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

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

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

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

The National Institute of General Medical Sciences (NIGMS) of the National Institutes of Health (NIH) invites applications for Institutional Development Award (IDeA) Networks of Biomedical Research Excellence (INBRE) grants to independent biomedical research institutes and/or biomedical research institutions that award doctoral degrees in the health sciences or sciences related to health within IDeA-eligible states. INBRE applications represent collaboration between research intensive universities and other research intensive institutions and institutes, primarily undergraduate institutions, community colleges and Tribally Controlled Colleges and Universities (TCCUs), as appropriate.

This Funding Opportunity Announcement (FOA) is to provide an opportunity to build on the successes of the INBRE program to augment and strengthen the state's biomedical research capacity. The primary goals of the INBRE program are to: 1) build on the established multi-disciplinary research network with a scientific focus to strengthen the lead and partner institutions' biomedical research expertise and infrastructure; 2) build and increase the research base and capacity by providing support to faculty, postdoctoral fellows and graduate students at the participating institutions; 3) provide research opportunities for students from primarily undergraduate institutions, community colleges and minority serving institutions and serve as a "pipeline" for these students to continue in health research careers within IDeA states; and 4) enhance science and technology knowledge of the state's workforce.

For the purposes of this FOA, primarily undergraduate institutions include U.S. two-year, four-year, masters-level, and small doctoral colleges and universities that (1) grant baccalaureate degrees in NIH-supported fields, or provide programs of instruction for students pursuing such degrees with institutional transfers (e.g., two-year schools); (2) have undergraduate enrollment exceeding graduate enrollment; and (3) award an average of no more than 10 Ph.D. or D.Sc. degrees per year in biomedical and behavioral sciences.

The INBRE program seeks to promote the development and expansion of unique, innovative, state-of-the-art biomedical and behavioral research at institutions in IDeA-eligible states, encompassing the full spectrum of basic, clinical and translational sciences. The NIH recognizes that the contributions from the institutions in IDeA-eligible states are important and essential in fulfilling the promise of the NIH research agenda. The intent of this FOA is to continue assisting these institutions to implement and use the technologies and other resources needed to conduct state-of-the-art biomedical and behavioral research and provide research experiences to students at baccalaureate institutions, community colleges and TCCUs.

The IDeA Program was authorized by Congress for broadening the geographic distribution of NIH funding for biomedical and behavioral research by enhancing the competitiveness for research funding of institutions located in states that historically have not received significant levels of research funding from NIH. Disparate funding distributions may stem in part from having relatively few competitively supported biomedical and behavioral investigators in IDeA states. Statewide IDeA Networks of Biomedical Research Excellence supported through this FOA are intended to develop the research resources and modern laboratories needed to attract established investigators, and to develop and enhance the research skills of talented investigators and promising students within each state.

The INBRE program began in 2001 by providing planning grants for three years. These programs were competed in 2004, 2008 and 2012 to establish inclusive statewide multidisciplinary research networks with scientific foci to promote the development, coordination, and sharing of research resources and expertise that will expand the research opportunities and increase the number of competitive investigators in the IDeA-eligible states. INBREs also were intended to enhance the caliber of scientific faculty at research institutions and primarily undergraduate schools, thereby attracting more promising students to these organizations. The purpose of this FOA is to build on the successes of the existing INBREs to augment and strengthen biomedical research capacity within IDeA states. Each INBRE is a statewide network to be composed of doctoral degree-granting institution(s) or research institute(s) with one organization serving as the lead institution, and to include primarily undergraduate institutions, community colleges and TCCUs as partner institutions appropriate to the state. The inclusion of investigators and institutions in the network that serves the under-represented minorities in biomedical and behavioral research within the INBRE is strongly encouraged.

The purpose of INBRE program is to:

• enhance the research capacity of institutions through collaborative partnerships, develop areas of potential research, enhance staff development, and provide access to research resources, so they can participate more fully in the competition for NIH awards; and
• provide hands-on research experiences and career enhancement activities for participating students at primarily undergraduate institutions, community colleges, and TCCUs and serve as a pipeline to health research careers.

The FOA is intended to strengthen the basic science departments of primarily undergraduate institutions, community colleges and TCCUs. This Program provides opportunities for primarily undergraduate institutions, community colleges, and TCCUs to support and retain current productive faculty and recruit outstanding faculty who conduct research in the specific proposed thematic areas which can attract promising students to health-related science through both didactic education and research experiences. These institutions may develop new courses or improve existing ones to augment the science curriculum, and to stimulate and strengthen the role of research into curricula traditionally limited to classroom instruction.

Students who are well trained in science and technology can enhance the quality of the scientific workforce available to participate in NIH funded research. With better employment opportunities, more students may choose to stay within the state. The primarily undergraduate institutions also serve as an important pipeline to the science departments of graduate schools within IDeA states for students to pursue graduate education. With access to promising, biomedically-trained students, the graduate schools in the IDeA states can more readily build a critical mass of investigators to conduct biomedical research by recruiting competitive investigators from other institutions as well as recruiting some of their own graduates. This aligns well with the NIH mission to diversify the workforce to lead recruitment of the most talented researchers from all groups; improve the quality of the educational and research environment; balance and broaden the perspective in setting research priorities; improve the ability to recruit subjects from diverse backgrounds into clinical research protocols; and improve the Nation's capacity to address and eliminate health disparities.

The application must include a scientific focus in one or more thematic areas, such as neuroscience, cancer, genomics, proteomics, developmental biology and genetics, toxicology or any of the biomedical and behavioral scientific areas relevant to the mission of NIH, and may include basic, clinical, and/or translational research approaches to attain the goals of the proposed network. The broad thematic areas will encourage and facilitate interactions and cross-collaborations among INBRE, Center of Biomedical Research Excellence (COBRE), IDeA Clinical and Translational Research Center (IDeA-CTR) and other NIH supported programs. This will also promote data and resource sharing within the statewide network and the region. It is also anticipated that, in some instances, support through this FOA will facilitate the development of new disease-specific research programs or augment the capability of existing programs.

Scientific leadership provided by one or more established biomedical research faculty is critical to the success of the INBRE initiative, especially for the career enhancement of promising investigators, postdoctoral fellows, and students. Some applicant institutions may have faculty who hold significant peer-reviewed funding from either Federal or non-Federal sources to conduct research. Those faculty may be included as advisors, collaborators, and scientific members of a multidisciplinary steering committee. The network is intended to support investigators from several complementary disciplines at the grantee and partner graduate and primarily undergraduate institutions, community colleges and TCCUs. The focus of the planned research network will determine the need for core research facilities and modern instrumentation. Faculty at participating institutions will receive support to establish or enhance existing research laboratories, acquire specialized equipment, and hire postdoctoral fellows, students and technical assistants.

The NIH is committed to working toward elimination of health disparities among racial and ethnic populations. Investigators proposing research that involves human subjects are strongly encouraged to include representation from the unique and diverse populations within the IDeA states for valid analyses of factors that may influence health disparities. INBREs are encouraged to interface and collaborate with other appropriate programs that address health disparities and health issues in underserved communities.

Under this FOA, INBREs are strongly encouraged to collaborate and interface with pre-kindergarten to grade 12 (P-12)/pre-college level programs such as Science Education Partnership Award (SEPA), for developing a continuous pipeline of students to provide for the INBRE program to train future generation of a diverse biomedical research workforce.

