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

Required Application Instructions

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

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 purpose of this funding opportunity announcement (FOA) is to invite the submission of renewal applications and to describe application, review, and award procedures for the renewal of large-scale collaborative project awards that were awarded under PAR-07-412, "Large-Scale Collaborative Project Awards (R24/U54)." This announcement applies to awards whose support from the National Institute of General Medical Sciences (NIGMS) for the Phase II application began in FY 2010. New applications for large-scale collaborative project awards are not being accepted by NIGMS and are not part of this FOA. Currently active large-scale collaborative project awards in their first period of support are eligible to compete for one renewal period of up to five additional years of support.

These awards were intended to solve critical, complex biological problems within the mission of NIGMS by supporting a team of independently funded investigators to synergize and integrate their research efforts. Critical elements of these multi-component renewal applications will include evidence that a highly integrated and functioning team has been established; that excellent progress is being made; that the progress makes feasible accomplishment of the final goals in the next time period; that results have been achieved that could not have been accomplished by individual efforts alone; that plans for the next project period should be compelling; and that plans are made to accommodate the termination of NIGMS support at the end of that period. Overall, the applications should describe the expected and unanticipated challenges that were met, how the project has evolved, where it stands currently, and how the final phase will be achieved.

The general parameters for the large-scale collaborative project awards are as follows and remain applicable to the renewal applications: the solution of a major question in biomedical science where a synthesis of information from participating laboratories is necessary; each of the participating investigators has to hold competitive independent support in the area of the large-scale collaborative project award; the funds are meant to support only collaborative and integrative activities; and the biological question has to fall within the mission of NIGMS (see http://www.nigms.nih.gov/About/Overview/Pages/default.aspx). It is expected that the research problem selected for the originally funded application will remain the focus of the renewal application.

The organizational structure of the large-scale collaborative project may vary depending on the approach needed to address the research problem. Participating investigators are expected to have support for their individual laboratories that they can contribute to the collaborative project; investigators who have previously participated in the project and have had their independent support interrupted may continue as participating investigators at the discretion of the steering committee. The award mechanism for large-scale collaborative projects is not meant to support R01-type projects. However, laboratories of participating investigators may need to enhance their efforts, to support the needs of the consortium or to integrate the work of a participating investigator with the consortium. To meet this need, bridging projects and pilot projects may be integrated as needed into the collaborative project.

Applications may propose new or continuations of existing bridging projects to support work in the laboratories of the individual participating investigators when that work is intended to provide either a bridging function to more fully integrate the individual work with the collaborative project or a service function to develop data or resources or technology to benefit the overall collaborative project. Bridging projects should add to or bridge the intellectual and technological approaches of the collaborative project and add to the overall cohesiveness of the large-scale effort. They are not meant to be stand-alone research efforts but are to be subprojects that tie together or enhance the contribution of the independent work and expertise of the participating investigator to the large-scale collaborative project and extend the independent work in new directions. A new bridging project to do more of what the investigator is already doing independently should be considered only if there are extraordinary circumstances that make it essential for the effective functioning of the large-scale project. If the participating investigator's work is already closely tied to the large-scale project, a bridging project should not be needed. Stand-alone new research projects should not be submitted for bridging projects. If a bridging project could be submitted as an R01 application, it should not be requested as a bridging project, even if it adds value to the large-scale project. Judgment is required on the part of applicants to distinguish between projects that are appropriate for support by consortium resources and those that should be submitted and reviewed as regular research grants (R01s). Requests for continuation of existing bridging projects must be justified in terms of progress to date as well as future plans.

New pilot projects may be requested in the renewal application, but require strong justification keeping in mind that the award will be in a final renewal period. Pilot projects may be requested for investigators with no current independent support in the area of the large-scale project, to add elements where gaps exist or to add investigators who have critical knowledge or expertise but do not have a research background in the area of the collaborative project. The pilot project should be of sufficient scope to qualify as a stand-alone research effort. It is primarily intended to allow the collaborative project to add investigators outside the scientific mainstream of the collaborative project area in a mode that will allow them to develop independent research in the area of the project. Applicants must explain why the Pilot Project Leaders' expertise is needed for the large-scale project and how the pilot project will contribute directly to accomplishing the aims of the large-scale project. Although funding for a pilot project may run for five years at the discretion of the steering committee, it is expected that the Leader of a pilot project will seek R01 funding during the period of the collaborative project, on the basis of results from the pilot project.

