Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov)

Title: Rheumatic Diseases Research Core Centers (P30)

Announcement Type  
This is a reissue of RFA-AR-06-004.

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-AR-11-001

Catalog of Federal Domestic Assistance Number(s)
93.846

Key Dates
Release Date:  May 14, 2010
Letters of Intent Receipt Date: July 27, 2010 
Application Receipt Date : August 27, 2010 
Peer Review Date: January 2011 
Council Review Date: May 2011 
Earliest Anticipated Start Date: July 2011 
Additional Information To Be Available Date (Url Activation Date):  Not Applicable
Expiration Date: August 28, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

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.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

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 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 coresCore 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. This 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. The 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 General Clinical Research Center (GCRC) or Clinical Translational Science Award (CTSA) funded by the NIH National Center for Research Resources may wish to identify the GCRC/CTSA as a resource for conducting the proposed research.  Details of the interactions of the Core Center staff with the GCRC/CTSA staff and/or research personnel may be provided in a statement describing the collaborative linkages being developed.  A letter of agreement from the GCRC Program Director or CTSA Principal Investigator must be included with the application. 

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.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the P30 award mechanism(s).

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

The NIAMS expects to award approximately $1.6 million (direct costs) in FY 2011 through this announcement;

Future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Number of Applications. Only one application may be submitted per institution.

Resubmissions.  Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are permitted in response to this FOA.

Section IV. Application and Submission Information


1. Address to Request Application Information

The current PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

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).

Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

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

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: July 27, 2010
Application Receipt Date: August 27, 2010
Peer Review Date: January 2011
Council Review Date: May 2011
Earliest Anticipated Start Date: July 2011

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

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

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application as well as an electronic version (prefererably in pdf format) of the application and all copies of the appendix material 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  

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. 

Applicants who have applied unsuccessfully to previous Rheumatic Diseases Research Core Center FOAs may apply to the current FOA, but must present the application as a new application. The application must not include an Introduction section or otherwise explicitly address the review of the previous application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

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. The Grants Policy Statement can be found at NIH Grants Policy Statement.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.)

6. Other Submission Requirements

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

Budget

This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations.  An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Not Applicable

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Unique research resources may be generated in a core of the proposed NIAMS Core Center. If this is anticipated, include (a) resource sharing plan(s) in the core proposal.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Review Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIAMS and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support 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.”

Review Criteria for the Overall Application:

Overall Impact

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 five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  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 and technical 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/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 or multi-PD/PI, 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?  If there will be a connection with an NIH funded GCRC or CTSA, is the collaboration well described and is there an adequate letter of agreement from the GCRC Program Director or CTSA Principal Investigator?  

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 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?  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

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.

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.

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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

Resubmission Applications.  Resubmissions are not allowed for this FOA.

Renewal Applications.  When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Additional Review Considerations

As applicable for the project proposed, reviewers will address 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.  Foreign applications are not allowed for this FOA.

Select Agents 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 (Not Applicable); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

The following will be considered in making funding decisions:

NIH considers the following in evaluating Center grant applications:

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Also Section IV.5. Funding Restrictions.

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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

3. Reporting

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.

Additional information for NIAMS Core Center reporting requirements are available at http://www.niams.nih.gov/Funding/Funding_Opportunities/P30_Guidelines.pdf.

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.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

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

2. Peer Review Contacts:

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  

3. Financial or Grants Management Contacts:

Steve Austin
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd.
Suite 800
Bethesda, MD 20892
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Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. 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 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


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