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 Biomedical Imaging and Bioengineering (NIBIB), (http://www.nibib.nih.gov)
National Cancer Institute (NCI), (http://www.cancer.gov/)
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/index.htm)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov/)
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (
http://www.ninds.nih.gov/)
National Library of Medicine (NLM), (http://www.nlm.nih.gov/)

Title:  Predictive Multiscale Models of the Physiome in Health and Disease (R01)

Announcement Type
New

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

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 weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-08-023

Catalog of Federal Domestic Assistance Number(s)
93.286, 93.396, 93.837, 93.838, 93.839, 93.233, 93.866, 93.846, 93.173, 93.279, 93.113, 93.859, 93.242, 93.853, 93.879

Key Dates
Release/Posted Date: November 5, 2007
Opening Date:   December 14, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 14, 2007, April 14, 2008, August 15, 2008, December 15, 2008, April 14, 2009, August 17, 2009, December 14, 2009, April 14, 2010, August 16, 2010
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 Submission/Receipt Date(s): January 14, 2008, May 14, 2008, September 15, 2008, January 14, 2009, May 14, 2009, September 15, 2009, January 14, 2010, May 14, 2010, September 15, 2010
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details
Additional Information To Be Available Date (November 15, 2007): http://www.nibib.nih.gov/Funding/MultiscaleModeling
Expiration Date: September 16, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

This Funding Opportunity Announcement (FOA) issued by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute on Drug Abuse (NIDA), National Institute of Environmental Health Sciences (NIEHS), National Institute of General Medical Sciences (NIGMS), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), and National Library of Medicine (NLM) solicits Research Project Grant (R01) applications from institutions/ organizations that propose to develop predictive multiscale models of the physiome in health and disease.

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. Submission, 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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
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 goal of this solicitation is to move the field of biomedical computational modeling forward through the development of more realistic and predictive models of health and disease. NIH recognizes the need for sophisticated, predictive, computational models of development and disease that encompass multiple biological scales. These models may be designed to uncover biological mechanisms or to make predictions about clinical outcome and may draw on a variety of data sources including relevant clinical data. Ultimately the models and the information derived from their use will enable biomedical and behavioral researchers and clinicians to better understand, prevent, diagnose and treat the diseases or aberrations in normal development. Specifically this FOA seeks the development of biomedical models that are 1) multiscale, 2) predictive of health and disease states, and 3) that must include models at higher scales of the physiome (see definitions in bold below).

1) Multiscale, biomedical modeling uses mathematics and computation to represent and simulate a physiological system at more than one biological scale. Biological scales include atomic, molecular, molecular complexes, sub-cellular, cellular, multi-cell systems, tissue, organ, multi-organ systems, organism, population, and behavior. This FOA seeks the development of mathematical and computational models that must incorporate substantial representations of the underlying biological mechanisms from at least two biological scales and at least one linkage between scales. These multiscale biomedical models may also include dynamical processes which span multiple time and length scales. Modeling and analysis methods inherently provide a fundamental infrastructure for understanding and predicting biological processes, diseases, and human behavior patterns. Biomedical and clinical scientists are recognizing the need to integrate models and data across multiple biological scales and disease states. In 2004 the Interagency Modeling and Analysis Group (IMAG) developed the Interagency Opportunities in Multiscale Modeling (MSM) in Biomedical, Biological, and Behavioral Systems Initiative, which laid the foundation for multiscale biomedical modeling by supporting grants that develop the mathematical and computational interfaces between biological scales (http://www.nsf.gov/pubs/2004/nsf04607/nsf04607.htm). This FOA moves to the next step of developing multiscale models at higher levels of the physiome that will be predictive of health and disease.

The original MSM initiative gave rise to the Multiscale Modeling Consortium which is composed of several working groups (http://www.nibib.nih.gov/Research/MultiScaleModeling/WorkingGroups) focusing on scientific and computational issues related to multiscale modeling. The MSM Consortium has now grown beyond the original grantees of this initiative and serves to bring together a community of modelers interested in multiscale modeling (http://www.imagwiki.org/mediawiki/index.php?title=Main_Page). In addition IMAG (http://www.nibib.nih.gov/Research/MultiScaleModeling/IMAG) continues to bring together many agencies interested in multiscale modeling. The spirit of IMAG is to promote the development of new or novel modeling and analysis methods throughout the scientific community. Through the MSM Consortium, IMAG promotes collaborative team science and the sharing of good quality scientific modeling and analysis tools as a result of employing appropriate software engineering practices.