Since only one award will be made per IDeA-eligible state, only one application should be submitted per state.

The statewide network is to be composed of baccalaureate, master's level degree-granting institutions, non-profit research institutes, community colleges, and/or TCCUs that will provide the sites for the conduct of thematic, multidisciplinary, biomedical and behavioral research. An INBRE scientific network must include a doctoral degree-granting institution or research institute as the applicant institution in the eligible IDeA states and ideally six to eight baccalaureate, master's level degree-granting institutions and community colleges or TCCUs participating in the thematic research activity. One or two additional biomedical research-intensive institutions may participate in the network and share in the portion of the budget dedicated to the lead institution. New undergraduate institutions that have not been a part of the network previously but contribute to the thematic research effort may be included, if appropriate, in the proposed scientific network. The states that elect to do so or states that do not have appropriate eligible undergraduate/graduate institutions with focus on the scientific area relevant to the thematic focus proposed in the application may include partner institutions from other IDeA states. In that case, the IDeA funds may be transferred to the partner institution in another IDeA state via subcontract. The inclusion of institutions representing faculty and students underrepresented in biomedical and behavioral sciences in the INBRE is encouraged. This is an effective means of developing a diverse scientific and academic workforce.

The six to eight baccalaureate, master's level degree-granting institutions, community colleges or TCCUs that participate in the thematic multidisciplinary research activity can serve as a pipeline for future independent biomedical investigators. Undergraduate institutions that are a component of a university that includes a graduate school that confers doctoral degrees in one or more sciences, but are not research intensive or do not conduct biomedical research as a principal activity, are eligible to participate as a network partner institution. Faculty at the undergraduate colleges of research-intensive institutions who do not have appointments in the graduate school may receive research support via this initiative. Further, new primarily undergraduate institutions and community colleges or TCCUs that have not been a part of the original network but could contribute to the proposed thematic research and/or efforts to address the health needs of the community may be included in the scientific network.

It is the responsibility of INBRE leadership to define an effective statewide partnership and collaboration. The network is to include undergraduate and graduate students and postdoctoral fellows, undergraduate and graduate science department faculty, and faculty and students from community colleges and TCCUs. Special efforts must be undertaken to enhance the recruitment and career development of participating students, fellows and faculty. This FOA strongly encourages forging interactions and cross-collaborations among INBRE, COBRE and IDeA-CTR programs to enhance communication among programs, leverage resources where appropriate, and provide students a broad continuum of research opportunities.

Administrative Core

The Administrative Core will provide the logistical support for the network and to the External Advisory Committee. The Administrative Core Lead (Program Director/Principal Investigator (PD/PI)) is responsible for management, staffing and resource allocation, and for administering the award in accordance with NIH policies. The Administrative Core Lead will serve as Chairperson of the INBRE Steering Committee and in consultation with this committee select the core directors. The Administrative Core will also develop programs to meet the career building and enhancement needs of the research faculty, fellows, and graduate and undergraduate students, and students from community colleges and TCCUs. For example, activities may be designed for students, fellows and faculty to hone their investigative skills. Support also may be provided for attending national scientific meetings and workshops to interact with the scientific leaders in the field and learn about the most current research advances in the field.

The Administrative Core will serve to oversee ongoing research activities, any clinical studies, analysis of research results, other funding sources, and other information relevant to the thematic scientific focus that is being investigated within the Network. Additionally, regional scientific grantsmanship and scientific presentation workshops, seminar and lecture series, and visiting faculty programs can be organized as a part of the Administrative Core's scope of career enhancement activities.

The Administrative Core may include a number of role-modeling and related career activities for four-year primarily undergraduate institutions, community colleges, and TCCUs. INBRE programs are encouraged to develop career activities designed to increase the number and quality of graduate program applications submitted by students. Activities to these institutions through mechanisms such as (but not limited to) seminars, lectures, workshops or short courses are encouraged. Activities could also include sponsorship of graduate school workshops and networking activities, improve communication skills, career counseling, and laboratory/research experiences at network research laboratories or field sites (e.g., community sites).

INBREs are encouraged to develop activities that focus on enhancing the quality of instruction and providing research experiences relevant to students and their communities from the partner institutions. This may include activities that focus on incorporating new courses in science curricula, and involving their students in research projects that are linked to reducing health disparities and developing interventions to improve the health status of their communities.

As communication among investigators within the research network is essential, the Administrative Core may provide electronic networking to inform investigators both within and outside the network of the availability of and access to modern technologies at research core facilities both within the network and located at other NIH-supported sites around the country.

Required Committees under Administrative Core

Steering Committee: The Program Director/Principal Investigator (PD/PI) will serve as Chairperson of the Steering Committee (SC). The PD/PI, Program Coordinator (PC) and representatives from network partner institutions must agree to participate as members of the INBRE SC. The SC will consist of no more than 20 members and will include up to two members from each network partner institution, one is a senior administrative person, the other one can be someone with scientific expertise and background. The Vice President for Research of the awardee institution, or their surrogate, must participate as a member of the SC. The members of the SC will establish the policies and operating procedures of both the Steering Committee and the INBRE. The SC will meet at least three times during the first year of the award and at least semi-annually thereafter. The SC will develop strategies as to how it will interact with the External Advisory Committee, the other mandatory committee described below. The Administrative Core will provide logistical support to the SC. The PC, in conjunction with SC, will provide management oversight for the development of an Evaluation Plan to determine the impact of the INBRE program. The PD/PI in consultation with this committee will select the core directors. Collaborations with investigators from outside an IDeA state are permissible, but must be agreed upon by the INBRE Steering Committee.

The members of the SC will regularly review the progress of faculty investigators and their career plans in terms of their research projects and providing research experiences to the students. This oversight and input are in addition to that provided by the EAC and may not act as a substitute for the EAC.

External Advisory Committee: Each INBRE must include an External Advisory Committee (EAC). The SC should establish rules governing the composition of the EAC and the tenure of the Chairperson. The composition of the EAC is to include at least three to five members with appropriate scientific expertise in the thematic focus area(s), who can provide advice to the SC for scientific, administrative, and other matters. The EAC must meet at least twice per year. The EAC critiques the scientific progress of the INBRE and also offers advice on scientific matters to the INBRE PD/PI. The EAC activities include developing and planning concepts and programs, encouraging and assisting faculty development and enhancement, identifying resources, evaluating the development of the network, and evaluating progress of the individual pilot projects as well as the overall INBRE program. The PD/PI will share the advice and critiques provided by the EAC with other INBRE investigators and the Steering Committee of the network. The EAC also will review and recommend candidate investigators for replacement/substitute projects, as required, before such requests are forwarded to the NIGMS for programmatic review. Video-, teleconferencing or other means may be used in situations where it would be difficult to hold an in-person meeting. A summary of the issues discussed at each EAC meeting, recommendations made, and actions taken must be included in the yearly progress reports submitted to the NIGMS.

Evaluation Plan and Milestones: The Administrative Core is responsible for overseeing an evaluation plan for monitoring and documenting progress towards achieving target goals and timelines. The evaluation should assess whether the effectiveness of the approach taken will meet the goals or benchmarks for building an effective institutional and statewide scientific network.

