Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
National Department of Energy (DOE)
U.S. Food and Drug Administration  (FDA)
National Science Foundation (NSF)

Components of Participating Organizations

 National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
Office of Behavioral and Social Sciences Research (OBSSR)  
National Department of Energy (DOE) - Office of Biological and Environmental Research  (BER)
U.S. Food and Drug Administration  (FDA) - Division of Cardiovascular Devices, CDRH
National Science Foundation (NSF) - Directorate for Mathematical and Physical Sciences (MPS)
National Science Foundation (NSF) - Directorate for Engineering (ENG)
National Science Foundation (NSF) - Office of Cyberinfrastructure (OCI)

Funding Opportunity Title

Predictive Multiscale Models for Biomedical, Biological, Behavioral, Environmental and Clinical Research (Interagency U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of PAR-08-023

Related Notices
  • January 31, 2014 - NIH and AHRQ Extend Due Dates for Applications Due Jan 31-Feb 3 to Feb 4. See Notice NOT-OD-14-047.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.
  • March 7, 2012 - Notice of Change in Participation of NIH Institutes and Centers in PAR-11-203. See Notice NOT-OD-12-077.
Funding Opportunity Announcement (FOA) Number

PAR-11-203

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

 93.286, 93.172, 93.866, 93.279, 93.859, 93.865, 93.113, 93.273, 93.837, 93.837, 93.396, 47.049, 47.041, 47.080

FOA Purpose

The goal of this interagency funding opportunity announcement (FOA) is to support the development of multiscale models to accelerate biological, biomedical, behavioral, environmental and clinical research.  The NIH, DOE, FDA, and NSF recognize that to efficiently and effectively address the challenges of understanding multiscale biological and behavioral systems, researchers will need predictive, computational models that encompass multiple biological and behavioral scales.  This FOA also encourages the development of new, non-standard modeling methods and experimental approaches to facilitate multiscale modeling. 

Key Dates
Posted Date

April 15, 2011

Open Date (Earliest Submission Date)

April 30, 2011

Letter of Intent Due Date

30 days before the Application Due Date

Application Due Date(s)

06/17/11, 09/27/11, 01/31/12, 05/31/12, 09/27/12, 01/31/13, 05/31/13, 09/27/13, Extended to 02/04/14 per NOT-OD-14-047 (previously 01/31/14) (Applicants interested in DOE funding may wish to use the September due dates, see Section IV.6) , by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

February 1, 2014

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The goal of this interagency funding opportunity announcement is to support the development of multiscale models to accelerate biological, biomedical, behavioral, environmental and clinical research.  The NIH, DOE, FDA, and NSF recognize that to efficiently and effectively address the challenges of understanding multiscale biological and behavioral systems, researchers will need predictive, computational models that encompass multiple biological and behavioral scales.  This FOA also encourages the development of new, non-standard modeling methods and experimental approaches to facilitate multiscale modeling. 

BACKGROUND

Multiscale modeling uses mathematics and computation to quantitatively represent and simulate a system at more than one scale while functionally linking the mathematical models across these scales.  This FOA is focused on biological and behavioral scales, which include atomic, molecular, molecular complexes, sub-cellular, cellular, multi-cell systems, tissue, organ, multi-organ systems, organism/individual, group, organization, market, environment, and populations.  Multiscale models of biological and behavioral systems can be used as important tools to address a range of biomedical, biological, behavioral, environmental, and clinical problems.  Multiscale modeling and analysis methods inherently provide a fundamental infrastructure for understanding and predicting biological and environmental processes; diseases; and human and organizational behavior patterns and outcomes.

