National Institute of General Medical Sciences (NIGMS)
Reissue of PAR-17-316
January 11, 2021 - Notice of Change to Funding Opportunity Description to Clarify the Requirement for a Sustainability Plan in PAR-20-104. See Notice NOT-GM-21-015.
May 05, 2020 - NIGMS Late Application Policy for NIGMS-Specific FOAs with Application Due Dates in May 2020. See Notice NOT-GM-20-029
February 20, 2020 - Notice of Informational Webinar on New NIGMS Funding Announcements for Team Science and Biomedical Technology Development and Dissemination Centers. See Notice NOT-GM-20-023.
July 26, 2019- Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128
August 23, 2019- Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137
This funding opportunity announcement (FOA) encourages grant applications for national Biomedical Technology Development and Dissemination (BTDD) Centers. The BTDD program supports the development of technologies once their feasibility has been established and the dissemination of these technologies to the wider biomedical research community. The program encourages investigators to propose projects that address any of the biomedical research areas within the mission of NIGMS. The Centers are required to make their technologies available to the research community in a sustainable manner, to provide user training, and to disseminate the Center’s technologies and results. Centers should be at the leading edge of their field with respect to both technology development and engagement of the relevant research community. Potential applicants are strongly encouraged to contact NIGMS staff at least 10 weeks prior to the application due date to ascertain whether the proposed project is appropriate for an NIGMS BTDD Center.
February 03, 2020
30 days prior to the due date
May 26, 2020; January 26, 2021; May 26, 2021; January 26, 2022; May 26, 2022; January 26, 2023
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
November 2020; July 2021; November 2021; July 2022; November 2022; July 2023
January 2021; October 2021; January 2022; October 2022; January 2023; October 2023
April 2021; December 2021; April 2022; December 2022; April 2023; December 2023
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.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
This Funding Opportunity Announcement (FOA) will support Biomedical Technology Development and Dissemination (BTDD) Centers in any of the basic or clinical biomedical research areas within the mission of NIGMS. The BTDD program supports the development of technologies once their feasibility has been established and the dissemination of these technologies to the wider biomedical research community.
The BTDD program replaces the long-standing Biomedical Technology Research Resources (BTRR) program. The activity code has been changed from P41 (multi-component) to RM1 (single component) to simplify grant application and administration processes. Like the BTRR program, the BTDD program will continue to focus on two goals: the development and dissemination of enabling technologies, and providing access to those technologies by the research community. A major change is that the BTDD program focuses on later stage technology development. The program goals are still addressed through three types of activities: Technology Development Projects (TDP), Driving Biomedical Projects (DBPs), and Community Engagement (CE).
NIGMS has established a technology research and development grant pipeline for early stage proof of concept and prototype development projects that provide support through the R21 and R01 funding opportunities in the Technology Development Programs. These funding opportunities provide support to develop validated prototypes for early stage technologies before they are ready to be used for biological research. The BTDD Centers will support prototype optimization and later stage development, focusing on demonstrating utility to biomedical research and dissemination of technologies that have been established through R21 and/or R01 technology research grants or other sources of support. Technologies developed through all three of these activities (R21, R01 and RM1) that are ready for product development may be eligible for SBIR/STTR support to facilitate commercialization.
The BTDD program focuses on later stage development with the DBPs acting as test beds for the TDPs. For a TDP to address the needs of basic biomedical research it must be developed sufficiently such that DBPs can act as beta testers for further technology development and refinement. The TDPs interact with the DBPs in iterative cycles of refinement, improving the research tools until they are ready for broad dissemination to the biomedical research community.
Centers refine and disseminate tools that can substantially improve present approaches to a wide variety of problems in the biomedical sciences. This is accomplished through a synergistic interaction of technical and biomedical expertise, both within the Centers and through intensive collaborations with other leading laboratories. Ideally, Centers should be uniquely positioned to recognize biomedical research problems that will benefit from access to and training in better tools derived from emerging, proven technologies. This intense synergy between technology development and community-driven biomedical problem-solving defines the Centers as fundamentally different in character from laboratories engaged in research projects that may have more narrowly defined, inwardly-focused goals.
TDPs are the central activity of a BTDD. Research teams bring critical, often unique technologies at the forefront of their respective fields from a point of development in which they have been proven and used in their own laboratories to a stage where they are robust tools ready to be disseminated to the research community. In support of that mission, the Centers are structured to cultivate two kinds of collaborations: Technology Partnership Projects (Partnerships) and DBPs.
Partnerships are dynamic, short-term collaborations with other technology developers that will enable the Center to adopt and incorporate emerging capabilities in rapidly evolving fields. BTDD investigators must be able to recognize significant parallel contributions by other technology developers, determine whether collaboration is appropriate, and if so, establish mutually beneficial partnerships. While a BTDD is expected to operate at the leading edge of a technology area, it is important to recognize, leverage and foster advances emerging from other research groups.
DBPs are biomedical research test beds that allow BTDD investigators to test technologies in the context of challenging problems in basic, translational, and clinical research, while providing biomedical researchers with the earliest possible access to these emerging tools. A deep understanding of needs and opportunities in the relevant areas of biomedical research is an essential prerequisite for all technology development. In a BTDD, this understanding is most clearly expressed through successful engagement of those researchers best positioned to benefit from early access to emerging tools.
