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

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

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

Purpose

The NIAMS requests applications for the NIAMS Resource-based Centers Program (P30) to provide critical research infrastructure, shared facilities, services, and resources to groups of investigators conducting research on bone, muscle and orthopaedic biology and diseases, with the broad overall goal of accelerating, enriching, and enhancing the effectiveness of ongoing basic, translational, and clinical research and promoting new research on bone, muscle and orthopaedics within the NIAMS mission. The Centers could potentially facilitate projects in many areas of bone, muscle, orthopaedics, including musculoskeletal tissue engineering and regenerative medicine research on muscles, skeleton, cartilage, and other connective tissues such as tendon and ligament. Key public health problems addressed by this research include, but are not limited to, osteoporosis, osteoarthritis, orthopaedic disorders, and muscle diseases including muscular dystrophies.

Background

The NIAMS uses a number of centers grant mechanisms to support research that require synergistic, integrated groups of investigators, significant infrastructure, and/or technological innovations. NIAMS convened a Centers Evaluation Working Group (CEWG) to advise the Institute as to how the Centers programs could be more responsive and supportive to current research needs and opportunities. The CEWG concluded that NIAMS should allow flexibility and dynamism in the design, structure, and conduct of its Centers, to accommodate the variable needs of NIAMS research areas that differ with respect to investigator community, resource availability, and knowledge depth and breadth (see NIAMS Centers Evaluation Working Group Report; https://www.niams.nih.gov/niams-centers-evaluation-working-group-report). The CEWG recommended that the "NIAMS Centers should prioritize improving access to resources, using as review criteria i) the importance of the resource and ii) the potential impact of providing access to that resource".

NIAMS expects that the Resource-based Center Program will:

• Efficiently provide critical research infrastructure to advance fields within the NIAMS mission
• Include Cores that offer resources and services in addition to equipment and other infrastructure
• Contribute and/or facilitate significant innovations in research and technology
• Facilitate expansion of research fields within the NIAMS mission
• Foster innovative exploratory projects and junior investigators
• Have flexibility to adopt and adapt to emerging needs and opportunities

NIAMS Resource-based Center Program Description

The emphasis of the NIAMS Resource-based Center Program is to improve access to critical research infrastructure, shared facilities, services, and resources.  Each Center will contain one or more Resource Core(s) that serve a strong research community. For the purposes of this particular announcement, the research community is defined as those investigators (and their funded projects) who will use Center resources for research within the focus of the Center which should be within the NIAMS mission. Successful Resource-based Centers are expected to expand the chosen field(s), provide new research opportunities, and increase the efficiency and impact of research due to resource access.

The focus of the Center is determined by the Program Director/Principal Investigator (PD/PI) and may encompass basic, translational, and/or clinical research. For this particular announcement, the Center focus is restricted to bone, muscle, and orthopaedic research areas within the NIAMS mission. Applications that are not within the NIAMS mission or not focused on bone, muscle and orthopaedic research will be deemed not responsive to this FOA and will not be reviewed. The focus may be very broad, e.g., bone, muscle, and orthopaedic research in general, and serve a diverse group of investigators that share the need for critical shared core services. Alternatively, a Center may have a narrow disease or biology focus or theme. In some cases, the relevant research community may share a highly specialized resource such as a well-defined patient cohort with associated patient data and biospecimens and/or may share a need for highly specialized technologies and services (e.g., advanced imaging, single cell analysis, or computational biology and machine learning). However, in all cases the focus of the Center must be within the NIAMS mission. Applications solely focused on clinical methodology core(s) supporting outcomes, epidemiology, clinical trials, and/or health services research exclusively are not responsive to this FOA and will not be reviewed. Potential PDs/PIs are strongly encouraged to contact the Scientific/Research Contact listed in Section VII. Agency Contacts early in the application planning process to discuss the NIAMS mission relevance and FOA responsiveness.

It has become increasingly common and practical for investigators at different institutions to collaborate to achieve common goals. Therefore, to facilitate collaborative and interdisciplinary research, resources and investigators may be distributed at different institutions and different geographic regions, particularly for resources that do not need to be duplicated at every research site. Similarly, the research community may be defined at the national, regional, or local institutional level, and may include foreign collaborators.

The NIAMS Resource-based Centers will provide support for:

• One or more Resource Cores
• An Administrative Core, that includes a Center Enrichment Program

Resource Cores

Each Center must include one or more Resource Core(s). A Resource Core is a facility and/or resource shared by or providing services to multiple research community investigators, enabling them to conduct their independently-funded individual and/or collaborative research projects more efficiently and/or more effectively. The selection of Resource Cores is left up to the PD/PI, but should be justified by the needs of the research community and should be appropriate for the focus of the Center which should be within the NIAMS mission. Resource Cores may be located at multiple institutions separated geographically as long as the PI can justify the feasibility.

