and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
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) |
Activity Code |
U42 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological
Materials Resource Cooperative Agreements |
Announcement Type |
Reissue of RFA-RR-09-003 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-OD-14-003 |
Companion Funding Opportunity |
None |
Only one application per institution is allowed. See Section III. 3. Additional Information on Eligibility. |
|
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 (former Mutant Mouse Regional Resource Center program). 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 serves the needs of the biomedical research community for transgenic, knockout and other genetically-engineered mutant mice and related biomaterials. The MMRRC consortium uses mutually agreed upon, defined standard operating procedures. Each MMRRC is responsible for importing mice from assigned donating investigators, and establishing banks of cryopreserved sperm, embryos, and related materials for distribution to research investigators. Each center also provides services on a fee-for-service basis which include such specialties as cryopreservation of mouse embryos and gametes, rederivation of living mice from cryopreserved embryos and sperm, quality control testing for mouse pathogens, mutagenesis and embryonic stem cell isolation and cloning, phenotyping and genotyping services. The Program Director/Principal Investigator (PD/PI) of each MMRRC is required to develop a high risk, high return, research pilot that complements the goals and needs of the MMRRC consortium. Examples of projects include, but are not limited to: improvement of methods for mouse cloning, preserving germplasm, health monitoring, testing for mouse pathogens, assisted reproductive technologies, phenotyping, developing new mouse models of human disease, genotyping services, or deriving ES cell lines. |
Posted Date |
January 24, 2014 |
Open Date (Earliest Submission Date) |
April 1, 2014 |
Letter of Intent Due Date(s) |
Not Applicable |
Application Due Date(s) |
May 1, 2014, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date. |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
July 2014 |
Advisory Council Review |
October 2014 |
Earliest Start Date |
January 2015 |
Expiration Date |
May 2, 2014 |
Due Dates for E.O. 12372 |
Not Applicable |
NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
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 resources described by this FOA focus on providing research resources for biomedical research. The MMRRC repositories are currently funded as cooperative agreements (U42 grant mechanism), to acquire and provide mutant mice, sperm, embryos, and embryonic stem cells lines (ES cells 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 research distribution centers. Each MMRRC also provides services on a fee-for-service basis which include such specialties as cryopreservation of mouse embryos and gametes, rederivation of living mice from cryopreserved embryos and sperm, quality control testing for mouse pathogens, mutagenesis and embryonic stem cell isolation and cloning, phenotyping and genotyping services. The PD/PI of each MMRRC Center is also required to develop a high risk, high return, research pilot that complements the goals and needs of the MMRRC consortium. Examples of projects include, but are not limited to: improvement of methods for cloning mice, preserving germplasm, health monitoring, testing for mouse pathogens, assisted reproductive technologies, phenotyping, developing new mouse models of human disease, genotyping services, or deriving ES cell lines. The applied research component may comprise no more than 10 percent of the direct costs associated with the U42 grant.
Additional Information
The U42 application 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 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 Project - Applied Research Section. The Applied Research Section is typically conducted at the Resource's location and not subcontracted. It is expected that MMRRC grants will generate Program Income and will recover a certain percentage of operating cost. 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 Resource Centers should result from Program Income. Note that the Center s use of Program Income is governed by the NIH Grants Policy Statement.
MMRRCs must have an External Advisory Board of experts and users who advise the Center and the NIH on the MMRRC’s long-term sustainability and relevance to biomedical research. The External Advisory Board should provide advice on how to enhance the capacity of the Center, should evaluate the processes by which the MMRRC engages biomedical researchers and encourages submission of new mouse strains and related materials and should recommend which potential new materials will be accepted for archiving and future distribution. The External Advisory Board must be comprised of a minimum of 4 members, and must meet a minimum of once per year. Tele- or videoconferencing is encouraged to decrease costs, unless the budgeted expense of face-to-face meetings is justified in the application. MMRRC Centers also may have Internal Advisory Boards, consisting of the members of their own institutions.
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. |
Application Types Allowed |
Renewal The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
ORIP intends to commit $5.6 M in FY 2015 to fund 4 awards. |
Award Budget |
The Direct Costs requested cannot exceed a 5% increase over the last year of the funded grant period. Requested Direct Costs must reflect the actual needs of the project. |
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 in response to this FOA.
Only grantees funded under the Mutant Mouse Resource and Research Centers are eligible to apply.
Higher Education Institutions
Nonprofits Other Than Institutions of Higher Education
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.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.
Only one application per institution (normally defined by having a unique DUNS number or NIH IPF number) is allowed.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Component Types Available in ASSIST |
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.
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:
When preparing your application in ASSIST, use Component Type Overall .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Overall)
Complete entire form.
PHS 398 Cover Page Supplement (Overall)
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Research & Related Other Project Information (Overall)
Follow standard instructions.
