Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
Components of Participating Organizations

National Institute of General Medical Sciences (NIGMS)
Funding Opportunity Title

Biomedical Technology Research Resource (P41)
Activity Code

P41 Biotechnology Resource Grants
Announcement Type

Reissue of PAR-10-225
Related Notices
  • June 14, 2017 - This PAR has been reissued as PAR-17-316.
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015)
  • November 20, 2014 - See Notice NOT-GM-14-136. Notice of Change in Application Due Dates for PAR-14-021 "Biomedical Technology Research Resource (P41).
  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • March 14, 2014 - See Notice NOT-OD-14-070. Adjustments to May 25-28, 2014 Grant Application Due Dates.
Funding Opportunity Announcement (FOA) Number

PAR-14-021

Companion Funding Opportunity

PAR-14-023, Pre-application for a Biomedical Technology Research Resource (X02)
Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.859

Funding Opportunity Purpose

This funding opportunity announcement (FOA) encourages grant applications for national Biomedical Technology Research Resources. These Resources conduct research and development on new technologies and new/improved instruments driven by the needs of basic, translational, and clinical researchers. The Resources are charged to make their technologies available, to train members of the research community in the use of the technologies, and to disseminate these technologies and the Resource s experimental results broadly. New applicants are strongly encouraged to submit a pre-application to PAR-14-023. The pre-application process provides feedback regarding the appropriateness for this program and competitiveness of a potential application.
Key Dates

Posted Date

July 19, 2013

Open Date (Earliest Submission Date)

August 25, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

January 25, 2015; May 25, 2015; January 25, 2016; and May 25, 2016 by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

May 7, 2015; September 7, 2015; May 7, 2016; and September 7, 2016 by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date

Standard dates apply

Expiration Date

September 8, 2016

Due Dates for E.O. 12372

Not Applicable
** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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; 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.

Required Application Instructions

It is critical that applicants follow the 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.

Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

The National Institute of General Medical Sciences (NIGMS) uses the P41 mechanism to support Biomedical Technology Research Resources (BTRRs) in a variety of areas of biomedical science. (BTRR and Resource are used as synonyms throughout this text.) BTRR research teams create critical, often unique, technologies at the forefront of their respective fields. The Resources are structured to foster collaborations with biomedical researchers to apply the technologies to a broad range of basic, translational, and clinical research. Resources also promote the broadest possible use of those technologies through training and dissemination activities. Details concerning current BTRRs can be found at http://www.nigms.nih.gov/About/Overview/BBCB/BiomedicalTechnology/BiomedicalTechnologyResearchResources.htm. New applicants are strongly encouraged to submit a pre-application (see PAR-14-023). 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 (NIBIB) has a similar program that supports Biomedical Technology Resource Resources. Details about that program can be found at http://www.nibib.nih.gov/Research/ResourceResources. 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.

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. The main focus of the program over the past fifty years 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. This should not be interpreted to exclude other areas. An important 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 goals.

A BTRR is expected to serve as a resource for the biomedical research community and must have a national impact. Each Resource has three critical components that set it apart from other NIH research centers. A BTRR must provide (a) service and (b) training to outside investigators and must (c) disseminate 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 service, training, and dissemination components of the Resource should aim for the widespread and routine application of the technologies being actively disseminated.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed

New
Renewal
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

Support may be requested for up to five years.

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.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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.

Required Registrations

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.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

Eligible Individuals (Program Director/Principal Investigator)

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

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

PD/PI(s) must possess the skills, knowledge and resources required to provide leadership to all key components of the Resource, not only to individual select activities.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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.

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12

Tech R and D (use for Technology Research and Development Projects)

12

Driving Bio Proj (use for Driving Biomedical Projects)

12

Collab and Service (use for Collaboration and Service)

12

Core

(In ASSIST, select component type "Core" when preparing the following application components:

  • Infrastructure
  • Training
  • Dissemination
  • Administration and Management)

6

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Overall: required

Overall Component

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.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

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.

Research & Related Senior/Key Person Profile (Overall)

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.

Budget (Overall)

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.

PHS 398 Research Plan (Overall)

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

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

Research Strategy: The narrative portion of the application should begin with an overview of the proposed BTRR. This 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), Collaboration and Service (C&S), Training, and Dissemination; and their integration to form a coherent whole.

The Overall section should describe the complementary nature of the TR&D projects. It should also 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. This section should describe the general approach to C&S in the proposed BTRR, and the relationship of the C&S activities to the technology development mission of the Resource. Similarly, this section should also describe the general approach to the Training and Dissemination components of the BTRR, and their relationship to the Resource as a whole.

