It is critical that applicants follow the Research (R) 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 research network for the Modeling Infectious Disease Agent Study (MIDAS) program consists of researchers funded by R01, R35, DP2, K and F series grants. MIDAS researchers are tasked with improving the science of computational modeling to study the interactions of infectious agents and their hosts as well as disease spread, prediction and response strategies. The threat of emergence or re-emergence of infectious disease epidemics continues to be a concern of policymakers and public health researchers. Better resources, knowledge and tools are needed to improve our understanding 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 the MIDAS program is to create a rational picture of the alternative response strategies 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 understand likely consequences of interventions. These capabilities can help responsible parties plan for and respond to an emerging epidemic.

The existing MIDAS network began in May 2004 with the funding of three research groups and an informatics group. In February of 2006, four additional research groups were added. These groups were funded by cooperative agreements. Following recent external and internal evaluation, the MIDAS network is being restructured to consist of R01 awards and an expanded network of researchers supported by other means (R35, R15, DP1, DP2 and K and F awards) who share an interest in advancing the science of modeling to study infectious disease spread. The network will continue to be a multidisciplinary, multicomponent effort, comprising an important research element for developing better methods for predicting and modeling infectious disease spread and outbreaks.

This FOA solicits applications for a MIDAS Coordination Center that will support and extend the work of the MIDAS research groups by (i) providing the infrastructure to maintain and make available all MIDAS-related resources; (ii) collecting, managing and generating Gold Standard Datasets relevant to the systems they are studying; (iii) providing support for collection and dissemination of information and for outreach; (iv) providing logistical support for MIDAS activities; and (v) conducting evaluation and meta-analysis of MIDAS resources. To maximize the output of the network, the Coordination Center will store, manage, and promote the shared efforts (i.e., models, synthetic population datasets) generated by the research groups in the MIDAS network.

The role of the MIDAS Coordination Center will encompass:

1. Resources

The MIDAS Coordination Center will be responsible for curating and making available MIDAS-related resources. Resources are identified as data, models, software, tools, methods, etc. The Center will maintain server space of sufficient capacity to maintain models, datasets and other resources contributed and utilized by members of the MIDAS network. Coordination Center Program Directors/Principal Investigators (PDs/PIs) are responsible for proactively seeking resources from members of the MIDAS network. Resources are to be inventoried and detailed in a user-friendly web menu. The menu must be made publicly available, but the Center may control access to some resources for limited time periods, such as datasets that have not yet been used in publications and that network members are not prepared to share yet without restriction. Once data sets are used in published work, they are expected to be made publicly available, as appropriate and consistent with achieving the goals of the program. Search, access, and utilization statistics of the resources are to be maintained and made readily available to NIGMS staff for review purposes. Web portals to MIDAS resources must be user-friendly and updated regularly to represent newly added or updated resources.

The MIDAS web menu will provide access to shared resources as well as search tools for ease of interpretation. The Coordination Center must maintain the computing infrastructure necessary to run all curated models. Specifications for computing infrastructure and resources should be available to the network and should be supported by a well-defined application programming interface (API). If a formal ontology/taxonomy is needed to develop the web menu, one or more widely used schemes should be employed (e.g., Medical Subject Headings (MeSH), Unified Medical Language System (UMLS), or the National Center for Biomedical Ontology). The Coordination Center is responsible for promoting the use of the web menu by the broader research community, gathering feedback on usability, and providing technical support for the tools on the menu.

Coordination Center PD(s)/PI(s) will describe a plan of action for sustained storage of resources for five years, ten years, and beyond ten years. Contributed resources must adhere to FAIR (Findable, Accessible, Interoperable, Reusable) principles. Coordination Center PD(s)/PI(s) will assign metadata to each resource, adhering to advances in data-tagging conventions such as digital object identifiers (DOI), and update resource metadata in a way that allows network members to cite MIDAS resources in observance of state-of-the-art expectations.

