RFA-OD-25-012-Revised-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Funding Opportunity Title

Informatics, Coordination and Service Center for the Mutant Mouse Resource and Research Centers (U42 Clinical Trial Not Allowed)

Activity Code

U42 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements

Announcement Type

Reissue of

RFA-OD-20-012

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-OD-25-012

Companion Notice of Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.351

Notice of Funding Opportunity Purpose

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.

Funding Opportunity Goal(s)

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).

Key Dates

Posted Date

December 04, 2025

Open Date (Earliest Submission Date)

December 12, 2025

January 12, 2026

January 12, 2026

Not Applicable

December 2026

May 01, 2026

May 01, 2026

Not Applicable

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.

Expiration Date

May 02, 2026

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

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.

Additional Information 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.

Section II. Award Information

Funding Instrument

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.

Application Types Allowed

New

Renewal

Resubmission

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.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

One award will be made contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

The application budget should be no more than $650,000 in direct costs per year.

Award Project Period

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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Foreign Organizations/International Collaborations

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.

Required Registrations

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.

System for Award Management (SAM) – 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.

Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. 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 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

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.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2- Definitions of Terms.

3. Additional Information on Eligibility 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:

A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.

A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package 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.

2. Content and Form of Application Submission 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.

Page Limitations All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Required

Required

Required

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Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component 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.

SF424(R&R) Cover (Overall) Complete entire form.

PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall) Follow standard instructions.

Project/Performance Site Locations (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 and Related Senior/Key Person Profile (Overall) 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.

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

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

PHS 398 Research Plan (Overall) Introduction to Application: For Resubmission 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:

A Data Management and Sharing Plan is not applicable for this NOFO.

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):

PHS Human Subjects and Clinical Trials Information (Overall) 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.

PHS Assignment Request Form (Overall) All instructions in the How to Apply- Application Guide must be followed.

Coordination Section 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.

SF424 (R&R) Cover (Coordination Section) Complete only the following fields:

PHS 398 Cover Page Supplement (Coordination Section) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Coordination Section) Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

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

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

Project/Performance Site Location(s) (Coordination Section) 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 (Coordination Section)

Budget (Coordination Section) 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 (Coordination Section) 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.

PHS Human Subjects and Clinical Trials Information (Coordination Section) 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.

Customer Service and Public Relation Section 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.

SF424 (R&R) Cover (Customer Service and Public Relation Section) Complete only the following fields:

PHS 398 Cover Page Supplement (Customer Service and Public Relation Section) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Customer Service and Public Relation Section) Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

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

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

Project/Performance Site Location(s) (Customer Service and Public Relation Section) 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 (Customer Service and Public Relation Section)

Budget (Customer Service and Public Relation Section) 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 (Customer Service and Public Relation Section) 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.

PHS Human Subjects and Clinical Trials Information (Customer Service and Public Relation Section) 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.

Informatics Section 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.

SF424 (R&R) Cover (Informatics Section) Complete only the following fields:

PHS 398 Cover Page Supplement (Informatics Section) Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Informatics Section) Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

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

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

Project/Performance Site Location(s) (Informatics Section) 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 (Informatics Section)

Budget (Informatics Section) Budget forms appropriate for the specific component will be included in the application…