Core resources may be requested to speed progress on the scientific goals of the project or to enhance the collaborative project by developing new or improved technology or standardizing data among the research teams. Each large-scale collaborative project must request core resources for information collection, coordination, and dissemination. A bioinformatics core, including assembly and organization of data for querying and development of tools for querying, computation, and modeling, may be requested as a separate core or in combination with the information dissemination core. Requests for core resources must be strongly justified in terms of value to achieve the goals of the project, value to increase the synergy of the collaborative project, and cost-effectiveness. Requests for continuing existing core resources must also be justified in terms of progress and results achieved to date.

A program goal of large-scale collaborative projects is to creative a community resource to move broad areas of science forward. NIGMS intends that, to the extent possible, all investigators within a field have equal access to research resources generated by these collaborative projects. It is expected that resources shared will include, among others, data and information, materials such as cell lines and mutant animals, and novel reagents and techniques (As described in section IV.2, Administrative Core and Resource Sharing Plan, policies should be discussed in the Administrative Core, but will apply to all components). Because dissemination is a critical aspect and fundamental purpose of this FOA and such a community resource, evidence of the commitment of the large-scale project leadership to the sharing of research resources and manage intellectual property in a manner to enhance broad sharing and use of these resources will be part of the scientific merit review. The adequacy and record to date of the proposed sharing plans will be an important factor in the Institute’s decision to make an award. Furthermore, the proposed sharing plans, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of annual progress reports and of subsequent renewal applications will include an assessment of the effectiveness of the sharing of research resources.

To aid the project in avoiding conflict-of-interest situations, it is suggested that the members of the large-scale collaborative project disclose to the steering committee any ties to profit-making organizations. The grantee institution is required to disclose each subject invention to the Federal agency providing research funds within two months after the inventor discloses it in writing to personnel of the grantee institution responsible for patent matters.

The National Advisory General Medical Sciences Council has recommended that NIGMS strengthen its commitment to diversity across all of its program areas and funding opportunities. Therefore, applicants for this FOA are strongly encouraged to identify creative ways to encourage the participation of individuals from diverse backgrounds underrepresented in biomedical research in the development of knowledge generated under this program, and in the dissemination of that information to institutions and investigators who serve underrepresented populations.

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.

Applicant institutions must have a currently active NIGMS-supported large-scale collaborative project award submitted in response to PAR-07-412.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

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

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

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

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

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

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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

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

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

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

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:

Michael Rogers, Ph.D.
Director, Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences
National Institutes of Health
Bldg 45, Rm 2As.53m
Bethesda, MD 20892-6200
Telephone: 301-594-3827
Fax: 301-480-2802
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	30
Admin Core	6
Core (use for Bioinformatics Core and Research Cores)	12
IDDC Core (use for Information Dissemination and Data Coordinating Core)	6
Project (use for Bridging Projects)	6
Pilot Project	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
• Bioinformatics Core: optional
• Information Dissemination and Data Coordinating Core: required
• Research Cores: optional
• Bridging Projects: optional
• Pilot Projects: optional, maximum of three

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

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Other Attachments: The application must include the following:

Consortium organizational structure: A diagram should be prepared with the organizational structure, leadership, management/administration, and interactions between research projects and cores. This should demonstrate how the center will achieve its stated goals. Submit as a PDF entitled Consortium_organizational_structure.

Consortium timeline: A timeline should be prepared with the consortium goals identified and completion of major progress points indicated. Identify key contributions by research projects and research core(s) (if applicable). Identify major decision points as appropriate. Include data release dates consistent with the sharing plans. Submit as a PDF entitled Consortium_timeline.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

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

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application. The major research activity of the PDs/PIs must be in the research area of the large-scale collaborative project application, and the PDs/PIs are expected to make an appropriate level of commitment of effort to directing and managing operation of the project. A substantial level of effort will be necessary to manage projects of the largest magnitude.

