and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
|
Funding Opportunity Title |
Multidisciplinary Clinical Research Centers (P60) |
Activity Code |
P60 Comprehensive Center |
Announcement Type |
Reissue of RFA-AR-12-001 |
Related Notices |
None |
Funding Opportunity Announcement (FOA) Number |
RFA-AR-13-001 |
Companion FOA |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.846 |
FOA Purpose |
The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health, invites new and renewal applications for Multidisciplinary Clinical Research Centers (MCRCs) in arthritis, musculoskeletal disorders, and/or skin diseases. Each MCRC will be organized around a methodology core. In addition to this core, each center must include a minimum of two highly meritorious clinical projects focused on diseases or conditions within the NIAMS mission (http://www.niams.nih.gov/Funding/Funding_Opportunities/Supported_Scientific_Areas/default.asp). The methodology core will be the foundation of the MCRC, providing key support for the development and implementation of clinical projects. Each clinical project must address a critical issue that directly involves prevention, assessment and/or outcomes for patients with chronic diseases or conditions within the mission of the NIAMS. The MCRCs will build on a meritorious research base and are expected to leverage existing institutional infrastructure resources. Clinical trials will not be supported by this funding mechanism. |
Posted Date |
January 10, 2012 |
Letter of Intent Due Date |
April 18, 2012 |
Application Due Date(s) |
May 18, 2012 |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
Sept/Oct 2012 |
Advisory Council Review |
January, 2013 |
Earliest Start Date(s) |
April 1, 2013 |
Expiration Date |
May 19, 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.
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
The purpose of the MCRC program is to support a full range of outstanding multidisciplinary clinical research in the areas of arthritis and musculoskeletal and skin diseases and disorders. The goals of this program are to support research on the prevention, assessment or improvement of outcomes for patients with arthritis, rheumatic diseases, skin diseases or diseases or disorders of the musculoskeletal system. For a comprehensive listing of conditions that fall within the NIAMS mission, please see http://www.niams.nih.gov/Funding/Funding_Opportunities/Supported_Scientific_Areas/default.asp For guidance on the relevance of a proposed study to the NIAMS mission, contact the Program Directors listed below under Scientific/Research Contacts.
Each MCRC should be organized around a methodology core and must include a minimum of two highly meritorious clinical projects. The projects and overall Center can be focused on one or more disease/condition. The methodology core must demonstrate that it can provide support for multidisciplinary approaches for clinical projects within and outside the MCRC. It is anticipated that some MCRCs may bring a multidisciplinary clinical approach to closely related diseases or disorders for which there is a paucity of clinical research nationally. Other MCRCs may focus on advancing clinical research on diverse diseases within the mission of NIAMS. The scientific focus of the MCRC may also be developed around already collected or ongoing significant cohorts or other patient resources.
The methodology core is the foundation of the MCRC, providing key support for the development and implementation of clinical projects. The methodology core is expected to provide expertise and support to ongoing projects within the research base of the MCRC and to other emerging research opportunities funded elsewhere that are relevant to the NIAMS mission. The methodology core is not expected to conduct laboratory assays, although such may be included in an additional, separate core. The director of the MCRC, aided by an executive committee and the methodology core, provides leadership to assure a rigorous research approach and to focus all clinical projects on critical issues relevant to disease prevention or to assessment and/or to improve patient outcomes. The proposed director should document this leadership with examples of the ability to network with colleagues from clinical and other areas of biomedical research.
The MCRCs are expected to leverage existing institutional infrastructure resources. A meritorious research base in patient-oriented research, biobehavioral and social sciences, epidemiology and/or health services is a prerequisite for proposing an MCRC. Each MCRC application should define its research base, goals for promoting clinical research utilizing that research base, and how multidisciplinary research will be promoted. Potential interactions and/or collaborations with a Clinical and Translational Science Award (CTSA), if present, must be documented.
Each clinical research project must address a critical issue that directly involves prevention, assessment and/or outcomes for patients with diseases/conditions within the mission of the NIAMS. Clinical approaches that could be utilized by the centers may include, but are not limited to:
Epidemiology, Outcomes and health services research, Biomarker analysis, Human genetics, Bio-psychosocial/behavioral research.
The NIH defines human clinical research as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research. Note: Studies falling under Exemption 4 for human subjects research are not considered clinical research by this definition.
For this MCRC program, neither animal studies nor clinical trials (of any phase) should be included.