In 2004 the Interagency Modeling and Analysis Group (IMAG) released the Interagency Opportunities in Multiscale Modeling (MSM) in Biomedical, Biological, and Behavioral Systems Initiative, which laid the foundation for multiscale modeling by supporting grants that develop the mathematical and computational interfaces between biological scales (http://www.nsf.gov/pubs/2004/nsf04607/nsf04607.htm).  In 2007 IMAG released the Predictive Multiscale Models of the Physiome in Health and Disease FOA to promote the development of multiscale models at higher levels of the physiome that are predictive of health and disease (http://grants.nih.gov/grants/guide/pa-files/par-08-023.html).  In 2010, the IMAG Futures Report produced a systematic assessment, at multiple biological scales and across multiple biomedical fields, the extent to which computational modeling has made an impact in the broader biomedical research endeavor, http://www.imagwiki.org/mediawiki/images/b/b5/IMAG_Futures_Report.pdf.  The current FOA reissue from IMAG promotes both the development of novel multiscale models and methods, and multiscale physiome modeling; in addition to the development of targeted partnerships to increase the impact of multiscale models in basic and translational biomedical, biological, behavioral, environmental and clinical research. 

The original MSM initiative gave rise to the Multiscale Modeling (MSM) Consortium which is composed of several working groups focusing on scientific and computational issues related to multiscale modeling. The MSM Consortium has now grown beyond the original grantees of the original initiative and serves to bring together a community of modelers interested in multiscale modeling of biomedical, biological and behavioral systems (http://www.imagwiki.org/mediawiki).  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.

SCOPE OF PROGRAM

Multiscale models can be designed to integrate diverse data, create testable hypotheses leading to new investigational studies, identify and share gaps in knowledge, uncover biological mechanisms, or make predictions about clinical outcome or intervention effects.  These models can draw on a variety of data sources including relevant physical, environmental, clinical and population data. Ultimately multiscale models and the information derived from their use will enable biomedical, biological, behavioral, environmental and clinical researchers to understand complex biological and behavioral systems in a manner not possible through traditional research methods.  The ultimate goal of the models would be to make realistic scientific predictions to address problems and issues in the environment; in the human body (e.g., to prevent, diagnose and treat the diseases or aberrations in normal development, and/or to predict treatment outcomes); and among individuals, groups, and within populations.

For this FOA specific topics of interest include, but are not limited to, those listed below:

In addition, this FOA seeks to achieve the scientific goals by encouraging highly interactive partnerships that strongly integrate truly diverse expertise to further increase the impact of multiscale models in the broader research and policy community. This list is not complete and is not limited to the following:

a) experimental and modeling expertise, so that the models create testable hypotheses leading to new investigational studies, or

b) mathematical and or statistical expertise with domain-modeling expertise, so that new methods enhance the function of the models, or

c) expertise focused on different spatial or temporal scales, or different experimental and observational scales, or different deterministic and statistics-driven scales, or

d) expertise from mature modeling disciplines with expertise from disciplines with an emerging use of models, or

e) expertise from different biological and behavioral modeling subfields; such as, computational neuroscience, systems biology, physiome research, agent-based modeling, system dynamics, and microsimulation.

As described in Section IV.2 (Research Plan) the application must include: 1) Partnership Plan to describe the proposed partnership, and 2) a Multiscale Modeling (MSM) Consortium Plan.  All awardees from this cooperative agreement FOA will be required to participate in the Interagency Modeling and Analysis Group (IMAG) MSM Consortium to contribute to the greater multiscale modeling community, http://www.imagwiki.org/mediawiki.  

IMPLEMENTATION

The Predictive Multiscale Models for Biomedical, Biological, Behavioral, Environmental and Clinical Research Program Announcement uses the U01 cooperative agreement mechanism.  Project requirements (described below), milestones and timeline for both scientific progress and participation within the MSM Consortium will be reviewed (Section V) and established prior to funding, and must be met prior to funding of each subsequent budget period.  Investigators funded from this FOA are expected to play an active role in the MSM Consortium, leading the working groups, sharing data, models, expertise and other efforts to contribute to the greater multiscale modeling community.  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.imagwiki.org/mediawiki/index.php?title=IMAG/MSM_Events).  Program staff from the IMAG award agency will have a significant, although not dominant, role in the planning and execution of the supported activities.  In addition, IMAG program staff will promote the mission of the MSM Consortium, organize annual meetings, facilitate awardee participation in the Consortium activities, and have a significant role in the assessment of annual milestone performance. 

Investigators are required to identify a compelling multiscale problem or approach that is currently not being addressed - that is, beyond current practice - and address its impact on the field. The proposed multiscale model must incorporate substantial representations of the underlying biological or behavioral mechanisms from at least two scales and at least one linkage between scales. These multiscale models may also include dynamical processes which span multiple time and spatial scales.

