Department of Health and Human Services

Part 1. Overview Information
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

Rheumatic Diseases Research Core Centers (P30)

Activity Code

P30 Center Core Grants P30

Announcement Type

Reissue of RFA-AR-11-001

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-AR-12-002

Companion FOA

None

Number of Applications

Only one application per institution is allowed.  See Section III. 3. Additional Information on Eligibility.

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

93.846

FOA Purpose

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) invites applications for Research Core Centers (P30s) in rheumatic diseases. The Rheumatic Diseases Research Core Centers (RDCCs) will provide shared facilities and services to groups of established, currently funded investigators addressing scientific problems in rheumatic diseases, in order to improve efficiency, accelerate the pace of research, and ensure greater productivity.

Key Dates
Posted Date

November 17, 2011

Letter of Intent Due Date

February 1, 2012

Application Due Date(s)

March 1, 2012

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

June/July  2012

Advisory Council Review

August 2012

Earliest Start Date(s)

 Sept 1,2012

Expiration Date

March 2, 2012

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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Research in rheumatic diseases is at a stage where a number of areas are making broad advances that can be effectively fostered by research Core Centers.  Examples of these areas include, but are not limited to:

The choice of a research area(s) upon which the RDCC would focus is made by the investigators.

In addition to providing services and resources to facilitate independently funded research projects, the Core Centers are encouraged to enhance the research environment and promote synergistic collaborations among the Center Investigators (the investigators of the research base).  Scientific core personnel should help to educate the Center Investigators in the capabilities and limitations of the technologies employed by the scientific cores.  Core personnel should be involved with the investigators in designing the experiments and interpreting the results.  The technologies of the cores should not only evolve with the science conducted by the Center Investigators, but the cores should help to drive the science with increasingly sophisticated and powerful technologies. 

The RDCCs will provide support for:

1.  Core resources and facilities to be used by investigators of individually supported research projects in order to enhance and coordinate their activities.  This support may include personnel, equipment, supplies, services, and facilities;

2.  An Enrichment Program, designed to expand the research base in the area of rheumatology research.  A minimum of $30,000 and up to $100,000 direct costs will be allocated each year to the Enrichment Program, which will be administered through the Administrative Core;

3.  An Administrative Core

An Administrative Core, including a Director, Associate Director, and an Advisory Committee, should be proposed to coordinate the Core Center activities, to evaluate and improve the Center and to administer an Enrichment Program.  The Advisory Committee should include users of the scientific cores and experts outside the Core Center Institution with expertise in the management of scientific core facilities.  This Committee should help the Director and Associate Director to regularly evaluate and optimize strategies to meet the scientific needs of the research base over the course of the grant award. 

An Enrichment Program, designed to expand the research base in the area of rheumatology, must be proposed.  The RDCC will allocate a minimum of $30,000 and up to $100,000 direct costs each year to the Enrichment Program, which will be administered through the Administrative Core.  Each RDCC can decide how much money and what type of activities to include as part of the Program, based on what best suits the needs of the RDCC.  The applicant must justify how the activities of this Program will aid in bringing new investigators (either early-stage or from a different field) into rheumatology research.  Through this Enrichment Program, the Administrative Core can utilize the Research Cores to foster the development of new investigators, new technologies, and/or new collaborations with those who have not previously participated in rheumatology research.  For example, types of activities that may be part of an Enrichment Program include (and are not limited to) mentoring programs and activities, pilot and feasibility studies (mentored or non-mentored), and support of seminars and visiting scientists.  Enrichment Program activities should occur within the context and/or with the involvement of the Research Cores.  Innovative approaches to Program Enrichment are encouraged.  If the RDCC chooses to include direct funding for research (e.g., through a Pilot and Feasibility program and/or mentored activity), descriptions of such projects or individuals named for support will NOT be included in the application.  However, plans for solicitation and review of project applications during the tenure of the core center, and/or plans to select mentees and projects should be included.  All Enrichment Programs  must include a detailed budget and description of Program leadership and management. 

Two or more research cores must also be proposed.  A research core is a facility shared by two or more Center investigators that enables them to conduct their independently-funded individual research projects more efficiently and/or more effectively.  Cores generally fall into one of four categories: (1) provision of a technology that lends itself to automation or preparation in large batches (e.g., histology, tissue culture, high throughput sequencing, genotyping); (2) complex instrumentation (e.g., electron microscopy, flow cytometry, confocal microscopy, whole animal imaging, microarray scanning, mass spectrometry); (3) animal preparation (including transgenic and knockout) and care; and (4) methodology cores (e.g., molecular biology, biostatistics, systems biology, bioinformatics, clinical).  

Core Center Directors are encouraged to leverage existing resources, such as registries, tissue banks and cohorts, and to coordinate with NIAMS-funded Core Centers at the same and/or other institutions, particularly if they provide similar or overlapping technologies and services.  Applicants from institutions that have a Clinical Translational Science Award (CTSA) funded by the NIH may wish to identify the CTSA as a resource for conducting the proposed research.  Details of the interactions of the Core Center staff with the CTSA staff and/or research personnel may be provided in a statement describing the collaborative linkages being developed.  A letter of agreement from the CTSA Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must be included with the application.  Leveraging of existing resources is encouraged, particularly when this provides a range of services or efficiency that would not otherwise be available. Furthermore, applicants must demonstrate that support for the existing resource through the Core Center provides added value to the resource beyond that which would be provided by paying for the use of the resource through a fee for service.