BTDD investigators are expected to actively engage scientists in the community whose research may benefit from the offered technologies. Active engagement of the relevant biomedical research community is essential for development of an informed, competent user base that can subsequently adopt the technology as it moves out of the Center. This is done through Community Engagement (CE) activities, which include training the user community in data acquisition and interpretation, access to mature forms of the technology at the Center, and to the extent possible, dissemination of available technology outside the Center. Technologies are moved out of the Center quickly to promote the broadest and most sustainable availability possible.
The success of BTDD-supported technology development is ultimately measured by adoption of the developed tools by the broader biomedical research community for continued impact. Achieving sustainable community access to the technologies developed by a Center is the goal of the BTDD program. A BTDD Center will be funded for no more than 15 years. Therefore, an objective of the BTDD program is for the resources they provide, rather than the Centers themselves, to become self-sustaining.
Dissemination of technologies can be achieved in a number of ways, and investigators are encouraged to develop plans best suited for the sustained access to valuable tools by the relevant research community. In some cases, this will entail commercializing the tools through licensing to existing businesses or through creation of new businesses with the assistance of small business (SBIR/STTR) grants, or other means. These might include dissemination through established providers of tools such as open-source software, reagents, plasmids, and protocols.
The BTDD program is investigator-initiated. NIGMS encourages applications in all areas within its mission and will give priority to areas not already supported in its current Centers. NIGMS encourages applications from institutions in Institutional Development Award (IDeA) states and partnerships between non-IDeA institutions and investigators in IDeA state institutions. Details concerning current BTRR and BTDD Centers can be found at https://www.nigms.nih.gov/about/overview/BBCB/biomedicaltechnology/Pages/btdd.aspx.
The National Institute of Biomedical Imaging and Bioengineering (http://www.nibib.nih.gov, NIBIB) has a similar program that supports Biomedical Technology Resource Centers (BTRCs). Details about that program can be found at https://www.nibib.nih.gov/research-funding/biomedical-technology-resource-centers. Applicants who are interested in submitting an application to the NIBIB program need to follow the NIBIB application procedures rather than those in this announcement. Applicants are encouraged to investigate both the NIGMS and NIBIB programs, and contact Institute staff for help determining which program is a better fit for their proposed Center.
In order to maintain a cutting-edge and diverse portfolio of technology development, NIGMS will not fund a BTDD center for more than 15 years (two renewals). Funding for previously supported P41 BTRR centers will be included in this 15 year limit.
Technology Research and Development: Together, the TDP projects are the central focus of the BTDD application and serve as the foundation for all other Center activities. The TDP projects should be synergistic. This synergy may be related to multiple applications of a common underlying technology, or complementary approaches supporting a common goal.
The technologies proposed for the Center must be at a stage where feasibility has been established, and improvements to the technologies will allow them to serve a wider range of users. In cases where a developed instrument, method, protocol, or platform may be accessible to experts with a deep understanding of the theory and practices of the field, the Center should continue development to allow access to a wider community made up of experts and non-experts alike. This can be done, for example, by combining established methods, improving automated approaches, establishing pipelines, incorporating known algorithms, etc.
A BTDD may focus on advancement of a single technology area or the development of an integrated approach to a general class of problems. BTDDs may be developed in a specific technological area. For example, a Center might focus on instrumentation and methods development for a specific instrument type. In contrast, a Center may integrate multiple technologies to create transformative approaches to a class of research problems.
The organizational structure of the Center, particularly the TDP projects, should be carefully justified, addressing the scientific rationale for the organization of the projects themselves on a basis other than the boundaries between research groups. Extensive interaction among the TDP, DBP, and CE components should be reflected in the distribution of funds and personnel effort; setting organizational boundaries along PD(s)/PI(s) research efforts may result in the pursuit of respective aims independently.
A TDP may include, if warranted, plans for one or more Technology Partnership Projects. A Partnership is appropriate if adopting an innovative technology being developed by another research group will significantly advance the technology development program of the Center. Partnerships should be of short duration, generally one to two years, usually conducted as funding-neutral collaborations analogous to DBPs. Alternatively, Partnerships may be supported through deployment of Center funds as consortium subcontracts (or redeployment if initiated later). If they are anticipated at the time of application, they should be described. They may be initiated at any time during the grant period at the discretion of the PD(s)/PI(s), consistent with NIH grant policy. BTDDs are encouraged to collaborate with industrial partners. In general, industrial partnerships should be funding neutral, characterized by in-kind contributions of effort and equipment.
A TDP should not focus on data collection. However, in some cases, modest subprojects designed to generate data for use in technology development or testing may be included as a part of a TDP. 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.
Driving Biomedical Projects: Development of biomedical research tools is most effective when pursued in the context of challenging problems. The DBPs of a BTDD are a set of biomedical research projects that will be pursued by the Center in collaboration with outside investigators to act as test beds during integration and refinement of Center technologies. This collection of projects is an essential aspect of a BTDD's mission and should represent a significant investment of time and effort by the Center.
