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: NIAMS Building Interdisciplinary Research Team (BIRT) Revision Awards (U01, U54, P01, P50, and P60)

Announcement Type
New

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

Request For Applications (RFA) Number: RFA-AR-09-002

Catalog of Federal Domestic Assistance Number(s)
93.846

Key Dates
Release Date: August 22, 2008
Letters of Intent Receipt Date: January 19, 2009  
Application Receipt Date:February 19, 2009
Peer Review Date: May/June, 2009
Council Review Date(s): New Date: August 2009 Per NOT-AR-10-013; Original Expiration Date: October, 2009
Earliest Anticipated Start Date: September, 2009
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: February 20, 2009

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

This Funding Opportunity Announcement (FOA) issued by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov/), National Institutes of Health, solicits applications that promote collaborations among groups of investigators who have not interacted traditionally but have a clear shared scientific area of interest and opportunity in specific NIAMS mission areas.

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 and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
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

The study of human biology and behavior is a dynamic process and requires the bridging of scientific disciplines to speed the pace of scientific discovery. The scale and complexity of today's biomedical research problems demand that scientists move beyond the confines of their individual disciplines and explore new organizational models for team science. Integrating different disciplines holds the promise of opening up scientific avenues of inquiry and, in the process, may result in new disciplines with which to tackle increasingly complex questions. Advances in musculoskeletal and skin tissue engineering and regenerative medicine, for example, will be enhanced through collaborations among diverse groups – cell biologists, material scientists, developmental biologists, engineers, immunologists, and clinicians.

The NIAMS intends to build interdisciplinary research teams that will lead to new scientific advances beyond the progress attainable in the absence of collaboration. A successful interdisciplinary approach is defined as combining aspects of individual disciplines to provide a new conceptual approach to solving a problem that is likely to yield insights that could not have been achieved by an isolated laboratory. This FOA pilots the BIRT awards that provide up to one (1) year of research revisions (formerly referred to as “supplements”) to active NIAMS U01, U54, P01, P50, or P60s in order to establish collaborations in basic and/or translational research among groups of investigators with expertise in specific NIAMS mission–relevant areas that:

  1. Develop new interdisciplinary collaborations among funded projects in different disciplines, or

  2. Develop new interdisciplinary collaborations that significantly expand the scope of a funded project by adding expertise and approaches from another discipline.

Revision applications for incremental additions to existing projects that do not meet these criteria are outside the scope of this FOA. It is anticipated that a successful collaboration will result in development of new competitive research projects (such as new multi-PI R01s), or new directions for the competitive renewal of the parent grant, or creation of resources and facilities shared in scientific communities, or establishment of a series of scientific meetings/workshops that will effectively exchange ideas and disseminate information/knowledge of an interdisciplinary nature.

This FOA solicits highly innovative applications with potentially high impact that build collaborations between the specific scientific areas listed below. Examples listed for each area below are not exhaustive.

It is becoming increasingly clear that gender and sex factors play a role in the pathogenesis of and responses to treatment in autoimmune and inflammatory diseases of interest to the NIAMS, such as lupus, rheumatoid arthritis, and systemic sclerosis. Autoimmune diseases are more prevalent in women than in men, and may be related to sex hormones and sex-related genes. Some important areas of study that could be explored through collaborations are the role of estrogen and estrogen receptors in tolerance and autoimmunity; the influence of gender and sex factors in development of inflammation and perception of pain; the interplay of gender and sex factors with genetic and environmental causes of disease; and clinical and translational research on sex differences and autoimmune diseases. Collaboration among researchers in different disciplines and sharing of information, data sets, and resources could accelerate advances in these areas.

The immune system is complex and dynamic, with a wealth of intra-and inter-cellular interactions.  Autoimmune diseases affecting the musculoskeletal and skin systems are characterized by harmful immune/inflammatory responses, and given the complexity of immune responses, etiologic and mechanistic questions are difficult to answer. Current technologies for studying autoimmune diseases generate very large data sets that require a systems biology approach if the data are to be integrated into a dynamic model that can be used to better understand the interrelationships between immune system components over time and their regulation.  For the BIRT applications, systems biology is defined as a research approach used to understand the network behavior of biological systems, in particular their dynamic aspects, through the acquisition of detailed quantitative data combined with conceptual and mathematical modeling of the systems’ components and their interactions, in order to predict the behavior of the system when perturbed or to develop novel ways to modulate the behavior of the system.

The development of musculoskeletal and skin tissues is also a complex dynamic process involving the growth and differentiation of multiple cell types in a well orchestrated manner. Multiple signal transduction pathways play important roles in coordinating this process and regulate the expression of a large number of genes. Current technologies for studying these processes and pathways produce large amounts of data. A systems biology approach to the analysis of these data should facilitate our understanding of the regulation of complex systems (as seen in a developing tissue or organism) and the interrelationships between system components over time.

