NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

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

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

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

The primary objective of the Centers of Research Translation (CORT) Program is to foster research that is translational in nature, directed at elucidating the relevance of basic research to human disease in an area within the NIAMS mission. Two major features of the CORT program include: 1) the overarching aim of disease-related research translation, and 2) the inclusion of resources and an administrative structure to facilitate research translation.

For the purpose of this particular announcement, translational research is defined as applied and clinical scientific research that is directed towards testing the validity and limits of applicability of knowledge derived from basic science and bioengineering to the understanding of human diseases and health. It could be research involving living human subjects (i.e., clinical), but it might also be non-clinical involving the study of human genes, tissues, specimens, or cells. Thus, although it is directed towards the generation of knowledge about humans, it could be non-clinical or clinical research. It could be research resulting in knowledge useful to persons (individuals, families, and populations) affected by or at risk for specific diseases. The overall CORT concept embraces both the translation of new scientific information to clinical application and the application of clinical findings to new research.

A CORT must focus on a single or a group of highly-related disease(s) entities or disorders in the NIAMS mission, although the proposed research may be relevant to more than one disease and an additional disease(s) may be used as a control if scientifically justified. The focus cannot be generic, e.g., autoimmune diseases, rheumatic and musculoskeletal disorders, or skin diseases. Potential PDs/PIs are strongly encouraged to contact the Scientific/Research Contacts for this FOA early in the application planning process to discuss NIAMS mission relevance.

A CORT research program could be carried out by a synergistic team of scientists who will address a highly significant translational research challenge in a disease or condition within the mission of the NIAMS. The focus of research could be either: 1) a disease-targeted translational theme addressed by synergistic Research Projects with optional Research Cores; or 2) a disease-related critical translational research question addressed through a single collaborative Research Project enabled by a number of highly interactive Research Cores whose work is integrated over time during the development and implementation of the Project.

The investigator has the flexibility to design a CORT with optimal structure to foster synergistic interactions or maximize integration and productive interdisciplinary collaborations to promote innovation in addressing the translational research needs. A CORT must have a minimum of three highly meritorious research components consisting of one or more translational Research Projects and optional Research Cores. For example, a CORT may propose three translational projects with varying degrees of interdependence and/or interrelatedness as long as the outcomes of each project inform or complement the others. Alternatively, a CORT may be designed to have a single research project supported by two or more research cores that will provide the technologies and other resources needed to accomplish the aims of the project and the overall translational objectives of the CORT. To facilitate a team science approach, the lead investigators of the research components must be drawn from relevant and, as appropriate, different research disciplines; they may be based in different departments, divisions and/or institutions. Combined, the projects and cores will generate new knowledge that will improve our understanding of human pathophysiology, and lead to identification of new targets, other tangible products or deliverables and development of more effective treatment, diagnostic or prevention strategies for human disease.

Each CORT must have an Administrative Core with an external advisory committee that includes scientific and lay members. The advisory committee will have a dual role; one will be to provide oversight of scientific progress of the CORT and guide research translation, and the other will be to review and recommend pilot and feasibility project applications for support by the Administrative Core. Each CORT must have a Director and Associate Director, one of whom is a clinical investigator and is responsible for fostering clinical translation and assuring a mutually supportive interaction between investigators of the clinical discipline and those of other research disciplines. The lead of the Administrative Core is also the Director of the CORT who is responsible for the organization and overall operation of the CORT. The CORT Director, the Associate Director and the Advisory Committee should have the collective expertise to assure focused development and implementation of high quality and meaningful translational research.

Once a CORT is established, pilot and feasibility projects, which have the potential to develop new directions in addressing the translational theme and overall objectives or to test and validate emerging new methodologies and approaches to accelerate research translation, will be required to be supported by the Administrative Core through a Pilot and Feasibility program. Up to two pilot and feasibility projects may be supported for up to two years each beginning the second, third or fourth year of the CORT funding. The scientific review of these pilot and feasibility project applications will be conducted by the CORT advisory group. The final funding decisions regarding these projects will be made by the CORT leadership with approval from the NIAMS. The Pilot and Feasibility program should not be used to fund clinical trials.