Investigators are required to provide rationale for the predictive aspects of the proposed multiscale model.  Furthermore, investigators are required to provide a convincing technical plan for achieving predictive outcomes from the model.  Predictive models generate new hypotheses, and do not merely recapitulate the data that were used to build them.  Challenges to predictive multiscale modeling arise as a result of our limited understanding of the complex, dynamic nature of the biological or behavioral system, the availability of and limited access to good quality 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.

The data used to develop the model must be identified and appropriately justified for each scale and link modeled. Parameter estimation and model validation should be based on experimental and/or observational data as appropriate. The use and development of standard datasets are strongly encouraged.  As a part of the IMAG/MSM Consortium (http://www.imagwiki.org/mediawiki) funded investigators of this FOA will interact with this community of modelers to further promote DATA sharing and scientific collaboration.

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 and explicitly shared with other modelers. Investigators are strongly encouraged to propose plans to link proposed models with other relevant models. As a part of the IMAG/MSM Consortium (http://www.imagwiki.org/mediawiki) 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.2 Plan for Sharing Models and Software). Investigators are strongly encouraged to employ standardized ontologies and languages for model representation where appropriate (e.g. domain-specific Extensible Markup Language (XML)-based model representations such as SBML and CellML). Current discussions on data and modeling sharing can be found on the IMAG wiki (http://www.imagwiki.org/mediawiki/index.php?title=Multiscale_Modeling_Working_Groups).  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 are welcome to use advanced computational resources to support fundamental research and technology development to achieve a predictive, systems-level understanding of complex biological systems. Advanced computing research could provide model development capabilities, data analytics, frameworks for integration and collaboration, and uncertainty quantification and as such computing frameworks are needed whereby multi-disciplinary, multi-scale data can be integrated with process models to examine coupled phenomena across a range of scales. Ideally, these frameworks would be flexible enough to enable community-level modeling efforts that integrate data and modeling approaches across a wide spectrum of biological, behavioral, clinical and environmental science disciplines. An ability to connect data with models from a wide variety of sources enables more holistic and robust predictions of complex system behavior. The DOE's Office of Science supports a computing user facility, National Energy Research Scientific Computing Center (http://www.nersc.gov/) that will enhance computational research in biology.  As well, the NSF Office of Cyberinfrastructure supports the TeraGrid facility (www.teragridforum.org), an open scientific discovery infrastructure combining leadership class resources at nine partner sites to create an integrated, persistent computational resource, which will also enhance computational research in biology.

Investigators interested in 1) proposing to develop models at a single biological or behavioral scale, or at multiple scales without crossing between scales; 2) proposing multiscale modeling without an explicit predictive component; 3) proposing multiscale modeling without representative biological or behavioral mechanisms; 4) proposing to develop models that do not incorporate a model architecture that will facilitate model sharing; or 5) proposing a project that does not include a Partnership Plan or a MSM Consortium Plan 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

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 in diseases or health conditions. 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, clinical or epidemiological questions related to cancer risk, prevention, diagnosis and treatment.

The National Center for Research Resources (NCRR) supports research to design, create, develop, and disseminate innovative technologies and techniques with broad applicability to biomedical research.  In MSM this may include but is not limited to creation of reusable models that integrate data and knowledge across fields, scales, and modalities and enable synergistic combining of technologies to develop new ways to look at complex problems; novel methods to fuse data from different conceptual frameworks with diverse levels of accuracy, granularity, and reliability; techniques that combine logical and probabilistic models to enable processing of incomplete and/or conflicting data; models that incorporate uncertainty quantification; models that enable identification of knowledge gaps.

The National Human Genomic Research Institute (NHGRI) is interested in the development of multiscale models to predict genetic/genomic effects and gene-environment interactions on phenotypes in model organisms or on the physiology, pathology, pharmacology, clinical phenotype progression/regression, and medication selections for disease treatment to use genomics to advance the science of medicine.

The National Heart, Lung, and Blood Institute (NHLBI) is interested in supporting innovative modeling methods and experimental approaches to facilitate predictive multiscale models of the physiology and pathophysiology of the cardiovascular, pulmonary, hematological and sleep systems.

