Department of Health and Human Services


Part 1. Overview Information
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 Centers of Excellence (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of RFA-GM-09-003

Related Notices

  • October 18, 2013 - See Notice NOT-OD-14-003. Guidance on Resumption of NIH Extramural Activities Following the Recent Lapse in Appropriations.
  • September 23, 2013 - See Notice NOT-GM-13-133. Notice of Clarification of Instructions in Section IV.2 under the topic "Instructions for the Submission of Multi-Component Applications".
  • May 8, 2013 - See Notice NOT-GM-13-115. Notice of Correction to Eligibility Information.

Funding Opportunity Announcement (FOA) Number

RFA-GM-14-009

Companion Funding Opportunity

RFA-GM-14-007, U01 Research Project – Cooperative Agreements
RFA-GM-14-008, U24 Resource-Related Research Projects – 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 applications for Centers of Excellence in Modeling of Infectious Diseases. This FOA is a reissuance of a prior FOA (RFA-GM-09-003). The Centers will comprise a component of the Modeling of Infectious Disease Agents Study (MIDAS) network, consisting of Centers of Excellence, a centralized Information Technology Resource (announced separately), and research projects (announced separately).  The overall objective of MIDAS is the coordination of a cadre of multidisciplinary scientists conducting computational and mathematical research to provide the U.S. scientific and public health communities better resources, knowledge, and tools to prepare for, identify and prevent the spread of infectious diseases caused by naturally occurring or intentionally released pathogens, including those relevant to biodefense. The Centers will address four major thematic areas – infectious disease research; computational, statistical, and mathematical research; education and outreach; and public health policy.

Key Dates
Posted Date

April 12, 2013

Letter of Intent Due Date(s)

September 18, 2013

Application Due Date(s)

(Extended to November 1, 2013 per NOT-OD-14-003), Originally October 18, 2013

AIDS Application Due Date(s)

November 26, 2013

Scientific Merit Review

February, 2014

Advisory Council Review

May, 2014

Earliest Start Date

July, 2014

Expiration Date

November 27, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Background

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/.

The Centers funded as a result of this FOA will be fully integrated into the MIDAS Network. The MIDAS Network will focus on developing scientific knowledge of computational and mathematical models of infectious diseases and providing that knowledge to the scientific, public health, and policy communities. Successful Center applications will address four major thematic areas – infectious disease research; computational, statistical, and mathematical research; education and outreach; and public health policy.  Centers will build outstanding research programs in infectious disease modeling by providing opportunities for multidisciplinary conversation and collaboration, by providing national and international leadership, and by training the leaders of tomorrow. Centers should evolve into foci of highly integrated and trans-disciplinary research, training, and knowledge related to modeling of infectious diseases.

Thematic Areas

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

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.

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 the model.  Underlying theories, including assumptions and approaches, strengths and weaknesses should be clearly explained. The projects 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 ensuring 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 output of MIDAS Centers should 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. Applicants are expected to 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.

Education and Outreach

The NIGMS MIDAS Centers are expected to provide national leadership in training a new generation of infectious disease modelers through a variety of approaches including, for example, support for visiting investigators, fellowships, workshops, summer courses, internships, symposia, curricula development, and/or other means.  Centers’ education and outreach programs should serve a variety of communities, including public health, policy and decision makers.

Education. Centers may conduct training at multiple levels, from K-12 education to professional career development, as appropriate to their institutions and to the goal of developing the field of infectious disease modeling.  Applicants are expected to identify current educational needs and to propose well-reasoned and well-justified responses. 

Career Development. Applicants should propose plans to support and nurture junior and new investigators, for example, by incorporating developmental research projects led by new investigators and/or by instituting career developmental programs.  Outreach to individuals underrepresented in biomedical research is required (see Special Requirements below).

Website. Centers should serve scientific communities beyond the participating investigators and institutions, including end users of the knowledge and tools generated.  Applicants should have a plan to construct a Center website for the dissemination of research data, software, and other resources of the project.  To the extent that established public databases have the capability for collecting and disseminating the data that would be collected under the grant, it is NIGMS' strong preference that a plan for the rapid deposition of data into such public databases is included in the application.  Funded Centers and projects may, in the future, decide on a MIDAS-wide plan for acquisition, storage, management, and dissemination of data, results, and tools.