For the purpose of this FOA, examples of Resource Cores include, but are not limited to, Cores providing the following:

• A technology that lends itself to standardized procedures, automation or preparation in large batches (e.g., histology, tissue culture, biobanking, high throughput sequencing, genotyping, and other genomic, epigenomic, proteomic, and microbiomic assays) or that requires complex instrumentation (e.g., electron microscopy, flow cytometry, confocal microscopy, intravital microscopy, and whole animal imaging, and mass spectrometry).
• Animal preparation (including transgenic, knockout, and other forms of genetic engineering/gene editing) and care.
• Highly specialized technologies, tools, and expertise such as genetics, medical informatics, bioinformatics, biostatistics, systems biology, computational biology and machine learning, pharmacogenomics, etc.
• Critical infrastructure to support broad sharing of accessible pre-existing patient cohorts and registries, including appropriately-consented patient samples and associated clinical data.

A single Center may propose multiple Resource Cores offering different types of technologies, services, and/or critical resources. However, applications solely focusing on clinical methodology core(s) supporting outcomes, epidemiology, clinical trials, and/or health services research exclusively are not responsive to this FOA and will not be reviewed. Prior consultation with the NIAMS Scientific/Research contact is strongly recommended.

Although the Cores themselves are not required to be innovative, they should be "state-of-the-art" and drive innovation within the research community. In addition, Cores are encouraged to support limited research focused on technology development and/or adaptation of technologies to meet the needs of the research community through new and/or unique state-of-the-art core services. Resource Core support may include personnel, equipment, supplies, services, and facilities. It is expected that the Resource Cores will be sustainable in their operation and receive some reimbursement for the cost of providing services or other resources through user fees.

Cores are encouraged to leverage existing resources, such as existing registries, tissue banks, and cohorts, and to coordinate with other Cores at the same and/or nearby institutions, particularly if they provide similar or overlapping technologies and services. Cores may support existing service cores, but should add value beyond the normal use of a resource by fee-for-service or simple access. Whenever possible, generic services (e.g., histology, flow cytometry, genetically engineered animals, etc.), whether offered by new or existing cores, should be customized to meet the needs of the research community. Examples of such customization include the provision of relevant reliable monoclonal antibodies (e.g., for immunostaining of cells and tissues, for flow cytometry, or for ChIP-seq) and tissue or cell type-specific promoters and cre-drivers for genetically engineered animal studies. All Cores are strongly encouraged to enhance the value of the resources they offer through education and training on technologies and other resources offered by the Core, as well as consultation on experimental design and data analysis and interpretation. Applicants from institutions that have a Clinical Translational Science Award (CTSA) funded by the NIH may wish to identify the CTSA as a resource for conducting the proposed research.

Administrative Core

The Administrative Core has oversight responsibility for the entire Resource-based Center (P30) and also plans and carries out activities that promote the goals of the Center. These goals and activities are selected by the PD/PI of the application, but at the very least need to include outreach activities that promote use of the resources offered by the Center, as well as enrichment activities that expand the research community and/or promote innovative research on the topic of focus of the Center and within the NIAMS mission. Where appropriate, outreach may be national. The Administrative Core should have a Director, an Associate Director, and an Advisory Committee to coordinate the Center activities and to evaluate and improve the Center. The Director of the Administrative Core is also the Director of the overall Center. The Advisory Committee should include users of the scientific cores and experts outside the Center with expertise in the management of scientific core facilities. This Committee should help the Director and Associate Director to regularly evaluate and optimize strategies to meet the scientific needs of the research community over the course of the grant award.

The following are examples of additional goals that would be appropriate for a Resource-based Center. This list is neither mandatory nor inclusive. PDs/PIs are encouraged to propose other innovative goals.

• Provides leadership at an institutional or broader level for research on the topic of focus by the Center
• Expands the research community by attracting new investigators and established investigators from other fields
• Enhances the research environment and promotes synergistic collaborations and/or interdisciplinary research

The Administrative Core must include an Enrichment Program that is designed to expand the research community and/or promote innovative research on the topic of focus of the Center. The Enrichment Program should include outreach activities for the Resource Core(s). Each Center may choose the activities that best suit the needs of the research community, but all activities should occur within the context of and/or with the involvement of the Resource Core(s). Through this Enrichment Program, the Administrative Core can utilize the Resource Cores to foster the development of new investigators, attract investigators from other research fields, develop new technologies, and/or foster new collaborations with investigators who have not previously engaged in research within the focus of the Center. The Enrichment Program may include a Pilot and Feasibility (P&F) grant program, but this is optional. Innovative approaches to the Enrichment Program are encouraged.