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. Progress in each of the component areas (TR&D, DBPs, C&S, Training and Dissemination) should be included in those components when appropriate.

The Overall section 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.

Progress Report Publication List: For renewal applications, the title and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the BTRR since it was last reviewed competitively must be included in the publication list included as part of the progress report. Publications that explicitly acknowledge support from this BTRR award should be distinguished from those that do not.

Letters of Support: Include letters of support from investigators specifically collaborating with Resource investigators on any TR&D, DBP, C&S, or other projects. 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).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

Technology Research and Development Project

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:

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.

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.

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.

PHS 398 Research Plan (Technology Research and Development Project)

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

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

Research Strategy: The central focus of a Biomedical Technology Research Resource should be its Technology Research and Development (TR&D) projects. TR&D projects serve as the foundation for all other Resource activities. 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, referenced above, for numerous examples of each type of Resource.) The BTRR technology must be dynamically evolving and an important area for research and development in its own right. A proposed TR&D project should be at the cutting edge of the technological field, with a goal of increasing the technology’s impact on biomedical research.

Regardless of the scope of the TR&D activities undertaken, a BTRR is an inherently multidisciplinary enterprise, requiring a range of specialized expertise to integrate multiple approaches to complex technical and biomedical challenges. For example, these projects may involve development of new or significant modification of existing 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, or development of innovative applications through the integration of existing technologies.

TR&D projects should be responsive to the emerging needs of the biomedical research community. To encourage synergistic interaction, Driving Biomedical Projects (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. This is treated in detail in the next section.

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.

A BTRR is expected to have at least three TR&D projects. Each TR&D project must be presented in detail, as a separate component of the application. Each TR&D project Research Strategy section should address the background and rationale for the project, its significance, specific aims, 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. The application should describe the relationship and complementarity among these projects, and their support of the overall goals of the BTRR. Elements of high risk (and potentially high payoff) are appropriate in the TR&D projects. Investigators should, however, present alternative approaches to solving technological problems in the event that their main conceptual thrust should prove unfeasible.

For renewal applications, new activities should be specifically identified. The continued development of innovative technology and the steady infusion of new areas 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.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

Planned Enrollment Report (Technology Research and Development Project)

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

PHS 398 Cumulative Inclusion Enrollment Report (Technology Research and Development Project)

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

Infrastructure

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

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

SF424 (R&R) Cover (Infrastructure)

Complete only the following fields:

PHS 398 Cover Page Supplement (Infrastructure)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Infrastructure)

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.

Project /Performance Site Location(s) (Infrastructure)

List all performance sites that apply to the specific component.

Research & Related Senior/Key Person Profile (Infrastructure)

Budget (Infrastructure)

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.

PHS 398 Research Plan (Infrastructure)

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

Specific Aims: Describe the specific aims for the Infrastructure section of the application.

Research Strategy: In some circumstances, TR&D activities may require substantial investment in the design and development or implementation of technological infrastructure that does not constitute a research challenge in its own right (e.g., a test platform for new instrument components or a laboratory information management system). If necessary, such activities may be included in the application in this component. In many applications, an Infrastructure section will not be necessary. This section of the application will be reviewed and will contribute to the overall score, but will not receive a separate score.

Infrastructure projects typically require expertise and intellectual effort from Resource investigators but are not innovative. Their focus must be clearly distinct from those of the TR&D projects. Activities such as software development or instrument design and fabrication that are obviously part of a TR&D project should be included within that project. This section is not intended to be used to describe the straightforward purchase and installation of commercial instruments. The description and justification of commercial instrument purchases should be included in the relevant section of the application (e.g., a specific TR&D project for which the equipment is essential.)

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

Planned Enrollment Report (Infrastructure)

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

PHS 398 Cumulative Inclusion Enrollment Report (Infrastructure)

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

Driving Biomedical Projects

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)

Complete only the following fields:

PHS 398 Cover Page Supplement (Driving Biomedical Projects)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Driving Biomedical Projects)

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.

Other Attachments: The following attachment is required:

The DBP section of the application must, as an attachment, 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 should also be included. Each entry in the table should include:

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

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)

Budget (Driving Biomedical Projects)

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 Driving Biomedical Projects component of the BTRR. This includes personnel and all other materials and associated expenses. No support may be requested for DBP activities conducted outside of the BTRR or personnel in the collaborating laboratories.

PHS 398 Research Plan (Driving Biomedical Projects)

Introduction to Application: For Resubmission 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: Development of new biomedical research tools is most effective when pursued in the context of challenging problems. This component of a BTRR is a set of biomedical research projects that will be pursued by the Resource in collaboration with outside investigators. 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 each of these individual scientific problems should also be clear. This collection of projects is an essential aspect of a BTRR's mission, and a significant investment 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 Driving Biomedical Project (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 Technology R&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.

