It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The X02 pre-application is the recommended first step in the application process for a new Biomedical Technology Research Resource (BTRR) application. Investigators whose X02 pre-applications are judged to be meritorious and programmatically relevant will be notified of the opportunity to submit a full BTRR application under PAR-17-316 Potential applicants should read both the X02 and P41 FOAs. The National Institute of General Medical Sciences (NIGMS) uses the P41 mechanism to support BTRRs in a variety of areas of biomedical science. (BTRR and Resource are used interchangeably throughout this text.)

The NIGMS BTRR program has recently been evaluated and the final report is available on the NIGMS BTRR web 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 overall program. 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).

New applicants are strongly encouraged to submit a pre-application in response to this announcement. The pre-application process provides feedback regarding appropriateness for this program and competitiveness of a potential application.

BTRR applications are complex, typically requiring a significant investment of time to prepare and review. This pre-application process for new NIGMS BTRRs is meant to minimize the burden on both the applicant and reviewer communities. All applicants will receive a written critique addressing the Review Criteria listed in this FOA. The critique will help the applicant understand more clearly whether a full application for a BTRR is appropriate for the work they propose. Before preparing a full application, applicants will also generally find it helpful to speak with program staff to discuss the critique of their X02 pre-application. At any point in this process, applicants are welcome and encouraged to contact program staff (https://publications.nigms.nih.gov/btrrs/searchresults.asp) with questions about either the X02 or P41 funding opportunity announcements.

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. The research tools developed in a BTRR may include instruments and other specialized devices, software, reagents, and methods. 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 or molecular sciences are included. 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.

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. The Resources are structured to foster two kinds of separately funded 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. Opportunities for independently funded exploratory (https://grants.nih.gov/grants/guide/pa-files/PAR-17-046.html) or focused (https://grants.nih.gov/grants/guide/pa-files/PAR-17-045.html) technology development projects are described here (https://www.nigms.nih.gov/about/overview/BBCB/biomedicaltechnology/Pages/technologydevelopment.aspx).

Conversely, 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.

A BTRR creates tools that can substantially improve present approaches to a wide variety of problems in the biomedical sciences. A successful Resource 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.

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. A BTRR must 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 requires 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).

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

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

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

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

For this specific FOA, the Research Strategy section is limited to 12 pages.

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

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

Type of Submission: Select "Pre-application".

Proposed Project Start and End Date: The start date should be the date that full BTRR application will be submitted. For NIGMS P41 application due dates see the P41 FOA (PAR-17-316. The ending date should be one year after the start date.

Estimated Project Funding: Enter zero for all Estimated Project Funding fields. The following fields in the Estimated Project Funding section of the SF424 R&R Cover page must be filled in as "0":

• Total Federal Funds Requested
• Total Federal and Non-Federal Funds
• Estimated Program Income

Pre-application: Do not add any attachments here even though the X02 is a pre-application mechanism.

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

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

Are Human Subjects Involved: Select "No" even if human subjects will be involved in the project,

Are Vertebrate Animals Used: Select "No" even if vertebrate animals will be involved in the project,

Other Attachments: Do not submit other attachments.

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

Biographical Sketches: Do not include biosketches for collaborating investigators who will not be included in the Resource (e.g. DBP investigators).

Budget forms are not included as part of the pre-application package.

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

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

Specific Aims: The Specific Aims attachment is not required for this X02 and must not be included.

Research Strategy: The narrative portion of the pre-application should begin with an overview of the proposed BTRR. This overview section need not adhere to a specific outline but should address the following topics: the rationale for the Resource, discussion of the technological theme(s) at its heart, and its anticipated impact on biomedical research; an overview of the Resource's components, including the Technology Research and Development (TR&D) projects, the Driving Biomedical Projects (DBPs), and Community Engagement (CE); and their integration to form a coherent whole. This section should explain both the rationale for the proposed BTRR, and how its components are integrated.

The Research Strategy must also include sections specifically addressing the following components of a BTRR:

Technology Research and Development Projects: The pre-application should describe the projected arc of the Resource's technology development program, placing the application 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. Each of the anticipated Technology Research and Development projects should be described. Describe the complementary nature of the TR&D projects, including the rationale for inclusion of Technology Development Partnerships, if any. This section should include preliminary data that is broadly supportive of the technological approach, if appropriate.

Driving Biomedical Projects: Describe the overall themes of the DBPs, the motivation for selection of the projects included in the application, and the expected interplay among the TR&D projects and DBPs.

Community Engagement: This section should describe 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 on 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.

Plans to make the facilities and expertise of the BTRR available to outside users must be described in the Community Engagement section. These topics must be addressed in sufficient detail to articulate a commitment to specific approaches and plans.

Equipment: Describe any major equipment that will be requested in a full BTRR application in order to pursue the proposed technology development program. Explain why it is necessary. If equipment is already available, please describe it in the Equipment attachment of the R&R Other Project Information form. Include cost estimates for equipment that will have to be purchased. Inclusion of price quotes is not necessary.

Administration and Management: 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.

Be sure to provide enough information in the Research Strategy narrative to allow reviewers to assess whether or not the proposed research is appropriate for the BTRR program. Reviewers will also need to assess the quality of the proposed effort, the likely impact, and the timeliness of the application. See Section V. Application Review Information.

Protection of Human Subjects: Even if human subjects will be involved in the project, no human subjects section should be included in the X02 pre-application.

Vertebrate Animals: Even if vertebrate animals will be involved in the project, no vertebrate animal section should be included in the X02 pre-application.

Letters of Support: Do not provide letters of support.

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:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix: Appendix material is not allowed.

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.

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.

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

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, 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.

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.

Pre-applications that are complete will be evaluated for scientific, technical, and programmatic merit by an appropriate peer review group convened by NIGMS using the review criteria stated below.

1. Is the proposed effort appropriate for a BTRR? Are the TR&D projects complementary? Are they relevant to the overall theme of the Resource? If major equipment is needed to support the proposed technology development program, is it well-justified?

2. Is the balance between early stage projects, iterative improvement in the context of the DBPs and optimization of mature technologies appropriate for the stage of each TR&D?

3. Will the proposed DBPs be appropriate test beds that drive development of the nascent technologies? Are the technology needs of the proposed DBPs representative of the broad research community?

4. Is the Community Engagement component integral to the proposed effort? Will the broader research community have access to the Resource's technology and expertise?

5. What will be the likely impact of the technology development on the broader research community? Will the technologies result in new approaches to biomedical research problems?

6. Is the technology development timely? Is the time right to focus a substantial effort in developing technology in the area proposed? Are the community needs for the technology apparent?

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIGMS, 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.

The following will be considered in making decisions about notifying applicants of the opportunity to submit a full BTRR application:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• The potential for technologies developed and disseminated by the proposed Resource to significantly impact the conduct of biomedical research, relative to currently available approaches.

Not Applicable.

Not Applicable

Not Applicable

Cooperative Agreement Terms and Conditions of Award

Not Applicable

Not Applicable

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: [email protected]

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

Stephanie Constant, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: [email protected]

Not Applicable

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.