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

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover. The applicant will not be able to enter the salaries for any individuals involved in the center leadership here; that information will be placed in the Administrative Core.

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

PHS 398 Research Plan (Overall)

Specific Aims: Provide a succinct description of the large-scale collaborative project's overall scientific goals, the expected outcomes, and the impact should those goals be achieved. Describe how the large-scale collaborative project will be organized, how it will be tracked, and what the plans are for continued activities and research resources beyond the end of the project period.

Research Strategy: A large-scale collaborative project should be organized and presented using the following format in a manner that best facilitates progress on the project, keeping in mind that the major purpose of a large-scale collaborative project award is to provide resources to enable collaboration rather than primary research support. Investigators should endeavor to be clear and concise.

Program Summary (Required). Describe the goals and operation of the large-scale project as follows:

• Explain the biomedical problem to be solved, why it is critical to advancing biomedical science, the necessity of using a large-scale collaborative project, and what remains to be accomplished in the second five-year period of support.
• Provide the background that has dictated approaches for the project, including how progress made and lessons learned have influenced those decisions.
• Discuss the range of scientific expertise to be used to address the research problem.
• Explain the interactions that will occur between investigators at the host site and participating sites.
• Outline how each element of the large-scale collaborative project will contribute to a cohesive overall program.
• Explain the programmatic value of the core resources, bridging projects, and pilot projects.

Describe how the information coming from the collaborative project and the laboratories of the participating investigators will be integrated into a comprehensive whole.

Progress Report (Required). Present an overall summary of progress since the inception of the collaborative project that has been made on the goals of the large-scale collaborative project award. Sufficient description of these research resources and their content should be included in the application text for a summary evaluation.

• Describe both the accomplishments of the large-scale project and the impact they have had within the consortium and on the larger relevant scientific community.
• Explain how progress made thus far has moved the field forward and has brought the ultimate goal of the consortium within reach.
• Highlight progress that could not have been achieved by individual investigator efforts alone.
• Delineate new research resources produced by the consortium that are now available to the research community and provide measures of the impact of those resources.

Administrative Management Plan (Required). Required elements of the administrative management plan are as follows:

• Describe the structure, organization, and operation of the project, and explain why and how this plan has evolved over the period of support. The effective functioning of the collaborative project team must be made clear.
• Discuss changes that have been made during the course of the project, including what elements have been dropped and what elements have been added.
• Explain the organizational framework, referring to the consortium organizational structure diagram requested above.
• Describe how information will flow within the large-scale collaborative project and how the information will be integrated into the solution of the biological problem being addressed.
• Explain the role of the steering committee.
• Discuss arrangements among the collaborating institutions that are important to effective operation of the project.
• Detail use of core resources by participating investigators and outreach to provide access by outside investigators.
• Explain how decisions will be made to add or delete participating investigators and to respond to changes in short-term goals necessitated by research findings.
• Discuss how the views of the scientific communities impacted by the collaborative project will be considered.

Project Management Plan (Required). A project management plan to keep the collaborative project moving forward and on track is required and its elements include:

• Define yearly milestones for the second five-year period of support, referring to the consortium timeline referred to above; the milestones can be modified at the time of the award with the concurrence of NIGMS.
• Describe the past and planned role of the steering committee in project management.
• Explain how progress in the bridging projects and pilot projects and efficiency of the core resources have been and will be tracked.
• Discuss the plan for evolving milestones.
• Explain how the advisory committee will be used in updating the project management plan.

Plan for Termination after Final Period of Support (Required). A special feature of the renewal application will be the PD(s)/PI(s)'s plans for these consortia beyond the renewal funding period. However, it is emphasized that the effort to complete the goals of the large-scale collaborative project awards should continue to the end of the ten-year funding period. Describe how the NIGMS ten-year limit on funding for a large-scale collaborative award will affect conduct of the award during the final period of support.