DBPs are collaborative projects. Center personnel are expected to work jointly with investigators from outside the Center 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 BTDD is expected to fund the Center staff for work done in the Center. However, the collaborating investigators may not receive financial support from the Center for the work that they do in their laboratory or for DBP investigators working at the BTDD performance site.
It is expected that turnover in DBPs will occur during the project period. The rationale for selection of the DBPs and a process for recruiting, selecting, and terminating DBPs is required. DBPs should be selected on the basis of both their potential for significant biomedical impact and their appropriateness as test beds for the technology project. A DBP should present an opportunity to clearly demonstrate the significant impact of technologies under development in the Center. The selected biomedical research projects should present substantial technical challenges providing the opportunity for an iterative relationship to develop between TDP and the DBPs, advancing both. Such efforts are expected to lead to joint publications.
Purely technical collaborations focused on advancing some aspect of TDP are not considered DBPs but can be included as part of the relevant TDP project, either as a fundamental, ongoing element of that project, or, if transient, as a Technology Partnership Project.
The collection of DBPs should be broad in scope and involve a variety of biomedical research areas. The Center 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 Center’s responsibility to identify user communities that both need and will use the research capabilities provided by the Center. The scope of a BTDD’s portfolio of DBPs should be reflective of the breadth of the technology’s potential impact.
Every TDP must have a relationship with at least one DBP. It is preferred that a DBP drive more than one TDP. DBPs are expected to be significant biomedical research problems. Because BTDDs 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). DBPs are expected in most cases to stem from ongoing biomedical research projects that have already been peer reviewed. In exceptional cases a majority of DBPs may be local, if sufficient justification can be provided.
Community Engagement: A BTDD Center is expected to serve as a resource for and to have a national impact on a particular biomedical research community. Therefore, strong community engagement is required. Leadership of a Center must include a clear vision for the relevance and potential impact of the technologies under development, and a strong desire to realize that vision through active engagement of the biomedical research community. For a BTDD to be successful, Center staff must actively work with researchers who need access to technology and expertise, including hands-on training for outside investigators. The Center must also invest effort in achieving genuine dissemination of the technology and methods it has developed. These efforts require the commitment of significant financial and personnel resources to activities outside of their primary research focus. Providing other investigators with ready access to Center 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, to the extent possible, to export the technology and expertise of the Center into the community, achieving a broader impact on biomedical research than would be possible through the projects in which the Center can participate directly. Industrial partnerships are not required, but they are encouraged when appropriate. Ultimately, the CE elements of the Center should aim for the widespread and routine application of the technologies being actively disseminated. An extended technology development cycle might require a renewal application for full maturation and community adoption. However, BTDD Centers will not be renewed beyond three cycles and all renewal applications will require a sustainability plan.
Ultimately, the approach to community engagement is largely left to the discretion of the Center PD(s)/PI(s). It is understood that some technologies are more readily shared, replicated, or commercialized than others, and unique constraints may dictate unique approaches. Further, BTDD investigators are encouraged to use multiple approaches to engage different segments of the biomedical research community. These approaches need not be novel, and applicants are encouraged to look to other successful BTRR and BTDD Centers for proven methods. The phrase 'community engagement' describes a process, rather than the goals of that process. The process is emphasized because active engagement with the research community is central to achieving those goals, which are to provide the broadest possible access to developed technologies, both within and beyond the Center, and moving those technologies out into the community as quickly and effectively as possible.
Centers may incorporate the following CE activities:
Advisory Committee: Each BTDD 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 Center, particularly in setting priorities for allocation of Center facilities. The committee chair should be knowledgeable about the Center's technology and the science it serves but should not be a member of the Center staff or a major user of the Center. Other committee membership should be balanced among scientists knowledgeable about the Center’s technology, experts in its application to biomedical research problems, and users of the technology. Members should represent a diversity of perspectives.
EAC members and the chair should be from outside the host institution. NIGMS encourages the inclusion of scientists who are not affiliated with the Center; however, inclusion of DBP collaborators or CSP investigators 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 to the PD(s)/PI(s).
Prior Consultation with Institutes and Centers (IC) Staff
Potential applicants are strongly encouraged to contact NIGMS staff at least 10 weeks prior to the application due date to ascertain whether the proposed research strategy meets the goals and mission of the Institute, whether it addresses one or more high priority NIGMS research areas, and whether it is appropriate for a BTDD Center. Institute staff will not evaluate the technical and scientific merit of the proposed program in advance; technical and scientific merit will be determined during peer review using the review criteria indicated in this FOA. During the consultation phase, if the proposed research strategy does not include the necessary subcomponents, meet NIGMS' programmatic needs, or is not appropriate as a BTDD Center for other reasons, applicants will be advised to consider other funding opportunities.See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The maximum budget that may be requested is $850,000 in direct costs per year, excluding equipment and consortium F&A costs. Applications requesting more than this amount will not be reviewed. Because of the technology-intensive nature of these Centers, there may be a need to acquire specialized equipment. Equipment requests are expected to vary with the nature of the technology development projects proposed. Funds for such specialized equipment may be requested in excess of the $850,000 operating limit if well justified.