Many MIDAS resources have already been curated by a resource center under a previous funding mechanism. An administrative supplement to an award could be requested to support the transfer of existing resources from their previous location, the aforementioned resource center, to the newly formed Coordination Center.

2. Gold Standard Datasets

Coordination Center PD(s)/PI(s) will identify and release to the network Gold Standard Datasets for testing and evaluating MIDAS models. Gold Standard Datasets, defined as MIDAS-related datasets that are well curated, can be contributed by network PDs/PIs and other relevant sources. The Coordination Center PD(s)/PI(s) will proactively collect these datasets and will have the expertise to identify datasets best suited for testing specific models. When a MIDAS researcher wishes to test a new model, the Coordination Center will provide Gold Standard Datasets best suited to the specific model under study. The MIDAS Coordination Center will define and enforce standards for quality of shared resources and Gold Standard Datasets. Coordination Center PD(s)/PI(s) will explain to the requesting investigator the fit of their provided Gold Standard Dataset to the model to be tested. All MIDAS datasets must adhere to the FAIR principles and be digitally identified (by DOI or other identifier).

3. Infrastructure

Infrastructure is identified as hardware and computational resources necessary to carry out goals of the MIDAS Coordinating Center. All infrastructure and resources must be housed in servers described in this application by make and model. Servers may be local or cloud-based. In either case, backup power supply systems, security and climate control for servers must also be described. Center may control access to some resources for limited time periods, such as certain datasets that have not yet been used in publications.

4. Coordination Activities

The MIDAS Coordination Center will lead the network’s organized research and outreach efforts.

The Coordination Center must identify and maintain relationships with public health agencies that would benefit from access to MIDAS resources and expertise. Researchers funded by the MIDAS program will not set public policy standards. It is hoped that models and methods developed through the MIDAS network will ultimately be useful in informing public health decision making, but the network itself is a research endeavor aimed at understanding the mechanisms of disease spread and developing improved modeling methods. The Coordination Center will not directly make public health recommendations but can assist public health agencies in understanding current state of the art in infectious disease modeling, including gaps and shortcomings, and can facilitate contacts with experts in the field.

Other coordinated efforts to be led by the Center include planning an annual investigators conference and may include hosting monthly teleconferences for collaboration and coordination within the MIDAS network. These gatherings are intended to alert all members of the network to the efforts of other network members and to enhance collaboration and avoid redundant effort. Annual conferences should be two or three days in length and held in parts of the United States that are most easily accessed by MIDAS network members. Recent MIDAS meetings have been held in Washington DC and Atlanta, GA. Monthly teleconferences could allow the network to gather updated programmatic information from NIH staff and present recent research progress.

5. Educational Opportunities

The MIDAS Coordination Center will spearhead educational efforts for participants and trainees of the MIDAS network. The Center will host at least one annual two- or three-day workshop for graduate students and postdoctoral researchers. The workshops will acquaint participants with the research resources contributed by the MIDAS network and curated by the Coordination Center. Participants will be trained in the use of the MIDAS resources and invited to collaborate on projects that utilize and improve MIDAS resources.

Some examples of workshop topics include but are not limited to:

• How to repurpose a synthetic population dataset to model a new outbreak;
• How to apply existing models to new questions;
• How to access and organize open data to address new research questions;
• How to predict outbreaks from public health data collected immediately before and after recent outbreaks; and
• How to evaluate outbreak response options using synthetic population datasets.

Other educational activities are also expected. Examples include facilitating temporary exchanges of postdoctoral researchers or graduate students among MIDAS research groups and organizing career development seminars during the annual investigators conference and at other times. Center PD(s)/PI(s) will coordinate partnerships to promote diversity in the infectious disease-modeling community. Toward this purpose, the Center will provide financial and logistical support for participation of individuals from diverse backgrounds, including those from groups underrepresented in the biomedical research workforce, in MIDAS workshops and conferences.

