National Institutes of Health (NIH)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
U42 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements
The purpose of this Notice of Funding Opportunity (NOFO) is to provide continuing support for the Informatics, Coordination and Service Center (ICSC) unit of the Mutant Mouse Resource and Research Centers (MMRRC) consortium. The ICSC is expected to provide informatics and coordinating services to the MMRRC consortium and biomedical researchers. Important functions of the ICSC are improvement, development, and maintenance of the Consortium’s in-house data management systems in a format that may facilitate their integration with other animal and non-animal resource databases and community standards for information accessibility and interoperability. Additional services include maintenance and further development of a public website portal and Customer Service Center; operation of the order processing system; review and processing of applications from donating investigators; facilitation of interactions with biomedical investigators, informatics services, database activities, and the archive of MMRRC documents and files; coordination of requests to donate mouse strains to the MMRRCs and to order mouse strains from the MMRRCs; oversight of marketing efforts; and completion of monthly and yearly metrics reports. Moreover, the ICSC will host and actively participate in the monthly teleconference, annual consortium meeting, and compose reports and summaries from these forums as requested by MMRRC consortium members or NIH staff. Of special interest of the announcement is a requirement of the Center’s close coordination with efforts to develop new approach methodologies (NAMs) that complement traditional animal-based research. These include cell culture, organoids, computational models, and microphysiological systems. Proposed activities should include collection and analysis of the comparative information on the use of NAMs that enhance the predictive power of human disease models and support their integration with traditional models.
The Office of Research Infrastructure Programs (ORIP) is a program office in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) dedicated to supporting research infrastructure and related research resource programs. ORIP consists of the Division of Comparative Medicine (DCM) and the Division of Construction and Instruments (DCI).
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| January 12, 2026 | January 12, 2026 | Not Applicable | July 2026 | August 2026 | December 2026 |
| May 01, 2026 | May 01, 2026 | Not Applicable | November 2026 | January 2027 | April 2027 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.
This Notice of Funding Opportunity (NOFO) announces an open competition to support the Informatics, Coordination and Service Center (ICSC) unit of the Mutant Mouse Resource and Research Centers (MMRRC) consortium. The overarching purpose of the research funded by the ORIP is to support infrastructure and resources for innovative biomedical research by creating models for human diseases using animals and cultured cells, managing the infrastructure required to maintain, distribute, and utilize these models, and conducting comparative analyses with relevant NAMs resources. The ICSC is currently funded as a cooperative agreement under the U42 grant mechanism. The ICSC supports the MMRRC consortium in its mission to provide mutant mice, sperm, embryos, and embryonic stem (ES) cell lines to qualified biomedical researchers at research centers, academic institutions, for-profit organizations, the NIH, and other federal agencies conducting research across multiple biomedical fields. The MMRRC consortium operates as a collaborative effort, with the role of the ICSC being to coordinate informatics and customer service activities in accordance with operational policies guidelines established by the Coordinating Committee and written Standard Operating Procedures. Currently, the MMRRC consortium consists of four regional distribution Centers (termed the MMRRCs) and an ICSC. This NOFO is intended to provide financial support exclusively to the ICSC.
The ICSC is expected to provide informatics and coordinating services to the MMRRCs and biomedical researchers to catalyze the rate of research progress across different biomedical fields. The ICSC should accept submission of relevant data from the community and generate its own data to store, organize, validate, archive, preserve, and distribute information in compliance with the FAIR (Findable, Accessible, Interoperable, and Reusable) Data Principles. Additionally, improving access to the ICSC’s databases and developing metrics to evaluate the usage, utility, and impact of repository activities will improve the ability of the Consortium to meet the needs of the biomedical research community. The ICSC’s services should include maintaining and further developing of a public website portal and Customer Service Center; operating the order processing system; reviewing and processing applications from donating investigators; facilitating interactions with biomedical investigators, overseeing informatics services, database activities, and archiving of MMRRC documents and files; coordinating requests to donate and order mouse strains, managing marketing efforts; and compiling monthly and annual metrics reports. Moreover, the ICSC will host and actively participate in the monthly teleconference, annual consortium meeting, and will compose reports and summaries from these forums. The Center should develop an active program for monitoring and collecting information on the impact of the MMRRC consortium’s ongoing activities on biomedical research. Such information should also be included in their progress reports to the NIH.