• Present the plan for an orderly termination of the project and how support will be sought if the project or some part of it is intended for continuation.
• Delineate research resources generated by the large-scale project that would be valuable to continue beyond the life of the large-scale award and the plan for support of these resources.

Letters of Support: Letters of support for participating investigators, collaborators, and institutions should be submitted as one pdf attachment.

Letters of investigator commitment: One-page letters of commitment from each participating investigator indicating his/her role in the consortium and willingness to follow guidelines and procedures established for the large-scale collaborative project.

Letters of collaborator support: One-page letters of commitment from each collaborator indicating his/her role in the consortium's activities.

Letters of Institutional Commitments: Letters, signed by authorized business officials of each of the participating investigators' institutions committing support to the large-scale collaborative project, must be included. Applicants that include consortium arrangements should refer to the NIH Grants Policy Statement appendix on consortium arrangements at http://grants.nih.gov/grants/policy/nihgps_2013/nihgps_ch15.htm.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide. The Resource Sharing Plan for the Overall Component should be included in the Administrative Core.

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 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.

SF424 (R&R) Cover (Administrative 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 (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative 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.

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

• 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 (Administrative Core)

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

Request funds as needed for salary and benefit of the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)), who will serve as the Administrative Core Lead, and the salaries and benefits for any other personnel dedicated to the administration and management of the center, such as secretaries and project coordinators. Describe their specific functions as well as levels of effort. Although a substantial level of effort is expected for the PD(s)/PI(s), NIGMS has not set minimum levels of effort; however, the appropriateness of the level of effort of the PD(s)/PI(s) will be a factor in the assessment of scientific merit and in the Institute's funding selections. The level of effort and commitment to the collaborative project of the members of the steering committee will also factor into the assessment of scientific merit as well as the Institute's funding decision.

Funds should be requested in the Administrative Core to support the travel of the PD(s)/PI(s) and possibly other individuals named as key personnel to attend meetings of the advisory and steering committees as necessary.

Include any funds needed to support the travel of members of the steering committee and an external advisory group to attend annual meetings to evaluate the consortium.

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 (Administrative Core)

Specific Aims: The Administrative Core is charged with providing management and administrate support the large-scale project. Describe the plans for consortium leadership and explain the Administrative Core Lead's specific roles and responsibilities in the management of the consortium. Refer to the diagrams requested as PDFs in the Overall section of the application.

Research Strategy: The plan for this Administrative Core should include: 1) the objectives of the core, 2) a description of staffing, 3) an evaluation plan to determine progress of the collaborative project; and 4) a listing of services to be provided to other core resources and to the participating investigators. Communicating the objectives of the collaborative project and fostering opportunities for collaboration are encouraged.

The activities of the Steering Committee and the Advisory Committee are described in section VI.2. The Administrative Core is charged with scheduling and logistical support for their meetings. This core is also responsible for scheduling and logistical support for the annual meeting of the large-scale project team. The request for Administrative Core resources must also be justified in terms of progress and results achieved to date.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications. Note that the policy described herein applies to all components of the application.

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan and a Plan for handling Intellectual Property and Sharing of Research Resources.
• Discuss how and when information and other research resources generated by the collaborative projects will be disseminated to the participants and to the scientific public.
• Address how the large-scale collaborative project has exercised intellectual property rights and describe plans for the future, should any be generated through this award.
• Provide a description of the consortium's approach and practice of resource sharing.
• Be very clear about responsibilities and timing for transfer of all data types, which may involve interactions with the research projects.
• Identify which of the key personnel will take specific responsibility for the oversight of sharing each set of data or data type generated by any core(s).
• A research center must anticipate and address the obstacles and support the culture of data sharing as appropriate. This should be reflected in the description of the center leadership's plans to ensure the timely publication of results and complete data and resource sharing.

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

Planned Enrollment Report (Administrative Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

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

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.

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 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 (Bioinformatics Core)

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

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

PHS 398 Research Plan (Bioinformatics Core)

Specific Aims: Describe the Core's plan for data assembly and organization for querying and developing tools for querying, computation, and modeling.