6. MIDAS-Related Research Activities

The MIDAS Coordination Center will conduct independent research. Research funding in line with the typical R01 level of support (~$250K/year Direct Cost) will be provided to enable an impactful research program on the evaluation and meta-analysis of existing modeling resources for the study of infectious disease spread and intervention. One objective of the Coordination Center is the maximization of use of shared MIDAS resources. The Coordination Center’s research program should serve that objective by implementing and evaluating the resources they maintain. Protocols for coordination of modeling resources and open data should be improved as part of the research effort. The research program will develop coordination as a research initiative, offering an example to be followed in other disciplines.

Additional Information: Organizational Structure of MIDAS

The Center must build a governance team consisting of one or more PDs/ PIs with expertise in modeling, data science, and management of personnel in a research setting. A multi-PD/PI structure is encouraged but not required. Leadership of the Center should leverage existing resources and unique institutional assets to meet the needs of the MIDAS network. Leadership must maintain a single Steering Committee to advise on event planning and allocation of Center resources. The Steering Committee will consist of a group of at least five funded MIDAS PDs/PIs each serving a two-year term with potential to renew. Applicants are not to form this Steering Committee prior to an award and should not contact or mention potential members of the Steering Committee in this application. Additional committees and subcommittees are discouraged. The Steering Committee will hold one in-person meeting at the annual investigators conference as well as optional teleconferences. A summary of the issues discussed by the Steering Committee, as well as recommendations made and actions taken, must be included in the yearly progress reports submitted to NIGMS.

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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)
• 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) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not 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. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.

Each PD/PI is required devote at least 2.25 (AY) person months to this effort and the contact PD/PI is required to dedicate at least 2.7 (AY) person months to this effort.

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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) 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.

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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.

Facilities and Other Resources: Provide information on the make and model of all servers to be used to house infrastructure and resources provided by the Coordination Center.

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

The Biographical Sketches must document the collaborative activities within the field of infectious disease modeling that have been led by the PD(s)/PI(s).

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

The budget request should be commensurate with all of the required elements; funds for organizing and planning annual investigator conferences may be included.

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: Applicants must address plans for collection and dissemination of useful products of the research, including approaches, technologies and tools to the relevant research and user communities.

Applicants must describe the approach and methods to be employed in development of web-based resources including descriptions for infrastructure and maintenance. Applicants must describe how curated resources will adhere to the FAIR Principles. If controlled access to resources is needed, applicants should describe the circumstances required for controlled access and the mechanisms to be put in place to ensure that access is opened at the appropriate time.

Applicants must describe approaches for developing, validating, and maintaining Gold Standard Datasets.

The MIDAS network relies on collegial and cooperative interactions among its constituent members. Applications must describe a plan for proactive leadership of collaborative MIDAS activities.

Applicants must describe logistical support, including planning and execution for the annual MIDAS meeting as well as support for communication within the MIDAS network.

Applicants must describe all educational activities that will enhance the MIDAS network and benefit its participants. They should include plans to provide education in rigorous research design and data interpretation and the responsible communication of results.

Finally, applicants must describe the research strategy that the investigators will employ to create an impactful research program on the evaluation and meta-analysis of existing modeling resources for the study of infectious disease spread and intervention.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Consistent with the goals of the program, applications are expected to include a statement that software developed by the Center through MIDAS funding will be deposited, in a timely manner, in the MIDAS repository. Coordination Center PD(s)/PI(s) are not exempt from the requirement of sharing research products with MIDAS network members, as appropriate and consistent with achieving the goals of the program.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

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 Coordination Center 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.

Does the Coordination Center address the needs of the MIDAS network that it will coordinate, administer and serve? Is the scope of activities proposed for the Center appropriate to meet those needs? How will successful completion of the aims bring unique advantages or capabilities to the MIDAS network?