As a part of the evaluation process, students who are receiving biomedical research experiences and career enhancement activities should be tracked, and their outcomes should be reported to the NIH in the annual progress report (for example, the total number of students who had research experiences, have gone to graduate and professional schools, or have entered the biomedical workforce).

One of the objectives of INBRE is to provide undergraduate faculty and students research support and serve as a pipeline for undergraduate students to continue in health research careers. The mission of most primarily undergraduate institutions and liberal arts colleges is teaching and in some cases teaching and research to provide students experiences and exposure to research. The intent of INBRE is not to transform liberal arts primarily undergraduate institutions into biomedical research centers but rather to augment the science curriculum. Obtaining R01 support by investigators at these institutions is not expected and is not a criterion for evaluation. However, these investigators may seek and obtain research support via mechanisms such as Academic Research Enhancement Award (AREA) and NIMHD Building Research Infrastructure and Capacity (BRIC) (previously known as the NIMHD Research Infrastructure in Minority Institutions (RIMI) program) grants. However, at the lead institutions, investigators may apply for and obtain R01 and Program Project grant support, and in some cases faculty at the primarily undergraduate institutions (PUIs) may participate as investigators in these Program Project grants.

The success of researchers from the network partner institutions may be measured by attainable metrics that are appropriate to the missions of their institutions. Criteria for evaluating the progress of these researchers may include evidence of scholarly activities including publications, offering of new courses and programs, providing research experiences to students, impact on the community, attending and presenting research findings at scientific meetings and conferences, submission of external grant applications to NIH and other Federal and non-Federal agencies, and acquisition of awards such as AREA (R15), exploratory/pilot project grants (R03 and R21), career development awards (K01 and K08) or other Federal or non-Federal Agency awards.

Bioinformatics Core

The Bioinformatics Core will provide resources in research, career enhancement, and education. For research, the Core will provide investigators access to the technical expertise and data management and analysis tools required for competitive, multidisciplinary biomedical research. Careful consideration must be given to optimizing access to bioinformatics and other related tools for investigators in the network. This core will have a substantial impact on enabling the pursuit of research areas by the faculty and students participating in the network. This core may promote informatics career enhancement and education, and development of Bioinformatics curriculum and degree programs as well as understanding of approaches and methods for data management, develop methods for multi-center research and resource sharing, and provide methods for secure and confidential data sharing.

Access to and utilization of bioinformatics tools and resources rely on a comprehensive supporting infrastructure (often termed cyberinfrastructure) that integrates data-gathering facilities, computing hardware, data analysis and informatics tools, software and middleware, high-bandwidth network connectivity, and technical support. Robust network connectivity facilitates research collaboration and sharing of resources across geographical boundaries and provides access to rural areas and other hard-to-reach populations. Enhanced network connectivity also broadens access to education and career enhancement programs that further national efforts to strengthen the biomedical research workforce. Under this Core, applicants may develop plans to enhance network connectivity and high-end computational power within their state. Applicants within a common geographical region may also develop a multi-state plan to collectively address research cyberinfrastructure needs and gaps. Such efforts should seek to leverage funds from other federal, state, and local sources to the greatest extent possible. The Bioinformatics Core may also provide resources to enhance communications within the state and with the rest of the world, including, but not limited to, library access to research journals and video-teleconferencing services, and the development of telemedicine networks.

Research Cores

Applicants may include cores, such as centralized research facility and instrumentation cores. Sharing research resources among INBRE and COBRE investigators is strongly encouraged. As much as practicable, applicants should seek to utilize existing equipment and instrumentation supported by other COBRE or INBRE awards.

It is expected that proposed core should be unique and not duplicate services or facilities that already exist at the applicant institution. Utilization/modification/expansion of existing resources to accomplish the goals of proposed research is strongly encouraged. Proposed research cores that appear to replicate services already available at the applicant institution will not be allowed without extensive justification.

Institutions may also include a Community-Based Participatory Research (CBPR) Core, to facilitate the conduct of new pilot projects or to expand ongoing projects in community-based research, with an emphasis on those diseases that disproportionately affect racial and ethnic minorities and rural and other medically underserved populations. A community-based participatory collaborative approach involves partners, community residents and scientists in the research process and recognizes the unique strengths that each brings to research. The CBPR Core can help develop critical infrastructure in medically underserved communities to increase their involvement in clinical and translational research and advise investigators in the conduct of this research modality.

Developmental Research Project Program

Each INBRE program must have a Developmental Research Project Program with an internal mechanism (internal Funding Opportunity Announcement) for obtaining and awarding multidisciplinary developmental research projects to investigators at the partner institutions. The projects, including research projects or pilot projects, should be collaborative and stand-alone, but share common scientific themes. The projects should focus on the broad, multidisciplinary research theme(s) of the network and include projects from both the research-intensive institutions as well as primarily undergraduate and other institutions involved in the INBRE. Projects selected should reflect the structure and breadth of the INBRE Network with the focus on the infrastructure to provide research opportunities to students.

Each faculty investigator of a developmental project should be assigned at least one science advisor. The advisors should have research expertise relevant to the scientific area(s) to be developed within the INBRE. The science advisor may be a collaborator on the faculty investigator's research project. They will help oversee the proposed research and career enhancement of promising investigators. The science advisor is an established faculty member experienced in obtaining external support and maintaining an independent research laboratory. In some instances a suitable advisor may not be available within the investigator's institution; therefore it is acceptable to enlist appropriate individual from outside institutions.

In some cases, COBRE investigators, where appropriate, may serve as science advisors to INBRE investigators and/or students. Attaining R01 support is not a criterion for evaluation of pilot project investigators located at primarily undergraduate institutions. Some research support may be attained by investigators at primarily undergraduate institutions, community colleges or TCCUs, i.e., Academic Research Enhancement Award (AREA/R15) grants, R03s, even R01s but that is not a requirement of this program.

A single investigator at the awardee or network institutions should supervise each research project. Each investigator is responsible for ensuring that the project's specific aims are met. The research excellence of these projects will be enhanced by effectively using the scientific and technical strengths of collaborating investigators and/or science advisors. Promising investigators who are resident at institutions in IDeA states but are not a part of the scientific network of the INBRE may receive research support through an adjunct appointment at one of the partner institutions or as collaborators on research projects.

The award of a Research Project Grant or a major grant award to a faculty investigator from the lead or primarily undergraduate institutions should be viewed as a milestone and a criterion for changing the status of an investigator supported by the INBRE to independent investigator. Investigators who have acquired independent status or completed a research project should not be excluded from Network activities. These investigators should be allowed access to core facilities and should be encouraged to participate in collaborative research efforts. If appropriate, an investigator who has acquired independent research support may direct a core facility or serve as a science advisor to other investigators and students. INBRE support cannot be provided in instances where an investigator receives a new award and that award overlaps or is significantly similar to that described in the INBRE application. However, if the specific aims of the investigator's grant application are significantly different from the project described in the INBRE, then the investigator should complete his/her INBRE project and provide research experiences to the students. In this latter case, continued support for personnel (e.g., postdoctoral fellows, graduate and undergraduate students, technicians, etc.) associated with the INBRE project can be provided.

An investigator who leaves the Network may be replaced by a new investigator. Replacement investigators and new research projects may be substituted following review by the PD/PI and the EAC. The PD/PI must communicate the EAC's recommendation along with the research project to the NIGMS for programmatic and administrative review.

