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

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

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

This Funding Opportunity Announcement (FOA) announces a limited 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 through the creation of models for human diseases using animals and cultured cells as well as management of the infrastructure required to maintain, distribute, and utilize these models. The ICSC is currently funded as a cooperative agreement (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 to conduct research across multiple biomedical fields. The MMRRC consortium is organized as a collaborative effort, with the role of the ICSC being to coordinate informatics and customer service activity centrally according to operational policies guidelines as set forth by the Coordinating Committee and written Standard Operating Procedures. Currently the MMRRC consortium is comprised of four regional distribution Centers (termed the MMRRCs) and an ICSC. This FOA is intended to give financial support only 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. These 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 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 ongoing activities on biomedical research. Such information should also be included in their progress reports to the NIH. 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 metrics to measure the impact of MMRRC consortium activities on biomedical research, computational approaches to assess the needs of specific mouse models to support innovative and fast developing biomedical fields, 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 multicomponent application, with 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 External Advisory Board (EAB) of experts as directed by the NIH on the MMRRC’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.

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

Only grantees previously funded under the auspices of PAR-15-156

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

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

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) 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.
• o NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

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

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

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

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

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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	6
Core (use for Coordination Section; Customer Service and Public Relation Section; and Informatics Section)	6
Project (use for Applied Research Project)	6

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

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

The application should consist of the following components:

• Overall: required (one maximum)
• Coordination Section: required (one maximum)
• Customer Service and Public Relation Section: required (one maximum)
• Informatics Section: required (one maximum)
• Applied Research Project: required (one minimum, three maximum)

When preparing your application, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions.

Enter primary site only.

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

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

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

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

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

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

Specific Aims: 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 plays 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.

The plan must discuss the following key areas:

• Organization of the proposed ICSC and its management structure, including integration of the separate components to maintain efficient operation, key personnel, section leaders and reporting relationships.
• Recruitment, training and retention of personnel
• How the various components of the proposed ICSC will be integrated, and how collaborations or subcontracts, if proposed, will be managed.
• Increasing the contribution of the ICSC to the whole MMRRC consortium for maintaining scientific rigor, transparency and experimental reproducibility of the biomedical research.
• Enhancement of the capacity to utilize innovative technologies and improve the quality of the MMRRC’s services for acquisition, evaluation, characterization, cryopreservation, storage, and distribution of mutant mouse strains, sperm, embryos and ES cell lines.
• Development of an active program for monitoring and collecting information on the impact of the MMRRC consortium ongoing activities on biomedical research.

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 SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. The ICSC Sharing Plan for the entire application should be consolidated in this section.

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 Grantee 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 Grantee 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 Grantee shall furnish to the Government, when requested by the Program Director, all evidence and information in possession of the Grantee pertaining to such suit or claim. Such evidence and information shall be furnished at the expense of the Government except where the Grantee has agreed to indemnify the Government.

(c) The Grantee 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 the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

Coordination Section

When preparing your application, use Component Type Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

List all performance sites that apply to the specific component.

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

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

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

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 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 ICSC will follow the policy guidelines developed by the MMRRC Coordinating Committee. Upon request, the ICSC will report to the Coordinating Committee on the details of policy implementation and will aid these groups in their decision making.
• The ICSC will manage and host monthly teleconference meetings for the MMRRC Coordinating Committee and when necessary for the associated subcommittees.
• The ICSC will host and contribute to the MMRRC Committees, Subcommittees, and the MMRRC annual consortium meeting. 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 SF424 (R&R) 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 Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) 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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

Customer Service and Public Relation Section

When preparing your application, use Component Type Core.

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

SF424 (R&R) Cover (Customer Service and Public Relation Section)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (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)

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

Budget (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 on-line 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 on-line 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:

• State-of-the-art search function that allows investigators to query the catalog of MMRRC mutant mouse strains including the ability to search using controlled filters, such as by Medical Subject Heading and Mammalian Phenotype ontology, and to view, select, and order mice, cryopreserved germplasm, and/or ES cell lines.
• Provide investigators a link to detailed information for each MMRRC strain, including origin, utility, genotypic and phenotypic characteristics, strain background, colony and husbandry management, genotyping, publications in the scientific literature, licensing, availability, pricing, and links to the MGI database and other public databases providing information on each strain.
• The website should provide up-to-date information and press releases on the latest proceedings at the MMRRCs. New strains should be marketed on the front page and should be labeled with NEW in the catalog. Similarly, lines that are to be discontinued as live colonies will be marketed on the front page to notify investigators of the upcoming change in availability status in case they would like to order mice while the live colony still exists.
• On-line application form accessible from the public MMRRC website that allows donating investigators to input information on the genetic, phenotypic and other characteristics of a strain proposed for acquisition by the MMRRCs. Donation system should have enhanced capacity for presentation, progress reporting, information gathering and print functions.
• Background information on the MMRRC consortium and links to other relevant public mouse strain databases.
• Provide a means for an investigator to register interest in a strain that has been accepted by the MMRRCs, but is not yet available for distribution.
• The awardee must provide a technical service function that can answer questions from investigators regarding the availability and ordering of strains, submission of strains, and other information in a timely manner. Access by email, telephone, facsimile, and mail should be provided.
• Processing of orders for MMRRC strains. The ICSC is expected to be the initial contact for all orders from requesting investigators. Upon receiving an order for a strain, the grantee is required to request a signed Material Transfer Agreement (MTA) and Conditions of Use (COU) from the requesting investigator and transmit the MTA, COU and order to the Center holding the strain. If necessary, the ICSC must send weekly email reminders to the requesting investigator to ensure timely fulfillment of orders. Additionally, the ICSC is required to maintain a file of the final signed MTAs and COUs received from donating investigators and requesting investigators.
• Review applications from donating investigators of strains proposed for acquisition by the MMRRCs. The ICSC is required to review applications for completeness, determine if the strain has been deposited in another public repository, prepare a file containing detailed information of the characteristics and utility of the strain, and assign scientific review of the application to one of the MMRRCs at least 2 weeks prior to the next scheduled teleconference. That Center will present and lead the scientific discussion of the application at the next teleconference. The ICSC must notify the donating investigator of acceptance or denial. If accepted, the ICSC is expected to request a signed MTA and the protocols required to verify the genotype of each submitted strain from the donating investigator. Once a strain is approved, the supplied information should be integrated into the strain detail page posted in the MMRRC consortium catalog.
• The effective marketing program should be aimed at increasing the awareness of the scientific community regarding the MMRRCs, and generating a plan to identify and recruit into the MMRRCs newly-generated mutant mouse lines that are valuable to the scientific community. It will include customized emails with MMRRC consortium branding and tracking components; presence at regional, national and international meetings; and designing and manufacturing of MMRRC consortium branded pamphlets and other marketing materials. Development of the new marketing methods based upon evaluation of researcher interest via machine learning approaches is highly encouraged. Development of additional methods to raise visibility of resources available from the MMRRCs, including social media, targeted publications, and development and implementation of a resource tagging system is also encouraged.
• The Customer Service and Public Relation Section should institute mechanisms that solicit regular feedback and opinion from the user community, including comment boxes on orders and online flash-surveys; regularly analyze the results; inform the MMRRC consortium; and work with investigators to encourage the use of Research Resource Identifiers (RRIDs) assigned by http://scicrunch.com/resources in their publications and reports.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, 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 Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) 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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

Informatics Section

When preparing your application, use Component Type Core.

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

SF424 (R&R) Cover (Informatics Section)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (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)

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

Budget (Informatics 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 (Informatics Section)

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. 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:

• Establish and maintain a password-protected, central electronic archive of MMRRC documents and other files. Ongoing collaboration among the geographically disperse MMRRC system demands a secure, on-line document archive and centralized link in order to share non-publicly displayed information between the ICSC and the repositories. In order to maintain a reasonable level of security, this archive should use the current Secure Sockets Layer, point-to-point encryption standard and individual username and passwords. In order to be a useful utility, this archive should contain all static information necessary for ongoing communication and decision making among the MMRRC repositories as well as interfaces to dynamic information, such as statistical reports of MMRRC repository activity that can be generated on-the-fly. The ICSC is required to provide access via the Internet to MMRRCs, ORIP program staff, and other individuals authorized by the Program Official.
• A list of every strain accepted by the MMRRC repositories. The grantee is expected to use standard scientific nomenclature for all MMRRC strains and must register strains in the MGI database at JAX (http://www.informatics.jax.org/). The catalog of the MMRRC strains must contain information on the mutated genes, the origin of the mouse strains, the genetic background, the genotypic and phenotypic information available on the strains, the list of publications on the particular strain, and the licensing, availability, and pricing as well as colony and husbandry management of the strain, etc.
• Track strains assigned to each MMRRC repository and the completion of each step of the acquisition process. When all steps are completed, the grantee is expected to authorize the MMRRC repository to begin distributing the strain to requesting investigators.
• Curation of strain information for all of the accepted MMRRC strains in the repository.
• Provide a means and appropriate security for each MMRRC to update information in the central database, and track who and when the update was made.
• Delivery of statistics and reports related to the overall MMRRC project to its stakeholders. As the centralized coordinator, the ICSC is required to compile and update monthly summaries of the numbers of mouse strain submissions (total and accepted); status of strain acquisitions; strain importation progress (by Center and overall); number of customer service contacts (total and type of inquiry); distributions of frozen embryos, spermatozoa, ES cell lines, and living mice (by Center, germplasm category, and overall); and a list of institutions that have sent or received strains from the MMRRC and the number of strains in each category.
• Informatics support for interactions with other web portals and repositories, such as KOMP2. Facilitate registering the current catalogs of MMRRC resources with resource tagging and identification initiatives, such as FORCE 11 (https://www.force11.org/group/resource-identification-initiative).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, 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 Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Informatics 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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