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; on age-related changes in inflammation and adaptation to stress; on predictive models of age-related increases in organ fibrosis or adipose cell infiltration; and on predictive models of Alzheimer's disease, frontotemporal dementia, and delirium.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in supporting multiscale modeling research related to the causes, consequences, treatment, and prevention of alcohol-related problems and alcohol use disorders. Examples of research topics include but are not limited to: models that characterize interactions between individual-level alcohol-related behaviors and population-level health and economic outcomes; models to explore underlying mechanisms of individual-, community-, or population-level preventive interventions; and models of the determinants and mechanisms underlying changes in drinking before, during, and after treatment, as well as treatment-seeking and utilization.

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is interested in predictive multiscale modeling related to a diverse set of research interests, including physiological and pathophysiological function related to the health, productivity, independence, and quality-of-life of people with disabilities, normal and/or abnormal development over time, and health and dynamics of human populations.

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.  Finally, NIDA is interested in treatment and prevention services multiscale modeling to support decision making within and among systems of care which can span organizational, temporal, and geospatial scales.

The National Institute of Environmental Health Sciences (NIEHS) is interested in the development of multiscale models that link personal exposure to mechanistic and phenotypic endpoints and that enable prediction of the biological effects of exposure.  An emphasis is placed on efforts that reflect ‘real world’ exposures such as complex chemical mixtures; the interaction between chemical exposures with genetic susceptibility or lifestyle factors; or chronic, low dose exposures.

The National Institute of General Medical Sciences (NIGMS) is interested in supporting research in multiscale modeling methods that apply to the core areas of (http://www.nigms.nih.gov/Research/) of cell biology, biophysics, genetics, developmental biology, pharmacology, physiology, biological chemistry.  NIGMS is also interested in new or innovative multiscale methods in computational science related to biomedical research.  In addition, NIH has a new program in computational social sciences/social, population, and behavioral modeling research. One major objective of this program is to connect systems biologists with researchers using systems approaches at that link physiology to population.

The Department of Energy (DOE) Office of Biological and Environmental Research (BER) advances world-class biological and environmental research programs and scientific user facilities to support DOE’s energy, environment, and basic research missions. The Biological Systems Science Division (BSSD, http://www.sc.doe.gov/ober/bssd_top.html) provides the scientific and analytical technologies needed to translate genomic sequence into a profound and comprehensive understanding of the myriad of processes carried out by biological systems. Research within this program leverage the genomic code as a starting point to understand systems biology through (1) Systems analysis of the collective ‘omics (e.g. transcriptomics, proteomics and metabolomics) of plants and microbes, (2) Development of new methods for characterizing and imaging molecular systems, and (3) Development of new approaches to synthesize and redesign biology processes. Applicants interested in DOE funding may wish to use the September due dates.

The Food and Drug Administration (FDA) is interested in development of predictive multiscale models of the anatomy, physiology and pathophysiology of the cardiovascular, pulmonary, orthopedic, ophthalmic, and neurological systems. Research that advances our understanding of the performance of medical products in humans are of greatest interest. To facilitate more effective medical product development, improved engineering analysis methods are needed to predict whether a proposed design will function properly and safely based on the intended function of the product and the anatomic and physiologic data gathered. Computational modeling should be integrated with in vitro and in vivo experiments in such a way that these distinct elements and their interplay will cumulatively guide product development and provide a more informative evaluation pathway.

The National Science Foundation (NSF) is the only federal agency dedicated to the support of basic research and education across all fields of science and engineering, in fulfillment of its statutory mission “to promote the progress of science; to advance the national health, prosperity, and welfare; and to secure the national defense.”  Participating NSF components are interested in supporting research at the interfaces of the life sciences, computational sciences, mathematical and physical sciences, and engineering to accelerate understanding of biological and biomedical systems.  Advances in methods and tools for predictive modeling, simulation, and analysis of emergent behavior in complex multiscale systems are of interest, including the issues of verification, validation, and uncertainty quantification across scales.  Advances in data-analysis techniques and tools that are relevant to these systems are also of interest, in particular for impact on the “data deluge.”