Research Core Center Guidelines where application requirements are described in more detail can be found at http://www.niams.nih.gov/Funding/Funding_Opportunities/P30_Guidelines.pdf.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The NIAMS intends to fund up to 3 awards for $1.2M Direct Costs ($1.8M Total Costs) in FY 2012.

Award Budget

Direct costs of up to $400,000 per year may be requested..

Award Project Period

Scope of the proposed project should determine the project period.  The maximum period is five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations 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.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Only one application per institution is allowed.  

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.

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

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.

Letter of Intent

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:

The letter of intent should be sent to:

Marie Mancini, Ph.D.
Program Director, Systemic Autoimmune Diseases Biology
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd.
Suite 800
Bethesda, MD 20892
Telephone: (301) 594-5032
Email: mancinim2@mail.nih.gov

Application Submission

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 five identical CDs containing all appendix materisl must be sent to:

Charles Rafferty, Ph.D.
Chief, Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd.
One Democracy Plaza, Suite 800
Bethesda, MD 20892
Telephone: (301) 594-4952
Email: raffertycn@nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).  Each budgeted component (administrative core, each research core) should be written as an individual project using form PHS398.  In addition to the budgeted components, each application should have an Overview Section that serves as a synopsis of the key elements of the proposed Core Center, describes the research base and institutional environment, the significance of the Core Center with respect to the research base, the interactions among the Center Investigators and the Cores, the innovation of the Core Center, the approach for providing core services and resources, and a progress report describing the impact of the Core Center on the research base (renewal applications only).

The Overview section should be organized in the following fashion:

1.  Introduction to the Overall Center

2.  Institutional Environment and Research Base

3.  Significance

4.  Investigators of the Research Base and Center

5.  Innovation

6.  Approach

7.  Progress Report (for renewal applications only)

The Research Strategy section for each Research Core and the Administrative Core may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts.  A Table denoting Use of Core Services (for a Research Core) should be inserted into the Resources Format Page, Item 4.7, in the General Materials of the Research Core Section.  The Overview Section for the Center may not exceed 12 pages. Letters of Support are excluded from the 12 page limit for the Overview section.  The required Table of the Research Base and the recommended Table denoting past Use of Core Services (for renewal applications only) should be inserted into the Resources Format Page, Item 4.7, in the General Materials Section.

Application instructions and materials specific to the P30 grant mechanism are available at http://www.niams.nih.gov/Funding/Funding_Opportunities/P30_Guidelines.pdf.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

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.

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information.  If an application is received after that date, it will not be reviewed.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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.

After the review of the individual components of the application, an overall impact/priority score will be assigned to the application. This score will reflect not only the quality of the individual Research Cores and Administrative Core, but also how the proposed RDCC will bring together all these elements in an effective and cohesive unit. The overall score may be higher or lower than the “average” of the components based on the assessment of whether the “whole is greater than the sum of its parts.”

Overall Impact - Overall

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

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a 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? What is the scientific quality of the individual Research Cores and Administrative Core?  Will the proposed cores enhance the research base in the field of rheumatology?  Does the set of proposed Research Cores collectively provide the most appropriate services and resources to meet the scientific needs of the research base?

Investigator(s)

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

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? Is it likely that there will be coordination, collaboration and synergy among the individual Research Core components, Administrative Core component and existing research base?

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

Review Criteria for the Administrative Core:

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

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

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

Enrichment Program.  Is there a well-designed and innovative plan for activities that are likely to enhance the communication, coordination and collaboration among Center Investigators and to expand the pool of investigators and broaden the spectrum of research in rheumatology conducted through the Center? 

Review Criteria for Research Cores:

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

Investigators.  Are the qualifications, experience, and commitment of the Research Core Director and his/her collaborations with Core Center investigators appropriate to the proposed technical area?

Innovation.  Will the services and resources provided by the Research Core not only evolve with the science conducted by the Center Investigators, but are they also likely to drive the science with increasingly sophisticated and powerful technologies?  Is the Research Core likely to promote interdisciplinary research?

Approach.  Are the services and resources of the Research Core of high quality? Does support for the service or resource through the Core Center provide added value beyond that which would be provided through a fee for service, 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 Center 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?  Does it include the institutional commitment to the program, including lines of accountability regarding management of the Research Core, and to individuals responsible for conducting essential Core Center functions?

Additional Review Criteria - Overall

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

Not Applicable.

Renewals

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

Revisions

Not Applicable.

Additional Review Considerations - Overall

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.   

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.   

2. Review and Selection Process

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. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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 Councill. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) 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.

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

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 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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: commons@od.nih.gov

Scientific/Research Contact(s)

Marie Mancini, Ph.D.
Program Director, Systemic Autoimmune Diseases Biology
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd.
Suite 800
Bethesda, MD 20892
Telephone: (301) 594-5032
Email: mancinim2@mail.nih.gov

Peer Review Contact(s)

Charles Rafferty, Ph.D.
Chief, Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd.
Suite 800
Bethesda, MD 20892
Telephone: (301) 594-4952
Email:  raffertycn@nih.gov 

Financial/Grants Management Contact(s)

Steve Austin
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892
Telephone: (301) 594-3535
Email: austins2@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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