Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of General Medical Sciences (NIGMS)
Funding Opportunity Title	Modeling of Infectious Disease Agent Study Research Projects (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	Reissue of RFA-GM-11-002
Related Notices	February 22, 2016 - This RFA has been reissued as PA-16-107. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
Funding Opportunity Announcement (FOA) Number	RFA-GM-14-007
Companion Funding Opportunity	RFA-GM-14-008, U24 Resource-Related Research Projects Cooperative Agreements RFA-GM-14-009, U54 Specialized Center- Cooperative Agreements
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.859
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA), solicits Cooperative Agreement (U01) applications from institutions/organizations that propose to provide the U.S. scientific and public health communities better resources, knowledge, and tools to improve their ability to prepare for, identify and prevent the spread of infectious diseases. Research projects will become part of the Models of Infectious Disease Agent Study (MIDAS) network. This FOA is a reissuance of a prior FOA (RFA-GM-11-002). The MIDAS network consists of a centralized Information Technology Resource (announced separately), a Centers of Excellence component (announced separately) and, with this announcement, the continuation of a network of multidisciplinary scientists conducting computational and mathematical research to improve the ability to prepare for, detect, control, and prevent emerging infectious diseases caused by naturally occurring or intentionally released pathogens, including those relevant to biodefense.

Posted Date	April 12, 2013
Open Date (Earliest Submission Date)	June 18, 2013
Letter of Intent Due Date(s)	June 18, 2013
Application Due Date(s)	July 18, 2013, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	July 18, 2013, by 5:00 PM local time of applicant organization.
Scientific Merit Review	October, 2013
Advisory Council Review	January, 2014
Earliest Start Date	May 2014
Expiration Date	July 19, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (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.

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

The threat of emergence or re-emergence of infectious disease epidemics continues to be a concern of policymakers and the public health services. Better resources, knowledge, and tools are needed to improve our knowledge of the dynamics of emergence, surveillance and detection of events, and the effectiveness and implications of prevention and mitigation efforts. The variety of possible scenarios complicates the challenge of confronting these threats. An important role of science is to create a rational picture of the alternatives by collecting, analyzing, and interpreting relevant data and by developing models. The models themselves can guide the collection of further data. In addition, good models can reveal important patterns in the data, allow investigators to examine scenarios, and to understand likely consequences of interventions. These capabilities can help responsible parties plan for and respond to an emerging epidemic or a bioterrorist threat.

Information on current and previous MIDAS activities, publications, and reports can be found on the MIDAS website at https://www.epimodels.org/midas/about.do, or http://www.nigms.nih.gov/Initiatives/MIDAS/.

This FOA encourages applications for MIDAS research groups that will offer to the MIDAS network complementary combinations of two or more competencies in: computational and mathematical methods, the biology of infectious disease systems, social networks and behavior, population dynamics, genetic variation and evolution, and environmental modeling. Also, research groups will participate fully in collaborative network research.

Areas of research could include, but are not limited to, the following:

I. Infectious Disease Research

Preparedness. Preparedness for outbreaks is a critical task for public health. Modeling is one approach to identifying components of preparedness and their interactions. Preparedness occurs at the levels of household, community, and nation. Modeling strategies may help improve how public health systems at many levels interact to protect the public.

Surveillance and Detection. A critical step in responding to an event is the ability to correctly identify and characterize it. In some cases, the speed and accuracy of a response (e.g., antimicrobials, vaccines, isolation, and community containment measures) may determine whether an outbreak will be contained or a crisis averted. Technological advances in disease detection will continue to provide considerable data, and statistical and modeling methods are needed to search for and characterize signals in the presence of highly variable background information. In addition, models may contribute to recognizing, identifying, and responding to intentionally released and/or engineered pathogens. These issues are relevant at many levels of organization from individual hospitals to communities, metropolitan areas, and countries.

Dynamics of Infectious Diseases. Infectious diseases are dynamic across temporal, spatial, and biological dimensions. Infectious disease systems provide an opportunity for modeling host / parasite coevolution, microbial population structure and the evolution of natural history parameters relevant to the spread of infectious diseases. Epidemiological modeling has and will continue to provide insights into how infectious diseases spread geospatially, temporally, and through social networks. Electronic social networking systems and continued widespread use of the Internet provide new data on both disease dynamics as well as responsive behaviors, which may contribute to epidemiological modeling.