Applicants focusing on specific disease or domain not aligned with the mission of the NIH components and participating agencies on these FOAs should contact the NIH Institute or Center or agency to find FOAs that are more appropriate to their research interest.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Resubmission
Revisions

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH, DOE, FDA, and NSF appropriations, and the submission of a sufficient number of meritorious applications.  

Award Budget

Projects are limited to Total Direct Costs of $500,000 per year.  Budgets are expected to range from $200,000 to $400,000 in Total Direct Costs each year.  

Award Project Period

 The maximum period is 5 years.  

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
 
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

Foreign (non-U.S.) components of U.S. Organizations are  allowed.  

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.   

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

All applications must include an MSM Consortium Plan as described in Section IV. Content and Form of Application Submission.  Applications lacking the MSM Consortium Plan will not be peer reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

All applications (unfunded applications and renewals of funded grants) previously submitted to PAR-08-023 must be submitted to grants.gov as NEW applications to this FOA because of the change of activity code from R01 in PAR-08-023 to the U01 mechanism in this FOA. Unfunded applications previously submitted to PAR-08-023, must be updated based upon the previous review panel comments.  These applications, however, must NOT include an introduction and must NOT mark the changes in text in response to the previous review panel comments. The reviewers will not have access to the previous summary statement. Renewals of previously funded grants submitted to PAR-08-023, must be submitted as NEW to this FOA.  The reviewers will not have access to the previous summary statement. Revisions to funded awards under PAR-08-023 are not allowed for this FOA.  Revisions to U01 awards funded under this FOA are allowed.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

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: grace.peng@nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

In the Research Strategy section:

Investigators are required to identify a compelling multiscale problem or approach that is currently not being addressed - that is, beyond current practice - and address its impact on the field and its significance to the problem being addressed. 

The proposed multiscale model must incorporate substantial representations of the underlying biological or behavioral mechanisms from at least two scales and at least one linkage between scales.

Investigators are required to provide rationale for the predictive aspects of the proposed multiscale model. Investigators are required to provide a convincing technical plan (approach) for achieving predictive outcomes from the proposed multiscale model. The data used to develop the model must be identified and appropriately justified for each scale and link modeled. Investigators must clearly describe the model architecture and highlight aspects of the architecture which will facilitate model sharing.

Investigators must include specific milestones and timeline of scientific progress.

Investigators should reach out to other experts to further complement their expertise, and indicate in a "Partnership Plan" the type of partnership that will be achieved in the proposed project, and how this partnership will address the particular goals and future impact of the proposed model.  As stated in Section I, this FOA encourages highly interactive partnerships that strongly integrate truly diverse expertise to further increase the impact of multiscale models in the broader research and policy community. This list is not complete and is not limited to the following:

a)    experimental and modeling expertise, so that the models create testable hypotheses leading to new investigational studies, or

b)    mathematical and or statistical expertise with domain-modeling expertise, so that new methods enhance function of the models, or

c)    expertise focused on different spatial or temporal scales, or different experimental and observational scales, or different deterministic and statistics-driven scales, or

d)    expertise from mature modeling disciplines with expertise from disciplines with an emerging use of models, or

e)    expertise from different biological and behavioral modeling subfields; such as, computational neuroscience, systems biology, and physiome research, agent-based modeling, system dynamics, and microsimulation.

SF424 (R&R) Other Project Information Component

Applicants should submit the following three, separate sections, each limited to one page : MSM Consortium Plan (required for all applications),  NSF Broader Impact statement (required for an application to be considered eligible for NSF funding), and the Plan for Sharing Models and Software,  into the SF424 (R&R) Other Project Information Component. 

MSM Consortium Plan (limited to one page)

As a cooperative agreement, investigators are required describe in a "MSM Consortium Plan" how this project will contribute to the IMAG-MSM Consortium activities, describing specific milestones and timeline of participation within the MSM Consortium.  Investigators are expected to play an active role in the MSM Consortium, leading the working groups, sharing data, models, expertise and other efforts to contribute to the greater multiscale modeling community.  Applicants are welcome to look at current and past MSM Consortium activities on the IMAG wiki, http://www.imagwiki.org/mediawiki.  Investigators must set aside personnel and effort to work towards the Consortium goals during the year, allocate funds for at least two key investigators with complementary expertise to attend annual IMAG-MSM Consortium meetings, and allocate other funds to participate in other MSM Consortium activities as appropriate.