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

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

o   Hispanic-serving Institutions

o   Historically Black Colleges and Universities (HBCUs)

o   Tribally Controlled Colleges and Universities (TCCUs)

o   Alaska Native and Native Hawaiian Serving Institutions

o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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 allowed.

Applicant Organizations

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

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• o   NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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

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

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

Although a letter of intent is not required, is not binding, and does not enter the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Sara Myers, MPH
Telephone: 301-594-5055
Email: NIAMSCentersProgram@mail.nih.gov

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (use for Administrative Core)	12
Core (use for Resource Core(s)	12

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

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

The application should consist of the following components:

• Overall: required
• Administrative Core: required; 1 maximum
• Resource Cores: required; 1 minimum

When preparing your application, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions.

Facilities and Other Resources: For each institution that is hosting a Resource Core, briefly describe the features of the institutional environment that are relevant to the effective implementation of the proposed Center. List institutional resources available to the Center and elaborate on how these resources will contribute to the success of the Center. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographic distribution of space and personnel, and consultative resources. Include a list of who occupies specific space, the square feet and equipment in that space, and a designation of the Center functions associated with the spaces designated. Applicants may include Campus maps and floor plans to illustrate the physical space available for the proposed Resource Cores and Administrative Core. Describe institutional commitments for space or other resources for the proposed Center.

Other Attachments:  The following supportive data tables should be included with the Overall Component. The filename provided for each attachment will be the name used for the bookmark in the application image.

Table of "Grants Supporting the Research Community": A table listing the grants relevant to the focus of the Center held by investigators in the research community, their duration, the current year direct cost, and their PD/PIs must be included. This table is particularly important for Centers that propose service cores. Avoid an exhaustive list of grants with indistinct relationship to the Center. It is helpful to group the grants into aggregates of projects with similar overall goals and objectives. A suggested format is given in Exhibit I of the Sample Exhibits.

Biographical Sketches of Research Community Investigators: Title this single attachment "Research Community Biographical Sketches." Provide biographical sketches for all investigators of the research community, as defined within the application, and organize them alphabetically by the last name of the research community investigator. Do not include duplicate biosketches for Senior/Key personnel. The Personal Statement in the Biographical Sketches may be used to provide details on the research programs of the research community investigators as they relate to the research focus of the Center, and to describe how Center resources would specifically and directly impact these research programs.

Enter primary site only.

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

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

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

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

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

Specific Aims: Describe the broad long-term objectives and goals of the proposed resource-based center.  Include the objectives for each of the Resource Cores and the Administrative Core.

Research Strategy:

The Research Strategy section of the Overall Component serves to introduce the proposed Center, to state the Center objectives, and to identify the focus (or theme) of research addressed in the proposed Center. This section also provides a sense of the overall significance of the Center, i.e., how the Center and any unique resources it provides will impact the research community and the field(s) of research covered by the Center. For the purposes of this FOA, the research community can be defined as those investigators (and their funded projects) who will use center resources for research within the focus of the Center. Members of a research community work in the same field or related fields and interact through common meetings, collaborations and shared activities and resources. This section should describe the research community, the significance of the Center with respect to the research community and field(s), the interactions among the Center Investigators and the Cores, the innovation of the Center, the approach for providing core services and resources, and any preliminary data and progress report (for renewal applications) regarding the impact of the Center on the research community.

The Research Strategy section of the Overall Component should be organized in the following fashion:

Orientation to the Overall Center

Describe the goals of the Center. Describe the scientific, organizational and management structure of the Center. Include the leadership structure of the Center and the individual Resource Cores. Include the theme or focus of the Center, the research field(s) of the Center and the research community, any needs assessments that were conducted that led to the selection of resources being shared through the Center, and unique aspects of the resources and services being offered by the Cores.

Research Community

Present an overview of current research on the topics of focus of the Center conducted by the research community in sufficient detail such that its extent and the interrelationships of ongoing research are clear. A strong research community is a fundamental requirement for establishing a Center. The research community may be defined at the local, regional, or national level (and may include foreign collaborators) as long as it is practical for the members of the research community to utilize the resources offered by the Center. The research community should be composed of funded investigators with well-defined connections to the focus or theme of the Center. Begin with a brief summary of the investigators in the research community and their strengths, and continue with a descriptive narrative of how the Cores can enhance their projects. This narrative presentation should be organized to address the focus and interrelationships of research conducted by the Center Investigators (including the research community investigators using the Cores and researchers leading and staffing the Cores) and how the research interests of the investigators in the research community are related to the focus or theme of the Center. Criteria for designating an investigator as a Center investigator should be defined in terms of the responsibilities and privileges.

The investigators of the research community of the proposed Center may be documented in greater detail in the Biographical Sketches (see Other Attachments) and Letters of Support. If the Letters of Support and/or Biographical Sketches are used in this way, they should be explicitly referenced within this section. It may also be useful to highlight ongoing and past successful collaborations between investigators in the research community and the Center personnel and to document the outcomes of these collaborations (e.g., publications, grants, major scientific advances, etc.).