Once a CORT is established, the CORT leadership has the flexibility to adjust the technical focus of research cores with newer cutting-edge or state-or-the-art technologies/methodologies to provide more effective services and approaches in support of the translational progress of the research project(s). The flexibility option may not be used to add new research cores over and above the number that were peer reviewed, even if no new funds are requested. The CORT directors are expected to make decisions about the continuation or discontinuation and replacement of research cores in consultation with internal and external advisors as well as other lead investigators on the CORT and with approval by NIAMS staff. Adjustments cannot be approved during the first year of the CORT funding.

The CORT research projects will NOT support:

• Clinical trials focused on testing intervention(s)
• Clinical and epidemiological research that does not include a laboratory component or capitalize upon a biological discovery relevant to human health or disease
• Research involving the use of animal models is not excluded; however, any proposed animal model(s) has to be highly relevant to human conditions and the demonstrated application to humans must be included in the specific aims of the proposed project(s).

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 in response to 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)
• Eligible Agencies of the Federal Government
• 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) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

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

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

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

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

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

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

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

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into 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:

Justine Buschman, M.S
Telephone: 301-496-4811
Fax: 301-480-1284
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core (Use for Administrative Core)	6
Core (Use for Research Core)	12
Project (Use for Research Project)	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
• Other Components: at least three research components (Research Projects and Research Cores) are required:

o Research Cores: Optional; two or more required if a single Research Project is proposed

o Research Projects: Required; minimum of one.

When preparing your application in ASSIST, use Component Type Overall .

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

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 participating in the CORT, briefly describe any unique features of the scientific and institutional environment, or collaborative arrangements that are relevant to the effective implementation of the proposed CORT. List institutional resources available to the CORT and elaborate on how these resources will contribute to the success of the CORT. 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. Describe the lines of accountability regarding management of the CORT, and the institution's partnership with the CORT, and the institutional commitment to individuals responsible for conducting essential Center functions. This also includes the academic environment and resources in which the activities will be conducted, including the availability of space, equipment, facilities, and the potential for interaction with scientists from other departments and schools to enhance collaboration. Applicants may include Campus maps and floor plans to illustrate the physical space available for the proposed CORT. Indicate if any of the proposed research cores will utilize or expand cores already existing at the institution. Applicants from institutions that have a Clinical and Translational Science Award (CTSA) funded by the NIH should describe any specific interactions or collaborations between the CORT and the CTSA staff and research personnel.

Enter primary site only.

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

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

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

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

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

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

Specific Aims: Describe the broad long-term objectives and goals of the proposed CORT. Include the objectives for each of the Research Projects, Research Cores, and the Administrative Core.

Research Strategy: The Research Strategy section of the Overall Component serves to introduce the proposed Center, to state the CORT objectives, and to identify the focus or theme of research addressed in the proposed CORT. This section also provides reviewers with a sense of the overall significance of the CORT, i.e., how the CORT and the unique research approaches proposed will advance translation of knowledge to improve our understanding of human pathobiology and lead to new therapeutic, diagnostic or prevention strategies or other tangible products or deliverables in the area of research selected by the CORT Directors.

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

Overview

Each CORT application should have an Overview. This section should describe the goals of the CORT, the disciplines brought together for the proposed CORT and explain the strategy for achieving the objectives of the overall program. Include the theme or focus of the proposed CORT. Describe the scientific, organizational and management structure of the CORT. Include the leadership structure of the CORT and the individual Research Components. It is important to emphasize the events that have led to the current application, and especially to describe the anticipated unique opportunities for translational research within the proposed CORT. Briefly describe each of the proposed project(s), and how the project(s) qualifies as translational research and addresses the overarching theme of disease-targeted research translation or disease-related critical translational research question. Briefly describe any research cores that are included in the application and how each core will support the proposed project(s).

Significance of the CORT

This section should succinctly present the current translational challenge in the proposed field of research, explicitly state and clearly describe the premise or the rationale for the proposed CORT study. The section should indicate the significance of the proposed work with respect to the research activities of the community and field(s), the unique and novel aspects of the CORT, any supporting data indicating the degree to which the CORT is expected to accelerate scientific and translational progress in the targeted disease area of research.

Innovation of the CORT

Describe the innovation brought by the CORT. Address how the CORT will 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 the potential of any interdisciplinary collaboration and synergistic interactions that will bring innovation to the CORT and to the proposed field of research in a broad sense.