The MSM Consortium Plan should be placed into the SF424 (R&R) Other Project Information Component.  Provide this information in a separate file, attaching it as Item 12, Other Attachments.  In the body of the text, begin the section with a heading indicating “MSM Consortium Plan.” When saving this file for uploading, name it “MSM Consortium Plan.”

Applications lacking the MSM Consortium Plan component will not undergo peer review.

NSF Broader Impact (limited to one page)

Describe the broader impacts of the proposed activity. Describe well the activity advances discovery and understanding while promoting teaching, training, and learning.  Explain how the proposed activity broadens the participation of underrepresented groups (e.g., gender, ethnicity, disability, geographic, etc.) Describe how this work would enhance the infrastructure for research and education, such as facilities, instrumentation, networks, and partnerships.  Describe how the results will be disseminated broadly to enhance scientific and technological understanding. Describe the benefits of the proposed activity to society. Indicate the mentoring activities provided to postdoctoral researchers supported on the project.

The NSF Broader Impact, if applicable, should be placed into the SF424 (R&R) Other Project Information Component.  Provide this information in a separate file, attaching it as Item 12, Other Attachments.  In the body of the text, begin the section with a heading indicating “NSF Broader Impact.” When saving this file for uploading, name it “NSF Broader Impact.”

Plan for Sharing Models and Software (limited to one page)

All applicants are expected to include a plan for sharing the models proposed in their grant application. Detailed sharing plans should be provided for the model components or modules, modeling parameters and associated datasets. 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  relevant models.

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, this FOA 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, biological, behavioral, environmental, and clinical 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.

Plans for Sharing Models and Software should be placed into the SF424 (R&R) Other Project Information Component.  Provide this information in a separate fileas applicable, attaching it as Item 12, Other Attachments.  In the body of the text, begin the section with a heading indicating “Plan for Sharing Models and Software.” as applicable. When saving such a file for uploading, name it “Plan for Sharing Models and Software.”

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modifications:

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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 only as described in the NIH Grants Policy Statement.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review. Applications lacking the required MSM Consortium Plan will be considered incomplete.  Incomplete applications will not be peer reviewed.  

Applicants interested in DOE funding

Applicants interested in DOE funding may wish to use the September due dates.  Applications to the January and May due dates will be accepted and reviewed, but funding decisions from DOE will not be made until the end of September.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

Applications will be evaluated according to the standard NIH review process.  Applicants interested in potential NSF support must also address The National Science Board-approved merit review criterion of “Broader Impact” to be eligible for NSF support (see below).

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

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific 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? 

Have the investigators identified a compelling multiscale problem or approach that is currently not being addressed (i.e. beyond current practice)?  Does the project provide a strong rationale for the predictive aspects of the proposed multiscale model?   

Investigator(s)    

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

Have the investigators reached out to diverse experts to further complement their expertise?  To what degree does the "Partnership Plan" describe the type of partnership that will be achieved in the proposed project?  How will this partnership address the particular goals and future impact of the proposed model?    

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? 

Are the proposed milestones and timeline feasible for the proposed science?  Does the proposed multiscale model incorporate substantial representations of the underlying biological or behavioral mechanisms from at least two scales AND at least one linkage between scales? Does the project provide a convincing technical plan for achieving predictive outcomes from the proposed multiscale model? To what degree does the project include the development of models that can be explicitly shared with other modelers? To what degree do the proposed model architecture, model components or modules, modeling parameters and associated datasets facilitate model sharing?    

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?      

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

MSM Consortium Plan 

Is the MSM Consortium Plan described in the application feasible and appropriate for this project?  Have the investigators set aside an adequate amount of time, personnel and effort to contribute adequately to the MSM Consortium?   Are the milestones and timeline appropriate for active participation within the MSM consortium?  Will the activities and efforts proposed in the plan contribute to the greater multiscale modeling community?