Research Strategy: Policies on future dissemination of data and computational tools should be explained. Computational tools developed to analyze, visualize, or model data are expected to be freely shared with the scientific community as well as the annotated source code, consistent with achieving the goals of the program. Others should be free to modify the source code and share the modifications, and the code should be made available for incorporation into commercial products. Include answers to the following questions and for each, describe any changes that were made during the first period:

• What are the nature and structure of the data? Describe the projected plans for ontologies, schema, or other data models.
  
  
• What is the underlying structure of the database (e.g., relational or object oriented)? Will this be continued?
  
  
• What is the projected mechanism for communication (both computational and human) between the distributed sites and the database managers? Are there data liaisons?
  
  
• What are the key interacting databases? How are the data to be linked? What are the plans for modifying or enhancing those linkages?
  
  
• How is progress made available to the public? Are lists of the systems being analyzed made available? Will the same arrangement continue or be modified during the next phase of the project?
  
  
• What experience in bioinformatics is available in the group, and on what resources can the consortium draw? Discuss the qualifications and experience of the bioinformatics team and how it has changed over the initial period of support.
  
  
• How has and will the bioinformatics plan evolve over the period of support?

Letters of Support: Include as appropriate for this core.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide. The Resource Sharing Plan for the Bioinformatics Core should be included within in the Administrative Core.

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

Planned Enrollment Report (Bioinformatics Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Bioinformatics Core)

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

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

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

SF424 (R&R) Cover (Information Dissemination and Data Coordinating 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 (Information Dissemination and Data Coordinating Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Information Dissemination and Data Coordinating 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.

Project /Performance Site Location(s) (Information Dissemination and Data Coordinating 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 (Information Dissemination and Data Coordinating Core)

• 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 (Information Dissemination and Data Coordinating Core)

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

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

PHS 398 Research Plan (Information Dissemination and Data Coordinating Core)

Specific Aims: Describe the Core's plan for dissemination of information on techniques, scientific findings, and methods. Computer technology, print media, and telecommunications are relevant.

Research Strategy: Required elements of the plan for this core are as follows:

• Describe the data and information to be made available to investigators within and external to the large-scale collaborative projects.
• Indicate plans to make research results or other unique features of the collaborative project available to the widest audience.
• Describe integration of data generated by core resources and participating investigators into the information to be disseminated.
• Discuss plans and timing for dissemination of published and unpublished data.

Letters of Support: Include as appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide. The Resource Sharing Plan for the Information Dissemination and Data Coordinating Core should be included in the Administrative Core.

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

Planned Enrollment Report (Information Dissemination and Data Coordinating Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Information Dissemination and Data Coordinating Core)

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

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 (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.

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 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 (Research Core)

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

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

PHS 398 Research Plan (Research Core)

Specific Aims: Describe the purpose and function of the research core, and provide a brief description of the core's scientific interactions in support of the research projects and participating investigators.

Research Strategy: Required elements of the plan are as follows:

Describe the planned direction, management, and use of the core and the duties of the professional and technical staff for the core.

Provide plans for use of the core, including services to be provided, to whom, and their bearing on productivity and quality of the collaborative research effort. For continuing cores, discuss how the direction, management and use of the core has changed and evolved over the initial period of support.

Letters of Support: Include as appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide. The Resource Sharing Plan for the Research Core should be included in the Administrative Core.

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

Planned Enrollment Report (Research Core)

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

PHS 398 Cumulative Inclusion Enrollment Report (Research Core)

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

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 (Bridging Project)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Bridging Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Bridging Project)

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

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

Project Narrative: Do not complete.

Project /Performance Site Location(s) (Bridging Project)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Bridging Project)

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

Budget (Bridging Project)

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

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

PHS 398 Research Plan (Bridging Project)

Specific Aims: Provide a succinct description of the research project's specific scientific goals, the expected outcomes, and the impact should those goals be achieved.