The scope of the proposed project should determine the project period. The maximum project period is 5 years. NIGMS will not support a BTDD center for more than 15 total years (2 renewals), including support for previous P41 BTRR Centers.
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
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations 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. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
PD(s)/PI(s) must provide a minimum of 3 person months' effort to the BTDD project.
NIGMS PD(s)/PI(s) holding a Maximizing Investigators' Research Award (MIRA ) are eligible to apply. They must maintain 51% research effort toward their MIRA, and 3 person months' effort toward the BTDD. The BTDD award can only provide support in a MIRA PD/PI's laboratory for late-stage technology development and dissemination efforts .
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Paul Sammak, Ph.D.
For Resubmission applications, the Introduction to Application section may consist of the following subsections with the indicated page limits:
|Overview, Administration and Management, and Driving Biomedical Projects (combined)||1|
|Technology Development Projects||1 each|
The Research Strategy section must consist of the following subsections with the indicated page limits:
|Administration and Management||
|Driving Biomedical Projects||12|
|Technology Development Projects (3 maximum)||12 each|
|Collaboration and Service Projects (if applicable)||12|
Revision applications must include an Overview subsection and the subsections that are affected by the revision. Therefore, the subsection requirements listed above may not apply to the Revision application.
Facilities and Other Resources: For projects with more than one performance site, describe the effect of the multiple locations on the BTDD. Provide any plans to mitigate adverse effects of geographic separation of Center activities.
1. EAC Report: The most recent External Advisory Committee report may be included as an attachment in this section, as appropriate. However, this is not a requirement.
2. Directly Supported BTRR Publications: For applications from former BTRRs, the title and complete references to all publications, manuscripts accepted for publication, patents, and other referenceable materials that have resulted from the Center since it was last reviewed competitively should be provided. All publications directly resulting from BTRR funded effort should explicitly acknowledge support from the BTRR award and be included in the publication list. These publications should be distinguished from those that do not benefit directly from BTRR funding. See Indirectly Supported Publications instructions below.
Name the file "Directly Supported Publications". Include the following two heading lines:
“Publications enabled by the BTRR since” and provide the start date of the last renewal.
* denotes Resource staff are included as author”
Organize the list using headings, as applicable: TDP# (title); Driving Biomedical Projects, Collaboration and Service Projects. Indicate publications that include Resource staff as authors with an asterisk.
3. Indirectly Supported BTRR Publications: The application may include a list of publications indirectly resulting from effort in the resource. Name the file “Indirectly Supported Publications”. Include the following text at the top of the page
“Indirectly-supported publications include work that benefitted from the existence of the resources developed by the Center while supported as a BTRR but involve no active engagement or effort by the Resource. An indirectly-supported publication might, for example, cite the use of Resource-developed software downloaded and used independently by a non-Resource investigator. This section is not required. These publications may be listed as evidence of the secondary impact of the BTRR, beyond the investigators actively working with the Resource. This is a measure of the effectiveness of the Resource’s Community Engagement efforts and the value of Resource technologies in the broader community.”
Include as key personnel the lead for each subsection (TDPs, CE, Administration and Management).
All instructions in the SF424 (R&R) Application Guide must be followed.
The budget should include a detailed justification for key personnel. The budget justification should include a table of all personnel and the level of effort for each project with which they are involved. Total effort cannot exceed 100%.
The PD/PI is required to dedicate a minimum of 3 person months effort to this program. For multi-PI applications, each PD/PI is required to dedicate a minimum of 3 person months effort. Subsection leads for TDDs and CE should be identified and provide a minimum of 1 person month effort to the project. If effort proposed is greater than support requested, this should be noted.
Equipment may be requested. A justification should be supplied for the equipment requested for the Center and organized by project usage (indicate which TDD or CSP). 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.
Funds should be requested in the Consultant Costs category of the budget for support of External Advisory Committee (EAC) member travel expenses for the annual EAC meeting.
Other than BTDD staff salary support, no support may be requested for DBP or CSP collaborative activities conducted outside of the BTDD (i.e., laboratory work undertaken by any personnel associated with the collaborating laboratories cannot be supported through the BTDD grant).
If a charge back system for CSP activities that results in program income is planned, include a description in the budget justification describing the rationale and any planned uses for the income. Note that special administrative requirements applying to program income must be observed. See the NIH Grants Policy Statement Section 8.3.2.
No funds may be requested to support travel or accommodations for training course registrants.
Support for Technology Partnership Projectscan be requested by including a consortium subcontract to the collaborating investigator’s institution for personnel, materials and travel for this work. The performance site for the work may be at the collaborating institution or at the performance site of the BTDD. The request should not span the entire 5-year project period for these dynamic, short-lived collaborations.
Introduction to Application: For Resubmission applications, see page limits above for the combined Overview, Administration and Management and Driving Biomedical Projects subsections, the CE subsection and for each TDP subsection. The Introductions for each subsection must be combined into a single PDF attachment.
Specific Aims: Describe the overall aims of the proposed Center. Note that the first page of each TDP Research Strategy subsection is reserved for Specific Aims for the respective TDP.