NSF Broader Impact

What are the broader impacts of the proposed activity? How well does the activity advance discovery and understanding while promoting teaching, training, and learning? How well does the proposed activity broaden the participation of underrepresented groups (e.g., gender, ethnicity, disability, geographic, etc.)? To what extent will it enhance the infrastructure for research and education, such as facilities, instrumentation, networks, and partnerships? Will the results be disseminated broadly to enhance scientific and technological understanding? What may be the benefits of the proposed activity to society? Are appropriate mentoring activities provided to postdoctoral researchers supported on 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. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, 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.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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

MODEL AND SOFTWARE SHARING PLAN:

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?

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?

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.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NIBIB, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate NIH National Advisory Council or Board. The following will be considered in making funding decisions:

Summary statements and grant applications will be made available to the DOE, FDA, and NSF for funding decsions.

NSF staff will give careful consideration to the following in making funding decisions:

Integration of Research and Education

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial IMAG programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the IMAG purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the IMAG as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

The Principal Investigator will have the primary responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies.

Awardees are responsible for identifying specific milestones and timeline for the scientific success of their multiscale model.

Awardees will join the MSM Consortium and are responsible for identifying specific milestones and timeline for their participation within the MSM Consortium, as described in their proposed MSM Consortium Plan.  Awardees are expected to play an active role in the MSM Consortium, leading the working groups, sharing data, models, expertise and other efforts to contribute to the greater multiscale modeling community.  Applicants to this FOA will use allocated funds for at least two key investigators with complementary expertise to travel to the annual MSM Consortium Meetings (http://www.imagwiki.org/mediawiki/index.php?title=IMAG/MSM_Events) and use other allocated funds to participate in other MSM Consortium activities as proposed in the MSM Consortium Plan.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
IMAG program officials will serve as Project Scientists and will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship in awards, as described below.

Each project will have the support of one or more Project Scientists from IMAG who are assigned an administrative role for the multiscale modeling project.

The IMAG Project Scientists will be responsible for assessing the progress of the projects toward the accomplishment of specified milestones and contributions to the MSM Consortium through milestone performance reviews.  Project Scientists will recommend if further funds should be released to the project.

The IMAG Project Scientists will recommend collaborations between awardees of the MSM Consortium and other persons or organizations whose participation will assist with the accomplishment of project goals. These persons or organizations may include other federal agencies, non-profit organizations, or commercial entities.

The IMAG Project Scientists will have a significant, although not dominant, role in the planning and execution of the supported activities.  Through the cooperative agreement, IMAG Project Scientists will facilitate awardee participation in the MSM Consortium activities, serve as liaisons to the MSM working groups, participate in twice a month virtual discussions of the MSM, and meet on a monthly basis to discuss awardee contributions in the MSM. 

An important aspect of IMAG is the coordination of a variety of research efforts across multiple funding agencies.  IMAG will continue to update the MSM Consortium of new funding opportunities, and research activities promote the mission and coordination of the MSM Consortium.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned Program Officer may also serve as an IMAG Project Scientist.

Areas of Joint Responsibility include:

The awardees, together with IMAG and the MSM Consortium, will organize the annual in-person MSM Consortium meetings.  These parties will identify the priority topics to be addressed each year, develop a meeting format that optimally addresses these topics, promote and attend these meetings during the duration of the funded project. 

Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Investigators are strongly encouraged to discuss their ideas with the respective program representatives listed under Scientific/Research contacts below.    

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

NIBIB

Grace C.Y. Peng, Ph.D.
Interagency Modeling and Analysis Group (IMAG)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: grace.peng@nih.gov 

NCI

Jennifer Couch, Ph.D.
Division of Cancer Biology (NCI)
National Cancer Institute
Telephone: 301-435-5226
Email: couchj@mail.nih.gov

NCRR

Olga Brazhnik, Ph.D.
Computer Scientist
National Center for Research Resources (NCRR)
Telephone: 301-435-0755
Email: brazhnik@nih.gov

NHGRI

Heidi Sofia, Ph.D.
Program Director
National Human Genome Research Institute (NHGRI)
Telephone 301-496-7531
Email:  sofiahj@mail.nih.gov

NHLBI

Albert Lee, Ph.D.
Program Director
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0513
Email: alee@nhlbi.nih.gov