Policy Studies

MIDAS interfaces with policy and decision making when its work is used as a tool for decision making in public health.  The issues of how, when, and by whom models are used underlies MIDAS’s mission and credibility.  MIDAS Center applicants must propose programs focused on narrowing the gap between science and policy related to infectious disease modeling.  Centers are expected to provide national and international leadership on the appropriate use of modeling tools in public health.  Examples of policy research topics could include:

The role of modeling in public health decision making. MIDAS modeling results, analyses, and tools have been used to study specific policy options. Center applicants might develop projects on the scholarly study of such questions as the following:  What is the appropriate role of modeling in public health decision making? How should models be constructed to address users’ questions?  What factors facilitate useful discussion among various communities providing and using modeling results?  Under what circumstances is it appropriate to use modeling approaches?

Fostering discussion among modelers, public health communities, and decision makers. Trans-domain conversation about the role of modeling and modeling results is critical.  Center applicants may choose to sponsor workshops, conferences, and meetings to explore interfaces of modeling and policy, particularly related to public health.

Identifying and addressing public health the needs of decision makers for modeling results and tools. Center applicants should present a clear plan for collaborating with end users and addressing their needs for computational, statistical, and analytical tools.

Ethical considerations in modeling infectious disease policies and practices. Center applicants should address ethical, legal, and social implications of modeling, particularly related to policy decisions.   Work could address (1) construction of modeling assumptions and scenarios; (2) the impact of modeling on policy development and implementation; (3) ethical boundaries of detailed demographic, geographic, behavioral, or cultural data; (4) release of detailed results of modeling simulations; and (5) release of model software, results, and conclusions.

The Centers are expected to work with NIGMS staff to link MIDAS with ongoing and emerging modeling efforts such as those at the Centers for Disease Control and Prevention and at DHHS/Office of the Secretary.

Special Requirements

Recruitment and Retention Plan to Enhance Diversity

The NIH recognizes a compelling need to promote diversity in the biomedical, behavioral, clinical, and social sciences workforce. The NIH expects that efforts to diversify the scientific workforce will lead to the recruitment of the most talented researchers, improve the quality of the educational and training environment, balance and broaden the perspective in setting research priorities, improve the ability to recruit subjects from diverse backgrounds into clinical research protocols, and improve the Nation’s capacity to address and eliminate health disparities.

Accordingly, the NIH continues to encourage institutions to diversify their trainee and faculty populations and to increase the participation of individuals currently underrepresented in the biomedical, clinical, behavioral, and social sciences such as individuals from underrepresented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in research. Institutions are encouraged to identify candidates who will increase diversity on a national or institutional basis. The NIH is particularly interested in encouraging the recruitment and retention of the following groups of candidates:

A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see http://www.nsf.gov/statistics/).  Nationally, groups found to be underrepresented in biomedical and behavioral research include, but are not limited to, African Americans, Hispanic Americans, Native Americans (including Alaska Natives), and natives of the U.S. Pacific Islands.  In addition, it is recognized that under-representation can vary from setting to setting and individuals from racial or ethnic groups that can be convincingly demonstrated to be underrepresented by the grantee institution should be encouraged to participate in this program.

B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities.

C. Individuals from disadvantaged backgrounds who are defined as:

1. Individuals who come from families with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml. For individuals from low income backgrounds, the institution must be able to demonstrate that such candidates have qualified for Federal disadvantaged assistance or they have received any of the following student loans: Health Professional Student Loans (HPSL), Loans for Disadvantaged Student Program, or they have received scholarships from the U.S. Department of Health and Human Services under the Scholarship for Individuals with Exceptional Financial Need.

2. Individuals who come from a social, cultural, or educational environment such as that found in certain rural or inner-city environments that have demonstrably and recently directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.