Applied Research Project

When preparing your application, use Component Type Project.

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

SF424 (R&R) Cover (Applied Research Project)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Applied Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Applied Research Project)

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

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

Project Narrative: Do not complete. 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) (Applied Research Project)

List all performance sites that apply to the specific component.

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

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

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

Budget (Applied Research Project)

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

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

PHS 398 Research Plan (Applied Research Project)

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. The application should demonstrate that overall consortium input was solicited in deciding on the goals of the project in order to improve the function of the entire MMRRC consortium.

Letters of Support: Include a Letter of Support from collaborators who will participate in the research activities to improve the function of the ICSC. All letters of the support for the Applied Research Project 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 SF424 (R&R) 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 Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Applied Research Project)

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 SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit 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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the Office of Reseach Infrastructure Programs, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

The U42 application is a multicomponent application, with 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. During the review process, "Merit Descriptors" will first be provided in individual Reviewer’s critiques for the Coordination, Informatics and Customer Service and Public Relation Sections, and the Applied Research Project. The three potential Merit Descriptors are outstanding, 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 ICSC 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 ICSC 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 Center that by its nature is not innovative may be essential to advance a field.

Does the ICSC address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the ICSC are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Are the design of the ICSC and the methods of providing information and services innovative? Are there innovative features in the planned ICSC/MMRRC consortium and ICSC/users interactions, and within the internal and external decision making processes? 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, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the ICSC? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the ICSC involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Are the plans for the operation and maintenance of the ICSC adequately developed and described? 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 the External Advisory Board's planned participation, frequency of meetings, members' expertise, and functions adequate? 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 Consortium ongoing activities or ICSC resource-related research on broad research areas?

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

Is there appropriate Institutional Support for the ICSC, and are plans for continuity appropriate for the scientific field’s needs? Is the form of this commitment (space, resources, plans for long-term continuity) appropriate? 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 Center 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.

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate merit descriptor (outstanding, acceptable, 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 (outstanding, acceptable, unacceptable) that reflects the following:

• Is there evidence that the ICSC intends to follow the policy guidelines developed by the MMRRC Coordinating Committee?
• Is the proposed plan for the ICSC adequate for effective coordination of MMRRC interactions and collaborations?
• Are there mechanisms for regular communication and coordination with PDs/PIs of the MMRRCs?
• Are the plans for the evaluation of the progress across the MMRRC consortium and communication strategies to manage and track progress of activities and services adequate?
• Are plans for the interaction of the ICSC with the ORIP/DPCPSI/OD, including providing progress reports, additional materials on request, and coordination of site visits, described?
• Are the mechanisms for regular communication with the MMRRC Coordinating Committee presented?
• Are details of the organization of monthly teleconferences for the MMRRC Coordinating Committee and associated subcommittees described?
• Are participation and contribution of the ICSC to the function of the MMRRC Committees and organization of the annual consortium meeting adequate?

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate merit descriptor (outstanding, acceptable, 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 (outstanding, acceptable, unacceptable) that reflects the following:
• Are the plans and administrative structure of the Customer Service and Public Relation Section sufficient to provide deliberate, useful and helpful support and services to the research community of MMRRC users?
• Will the Customer Service and Public Relation Section provide adequate activities to optimize awareness, access and use of mouse strains, as well as MMRRC services by the biomedical community?
• Do the suggested ICSC activities to provide and maintain a free, public website serve adequately the variety of catalog search functions, publicize current information on MMRRC holdings and activities and allow data sharing and communication with other repositories, consistent with the goals of the program?
• Is the provided on-line mechanism of registering and donating mouse strains easy to use and effective in collecting required curation information such as genetic, phenotypic and other characteristics of a strain?
• How adequate is the background information on the MMRRC consortium and links to other relevant public mouse strains databases?
• How adequate is the feature allowing an investigator to register interest in a strain that has been accepted, but not yet available for distribution?
• How appropriate are the plans for access to technical service and responding in a timely manner to requests?
• How appropriate are the procedures for strain orders and signing of the MTA and COU?
• Is the handling and review process of applications from donating investigators effective and allow for the quick acquisition of the strains and their integration into the MMRRC catalog?
• Are the organization and description of innovative and broad marketing programs presented and allow identification and recruitment into MMRRC newly-generated mutant mouse lines that are valuable to the scientific community?
• Will the Customer Service and Public Relation Section institute the mechanisms that solicit regular feedback and opinion from the user community?

