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

Limited Competition: 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 Agreement

Announcement Type

Reissue of RFA-OD-14-003

Related Notices
  • August 23, 2019 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137.
  • July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128.
Funding Opportunity Announcement (FOA) Number

PAR-19-175

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.351

Funding Opportunity Purpose

 This Funding Opportunity Announcement (FOA) invites applications for the continued support and advancement of the Mutant Mouse Resource and Research Centers (MMRRC). The MMRRC consortium is expected to facilitate research by identifying, acquiring, evaluating, characterizing, cryopreserving, and distributing mutant mouse strains to qualified biomedical investigators. A regional network of four MMRRCs and an Informatics, Coordination and Service Center (ICSC) collectively serve the needs of the biomedical research community for transgenic, knockout and other genetically-engineered mutant mice and related biomaterials. MMRRC strains are held to the highest standards to optimize reproducibility of studies and assure scientific rigor and transparency; all submitted strains are thoroughly reviewed and documented and include additional quality control measures. The Program Director/Principal Investigator (PD/PI) of each MMRRC in addition to the major resource activities is required to develop a small high risk, high return, research pilot project that complements the goals and needs of the MMRRC consortium.  

Key Dates

 

Posted Date

January 30, 2019

Open Date (Earliest Submission Date)

April 1, 2019

Letter of Intent Due Date(s)

Not applicable

Application Due Date(s)

May 1, 2019, September 1,2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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.

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

July 2019, November 2019

Advisory Council Review

October 2019, January 2020

Earliest Start Date

January 2020, April 2020

Expiration Date

September 2, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Table of Contents

    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


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

     This Funding Opportunity Announcement (FOA) announces a limited competition to support the continued availability of mutant mice and related biomaterials to biomedical researchers in the United States and worldwide. The overarching purpose of the research funded by the ORIP is to reduce the societal burden of morbidity and mortality from diverse conditions and diseases, and to better understand normal and abnormal physiology. The projects described by this FOA focus on providing research resources, which are helping to optimize and enhance scientific rigor, transparency and experimental reproducibility of biomedical research. The MMRRC repositories are currently funded as cooperative agreements (U42 mechanism) to acquire and provide mutant mice, sperm, embryos, and embryonic stem cell lines (ES cell lines) to qualified biomedical researchers at research centers, academic institutions, for-profit organizations, the NIH, and other federal agencies. Currently the MMRRC consortium is comprised of four regional distribution Centers (termed the MMRRCs) and an Informatics, Coordination and Service Center (ICSC). This FOA is intended to provide support only to the four regional distribution centers. Each MMRRC also provides services on a fee-for-service basis which include such specialties as colony management and breeding services, assisted reproduction services, embryonic stem cell and microinjection services, genetic analysis, phenotyping, pathology and diagnostics. The Program Director/Principal Investigator (PD/PI) of each MMRRC is required to develop a high risk, high return, research pilot project that complements the goals and needs of the MMRRC consortium. Examples of projects include but are not limited to: improvement of mouse gene editing and cloning technologies; preserving germplasm; health monitoring; characterization of the mouse colonies microbiome and its management and influence on mouse phenotypes; and effect of environmental factors on germ cell epigenetics, embryo development, fertility and mouse phenotypes. The applied research component may comprise no more than 10 percent of the direct costs of the proposal.

    Additional Information

    The U42 is a complex application, with an Overall Component that is the aggregate of the major "Resource Section" Component and the minor "Applied Research Section" 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 the Core Head of the Resource Section and can serve as the Project Lead of the Applied Research Section.  The Applied Research Section is typically conducted at the Resource's location and not subcontracted. It is expected that MMRRC cooperative agreements will generate Program Income and will recover a certain percentage of their operating cost. In general, Renewal (a.k.a. Type 2) applications should recover in the initial year of the proposed grant cycle a greater percentage of operating costs from Program Income than for the last year of the previous grant cycle.  In addition, each of the up to 4 following years in the proposed grant cycle should reasonably expect to recover a greater percentage of operating costs from Program Income than the previous year. Costs specifically associated with the establishment, improvement, or expansion of animal or material distributions and long-term resource maintenance should be recovered from users through a charge schedule acceptable to the NIH. Significant growth of Animal and Biological Material Resource Centers should result from Program Income and not from an ever-increasing U42 award. Note that the Center’s use of Program Income is governed by the NIH Grants Uniform Guidance.