Response Strategies. MIDAS uses modeling approaches to study the implications of various response strategies. When there are urgent national needs MIDAS research groups with pertinent expertise may be asked to focus MIDAS research on specific tasks of national importance. For example, MIDAS has studied the spatial and temporal deployment of antivirals and vaccines in response to an influenza outbreak and contributed to assessing the impact of community containment on the spread of pandemic influenza in the U.S. In addition to national response strategies, local, community, regional, and global should be considered.

Antimicrobial Resistance and Vaccine Escape. Modeling may contribute to understanding the evolution, sources, and spread of resistance in microbial populations and to understanding the dynamics of pathogen escape from vaccines. This subject is relevant at many levels, including individuals, hospitals, public health systems, and communities.

Behavior. Individual and social behavior contributes greatly to the dynamics of infectious disease emergence and spread as well as to compliance with public health policies. Issues include implications of social organization, migrations, decision-making, beliefs, norms, health practices, and trust. Research could address, for example, the impact of behavioral changes on the course of an outbreak (and vice versa), how to measure behavior, heterogeneity in behavioral response, and representation of complex behaviors.

Domestic, Agricultural, and Wild Animals. Although the major focus of this announcement is human disease, one cannot ignore the relevance of animals as reservoirs, hosts and vectors of infectious agents. For example, bird movements via migration or illegal trafficking facilitate the spread of avian influenza. Population dynamics of arthropod vectors are highly relevant to the spread of infectious disease. Zoonoses are also critical, and have been documented for several diseases, including HIV-AIDS and influenza. Studies of animal populations should focus on issues or modeling approaches relevant to human health.

Virtual reality. There has been considerable interest in using Web-based gaming systems to study behavior, transmission characteristics, social organization, and other factors relevant to the emergence and spread of infectious diseases. Research using virtual reality gaming systems may be especially useful to validate models or estimate parameters. Applicants may propose to use virtual communities to advance modeling of infectious diseases.

II. Computational, Mathematical, and Statistical Model Research

One of MIDAS’s central goals is to develop and improve mathematical, computational, and statistical methods for studying infectious diseases and to develop tools that will assist public health decision makers. Applicants should take account of the needs of the public health and research communities in designing and producing models. The following areas should be addressed:

Conceptual development of models. Underlying theories, including assumptions and approaches, strengths and weaknesses, should be clearly explained. Applicants should take into account the needs of the communities (i.e., public health, policy and decision making) that will be end users of the products of the research. The projects should also address plans for the dissemination of useful products of the research, including approaches, technologies and tools, to the relevant research and user communities. Other potential areas of research include (1) tools for archiving, managing, integrating querying, retrieving, and visualizing model results; (2) analytical and statistical tools for interpreting and using large data sets or model results; and/or (3) platform-independent translational tools for data exchange, interoperability, and exchange of models, tools, and results. Computational, mathematical, and statistical research proposed should be future-oriented, fill an area of need or projected need, and exceed the current state of the art.

Model verification and validation. The applicant must propose steps to verify that methods employed behave as expected, that is, that the software or equations have been reviewed, tested, and documented. Validation is an important goal but may or may not be possible, depending on the nature of the model. Indeed, approaches to validation of stochastic dynamic models is an important research topic. Applicants should explain how they will approach model validation.

Dissemination. One product of MIDAS research groups may be software tools that are of value to the public health, research, and policy and decision making communities. Software tools developed with MIDAS support will be available, where feasible, to researchers, educators, the public health community, and government organizations. Software tools should be designed and developed in collaboration with the user community, and with the MIDAS Information Technology Resource. Include a plan for software dissemination.

Software products must meet the high standards expected of contemporary biological software. These standards include:

First, software must be fully documented and easy to access, modify, and extend. Users who experience problems should be able to report and resolve issues with minimal effort. Problems should be tracked and appropriate changes incorporated into the software. It is particularly important that software be able to evolve as needs change.