In summary, the key elements of an MCRC must include:
A Center Director, Associate Director and executive committee with outstanding credentials for promoting clinical research;
A meritorious research base that encompasses diseases/conditions within the NIAMS mission and provides professional and patient resources for developing clinical projects;
A methodology core that will 1) play a key role in providing support for multidisciplinary approaches for clinical projects within and outside the MCRC and 2) contribute to the clinical research training environment of the center; and
A minimum of two highly meritorious clinical research projects that 1) target one or more of the diseases/conditions within the NIAMS mission, and 2) each utilizes the methodology core.
Optional elements of an MCRC are:
A pilot/feasibility project (no more than one may be proposed) supported by the methodology core and
Other core(s) supportive of two or more of the proposed projects.
Additional information about the MCRC program can be found at http://www.niams.nih.gov/Funding/Funding_Opportunities/P60_Guidelines.pdf. These guidelines are intended to assist the applicant in assembling an application in a manner to facilitate an optimal review of the complex topics covered in the application.
Funding Instrument |
Grant |
Application Types Allowed |
New |
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. NIAMS intends to fund up to three awards, corresponding to a total of $3.6M, for fiscal year 2013. Future year amounts will depend on annual appropriations. |
Award Budget |
An applicant may request a project period of up to 5 years and a budget for direct costs up to $800,000 per year exclusive of facilities and administrative costs of subcontracts with collaborating organizations. |
Award Project Period |
Scope of the proposed project should determine the project period. The maximum period is 5 years. For the pilot/feasibility project (no more than one may be proposed) supported by the methodology core in the P60, a yearly budget of up to $50,000 in direct costs for no more than three years may be requested. |
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
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
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH
Grants Policy Statement, are not allowed.
Applicant organizations 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.
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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.
For this MCRC program, multiple PD(s)/PI(s) are permitted only for the subprojects and cores but not for the entire MCRC center program
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.
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.
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:
Justine F. Buschman, M.S.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza
6701 Democracy Blvd., Suite 877
Bethesda, MD 20892
office 301-496-4811
[email protected]
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 Rafferty, Ph.D.
Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy One, Room 818
6701 Democracy Blvd.
Bethesda, MD 20892
Telephone: (301) 594-5019
Fax: (301) 402-2406
Email: [email protected]
All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following requirements:
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, with the following modification:
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.
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.
Guidelines are available for the MCRC program at http://www.niams.nih.gov/Funding/Funding_Opportunities/P60_Guidelines.pdf. These guidelines are intended to assist the applicant in assembling an application in a manner to facilitate an optimal review of the complex topics covered in the application.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the entire MCRC) 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 overall MCRC and its components proposed). This overall impact/priority score will reflect not only the quality of the individual projects, cores, and administration, but also how the proposed MCRC will bring together all these elements into a workable 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 that the sum of its parts..
Reviewers will consider each of the review criteria below in the determination of scientific merit,. 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 proposed MCRC address an important problem or a critical barrier to progress in the field? If the aims of the MCRC 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? Do the Director and Associate Director have the leadership and research qualifications to lead a Center? Does the leadership team (Director, Associate Director, and executive committee) have the collective expertise to assure focused development and implementation of high quality and meaningful clinical research projects?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the MCRC 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(s)/PI(s), 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 MCRC? Are potential problems, alternative strategies, and benchmarks for success presented?
If the MCRC is in the early stages of development, will the strategy establish
feasibility and will particularly risky aspects be managed?
If the MCRC 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 MCRC benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Is there evidence of sufficient institutional commitment for the MCRC? Will the MCRC add an important multidisciplinary element to the institutional environment? Does the proposed MCRC utilize available resources well?
Research Base
Is there a substantial productive and funded research base? Is the research base sufficiently broad to foster new multidisciplinary research? Is there a definition of who will be a Center investigator and what this designation might mean? Does the application convey how the proposed MCRC will enhance the research base of the host institution?
Integration
Does the proposed MCRC leverage existing institutional resources? Is there evidence of interaction between the proposed clinical projects and the methodology core? Are there clear advantages of conducting the proposed research as MCRC rather than through separate research efforts?
Past Progress of a Renewal MCRC (IF APPLICABLE):
Does the progress report reflect significant accomplishments and impact of the MCRC during the last funding cycle? Is the work of the MCRC reflected in new concepts and publications?
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 MCRC; and the importance of the individual project to the success of the MCRC. 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? If a Pilot/Feasibility project is proposed, is it likely to yield meaningful preliminary data as the basis for the development of a successful full-scale research application?
Investigators
Are the PD(s)/PI(s), 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-PD(s)/PI(s), 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? If a Pilot/Feasibility project is proposed, is the research topic one that promotes innovative research related to the MCRC?
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? Does the project utilize the multidisciplinary resources of the MCRC, especially the Methodology Core? If a Pilot/Feasibility project is proposed, does the project utilize the multidisciplinary resources of the MCRC, especially the Methodology Core and does it employ useful collaborative arrangements?