    The MMRRC consortium must have an External Advisory Committee (EAC) of experts and users who advise the Centers and the NIH on the MMRRC’s long-term sustainability and relevance to biomedical research. The EAC must provide advice on how to enhance the capacity of the Centers, must evaluate the processes by which the MMRRCs engage biomedical researchers and encourage submission of new mouse strains and related materials and should recommend which potential new materials will be accepted for archiving and future distribution. The EAC must be comprised of a minimum of 5 members and must meet a minimum of once per year. Tele- or videoconferencing is encouraged to decrease costs. MMRRCs also may have Internal Advisory Boards, consisting of the members of their own institutions.

    The MMRRCs will have an annual meeting to present center updates and research progress, to articulate new opportunities for collaboration, to evolve long-term program goals/strategies, plan and strategize responses to the MMRRC EAC 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. The MMRRCs must include a budget for attendance to each of the annual meetings for their PD/PIs and key personnel. The MMRRCs will have an annual meeting to present center updates and research progress, to articulate new opportunities for collaboration, to evolve long-term program goals/strategies, plan and strategize responses to the MMRRC EAC 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.

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

    Section II. Award Information

     

    Funding Instrument

    Cooperative Agreement: A support 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 FOA.  

    Application Types Allowed

     
    Renewal
    Resubmission

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Not Applicable

    Funds Available and Anticipated Number of Awards

    ORIP intends to fund four awards

    Award Budget

    Requested Direct Costs must reflect actual needs of the project.

    For Renewal (a.k.a. Type 2) applications, no more than a 5 percent (direct cost) increase from the last non-competing year will be accepted.

    Award Project Period

    The total project period may not exceed five years.    

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Only grantees previously funded under the auspices of RFA-OD-14-003 are eligible to apply.

    Foreign Institutions

    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.

    Required Registrations

    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.
    • 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.

    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. 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.

    2. Cost Sharing

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

    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.  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).
    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 FOA. See your administrative office for instructions if you plan 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 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.

     
    Page Limitations

    Available Component Types

    Research Strategy/Program Plan Page Limits

    Overall

    6

    Core (use for Resource Section)

    12

    Project (use for Applied Research Section)

    6

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

    Instructions for the Submission of Multi-Component Applications

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

    Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

    The application should consist of the following components:

    • Overall: required (one maximum)
    • Resource Section: required (one maximum)
    • Applied Research Section: required (one minimum, 4 maximum)
    Overall Component

    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.

    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 Location(s) (Overall)

    Enter primary site only.

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

    Research & Related Senior/Key Person Profile (Overall)

    Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application. The effective management of a MMRRC requires a significant commitment by the PD/PI. The applicant is expected to have direct experience, knowledge, and hands-on involvement in daily operations.  It is expected that this individual will be an established scientist with a fitting level of seniority within the applicant organization, and with appropriate authority to manage the MMRRC effectively. Each PD/PI(s), Core Head(s) and Project Lead(s) under this FOA must devote at least 1.2 Person Months effort to the entire project.

    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, an Introduction to Application is required in the Overall component.

    Specific Aims:   State concisely the goals of the proposed resource and summarize the expected outcome(s), including the impact that the results of the proposed resource will exert on the research field(s) that it supports.          

    Research Strategy:  Briefly describe the purpose and history of the overall MMRRC Program, the role this MMRRC has played, and the research communities that it serves. Describe the overall design, development and advancement of the MMRRC. Describe how the Center and the whole 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 Center will be made available to investigators on a local, regional, and national basis.

    Regarding the operation and maintenance of the Overall Center, provide an 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:

    • Increasing the contribution of MMRRC for maintaining scientific rigor, transparency and experimental reproducibility of the biomedical research.
    • Innovative approaches that the Center will apply to interact with users of the resource, and within the internal and external decision-making processes.
    • Enhancing utilization of innovative technologies to improve the quality of the resource’s capacity for acquisition, evaluation, characterization, cryopreservation, storage, and distribution of mutant mouse strains, sperm, embryos and stem cells.
    • Outline the Center’s disaster plan to minimize total loss of resources in the event of a catastrophic disaster, such as loss of power, fire, flooding, or data breach.