Approach of the CORT

Summarize the overall strategy and the unique research approaches or any unique cohorts proposed by the CORT that will accomplish the specific aims of the CORT, and accelerate discovery and translation of knowledge to improve our understanding of human pathobiology and lead to new therapeutic, diagnostic or prevention strategies in the area of research selected by the CORT. Describe any anticipated problems, alternative strategies and benchmarks for success. Indicate if the CORT leverages any existing resources at the participating institutions to advance the goals and objectives of the proposed CORT.

Describe the strategy and approaches that the proposed CORT will employ in bringing together all the individual elements into a functional and cohesive unit such that the whole is greater than the sum of its parts. If more than one project is proposed, describe strategies and approaches used to stimulate and foster synergistic interactions among projects. If a single project is proposed with two or more research cores, describe how the proposed research cores serve as an integral part of the CORT and are essential to the accomplishment of the translational objectives of the research project. This section should include a description of ways, type and frequency of interactions designed to maximize integration of cores with the project, and present an integrated list of milestones and combined timeline.

Renewal Applications: Additional Material Required

Summarize the progress of the CORT during the previous funding period at the overall level. Include the specifics of the progress for each component, i.e., Projects and Cores, under the respective 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 CORT. 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 CORT and the existing resources.

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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

When preparing your application in ASSIST, 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 CORT Director, who is responsible for the organization and operation of the CORT, and an Associate Director. The Associate Director will be involved in the administrative and scientific aspects of the CORT and will serve as Acting Center Director in the absence of the Director. The Lead of the Administrative Core is also the Director of the CORT. The Biographical Sketches should reflect the expertise and qualifications of the Director and Associate Director.
• List administrators and staff for the Administrative Core. If the lead(s) of Research Projects or Research Cores also help administer the overall CORT, list them as well.

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

The CORT Director is expected to make a commitment of at least 1.8 calendar months (CM) to the overall administration of the CORT. The CORT Associate Director is expected to commit at least 1.2 CM to administration. Administrative support personnel may be requested at no more than one full time equivalent (FTE) which may be divided among one or more positions. This position must be fully justified.

Applications should include $2,500 yearly travel expenses in the Administrative Core to pay for two individuals to attend one 2-day meeting related to the CORT program.

The pilot and feasibility projects must be budgeted under the Administrative Core beginning in Year 2, and the amount should be within the $1M cap of direct cost.

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

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Administrative Core.

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

Research Strategy: The Administrative Core is responsible for the planning, development, coordination, and overall administration of the CORT as well as the Pilot and Feasibility Project Program. Applicants are encouraged to organize the Research Strategy section of the Administrative Core to align with the review criteria for the Administrative Core including the following headings:

Leadership

Define the responsibilities of the CORT Director and Associate Director, Advisory Committee, institution officials and other involved parties. Describe in detail, and by diagram if appropriate, the line of authority or chain of responsibility for decision-making and administration. Include to whom the CORT Director reports and the administrative structure as it relates to the investigators responsible for the research projects and research cores.

The Administrative Core will also manage interactions with the CORT 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 so as not to limit the pool of potential reviewers. The Advisory Committee should consist of three to six members including scientists both from the parent and from other research institutions, and one or more lay members who can bring the patient perspective about the disease to the group. Their collective expertise should reflect key issues addressed in the translational theme and target disease areas of the CORT

Management

The Administrative Core is responsible for coordinating and integrating the CORT components and activities. Describe the management plans for the CORT, including fiscal administration, procurement, property and personnel management, planning, budgeting, etc. If the CORT 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).

A CORT should conduct ongoing evaluation and assessment of its activities, scientific progress of the research projects and whether the Center is meeting the goals and expected outcomes, milestones or deliverables in a timely fashion set forth in the grant application. These evaluations should also include use of the Research Cores, the quality and efficiency of the services and resources provided to the research projects in accomplishing the proposed specific aims. Describe how the CORT Directors plan to make decisions if necessary to adjust the focus or direction of the initially proposed research core based on the results of the CORT research to provide more effective services and approaches in support of the translational progress of the research projects.

The Advisory Committee should be actively involved in the evaluation and planning process of the CORT. The Advisory Committee should meet formally at least annually to assist the CORT Directors in evaluating the scientific progress and optimizing strategies to meet its overall translational goals over the course of the grant award, and conduct review and recommend pilot and feasibility project applications for support by the Administrative Core. Indicate the format of the Advisory Committee meetings; describe any reports on CORT activities that will be provided to the committee members and how the committee may convey comments and recommendations back to the CORT Directors. Describe how the recommendations from this committee will be integrated into the planning and management of the CORT over the course of the award.