Significance

This section should expand on the goals of the Center and should describe the effect of the Center on the research community as well as on the field(s) of research chosen as the topic of focus of the Center. Include the importance of the resources being shared and the expected effect of providing access to those resources. Explain the degree to which the Center is expected to accelerate progress on the aims of the research community grants and projects, improve efficiency and enhance productivity of the research community investigators. Describe how the Center helps to expand and enhance the capabilities of the pool of investigators engaged in research related to the research topic(s) of the Center. For a Center that provides access to a unique highly specialized resource, provide examples of research projects that would be enabled and/or significantly enhanced by access to that resource.

Innovation

Address how the Center will not only evolve with the science conducted by the Center Investigators, but also challenge and seek to advance or change current research or clinical practice paradigms by using novel theoretical concepts, approaches or methodologies, instrumentation, or interventions. Describe plans to develop or adapt new and/or unique state-of-the-art core services during the tenure of the Center through technology development and/or adaptation of technologies to meet the needs of the research community. Explain how the synergy of the Center with the research community will lead to novel services and resources in the Cores and their application to important questions in the topic of focus of the Center. Describe the potential for interdisciplinary collaborations among Center Investigators. For a Resource Core that by its nature is not innovative, describe how it is essential to advance the field.

Approach

Summarize the services and resources provided by the Center, and how they are managed and coordinated. Describe how the Center will address the scientific needs of the research community. Indicate if any of the proposed Cores will utilize or expand cores already existing at the participating institutions. Describe how the proposed Center will make existing resources broadly available to the research community, leverage existing resources, and fill gaps in the services available. If resources are provided to investigators at distant sites, briefly describe the logistics for doing so. Also describe how the Center will use enrichment activities to expand the research community and promote innovative research on the topic of focus of the Center.

Leveraging of existing resources is encouraged, particularly when this provides a range of services or efficiency or access to resources that would not otherwise be readily available. Furthermore, applicants should demonstrate that support for the existing resource through the Center provides added value to the resource beyond that which would be provided by paying for use of the resource through a fee for service or access. Applicants from institutions that have a Clinical Translational Science Award (CTSA) funded by the NIH may wish to identify the CTSA as a resource for conducting the proposed research, if appropriate. Provide details of any interactions between Center staff and CTSA staff and/or research personnel describing collaborative linkages being developed.

Progress Report (if application is a Renewal Application)

All applications for renewal must provide the following information in the progress report:

• A description of the impact of the Center on the institution(s) and research community (e.g., increased numbers of research grants and research papers, or new investigators attracted from other fields to work on the focus of the P30);
• The results of each core supported by the Center during the previous grant period;
• The results of each pilot project supported by the Center over the previous grant period (if applicable); and
• A list of publications that have acknowledged the resources and cores of the Center. All publications should comply with the Public Access Policy. The Progress Report Publication lists are excluded from the 12-page limit for the Research Strategy section of the Overview component.

It may help to utilize a table (see Exhibit II in the Sample Exhibits for example) to provide details of core facility usage. Please be sure to note in the Progress Report section of the Overall and relevant Research Core components that you have inserted this table into the Overall Resources Section. Please also indicate in the relevant Research Core component(s) if Progress Report Publication lists are included in the Overall component rather than in the Research Core component.

Letters of Support: Include any letters of support for the proposed Center by appropriate institutional officials of each performance site. These letters should include commitments of space and other resources required by the Center. A letter of agreement from existing resources (such as the CTSA PD(s)/PI(s)) should be included here if collaborative linkages are being developed between the Center and existing resources. Letters from the investigators of the research community may be provided to document their research interests, current or planned interactions with other Center investigators, the need for and impact of shared resources proposed by the Center, and likely use of Center resources. A table listing the individuals providing the letter of support and their institution is requested.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

•     All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

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

When preparing your application, use Component Type Admin Core.

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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

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

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

List all performance sites that apply to the specific component.

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

•     In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
•     In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
•     Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
•     If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
•     Personnel of the Administrative Core should include the PD/PI, who is responsible for the organization and operation of the Center, and an Associate Director, who will be involved in the administrative and scientific aspects of the Center, and will serve as Acting Center Director in the absence of the PD/PI. The Director of the Administrative Core should be the Resource-based Center PD/PI. The Biographical Sketches should reflect the expertise and qualifications of the PD/PI and Associate Director.
•     List administrators and staff for the Administrative Core (not individual Resource Cores). If Resource Core Directors also help administer the overall Center, list them as well.