    Letters of Support: Include a Letter of Support from any institution providing space or 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, must address a Data Sharing Plan as a part of 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.

    Technology Transfer

    The MMRRCs have worked with the community to develop Conditions of Use (COU) and Donor Material Transfer Agreement (MTA) forms that are used for transferring mouse stocks in and out of the MMRRC repository. These documents can be found on the following web link https://www.mmrrc.org/catalog/mtaInstructions.php. These MMRRC documents have been developed with MMRRC institutional officials as well as with the NIH technology transfer community. The COU and Donor MTA are designed to be time-efficient and eco-friendly paperless forms. While the COU is completely paperless, the Donor MTA can be printed if electronic signatures are not acceptable to a donating institution. All documents must be signed by an authorized Technology Transfer representative from the requesting or donating institution. Where applicable, the documents will be counter-signed by a designated representative from the MMRRC and the submission or request will be processed. Each MMRRC institution is strongly encouraged to consult with their respective technology transfer office or appropriate office for their institution to determine what intellectual property licenses may be necessary to carry out the goals of the MMRRC.

    “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.  U42 applicants can provide a Table that summarizes the survey of potential users (and actual users for renewal applications) of the Center, and the user's source of support from the various Institutes, Centers and Offices of NIH as well as non-NIH sources.    

    PHS Human Subjects and Clinical Trials Information (Overall)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

    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

    PHS Assignment Request Form (Overall)

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

    Resource 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 (Resource 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 (Resource Section)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Resource 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.

    Project /Performance Site Location(s) (Resource 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 (Resource Section)
    • ·    In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Head’ 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 (Resource 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 (Resource Section)

    Introduction to Application: For Resubmission, an Introduction to Application is allowed for each component.

    Specific Aims:  State concisely the goals of the proposed Resource Section and summarize the expected outcome(s), including the impact that the results of the proposed Resource Section will exert on the ability of biomedical researchers at research centers, academic institutions, the NIH and other federal agencies to advance scientific knowledge in broad areas.      

    Research Strategy:   A detailed progress report summarizing the previous 5-year funding cycle must be included in this section as background to document the development and progress of the resource. The application must also discuss how the overall goals of the program are advanced by the structure of the MMRRC, describe the living and cryopreserved mutant mouse strains, cryopreserved sperm, embryos and stem cells, and services offered by the Center. The efforts of the MMRRC to obtain approved vendor status at different institutions so that mouse models can be distributed most efficiently and in the shortest period of time should also be described.

    A. Proposed Plan:

    The applicant must propose detailed plans describing the design and development of the MMRRC, including current and future capacities of the research resource, procedures for acquisition, evaluation, characterization, cryopreservation, and distribution of mutant mice, sperm, embryos, stem cells and pathogen screening. The applicant must describe the design of quality control procedures, data collection, analysis, and verification tests. The design and development of the database and free public homepage should be such that they provide a user-friendly accounting of the resource’s holdings. Efforts aimed at enhancing the capacity and evaluating the process of the MMRRC to engage biomedical researchers and encourage requests for living and cryopreserved mouse strains and related biomaterials should be presented.

    B. Administrative Structure:

    This section should describe the proposed administrative structure of the project, e.g., PD(s)/PI(s), collaborators, interaction with committees or special interest groups, other collaborating research support resources, and how these units/components function to support and maintain the research plan of the MMRRC.  The application should describe plans to maintain communication with other mouse research projects and the biomedical research community. Provide the names of key personnel and their functional title. Identify who will be responsible for overseeing the acquisition, evaluation, characterization, cryopreservation, storage, and distribution of mutant mice and cryopreserved germplasm, (i.e., sperm and embryos) as well as stem cells. Methods used for quality control of specimens should be described. MMRRC operating protocols should be described.

    C. Customer Service:

    The applicant must describe the current status and future plans for customer service and public relations. The applicant must describe the two current customer service interfaces of the MMRRC project: the first one located at each MMRRC, and the second one, at the ICSC. The plan needs to provide access for biomedical researchers who have technical questions regarding the search for or specification of mutant mouse strains, or who need assistance with decisions on ordering living mice, or cryopreserved sperm and embryos, or who are looking for a specific fee-for-service.  Moreover, the applicant must outline current status and plans for communication and enhancement of public relations of the MMRRC with government, public and private research facilities.