In some instances, an investigator may be placed on probation or considered for removal from the INBRE program if a review by the EAC indicates a failure by the investigator to make significant progress toward achieving the specific aims of his/her project and/or achieving the goals and objectives of the INBRE program to provide research experiences to students.

Alteration and Renovation

Alteration and Renovation (A&R) costs to improve existing core laboratories, research laboratories and/or animal facilities at the primarily undergraduate institutions, community colleges, and tribally controlled colleges and universities are allowed. A&R projects must be relevant to the scope of the proposed research for faculty and students.

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

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

Higher Education Institutions

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

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

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

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

The following states/commonwealth are the IDeA states eligible to apply to this FOA:

Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South Dakota, Vermont, West Virginia, Wyoming.

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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

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

The goals of this program are accomplished through the direction provided by a PD/PI at the lead institution, who has the primary responsibility for administering the program and for overseeing the scientific network and its associated core facilities. The PD/PI of the INBRE application must be an established biomedical or behavioral research scientist with expertise directly related to the research theme(s) of the grant application. The PD/PI will ensure that high-quality research is performed and has the experience to administer effectively and integrate all components of the program. The PD/PI must have the requisite administrative experience and leadership skills to direct this multi-faceted program.

The PD/PI at the lead institution will serve as the director of the INBRE and will coordinate its activities.

PD(s)/PI(s) may not simultaneously lead two or more IDeA program awards.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed. Only one award will be made per state.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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

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

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Krishan K. Arora, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3900
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (use for Administrative Core)	12
Core (use for Research Cores, Bioinformatics Core)	12
Project (use for Developmental Research Project Program)	6
Alt and Renov (use for Alteration and Renovation)	12

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

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

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Research Cores: optional
• Bioinformatics Core: required
• Developmental Research Project Program: required, maximum of 1
• Alteration and Renovation: optional

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

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

Complete entire form.

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

Follow standard instructions.

Facilities and Other Resources: Resources including existing equipment, instrumentation, collaborative resources and laboratory space at the lead and network institutions to support INBRE research activities should be described.

Other Attachments: Memorandum of Understanding: A memorandum of understanding (MOU) must clearly describe the arrangements between the network partner institutions and the lead institution and must provide for release time for investigators. Faculty at 4-year baccalaureate institutions must have a commitment for 50% release time (equivalent to 6.0 person months) for the conduct of research as part of the MOU. Women, minorities and individuals with disabilities are strongly encouraged to participate.

Enter primary site only.

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

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

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

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

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

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

Specific Aims: Provide specific aims for the overall network.

Complete entire form.

Research Strategy:

Progress and Accomplishments: The renewal and resubmission renewal applications must provide a description of progress and accomplishments made during the current INBRE in the following areas:

• Research Infrastructure as measured by improved research facilities and support services, including bioinformatics in the research network; acquisition and utilization of new and major instrumentation;
• Research Environment as evidenced by successful recruitment of science faculty from different disciplines at the institutions in the network; increased collaboration among researchers and institutions;
• Development of science curriculum (courses and programs) offered at the network institutions;
• Development of research laboratories and facilities in the network institutions;
• Students majoring in science and health-related fields;
• Students and faculty participating in research activities;
• Research Productivity as measured by scientific publications in peer-reviewed journals and presentations at scientific meetings and other conferences;
• Grant applications from research intensive institutions for NIH and other research grants submitted and awarded;
• Number of undergraduate students pursuing science and health-related careers;
• Research projects completed in the prior grant period to demonstrate past progress and/or support success of the program. This information may be represented in a table format;
• Impact on the state's workforce and economy;
• Impact on students and faculty from primarily undergraduate institutions, community colleges, and TCCUs as a pipeline into the graduate science programs within the state;
• Other metrics as defined by the applicant that demonstrate accomplishments of participating institutions, faculty, and students in the network; and
• Any programmatic change(s)/corrective actions that occurred during the current INBRE funding period as a result of evaluation.

Overall Network Organization and Management Plan: The application must provide an overall network organization and management plan. The important elements that need to be included in the section are the following:

• Justification of a five-year support for the thematic scientific network which includes the proposed organization and component functions of the INBRE;
• A description of the priorities and objectives of the network. The plan should demonstrate the applicant's knowledge, ingenuity, practicality, and commitment to developing and maintaining a significant and productive research program;
• A description of organizational structure established for various cores and the statewide network of baccalaureate/master's level degree-granting institutions and community colleges and TCCUs that will provide the sites for the conduct of the thematic, multidisciplinary, biomedical or behavioral research;
• A description of the plan for networking, sharing of resources and cross-collaborations with COBRE, other INBREs, and other appropriate NIH programs;
• A description of the unique research opportunities that will be provided to the project investigators at the lead and partner institutions; and
• A description of how the efforts of project investigators and core service facilities will assist in the establishment of a multidisciplinary research network

Progress Report Publication List: A list of publications produced from INBRE should be included.

Letters of Support: While non-Federal matching funds are not required, the application must show clear evidence of strong and specific institutional commitment. It is recognized that the availability of resources is variable among institutions. Consequently, the level of institutional commitment will differ among applicant institutions. At a minimum, the application should include communication from a senior institutional official from the lead institution (e.g., President or Dean) outlining the resources and facilities that will be committed by the institution to support and sustain the INBRE program throughout the period of funding. Some examples of institutional commitments that may be documented include financial support, adequate space, release time agreements, core consolidation and maintenance. As appropriate, letters of support with institutional commitment from partner institutions in the network should also be included.

As appropriate, letters from the Program Directors/Principal Investigators of other awardees of NIH and other Federal and non-Federal entities (e.g., COBREs, IDeA-CTRs) may be included indicating their program's role in supporting the INBRE's goals and objectives.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

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

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

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

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

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

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

List all performance sites that apply to the specific component.

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

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

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

Funds will be provided to strengthen research infrastructure and capacity at the lead and partner institutions, including instrumentation for Core laboratories, optional cores such as for Community Based Participatory Research, and support for investigators, postdoctoral fellows, graduate and undergraduate students, students from community colleges and TCCUs, and technical assistants.

The maximum allowable direct cost for the INBRE program is $2.5 million per year of which $1.0 million is available to support the Administrative and Bioinformatics Cores, Core facilities, career building and enhancement activities, and research activities at the awardee institution and at other research-intensive institutions in the network.

The remaining direct costs, up to a maximum of $1.5 million, are to be distributed among the participating network partner institutions including baccalaureate/master's degree institutions, community colleges, and TCCUs as consortium arrangements and/or subcontracts to build infrastructure and research capacity for the proposed multidisciplinary research projects. Funds allocated to partner institutions are to cover expenses including but not limited to salary, research support, and equipment acquisition. A maximum of 15% of the total direct cost requested at each partner institution may be used for administrative costs. Funds allocated to community colleges and TCCUs may be used to establish science programs/courses and conduct meaningful research projects relevant to their communities during the summer and academic year.

The applicant institution that is located in a state that has no medical school and fewer than four additional accredited undergraduate institutions that award degrees in both biology and chemistry, may consider the budgetary allocation guidelines regarding the available $2.5 million direct costs to be flexible.