Of special interest of the announcement is a requirement of the Center’s close coordination with efforts to develop new approach methodologies (NAMs) that complement traditional animal-based research. These include cell culture, organoids, computational models, and microphysiological systems. NAMs enable research to be done more quickly, by more researchers, at a more affordable cost. Importantly, these advances are opening doors to complementary and more effective non-animal-based approaches for a variety of applications. The development of these NAMs holds tremendous promise for increasing the tools available to achieve the NIH mission and potentially reduce and refine the future use of animals in some areas of research in the future. It is important that the community fully understand the strengths and limitations of mouse models, as well as areas of opportunity given the current state of science, that in turn will improve selection, design, and relevance of all human disease models.
The PD/PI of ICSC is also required to develop a high risk, high return, research pilot that complements the goals and needs of the MMRRC consortium in informatics services (the Applied Research Project). Examples of Applied Research Projects include, but are not limited to developing new metrics to measure the impact of the MMRRC consortium’s activities on biomedical research, computational approaches to assess the needs of specific mouse models to support innovative and fast developing biomedical fields as well as to assist investigators to search repository content for human disease associations, comparative data searches to increase applicability of NAMs and promote integration of the most predictive human disease models, and new marketing methods based upon evaluation of researcher interest via machine learning approaches. The Applied Research Project may comprise no more than 10 percent of the direct costs of the proposal.
The U42 application is a multi-component application that includes an Overall Component that is the aggregate of the major "Coordination Section", Informatics Section, Customer Service and Public Relation Section Components and the minor "Applied Research Project" Component. Each of these Components is described in Section IV.2. Typically, one or more of the PDs/PIs of the Overall application also serves as a Section Head and can serve as the Lead of the Applied Research Project.
The ICSC is expected to follow the advice of the existing MMRRC’s consortium External Advisory Board (EAB) of experts as directed by the NIH on the MMRRC consortium’s long-term sustainability and relevance to biomedical research. The EAB should provide recommendations to the PD/PI on how to enhance the capacity and quality of service provided by the ICSC, should evaluate the processes by which the ICSC engages biomedical researchers and encourages submission of new mouse strains and related materials, and should recommend which new approaches should be employed for steadily increasing new accepted materials for archiving and future distribution. Tele- or videoconferencing is encouraged to decrease costs unless the budgeted expense of face-to-face meetings is justified in the application. The ICSC also may have Internal Advisory Boards consisting of the members of its own institution.
The MMRRCs will have an annual consortium meeting to present Center updates and research progress; to articulate new opportunities for collaboration; to evolve long-term program goals/strategies; to plan and strategize responses to the MMRRC’s EABs and user feedback; and to provide a venue for engagement with external advisors, NIH program officials, MMRRC users and other leaders of the scientific community. Each MMRRC must include a budget for attendance to each of the annual consortium meetings for their PD/PIs and key personnel.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.
The OER Glossary and the How to Apply - Application Guide provides details on these application types. Only those application types listed here are allowed for this NOFO.
Not Allowed: Only accepting applications that do not propose clinical trials.
One award will be made contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The application budget should be no more than $650,000 in direct costs per year.
The total project period may not exceed four years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions - Includes all types
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.
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.
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 How to Apply - Application Guide.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.
It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts) and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.
| Component | Component Type for Submission | Page Limit | Required/Optional | Minimum | Maximum |
|---|---|---|---|---|---|
| Overall | Overall | 6 | Required | 1 | 1 |
| Coordination Section | Core | 6 | Required | 1 | 1 |
| Customer Service and Public Relation Section | Core | 6 | Required | 1 | 1 |
| Informatics Section | Core | 6 | Required | 1 | 1 |
| Applied Research | Project | 6 | Required | 1 | 3 |
The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.
When preparing the application, use Component Type ‘Overall’.
