Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Funding Opportunity Title	Support of NIAMS Program Project Grants (P01)
Activity Code	P01 Research Program Projects
Announcement Type	New
Related Notices	May 13, 2013 - See Notice NOT-AR-13-019. Notice of Termination of this PAR.
Funding Opportunity Announcement (FOA) Number	PAR-11-188
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.846
FOA Purpose	This FOA is not intended to request new (Type 1) P01 applications. As published in NOT-AR-05-007 , the NIAMS does not currently accept new P01 applications. This FOA is being issued solely for the purpose of providing a means for eligible NIAMS investigators who currently have an active, awarded Type 1P01 to apply for their second competing P01 (renewal) as described in NOT-AR-05-007.

Posted Date	April 1, 2011
Letter of Intent Due Date	Not applicable
Application Due Date(s)	Standard dates
AIDS Application Due Date(s)	Not applicable
Scientific Merit Review	Standard dates
Advisory Council Review	Standard dates
Earliest Start Date(s)	Standard dates
Expiration Date	(Now Expiring May 26, 2013 per NOT-AR-13-019), Originally May 8, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This funding opportunity announcement (FOA) issued by the National Institute of Arthritis and Musculoskeletal and Skin Diseases allows current eligible NIAMS P01 grantees to submit innovative, interactive program project grant renewal applications. This FOA is not intended to request new (Type 1) P01 applications. As published in NOT-AR-05-007 , the NIAMS does not currently accept new, P01 applications. This FOA is being issued solely for the purpose of allowing NIAMS investigators who who will not have had 10 years of P01 or 2 competing segments of support as stated in NOT-AR-05-007. to apply for their second competing P01 renewal. Resubmissions of and revisions for this second competing renewal may also be permitted. These applications should propose to continue research which aims to solve a significant biomedical or behavioral research problem which addresses the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. The program project mechanism is designed to support research in which the funding of several interdependent projects offers significant scientific advantages over support of these same projects as individual regular research grants.

Successful program projects generally bring together scientists to apply complementary approaches to work on an important well-defined problem. All of the projects are expected to be relevant to the common unifying central theme, focus, and overall objective of the entire program project. In addition to individual research projects, applicants may propose one or more shared resource cores if needed for the proposed research. Each Shared Resource Core must provide support and enhance the productivity, cost-effectiveness, and/or research outcome of at least two of the proposed research projects. New cores may be proposed and/or existing cores may be augmented to support the proposed research. In this way the program project can facilitate the support of essential shared core facilities, e.g., major equipment, although the need of a group of investigators for a major piece of equipment or a core facility does not in itself justify a program project grant. Further, it is expected that successful program projects will establish effective collaborations, particularly in emerging areas of research, that extend beyond the life of the program project grant itself. Hence, a program project generally has a finite lifetime, and this solicitation is only for those current P01 grantees who will not have had 10 years of P01 or 2 competing segments of support as stated in NOT-AR-05-007. New applications will not be accepted.

Normally, a program project consists of a minimum of three individual, interdependent projects from different investigators. All of the projects are expected to be relevant to the common unifying central theme, focus, and overall objective of the entire program project. Each individual project should reflect a distinct, separate, scientifically meritorious research effort led by an independent investigator. The individual projects must be clearly interrelated and synergistic so that the research ideas, efforts, and outcomes of the program as a whole will offer a distinct advantage over pursuing the individual projects separately. It is expected that one PD/PI will be identified as the leader of the program project and that person will be responsible for coordinating the entire program project; however multiple PIs may be allowed as the overall coordinator/project leader. (Note that only one PD/PI may direct each project component.) The scientist(s) designated as the program project leader bear(s) responsibility for the overall scientific leadership and fiscal management of the program project grant. The option to designate one of the leaders of the individual projects or cores as project leader of the overall application is allowed. It is expected that each of the collaborating scientists responsible for the individual projects will be independent investigators. In addition, the program project and each individual project must represent a significant effort on the part of the participating scientists and be distinct from their other funded efforts.

Funding Instrument	Grant.
Application Types Allowed	Renewal Resubmission Revision The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	It is strongly recommended that applicants not request a budget of more than $1,000,000 in direct costs per year. These costs are exclusive of subcontract facilities and administrative costs.
Award Project Period	Scope of the proposed project should determine the project period. The maximum period is 5 years.

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

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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

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 Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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 PHS398 Application Guide.

Multiple PD/PIs are allowed only for the overall Program Project grant. Multiple PD/PIs for the individual projects or cores will not be allowed.

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.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

This solicitation is not intended to alter the current NIAMS policy as stated in NOT-AR-05-007. No new applications will be accepted.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Charles N. Rafferty, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Boulevard, Ste 800, MSC 4872
Bethesda, MD 20892-4872 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Telephone: 301-594-5019
Email: [email protected]

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed

All instructions in the PHS398 Application Guide must be followed.