    D. Management of Integration Plans:

    The applicant must describe the management plan for the proposed project, and how it will support achievement of the proposed goals and milestones.  The application should describe the organization of the proposed MMRRC effort, and its management structure, including the integration of the separate components to form an efficient pipeline from a request from a donating investigator to submit a mutant mouse strain to the MMRRC consortium, through the processes of acquiring, evaluating, characterizing, cryopreserving, and distributing high-quality mutant mice to a requesting investigator. The plan should include reporting relationships of the key personnel. The plan should also describe how the various components of the proposed research resource effort will be integrated, and how collaborations or subcontracts, if proposed, will be managed.  Coordination of the awardee’s activities with those of the other MMRRCs, the ICSC, other national and international programs aimed at providing mutant mouse strains such as the Knockout Mouse Project (KOMP), must be described. The recruitment and training of personnel should be discussed.

    E. The applicant must also discuss the following key areas:

    i. Evaluating and continually maintaining safety regarding biohazards

    ii. Evaluating and maintaining adherence to Health and Human Services and NIH guidelines and regulations.

    iii. Procedures should be described for the evaluation of MMRRC operations (e.g., by the External Advisory Board and internal advisory boards, if applicable) and for implementing recommendations resulting from such evaluations. The evaluation should include: 1. The ability of the MMRRC to promote its products, to meet product demand by the biomedical research community, and to work toward self-sufficiency in the long-term; 2. The efficacy of product, service and information delivery both within and outside the MMRRC; of communication both within and outside the MMRRC; and the ability to provide information about research advances and updates to the biomedical research community; and 3. The capacity to institute and implement new technologies, services and products to improve the quality of the MMRRC's acquisition, evaluation, characterization, cryopreservation, storage and distribution of mutant mice, germplasm, stem cell lines and related biologics. The applicant must describe and propose external evaluation review procedures by external advisors, and internal evaluation review procedures by internal evaluators, and the strategies and processes of implementing action plans

     upon mutual agreement. An important part of the evaluation should be feedback from MMRRC users on catalog offerings, the ordering process and services. Mechanisms for regular solicitation of such feedback should be proposed.

    Letters of Support:

    Include Letters of Support from the past and potential future users of the resources and services. All letters of the support for the Resource Section 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 (Resource Section )

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

    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 Section

    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 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 (Applied Research Section)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Applied Research 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.

    Project /Performance Site Location(s) (Applied Research 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 (Applied Research Section)

    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 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 (Applied Research Section)

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

    Specific Aims:  State concisely the goals of the proposed Applied Research Section and summarize the expected outcome(s), including the impact that the results of the proposed Applied Research Section will exert on the function of the Resource Section.

    Research Strategy: Describe how the Applied Research Section will generate new information, services, products, or models that will improve the Resource. Describe the framework, design, methods and analyses, which should be adequately developed, well integrated, well-reasoned and appropriate to the aim of the Applied Research Section. Examples of projects include but are not limited to: improvement of mouse gene editing and cloning technologies; preserving germplasm; health monitoring; characterization of the mouse colonies microbiome and its management and influence on mouse phenotypes; effect of environmental factors on germ cell epigenetics, embryo development, fertility and mouse phenotypes. Describe how refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions will be achieved. Describe how the scientific rationale for the Applied Research Section will develop or apply new methodologies to the functions of the Resource Section. Describe how the Resource and Applied Research Sections synergize beyond what could be achieved through a traditional research project. The application should demonstrate that overall consortium input was solicited in deciding on the exact nature of each project in order to improve the function of the entire MMRRC consortium. 

    Letters of Support: Include a Letters of Support from collaborators which will participate in a research activity that will improve the function of the Resource. All letters of the support for the Resource Section 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:  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 Section)

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

     
    3. Unique Entity Identifier and System for Award Management (SAM)

    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.

    4. Submission Dates and Times

    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.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    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.

    7. Other Submission Requirements and Information

    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. Applications that are incomplete and/or non-compliant will not be reviewed.

    Requests of $500,000 or more for direct costs in any year

    Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

     
    Post Submission Materials

    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.