IMAG generated this FOA and encourages investigators to join the MSM Consortium and seek out other related funding opportunities as appropriate to the missions of the other participating IMAG agencies. All investigators are encouraged to attend the annual MSM Consortium meetings and consult their respective funding agencies to provide travel support when necessary. Applicants to this FOA must allocate funds for at least two key investigators with complementary expertise to travel to the annual MSM Consortium Meetings (http://www.nibib.nih.gov/Research/MultiScaleModeling).

2) Predictive models generate new hypotheses, and do not merely recapitulate the data that were used to build them. This FOA seeks the development of models that can quantifiably predict biomedical and behavioral processes in health and disease states. Predictive models of health should be developed to inform models of disease states. Predictive, multiscale models are built from biomedical data obtained at and between multiple biological scales. Current approaches to predictive medicine are largely qualitative (based on expert/clinical experience), or use computational techniques that perform data fitting or statistical data mining for prediction. Progress in predictive medicine could be greatly accelerated by coupling the wealth of data and knowledge obtained from biomedical research with robust, mechanistic, computational models. Mechanistic predictive modeling represents biomedical and behavioral processes by performing state and or parameter estimation which are validated with experimental data. It reveals mechanisms underlying physiological or pathophysiological functions, and predicts causal relationships between these mechanisms and normal or abnormal biological functions or disease states that experiments alone can not easily achieve. The resulting improved understanding can be used to derive new hypotheses and or direct future experimental design. Mechanistic predictive models could be used to drive integrative biomedical research activities towards the preservation of health, early diagnosis, and more effective therapies, yet currently, the potential for modeling in this manner is not being adequately tapped.

Challenges to predictive multiscale modeling arise as a result of our limited understanding of the complex, dynamic nature of the biological system, the availability of and limited access to good quality biomedical data, and the difficulties involved in understanding, communicating, and sharing modeling methods among multiple disciplines. It may be beneficial to use both bottom-up and top-down approaches to multiscale modeling to facilitate the development of predictive models.

3) Models at higher scales of the physiome represent multi-cell systems, tissue, organ, multi-organ systems, organism structure and function, population and behavior. Currently much of the multiscale modeling efforts concentrate on lower scales with models of genes, proteins, carbohydrates, lipids, signaling pathways and networks, metabolic pathways and networks, and molecular interactions at the cellular level. Linking lower scale models with higher scale models will bring model development one step closer to models for predictive medicine.

The following are examples of higher levels of the physiome to be included in the models sought by this FOA (examples at increasing physiome scales). This list is not complete and is not limited to the following:

Specific objectives

To address the specific objectives above, the investigators must clearly identify the biological levels of modeling and the connection(s) or linking method(s) between the levels of modeling. The investigators must clearly identify the link to higher levels of the physiome. All links must be physiologically mechanistic. The model itself must bridge multiple scales (using a systems approach) and not simply include data from multiple scales. The investigators must provide rationale for the predictive aspects of the model. The data used to develop the model must be identified and appropriately justified for each level and link modeled. Parameter estimation and model validation should be largely based on experimental data. Investigators must include a timeline to define progress toward the endpoint goal for the proposed project.

A challenge in modeling translational problems is the availability of accurate data that can feasibly be obtained in the clinical setting. When appropriate, investigators are encouraged to address this issue and detail methods for obtaining the most appropriate data. Investigators proposing to develop models of only healthy function or normal physiological states must include a long-term plan describing the necessary steps towards applying the model to a specific disease process or clinical application.

The key investigators on the research team must include (1) person(s) with modeling expertise and (2) person(s) with biomedical expertise. It is envisioned that this team may include engineers, mathematicians, computational scientists, biomedical, biobehavioral researchers, or clinician scientists. Where appropriate this FOA encourages clinicians or clinical scientists to provide clinical expertise for the translational portion of the project.