The Administrative Core Lead must devote a minimum time commitment of 3.6 person months per year for career guidance and administrative oversight of the INBRE; however, up to 6.0 person months will be supported.

Support will be provided at 3.6 - 6.0 person months annually for an additional faculty within the INBRE network to serve as a Program Coordinator.

It is not required or expected that each applicant will request the categorical maximum allowable costs stated herein. These numbers are provided as a guide for purposes of developing the INBRE network. The actual costs requested will be based on the INBRE network (i.e., number of participating institutions) and activities (i.e., number of scientific projects in the Developmental Research Project Program, core support costs) providing the justification for the appropriate expenditure of proposed costs.

Salary costs are allowable to the extent that they are reasonable; conform to the established policy of the organization consistently applied regardless of the source of funds; and reflect no more than the percentage of time actually devoted to the NIH-funded project. If full-time 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary.

There will be an annual meeting of the leadership of the grantee networks with NIGMS staff in Bethesda, Maryland. The costs to attend this meeting should be included in the travel budget of the application. Estimate the costs for key staff to attend this meeting annually. The key staff may include PD/PI, PC and Bioinformatics Core Director. These meetings will provide a forum for the exchange of ideas, information and address their concerns, needs and problems that arise. In addition, NIH staff will provide updates on program, policies and regulations that relate to the conduct of research.

If requesting items that are normally treated as F&A costs (for example, general office supplies) as direct costs, the applicant must provide a strong justification for those items and demonstrate that the cost is commensurate with the benefit that particular item of cost will have on the associated project. Failure to adequately justify such costs will likely result in their deletion from the requested budget.

Tuition Remission and other forms of compensation paid as, or in lieu of, wages to students are allowable provided:

• The individual is performing activities necessary to the grant;
• Tuition remission and other forms of compensation are provided in accordance with established institutional policy, consistently provided to students performing similar activities conducted in non-sponsored as well as in sponsored activities; and
• During the academic period, the student is enrolled in an advanced degree program at a grantee or affiliated institution and the activities of the student in relation to the federally sponsored research project are related to the degree program.

"Stipends" as defined by the NIH are an allowable cost of living allowance for trainees and fellows only under Kirschstein-NRSA individual fellowships and institutional research training grants and are NOT allowable for this initiative. Compensation of Students however is an allowable cost on the grant.

Salary and research support will be provided for participating graduate, undergraduate and community college and TCCUs students, and postdoctoral fellows.

Expenses of the External Advisory Committee (EAC), including travel and consultant fee, should be included in the budget request.

While the PD/PI and PC positions are considered mandatory for carrying out the INBRE mission, support for other scientific or staff positions can also be requested as long as their role in the program is justified.

The INBRE must have an independent, external evaluation in addition to the monitoring and formative evaluation process provided internally and by the External Advisory Committee.

Funds for the external evaluation, up to 2% of the total direct costs, if appropriately justified, may be requested in the Administrative Core budget.

Collaborations between or among IDeA eligible states as well as collaborations with institutions in other non-IDeA states are allowable. However, grant funds awarded to an IDeA-eligible institution may not be transferred via subcontract to a non-IDeA state. IDeA funds may be used in other IDeA and non-IDeA states for fee-for-service activities, such as attending instructional activities and learning new techniques, sample and data analyses, workshops and compensating for scientific career advice and career enhancement efforts, etc.

The program may support development and implementation of curricular activities aimed at broadening experience to better prepare students for research careers in a variety of venues, such as academia, industry, government or entrepreneurial enterprises.

Sharing resources among INBRE and COBRE investigators is strongly encouraged. If a core facility already exists for equipment and instrumentation supported by a COBRE program, these should not be proposed de novo in the INBRE application. However, if duplicate equipment is to be requested under this FOA, it should be appropriately justified.

Other Allowable Costs include:

• Salary support for a Program Coordinator and other scientific or staff positions;
• Salary support for an administrative assistant if required and justified;
• Research equipment and instrumentation for laboratories;
• Supplies for research.

A detailed justification for each item requested, including personnel, supplies, and equipment, must be provided.

The PD/PI of the INBRE is not eligible for research project support, nor can he/she use INBRE funds to supplement research activities within his/her laboratory.

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

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Administrative Core component. The Introduction should include responses to the criticisms and issues raised in the prior Summary Statement and summarize the substantial additions, deletions, and changes.

Specific Aims: The SF424 application Guide must be followed

Research Strategy: The important elements that must be included in this section include the following:

• Qualifications and role of the Administrative Core Lead and Project Coordinator that are not reflected in the biosketch. The PC may be selected from among the participating institutions in the proposed scientific network.
• A description of administrative structure of the network and arrangements and the mechanisms to be used to resolve differences of opinion among network partner institutions.
• Career enhancement plans for faculty investigators at partner institutions. This should involve oversight by established senior faculty members assigned as science advisors, constructive evaluations provided by members of the Steering Committee and External Advisory Committee coordinated by the Administrative Core Lead. Describe how faculty investigators will be protected for release time for research. In some cases, COBRE investigators, where appropriate, may serve as science advisors to INBRE investigators and/or students.
• The network's plan to develop the research skills of both graduate and undergraduate students and faculty. The plans should include the role of the undergraduate faculty.
• Plans to attract and retain promising students into biomedically-related science majors and opportunities for exposure to cutting-edge research.
• A description of infrastructure needs at the INBRE partner institutions and how the Administrative Core will prioritize those infrastructure needs.
• A description of External Advisory Committee, including the number and types of individuals to be included and their professional qualifications. Only the established External Advisory Committee members should be identified and named in the application. However, potential new members should not be contacted or identified.
• Roles of the INBRE Steering Committee and External Advisory Committee in establishing the approaches to set priorities for future research efforts in primarily undergraduate and graduate institutions, community colleges, and TCCUs.
• A description of the development and implementation of the plan for formative and summative evaluations of the network along with strategies for implementing required network modifications, if deemed necessary. The evaluation plan should assess whether the effectiveness of the approach taken will meet the goals or benchmarks for building an effective institutional and statewide scientific network. The evaluation plan should set benchmarks for the overall network's impact on:

- elements such as enhancement of research infrastructure and environment, quality and number of students, productivity of the investigators, and impact on the state's biotechnology industry, economy and workforce; and

- recruitment and retention of outstanding faculty and students at participating undergraduate and graduate institutions, community colleges and TCCUs.

Letters of Support: Letters indicating institutional commitment and any letter of support for the proposed Administrative Core should be included.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

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

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

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

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 (Bioinformatics Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Bioinformatics Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Bioinformatics Core)

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

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

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

Project /Performance Site Location(s) (Bioinformatics Core)

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 (Bioinformatics Core)

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

Qualifications and Responsibilities of Bioinformatics Core Director(s)

The Core Director(s) of Bioinformatics Core must be experienced personnel with the requisite stature, knowledge, authority, leadership, and administrative skills and capabilities to direct the resource. The Core Director will lead a team of specialists in the specific area of service to: (1) develop plans for standard operating procedures governing the utilization and management of core expertise and resources; and (2) develop plans for disseminating information, training, and serving as subject matter experts to investigators.

Budget (Bioinformatics Core)

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

A detailed budget for the entire proposed project period (5 years) must be provided.

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 (Bioinformatics Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Bioinformatics Core component. The introduction should include responses to the criticisms and issues raised in the prior Summary Statement and summarize the substantial additions, deletions, and changes.