Second, where possible, software packages relevant to infectious disease modeling and data management should be interoperable and portable to a variety of common platforms.

Third, software should be consistent with existing ontologies and controlled vocabularies. Where needed, software development projects should include (1) defining vocabularies and terms, (2) defining relationships among terms and functions, (3) defining data models, (4) defining data requirements and uses, and (5) similar activities.

Fourth, software must be tested, verified, and maintained. The final product should include user manuals and other training resources (e.g., workshops, online training, help desk).

Applicants should describe the approach and methods to be employed in the software development process. Applicants must demonstrate their experience in developing software using these approaches and methods.

Additional Information: Organizational Structure of MIDAS

The MIDAS program has five components: a Steering Committee, an Executive Committee, Centers of Excellence, an Information Technology Resource, and research groups.

The Steering Committee is the main oversight body for MIDAS and makes recommendations to NIGMS regarding scientific direction, resources, concerns and issues, evaluation, and similar topics. The committee includes representation from user groups such as public health officials, representatives of the research community, and NIH scientist administrators with relevant expertise. Outside expertise ensures sufficient breadth and balance on the committee. NIH scientist administrators will not comprise more than 40% of the voting members of the Steering Committee.

The executive committee coordinates and manages the MIDAS network, including coordination of multi-group projects. It is made up of the Program Directors/Principal Investigators of grants funded through the MIDAS program and will meet monthly by videoconference or conference call.

The research groups are teams of multidisciplinary, collaborating scientists from one or more institutions who have expertise in fields relevant to MIDAS. The research groups will offer to the MIDAS network complementary combinations of two or more competencies in: computational and mathematical methods, the biology of infectious disease systems, social networks and behavior, population dynamics, genetic variation and evolution, and environmental modeling. When there are urgent national needs each MIDAS research group must make a commitment to focus MIDAS research on specific tasks of national importance. Also, research groups will participate fully in collaborative network research.

The Centers of Excellence provide national and international leadership in four major thematic areas infectious disease research; computational, statistical, and mathematical research; education and outreach; and public health policy.

The Information Technology Resource supports and extends the work of the MIDAS Centers of Excellence and research groups by (1) collecting, managing, and generating data relevant to the systems the research projects and centers are studying; (2) supporting software development and testing when needed by the MIDAS consortium; (3) providing support for dissemination of information and for outreach, including design and maintenance of a MIDAS web site; and (4) providing logistical support for MIDAS activities. The Information Technology Resource acts in partnership with the MIDAS Centers of Excellence and research groups. Partnerships are expected to be highly interactive and collaborative in defining needs, planning and carrying out projects, and disseminating results and products.

Where appropriate to address urgent national needs, funded projects will be expected to focus MIDAS research on specific tasks of national importance. In addition, projects will participate fully in collaborative network research as developed by the MIDAS executive committee. The MIDAS network requires a commitment to cooperative interactions that must be addressed in the application. Specific domains of interaction can be found in Section IV.6.

Projects funded through MIDAS use existing sequence, genetic, epidemiological, clinical, climate, etc., information to conduct research. They will not generate primary data using MIDAS funding, with the exception of synthesized data.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New Renewal of awards funded under RFA-GM-05-011, RFA-GM-09-001, or RFA-GM-11-002 The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIGMS intends to commit $3.5 million (total costs) in FY 2014.
Award Budget	Application budgets may not exceed $500,000 Direct Costs per year, exclusive of subproject F&A costs.
Award Project Period	The maximum term of award will be five 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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 SF424 (R&R) Application Guide.

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

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

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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.

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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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 activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Douglas M. Sheeley, Sc.D.
Division of Biomedical Technology, Bioinformatics, and Computational Biology
NIGMS
45 Center Drive MSC6200
Bethesda, MD 20892
Telephone: 301-451-6446
Email: [email protected]

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

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

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed. The MIDAS program holds up to three meetings per year, at least one of which includes a meeting of the steering committee. Each research group will present its research findings at annual meetings of the Steering Committee and at no more than two other network consultations per year. Funds for travel of the Program Director(s)/Principal Investigator(s) and relevant staff to these meetings should be included in the proposed budget.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

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

Research Strategy: Investigators should address plans for dissemination of useful products of the research, including approaches, technologies, and tools, to the relevant research and user communities. Include a plan for software dissemination.