Research Resources

In some cases, a DBP may involve, in addition to the biomedical collaborators, additional technology partners. 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. 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. The description of the DBP should include the entire team and their roles, in the context of the biology problem, focusing on the appropriateness of that problem as a DBP to advance the collaborative technology development effort ongoing among the technology-oriented laboratories. However, details of collaborative technology development should be described in the research plan of the appropriate TR&D project(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. 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 Collaboration and Service section (see below).

The DBPs served by the new technology 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.

New applications should have at least one DBP related to each TR&D project. 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.

There is no upper limit to the number of DBPs that can be proposed. A representative selection of no more than ten proposed DBPs may be presented in detail. In the case of a renewal, these may include ongoing projects carried over from the previous competing segment. It is expected that turnover in DBPs will occur during the project period. A process for recruiting, selecting, and terminating DBPs should be presented in the Administration and Management section of the application.

Project descriptions should focus on their role as a test bed and/or driver for technology development, and the relationship of the DBP to the corresponding TR&D project(s). The biomedical aspects of the project should be described only in sufficient detail to allow the reader to understand the significance of the project and how it will benefit from access to the technologies being developed in the Resource. DBPs are expected to be significant biomedical research problems.

Details of the biomedical project should not be the focus of the project description. Because this program does not provide direct support for the collaborating biomedical investigator, the description in the BTRR application should not focus on the approach or feasibility of that aspect of the proposed DBP. DBPs are expected in most cases to stem from ongoing biomedical research projects that have already been peer reviewed.

The description of each DBP should follow the following outline:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

Planned Enrollment Report (Driving Biomedical Projects)

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

PHS 398 Cumulative Inclusion Enrollment Report (Driving Biomedical Projects)

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

Collaboration and Service

When preparing your application in ASSIST, use Component Type Collab and Service'.

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

SF424 (R&R) Cover (Collaboration and Service)

Complete only the following fields:

PHS 398 Cover Page Supplement (Collaboration and Service)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Collaboration and Service)

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.

Other Attachments: The following attachments are required in the Collaboration and Service component.

Attachment 1: There is no limit to the number of C&S projects that may be proposed. A table of all Collaboration and Service 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:

Attachment 2: A representative sample of no more than 10 C&S projects should be presented in greater detail. Each project should be described in sufficient detail to allow the evaluation of the need for the BTRR technologies in the proposed project. The description of each C&S project should be limited to no more than one page, and include the following:

Project /Performance Site Location(s) (Collaboration and Service)

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 (Collaboration and Service)

Budget (Collaboration and Service)

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 Collaboration and Service component of the BTRR. This includes personnel and all other materials and associated expenses. No support may be requested in the application for C&S activities conducted outside of the BTRR in the collaborating laboratories, or for personnel associated with the collaborating laboratories.

PHS 398 Research Plan (Collaboration and Service)

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

Specific Aims: Describe the aims of the Collaboration and Service component of the proposed center.

Research Strategy: The primary purpose of this component of a BTRR is 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. A BTRR is expected to actively engage the research community to collaborate and provide broad access to Resource capabilities. The Collaboration and Service component is a key element of a BTRR, but this program is not intended for support of a Resource that is predominately focused on routine service.

Collaboration and Service (C&S) projects are distinct from DBPs. DBPs are selected because they present challenges that require development of new technological solutions, but C&S projects directly apply more established technologies to biomedical research problems. Nonetheless, the Collaboration and Service component may involve long-term projects and may require significant creativity and intellectual involvement on the part of both Resource staff and the collaborating biomedical or clinical researchers, resulting in joint publications. 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.

The Collaboration and Service component may also include 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. It also includes 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 C&S research projects, regardless of whether BTRR staff are listed as authors. That acknowledgement should use the NIGMS grant number.

This component of the application should begin with a description of the overall goals of the C&S functions of the Resource. The Resource s approach to, and plans for, Collaboration and Service activities should be described, as well as the manner in which service will be provided. That should be the focus of this section of the application, rather than concentrating solely on the scientific aspects of the C&S projects that are included. This section should make clear the impact of the C&S functions of the Resource on the research community. 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. Program income means gross income earned by the recipient that is directly generated by a supported activity or earned as a result of the award (additional information is available in 45 CFR 74.2 and 74.24, which can be obtained by searching the Code of Federal Regulations at http://www.access.gpo.gov/nara/cfr/cfr-table-search.html). Net program income earned during a budget period must be reported on the long-form Federal Financial Report (except for program income earned as a result of inventions, to which special rules apply). Costs incident to the generation of program income may be deducted from gross income to determine program income, provided these costs have not been charged to the award.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

Planned Enrollment Report (Collaboration and Service)

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

PHS 398 Cumulative Inclusion Enrollment Report (Collaboration and Service)

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

Training

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

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

SF424 (R&R) Cover (Training)

Complete only the following fields:

PHS 398 Cover Page Supplement (Training)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Training)

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.