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? If a Pilot/Feasibility project is proposed, is the project appropriate to the research base of the center? Does one or more of the cores offer needed materials/assistance?
The required Methodology Core must provide essential methodological, biostatistical and educational functions as well as maintenance of data integrity and development of safety plans for all projects in the MCRC. The merit of the Methodology Core will be assessed based on the following criteria:
Purpose
Is the proposed Methodology Core well matched to the needs of the overall MCRC? Does it serve all research projects proposed for the Center? Are unique services offered? Is the process for maintenance of data integrity and assistance with development of safety plans for the projects supported by the MCRC adequately addressed? Is there evidence that the Methodology Core can and will support clinical research projects in more than one chronic disease or condition of interest to the NIAMS?
Quality and Quality Control
What is the overall quality of the proposed core services? Are there adequate quality control processes proposed for the services provided by the Methodology Core (including procedures, techniques, and quality control)? What are the criteria for prioritization and usage of Core products and/or services? Is the Methodology Core likely to promote multidisciplinary research?
Leadership
Are the qualifications, experience, and commitment of the leader of the Methodology Core and other key personnel adequate and appropriate for providing the proposed services?
Cost-effectiveness
Is the core cost effective? How is cost reimbursement proposed?
Environment
Is the environment for the Methodology Core adequate and appropriate to support the MCRC as proposed? Are the facilities and equipment adequate and appropriate? Is there evidence of institutional support?
Training Activities
Does the methodology core propose an adequate plan for enhancing the clinical training environment at the center? Will the core provide opportunities such as seminars, courses, workshops or computer based training to enhance the capabilities of faculty, staff, students and fellows associated with the center to conduct clinical research using a wide range of approaches?
Purpose
Is the proposed Core well matched to the needs of the overall program? Will the core have utility to at least two of the MCRC projects? Do the services offered best fit within a core structure? If this is an add-on to a preexisting core, what is the benefit to the MCRC over direct purchase of services from the existing core?
Quality and Quality Control
What is the overall quality of the proposed core services? Is the quality of services high? Are there procedures for quality control?
Leadership
Are the qualifications, experience, and commitment of the leader of the Core and other key personnel adequate and appropriate for providing the proposed facilities or services?
Cost Effectiveness
Is the core cost effective? If the core offers new services that may be used by non-MCRC funded projects, how will the non-MCRC funded projects purchase these services from the core?
Environment
Are the facilities and equipment adequate? Is there institutional commitment to the core?
The Administrative Core provides for leadership and management of all MCRC activities. The merit of the Administrative Core will be assessed based on the following unscored criteria:
Purpose
Is the proposed Administrative Core well matched to the needs of the overall center?
Management
Is the management proposed appropriate for scientific administration as well as fiscal administration, procurement, property and personnel management, planning, budgeting, etc.? Are there scientific and administrative leadership, commitment and ability, and adequate time commitment of the MCRC Director and Associate Director for the effective management of the MCRC program?
Leadership
Do the Director and Associate Director have the leadership and research qualifications to lead a MCRC? Do the proposed MCRC Director, Associate Director and executive committee have the collective expertise and leadership to identify and focus research projects on clinically relevant issues?
Communication
Is there an appropriate plan for establishment and maintenance of internal communication and cooperation among the MCRC investigators, core leaders and executive committee? Are there appropriate plans for outside review and input?
Environment
Is the environment for the Administrative Core adequate and appropriate to support the overall program project as proposed? Is there evidence of institutional support for the management of the MCRC?
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
Resubmissions applications are not permitted in response to this FOA.
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.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the 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 be assigned to the appropriate NIH Institute or Center and 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 . The following will be considered in making funding decisions:
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.
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.
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 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.
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]
Yan Wang, M.D., Ph.D.
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza, Suite 800
6701 Democracy Blvd.
Bethesda, MD 20892-4872
Telephone: (301) 594-5032
Fax: 301-480-1284
Email: [email protected]
James Panagis, M.D., MPH
Division of Musculoskeletal Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd
One Democracy Plaza, Suite 800
Bethesda, MD 20892
Telephone: (301) 594-3513
Email: [email protected]
Charles Rafferty, Ph.D.
Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Democracy One, Room 818
6701 Democracy Blvd.
Bethesda, MD 2089
Telephone: (301) 594-5019
Fax: (301) 402-2406
Email: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Natalie Reyes
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Boulevard, Suite 800
Bethesda, MD 20892
Telephone: (301) 451-3648
FAX: (301) 480-5450
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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NIH Funding Opportunities and Notices
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