The investigators must clearly describe the model architecture and highlight aspects of the architecture which will facilitate model sharing. Models must be designed so that components or modules within the models are clearly documented and can be independently shared with other modelers. Investigators are expected to propose plans to link proposed models with other disease related models, or other relevant models, especially if the proposed model does not already have a disease focus. As a part of the IMAG/MSM Consortium (http://www.imagwiki.org/mediawiki/index.php?title=Main_Page) funded investigators of this FOA will interact with this community of modelers to further promote model sharing and scientific collaboration.

Investigators are expected to include appropriate data, model and software sharing plans to collaborate with others not on the investigative team and allow others external to the investigative team to test, validate, reuse and extend the models (see section IV.6). Investigators are strongly encouraged to employ standardized ontologies and languages for model representation where appropriate (e.g. domain-specific XML-based model representations such as SBML and CellML). Current discussions on modeling standards can be found in the Working Group 10 Wiki page of the MSM Consortium: (http://www.nibib.nih.gov/Research/MultiScaleModeling/WorkingGroups). Investigators are encouraged to budget for and plan model repositories, and appropriate software engineering efforts. The benefits of software engineering practices are expected to include, but are not limited to, improved functionality by linking disparate but scientifically appropriate software, reduction of redundant software efforts, efficient software reuse, and improvement in quality of software by opening the development process to more scientists.

Investigators interested in 1) proposing to develop models at a single biological level, or at multiple biological levels without crossing between scales; 2) proposing multiscale modeling without an explicit predictive component; 3) proposing multiscale modeling using statistical methods which do not directly and mechanistically represent physiological mechanisms; 4) proposing to develop lower level models not tied to higher levels; or 5) proposing to develop models that do not incorporate a model architecture that will facilitate model sharing should respond to other FOAs.

Specific interests

The following section briefly describes the specific interests of the participating funding components of this FOA. All interests are examples and are not limited to these cases. Investigators are strongly encouraged to discuss their ideas with the respective program representatives listed in section VII.1.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is interested in supporting the development of predictive multiscale models that have broad therapeutic and interventional applications. Other areas of interest include multiscale modeling to complement technology development in all other program areas of the NIBIB, http://www.nibib.nih.gov/Research/ProgramAreas.

The National Cancer Institute (NCI) is interested in supporting the development of predictive multiscale models of cancer processes. These models may be designed to elucidate basic mechanisms underlying cancer initiation and progression and/or to address important translational or clinical questions related to cancer risk, prevention, diagnosis and treatment.

The National Heart, Lung, and Blood Institute (NHLBI) is interested in development of predictive multiscale models of the physiology and pathophysiology of the cardiovascular, pulmonary, and hematological systems that have translational potential or clinical relevance.

The National Institute on Aging (NIA) is interested in supporting research on multiscale models that link molecular mechanisms with age-related changes in cognition, emotion, vision, taste, smell, touch, audition, motor, endocrine, metabolic, cardiovascular, hematopoietic, renal, immunologic, and musculoskeletal function, and on predictive models of Alzheimers disease, frontotemporal dementia, and delirium.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is interested in supporting research on predictive models related to the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. Some examples of research topics for investigation may include, but are not limited to, the development of models to aid in the understanding of the pathogenesis of the rheumatic diseases or of other chronic inflammatory diseases that affect skin, bone and muscle; models of repair and/or regeneration of tissues such as muscle, bone, or skin; or models that address the relationship between imaging findings and musculoskeletal pain.

The National Institute on Deafness and Other Communication Disorders (NIDCD) is interested in supporting development of predictive multiscale models with clinical relevance that address normal and disordered processes of voice, speech, language, smell, taste, balance, and hearing.

The National Institute on Drug Abuse (NIDA) is interested in supporting multiscale modeling research that links molecular mechanisms, intracellular signaling networks, or neural plasticity at the single cell level with brain function or behavior of relevance to understanding drug abuse and addiction. Also of interest are multiscale models that can aid in the prediction of physiological systems pathologies from drug effects at the cellular level and multiscale models that include social networks or populations.