NIA

Wen G. Chen, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: chenw@nia.nih.gov  

NIAAA

Gregory Bloss
Division of Epidemiology and Prevention Research
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-3865
Email: gbloss@mail.nih.gov

NICHD

Nancy L. Shinowara, PhD
Program Director: Spinal Cord & Musculoskeletal Disorders & Assistive Devices
National Center for Medical Rehabilitation Research
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Telephone:  301-402-2242
Email:  shinowara@nih.gov

NIDA

Susan Volman, Ph.D.
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-1315
Email: svolman@mail.nih.gov  

NIEHS

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, K3-04 (NIEHS)
Telephone: 919-541-2448
Email: balshaw@niehs.nih.gov  

NIGMS

Peter Lyster, Ph.D.
Center for Bioinformatics and Computational Biology
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email: lysterp@mail.nih.gov

DOE

Susan K. Gregurick, Ph.D.
Program Manager
Computational Biology and Bioinformatics
OBER/DOE
Telephone: 301-903-7672
Cell: 301-538-9781
Email: Susan.Gregurick@science.doe.gov
Twitter: @SGregurickDOE

FDA

Donna R. Lochner
Deputy Director
Division of Cardiovascular Devices (FDA)
Food and Drug Administration
Phone: 301-796-6309
Email:  Donna.Lochner@fda.hhs.gov

NSF

Thomas Russell, Ph.D.
Program Director, Division of Mathematical Sciences
Senior Staff Associate, Office of Integrative Activities
National Science Foundation (NSF)
Telephone: 703-292-4863
Email: trussell@nsf.gov

Semahat Demir, Ph.D.
Program Director, Division of Chemical, Bioengineering, Environmental, and Transport Systems
National Science Foundation (NSF)
Telephone: 703-292-7950
Email: sdemir@nsf.gov

Manish Parashar, Ph.D.
Program Director, Office of Cyberinfrastructure
National Science Foundation (NSF)
Telephone: 703-292-4766
Email: mparasha@nsf.gov

Peer Review Contact(s)

David T. George, Ph.D.
Director, Office of Scientific Review
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 920, Room 956, MSC 5469
Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services)
Telephone: 301-496-8633
Email: GeorgeD@nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

James Huff
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4782
Email: James.Huff1@nih.gov  

NCI

Crystal Wolfrey
Office of Grants Administration
National Cancer Institute (NCI)
Telephone: 301-496-8634
E-mail: crystal.wolfrey@nih.gov

NCRR

Courtney Tardd-Wright
National Center for Research Resources (NCRR)
Telephone: 301-496-9441
Email: tarddwrightc@mail.nih.gov

NHGRI

Cheryl Chick
Grants Administration Branch
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-0733
Email: chickc@mail.nih.gov

NHLBI

Anthony Agresti
Team Leader
Office of Grants Management
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0186
Email:  agrestia@mail.nih.gov

NIA

Ryan Blakeney
Grants Management Specialist
National Institute on Aging (NIA)
Telephone:  301-451-9802
Email:  blakeneyr@mail.nih.gov

NIAAA

Judy Fox, GMO
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov   

NICHD

Maggie Young
Supervisory Grants Management Specialist (Team Leader)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-7008
Email: my68g@nih.gov

NIDA

Carol Alderson
Deputy Chief Grants Management Officer
National Institute on Drug Abuse (NIDA)
Telephone: 301-933-6196
E-mail:  aldersoc@mail.nih.gov

NIEHS

James R. Williams
Grants Management Specialist
National Institute of Environmental Health Sciences (NIEHS)
Telephone:  919-541-1403
Email:  williamsjr@niehs.nih.gov

NIGMS

Lori Burge
Grants Administration Branch
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-3781
Email: burgel@nigms.nih.gov

DOE

Joanne Corcoran
Office of Biological and Environmental Research (DOE)
Telephone: 301-903-6488
Email: joanne.corcoran@science.doe.gov

FDA

Yemisi Akinneye
Grants Management Specialist
Office of Acquisitions & Grants Services, FDA
Telephone: 301-827-0079
Email:  Oluyemisi.Akinneye@fda.hhs.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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