Applicants should describe the approach and methods to be employed in the software development process. Applicants must demonstrate their experience in developing software using these approaches and methods.

The applicant must propose steps to verify that methods employed behave as expected, that is, that software or equations have been reviewed, tested, and documented. Applicants should explain how they will approach model validation.

The MIDAS network relies on collegial and cooperative interactions among its constituent members, particularly for MIDAS special initiatives that may emerge as a result of urgent national needs. Renewal applications should include evidence that the applicant has engaged in collaborative activity within the network.

The MIDAS network requires a commitment to cooperative interactions that must be addressed in the application. NIGMS has adopted several policies that are applicable to the MIDAS network. These policies can be found in Section IV.6, Applicants must present plans to adhere to the policies, where appropriate.

Relationship to the MIDAS Information Technology Resource. Each research group must identify a data liaison to interact with the Information Technology Resource. This basic or bioinformatics scientist will advise the Information Technology Resource on the management and display of data generated or used by the research group, and will coordinate any joint software development.

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:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Software Development: Consistent with achieving the goals of this program, applications are expected to include a statement that software developed through MIDAS funding will be deposited, in a timely manner, in the MIDAS repository maintained by the Information Technology Resource; this repository will have restricted access to MIDAS grantees and Federal agencies. Also, if the MIDAS steering committee recommends that a particular software application should be made available for public use, the applicant will cooperate with the Information Technology Resource in producing and maintaining a user-friendly version.

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date 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.

This initiative is not subject to intergovernmental review.

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.

Applications must be submitted electronically following the instructions described in the SF424 (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(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(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. See Section III of this FOA for information on registration requirements.

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 System for Award Management. 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIGMS Referral Office by email at {[email protected]} when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI "Award Administration Information".

The MIDAS network relies on collegial and cooperative interactions among its constituent members, particularly for MIDAS special initiatives that may emerge as a result of urgent national needs.

NIGMS has adopted several policies that are applicable to the MIDAS network. Applicants must adhere to the following policies, where appropriate.

Data Sources. Research groups will use existing or simulated datasets, as well as real-time information, to build computational models relevant to the goals of MIDAS. Research groups will not use MIDAS funding to generate primary data, except in the case of simulations.

Relationship to the MIDAS Information Technology Resource. Each research group must, through its identified data liaison (see Section IV.2 above) advise the Information Technology Resource on the management and display of data generated or used by the research group, and will coordinate any joint software development.

Databases and Software. Research groups may develop their own (local) databases to meet their computational needs. They may request funds to support the design, testing, and validation of bioinformatics tools and the storage of data needed to accomplish their research objectives. If relevant, each research group is required to use the standard data exchange format established by the Information Technology Resource for transmitting information among projects. Software developed with MIDAS funding will be shared among MIDAS investigators and the research community according to policies determined by the MIDAS consortium and Federal officials, consistent with achieving the goals of this program.

Data, Software, and Intellectual Property. Each research group must propose a data and software release policy as described in Section IV.2. Each research group must also provide a separate plan that addresses intellectual property rights. These plans may be further negotiated prior to funding.

Meetings and Reports. The Program Director(s)/Principal Investigator(s) of each research group serves as a member(s) of the MIDAS executive committee and will participate in monthly videoconferences or conference calls. In addition, each research group will present its research findings at annual meetings of the Steering Committee and at no more than three network consultations per year. Funds for travel of the Program Director(s)/Principal Investigator(s) and relevant staff to these meetings should be included in the proposed budget.

National Emergencies. In the event of an attack or the emergence of an infectious disease, the NIGMS Program Director, upon request of the Project Scientist, may ask the Program Directors/Principal Investigators of MIDAS research groups, in concert with the MIDAS Centers of Excellence and the Information Technology Resource, to apply their expertise to the public health emergency. Should this occur NIGMS will be flexible in allowing the Program Director/Principal Investigator to reorganize and reorient specific project goals and to renegotiate the scope of the grant to include new objectives. The awardee may also be able to request additional funding to cover costs that were not included in the initial application.