Special Instructions: Application Format

The program project grant application should be structured as a series of separate but interrelated project proposals. The following format should be used:

Form Page 2

Description, Performance Sites, and Key Personnel: Under Description, state the proposed program’s broad, long-term objectives, specific aims, and the significance to the mission of NIAMS. Define the relevance of each proposed project and shared resource core to the overall theme and goals of the program. List all performance sites and all Key Personnel and Other Significant Contributors and their role on the project for the entire P01, beginning with the PI/PD followed by an alphabetical listing of Key Personnel and then Significant Contributors. Include all project and core leaders and consultants and consortium collaborators, if applicable.

Form Pages 4 and 5

Detailed Budget for Initial Budget Period; Budget for Entire Proposed Period of Support: Prepare a detailed composite budget for all requested support categories for the first years using Form Page 4 and a summary budget for the entire proposed period of support using Form Page 5 of the PHS 398 application. Prepare detailed and summary budgets for individual projects and cores as well. In the upper left-hand corner of the initial year and summary budget forms, identify the project or core. If applicable, provide additional budget pages pertaining to Consortium/Contractual arrangements (following the standard PHS 398 instructions).

Biographical Sketches:

Compile all biographical sketches after the Overall Budget, starting with the overall program project leader followed by all other investigators, including the individual project/ core leaders, in alphabetical order. Do not repeat biographical sketches in the individual research projects or shared resource cores.

Program Overview:

Summarize the overall goals and significance, the overall theme and integration, the overall research strategies, preliminary studies and progress (for competing renewal applications), the overall institutional resources and environment, and the overall organization and administrative structure for the P01 as a whole. The overview section must contain justification for the program project grant mechanism and describe those goals that are not readily attainable through individual research project grants. This section should include: a description of the objectives of the program as a whole that delineates the relationship of the individual research projects to the entire program project and the special scientific benefits to be achieved by funding as a program project grant rather than as a series of individual research grants; a description of facilities available including major instruments and special program resources; administrative arrangements for overall scientific leadership, quality control, and management of the program project grant. The length of this section may be no more than 12 pages.

Individual Research Projects:

Each P01 program project application must include a minimum of three individual (albeit connected) research projects each of which is pertinent to the central goal of the program. Each research project should be prepared according to the standard PHS 398 instructions. The overall format and page limits for an R01 application apply to each of the component projects. Each individual project of a program project grant should represent both a separate and an interdependent research effort. The P01 application should include the cover page, an overall Research Strategy section and any justification for human and animal experimentation. The special benefits associated with being part of the program project must also be addressed. Do not repeat the individual budget pages and biosketches. If support of core resources is requested, a separate component describing and justifying these should be included. For each individual project, page limits are 1 page for the Introduction in Resubmission or Revision applications, if applicable, 1 page for Specific Aims and 12 pages for the Research Strategy portion. For cores, the page limit is 6 pages (including Specific Aims, if relevant). The component projects should include:

Introduction

For Resubmission or Revision Application only

Specific Aims

State concisely the goals of the proposed research and summarize the expected outcome(s), including the impact that the results of the proposed research will exert on the research field(s) involved. Specific aims should be built around serving the goals of the program project.

Research Strategy

• Significance

Applicants are expected to elaborate on the importance of the problem to be addressed by the proposed project. A compelling reason for conducting the proposed research should be the focus of this section.

• Innovation

Describe the innovative nature of the proposed research.

• Approach

Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Applicants should also discuss the rationale for assembling the research team, including qualifications and selection criteria for the participating investigators and collaborators. The special benefits associated with being part of the program project and the relationship of this project to the other projects and cores should also be addressed.

As appropriate, provide (within the 12-page limit for Research Strategy):

Progress Reports for Renewal/Revision Applications

For renewal/revision applications, provide a Progress Report as part of the Approach section. Provide the beginning and ending dates for the period covered since the last competitive review. Summarize the specific aims of the previous project period and the importance of the findings, and emphasize the progress made toward their achievement. Explain any significant changes to the specific aims and any new directions including changes resulting from significant budget reductions.

Shared Resource Cores

Applicants may propose one or more (as needed) appropriate shared resources, or cores. One administrative core is allowed. Shared resource cores must not duplicate analogous resources already established in the applicant institutions, although supplemental funding to such existing resources may be requested. Each shared resource core must have a single designated Core Director. Instead of the standard PHS 398 face page for each shared resource core, create a title page that lists the shared resource core number, the name of the shared resource core and the name of the shared resource core director. Do not repeat biographical sketches included at the beginning of the application. Do not exceed six (6) pages for the description of each core. If a core includes major equipment for which additional funds are requested, the core description must include information about which P01 projects will make use of the equipment and how the equipment will facilitate interactions among the projects and progress on the central theme of the P01.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates.

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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.

An upper limit of $1,000,000 direct costs for each year may be requested in a competing program project grant application to the NIAMS. This amount is exclusive of subcontract facilities and administrative costs. Applications that exceed this cost limit without prior approval will be returned without review.

Applications must be postmarked on or before the due dates in Part I. Overview Information.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review , NIH. Applications that are incomplete will not be reviewed.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS398 Application Guide.