Research Strategy: Required elements of the plan for bridging projects are as follows:

• Describe the research proposed in the bridging project, and explain how it more fully integrates the participating investigator's independently supported work into the large-scale collaborative project or provides a necessary service or technology to the project.
• Address the underlying rationale and potential impact of the studies.
• Indicate whether this is a new or continuing bridging project. For continuing projects, report progress that has been made and discuss how the project has changed from and builds on the initial period of support.

Letters of Support: Include as appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide. The Resource Sharing Plan for the Bridging Project should be included in the Administrative Core.

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

Planned Enrollment Report (Bridging Project)

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

PHS 398 Cumulative Inclusion Enrollment Report (Bridging Project)

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

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

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

SF424 (R&R) Cover (Pilot Project)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Pilot Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Project)

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

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

Project Narrative: Do not complete.

Project /Performance Site Location(s) (Pilot Project)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Pilot Project)

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

Budget (Pilot Project)

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

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

PHS 398 Research Plan (Pilot Project)

Specific Aims: Describe the purpose of the pilot project and how it will support the goals and add to the cohesiveness of the large-scale collaborative project. Explain how the pilot project will support the work of investigators not already supported in the area of the collaborative project who have unique skills or expertise to add to the project effort.

Research Strategy: Required elements of the plan for pilot projects are as follows:

• Address the underlying rationale and potential impact of the studies.
• Describe how the pilot project will add new elements essential to achieving the goals of the collaborative project. It is necessary to justify the use of a pilot project taking into account that the collaborative project is entering its final period of support.
• For continuing pilot projects, report progress that has been made and discuss how the project has changed from and builds on the initial period of support.

Letters of Support: Include as appropriate.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide. The Resource Sharing Planfor the Pilot Project should be included in the Administrative Core.

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

Planned Enrollment Report (Pilot Project)

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

PHS 398 Cumulative Inclusion Enrollment Report (Pilot Project)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion

Enrollment Report as described in the SF424 (R&R) Application Guide

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

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.

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by NIGMS, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIGMS Referral Officer by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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

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

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

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

Significance

Does the large-scale collaborative project address an important problem or a critical barrier to progress in the field? If the aims of the large-scale collaborative project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Additionally, has progress been achieved that has moved its field of research forward that could not have been achieved by separate grants? Is there a commitment to maximize the impact of the collaborative project on research through the sharing of research resources generated by the large-scale project? Is this team well poised to reach its ten-year goal in the next time period?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the large-scale collaborative project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI , do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Has the PD/PI proven to be well suited for the scientific and administrative leadership required to carry out this work? Have the investigators functioned effectively as a team? Is the plan to add and delete participating investigators to and from the collaborative project satisfactory?

Innovation

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

Approach

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

If the large-scale collaborative project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? Do the plans for future studies build logically on the progress made to date? Is the project management plan adequate? Is the administrative framework appropriate? Are the requested components, such as core facilities, critical to achieving the scientific goals of the collaborative project and are they cost effective? Do milestones articulate key indicators set for appropriate times that will demonstrate significant forward progress for the collaborative project? Are the plans to monitor and evaluate progress of the collaborative project adequate? Will the group take the views of the scientific community impacted by the large-scale collaborative project into consideration? Are reasonable and adequate plans for the termination of the large-scale collaborative project described? Will there be value added over individual grants?

Environment

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

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

Leadership Commitment

Is the demonstrated and planned commitment to the project by the PD(s)/PI(s) and the members of the steering committee appropriate for their roles and the success of the large-scale collaborative project?

Host and Participating Institutions Commitment

Have efforts been made to work out ahead of time potential intellectual property issues and to remove any institutional barriers to the establishment and healthy maintenance of the collaborative project?

Intellectual Property Issues

Have adequate plans been made to deal with the intellectual property issues for the collaborative project?

Websites and Databases

Is the quality and accessibility of websites and databases available to the broader scientific community adequate?

Resource Sharing Plan

Are plans for sharing research resources appropriate and effective? Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed large-scale collaborative 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.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Budget and Period of Support

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

Review Criteria for the Core Resources

Consideration of the technical merit of the core units will include the strengths and weaknesses of the following items. These will not be scored individually, but will be considered in setting the overall impact score:

(1) Facilities within the core compared to the state of the art. The contributions of the cores to fulfilling the goals of collaborative project.