The National Institute of Environmental Health Sciences (NIEHS) is interested in the development of multiscale models that aid in the prediction of phenotypic effects of exposure to chemical, physical or biologically derived stressors within our environment. A particular interest is on modeling the behavior of common pathways of biological response that determine the specific outcome of an exposure. This information could be useful in predicting how a single agent can lead to multiple disease endpoints or how multiple unrelated exposures can result in a common endpoint.

The National Institute of General Medical Sciences (NIGMS) is interested in supporting research (http://www.nigms.nih.gov/Research/) that encompass the areas of cell biology, biophysics, genetics, developmental biology, pharmacology, physiology, biological chemistry, bioinformatics, and computational biology.

The National Institute of Mental Health (NIMH) is interested in supporting research on multiscale models that link molecular mechanisms with brain function.

The National Institute of Neurological Disorders and Stroke (NINDS) is interested in predictive multiscale modeling of physiological and pathophysiological functions of the nervous system and mechanisms underlying neurological and neuromuscular disorders and stroke.

The National Library of Medicine (NLM) is interested in new or enhanced predictive models of health and disease that incorporate cell, tissue, organ function, and/or physiological processes. We are also interested in models of health and disease that are relevant to public health and population health studies, such as those which incorporate behavioral, cultural or environmental factors.

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 Announcement (FOA) will use the NIH Research Project Grant (R01) award mechanism.   

The applicant will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses Just-in-Time information concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are a U.S. organization and are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 3.4, Modular Budget Component, of the Application Guide).

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 found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

Renewals and Resubmissions

Applicants may submit a competing renewal (formally competing continuation) if the proposed research is a logical progression of a currently funded NIH R01 grant. Applicants who did not receive funding may submit a resubmission application, but such application must include an Introduction (1 page maximum) addressing the previous peer review critique (Summary Statement). This introduction should precede the 12 page research plan.

2. Funds Available

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 Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

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.

F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.  

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions
You may submit an application(s) if your institution/organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual(s) with 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, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach that clearly does 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 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 single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. 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 PD/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

Applications for renewal (of a currently funded NIH R01 grant) are eligible to compete with applications for new awards.

Applicants may submit more than one application in response to this FOA, provided each application is scientifically distinct.

Section IV. Application and Submission Information


Registration:
Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. 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 with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered ?on-time? (see 3.C.1 for more information about on-time submission).

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp 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 eRA Commons.

Several additional separate actions are required before an applicant institution/organization 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 PD/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 301-435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all applications using the 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. There are fields within the SF424 (R&R) application components that, 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/PIs 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.)
Research & Related Budget (required for foreign applications)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

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/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 or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

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 13 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 of the 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, including 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.

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 3.4 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:  December 14, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): December 14, 2007, April 14, 2008, August 15, 2008, December 15, 2008, April 14, 2009, August 17, 2009, December 14, 2009, April 14, 2010, August 16, 2010
Application Submission/Receipt Date(s): January 14, 2008, May 14, 2008, September 15, 2008, January 14, 2009, May 14, 2009, September 15, 2009, January 14, 2010, May 14, 2010, September 15, 2010
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.

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:

Grace C.Y. Peng, Ph.D.
Program Director
National Institute of Biomedical Imaging and Bioengineering, NIH, DHHS
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892-5477

Telephone: (301) 451-4778
Email: penggr@mail.nih.gov

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. 

3.C. Application Processing


3.C.1 Submitting On-Time

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. All applications must meet the following criteria to be considered on-time:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step - applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.

Note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified 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 assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the CSR. Incomplete applications will not be reviewed.

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 competing renewal (formerly competing continuation) award if such costs: are necessary to conduct the project, and 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 competing 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

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/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

Item 3 of the PHS398 Research Plan is limited to 12 pages.    

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:

Special Instructions for Modular Grant applications

R01 applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See Section 3.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.

Foreign organizations may not submit modular budgets. See NOT-OD-06-096.

Special Instructions for Applications Requesting $500,000 (direct costs) or More Per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:

1) Contact the appropriate IC to determine specific policies regarding submission of applications requesting more than $500,000 in direct costs per year. Most participating IC program staff require at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include the PHS398 Cover Letter component with the application to identify the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new applications, competing renewal (formerly competing continuation) applications, resubmission (formerly revised/amended) applications, and revision (formerly competing supplemental) applications. See NOT-OD-02-004, October 16, 2001.