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

The budget of the Administrative Core may include appropriate salary for the Director, Associate Director and support personnel, expenses related to the Advisory Committee (travel, teleconferences, etc.) and expenses associated with the Enrichment Program. Carefully explain and justify requested support. Indicate the level of time commitment by the Director and Associate Director devoted specifically to the Center. Administrative support personnel may be budgeted at no more than one full time equivalent (FTE), which may be divided among one or more positions. This FTE must be fully justified.

The Center must allocate a minimum of $20,000 and up to $100,000 direct costs each year to the Enrichment Program, which will be administered through the Administrative Core.

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.

Specific Aims: Describe the broad long-term objectives to be accomplished by the Administrative Core.

Research Strategy:

The Administrative Core manages the overall Center as well as the Enrichment Program. Applicants are encouraged to organize the Research Strategy section of the Administrative Core to align with the Centers' review criteria for the Administrative Core.  Please include the following headings:

Leadership

Define the responsibilities of the Director and Associate Director, Advisory Committee, Resource Core Directors, institution officials and other involved parties.

The Administrative Core will also manage interactions with the Advisory Committee. Describe the plans and procedures for nominating and selecting members of this committee. Describe the expected composition of the Advisory Committee (number of members, types of expertise, etc.), but do NOT name the members of the committee who are not from the Center Institution in the application. The Advisory Committee should include both users of the Cores and investigators external to the Center who may have expertise in the design and management of other core facilities or expertise in the technologies, services, and/or resources offered by the Cores or expertise in the research fields covered by the research community.

Management and Evaluation

The Administrative Core is responsible for coordinating and integrating the Center components and activities. Describe the management plans for the Center, including fiscal administration, procurement, property and personnel management, planning, budgeting, etc. If the Center will involve more than one institution, it may be necessary to explain how the management plans will coordinate activities at each of these sites. Describe plans for the management of conflict of interest relating to intellectual property (when applicable).

It is expected that the Resource Core(s) should be sustainable, and will recover at least a portion of the cost of providing services or other resources in the form of user fees that are charged to the funds of the users.  Describe how the Resource Core(s) will set user fees, taking into account applicable Federal cost principles as discussed in NOT-OD-13-053 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-053.html).

If the demand for the services or resources provided through the Center exceeds the supply or if a queue is likely to develop, describe criteria for establishing priorities or other strategies for managing supply or demand.

Resource-based Centers should conduct ongoing evaluation and assessment of its activities and whether the Center is meeting the goals and expected outcomes and outputs set forth in the grant application. These evaluations should include use of the Cores, the quality of the services and resources provided, and the efficiency by which they are delivered. The Administrative Core should work with the Resource Core Directors to formulate evaluation plans and conduct evaluations of the Resource Cores. The effectiveness of outreach and other enrichment activities in helping the Center meet its goals should also be evaluated. The Center should monitor current and predict future scientific needs of the research community, and Resource Core activities should adapt to those needs. The Advisory Committee should be actively involved in this evaluation and planning process. Describe the plans for the Director, Associate Director and Resource Core Directors to meet regularly with this committee. Indicate the format of the meetings; describe any reports on Center activities that will be provided to the committee members and how the committee may convey comments and recommendations back to the Center leadership. Describe how the recommendations from this committee will be integrated into the planning and management of the Center over the course of the award.

Communication

Describe the plans for maintaining effective communication within the Center and the plans for communication with the investigators of the research community and other potential users of the Cores. This plan should take into consideration the geographic distribution of Center investigators and Resource Cores. Explain how the communication plans will help to coordinate and integrate the investigators and the activities of the Center to promote the goals of the Center.

Enrichment Program

An Enrichment Program must be proposed. This Program should include outreach activities for the Resource Core(s) as well as activities that will serve to expand the research community and/or promote innovative research on the topic of focus of the Center. Each Center may choose the activities that best suit the needs of the research community, but should justify how the activities fulfill these goals as well as the overall goals of the Center. Types of activities that may be part of an Enrichment Program include (and are not limited to) mentoring programs and activities, Pilot and Feasibility studies (mentored, non-mentored, or technology development), and support of seminars and visiting scientists. All activities should occur within the context of and/or with the involvement of the Resource Core(s). Innovative approaches to Program Enrichment are encouraged. All Enrichment Programs must include a detailed description of Program leadership and management.

If the Center chooses to include direct funding for research (e.g., through a Pilot and Feasibility program and/or mentored activity), descriptions of such projects or individuals named for support should NOT be included in the application. However, plans for soliciting, reviewing, selecting, managing and reporting on the results of projects during the tenure of the Center, and/or plans to select mentees and their projects should be included in the application. Describe the internal institutional plans and procedures to ensure that all projects supported from this award will comply fully with all applicable Federal regulations, policies, and Guidelines, including those for research involving human subjects, including the evaluation of risks and protections in project proposals and appropriate ethical oversight of funded projects. Human Subject and Animal Subject approval dates for Pilot and Feasibility projects (if applicable) should NOT be submitted with the application, but should be provided to NIAMS for approval with Just in Time information, or prior to the start of the pilot project, and with annual progress reports. Otherwise please indicate in the appropriate section that human subjects or vertebrate animals are not involved. A Pilot and Feasibility program should not be used to fund clinical trials.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

When preparing your application in ASSIST, use Component Type 'Core.'