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.
Complete entire form.
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Follow standard instructions.
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.
Specific Aims: State concisely the goals of the proposed ICSC and summarize the expected outcome(s), including the impact that results of the proposed informatics resource will exert on the research field(s) the MMRRC consortium supports.
Research Strategy: Briefly describe the purpose and history of the overall ICSC Program as well as the role it will play within the MMRRC consortium and the research communities that it serves. Describe the overall design, development and advancement of the ICSC. Describe how the ICSC and the MMRRC consortium will serve the needs of investigators in a variety of research areas rather than in a single or few research areas. Describe how the ICSC activities will be made available to investigators on a regional, national and international basis. Regarding the plans for the operation and maintenance of the ICSC, provide a general overview of how the resources generated by this project will be made available rapidly and efficiently to the NIH-supported research community. Describe how the Center will coordinate its activities with development of NAMs, assist in a search of the comparative information for the decision-making process, and contribute to assessing the value and limitations of NAMs.
The plan must discuss the following key areas:
Letters of Support: Include a Letter of Support from any institution providing space, resources, or financial support other than Program Income from distribution of resources and services. All letters of the support for the Overall Component should be uploaded as a single attachment to the Research Plan.
Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.
The Resource Sharing Plan should focus on the sharing the information about research resources generated by the MMRRC consortium, including but not limited to mouse strains, tissues and biofluids, custom reagents, and specialized mouse facilities and services that are made available to the biomedical research community on a national basis, material quality assessment information. All applications, regardless of the amount of direct costs requested for any one year, must address a Resource Sharing Plan. The Resource Sharing Plan for the entire application should be consolidated in this section.
A critical component of improving research reproducibility is to develop approaches for unique identification of research resources in public databases, including publications. The Centers should register catalogs of their resources with current resource tagging and identification initiatives, such as FORCE 11. These centers should also work with investigators to encourage the use of Research Resource Identifiers (RRIDs) assigned by http://scicrunch.com/resources in their publications and reports.
Other Plan(s):
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:
Authorization and Consent
The Government authorizes and consents to all use and manufacture of any invention described in and covered by a United States patent in the performance of this Cooperative Agreement at all tiers.
Notice and Assistance Regarding Patent and Copyright Infringement.
(a) The recipient shall report to the Program Director, promptly and in reasonable written detail, each notice or claim of patent or copyright infringement based on the performance of this Cooperative Agreement of which the recipient has knowledge.
(b) In the event of any claim or suit against the Government on account of any alleged patent or copyright infringement arising out of the performance of this Cooperative Agreement or out of the use of any supplies furnished or work or services performed under this Cooperative Agreement, the recipient shall furnish to the Government, when requested by the Program Director, all evidence and information in possession of the recipient pertaining to such suit or claim. Such evidence and information shall be furnished at the expense of the Government except where the recipient has agreed to indemnify the Government.
(c) The recipient agrees to include, and require inclusion of, this clause in all sub-awards and subcontracts at any tier for supplies or services (including construction and architect-engineer sub-awards and subcontracts and those for material, supplies, models, samples, or design or testing services).
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.
The following modifications apply:
Appendix materials are REQUIRED for all RENEWAL and RENEWAL-RESUBMISSION applications. RENEWAL and RENEWAL-RESUBMISSION applications missing these required appendix materials will be withdrawn prior to review.
The following are allowable Appendix materials for the Overall Component (15 pages maximum):
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply - Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type ‘Core.’
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.
Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
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.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Describe concisely the plans and administrative structure of the proposed Coordination Section and how the ICSC will provide centralized processing and infrastructure for the individual MMRRC facilities and coordination of the activities with the MMRRC repositories as well as with the activities of other national mouse programs.