Research Strategy: The Research Strategy must consist of the following subsections, in the order listed below, uploaded as a single pdf attachment:
Note: Projects may not be supported beyond a combined total of 15 years as BTRRs or BTDDs. Applicants submitting for the final project period should be aware that BTDD funding will not be extended past the end of the final project period, and should propose a Research Strategy and sustainability plan for the final five-year project period that takes this into account.
Provide an overview of the proposed BTDD: Describe the long-term goals of the BTDD. Provide the current state of the art in the field and the project objectives, which should be a significant advance beyond the state of the art. Describe competing/similar existing technologies and centers, and point out what makes the proposed BTDD unique.
Describe the TDPs and Partnerships, if any, highlighting the synergy and complementarity among them.
Describe plans to ensure geographic distribution of center DBP, CSP and Partnership collaborators and broad geographic reach of technology dissemination.
Describe the needs that will be addressed by the Center, of the research community in general, and the DBPs in particular, in terms of what technologies and resources are currently available and why the proposed work is timely. Describe the primary strategies for CE, explaining why the projects and plans presented in detail in the corresponding components of the application will position the BTDD to bring the subject technologies into broad use. Include an explicit description of the specific technology to be disseminated and the proposed methods of dissemination. Describe any circumstances that factor into the CE plans, justifying why the proposed approach has been chosen.
Annotated timeline: Include an annotated timeline/graphic that depicts how the proposed TDPs, Partnership Projects, and DBPs relate to one another as a work-flow, and the target dates for availability of technologies.
For new Centers, include information on factors and events contributing to the decision to create the BTDD. For projects that are currently NIGMS BTRRs, include a brief summary of the BTRR’s progress in the current project period. Include progress in technology development. Include relevant metrics for any research products (publications, software, videos, tutorials, etc), both those demonstrating impact through dissemination alone and through collaborative interactions. Highlight technology dissemination, of both commercial and non-commercial distribution of mature tools (reagents, instruments, methods, software).
Administration and Management
Include the following sections, with headings: Organizational Structure and Staff Responsibilities, Center Operating Procedures, External Advisory Committee (EAC), and Sustainability Plan.
Organizational Structure and Staff Responsibilities: Describe the organizational structure of the BTDD. Indicate the relationship of the Center to the administrative structure of the applicant institution. Describe how the PD(s)/PI(s) and the proposed Center staff will be organized with respect to the Center components: each of the TDPs, DBPs, CE, and Administration and Management functions. Provide a table depicting how BTDD staff will allocate their effort across these components.
Describe how the PD(s)/PI(s) will provide leadership and direction to the key components of the Center, including directing and coordinating the TDP project leaders, overseeing the progress and turnover of DBPs, and overseeing all CE activities, including ensuring proper access to Center resources through CSPs, if applicable.
If multiple PD(s)/PI(s) are proposed, describe in general the structural and procedural elements that will ensure this integration and prevent fragmentation of the Center, underscoring how it is not simply a collection of individual projects with a common technological theme. Refer to the multi-PI (MPI) leadership plan, where details may be fully elaborated.
Center Operating Procedures: Describe operating procedures and policies planned for the Center. Include criteria and mechanisms to review requests for the use of the equipment and facilities in the Center, to provide feedback to both successful and unsuccessful applicant users, and to schedule use once approved. Describe criteria and processes for prioritizing and selecting any collaborative projects, such as Technology Partnerships, DBPs, or if applicable, CSPs. Include a description of how the Center will educate and monitor users in the requirements to acknowledge support provided by the Center in any resulting publications, and about all NIH data sharing policies.
External Advisory Committee: Describe the role of the EAC in advising on instrument purchases, Technology Partnerships, reviewing DBP and CSP for merit and appropriateness, allocating instrument time, and on the proposed plans for the BTDD. For existing and proposed Centers with an established EAC, include names of current committee members and a brief description of their qualifications and diverse backgrounds. For applications for new Centers, describe the scientific disciplines of anticipated committee members that would be represented on the EAC. Do not name in the application, contact, or appoint potential EAC members prior to completion of the grant submission, review, and funding process. However, if an EAC was already constituted before the preparation of the application, the membership of that committee must be disclosed in the application.
Additional advisory committees are allowed. Describe the function and meeting schedule for any local executive committee or other local committee appointed as an adjunct to the EAC to deal with specialized topics.
Sustainability Plan: Describe the plans for achieving continuing, long-term access to and adoption of Center-developed technologies and related resources beyond the life of the BTDD. Include metrics for determining success of these plans. Delineate the plans as those activities occurring in the proposed project period that will work toward ensuring sustainability, and those envisioned to occur at a later date.
Driving Biomedical Projects
All applications must provide the following (suggested page limits provided as guidance): a table of proposed DBPs (1 page), a summary of DBPs (1 page) and descriptions of a maximum of 10 DBPs (1 page per DBP), excluding references.
Table: Provide a 1-page table of up to 10 DBPs. Format the table to include the following columns:
Summary: Provide a 1-page summary of the DBPs. This should be a succinct and accurate description of the overall goals. Provide a description of criteria used for including new DBPs and rotating existing DBPs out of the BTDD during the award period.