A software dissemination plan, with appropriate timelines, is expected in the application only if software development is a part of the application. Software sharing plans should be included with the Resource Sharing Plan. There is no prescribed single license for software produced through grants responding to this announcement. However, NIH does have goals for software dissemination, and reviewers will be instructed to evaluate the dissemination plan relative to these goals:

• The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.
• The terms of software availability should permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
• To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
• The terms of software availability should include the ability of researchers to modify the source code and to share modifications with other colleagues. An applicant should take responsibility for creating the original and subsequent official versions of a piece of software.
• To further enhance the potential impact of their software, applicants are expected to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This proposal may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution.

The plan for software sharing will be evaluated during peer review together with any other resource sharing plans.

The adequacy of the software sharing plans will be considered by program staff when making recommendations about funding applications as appropriate. In making such considerations, prior to funding, program staff may negotiate modifications of software sharing plans with the Principal Investigator(s). Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support and abide by the plan.

An institution's stance must be consistent with the goals of the funding program in advancing and not hindering future research. Please refer to the NIH Intellectual Property Policy and the Grants Policy Statement for more details. The institution’s intellectual property statement may be considered by program staff when making recommendations about funding applications as appropriate.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

Reviewers will provide an overall impact/priority score after the review of the individual components of the application. The overall impact/priority score will take into consideration: the core review criteria and any specified additional review criteria; the individual quality of the research projects and cores; the extent to which the individual projects enhance the strength of the overall program project; and the importance of the individual projects to the success of the program project. The overall impact/priority score may be higher or lower than the average of the component impact/priority scores based on the assessment of whether the whole is greater than the sum of its parts.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the entire program project 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 program project and its components proposed).

Not applicable.

Significance

Does the entire program project address an important problem or a critical barrier to progress in the field? If the aims of the program project and its components 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?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the program project and its components? 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? Are the qualifications of the leader of the program project and other senior scientists appropriate to lead the P01 and coordinate all P01 activities? Do they provide effective scientific and administrative leadership, as demonstrated by selection of individual projects for scientific excellence and thematic relatedness? Is the commitment (percent effort) of the leader and other senior investigators adequate?

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 P01? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the P01 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? Is the overall design of the P01, including strategies, methodologies and analyses, well-reasoned and appropriate to accomplish the specific aims of the program? What is the overall quality of the projects and the adequacy of the services provided by the shared resource cores (if 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? Is there evidence of sufficient institutional support for the Program Project?

Integration

Is there evidence of scientific and administrative integration of the proposed P01 and its components? Is there evidence of coordination, interrelationships, and synergy among the individual research projects and core components? Are there clear advantages or value added by conducting the proposed research as a Program Project rather than through separate research efforts? For competing renewal applications, is there evidence of productive collaborations during the current funding period?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

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

Renewals

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

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not for recommended approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

Software Sharing Plan

The reviewers will comment on the plan for software sharing.

Applications from Foreign Organizations

Not applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. The overall impact/priority score will take into consideration: the scored review criteria and any specified additional review criteria; the extent to which the individual project enhances the strength of the overall program project; and the importance of the individual project to the success of the program project. 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? 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?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative, 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? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the 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?

Shared Resource Core(s) (IF APPLICABLE)

Each Shared Resource Core must provide essential functions or services for at least two projects. The merit of each shared resource core will be assessed based on the following criteria:

• Purpose: Is the proposed Shared Resource Core well matched to the needs of the overall program? Does it provide essential facilities or services for two or more research projects?
• Quality and Quality Control: What is the overall quality of the proposed core services? Are there adequate quality control processes proposed for the facilities or services provided by the Shared Resource Core (including procedures, techniques, and quality control)? What are the criteria for prioritization and usage of Core products and/or services?
• Leadership: Are the qualifications, experience, and commitment of the leader of the Shared Resource Core and other key personnel adequate and appropriate for providing the proposed facilities or services?
• Cost-effectiveness: Will the proposed shared resource core provide cost effective services to the Program?
• Environment: Is the environment for the shared resource core adequate to support the program as proposed?

Administrative Core (IF APPLICABLE)

The Adminstrative Core provides for leadership and management of all Program Project activities. The merit of the Administrative Core will be assessed based on the following criteria:

• Purpose: Is the proposed Administrative Core well matched to the needs of the overall program? Does the inclusion of an Administration Core improve the scientific and financial management of the Program Project?
• Management: Is the proposed management plan appropriate for scientific administratiion as well as fiscal administration, procurement, property and personnel management, planning, budgeting, etc.?
• Leadership: Are the qualifications, experience, and commitment of the Program Project PD/PI(s) and other key personnel adequate and appropriate for effective management of the Program Project?
• Communication: Are there adequate plans for the establishment and maintenance of internal communication and cooperation among Program Project investigators, Program Project leadership, and the Advisory Committee (if applicable)?
• Environment: Is the environment for the administrative core adequate to support the overall program project as proposed?

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

As part of the scientific peer review, all applications:

• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Institute of Arthritis and Musculoskeletal and Skin Diseases Advisory Council . 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.
  • The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application.
  • The appropriateness of any proposed software sharing plan.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

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

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

Not Applicable.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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.

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Laura K. Moen, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-451-6515
Email: [email protected]

Charles N. Rafferty, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5019
Email: [email protected]).

Gail Hamilton
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-3506
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.