A Resource Core in a Resource-based Center can be defined in multiple ways, and can offer shared resources for basic, translational, and/or clinical research. It can be a shared facility and/or resource that provides a service(s) that enables Center investigators to conduct their independently-funded individual research projects more efficiently and/or more effectively. These Cores should be designed to furnish a group of investigators some service, technique, assay, or instrumentation in a manner that will enhance the research in progress, utilize human resources more effectively, and improve the quality and cost effectiveness over investigators conducting the same studies without the Core.  Alternatively, the Core may provide critical infrastructure to support broad sharing of a unique highly specialized existing resource such as a well-defined patient cohort with associated patient data and biospecimens or a bank of patient-specific iPS cells. All Cores should also attract investigators from other fields to the focus and theme of the Center's research by offering specialized services or resources not easily duplicated in an individual laboratory. See Section I. Section I. Funding Opportunity Description for some examples of shared resources.

Resource Cores should be justified by the needs of the research community and should be appropriate for the focus of the Center.

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

SF424 (R&R) Cover (Resource Core)

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 Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Resource Core)

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

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

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

Facilities and Other Resources: Describe the physical space available for the proposed Resource Core. Document any institutional commitments to provide space or renovate existing facilities. Whenever possible, Resource-based Centers are encouraged to enter into cooperative arrangements with established cores in other centers or resource grants offering a similar type of service or resource at the applicant institution.

Equipment: In addition to listing equipment (including location and capabilities) already available for this Resource Core, document any institutional commitments to cost share in equipment.

Other Attachments:  The following supportive data table should be included with the Resource Core Component. The filename provided for the attachment will be the name used for the bookmark in the application image

Table of "Use of Resource Cores" may be helpful to describe the projected use of the proposed Core by funded investigators, and for renewal applications, details of past core facility usage. This table should contain the name of the Resource Core, a list of services and/or other resources offered by the Core, followed by a list of users, their funded projects, and projected usage of each of the services/resources by each project. A suggested format is given in Exhibit II of the Sample Exhibits.

Project /Performance Site Location(s) (Resource Core)

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 Core)

•     A director should be named for each Resource Core. Cores may also have an Associate Director(s).
•     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 (Resource Core)

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

Resource Core support may include personnel, equipment, supplies, services, and facilities. It is important to provide comprehensive budgetary justifications, and to discuss mechanisms for reimbursing Core services.

This FOA is not intended for acquisition of high-cost equipment. Equipment purchases by any Resource Core in excess of $25,000 for any year of the grant would require special justification. Under unusual circumstances, where costly items of equipment are requested, the application must document available equipment within the institution and provide clear justification in terms of core service to be provided by the Center. Costly items of equipment should be funded through other sources.

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 Core)

Specific Aims:

Describe the broad, long-term objectives, and describe concisely the specific aims to be accomplished by the Core. Include research to enhance the capabilities of the Core, and/or training activities, if proposed.      

Research Strategy:

Describe the background information and gaps that led to the proposal of the Core. How are the shared resources critical for research on the topic of focus of the Center? Document that these resources are essential for the research of multiple independently-funded Center investigators. What value will be added to the research community by support through the Center, beyond that which could be accomplished by a similar level of funding used to purchase services from another source? This is an especially important point to document if the plan is to buy into an existing institutional core. How the Core will enhance the research productivity of investigators in the research community should be described.

Each proposed technique or service should be described in detail. Where applicable, include sections on quality control and data analysis. Whenever possible, generic services (e.g., histology, flow cytometry, genetically engineered animals, etc.), whether offered by new or existing cores, should be customized to meet the needs of the research community. Provide details of any customization of services that is planned. For Cores that offer access to a unique resource such as a patient cohort or an existing bank of tissues or cells, the unique resource should be described in a way that emphasizes the effect on the field of access to that resource. For example, the description of a cohort should include size, clinical characteristics, clinical data and patient samples available, whether patients can be re-contacted, etc. If resources are provided to investigators at distant sites, describe in detail how this will be accomplished. See Exhibit III in the Sample Exhibits as an example.

All Cores are strongly encouraged to enhance the value of the resources they offer through education and training on technologies and other resources offered by the Core, as well as consultation on experimental design and data analysis and interpretation.  The extent of, and approach to this training and consultation should be included.