    Section V. Application Review Information
    1. Criteria

    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 multi-Component application, with an "Overall" Component that is the aggregate of the major Resource Section and the minor Applied Research Section.  During the review process, "Merit Descriptors" will first be provided in individual Reviewer’s critiques for the Resource and Applied Research Sections. The three potential Merit Descriptors are outstanding, acceptable, or unacceptable.  Then, numerical scoring of the application will be assigned for the Overall application.  In the detailed sections below, each of the three Components' Review Criteria appear in the standard order used in FOAs.

    Overall Impact - Overall

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

    Scored Review Criteria - Overall

    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.

    Significance

    Does the Overall MMRRC 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 Center 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?

    In addition to the standardized criteria above, the following will be evaluated as part of the Significance score for the Overall Component. How will the Center activities contribute to maintaining scientific rigor, transparency and experimental reproducibility of the biomedical research? Does the Center serve the needs of investigators in a variety of research areas rather than in a single or few areas? Will the Center be available to investigators on a local, regional, and national basis?   

    Investigator(s)

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

    In addition to the standardized criteria above, the following will be evaluated as part of the Investigator(s) score for the Overall Component.  Are the PD(s)/PI(s), Core Head(s), and Project Lead(s) appropriately trained and well suited to manage a national resource Center? Do the PD/PI(s), Core Head(s) and Project Lead(s) devote sufficient time to the project?   

    Innovation

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

    In addition to the standardized criteria above, the following will be evaluated as part of the Innovation score for Overall Component. Are the design of the MMRRC and the methods of providing information, services, products and models innovative?  Are there innovative features in the planned MMRRC's interactions with users of the resource, 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 Resource’s acquisition, evaluation, characterization, cryopreservation, storage, and distribution of mutant mouse strains, sperm, embryos and stem cells?     

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Overall Center? 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 Center 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?   

    In addition to the standardized criteria above, the following will be evaluated as part of the Approach score for the Overall Component. Are the plans for the operation and maintenance of the Overall Center adequately developed and described? Will the resources and services generated by this project be made available rapidly and efficiently to the NIH-supported research community? 

     Are the procedures and components for the evaluation of the MMRRC functions (e.g., by external and internal advisory boards) and for implementing recommendations resulting from such evaluations appropriate? Are the MMRRC’s 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? 

    Environment

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

     In addition to the standardized criteria above, the following will be evaluated as part of the Environment score for the Overall Component. Is there appropriate Institutional Support for the Overall Center, and are plans for continuity appropriate for the multiple 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 Center activity with other MMRRC consortium centers and the ICSC as well as other mouse programs such as KOMP?

    Additional Review Criteria - Overall, Resource and Applied Research Sections

    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.

    The Resource Section will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects the following:

    • ·    Is there evidence of the ability to acquire, evaluate, characterize, cryopreserve, store, and distribute mutant mice?
    • ·    Are there efforts by the MMRRC to obtain approved vendor status at different institutions?
    • ·    Is the proposed plan for the design and development of the MMRRC adequate to accomplish the work set out in a five-year time frame?
    • ·    Are procedures for quality control, data collection, analysis, and diagnostic verification sufficient to maintain high quality standards of animal strains, related biomaterials and services provided to the biomedical research community?
    • ·    Are there mechanisms for regular communication with biomedical researchers to encourage requests for living and cryopreserved mouse strains and related biomaterials as well as for associated services?
    • ·    Is there evidence of appropriate administrative structure to support and maintain the research resource plan of the MMRRC, and to maintain communication with other mouse research projects?
    • ·    Are key personnel appropriately trained and assigned with clear responsibilities in regard to the acquisition and production pipelines?
    • ·    Are the plans for disseminating protocols/methods to the biomedical research community adequate?
    • ·    Are plans for handling requests for resources adequate?  Are there plans for periodic assessments of performance, including timelines and milestones?
    • ·    Are there adequate current and future plans for customer service and public relations with government, public and private research facilities?
    • ·    Are there mechanisms for regular communication with biomedical investigators requiring assistance with technical questions and decisions on choosing the animal strains, biomaterials or other MMRRC services appropriate for the purposes of their research?
    • ·    Does the PD/PI of the MMRRC have direct experience, knowledge, and hands-on involvement in daily operations of the repository? Does he/she have the required level of seniority and authority within the applicant organization?
    • ·    Are there mechanisms for regular communication and coordination with the PDs/PIs at other MMRRCs as well as the ICSC PD/PI?
    • ·    Are plans for the following adequate:  Coordinating Center functions in regard to the overall mission of the MMRRC consortium; monitoring timelines for achieving milestones;  coordinating and integrating separate components of the MMRRC to form an efficient production pipeline; implementing a plan for regular evaluation of production and scientific progress; working with the applicant Institution to enhance the visibility and effectiveness of the MMRRC; ensuring appropriate prioritization of activities, including course corrections, when needed, and identifying and resolving problems; encouraging and providing required training for MMRRC personnel.