Appendix Materials

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

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

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

Plan for Sharing Research Data

Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal Web site, through a data archive or enclave). The precise content of data-sharing plans will vary, depending on the data being collected and how the investigator is planning to share the data. Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants are expected to include a plan for sharing research data and model datasets used for parameter estimation, model building, and model validation as described in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the impact/priority score. The assessment of the review committee will be considered by Program staff of the funding organization when making recommendations about funding applications. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Plan for Sharing Models and Software

All applicants are expected to include a plan for sharing the models proposed in their grant application. This should be included in a separate heading in the Approach section. Detailed sharing plans should be provided for the model components or modules, modeling parameters and associated datasets (as described above). The plan should include the minimum requirements for model documentation, model building, and model validation. Applicants are also expected to include plans to link proposed models with other disease related models, or other relevant models, especially if the proposed model does not already have a disease focus.

A software dissemination plan, with appropriate timelines, is expected to be included in the application. There is no prescribed single license for software produced through grants responding to this announcement. However, NIH does have goals for software dissemination, and reviewers will be instructed to evaluate dissemination plans relative to these goals:

1. The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government laboratories.

2. The terms of software availability should permit the commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.

3. To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.

4. The terms of software availability should include the ability of researchers to modify the source code and to share modifications with other colleagues. An applicant should take responsibility for creating the original and subsequent official versions of a piece of software, and should provide a plan to manage the dissemination or adoption of improvements or customizations of that software by others. This plan should include a method to distribute other user's contributions such as extensions, compatible modules, or plug-ins.

The reasonableness of the resource sharing plan or the rationale for not sharing resources will be assessed by the reviewers. However, reviewers will not factor the proposed resource sharing plan into the determination of scientific merit or the impact/priority score. The assessment of the review committee will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.

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 submitted for this funding opportunity will be assigned to the participating ICs on the basis of established PHS referral guidelines.

Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. 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, weighting them 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 high impact/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.

Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) Protections for Human Subjects, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? 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?

Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

  • Does the project include an appropriate plan to communicate and train within the investigative team (i.e. develop a common language between diverse disciplines)?

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 impact/priority score:

Resubmission Applications (formerly revised/amended applications): When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Protections for Human Subjects: For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials..

Inclusion of Women, Minorities, and Children: When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals: The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

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.

Additional Review Considerations

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact score.

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

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

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

Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).



Budget and Period 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 impact/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. Sharing Research Data

Data Sharing Plan: All applicants are expected to include a plan for sharing research data and model datasets used for parameter estimation, model building, and model validation as described in their application. The reasonableness of the data sharing plan or the rationale for not sharing data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the impact/priority score. The assessment of the review committee will be considered by Program staff of the funding organization when making recommendations about funding applications. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared. All applicants address the are expected to sharing of the models proposed in their grant application. Any,, as well as includeingany sThe reasonableness of the resource sharing plan or the rationale for not sharing resources will be assessed by the reviewers. However, reviewers will not factor any proposed resource sharing plan into the determination of scientific merit or the impact/priority score. The assessment of the review committee will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting. 

Model and Software Sharing Plan Considerations:

  • Does the project include data, model and software sharing plans to collaborate with others who are not on the investigative team? If yes, to what degree?
  • Does the project include appropriate sharing plans to link proposed models with other modeling efforts or other disease related models, especially if the proposed model does not already have a disease focus?
  • Is the plan for sharing the model components or modules, modeling parameters and associated datasets conducive to successful sharing?
  • Do the sharing plans include minimum requirements for model documentation, parameter estimation, model building, model validation, and the use of effective software engineering where appropriate (i.e., evidence of open, collaborative, software development process that will lead to quality software)? If yes, to what degree?
  • Will the sharing plans adequately allow others to test, validate, reuse and extend the proposed models? If yes, to what degree?

Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations.

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 are encouraged to report any scientific highlights, publications, patents, and products resulted from the awards directly to the scientific program staff of the funding agency.