Regenerative medicine encompasses the knowledge and practice of tissue engineering as well as healing through endogenous recruitment or exogenous delivery of appropriate cells, biomolecules, and supporting structures. It can also involve gene therapy to block a disease process, replace a missing or defective protein, or enhance tissue regeneration. Adverse immunological reactions prevent the physiological integration and function of the regenerated organ/tissue equivalents. Immune reaction to vectors or transgene products can limit the effectiveness of gene therapy approaches. On the other hand, recent scientific advances suggest that inflammation might be able to enhance regeneration when precisely controlled temporally and spatially. Therefore, partnerships between regenerative medicine and immunology communities are likely to accelerate the accumulation and translation of knowledge in the respective scientific fields and ultimately may lead to the development of more effective therapies.

There are developing needs related to our understanding of musculoskeletal soft tissues (cartilage, growth plate, muscle, tendon, ligament, synovium, meniscus, and intervetebral disc). Musculoskeletal soft tissue injuries are very common and, if left untreated, often lead to development of chronic disease/problems such as carpal tunnel syndrome, muscle atrophy, or osteoarthritis. Diseases such as the muscular dystrophies, rheumatoid arthritis and other diseases of muscle and joints cause disability and even death. Yet our knowledge of the biology, healing, and repair of these tissues and the availability of non-invasive means to assess onset and progression of disease/injury and outcomes of treatments are relatively limited.  Non-invasive imaging technologies can assist in detection and assessment of injuries, and inherited or acquired diseases of musculoskeletal soft tissues that lead to changes in the volume, composition and physical properties of tissue. One area that could be pursued under this initiative is the development of quantitative or semi-quantitative methods to assess disease progression, repair or regeneration of these tissues as measures of treatment efficacy. Imaging technologies can also assess physiologic and metabolic states, providing insight into normal function and disease processes. While clinical imaging methods currently exist, collaborative efforts between soft tissue biologists, tissue engineers, clinical investigators and imaging scientists are needed to develop more sensitive and accurate quantitative methods to monitor outcomes. 

Tissue engineers seek to create organ/tissue equivalents or introduce/induce exogenous/endogenous molecules to repair, replace, preserve, or enhance tissue/organ function lost due to disease, injury, aging, or genetic abnormalities. Understanding the developmental process by which a multicellular organism develops from its early immature form into mature form may have direct impact on tissue engineering efforts. The significance of applying principles learned from developmental to regenerative processes is evident. Therefore, partnerships between tissue engineering and developmental biology communities are likely to accelerate the accumulation and translation of knowledge in the respective scientific fields and ultimately may lead to the development of new or more effective therapies.

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 revision (formerly referred to as “competing supplement”) to the U01, U54, P01, P50 or P60 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 estimated amount of funds available for support of up to 10 BIRT projects awarded as a result of this announcement is $1M direct cost for both RFA-AR-09-001 and RFA-AR-09-002 in fiscal year 2009. 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 NIAMS 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 http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

The NIAMS is looking for new collaborations between different, specific disciplines that will lead to new scientific advances in areas relevant to the NIAMS mission – not incremental additions to existing grants. A BIRT application can not be requested to support collaborations among investigators who already have on-going, formal collaborations in the parent grant or other funded projects, with the exception that when subproject PIs of U54, P01, P50, or P60 develop new interdisciplinary collaborations with independent investigators of other disciplines, the subproject PI and the collaborator(s) must use multi-PI application and apply with the parent PD/PI as the “Contact PI”.

Research revision support will be awarded to active NIAMS U01, U54, P01, P50, or P60s. To ensure sufficient time for full development of collaboration, all of the involved grants should not end earlier than January 31, 2011. The budget period for the revision must not exceed that of the parent award.   

The scope of the revision should be relevant to and beyond that of the NIAMS U01, U54, P01, P50, or P60. The goal(s) of the revision should not substitute for the specific aims of the originally anticipated competitive renewal of the parent grant, and should represent a significant addition to the initial specific aims. They should either lead to new directions or add to the parent grant a new dimension or significant expertise from different disciplines.

No competing renewals are allowed. 

Applicants may submit more than one application, provided each application is scientifically distinct. A BIRT application can be submitted for each active NIAMS U01, U54, P01, P50, or P60, and/or for each of their subprojects, i.e. more than one BIRT application can be submitted for each U54, P01, P50, or P60. If a new interdisciplinary collaboration is developed by a subproject PI with independent investigators of other disciplines, the application must be submitted as a multi-PI application with the parent PD/PI as the “Contact PI”, and the PD/PI of an NIAMS U54, P01, P50, or P60 grant must also write a letter of agreement stating that the revision support will be used for the requested collaboration. The funding period requested in the revision must not exceed that of a parent grant.