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The important elements that must be included in this section are the following:

• Progress made by the Bioinformatics Core in creating infrastructure and other related tools for investigators in the network during INBRE.
• A description of impact of the Core on multidisciplinary thematic research efforts and the environment in which to develop a new generation of researchers and how the Core will serve the scientific needs of the individual pilot projects.
• A description of new approaches to be undertaken within the proposed scientific network to provide access to bioinformatics tools for data mining and model development, database management and the need for training investigators in the effective use of those tools.
• If access to high-end computational power is required, describe how and where investigators can access this capability.
• A description of operating procedures of the Core.

Letters of Support: Letters indicating institutional commitment to support and maintain the Core and any letter of support for the proposed Bioinformatics Core should be included.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

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

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

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

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.

If core research resources are requested, they must be for multiple users, including infrastructure applicable to various disciplines in the lead or partner institutions for the benefit of researchers and research projects.

SF424 (R&R) Cover (Research Core)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Core)

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

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

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

Facilities and Other Resources: The applicants should describe the scientific environment including physical resources in which the research will be done. A description of the major existing equipment and instrumentation for conducting research should be provided.

Project /Performance Site Location(s) (Research Core)

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 (Research Core)

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

Qualifications and Responsibilities of Core Director(s)

The Core Director(s) of a research core facility must be experienced personnel with the requisite stature, knowledge, authority, leadership, and administrative skills and capabilities to direct the resource. The Core Director will lead a team of specialists in the specific area of service to: (1) develop plans for standard operating procedures governing the utilization and management of core expertise and resources; (2) develop plans for disseminating information, training, and serving as subject matter experts to investigators; (3) maintain state-of-the-art technologies and knowledge capabilities; and (4) recommend to the INBRE PD(s)/PI(s) any updates and/or replacement of equipment or personnel.

Budget (Research Core)

Funds may be requested to establish core facilities. In addition to personnel and supply costs, the acquisition of new equipment and modernization of instrumentation may be proposed. Salaries for support and technical staff as well as professional staff who will direct Cores should be included.

A detailed budget for the entire proposed project period (5 years) must be proposed.

The level of support requested must be justified by the projected use by researchers from the lead or partner institutions.

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 (Research Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Research Core component. The introduction should include responses to the criticisms and issues raised in the prior Summary Statement and summarize the substantial additions, deletions, and changes.

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: The important elements that need to be included in this section are the following:

• A description of the impact of proposed core on the development of the network and how they will serve and facilitate the scientific needs of the proposed developmental research project program.
• A description of plans to recruit personnel to operate the core, if needed. Provide the rationale for continuing existing INBRE-supported Core facilities or for adding new Core facilities.
• Justification of additional research instrumentation needs of the INBRE partner institutions and how those needs can be addressed through this program.
• A description of how the core will be operated. The applicant should describe the standard operating procedures of each core, how state-of-the-art techniques will be maintained, how quality control will be managed, how disputes concerning core usage will be resolved, and how research investigators will be trained in the capabilities of the core and the techniques required.
• A description of proposed business plan for operation of the Core including prioritization of the service requests and charge back fees for non-INBRE users.

Letters of Support: Letters indicating institutional commitment to support and maintain the Core and any letter of support for the proposed core should be included.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

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

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

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

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

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

SF424 (R&R) Cover (Developmental Research Project Program)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Developmental Research Project Program)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Developmental Research Project Program)

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

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

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

Project /Performance Site Location(s) (Developmental Research Project Program)

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 (Developmental Research Project Program)

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

Budget (Developmental Research Project Program)

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

Science advisors may be supported for up to 2.4 person months if he/she will be extensively involved in interacting directly with and providing career enhancement to the faculty, investigators and students at the primarily undergraduate institutions, community colleges and TCCUs.

Individual projects in the Developmental Research Project Program may be funded at a level not to exceed $125,000 per year in direct costs.

It is expected that the research project investigators at the awardee and network partner institutions will devote at least 50 percent of their professional effort (equivalent to 6.0 person months) to career development and research activities. Institutions must provide release time for project investigators, thus permitting a significant time commitment to the research enterprise. To allow flexibility to investigators who cannot devote 6.0 consecutive months throughout the year, the effort can be distributed over the year to achieve a total of 6 person months (for example, 3.0 person months during academic year and 3.0 person months in summer (up to three months) to account for a yearly 6.0 person months effort).

The COBRE and IDeA-CTR investigators are not eligible for research funding from INBRE as project investigators. Similarly, INBRE investigators may not receive simultaneous research project support from a COBRE or IDeA-CTR program. COBRE and IDeA-CTR investigators may serve and be supported as science advisors or collaborators in INBRE programs as appropriate.

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 (Developmental Research Project Program)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for the Developmental Research Project Program component. The Introduction should include responses to the criticisms and issues raised in the prior Summary Statement and summarize the substantial additions, deletions, and changes.

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: Applicants should not propose individual research projects in the application. The important elements that must be included in this section are the following:

• A description of an internal mechanism (internal Funding Opportunity Announcement) for obtaining and awarding multidisciplinary developmental research projects.
• A description of the scope; eligibility requirements; the limit on the dollars available and the number of years of support per project; the solicitation, submission, review, and selection criteria and process; prioritization of the projects and review of their methodology and research performance, oversight and evaluation procedures; and a defined procedure and organizational structure to provide assurance that all projects supported from this grant will be in full compliance with all applicable Federal policies, rules, and guidelines for research involving human subjects, vertebrate animals, and/or biohazards as described in the SF424 (R&R) Application Guide.
• A general career enhancement plan.

Letters of Support: Letters indicating institutional commitment to support the Developmental Research Project Program and any letters of commitment from science advisors and/or from collaborators and/or consultants for the proposed program should be included.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

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

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

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

When preparing your application in ASSIST, use Component Type Alt and Renov .

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

SF424 (R&R) Cover (Alteration and Renovation)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Alteration and Renovation)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Alteration and Renovation)

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

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

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

Other Attachments: Line drawings should be submitted as described below:

• Submit line drawings on 8-1/2" x 11" paper only as PDFs. (DO NOT SUBMIT BLUEPRINTS.) All floor plans must be legible, with the scale clearly indicated.
• The line drawings of the proposed renovation must be at a scale adequate to explain the project. The drawings should indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given.
• The floor plan should indicate the location of the proposed renovation area in the building.
• Include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished.

Project /Performance Site Location(s) (Alteration and Renovation)

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 (Alteration and Renovation)

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

Budget (Alteration and Renovation)

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

Alteration and Renovation (A&R) costs to improve existing core laboratories and/or research laboratories at the primarily undergraduate institutions, and community colleges and TCCUs are allowed up to $250,000 in direct costs only in year one of the award as a one-time cost expenditure. Direct costs requested for A&R are not subject to facilities and administrative costs (F&A). A&R costs will be approved for facilities improvements ONLY at the consortia sites (the primarily undergraduate institutions, community colleges and TCCUs). All alteration and renovation must be complete within three years of the award.

Sufficient details must be provided to estimate the cost and suitability of the project. Failure to adequately justify A&R requests will likely result in their deletion from the requested budget. A&R funds provided under this FOA cannot support new construction, including completion of shell space, or the purchase of movable research equipment or instrumentation or equipment intended for teaching or other non-research related purposes.