Project /Performance Site Location(s) (Training)

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 (Training)

Budget (Training)

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

Funds to support courses given for academic or other types of credit may not be requested.

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.

PHS 398 Research Plan (Training)

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

Specific Aims: Describe the aims of the Training component of the proposed Resource.

Research Strategy: The technologies, methods, and software developed in BTRRs are frequently sophisticated and conceptually novel. Training generally is necessary to facilitate use by scientists outside the BTRR. Training of 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 training do not need to be novel. Training should simply be well thought out, accessible, and effective. The Resource’s Training component should aim to build technical competence in the broader community of researchers.

The overall goal of the Training component of a BTRR 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 trained in the technology so that they can effectively apply it in their own research.

Well-defined plans for 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 Training activities is the direct interaction between Resource personnel and the trainee. Note that activities such as web-based, self-service tutorials would fall under Dissemination since there is no direct interaction between Resource personnel and the researcher. Plans for tracking the demand for and utilization of Training resources should be described.

Examples of successful Training approaches may include hands-on laboratory experience such as residencies 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.

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 a component of the Resource s Training mission and should not be included in this section. Individuals benefiting from the training experiences may not be paid a salary nor may the training 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 components 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 the focus of the Training component of a BTRR.

The boundary between Training and Dissemination activities may not be well defined. Approaches that incorporate elements of both components should be presented only within one section of the application, whichever is deemed more appropriate by the applicant.

For renewal applications, a progress report on Training activities from the previous project period should be included in this section.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

Planned Enrollment Report (Training)

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

PHS 398 Cumulative Inclusion Enrollment Report (Training)

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

Dissemination

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

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

SF424 (R&R) Cover (Dissemination)

Complete only the following fields:

PHS 398 Cover Page Supplement (Dissemination)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Dissemination)

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.

Project /Performance Site Location(s) (Dissemination)

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 (Dissemination)

Budget (Dissemination)

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.

PHS 398 Research Plan (Dissemination)

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

Specific Aims: Describe the aims of the Dissemination component of the proposed center.

Research Strategy: 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 DBPs, C&S, and Training components of a BTRR all build toward this overall goal of broad dissemination.

Dissemination activities should have two overall objectives: informing the scientific community about the technical capabilities and accomplishments of a BTRR, as well as promoting and enabling the broader use of technologies. A variety of approaches can be proposed to meet these goals. These approaches can include, but are not limited to: publishing articles, books, newsletters, annual reports, or special issues of technical journals; patenting; issuing press releases; presenting research results at meetings; conducting workshops and conferences; distributing software products; transferring technologies to other laboratories directly; licensing technologies to industry; and web-based training modules and tutorials. 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:

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.nihBTRR.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 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 about 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

The boundary between Training and Dissemination activities may not be well defined. Approaches that incorporate elements of both components should be presented only within one section of the application, whichever is deemed more appropriate by the applicant.

Plans for tracking the demand for and utilization of Resource resources should be described.

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

Planned Enrollment Report (Dissemination)

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

PHS 398 Cumulative Inclusion Enrollment Report (Dissemination)

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

Administration and Management

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

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

SF424 (R&R) Cover (Administration and Management)

Complete only the following fields:

PHS 398 Cover Page Supplement (Administration and Management)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administration and Management)

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.

Project /Performance Site Location(s) (Administration and Management)

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 (Administration and Management)

Budget (Administration and Management)

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.

Funds to support travel by the PD(s)/PI(s), and in the case of a single PD/PI, one other senior member of the BTRR to the annual PD/PI meeting should be requested in the budget.

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 meeting. The funds will be restricted for this purpose, and may not be re-budgeted without prior approval by program staff.

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.

Applicants are strongly encouraged to contact program staff early in the process of developing an application to discuss the budget for the proposed center.

Major equipment purchases (more than $500,000 over the course of the project period) often require support from other sources when the BTRR Program is unable to fund the entire request. Plans for such shared funding should be detailed in the application.

PHS 398 Research Plan (Administration and Management)

Introduction to Application: For Resubmission 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, and the External Advisory Committee (EAC).