Section IV. Application and Submission Information


1. Address to Request Application Information

The 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

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. 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.

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600260.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

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

Opening Date: January 19, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: January 19, 2009
Application Due Date: February 19, 2009
Peer Review Date(s): May/June, 2009
Council Review Date: October, 2009
Earliest Anticipated Start Date: September, 2009

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:

Elijah Weisberg, MSE
Research Program Analyst
Division of Musculoskeletal Diseases
NIAMS, NIH, DHHS
6701 Democracy Blvd, Suite 800
Bethesda, MD 20872-4872
Tel: (301) 594-5055
FAX: (301) 480-4543
Email: weisberge@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 must be sent to:

Charles H. Washabaugh, PhD, MS
Scientific Review Officer
Scientific Review Branch
NIAMS, NIH, DHHS
6701 Democracy Plaza, Suite 800
Bethesda, MD 20892-4872
Tel: (301) 496-9568

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.

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 and Information

Research Plan Page Limitations

Must not exceed 5 pages

Appendix Materials

No appendix materials will be allowed for applications submitted to this FOA.

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/.

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

Special Instructions

BIRT revision applications can be requested only for active NIAMS U01, U54, P01, P50, or P60s that meet eligibility criteria. Please note that the BIRT applications will be evaluated by review panels that represent a diversity of the NIAMS scientific interests and broad expertise.  Therefore, jargon must be avoided. Clearly explain the challenge, the potential impact, and the approach in language that scientists in related fields can understand. Reviewers will be asked to evaluate the BIRT applications with emphases on significance  and innovation.

Application details

A BIRT revision application must include the following:

Any revision application that exceeds the page limits will not be reviewed.

Applicants are invited to visit the NIAMS BIRT website for answers to commonly asked questions (http://www.niams.nih.gov/Funding/Funding_Opportunities/Supported_Scientific_Areas/Musculoskeletal_Diseases/birt_faq.asp).

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).
Only the review criteria described below will be considered in the review process.

2. Review and Selection 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 the NIAMS Scientific Review Branch 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 following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.  Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application.  Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. 

A single numerical priority score will be assigned to the BIRT application as a whole after review elements have been discussed and weighted as listed below. For this FOA, reviewers will be instructed to emphasize significance and innovation in their consideration of highly meritorious applications, and to consider the approach for general feasibility. Neither unavoidable risk, which is intrinsic to novel and innovative approaches and expected for the BIRT applications, nor lack of preliminary data will preclude an application receiving an outstanding priority score.

Significance: Does this study address an important problem? If the goals of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the impact of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does it promote interdisciplinary collaboration in the specific NIAMS mission–relevant areas solicited in the FOA?

Innovation:  Is the project’s research and collaboration original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Is the level of risk commensurate with the anticipated reward?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the goals of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs? Is a collaboration plan included and appropriate? Does the proposed research benefit by the interdisciplinary collaboration?

Investigators: Are the PD(s)/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Do(es) the PD(s)/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?  

Environment:  Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed. 

2.C. Resource Sharing Plan(s)   

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

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 (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the 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.

Grantees are expected to report any outcomes of the revision awards leading to:

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:

Carl C. Baker, MD, PhD
Program Director
Division of Skin and Rheumatic Diseases
NIAMS, NIH, DHHS
6701 Democracy Blvd, Suite 800
Bethesda, MD 20892-4872
Tel:  (301)594-5017
Fax:  (301)480-4543
Email:  bakerc@mail.nih.gov

Fei Wang, PhD
Program Director
Division of Musculoskeletal Diseases
NIAMS, NIH, DHHS
6701 Democracy Blvd, Suite 800
Bethesda, MD 20872-4872|
Tel: (301) 594-5055
FAX: (301) 480-4543
Email: wangf@mail.nih.gov

Elijah Weisberg, MSE
Research Program Analyst
Division of Musculoskeletal Diseases
NIAMS, NIH, DHHS
6701 Democracy Blvd, Suite 800
Bethesda, MD 20872-4872|
Tel: (301) 594-5055
FAX: (301) 480-4543
Email: weisberge@mail.nih.gov

2. Peer Review Contact(s):

Charles H. Washabaugh, PhD, MS
Scientific Review Officer
Scientific Review Branch
NIAMS, NIH, DHHS
6701 Democracy Plaza, Suite 800
Bethesda, MD 20892-4872
Tel: (301) 496-9568
Fax: (301) 402-2406
Email: washabac@mail.nih.gov

3. Financial/Grants Management Contact(s):

Melinda Nelson
Chief Grants Management Officer
NIAMS, NIH, DHHS
6701 Democracy Blvd, Suite 800
Bethesda, Maryland 20892
Tel: (301) 594-3535
Fax: (301) 480-5450
E-mail: nelson1@mail.nih.gov

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).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

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. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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-02-005.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. Applications that do not provide this information will be returned without review.

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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