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 should 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. PD/PI(s), Core Head(s) and Project Lead(s) under this FOA should 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)
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 plans for 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:
i. Innovative features in the planned Center's interactions with users of the resource, and within the internal and external decision making processes.
ii. Enhancing the capacity to utilize innovative technologies and 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.
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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:
Technology Transfer
The MMRRC has worked with the community to develop Conditions of Use (COU) and 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 http:// http://www.mmrrc.org/submission/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"
(a) 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.
(b) 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.
(c) 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.
(d) 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Surveys may be submitted in the Appendix as necessary. 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 ICOs of NIH as well as non-NIH sources.
When preparing your application in ASSIST, use Component Type Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Resource Section)
Complete only the following fields:
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.
Research & Related Senior/Key Person Profile (Resource Section)
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)
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 ability of biomedical researches 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, and must describe the living and cryopreserved mutant mouse strains, cryopreserved sperm, embryos and stem cells, and services offered by the Center. 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 be described.
A. Proposed Plan:
The applicant must propose detailed plans describing the design and development of the MMRRC, to include 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 of 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 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 functioning (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 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 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 a 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: Resource Sharing Plans should be consolidated in the Overall Component.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Resource Section)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Resource Section)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Project.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Applied Research Section)
Complete only the following fields:
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.
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.
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 Revision applications, an Introduction to Application is allowed for each 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 methods for mouse cloning, preserving germplasm, health monitoring, testing for mouse pathogens, assisted reproductive technologies, phenotyping, developing new mouse models of human disease, genotyping services, or deriving ES cell lines. Describe how a 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 Letter of Support from collaborators which will participate in a research activities improve the function of the Resource. All letters of the support for the Applied Research Section should be uploaded as a single attachment to the Research Plan.
Resource Sharing Plan: Resource Sharing Plans should be consolidated in the Overall Component.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Applied Research Section)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Applied Research Section)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD(s)/PI(s) and component Project Leads must include their
eRA Commons ID in the Credential field of the Senior/Key Person Profile
Component of the SF424(R&R) Application Package. Failure to register
in the Commons and to include a valid PD/PI Commons ID in the credential field
will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
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 s Review Criteria appear in the standard order used in FOAs.
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 described below. The Center's Overall Impact, Significance, Investigators, Innovation, Approach and Environment scores should emphasize the Resource Component and the resource aspect of the Center. (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a 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? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
In addition to the standardized criteria above, the following will be evaluated as part of the Significance score for the Overall Component. 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), Core Head(s), Project Lead(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; 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 at least 1.2 Person Months to the entire 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? Are potential problems, alternative strategies, and benchmarks for
success presented? If the project is in the early stages of development, will
the strategy establish feasibility and will particularly risky aspects be
managed?
If the 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 children,
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 MMRRC functioning (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 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?
Scored Review Criteria for the Resource Section
The Resource Section will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects the following:
Scored Review Criteria for the Applied Research Section
The Applied Research Section will receive a merit descriptor (outstanding, acceptable, unacceptable) that reflects the following:
As applicable for the Overall Center and two other components being proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed Overall Center and two other components involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Resubmissions are not allowed.
Renewals
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 MMRRC.
Was there a demonstrated need for the MMRRC in the research community? Could the need have been easily satisfied in other ways? Did the MMRRC support progress in the field? Did the MMRRC serve the needs of investigators in a variety of research areas where work is sponsored by categorical NIH ICOs? Was the MMRRC available to investigators on a local, regional, and national basis? Was a significant effort made by the MMRRC 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 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 for resources, and for the adequate distribution of the resources? Was there progress toward financial self-sufficiency via Program Income in the last grant cycle?
Revisions
Revisions are not allowed.
As applicable for the Overall Center and two 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.
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) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by 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:
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. 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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), 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, 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 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, serve as a liaison between the awardee and External Advisory Board, coordinate the efforts of the awardee with other participants in the program and the larger biological research community, assist 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 on all major interactions.
Additionally, a NIH ORIP/DPCPSI Program Official 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 the RFA. The MRC is also responsible for selecting members of the
External Steering Committee (SC) 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. Depending on availability of appropriate expertise, the Steering Committee could be constituted as a sub-committee of the MRC.
The MRC will meet at least three times in the first year to plan strategies, develop and approve operating procedures, and to 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, reviewing established and new policies and priorities. The ORIP/DPCPSI Program Officer will participate in discussions at these meetings.
The ORIP/DPCPSI Program Official 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 mouse 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.
It will have three members: a designee of the Steering Committee chosen without
NIH staff voting, one NIH designee, and a third designee with expertise in the
relevant area who is chosen by the other two; in the case of individual
disagreement, the first member may be chosen by the individual awardee. This
special 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.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]
Grants.gov Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]
Oleg Mirochnitchenko, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0749
Email: [email protected]
Christine L. Melchior, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1713
Email: [email protected]
Leslie Le
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0856
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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