Communication

A key role of the Administrative Core is to foster productive interactions and promote synergistic collaborations to enhance innovative interdisciplinary research. Describe the plans for maintaining effective communication and cooperation among the CORT investigators and the plans for communication with the investigators of the research community. This plan should take into consideration the geographic distribution of CORT investigators. Explain how the communication plans will help to coordinate and integrate the investigators and the activities of the CORT to enhance the research environment and promote the goals of the Center.

Pilot and Feasibility Project Program

It is envisioned that the synergy present in the research projects and/or between project(s) and research cores of the CORT will lead to new ideas and the need to test new hypotheses or test and validate emerging new methodologies and approaches relevant to the translational theme or objectives of the CORT. The pilot and feasibility projects must be budgeted within the Administrative Core. The actual descriptions of such projects or individuals named for support should NOT be part of the initial application. However, plans for soliciting, reviewing, selecting, managing and reporting on the results of projects during the tenure of the CORT 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 prior to the start of the pilot project. Once a CORT is established, up to two pilot and feasibility projects can be supported for up to two years each beginning in year two, three or four of the CORT funding. The CORT External Advisory Committee will conduct review of the pilot and feasibility projects. The final decisions regarding these projects will be made by the CORT leadership with approval by the NIAMS. A Pilot and Feasibility program should not be used to fund clinical trials.

Enrichment Program

The Administrative Core may include limited funds for program enrichment for outreach activities (i.e., seminars, visiting scientists, etc.).

Renewal Applications: Additional Material Required

Include here any specifics of the progress during the last funding period for the Administrative Core.

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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Administrative Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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

SF424 (R&R) Cover (Research 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 (Research Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research 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 environment, facilities and resources as well as the institutional commitment to the Research Core, including physical space, and commitment to the individuals responsible for conducting essential core functions.

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

• 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.
• A director should be named for the Research Core. An associate director may also be proposed. The combined efforts should devote at least 1.8 CM to the research core. The CORT Director or Associate Director can also be the Director of a Research Core. Minimum effort on both the Administrative Core and the Research Core, as indicated above, should be maintained.

Budget (Research Core)

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

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

Budget Justification: In presenting the scope of the core, it would be helpful to prepare a table indicating the research project(s) that each research core will serve and the estimated proportion of the cost (in dollars) of the core associated with each research project.

PHS 398 Research Plan (Research Core)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Research 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. CORT applications that choose to address a disease-related critical translational research question, rather than a disease-targeted translational theme, with a single collaborative project enabled by highly interactive research cores may use a single set of specific aims repeated in every individual research component, provided that each component includes a distinct Research Strategy based on the unique discipline and technologies represented by the investigators conducting the research component.

Research Strategy: Explain how the research core is justified by the scientific and translational needs of the CORT. Describe the expected contributions of the core such as technical support and services or other resources to accelerate progress, and promote innovative and more effective approaches to enhance the likelihood of success of the research project(s) in achieving the overall translational objectives of the CORT, and how the research core is likely to promote interdisciplinary team approach to the CORT. For a Research Core that by its nature is not innovative, describe why it is essential to advance the translational theme or objectives of the CORT.

Describe in detail the techniques or services or any unique resources such as patient cohort(s) or banked tissues and cells provided by the currently proposed core to support research project(s) within the CORT. A core may be a unit designed just for the CORT projects or may be an existing institutional core. However, funds may only be requested for CORT project use. Explain why support for the service or resource through the CORT provides added value beyond that which would be provided through a fee for service or access, especially where support is proposed for an existing resource. Describe plans and procedures for quality control and cost-effectiveness of the services and resources provided by each Core to the CORT investigators. Where applicable, include sections on plans for data management and data analysis.

Include plans to develop new and/or unique state-of-the-art core services during the tenure of the CORT through technology development and/or adaptation of technologies to meet the translational research needs of the CORT. It is expected that the services and resources provided by the Research Core will not only evolve with the science conducted by the CORT investigators, but they are also likely to drive the science with increasingly sophisticated and powerful technologies. The Core should propose main approaches, metrics for go/no-go decisions, and options for alternative approaches to enhance the effectiveness of services to support the progress of the proposed research project(s). Describe any interactions with the CORT leadership and other lead investigators on the CORT in formulating an ongoing evaluation plan and development of metrics for go/no-go decisions.