(2) The extent to which core units promote greater collaboration and cohesiveness among the participating investigators.

(3) Qualifications, experience, and commitment to the large-scale collaborative project mission of the investigators responsible for the core resources and their abilities to devote the required time and effort to the program.

Review Criteria for Bridging Projects and Pilot Projects

Reviewers will be asked to discuss the strengths and weaknesses of the following aspects of each bridging and pilot project. These will not be scored individually, but will be considered in setting the overall impact score.

Significance

Does the bridging or pilot project address an important problem or a critical barrier to progress in the field? If the aims of the bridging or pilot project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How will the proposed studies contribute to achieving the goals of the large-scale collaborative project award? Will/does the bridging project tie or enhance the independent work of the participating investigator to the collaborative project, or will/does the pilot project add an essential missing aspect to the collaborative project?

Investigator(s)

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

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Additionally, for continuing bridging and pilot projects, have innovative results been achieved to date?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Additionally, for continuing bridging and pilot projects, has the project evolved in a logical and compelling fashion?

Environment

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

Additional Review Criteria - Cores, Bridging, and Pilot Projects

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

Protections for Human Subjects

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

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

Vertebrate Animals

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

Inclusion of Women, Minorities, and Children

When the proposed large-scale collaborative 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.

Resource Sharing Plan

Are plans for sharing research resources appropriate and effective? Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Biohazards

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

As applicable for the large-scale collaborative 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.

Select Agent Research

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

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 National Advisory General Medical Sciences Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 

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

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable administrative guidelines of the Office of Management and Budget (OMB), grant administration regulations of the Department of Health and Human Services (DHHS) at 45 CFR Parts 74 and 92. Part 92 is applicable when State and local governments are eligible to apply. Guidelines of other DHHS, Public Health Service (PHS), and NIH grant administration policies also apply.

The administrative and funding instrument used for this program will be the cooperative agreement U54 mechanism, an "assistance" mechanism rather than an "acquisition" mechanism. Substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined here.

The PD(s)/PI(s) will have the primary responsibility for:

• Exercising prime responsibility and authority for scientific and technical direction, administration, and overall operation of the large-scale collaborative project.
• Selecting and chairing the steering committee.
• Abiding by the operating rules and guidelines developed by the Steering committee.
• Ensuring timely dissemination of information generated by the large-scale collaborative project to both the project members and the scientific public.
• Coordinating project activities scientifically and administratively.
• Annually as warranted by scientific progress and recommendations of the advisory committee, negotiate changes with NIGMS to the milestones for the collaborative project.
• Awardees will retain custody of and have primary rights to the data and research resources, including software, developed under these awards, subject to government rights of access consistent with current DHHS, PHS, and NIH policies.

An NIGMS scientific officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards:

• Duties and responsibilities of a Steering committee member, attendance at all meetings, and service as a voting member.
• Substantial programmatic involvement.
• Facilitation of interactions among the steering committee, advisory committee, and NIGMS.
• Provision of advice and guidance to ensure adherence of the large-scale-collaborative project to the NIH and NIGMS rules and regulations.
• Facilitation of communication with the scientific community directly affected by the collaborative project.
• Actions to ensure that the steering committee and the advisory committee address issues and concerns raised by the community.
• Additional responsibilities as negotiated at the award, depending on characteristics of the award.

An NIGMS program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice:

• Act as the official Institute contact to the PD(s)/PI(s) for study section, Council, and other closed confidential reviews.
• Organize and conduct any interim assessments (see below) convened for the purpose of obtaining confidential advice on scientific progress and/or funding.
• Review and approve or disapprove recommendations by the NIGMS scientific officer for the following: competing (T2) awards, non-competing (T5) awards, supplemental awards and carryover requests, terms and conditions of awards and other agreements, changes in project scope, key personnel, governance, or management plan.
• Assess progress in consultation with the NIGMS scientific officer, and external scientist consultants as needed, and approve annual progress reports from the project and report to the NIGMS Advisory Council on that progress.
• Negotiate and approve changes to annual milestones for the large-scale collaborative project award.
• Avoid close interactions that might diminish or appear to diminish objectivity.