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

    • ·    Are the conceptual framework, design, methods and analyses adequately developed, well integrated, well-reasoned and appropriate to the aims of the Research Section?
    • ·    Will the Applied Research Section generate new information, services, products or models that will improve the function of the MMRRC? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
    • ·    How sound is the scientific rationale for the Applied Research Section for developing or applying new methodologies to the functions of the Resource Section? Will the Resource and Applied Research Sections synergize appropriately?
    • ·    Was input from the entire MMRRC consortium solicited when deciding which Applied Research Section to pursue?  Will the entire MMRRC consortium and the biomedical community benefit from the proposed research?
    Protections for Human Subjects

    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.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan  

    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.

    Vertebrate Animals

    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.

    Biohazards

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

    Resubmissions

    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.

    Renewals

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

    Revisions

    Not Applicable

    Additional Review Considerations - Overall, Resource and Applied Research Section

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

    Applications from Foreign Organizations

    Not applicable

    Select Agent Research

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

    Resource Sharing Plans

    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 .


    Authentication of Key Biological and/or Chemical Resources

    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.

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center of 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:

    • Will be discussed and assigned an overall impact score.
    • Will receive a written critique.

    Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NIH 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.  
    3. Anticipated Announcement and Award Dates

    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.

    Section VI. Award Administration Information
    1. Award Notices

    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.

     
    2. Administrative and National Policy Requirements

    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 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, primary responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and primary 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 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.

    Awardees 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, coordination; serves as a liaison between the awardee and External Advisory Board; coordinates the efforts of the awardee with other participants in the program and the larger biological 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 research consortium (MRC) 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 MRC, which serves as the governing board for the group of awards, as defined below. The MRC members are responsible for reviewing the plans for development and operation of the MMRRCs as proposed in the individual applications of awardees. The MRC 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 MRC will also review and approve the operating procedures proposed by individual awardee organizations, to ensure they are compatible with the overall goals of this PAR. The MRC is also responsible for selecting members of the External Advisory Board to the MMRRC (see below).

    The MRC voting members will consist of the PD/PI of each MMRRC, and the ORIP/DPCPSI Project Scientist. Additional members can be added by consensus of the MRC. The structure of the MRC should be established at the first meeting as noted below. The Chair of the MRC will be responsible for coordinating MRC activities. The ORIP/DPCPSI Project Scientist will be responsible for approving the agenda and minutes.  Subcommittees will be established by the MRC, as it deems appropriate. The ORIP/DPCPSI Project Scientist will serve on subcommittees as he/she deems appropriate. 

    At its initial meeting, the MRC will elect a chairperson, who must not be the ORIP/DPCPSI Program Official or ORIP/DPCPSI Project Scientist. The MRC will determine whether additional MRC representation is required, or if standing or temporary committees are needed.

    The MRC 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 MRC.

    Steering 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 MRC and ORIP/DPCPSI Program Official. Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering 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 Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special 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.

    3. Reporting

    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.

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Oleg Mirochnitchenko, Ph.D.
    Office of Research Infrastructure Programs (ORIP)
    Telephone: 301-435-0749
    Email:oleg.mirochnitchenko@mail.nih.gov

    Peer Review Contact(s)

    Eugene Carstea, Ph.D.
    Center for Scientific Review (CSR)
    Telephone: 301-408-9756
    Email:carsteae@csr.nih.gov

    Financial/Grants Management Contact(s)

    Gavin Wilkom, M.I.M.
    Office of Research Infrastructure Programs (ORIP)
    Telephone: 301-435-0964
    Email:wilkomg@mail.nih.gov

    Section VIII. Other Information

    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.

    Authority and Regulations

    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.    

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