Description: Provide a one-page description of each DBP. Begin each on a new page with the following information:
Describe the DBP and the portion of the project relevant to the BTDD application. Describe how the DBP will provide a context for demonstration, integration, and refinement of Center technologies. Describe the potential impact of the proposed technology development on the DBP. Include a progress report for continuing DBPs. As appropriate, provide DBP requirements and proposed TDP capabilities, which should exceed requirements (e.g., resolution, precision, sensitivity, etc.).
Technology Development Projects
Provide a subsection for each TDP, with a maximum of three. Name the TDPs sequentially as TDP# followed by a short descriptive title.
For each TDP, begin on a new page with the TDP name as a heading. List the DBPs associated with the TDP, by number and title, immediately after the TDP heading. Describe the goals of the TDP. Present the Research Strategy in sufficient detail for critical evaluation of the the potential impact of the technology, the quality of the technology development, and the role of the project in the overall Center. Describe why the TDP project is at the cutting edge of the technological field and how the Center will meet the goal of increasing the technology’s impact on biomedical research. Provide evidence that the technology has been developed to the point where feasibility has been established. Address the background and rationale for the TDP, its significance, and methods. Describe how the technology under development improves upon any existent or alternative technologies that address the same research needs.
List the lead investigator(s) who will be primarily responsible for the TDP.
Describe plans for the optimization of the technology project to a point where dissemination is realistic. As appropriate, relate TDP optimization plans to dissemination plans for the technologies. Present alternative approaches to solving technological problems in the event that the main conceptual thrust should prove infeasible. Include plans for validation of prototypes and methods, and authentication of reagents and biologicals, that ensure the technologies can achieve the intended biological aims.
Include the following under the specific subheadings in the TDP subsection:
Technology Partnership Projects: If one or more Technology Partnership Projects are proposed, explain plans for the Partnership and provide the supporting rationale as being dynamic, short-term collaborations with other technology developers that will enable the Center to adopt and incorporate emerging capabilities in rapidly evolving fields.
Technology Development Integration: Describe the relationship of this TDP project to the overall technology development program of the BTDD. Discuss the complementarity between this TDP project and the other proposed TDPs.
DBP/TDP Interactions: Describe how the TDP project is responsive to the emerging needs of the biomedical research community. Describe how each associated DBP will serve as a test bed for the TDP. Describe how each DBP is enabled by the TDP. As appropriate, provide DBP requirements and proposed TDP capabilities, which should exceed requirements (e.g., resolution, precision, sensitivity, etc.)
BTRR Research Progress: For projects that are currently BTRRs, include progress made during the current project period, and identify all new activities.
Describe overarching plans for active community engagement with the research community, providing rationale for the approach. List the lead investigator(s) who will be primarily responsible for CE.
A strategy for engaging the community to promote adoption of new technologies and to achieve sustainability should be addressed in an integrated manner in the CE section. If applicable, provide innovative plans to mitigate any obstacles to dissemination, promotion, and adoption of developed technologies. For example, if replication of a technology outside the Center is not feasible, consideration should be given to how this might be overcome to make the technology truly portable, and if not, how to ensure widespread access. A progress report of Community Engagement activities from the previous project period for existing BTRRs should be included in this section.
Provide details for the following activities under the appropriate heading:
Technology Training for the User Community: Describe plans for providing training to the scientific community about the technical capabilities and accomplishments of the subject technologies developed in the BTDD, and how these tools can be applied to their problems. Describe how successful user training activities will enable researchers to fully utilize the technologies and resources developed by the BTDD. The user training should be well thought out, accessible, and effective but does not need to be novel.
Examples of appropriate approaches to user training include hands-on laboratory experience such as visits in the BTDD laboratories for researchers from other laboratories or reciprocal visits by BTDD 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 BTDDs technology in biomedical research. Because of the increasing importance of translational and clinical research, plans for training researchers involved in those efforts are encouraged where appropriate.
If on-site user training and collaborative work will be supported, describe plans to make workspace available for visiting scientists. Do not include academic courses that are offered as part of the curriculum of the Center’s institution, that are not available to those outside the institution. These cannot be considered an element of the Center’s user training mission. Individuals benefiting from the user training experiences may not be paid a salary in conjunction with the experience, nor may the experience be a requirement for receipt of an academic degree. Do not include formal pedagogy training activities of students and post-doctoral fellows involved in the BTDD, as those educational activities are not considered relevant to the user training element of a BTDD, which is focused on the external research community.
For applications from former BTRRs, provide a progress report on user training activities from the previous project period, including data collected as part of the demand/utilization tracking plans. Note that NIGMS will not provide support for a BTRR/BTTD for more than a total of 15 years (2 renewals).
Technology Dissemination: Provide plans to disseminate the developed technologies of the BTDD. Approaches can include, but are not limited to distributing and supporting software products; transferring technologies to other laboratories directly; and patenting inventions, and licensing technologies to industry, including partnerships with small businesses and support from the SBIR and STTR programs.
Provide plans for measuring the success of dissemination efforts, including plans for tracking the demand for and utilization of resources provided directly by the BTDD.
In Centers that are developing software, emphasis should be placed on producing portable, well-documented, user-friendly software, making it readily available to the user community and providing user support. NIGMS encourages sharing of source code, consistent with the NIH data-sharing policy. Although software is not required to be open source, if a restrictive license will be used to distribute the software, written justification is required in the application.