Research Strategy: The Coordination Section will effectively coordinate interactions and collaboration of the regional MMRRCs and investigators as well as coordinate activities with the ORIP/DPCPSI/OD/NIH Program Official. The application should clearly define the management plan for the proposed project, prioritization of the action items according to needs of the repositories, and how it will support achievement of the proposed goals and milestones. The application should also describe the plans for evaluation of progress across the MMRRC consortium and communication strategies to manage and track progress of the activities and services. The Coordination Section should coordinate participation in MMRRC consortium’s evaluation activities, including progress reports, site visits, and providing additional communication and materials to the ORIP/DPCPSI/OD/NIH Program Official as needed. The proposed plan should also include detailed description and statements of the following:
The PD/PI and other key personnel are required to attend the annual consortium meeting of the MMRRCs. ICSC staff should attend other subcommittee meetings to help facilitate, open video conferencing, and provide general assistance to the subcommittees. They will record discussions regarding IT requirements and work closely with the repositories to fulfill those needs. The ICSC will post submitted meeting minutes to the appropriate committee directory, notifying the repositories when minutes become available. The ICSC will work with the MMRRC subcommittees to review and update posted web pages at least annually, or as needed if immediate changes are required.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:
Resource Sharing Plans should be consolidated in the Overall Component.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type ‘Core.’
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.
Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
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.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Describe concisely the plans and administrative structure of the proposed Customer Service and Public Relation Section, which should provide deliberate, useful and helpful support and services to the research community of MMRRC users. Also describe the ICSC activities to optimize awareness, access and use of mouse strains, as well as MMRRC services by the biomedical community. The Customer Service and Public Relation Section will provide centralized processing and infrastructure for the individual MMRRC facilities and coordination of activities with the MMRRC repositories as well as with the activities of other national mouse programs.
Research Strategy: The ICSC should provide and maintain a free, public website that serves up state-of-the-art catalog search functions and links to detailed information on mouse strains, publicizes current information on the MMRRC holdings and activities, operates an online donor application form, provides links to other relevant repositories and databases (e.g., Mouse Genome Informatics [MGI]), and allows open data sharing with other repositories, research related associations, and bioinformatics databases. Search results should contain detailed information about each mouse strain and include both local data as well as data consolidated and linked from other relevant repositories and databases. The ICSC should also facilitate strain donation by publishing an easy to use online donor application form, which collects and stores information about the donor as well as any donated strains for later reuse in the approval process and strain curation.
The Customer Service and Public Relation Section at the ICSC is expected to include the following capabilities and information:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:
Resource Sharing Plans should be consolidated in the Overall Component.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type ‘Core.’
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.
Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
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.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: Describe concisely the plans of the proposed Informatics Section and its role in the functions of the ICSC.
Research Strategy: The ICSC must maintain, and regularly update a secure, central (true) database that facilitates user access, tracking, and expression of interest on professionally curated data and information on mutant mouse lines. It should use industry standard information management practices according to the FAIR data principles, alignment of existing data repositories with TRUST (Transparency, Responsibility, User focus, Sustainability, and Technology) principles, and evaluation of usage, utility, and impact. The MMRRC consortium requires a database that provides secure, defined access to website users, MMRRC collaboration members, and autonomous software agents developed by the ICSC informatics staff. Although hidden from the view to all but the ICSC staff, the relational database management system should provide a secure and robust framework of features that facilitate security, data integrity, and developmental flexibility. The primary function of the database is to hold curated information for each repository item, track all customer service and order related information, and track all product interests as expressed by users. One of the key responsibilities of the ICSC is generation of advanced programming language and providing the high quality monthly and yearly metrics reports on catalog holdings, other activities and responsiveness.
In addition, the Research Strategy is expected to include detailed information on the following:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:
Resource Sharing Plans should be consolidated in the Overall Component.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
When preparing your application, use Component Type ‘Project.’
All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.
Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
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.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: State concisely the goals of the proposed Applied Research Project and summarize the expected outcome(s), including the impact that the results of the proposed Applied Research Project will exert on the function of the ICSC.
Research Strategy: Describe how the Applied Research Project will generate new information services, activities, and data integration products that will improve the function of ICSC and the whole MMRRC consortium. Describe the framework, design, methods and analyses, which should be adequately developed, well integrated, well-reasoned and appropriate to the aims of the Applied Research Project. Describe how the Applied Research Project and other Sections of the Center will synergize beyond what could be achieved through a traditional software development in the Informatics Section. At least one of the Applied Research projects should be focused on citing of comparative data to increase applicability of NAMs and promote integration of the most predictive human disease models.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:
Resource Sharing Plans should be consolidated in the Overall Component.