The organization and proposed mode of operation of the Core should be presented. Included should be a plan to prioritize investigator use of the Core as well as a definition of qualified users. Choose this definition carefully, since a goal of the Center should be to expand the ranks of investigators engaged in research on the topic of focus of the Center and to promote interdisciplinary research, while including investigators distantly related to the field may cause the resources of the Core to be spread too thinly.

It is expected that the Resource Cores should be sustainable and will receive some reimbursement in the form of user fees that will offset some of the Core costs specific for a project using the Core, in order to optimize efficient resource usage and enhance core sustainability. The reimbursement plan should be described. In addition to providing a product or a service, a Core must maintain appropriate quality control. Cores are expected to have an ongoing program that assesses the quality and use of services and resources provided and whether the Core is meeting the needs of the research community. An evaluation plan should be described.

For renewal applications, recent progress report on the research core may be included here, but this should not duplicate the content included in the overall progress report included in the Overall component.  Please indicate if the Progress Report Publication Lists are included in the Overall component rather than in the Research Core component.  Please also note if a table of use of the core facility has been included in the Overall component. 

Letters of Support: Provide letters of support from outside consultants that will help develop services or provide resources for sharing. Also provide letters of support from potential users of the resources provided by the Resource Core documenting the services and resources that would be used by each investigator and the potential for specific and direct impact on the research projects using those services and resources. If these documents are included in the Overall component, please state so.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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 Information (Resource Core)

When involving NIH-defined human subjects research and/or clinical research follow all instructions for the PHS Human Subjects 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 Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects 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. 

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

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

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

For this particular announcement, note the following: After the review of the individual components of the application, an overall impact score will be assigned to the application. This score will reflect not only the quality of the individual Resource Cores and Administrative Core, but also how the proposed Resource-based Center will bring together all these elements in an effective and cohesive unit. The overall score may be higher or lower than the "average" of the components based on the assessment of whether the "whole is greater than the sum of its parts."

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Resource-based 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 Center 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 resource core that by its nature is not innovative may be essential to advance a field.

Does the Center 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?

Specific to this FOA
W What is the likelihood that the shared resources and environment of the Center will lead to major advances in the field? Will the proposed Resource Core(s) enable the investigators to conduct their research more efficiently and effectively?  Are the resources likely to accelerate progress beyond what can be achieved through access to centralized resources supported by other sources? Do generic services, if offered, require customization to meet the needs of the proposed research community and thus justify inclusion in the Center?

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

Specific to this FOA
Do the PD/PI and Associate Director have the leadership and research qualifications to lead a Center? Does the leadership team (PD/PI, Associate Director, and Advisory Committee) have the collective expertise to assure focused development and implementation of high-quality and meaningful basic, translational, and/or clinical research projects?

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?

Specific to this FOA
Are there plans to develop new and/or unique state-of-the-art core services during the tenure of the Center through technology development and/or adaptation of technologies to meet the needs of the research community? Will the services and resources provided by the Center not only evolve with the science conducted by the research community investigators, but are they also likely to drive the science with increasingly sophisticated and powerful technologies? For a Resource Core that by its nature is not innovative, is it essential to advance the field?

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

Specific to this FOA
Are there effective Leadership, Management and Evaluation, and Communication plans?  Is the Enrichment Program designed to effectively expand the research community in the area of focus of the Center? Is it likely that there will be coordination, collaboration and synergy among the individual Resource Core components, Administrative Core component and existing research community? Are the services and resources of the Resource Cores of high quality? Does support for the service or resource through the Center provide added value beyond that which would be provided through a fee for service or access, especially where support is proposed for an existing resource? Are the Resource Cores cost-effective in providing services and resources to the Center Investigators?  Do the Resource Cores effectively leverage existing resources at this or another institution?

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?

Specific to this FOA
Does the application define a productive, high quality and adequately funded (with federal, state, and private peer-reviewed funding awards) research community that needs the services and resources proposed by the Center?  Are the Center Investigators well defined in terms of their relationship to the Center, and are their letters of support for the application adequate to suggest that the Cores will be fully utilized?  Is the research community sufficiently broad to foster new research and to promote interdisciplinary collaborations?  Does the proposed Center utilize available resources well?  Where support by the Center for existing institutional scientific resources is proposed, does that resource provide a range of services or efficiency that would not otherwise be available to members of the Center? If there will be a connection with an NIH funded CTSA, is the collaboration well described and is there an adequate letter of agreement from the CTSA Program Director(s)/Principal Investigator(s)?

Reviewers will consider the following criteria in the determination of an overall impact score for the Administrative Core, although scores for the individual criterion will not be provided.

Leadership

Do the PD/PI and Associate Director have the leadership and research qualifications to maximize the success of the Center? Have the Director and Associate Director proposed adequate time commitment to effectively manage the Center? Are appropriate and well-defined responsibilities described for the Director and Associate Director, Advisory Committee, Resource Core Directors, institution officials and other involved parties? Are there adequate plans for establishing the Advisory Committee and for the Director and Associate Director to communicate regularly with the committee? Are the composition and plans for selecting the members of the committee appropriate?