Use of Common Data Elements in NIH-funded Research: NIH encourages the use of the FAIR (Findable, Accessible, Interoperable and Reusable) principles and common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects
Website: Describe plans to provide a robust web presence for a newly formed Center, or describe the current web presence for an existing center. Information required on the website includes:
Plans for Collaboration and Service (if applicable):Present plans to provide access to the advanced technologies such as instrumentation, software, methods, and expertise developed in a BTDD, available in the Center. Explain how the BTDD will actively engage the research community to collaborate and provide broad access to Center capabilities. Note that this program is not intended for support of a Center that is predominately focused on routine service.
Describe the overall goals of the CSP functions of the Center. Include the Center’s approach to, and plans for, CSP activities, as well as the manner in which service will be provided. Include the impact of the CSP functions of the Center on the research community.
Describe the overall range of CSP projects to be supported by the Center. Describe plans for the selection and evaluation of CSP projects. Present plans for ensuring and tracking acknowledgement of Center support.by all CE users, who must acknowledge the BTDD grant number in publications enabled by the resource, regardless of whether or not BTDD staff are listed as authors. Present plans for ensuring that CE users abide by NIH data sharing policies, including public access policies.
If a charge back system that results in program income is planned, include a description of how costs are to be shared by the users. Note that special administrative requirements applying to program income must be observed. See the NIH Grants Policy Statement Section 8.3.2.
Collaboration and Service Projects (if applicable)
Table of Collaboration and Service Projects
CSPs are not required. If present, up to 10 new CSPs may be proposed. If applicable, a table of all CSPs should be provided. For applications from former BTRRs, CSPs accessing the Resource since the last competing award start date should be included in the table following the listing of current and proposed activities. Each entry in the table should include:
Letters of Support: Provide a table of contents for Letters of Support. Include the name of the signatories and their institutions. Letters expressing institutional support should be presented first. Letters of support from investigators specifically collaborating with Center investigators on any TDP, DBP, or other projects described specifically in the application should be included next. The purpose of collaborative letters of support is to describe the nature of the collaborative relationship, including its scope, and any special circumstances (e.g., materials or technology transfer, or intellectual property agreements). Do not include letters of support from resource users whose interactions are limited to activities described in the CE component.Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
, with the following modifications:
Blank application forms for user requests to access Center CE activities may be included in the appendix (e.g., for CSPs, training or dissemination of resources).
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.For this particular announcement, note the following:
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the proposed Center address the needs of the research community that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research community?
For this Announcement:
To what extent does the collection of technology projects enable biomedical research that could not be accomplished with current technology?
If there are existing, alternative competing technologies that reduce the significance of this project, to what extend is the proposed technology still an important tool for the biomedical research community?
To what extent will the proposed Center have a national significance and a wide geographic reach?
Will the proposed BTDD enable biomedical research for the community which it serves by developing and disseminating important technologies and training users in the use of these technologies?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments managing technology development research? Do the investigators demonstrate significant experience with coordinating collaborative basic research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills: are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center?
For this Announcement:
Do the PD(s)/PI(s), TDP and CE lead investigators demonstrate significant experience with coordinating collaborative basic research and training, as required? Will they be well-suited to running a Center whose mission is further development of proven technologies, testing through collaborative DBPs, and the training and dissemination of these technologies?
If the Center is multi-PD/PI, do the investigators each operate in a leadership capacity regarding all components of the BTDD?
Does the application propose novel organizational concepts, management strategies or instrumentation in coordinating the research projects the Center will serve? Are the concepts, strategies or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of technologies proposed?
For this Announcement:
Where applicable, are the proposed scientific concepts and strategies novel? Does the application propose to refine and disseminate novel technologies? Are innovative methods used to improve existing technologies in an impactful way? Are standard methods, instrumentation, or processes combined to produce an innovative outcome? Were the technologies being refined in the TDPs originally innovative?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research community the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the community, as appropriated for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the project?
Are an appropriate plan for work-flow and a well-established timeline proposed?
Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
For this Announcement:
Is the approach appropriate for the BTDD program? Are the technology development (TDP and any Partnerships), driving biomedical projects, and community engagement subcomponents of the BTDD necessary and sufficient to address the stated need? Is there synergy among all of the BTDD components?
Does the proposed collection of TDP projects constitute a potentially effective, integrated approach to accomplishing the technology goals of the Center? Has feasibility of the proposed technologies been well established? Have the TDPs been developed to a stage where they are ready for iterative refinement and testing through collaborative interactions with DBP investigators? Are the DBPs effective test beds for the associated technology development projects? Do the DBPs demonstrate national geographic reach? Is there synergy among the TDPs and do they represent a coherent vision to advance the field (as opposed to a collection of independent but related development projects)?
Assuming success, are the plans for Community Engagement adequate to ensure dissemination of developed technologies, either through free distribution, fee-for-service, or commercialization? Will the biomedical community served by the Center have access to training in the developed technologies, and if appropriate, to the technologies themselves?
Is the organizational structure of the BTDD conducive to its development and operation as a well-integrated multidisciplinary team? Are the structural and procedural elements of the BTDD adequate to ensure
of the technology development program? Is the sustainability plan appropriate to ensure access to the technologies after grant support ends?