In the CORT application, the PD(s)/PI(s) should describe the initial research cores proposed and how they plan to adjust direction if necessary based on the results of their research. Each Core should propose main approaches, metrics for go/no-go decisions, and options for alternative approaches.

Describe any special arrangements to effectively leverage other existing resources at this or another institution. If any research core is located at a different institution separated geographically, describe the processes that will be in place to facilitate coordination, distribution and accessibility to the services, facilities or resources that the core proposes to provide.

Organize the Research Strategy in the order specified in the SF 424 (R&R) Application Guide. Make sure to start each section with the appropriate section heading in order, Significance, Innovation, and Approach.

Renewal Applications: Additional Material Required:

Include here any specifics of the progress during the last funding period for the Research Core, if applicable.

Letters of Support: Provide letters of support from outside consultants who will help develop services or provide resources for sharing. 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Research Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Research Project

When preparing your application in ASSIST, use Component Type Project.

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

SF424 (R&R) Cover (Research Project)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

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

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

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

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

List all performance sites that apply to the specific component.

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

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

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• A Director should be named for the Research Project. An Associate Director may also be proposed. The combined efforts should devote at least 2.4 CM to the project. The CORT Director or Associate Director can also be the Director of a Research Project. Minimum effort on both the Administrative Core and the Research Project, as indicated above, should be maintained.

Budget (Research Project)

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

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

PHS 398 Research Plan (Research Project)

Introduction to Application: For Resubmission applications, an Introduction to Application is required in each of the Research Projects.

Specific Aims: Clearly state the broad long-range goals of the proposed project and the expected outcome(s). Concisely describe the specific objectives of the research proposed and the specific aims to be accomplished by the project. CORT applications that choose to address a disease-related critical translational research question, rather than a disease-targeted translational theme, with a single collaborative project enabled by highly interactive cores may use a single set of specific aims repeated in every individual research component, provided that each component includes a distinct Research Strategy based on the unique discipline and technologies represented by the investigators conducting the research component.

Research Strategy: Use this section to describe in more detail how the proposed research project will contribute to meeting the goals and objectives of the CORT and explain the rationale for the proposed approach, methodologies, technologies, and/or analyses to accomplish the specific aims.

Organize the Research Strategy in the order specified in the SF 424 (R&R) Application Guide. Make sure to start each section with the appropriate section heading in order, Significance, Innovation, and Approach.

Under Significance, include a paragraph that clearly describes how the research project contributes to the translational theme of the CORT or addresses the critical question identified by the CORT to advance the overall translational objectives as a whole. Further, describe how this project relates to other projects or research cores, and when appropriate, how the outcomes of this will inform the other projects proposed in the CORT. If it is a clinical research project, describe the rationale of including it as a clinical research project within the theme of the CORT.

Renewal Applications: Additional Material Required:

Include here any specifics of the progress during the last funding period for each of the Research Projects.

Letters of Support: Provide letters of support from outside consultants or collaborators that will contribute to the project or provide resources necessary to carry out the proposed research. 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: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Research Project)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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: https://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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 individual quality of the projects, cores, and administration, but also how the proposed CORT will bring together all these elements in a functional and cohesive unit. The overall score may be higher or lower than the average of the descriptors 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 CORT 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 CORT 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 Research Component that by its nature is not innovative may be essential to advance a field.

Does the CORT address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the CORT are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

Specific to this FOA: Do the Director and Associate Director have the leadership and research qualifications to lead a CORT? Does the leadership team (Director, Associate Director, and Advisory Committee) have the collective expertise to assure focused development and implementation of high quality and meaningful translational research?

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

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the CORT? 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 CORT involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: Does the overall CORT design foster synergistic interactions and productive collaborations among the research projects and/or between projects and the research cores? Are the Research Cores an integral part of the CORT and essential to the accomplishment of the translational objectives of the Research Project(s)? Does the CORT program foster synergistic interactions and productive collaborations among (or between) teams of scientists?

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: Is there evidence of a supportive institutional environment for the proposed CORT? Are the institutional commitment to the program, including lines of accountability regarding management of the CORT, the institution’s partnership with the CORT, and the institution’s commitment to individuals responsible for conducting essential CORT functions appropriate and of high quality?