Recruitment and retention plans related to a disadvantaged background (C1 and C2) are most applicable to high school and perhaps undergraduate candidates, but would be more difficult to justify for individuals beyond that level of achievement

The scope and nature of MIDAS provides an excellent opportunity to enhance diversity of the biomedical research workforce.  Proposed activities must be integrated in the ongoing research and educational activities of the Center.  Applicants must describe their specific plans for and recent experience with the recruitment and selection process.  Furthermore, Center applicants must establish a position for an outreach coordinator who will be responsible for, among other tasks, leading the recruitment effort, overseeing selection and placement of trainees, assessing academic and research progress of students, etc.  Center applicants may wish to develop partnerships with minority and minority-serving institutions and organizations.  Information on relevant minority-serving institutions may be obtained by consultation with staff of the NIGMS Division of Training, Workforce Development, and Diversity (http://www.nigms.nih.gov/Training/).  This FOA requires all applicants to submit a recruitment and retention plan to enhance diversity, which will be evaluated by reviewers and included in the determination of scientific merit and priority score of the application. 

Other NIH funding opportunities exist that can be utilized by funded projects to obtain supplemental support to promote diversity in biomedical research.  Those are described in a separate announcement (http://grants.nih.gov/grants/guide/pa-files/PA-12-149.html).

Program Director/Principal Investigator Effort

The Program Director/Principal Investigator of a Center grant must commit a minimum effort of 30% or 3.6 months per year to the project.

Organizational Structure of the MIDAS Network

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 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.

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
Renewal

The OER Glossary and the PHS 398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIGMS intends to commit $9 million (total costs) in FY 2014.

Award Budget

Application budget direct costs may not exceed $2 million, not including F&A costs of subcontracts, in any single year.

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed 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.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(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 PHS 398 Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

NIH will not accept any application 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:

Section IV. Application and Submission Information


1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS 398 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.

Letter of Intent

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

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

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: sheeleyd@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Helen Sunshine, Ph.D.
Office of Scientific Review
NIGMS
45 Center Drive MSC6200
Building 45, Room 3AN12F
Bethesda, MD 20892
Telephone: (301) 594-2881
FAX: (301) 594-8506
Email: sunshinh@mail.nih.gov

Page Limitations

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the Research Strategy section of each component of the application.

Training, Outreach and Diversity Plan: 12 pages

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the PHS398 Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

Each section listed above is required.

Renewal applications should include a brief report of overall progress during the prior project period in the Program Summary, and more specific information in other sections as appropriate.

Overall Component

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Overall)

All instructions in the PHS 398 Application Guide must be followed. The Program Director/Principal Investigator of a Center grant must commit a minimum effort of 30% or 3.6 months per year to the project.

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Overall)

All instructions in the PHS 398 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

Budget for Entire Proposed Period of Support (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Research Strategy: The Program Overview section should summarize the overall plan for the center, and discuss the integration of all the component sections that follow. It should also describe all of those activities that the applicant deems essential elements of the center that are not covered elsewhere.

The Program Overview should also specifically include the following:

Organizational Structure and Management Plan: These are large centers incorporating multiple research projects, large numbers of investigators, substantial training and outreach components, and engagement with a large community of researchers and public health agencies. The centers also exist within the context of the MIDAS program. Specific plans for management of this complex enterprise should be presented.

Plans for Intellectual Property Handling, Data/Resource/Software Sharing: This is an essential aspect of the program. Please be specific. 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.

A timeline for the project: The timeline should outline how the project's goals can be met within the time frame of the grant. The timeline also will assist the investigators, the NIGMS, and its advisors in evaluating progress toward the project's goals.

Renewal applications should include a brief report of overall progress during the prior project period in the Program SummaryOverview, and more specific information in other sections as appropriate.

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.  This 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. Renewal applications should include evidence that the applicant has engaged in collaborative activity within the network.

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 PHS 398 Application Guide, with the following modification:

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.  And, 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.

Research Projects

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Research Projects)

All instructions in the PHS398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Research Projects)

All instructions in the PHS398 Application Guide must be followed.

Table of Contents (Research Projects)

All instructions in the PHS398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Research Projects)

All instructions in the PHS398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Research Projects)

All instructions in the PHS398 Application Guide must be followed.

Biographical Sketch (Research Projects)

All instructions in the PHS398 Application Guide must be followed.

Resources (Research Projects)

All instructions in the PHS398 Application Guide must be followed.