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate merit descriptor (outstanding, acceptable, unacceptable). An application does not need to be strong in all categories to be judged likely to have major scientific impact.

• Are plans for maintaining regular updates of a secure, central database, which facilitates user access, tracking, and expression of interest on data and information on mutant mouse lines, adequate?
• Does information on accepted MMRRC strains contain sufficient information, including information on the mutated genes, the origin of the mouse strains, the genetic background, the genotypic and phenotypic information available on the strains, the list of publications on the particular strain, and the licensing, availability, and pricing as well as colony and husbandry management of the strain?
• Will the Informatics Section be able to track strains assigned to each MMRRC repository and the completion of each step of the acquisition process?
• Will the Informatics Section curate strain information for all of the accepted MMRRC strains in the repository?
• Will procedures and protocols provide appropriate security for each MMRRC to update information in the central database, and track who and when the update was made?
• Are there plans for regular generation and delivery of statistics and reports related to the overall MMRRC project to its stakeholders?
• Is the informatics support for the communication with other mouse repository portals sufficient and adequate?

The Applied Research Project will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects the following:

• Are the conceptual framework, design, methods and analyses adequately developed and integrated to generate new information services, activities, and data integration products which will improve the function of ICSC and the whole MMRRC consortium?
• Is there a synergism between the Applied Research Project and other sections of the ICSC?
• Is there evidence that input from the overall MMRRC consortium was solicited in deciding on the goals of the project?

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

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

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

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

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

The progress should be evaluated for accomplishment of objectives for the ICSC.

Was there a demonstrated need for the ICSC in the MMRRC consortium and in the research community? Did the ICSC support progress in the field? Did the ICSC serve the needs of investigators in a variety of research areas where work is sponsored by categorical NIH Institutes? Was the ICSC available to investigators on a local, regional, and national basis? Was a significant effort made by the ICSC for unique contributions to the mission of the whole consortium?

Have investigators clearly and concisely described the previous specific aims, and whether they were achieved? Are the proposed Aims of the renewal logical extensions of the Aims of the previous grant cycle? Were the informatics resources generated by this project made available rapidly and efficiently to the NIH-supported research community? 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 Overall and four other components proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable.

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

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

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

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

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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

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

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

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

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

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

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

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

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

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 awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 75, 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 awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

The Principal Investigators will have primary and lead responsibilities for the project as a whole, and agree to accept close assistance, advice, coordination, and to collaborate with the ORIP/DPCPSI Project Scientist and other MMRRC awardees. The responsibility for planning, direction, and execution of the proposed project will be solely that of the Principal Investigators. The PDs/PIs will be responsible for defining the details for acquiring, collection, archiving and dissemination of mutant mice, animal germplasm, and related biological materials.

Awardee will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The Project Scientist provides technical assistance, advice, and coordination; serves as a liaison between the awardee and EAB; coordinates the efforts of the awardee with other participants in the program and the larger biomedical research community; and assists awardees in the development, if needed, of policies for dealing with situations that require coordinated action. He/She participates in all meetings of the MMRRC consortium as a voting member of the MRC, attends major meetings of the subcommittees, and should be informed of all major interactions.

Additionally, a NIH ORIP/DPCPSI Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

The ORIP/DPCPSI Project Scientist and awardees 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 awardees. 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 awardee 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. 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 awardees 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. Awardee 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 award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. The three members will be comprised of: a designee of the Coordinating Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

The ORIP reserves the right to terminate or curtail the project (or an individual component of the award) in the event of inadequate progress, data reporting, or insufficient use of the resource.

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

A 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.

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

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

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

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Oleg Mirochnitchenko, Ph.D.
Office of Research Infrastructure Programs
Telephone: 301-435-0748
Email: oleg.mirochnitchenko@nih.gov

Mark Caprara, Ph.D
Center for Scientific Review
Telephone: 301-613-5228
Email: mark.caprara@nih.gov

Nicole Franklin
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-402-8682
Email: nicole.franklin@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 45 CFR Part 75.