Organizational Structure and Staff Responsibilities

Describe the organizational structure of the BTRR. Indicate the relationship of the Resource to the administrative structure of the grantee 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, C&S, Training, Dissemination, and general Resource Administration. Describe the scientific and technical expertise of the staff that will operate, maintain, and develop the Resource capabilities specifying their distribution of effort across their areas of responsibility. Include a table specifying distribution of personnel effort across these domains.

It is essential that a BTRR function 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 balkanization 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. All PD(s)/PI(s) are expected to commit adequate levels of effort to provide the leadership commensurate with that role.

There is an annual meeting of BTRR PDs/PIs, usually in the Washington, DC area. It is strongly encouraged that the PD(s)/PI(s), and in the case of a single PD/PI, one other senior member of the BTRR, attend this meeting.

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 DBPs as well as 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, reviewing 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. If an EAC has not been constituted, potential EAC members should not be contacted or appointed prior to submission and should not be named in the application; however, the scientific disciplines of anticipated committee members should be described.

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.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

Include samples of any forms to be filled out by collaborators and users.

Planned Enrollment Report (Administration and Management)

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

PHS 398 Cumulative Inclusion Enrollment Report (Administration and Management)

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

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: https://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.

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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

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

Section V. Application Review Information

Important Update: See NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.



1. Criteria

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.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Resource 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 Resource proposed).

Scored Review Criteria - Overall

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 project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

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

Environment

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

Additional Review Criteria - Overall

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

Protections for Human Subjects

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.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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.

Resubmissions

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.

Renewals

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

Revisions

Not Applicable

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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).

Resource Sharing Plans

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) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Scored Review Criteria -Technological Research and Development, Driving Biomedical Projects, Collaboration and Service, Training, Dissemination

Reviewers will consider the review criteria below in the determination of scientific merit, and give a single separate score for each component (Technological Research and Development, Driving Biomedical Projects, Collaboration and Service, Training, Dissemination).

Technological Research and Development

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? What is the potential for achievement of the BTRR's technological goals to enable biomedical research? Is there synergy between a TR&D project and the DBP(s) in advancing the focal technology? How is this Resource unique and useful to the community in the technological goals it is pursuing as well as in the cluster of driving biomedical projects to which the advanced technology is being applied? Is the Resource technology already broadly available? Are the TR&D projects complementary and synergistic? Are Resource TR&D personnel suitably qualified?

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

Driving Biomedical Projects

Is the Resource staff continuously developing new, significant applications of the Resource technology in the biomedical sciences through high quality Driving Biomedical Projects? Does each DBP serve as a test bed and/or driver for the associated TR&D project(s)?

Does the DBP advance and motivate further technological research and development in the Resource? Is the technology appropriate and will it have high impact on the science being explored in the DBP?

Does the BTRR have an appropriate balance between time and effort spent on DBPs and on C&S projects? Are DBPs driving and/or providing test beds for TR&D research? Are DBPs making good use of the new technological advances? For this Resource, 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?

Collaboration and Service

Is the BTRR available to outside users? Are the equipment and technology utilized for C&S state of the art? Do the equipment and technology meet significant biomedical research needs? Do the 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 C&S staff suitably qualified?

Training

Are plans for providing opportunities for training effective and appropriate? Are Resource Training staff suitably qualified?

In renewal applications, have there been reasonable results accruing from these efforts to date?

Dissemination

Are the proposed Dissemination plans adequate and appropriate? In Resources that are developing software, is the software 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?

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?

Additional Review Criteria - Administration and Management, Infrastructure

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.

Administration and Management

Are the administrative and managerial aspects presented in the application appropriate and adequate? In addition, is the discrete space set aside for the Resource, including those available to visiting scientists, appropriate and adequate? In the case of a renewal application, is the usage of the instruments developed and supported by the Resource appropriate and adequate? Are instruments in place and operational, and are staff members currently on site?

Is the institution's commitment to the Resource appropriate and adequate? For example, are the allocated space, costs associated with alterations and renovations and purchase of instrumentation and computers, and salary support for some Resource staff adequate?

Are the scientific and managerial credentials of the PPD/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?

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?

Infrastructure

Is the technological infrastructure requested in this section necessary for the BTRR? Has the applicant chosen the most cost effective and appropriate infrastructure?

2. Review and Selection Process

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:

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 (NAGMSC). The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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)Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

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)
Telephone: 301-945-7573
TTY: 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Douglas M. Sheeley, Sc.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email: sheeleyd@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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.

Authority and Regulations

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 Parts 74 and 92.

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