Appendix:
Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.
When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:
If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the How to Apply- Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.
See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
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 How to Apply- 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 Section 7.9.1 Selected Items of Cost.
Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.
For information on how applications will be automatically assembled for review and funding consideration after submission, refer 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 How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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 form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in How to Apply - Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this announcement, note the following:
The U42 application is a multi-component application, with an Overall component that is the aggregate of the major Coordination, Customer Service and Public Relation, and Informatics Section Components in addition to the minor Applied Research Project Component. During the review process, "Merit Descriptors" will first be provided in individual Reviewer’s critiques for the Coordination, Customer Service and Public Relation, and Informatics Sections as well as the Applied Research Project. The two potential Merit Descriptors are acceptable or unacceptable. Then, numerical scoring of the application will be assigned for the Overall application.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the 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 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.
Does the proposed Center address the needs of the research program that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing animal model research? Do the investigators demonstrate significant experience with coordinating collaborative basic research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if needed?
Does the application propose novel management strategies in coordinating the research consortium the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of management strategies proposed?
Specific to this NOFO: Does the application enhance the capacity to utilize innovative technologies and improve the quality of the MMRRC consortium’s acquisition, evaluation, characterization, and distribution of mutant mouse strains, sperm, embryos and ES cell lines?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
Specific to this NOFO: Will the services and informatics resources generated by this project be made available rapidly and efficiently to the MMRRCs and the NIH-supported research community? Are the procedures and components for the evaluation of ICSC's functions (e.g., by external and internal advisory boards) and for implementing recommendations resulting from such evaluations appropriate? Are adequate approaches proposed to receive feedback from MMRRC users on catalog offerings, ordering processes and services? Does the application describe a plan to track the impact of the MMRRC? Are the plans for how the Center will coordinate its activities with development of NAMs, assist in generation of the comparative data for the decision-making process, and contribute to assessing the value and limitations of NAMs adequate?
Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
Specific to this NOFO: Is there evidence of coordination and integration of ICSC activity within the MMRRC consortium as well as other national mouse programs, such as KOMP?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Additional Review Criteria for Coordination Section
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate merit descriptor (acceptable or unacceptable). An application does not need to be strong in all categories to be judged likely to have major scientific impact.
The Coordination Section will receive a merit descriptor (acceptable or unacceptable) that reflects the following:
Additional Review Criteria for Customer Service and Public Relation Section
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate merit descriptor (acceptable or unacceptable). An application does not need to be strong in all categories to be judged likely to have major scientific impact.
The Customer Service and Public Relation Section will receive a merit descriptor (acceptable or unacceptable) that reflects the following:
Additional Review Criteria for Informatics Section
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate merit descriptor (acceptable or unacceptable). An application does not need to be strong in all categories to be judged likely to have major scientific impact.
The Informatics Section will receive a merit descriptor (acceptable or unacceptable) that reflects the following:
Additional Review Criteria for Applied Research Project
Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate merit descriptor (acceptable or unacceptable). An application does not need to be strong in all categories to be judged likely to have major scientific impact.
The Applied Research Project will receive a merit descriptor (acceptable or unacceptable) that reflects the following:
For research that involves human subjects but does not involve one of the 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 categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for inclusion. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the American Veterinary Medicine Association (AVMA) Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions (as applicable), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals (as applicable), the committee will consider the progress made in the last funding period.
Specific to this NOFO: The progress should be evaluated for accomplishment of objectives for the ICSC. Evaluate the extent to which the specific aims of the previous grant cycle were achieved. Did the ICSC serve the needs of investigators in a variety of research areas where work is sponsored by categorical NIH Institutes? Were the informatics resources generated by this project made available rapidly and efficiently to the NIH-supported research community? Was a significant effort made by the ICSC for unique contributions to the mission of the whole consortium?