For new Centers, are plans for the External Advisory Committee and types of committee members appropriate? For former BTRRs and new Centers with established EACs, is the role of the EAC appropriate? Does it include the necessary expertise and a diversity of perspectives to effectively advise the PD(s)/PI(s) in the Center operations? Is there evidence that the committee is active?
If there are multiple PD(s)/PI(s), are they integrated into an effective team? Will the Multiple PD/PI Leadership Plan and Administrative and Management plans provide effective scientific direction? Is a robust framework for making decisions proposed? Are sound principles for scientific and budgetary decision making set forth? Have the applicants anticipated and addressed management issues and problems that may arise during the course of the project?
Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the TDP, DBP and CE projects it serves? Are the institutional support, equipment, workspace, and other physical resources available to the staff and, if appropriate, to visiting investigators, adequate for the Center? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
For this Announcement:
For projects with more than one performance site, what effect will the multiple locations have on the BTDD? Are plans in place to mitigate geographic separation of Center activities?
In the case of former BTRRs, is the usage of the technologies developed and supported by the Center appropriate and adequate? Are technologies in place and operational, and are staff members currently on site?
Each Technology Development Project will receive merit descriptors (Exceptional, Excellent, Good, Fair or Marginal) based upon the following criteria:
Quality of Research: Does the TDP address an important problem or a critical barrier to progress in the field? To what extent will successful completion of the aims improve scientific knowledge, technical capability, and/or clinical practice? To what extent will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? To what extent does the TDP enable biomedical research that can not be accomplished with current technology? What is the significant technical advance over the state of the art?
Has feasibility of the TDP been well established? Has the TDP been developed to a stage where it is ready for iterative refinement and testing through collaborative interactions with DBP investigators?
DBP/TDP Interaction: Will the proposed DBPs serve as appropriate test beds for the specific associated TDP project? Is the technology appropriate for the proposed DBPs and will it advance the science being explored in them?
Overall Technology Development Program: Is the overall technology development of the BTDD a coherent program, rather than a collection of individual but related projects? Is it clear that technology development will be carried through to completion, including optimization for use by non-specialists where appropriate? Are Resource TDP personnel suitably qualified to lead these technically complex and specialized projects?
For applications that are currently supported as Biomedical Technology Research Resources: Are DBPs making good use of the technological advances? Are new DBPs in important biomedical fields being actively sought to invigorate the Center? Is evidence provided of new meritorious efforts and significant progress during the past grant period?
Technology Partnership Projects: If Technology Partnerships are proposed, are they justified as dynamic, short-term collaborations with other technology developers that will enable the Center to adopt and incorporate emerging capabilities in rapidly evolving fields? Are planned partnerships likely to result in successful integration of partner technologies into the Center?
The Community Engagement subcomponent will receive merit descriptors (Exceptional, Excellent, Good, Fair or Marginal) based upon the following criteria:
Are plans for Community Engagement (CE) responsive to community needs, using multiple approaches, that need not be novel, to engage relevant segments of the biomedical research community? Are the plans reasonable? Are Center CE staff suitably qualified in their roles?
Does the CE component include detailed and reasonable plans to provide access to technologies in the Center as they mature? If present, do CSPs have a national geographical distribution? For Centers that do a substantial amount of service, are the plans for sharing costs by the users, including fee for service systems, appropriate?
Are the CE plans likely to result in development of an informed, competent user base in the research community? Are plans presented for direct hands-on user training in data acquisition and interpretation? Are the plans presented likely to result in the ability of researchers to successfully adopt Center technologies? Are Center user training staff suitably qualified?
Are plans for dissemination commensurate with the portability of the technologies? Will technologies be moved out of the Center quickly? Are dissemination plans likely to result in broad, sustainable availability? Are there specific plans for technology transfer? Are plans for tracking success of dissemination and Center demand appropriate? In projects formerly supported as BTRRs, is there evidence of progress in dissemination of technologies?
In Centers that are developing software, is it or will it be portable and open-source when appropriate, well documented, user-friendly, and readily available to the user community? Have there been efforts to make both non-expert and expert communities aware of the new technology? Is software development pursued in a manner that will promote dissemination and widespread adoption? Are plans likely to result in robust, adaptable, and stable software?
Are the plans for the website appropriate? How effective are the plans for the website in conveying the required information (the Center’s research focus and capabilities, technologies being developed and available, contact information, how to collaborate)? For projects that are currently BTRRs, is the website easy to find? Does the material on the website provide useful information to the biomedical research community? Has there been reasonable and timely progress in this area?
For research that involves human subjects but does not involve one of thecategories 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Reviewers may evaluate the Resource Sharing Plan and/or the appropriate activities within the Community Engagement subsection, as appropriate.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific 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 on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
NIGMS will give priority to areas of technology development not already supported in its current Centers.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.htmlor call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
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 agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings.Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
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Paul Sammak, Ph.D.
National Institute of General Medical Sciences (NIGMS)
James Li, Ph.D.
Center for ScientificReview(CSR)
National Institute of General Medical Sciences (NIGMS)
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