An itemized budget and justification of the impact that this alteration and renovation would have on the INBRE activities for faculty and students must be provided. Provide justification of all fixed equipment items requested for the renovated area.

Detailed cost estimates must be included, provide vendor quotes when available.

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 (Alteration and Renovation)

Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for Alteration and Renovation component. The Introduction should include responses to the criticisms and issues raised in the prior Summary Statement and summarize the substantial additions, deletions, and changes.

Specific Aims: The SF424 application Guide must be followed.

Research Strategy: A narrative summary as outlined below must be provided:

• A description of how proposed renovations relate to the research projects that will use the facility. If renovations to animal facilities are proposed, they should be related to the projected animal populations (by species) in the proposed projects. If renovations to animal facilities are proposed, include the lines of authority and responsibility for administering the institution's animal care and use program. The role and composition of the Institutional Animal Care and Use Committee (IACUC) and how compliance with relevant laws, policies, and guidelines are achieved should also be included.
• List the functional modules, including the size (dimensions) and square footage of each module (room, alcove, or cubicle) that will be directly affected by the renovation project.
• List engineering criteria applicable to each module (mechanical, electrical, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam.
• List appropriate architectural criteria (such as width of corridors and doors, surface finishes).
• List and justify all fixed equipment items requested for the renovated area. A list of allowable fixed equipment can be found at http://dpcpsi.nih.gov/orip/diic/instru_fixed_equip_s10.aspx (refer to: Allowable as "Fixed Equipment" under C06/G20).
• Changes or additions to existing mechanical and electrical systems should be clearly described in notes made directly on the plan or attached to the plan.
• Indicate the type(s) of new finishes to be applied to room surfaces.

Letters of Support: Letters indicating institutional commitment and any letter of support for the proposed alteration and renovation should be included.

Resource Sharing Plan: Not required for this component.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Alteration and Renovation)

Not Applicable

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

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

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

For this announcement, note the following:

The INBRE program is to augment and strengthen the biomedical research capacity of an IDeA-eligible state. The review of an INBRE application is additionally based on the qualification and stature of the PD(s)/PI(s) to provide both scientific and administrative leadership and on the feasibility and potential for investigators to obtain independent grant support and provide research experiences to students to develop a pipeline to health research careers.

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

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

Does the network address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the network 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?

Are the overall network vision and strategy adequate to continue to build a multi-disciplinary research network? Will the proposed INBRE network augment and strengthen the IDeA-eligible state's biomedical research capacity at the lead and partner institutions?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the program? 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?

Do(es) the PD(s)/PI(s) have the qualifications and skills to provide scientific and administrative leadership in developing and directing the INBRE, and to continue building on the established thematic, multi-disciplinary research network with a scientific focus?

Do the PD(s)/PI(s) and PC have the experience and committed time to administer the proposed INBRE program? Do the program leadership and management team bring complementary and integrated expertise to the network?

Have the PD(s)/PI(s) shown effective leadership in developing, directing and enhancing activities of the Cores and network? Do the PD(s)/PI(s) present a plan for the continued development of investigators and faculty, students and postdoctoral fellows in the network? Do the PD(s)/PI(s) demonstrate leadership by showing that the infrastructure necessary for the proposed network (e.g., facility improvements, modernization/acquisition of equipment, implementation of administrative resources, etc.) is in place, and that the network is committed to support the resources and infrastructure?

Will the proposed INBRE program have the professional staffing to benefit significantly the overall network and quality of biomedical research? Do the Directors of the cores have the appropriate training, experience and resources to assume leadership roles? Have the core Directors committed sufficient time to this Program? Will the core Directors have the authority to implement best practices identified by the INBRE Steering Committee? Are the administrative and professional staff appropriately trained and well suited to carry out this work?

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?

Is the network likely to develop novel approaches to increasing the research opportunities for faculty, postdoctoral fellows, graduate students and undergraduate students at the participating institutions?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the network? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

Will the proposed INBRE activities include relevant scientific disciplines and collaborations to strengthen the network and increase the productivity?

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?

Are environment and institutional support necessary for the resources committed by the institution(s) for the INBRE appropriate?

Will the INBRE program enhance, complement, and extend the applicant's current resources for biomedical research to address health concerns and provide research opportunities to students and faculty in the participating institutions?

Each of the following components of the application will be assessed and given a score; the component scores will also be considered in assigning an Overall Impact score to the overall application.

Administrative Core

Are plans to direct and manage the research training, career development and enhancement of investigators, postdoctoral fellows and students of the institutions involved in the network appropriate? Will these plans be effective in meeting the program's goals? If there are plans to recruit new faculty at the lead or partner institutions, are these plans reasonable and suitable and consistent with the effective growth and development of the network to make meaningful and significant contributions?

Are plans to undertake capacity building at the lead and participating institutions in the network appropriate and reasonable?

Is the quality of the plan to develop an effective research network for faculty and students that will contribute significantly to the state's research base appropriate?

Will the External Advisory Committee be constituted to provide critical, stimulating, and thoughtful advice for the overall network performance?

Are the structure, composition and organizational plans for the External Advisory Committee and Steering Committee to effectively provide advice and recommendations to the participating institutions in the network appropriate?

Are evaluation strategies to achieve the specific goals of the INBRE program appropriate and suitable? Are there appropriate and suitable evaluation strategies and specific milestones to measure progress, not only of the investigators, but of the network as a whole, toward attaining its long-range goals? In addition to the SC and EAC, does the applicant identify an independent external evaluator, not a part of the INBRE, who will perform the evaluation?

Bioinformatics Core

Are key personnel and the Core Director qualified to lead in developing and enhancing research activities of the Core?

Are plans for familiarizing investigators and students with bioinformatics tools and resources appropriate?

Developmental Research Project Program

Is the Developmental Research/Pilot Program well integrated into the overall INBRE goals and objectives? Is the program designed to serve the needs of investigators from a variety of research areas? Will the expected benefits to the lead and partner institutions be measured and tracked?

Is there an adequate plan to solicit proposals, to prioritize the projects and to review their methodology and research performance? Are plans adequate to assure compliance with applicable federal policies and guidelines for research and research protections?

Is there a pool of qualified investigators from network institutions to solicit applications? Are the plans for constituting the review panel, their qualifications and expertise, appropriate to evaluate research/pilot project applications?

Research Core Facilities (if included)

Are the proposed Research Core Facilities appropriate to the needs of the overall program? Will the proposed core enhance the statewide network research effort?

Are quality control processes (including procedures, techniques, and quality control) proposed for the facilities or services provided by the Research Core adequate? Are the criteria for prioritization and usage of Core products and/or services appropriate?

Are the qualifications, experience, and commitment of the Research Core Director and other key personnel adequate and appropriate for providing the proposed facilities or services?

Will the proposed Research Core Facility provide cost-effective services to the Network?

Is the environment for the Research Core Facility adequate to support the Network as proposed? Does the applicant indicate any institutional commitment to support and maintain the ongoing and proposed core facilities/services?

Community Engagement and Outreach Core (if included)

Are there clear and detailed plans for identifying a health issue that fits community priorities and academic capacity to respond? Is the proposed core appropriate to the needs of the program?

Are the plans for developing a coalition of community and academic stakeholders and for implementing evaluation strategies for the proposed projects appropriate?