Collaborative responsibilities include:

Participating Investigators

Participating investigators are scientists who have externally peer-reviewed grant support in the area of the project and who are involved with and committed to the goals of the project. It is expected that the majority will be funded through research grants supported by NIGMS, other NIH institutes, centers, or both; and other governmental and private agencies. Exceptions may include participating investigators from industry, foreign institutions, or allied fields not traditionally supported by the NIH (e.g., physics and mathematics). PD(s)/PI(s) of pilot projects are also included as participating investigators.

Participating investigators will have the following responsibilities:

• Work with the PD(s)/PI(s), the steering committee, and the other members of the large-scale collaborative project to set goals and develop working procedures.
• Support the project goals and abide by operating guidelines and procedures established for the project.
• Provide a list of organizational resources from their institution that will be committed to the project.
• Be actively involved in the project and interactive with the other members of the project.
• During the period of the award, a participating investigator whose independent research support terminates may continue as a participating investigator at the discretion of the steering committee and with the approval of the NIGMS program director. However, funds from this award are not to be used to support the independent research of such an investigator. It is expected that new participating investigators will be added to the collaborative project over the period of the award as deemed appropriate by the PD(s)/PI(s) and the steering committee and with the approval of the NIGMS program director. These additions will be reported in the annual progress report.

Steering Committee

Steering committee members will be chosen from a select group of investigators actively involved in the consortium, including the PD(s)/PI(s), scientists and administrators from the staff, and participating investigators of the project. Membership of the steering committee must be sufficiently broad and balanced to be representative of the overall project. Members will be selected by the PD(s)/PI(s) in consultation with the existing members of the steering committee and with the approval of the NIGMS project scientist. The steering committee will include the NIGMS project scientist as a voting member. The steering committee will meet annually with the advisory committee.

The steering committee will have the following responsibilities:

• Give scientific and administrative advice to and assist the PD(s)/PI(s) by providing oversight and strategic planning for the consortium as a whole and for the individual components.
• Work with the PD(s)/PI(s) to establish the scientific and technical direction of the project, develop common guidelines and procedures, establish rules for access to resources of the project, deal with intellectual property issues, and participate in the process of developing a cohesive group.
• Develop a policy on disclosure of ties between scientists and for-profit organizations, to help avoid conflicts of interest.
• Monitor bridging projects, core resources, and pilot projects for progress and efficiency and recommend modification of support and addition or deletion of these activities to facilitate progress toward the goals of the large-scale collaborative project.

Advisory Committee

The advisory committee will continue its role. At least three scientists not otherwise associated with the large-scale collaborative project will serve on the committee. The NIGMS project scientist will attend the meetings of the advisory committee as a member of the steering committee but will not be a member of the advisory committee.

The advisory committee will have the following responsibilities:

• Provide scientific and administrative advice to the PD(s)/PI(s), the steering committee, and consortium members.
• Meet at least once a year immediately before submission of the annual progress report, to advise the PD(s)/PI(s) and steering committee about meeting the goals of the large-scale collaborative project and to comment on plans for future directions.
• Raise issues for consideration by the PD(s)/PI(s) and the steering committee.
• Offer advice on the appropriateness of the level of NIGMS support to achieve the project goals.
• Comment on the impact of the collaborative project on the relevant scientific communities.
• Submit its comments and recommendations as an annual report to the PD/PI.

Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement. The NIGMS program director will summarize and make progress reports annually to the National Advisory General Medical Sciences Council. Near the end of the fourth year of the five-year award period, the progress report to Council will be prepared and presented in person by the large-scale project PI/PD. The PI/PD should plan for this in the requested budget.

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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
TTY 301-451-5936
Email: [email protected]

Michael E. Rogers, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3827
Email: [email protected]

Helen Sunshine, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3881
Email: [email protected]

Lisa Moeller
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3914
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 Parts 74 and 92.