Management and Evaluation

Is the management plan appropriate for fiscal administration, procurement, property and personnel management, planning, budgeting, etc.; are the Center budgets appropriate for the proposed work to be done in Resource Cores, for an Enrichment Program, and for any other proposed programs in relation to the total Center?  Are there adequate plans for objectively evaluating the functioning of the Center by the Director and Associate Director, with input from the Advisory Committee?  Are there adequate plans for integrating future recommendations of the Advisory Committee into the effective fiscal, personnel and scientific management of the Center over the course of the grant award?

Communication

Are there adequate plans for the establishment and maintenance of effective internal communication and cooperation among the Center investigators, Core personnel, leadership of the Center, and the Advisory Committee? If the Center will involve multiple sites or institutions, is there a detailed plan of the communication strategies aimed to integrate the distant components and investigators into a coordinated Center? Will communication and outreach through the Enrichment Program reach all of the research community investigators as well as investigators beyond the Center in order to promote expansion of the pool of users of the Core facilities for research on the topic of focus of the Center?

Enrichment Program

Is there a well-designed and innovative plan for activities that are likely to enhance the communication, coordination and collaboration among research community investigators and to expand the pool of investigators and broaden the spectrum of research on the topic of focus of the Center conducted through the Center? If the Center chooses to include direct funding for research (e.g., through a Pilot and Feasibility program and/or mentored activity), are there adequate descriptions of plans for soliciting, reviewing, selecting, managing and reporting on the results of projects, and/or plans to select mentees and their projects?

Reviewers will consider the following criteria in the determination of an overall impact score for the Resource Cores, although scores for the individual criterion will not be provided.

Significance

Does the Resource Core provide services and/or resources to meet the scientific needs of the research community? Will the Core be used by multiple investigators? What is the likelihood that the Resource Core will increase efficiency, accelerate progress and promote new research directions and meaningful collaborations among research community investigators?

Investigators

Are the qualifications, experience, and commitment of the Resource Core Director and his/her collaborations with Center investigators appropriate to the proposed technical area and/or shared resource?

Innovation

Are there plans to develop new and/or unique state-of-the-art core services during the tenure of the Center through technology development and/or adaptation of technologies to meet the needs of the research community? Will the services and resources provided by the Resource Core not only evolve with the science conducted by the Center Investigators, but are they also likely to drive innovation of the science with increasingly sophisticated and powerful technologies? Is the Resource Core likely to promote interdisciplinary research? For a Resource Core that by its nature is not innovative, is it essential to advance the field?

Approach

Are the services and resources of the Resource Core of high quality? Does support for the service or resource through the Center provide added value beyond that which would be provided through a fee for service or access, especially where support is proposed for an existing resource? Are there procedures for quality control of the services and resources for each Core? Is the Resource Core cost-effective in providing services and resources to the research community investigators?  Do the Resource Cores effectively leverage existing resources at this or another institution?

Environment

What is the overall quality of the environment for the Resource Core? Is there adequate institutional commitment to the Center, including physical space for each Resource Core, lines of accountability regarding management of the Resource Cores, and commitment to the individuals responsible for conducting essential Center functions?

As applicable for the Center and Resource Cores 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.

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

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

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

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

Not Applicable

For Renewals, the committee will consider the progress made in the last funding period. Have the benefits of the Resource-based Center been documented in the forms of enhanced scientific productivity, increased collaboration, success in achieving funding for new research directions, attracting new investigators to the field, and cost savings?

Not Applicable

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

Not Applicable

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

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

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

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

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

As part of the scientific peer review, all applications:

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

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

Applications will be assigned 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 National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC). The following will be considered in making funding decisions:

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

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

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

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

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

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

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

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

If Pilot and Feasibility projects are included in the Centers program, a complete project application (including biographical sketches, personnel and budget justification, research plan, human and/or animal subject sections and any IACUC, IRB or other required documentation), and the critiques of the proposals by the Advisory Committee must be provided to the NIAMS Grants Management Specialist for approval with the Just in Time information or prior to the start of the Pilot and Feasibility projects. A Pilot and Feasibility program should not be used to fund clinical trials.

• The awardee institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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

Not Applicable

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. If Pilot and Feasibility projects are included in the Centers program, RPPR should briefly describe status of pilot projects.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

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

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

Aron Marquitz, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-435-1240
Email: aron.marquitz@nih.gov

Kathy Salaita, Sc.D.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: (301) 594-5033
Email: Kathy.Salaita@nih.gov

Steve Austin
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-3504
Email: austins2@ep.niams.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.