Are the qualifications, experience, and commitment of the Core Director and other key personnel adequate and appropriate for providing the proposed facilities or services?

Alteration and Renovation (if included)

Scientific Needs: Are requested alteration and renovation projects relevant to the scope of the proposed research? Are the costs and suitability of the project justified? If renovations to animal facilities are proposed, do the proposed renovations relate to the projected animal populations (by species)? If renovations to animal facilities are proposed, are the lines of authority and responsibility for administering the institution's animal care and use program indicated?

Architectural Plans: Are the projected costs commensurate with the architectural plans for the proposed A&R? Are there lists of the functional components, including the size (dimensions) and square footage of each component (room, alcove or cubicle) that will be directly affected by the renovation project? Are there appropriate descriptions of the engineering criteria applicable to each component (mechanical, electrical, and utilities) including information such as the number of air changes per hour, electrical power, light levels, hot and cold water, and steam, as well as the appropriate architectural criteria (such as width of corridors and doors, surface finishes)? Is justification provided for all fixed equipment items requested for the renovated area?

Are legible line drawings provided for all floor plans with the scale clearly indicated? Are the line drawings of the proposed renovation drawn to a scale adequate to explain the project? Do the drawings indicate size (dimensions), function, and net and gross square feet of space for each room? Are the total net and gross square feet of space to be renovated provided? Does the plan indicate the location of the proposed renovation area in the building? Does the plan include the as-built drawings of the proposed renovation area and indicate any areas that will be demolished? Do the plans indicate changes or additions to existing mechanical and electrical systems in notes made directly on the plan or attached to the plan? Do the plans indicate the type(s) of new finishes to be applied to room surfaces?

As applicable for the overall application 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.

Network Organization and Management Plan (overall application only)

Are the plans for augmenting and strengthening the state's biomedical research capacity appropriate? Will a scientific thematic focus be established and maintained? Are the nature, scope, and effectiveness of the plans for coordination and cooperation among institutions appropriate and will they contribute to the establishment/continuation of the network?

Does the application describe the nature, scope, and effectiveness of the plans for coordination and cooperation among research project investigators?

Is the level of institutional commitment sufficient to assure that the resources and facilities to sustain the INBRE are present, including, but not restricted to, existing relevant equipment, animal, and/or computer resources, and departmental or inter-departmental cooperation?

Are the plans to develop undergraduate and graduate educational opportunities, ranging from formal programs to courses and seminars, visiting scientist programs and other similar activities appropriate?

Does the applicant include the plans to establish a formalized agreement (MOU) among institutions that are to constitute the scientific network? Does the MOU describe the recourse available to arbitrate differences in the event that disputes arise? Are issues such as tenure, promotion, release-time, and other personnel matters pertaining to the success of the INBRE addressed?

Will the INBRE Award contribute to salaries and startup funds for promising investigators? Are there other sources of support for salaries and startup funds?

Does the applicant describe plans to reach institutions and programs outside the scientific network? Are plans for networking, sharing of resources and cross-collaborations with COBREs, other INBREs, and other NIH-supported Centers, if proposed, appropriate?

Are the plans to encourage basic, clinical and /or translational research across the network adequate?

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

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

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

Program Accomplishments (overall application only)

Has previous support allowed the network to achieve specific benchmarks, which include developing the research infrastructure and enhancing the research capacity in the partner institutions, development of science curriculum at the partner institutions, students, postdoctoral fellows and faculty participating in biomedical research activities, publishing data in peer-reviewed journals and impact on the state's workforce?

Is there evidence that undergraduate students are pursuing science and health-related careers?

Not Applicable

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

Not Applicable

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

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

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by National Institute of General Medical Sciences (NIGMS) in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NIGMS Advisory Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities as only one award will be made per IDeA-eligible state. If there are more than one applications from a state, preference will be given to the one with currently existing effective statewide INBRE network.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA. For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file. Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials by law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nig.gov/ClinicalTrials_fdaaa/.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

It is emphasized that support cannot be provided in instances where a pilot project investigator's new award overlaps or is significantly similar to that described in the INBRE program. When submitting a new research grant application, the INBRE funded investigators should include a statement acknowledging INBRE program support and a plan for relinquishing that support if the proposed research overlaps or is similar to the INBRE project.

If the specific aims of the newly funded project are significantly different from the project described in the INBRE, then that investigator has an obligation to remain in the program to complete his/her INBRE project. In this latter case, continued support for personnel (e.g., postdoctoral associates, graduate students, technicians, etc.) associated with the INBRE project but also listed on the other award can be provided. However, the percent efforts of these individuals must be appropriately adjusted.

Investigators who have acquired independent status or completed a pilot project should not be excluded from network activities. These investigators should be allowed access to core facilities and should be encouraged to participate in collaborative research efforts. If appropriate, an investigator who has acquired independent status may direct an INBRE or COBRE core facility or serve as an advisor/collaborator.

An investigator who has achieved independent status and no longer leads a pilot project may be replaced by a new investigator. Replacement of investigators and new pilot projects may be selected by the PD(s)/PI(s) and reviewed by the EAC. In some instances, an investigator may be placed on probation or considered for removal from the INBRE program if a review by the EAC indicates a failure by the investigator to make significant progress toward achieving the specific aims of his/her project. Prior approval by the NIGMS is required for adding or removing investigators. The PD/PI must communicate the EAC's recommendation to the NIGMS for programmatic and administrative review.

Awardee-selected projects require prior approval by NIH prior to initiation.

Prior to the commencement of any pilot or research project, the following documentation must be submitted to NIGMS staff for administrative review (see Notice NOT-GM-14-111 for details):

Using PHS398 forms and instructions, only the following sections need to be submitted:

• Face page (signed by institutional signing official)
• Project Summary (page 2)
• Research Strategy section
• Research proposal
• Rigor and transparency: As appropriate, a description of the scientific premise for the proposed project, including consideration of the strengths and weaknesses of published research or preliminary data crucial to the support of project, and a description of the experimental design and methods proposed and how the investigator will achieve robust and unbiased results. If applicable, a brief description of the methods to ensure the identity and validity of key biological and/or chemical resources used in the proposed project (see Notice NOT-OD-16-011 for details).
• External Advisory Committee approval communication from the EAC chair (at a minimum) indicating that the EAC concurs with supporting the pilot project.
• If proposed study involves human subjects, following documents must be submitted to NIH:
• Written protocol addressing the risks and protections for human subjects, in accordance with NIH’s Instructions for Preparing the Human Subjects Section of the Research Plan.
• Institutional Review Board (IRB) approval.
• Human Subjects education certification.
• Create Inclusion Data Record (IDR) and enter inclusion data in Inclusion Management System (IMS).
• If the proposed project involves clinical trials, in addition to above documents, following documents must also be submitted to NIH:
• Specific plans for data and safety monitoring.
• If the proposal involves Vertebrate Animal, IACUC approval and Vertebrate Animal Section as described above must be submitted.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A summary of the issues discussed at each EAC meeting, recommendations made, and actions taken must be included in the yearly progress reports submitted to the NIGMS.

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

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Krishan K. Arora, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3900
Email: [email protected]

Brian Pike, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3907
Email:[email protected]

Christy Leake
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-7706
Email: [email protected]

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

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