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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 Contact(s):

Grace C.Y. Peng, Ph.D.
Interagency Modeling and Analysis Group (IMAG) http://www.nibib.nih.gov/Research/MultiScaleModeling/IMAG
Program Director
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 200, MSC 5477
Bethesda, MD 20892-5477
Telephone: (301) 451-4778
FAX: (301) 480-1614
Email:
penggr@mail.nih.gov

Jennifer Couch, Ph.D.
Division of Cancer Biology
National Cancer Institute
6130 Executive Blvd, EPN 5004, MSC 7385
Rockville, MD 20892
Telephone: (301) 435-5226
FAX: (301) 480-2854
Email couchj@mail.nih.gov

Jennie Larkin, Ph.D.
Program Director
Advanced Technologies and Surgery Branch
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
Department of Health and Human Services
Rockledge II, Room 8200, MSC 7940
Telephone: (301) 435-0513
FAX: (301) 480-1454
Email: larkinj2@nhlbi.nih.gov

Wen G. Chen, Ph.D.
Program Director, Sensory and Motor Disorders of Aging
Neuroscience and Neuropsychology of Aging
National Institute on Aging
7201 Wisconsin Avenue, Suite 350
Bethesda, MD 20892
Telephone: (301) 496-9350
FAX: (301) 496-1494
Email: chenw@nia.nih.gov

Gayle Lester, Ph.D.
Program Official
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd, Suite 800, MSC 4872
Bethesda, MD 20892
Telephone: (301) 594-3511
FAX: (301) 480-4543
Email: lester1@mail.nih.gov

Roger L. Miller, Ph.D.
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, MSC 7180
Bethesda, Maryland 20892-7180
Telephone: (301) 402-3458
FAX: (301) 402-6251
Email: millerr@nidcd.nih.gov

Susan Volman, Ph.D.
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 435-1315
FAX: (301) 594-6043
Email: svolman@mail.nih.gov

David M. Balshaw, Ph.D.
Program Administrator
Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of Environmental Health Sciences, EC-27
PO Box 12233
111 TW Alexander Dr.
RTP, NC 27709
Telephone: (919) 541-2448
FAX: (919) 541-4937
Email: balshaw@niehs.nih.gov

Peter Lyster, Ph.D.
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences
45 Center Dr. #2as.55k, MSC 6200
Bethesda, MD 20892
Telephone: (301) 451-6446
FAX: (301) 480-2802
Email: lysterp@mail.nih.gov

German Cavelier, Ph.D.
Chief Neurotechnology Program
Office of Cross-Cutting Science and Scientific Technology
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7200, MSC 964
Bethesda, MD 20892-9645
Phone: (301) 443-1815
FAX: (301) 443-1815
Email: gcavelier@mail.nih.gov

Yuan Liu, Ph.D.
Director, Computational Neuroscience & Neuroinformatics Program
National Institute of Neurological Disorders and Stroke
6001 Executive Boulevard, Room 2187, MSC 9523
Bethesda, MD 20892-9523
Phone: (301) 496-0012
FAX: (301) 480-1080
Email: liuyuan@ninds.nih.gov

Jane Ye, Ph.D.
Program Officer
Division of Extramural Programs
National Library of Medicine
6705 Rockledge Drive, Suite 301, MSC 7968
Bethesda, MD 20892
Phone: (301) 594-4882
FAX: (301) 402-0421
Email: YeJ@mail.nih.gov

2. Peer Review Contact(s):

George Chacko, Ph.D.
Chief, Bioengineering Sciences and Technologies IRG
Center for Scientific Review
6701 Rockledge Drive, Room 5170
Bethesda, MD 20814
Telephone: (301) 435-1245
FAX: (301) 480-1988
Email: chackoge@mail.nih.gov

3. Financial/Grants Management Contact(s):

Angelos Bacas
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 900
Bethesda, MD 20892-5469
Telephone: (301) 451-4785
FAX: (301) 451-5735
Email: bacasa@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

Vertebrate Animals:
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 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 impact/priority score.

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. 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.

Inclusion of Women, Minorities, and Children:
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-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov// and view the Policy or other Resources and Tools, including the Authors' Manual.

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 or Health Systems Agency review. 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/.


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NIH Funding Opportunities and Notices


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