Are the academic environment and resources in which the activities will be conducted, including the availability of space, equipment, facilities, and the potential for interaction with scientists from other departments and schools to enhance an interdisciplinary approach appropriate and of high quality? Does the proposed CORT utilize available resources well?

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

Leadership

Are there scientific and administrative leadership, commitment and ability, and adequate time commitment of the CORT Director and Associate Director for the effective management of the CORT? Is either the CORT Director or Associate Director a clinical investigator who will be responsible for fostering clinical translation?

Management

Is the management proposed appropriate for scientific administration as well as fiscal administration, procurement, property and personnel management, planning, budgeting, etc.?

Communication

Is there a plan for the establishment and maintenance of internal communication and cooperation among the CORT investigators? Are there plans for effective use of the CORT advisory committee?

Pilot and Feasibility Project Program

Is the plan for soliciting, reviewing, selecting, managing and reporting on the results of pilot and feasibility projects during the tenure of the CORT appropriately described?

Enrichment Program (if applicable)

Are the proposed activities appropriate in relation to the overall objectives of the CORT?

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. The overall impact score will take into consideration: the scored review criteria and any specified additional review criteria. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

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

Specific to this FOA: How does the project(s) relate to the overall translational objectives of the CORT? If applicable, will the outcomes from one project inform the other projects in the CORT?

Investigators

Are the project leads, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, 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-lead, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Describe the experimental design and methods proposed and how they will achieve robust and unbiased results. Are potential problems, alternative strategies, and benchmarks for success presented? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

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

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

Significance

Does the Research Core provide technical support and services or other resources to meet the scientific and translational needs of the CORT? Does the Research Core have the potential to accelerate progress, and promote innovative and more effective approaches to enhance the likelihood of success of the research project(s) in achieving the overall translational objectives of the CORT?

Investigators

Are the qualifications, experience, and commitment of the Research Core Director and his/her collaborations with CORT 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 CORT through technology development and/or adaptation of technologies to meet the translational research needs of the CORT? Will the services and resources provided by the Research Core not only evolve with the science conducted by the CORT Investigators, but are they also likely to drive the science with increasingly sophisticated and powerful technologies? Is the Research Core likely to promote interdisciplinary team approach to the CORT? For a Research Core that by its nature is not innovative, is it essential to advance the translational theme or objectives of the CORT?

Approach

Are the technical services and resources of the Research Core of high quality? Does support for the service or resource through the CORT 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 Research Core cost-effective in providing services and resources to the CORT investigators? Do the Research Cores effectively leverage existing resources at this or another institution?

Environment

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

As applicable for the CORT, project(s), or 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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

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

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

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

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

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

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

Not Applicable

As applicable for the CORT, project(s), or 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 the 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.

Beginning in year two of the award, a CORT can support up to two pilot and feasibility projects for up to two years each by the Administrative Core. A complete application for each pilot and feasibility project (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 each application by the CORT External Advisory Committee as well as the recommendation by the CORT leadership for funding must be provided to NIAMS prior to the start of the Pilot and Feasibility projects.

• The awardee institution will provide NIH with written study protocols that address risks and protections for human subjects in accordance with NIH s Instructions for Preparing the Human Subjects Section of the Research Plan.
• 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.

If the CORT leadership, in consultation with other lead investigators on the CORT as well as internal and external advisors, believes that there is a need to adjust the technical focus or substitute an existing research core, a written justification with details of the proposed adjustment(s) or for discontinuation and replacement of an existing core must be provided to NIAMS for approval prior to the initiation of the changes. If a new research core is proposed to substitute for an existing core, the awardee must submit to NIAMS a complete application of the replacement research core (including biographical sketches, personnel and budget justification, research plan, human and/or animal subject sections and any IACUC, IRB or other required documentation) prior to the initiation of the new research core. Any evaluation report and recommendations by the advisory committee should also be included. Any changes or adjustments cannot be approved during the first year of the CORT funding.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.

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.

Progress reports should include a detailed progress report on all approved pilot and feasibility projects; and any new proposed pilot projects should include a complete project application as outlined in the Prior Approval of Pilot Projects section above.

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

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-710-0267

Yan Wang, M.D., Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
Email: [email protected]

Chuck Washabaugh, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5055
Email: [email protected]

Kathy Salaita, Sc.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5033
Email: [email protected]

Steve Austin
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-3504
Email: [email protected]

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

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