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

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.

Reviewers will provide an overall impact 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).

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?

Investigator(s)

Are the PD(s)/PI(s), 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?

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?

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?

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 score, but will not give separate scores for these items.

Cooperation

Does the research team demonstrate its willingness and capability to work with other members of the MIDAS network to enhance the MIDAS program’s productivity? Are the plans presented for cooperation with the Information Technology Resource satisfactory? Are plans presented for adherence to NIGMS policies for the MIDAS program adequate? In the case of Renewal applications, have the PD/PI and investigative team provided evidence of productive collaborations with other members of the network during the preceding project period?

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

Not Applicable

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

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 score.

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; 3) Genome Wide Association Studies (GWAS); and 4) Software Sharing Plan.

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.

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to NIGMS. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Compliance with MIDAS policies as described in Section IV.6 Other Submission Requirements and Information; and compliance with data and software deposition and sharing policies as described in Resource Sharing Plan(s) Data Sharing Plan, and Software Development sections.

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.

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’s 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, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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 U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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 NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH 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 NIH as defined below.

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

• determining and coordinating research approaches and procedures;
• setting project milestones for the research group;
• participating actively in MIDAS meetings, including the executive committee meetings;
• implementing policies and guidelines approved by the MIDAS steering committee;
• submitting data and software to the MIDAS repository through the Information Technology Resource according to policies established by the steering committee;
• attending steering committee meetings; and
• contributing to the cooperative nature of the effort.

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 DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• NIGMS Project Scientists with expertise in relevant areas will (a) serve as voting members of the steering committee as representatives of the NIH extramural staff; (b) help guide the development of the MIDAS network by providing overall advice and coordination; (c) facilitate a partnership among NIH, the Centers of Excellence, research groups, and the Information Technology Resource; (d) ensure that the directions taken by MIDAS are consistent with NIH missions and goals; (e) make recommendations regarding support, to maintain a scientific balance between accomplishing the goal and objectives of MIDAS and addressing emerging research opportunities; and (f) facilitate, not direct activities. Decisions will be reached, where possible, through consensus with the PD(s)/PI(s) and the MIDAS steering committee.
• Additionally, an NIGMS Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• The MIDAS network steering committee is the oversight body for MIDAS. Members, who are appointed by the Director, NIGMS, will include representation from user groups such as public health officials, representatives of the research community, and NIH Scientist Administrators with relevant expertise. Outside expertise ensures sufficient breadth and balance on the committee. NIH Scientist Administrators will not comprise more than 40% of the voting members of the steering committee, and may not serve as Chair. The NIGMS Program Official is a central contact for all scientific and fiscal issues and serves as a resource to the project regarding DHHS, NIH, and NIGMS recommendations and policies. The NIGMS Program Official or designate will attend all steering committee meetings but is not a voting member of the steering committee.
• The steering committee decides on the schedule of meetings, once each year, usually in Bethesda, MD. The steering committee may also call meetings to address urgent national needs, and will participate in network meetings and teleconferences as needed. The steering committee may establish subcommittees as necessary. The steering committee also may add members, with the approval of the NIGMS Director.
• Specifically, the steering committee will (a) serve as the main oversight board of the MIDAS network; (b) communicate the views and needs of the scientific and public health communities; (c) recommend refinements of software developed by MIDAS researchers to meet Public Health needs; (d) set overall milestones for MIDAS; (e) assess progress within the MIDAS network; (f) develop guidelines and policies for data and software sharing and release to public domains; (g) reflect the views of other researchers; (h) contribute to the development of a cohesive effort; and (i) alert NIH to scientific opportunities, emerging needs, and impediments.

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 Dispute Resolution. A Dispute Resolution 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 dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

Douglas M. Sheeley, Sc.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email: [email protected]

Helen R. Sunshine, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: [email protected]

Ms. Lori Burge
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-3781
Email: [email protected]

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.

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.