Are the proposed Aims of the renewal logical extensions of the Aims of the previous grant cycle? Were appropriate plans in place for assurance of quality control? Were appropriate procedures in place for handling requests from the MMRRCs?
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policies and practices, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the NIH Council of Councils. The following will be considered in making funding decisions:
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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
After the peer review of the application is completed, the PD/PI will be able to access their Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.
In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.
Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.”
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).
Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
Successful recipients under this NOFO agree that:
When recipients, subrecipients, or third-party entities have:
Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients 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 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
An NIH project scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
The ORIP/DPCPSI Project Scientist and grant recipients are responsible for forming the MMRRC consortium, which serves as the governing board for the group of awards, as defined below. The MMRRC consortium members are responsible for reviewing the plans for development and operation of the MMRRCs as proposed in the individual applications of MMRRC recipients. The MMRRC consortium members will develop and use uniform procedures for quality control, acquisition of mutant mice, mouse husbandry, maintenance of animal facilities, shipping and receiving animals, germplasm cryopreservation, reconstitution of embryos and gametes by rederivation, phenotypic characterization, embryo and gamete quality control, maintenance of local electronic databases, administrative direction, and reporting procedures. The MMRRC consortium will also review and approve the operating procedures proposed by individual recipient organizations, to ensure they are compatible with the overall goals of this RFA. The MMRRC consortium is also responsible for selecting members of the EAB to the MMRRCs (see below).
The MMRRC consortium voting members will consist of the PD/PI of each MMRRC, ICSC and the ORIP/DPCPSI Project Scientist. Additional members can be added by consensus of the MMRRC consortium. However, the Project Scientist will be the sole voting member on behalf of NIH. All NIH staff members share one vote in support of the project. The structure of the MMRRC consortium should be established at the first meeting as noted below. The Chair of the MMRRC consortium will be responsible for coordinating MMRRC consortium activities. The ORIP/DPCPSI Project Scientist will be responsible for approving the agenda and minutes. Subcommittees will be established by the MMRRC consortium, as it deems appropriate. The ORIP/DPCPSI Project Scientist will serve on subcommittees as he/she deems appropriate.
At its initial meeting, the MMRRC consortium will elect a Chair, who must not be the ORIP/DPCPSI Program Official or ORIP/DPCPSI Project Scientist. The MMRRC consortium will determine whether additional MMRRC consortium representation is required, or if standing or temporary committees are needed.
The MMRRC consortium will meet at least three times in the first year to plan strategies, develop and approve operating procedures, and evaluate progress. The initial meeting will be held as soon as possible after funding. Meetings may be held via teleconference, video conference, or in person at convenient locations. These meetings will focus on coordinating the activities of the participating Centers as well as reviewing established and new policies and priorities.
The ORIP/DPCPSI Program Officer will participate in discussions at these meetings.
The ORIP/DPCPSI Program Officer will assure that operating policies are acceptable to the ORIP/DPCPSI. An arbitration system, as detailed below, will be available to resolve disagreements between recipients and ORIP/DPCPSI staff. Decisions such as whether to accept live animals, cryopreserved gametes, embryos and/or other germplasm formats, or to distribute live animals or only cryopreserved germplasm will be determined by the MMRRC consortium.
Coordinating Committee members may include expert researchers with broad expertise in key disciplines needed for successful operations, such as developmental biologists, pathobiologists, molecular geneticists, and cryobiologists. When and if additional expertise is needed, experts can be recruited with the concurrence of the MMRRC consortium and ORIP/DPCPSI Program Official. Each full member will have one vote. Grant recipient members of the Coordinating Committee will be required to accept and implement policies approved by the Committee.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the MMRC Consortium 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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.
Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
Not Applicable
A final RPPR, 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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk - Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues.
Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).
Office of Research Infrastructure Programs (ORIP)
Email: ORIPDCM@mail.nih.gov
Center for Scientific Review (CSR)
Email: NOFOReviewContact@csr.nih.gov
National Heart, Lung, and Blood Institute (NHLBI) – ORIP Team
Email: nhlbioripogm@nhlbi.nih.gov
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 2 CFR Part 200.