and Human Services (HHS)
EXPIRED
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 (R01)
Announcement Type
New
Request for Applications (RFA) Number: RFA-AR-09-001
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)
93.846
Key Dates
Release/Posted Date: August 22, 2008
Opening Date: January 19, 2009 (Earliest date an application
may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January
19, 2009
NOTE: On-time submission requires that applications be successfully submitted
to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due
Date(s): February
19, 2009
Peer Review Date(s): May/June,
2009
Council Review Date(s): August 2009
Earliest Anticipated Start Date(s): September, 2009
Additional Information To Be Available Date (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 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 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. 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. Submitting an Application
Electronically to the NIH
C. Application Processing
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 Contacts
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 R01s in order to establish collaborations in basic and/or translational research among groups of investigators with expertise in specific NIAMS mission relevant areas. Revisions must either:
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 intervertebral 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 FOA will use the revision (formerly
referred to as competitive supplement ) to the R01 award mechanism.
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 (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, a U.S. organization submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs) must use the PHS398 Modular Budget component.
U.S. applicants requesting more than $250,000 in annual direct costs and all Foreign applicants must complete and submit budget requests using the Research & Related Budget component.
2. Funds Available
The NIAMS intends to commit approximately $1M direct cost for both RFA-AR-09-001
and RFA-AR-09-002 in
fiscal year 2009 to make up to 10 awards. The expected direct cost for each
BIRT award is up to $100,000.
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.
Facilities and Administrative (F&A) 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 will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following organizations/institutions are eligible
to apply:
This FOA is a revision that involves an active NIAMS R01. Only current active NIAMS R01 grantees are eligible to submit applications. Grantees with other equivalent awards are encouraged to apply with NIAMS R01 grantees.
1.B. Eligible Individuals
Any individual(s) with (an) active NIAMS R01 grant award(s) and the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
More than one PD/PI (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH electronic Research Administration (eRA) Commons prior to the submission of the application (see 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 grant 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 the multiple PD/PI option, 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.
Research revision support will be awarded to active NIAMS R01s. 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 R01. 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. However, only one BIRT application can be submitted for each active NIAMS R01. The revision must have the same budget format as that of the parent R01, and the contact PI in a multiple PI application must be the PI of the parent R01. The funding period requested in the revision must not exceed that of a parent grant.
Section IV. Application and Submission Information
To download a SF424 (R&R)
Application Package and SF424 (R&R) Application Guide for completing
the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button
in this FOA or link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note that if a PD/PI is also an NIH peer reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.
1. Request
Application Information
Applicants must download the SF424 (R&R) application
forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package
directly attached to a specific FOA can be used. You will not be able
to use any other SF424 (R&R) forms (e.g., sample forms, forms from
another FOA), although some of the "Attachment" files may be
useable for more than one FOA.
For further assistance, contact GrantsInfo -- Telephone
301-710-0267; Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:
Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., Special Instructions, regarding appropriate required budget component.)
Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s)
Form
Foreign Organizations (Non-Domestic [non-U.S.] Entities)
NIH policies concerning grants to Foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.
Applications from Foreign organizations must:
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 (U.S.) or that augment existing U.S. resources.
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.
Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
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 [Section 14 of the Research Plan Component in the SF424 (R&R)], 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 (NoA).
Applications Involving a Single Institution
When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.
Applications Involving Multiple Institutions
When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form.
When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, 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(s): January 19, 2009
Application Due Date(s): February
19, 2009
Peer Review Date(s): May/June,
2009
Council Review Date(s): August
2009
Earliest Anticipated Start Date(s): 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: [email protected]
3.B.
Submitting an Application Electronically to the NIH
To submit an application in response to this FOA, applicants should access
this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp
and follow Steps 1-4. Note: Applications must only be submitted electronically. PAPER
APPLICATIONS WILL NOT BE ACCEPTED.
In order to expedite the review, applicants are requested to notify the NIAMS Referral Office by email ([email protected]) when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.
3.C. Application Processing
Applications may be submitted on or after
the opening date and must be successfully received by Grants.gov
no later than 5:00 p.m. local time (of the applicant
institution/organization) on the application
due date(s). (See Section IV.3.A. for all dates.) If an application
is not submitted by the due date(s) and time, the application may be delayed
in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.
Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.
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.
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.
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
the NIH
Grants Policy Statement).
6. Other Submission Requirements and Information
PD/PI Credential (e.g., Agency Login)
The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:
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 and further the advancement of the 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 the 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 (e.g., 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 (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)
Foreign Applications (Non-Domestic [non-U.S.] Entities)
Indicate how the proposed project has specific relevance to the mission and objectives of the NIH/IC and has the potential for significantly advancing the health sciences in the United States.
Special Instructions
BIRT revision applications can be requested only for active NIAMS R01s 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 other 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:
Applicants should provide:
- Realistic BIRT research goal(s) within a one year time frame
- A feasible research plan with potential alternative(s) to address pitfalls if any
- A collaboration plan that clearly defines the role of each collaborator in the proposed BIRT research
- A short list of any milestone(s) or specific output(s) that will be used for future BIRT program evaluations
- Brief details of any future direction(s) anticipated from the proposed BIRT research
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 this 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:
Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. 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. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
A single numerical priority score will be assigned to the BIRT application as a whole after review elements have been discussed and weighed 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: Are 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 Human Subjects Sections
of the PHS398 Research Plan component of the SF424 (R&R).
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 Human Subjects Sections of the
PHS398 Research Plan component of the SF424 (R&R)
Care and Use of Vertebrate Animals in Research: If vertebrate animals
are to be used in the project, the adequacy of the plans for their care
and use will be assessed. See the Other Research Plan Sections of the
PHS398 Research Plan component of the SF424 (R&R).
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 and Period of Support: The
reasonableness of the proposed budget and the appropriateness of the requested
period of support in relation to the proposed research may be assessed by
the reviewers. 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 NIH
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 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 and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
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 l:
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.
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 (program), peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
Section VIII. Other Information
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 (45 CFR 46) 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 institutional review board (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/.
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. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal 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.
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.
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 SF424 (R&R) application; 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, investigators funded by the NIH must submit
or have submitted for them to the National Library of Medicine’s PubMed
Central (see http://www.pubmedcentral.nih.gov/), an
electronic version of their final, peer-reviewed manuscripts upon acceptance
for publication, to be made publicly available no later than 12 months after
the official date of publication. The NIH Public Access Policy is available
at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS)
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 HHS 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)
or PubMed Central (PMC) submission identification numbers must be used
for publicly accessible on-line journal articles. Publicly accessible
on-line journal articles or PMC articles/manuscripts accepted for publication
that are directly relevant to the project may be included only as URLs or PMC
submission identification numbers accompanying the full reference in
either the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH
grant application. A URL or PMC submission identification number citation
may be repeated in each of these sections as appropriate. There is no limit
to the number of URLs or PMC submission identification numbers that can
be cited.
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 Part 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 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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