Are the PD(s)/PI(s) well suited to coordinate the MIDAS network? Do they have appropriate experience and training? 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 approaches, governance and organizational structure appropriate for the Center? Do the Coordination Center PDs/PIs demonstrate willingness and capability to proactively work with other members of the MIDAS network to enhance the MIDAS program's productivity?

Does the application propose novel strategies in coordinating the research network the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts or management strategies proposed?

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of biological variables, such as sex, for studies of vertebrate animals or human subjects?

Will the proposed Coordination Center's approach for collection and dissemination of MIDAS-related resources (such as data, models, software etc.) enhance overall usability of these research products? Are the plans to make MIDAS research products FAIR appropriate? Is there a strong rationale for restricted data access and if so, is the plan for controlled data access appropriate and well justified?

Are the proposed web menu and computing infrastructure effective and user-friendly? Have the most modern and cost-effective approaches (e.g., cloud-based resources) been considered? Will the proposed approaches for developing, validating and maintaining Gold Standard Datasets enhance the models and software testing and validation by the MIDAS community? Are the collaborative and coordination activities well justified and will they enhance the overall productivity of the MIDAS network? Are the educational activities well justified and will they result in a benefit to participants of the MIDAS network? Are rigorous methods and interpretation of data emphasized in the educational activities? Is education in responsible communication of results provided?

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling? Does the institutional environment provide the infrastructure necessary to house MIDAS resources and host workshops for MIDAS trainees?

As applicable for the Coordination Center 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.

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 Guidelines for the Review of Human Subjects.

When the proposed Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

Not Applicable

Not Applicable

As applicable for the Coordination Center 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.

Not Applicable

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).

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) Genomic Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 the appropriate NIH Institute or Center. 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.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this 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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 Part 75 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;
• organizing and participating actively in MIDAS meetings, including the Steering Committee meetings;
• implementing policies and guidelines approved by the MIDAS 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:

Project Coordinator:

NIGMS Project Coordinator with expertise in relevant areas will:

(a) help guide the development of the MIDAS network by providing overall advice and coordination;

(b) facilitate a partnership with NIH and ensure that the directions taken by the MIDAS Coordination Center are consistent with NIGMS missions and goals;

(c) make recommendations regarding project direction to maintain scientific balance between accomplishing the goal and objectives of MIDAS and addressing emerging research opportunities;

(d) serve as voting member of the Steering Committee as representative of the NIH extramural staff; and

(e) facilitate, not direct, activities.

Decisions will be reached, where possible, through consensus with the PD(s)/PI(s) and the MIDAS Steering Committee. The Project Coordinator will not participate in the oversight of the funding announcement, application review or programmatic and budgetary stewardship of the award. The Project Coordinator will also not participate as an active researcher in the execution of the funded research.

Program Official:

The NIGMS Program Official will be responsible for oversight of the funding announcement and the normal programmatic stewardship of the award, including funding decisions, and will be named in the award notice. The Program Official will not serve as a voting member of the Steering Committee or partake of the duties of the Project Coordinator.

Areas of Joint Responsibility include:

The MIDAS network Steering Committee is the oversight body for MIDAS. Members, who are appointed by the PD(s)/PI(s) of the award, will include representation from user groups such as public health officials, representatives of the research community, and the NIH Project Coordinator. Outside expertise ensures sufficient breadth and balance on the committee. The NIH Project Coordinator may not serve as Chair. The 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 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. 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 also may add members, with the approval of the NIGMS Project Coordinator.

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) set overall milestones for MIDAS; (d) assess progress within the MIDAS network; (e) develop guidelines and policies for data and software sharing and release to public domains; (f) reflect the views of other researchers; (g) contribute to the development of a cohesive effort; and (h) 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. The panel will consist of a designee of the Steering Committee, 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 Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Daniel E. Janes, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0943
Email: daniel.janes@nih.gov

Stephanie Constant, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: Stephanie.Constant@nih.gov

Justin Rosenzweig
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0158
Email: rosenzwj@mail.nih.gov

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 Part 75.