing costs by the users, including fee for service systems, appropriate? Are Resource CE staff suitably qualified? Is the BTRR technology available to outside users?

Are the CE plans likely to result in development of an informed, competent user base in the research community? Are plans presented for direct hands-on user training in data acquisition and interpretation? Are the plans presented likely to result in the ability of researchers to successfully adopt Resource technologies? Are Resource user training staff suitably qualified? In renewal applications, have strong results accrued from user training efforts? Are there clear metrics to assess success?

Are plans for dissemination commensurate with the portability of the technologies? Will technologies be moved out of the Resource quickly? Are dissemination plans likely to result in broad, sustainable availability? Are there specific plans for technology transfer? Are plans for tracking success of dissemination and resource demand appropriate? In renewal applications, is there evidence of progress in dissemination of technologies?

In Resources that are developing software, is it or will it be portable when appropriate, well documented, user-friendly, and readily available to the user community? Have there been efforts to make both non-expert and expert communities aware of the new technology? Is software development pursued in a manner that will promote dissemination and widespread adoption? Are plans likely to result in robust, stable software?

Are the plans for the web site appropriate? Do they include the required information (the Resource’s research focus and capabilities, technologies being developed and available, contact information, how to collaborate, available resources)? In renewal applications, is the web site easy to find? Does the material on the web site provide useful information to the biomedical research community? Has there been reasonable and timely progress in this area?

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:

• Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical 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 balance and distribution of the NIGMS technology development grant portfolio.

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.

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.

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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.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 https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/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 https://www.hhs.gov/ocr/about-us/contact-us/index.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.

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.

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 RPPR, 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
Email: support@grants.gov

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

Mary Ann Wu, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-435-0787
Email: wum2@mail.nih.gov

Ross D. Shonat, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-2786
Email: Ross.Shonat@nih.gov

Lori Burge
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-3781
Email: BurgeL@mail.nih.gov

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

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