Research Plan (Research Projects)

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Research Strategy:

The MIDAS program develops scientific knowledge of computational and mathematical models of infectious diseases and providing that knowledge to the scientific, public health, and policy communities. Successful Center applications will include research projects, as described in Section I of this FOA, that are focused on infectious disease and computational, statistical, and mathematical modeling.  Center research programs should provide opportunities for multidisciplinary conversation and collaboration, provide national and international leadership, and train the leaders of tomorrow. Centers should evolve into foci of highly integrated and trans-disciplinary research, training, and knowledge related to modeling of infectious diseases. This should be reflected in the choice of research project areas.

A minimum of three, and up to five research projects may be included in the application. These projects could include but are not limited to problems in preparedness, surveillance and detection, dynamics of infectious disease, response strategies, antimicrobial resistance and vaccine escape, behavior, or infectious disease in animals, including zoonoses. The center research program should develop and improve mathematical, computational, and statistical methods for the study of these and other phenomena.

One of the goals of MIDAS is to develop tools that will assist public health decision makers. Applicants should take the needs of both the public health and research communities in designing and producing models.

Software Development and Core Facilities

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Software Development and Core Facilities)

All instructions in the PHS398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Software Development and Core Facilities)

All instructions in the PHS398 Application Guide must be followed.

Table of Contents (Software Development and Core Facilities)

All instructions in the PHS398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Software Development and Core Facilities)

All instructions in the PHS398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Software Development and Core Facilities)

All instructions in the PHS398 Application Guide must be followed.

Biographical Sketch (Software Development and Core Facilities)

All instructions in the PHS398 Application Guide must be followed.

Resources (Software Development and Core Facilities)

All instructions in the PHS398 Application Guide must be followed.

Research Plan (Software Development and Core Facilities)

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Research Strategy:

The MIDAS program develops improved mathematical, computational, and statistical methods, which are expressed largely through the development of software tools. Plans for development of software, as well as any other core facilities for support of the research community, should be included here.

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.

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.

Software products must meet the high standards expected of contemporary biological software, as described in Section I above.  These standards include documentation, extensibility, interoperability, consistency with existing ontologies and cotrolled vocabulariers, testing, and validation.

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.

Policy Studies

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Policy Studies)

All instructions in the PHS398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Policy Studies)

All instructions in the PHS398 Application Guide must be followed.

Table of Contents (Policy Studies)

All instructions in the PHS398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Policy Studies)

All instructions in the PHS398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Policy Studies)

All instructions in the PHS398 Application Guide must be followed.

Biographical Sketch (Policy Studies)

All instructions in the PHS398 Application Guide must be followed.

Resources (Policy Studies)

All instructions in the PHS398 Application Guide must be followed.

Research Plan (Policy Studies)

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Research Strategy:

MIDAS interfaces with policy and decision making when its work is used as a tool for decision making in public health. MIDAS Center applicants must propose programs focused on narrowing the gap between science and policy related to infectious disease modeling.  Centers are expected to provide national and international leadership on the appropriate use of modeling tools in public health.  Examples of policy research topics could include, as described in Section I above: the role of modeling in publich health decision making, fostering discussion among modelers and decision makers,  identifiying and addressing public health needs of decision makers, ethical considerations in modeling infectious disease.

Specific plans should be presented for policy studies in the center. The Centers are expected to work with NIGMS staff to link MIDAS with ongoing and emerging modeling efforts such as those at the Centers for Disease Control and Prevention and at DHHS/Office of the Secretary.

Training, Outreach, and Diversity Plans

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Training, Outreach, and Diversity Plans)

All instructions in the PHS 398 Application Guide must be followed.  

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Training, Outreach, and Diversity Plans)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Training, Outreach, and Diversity Plans

All instructions in the PHS 398 Application Guide must be followed. 

Detailed Budget for Initial Budget Period (Training, Outreach, and Diversity Planst)

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Training, Outreach, and Diversity Plans)

All instructions in the PHS 398 Application Guide must be followed. 

Biographical Sketch (Training, Outreach, and Diversity Plans)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Training, Outreach, and Diversity Plans)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Training, Outreach, and Diversity Plans)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Research Strategy:

The NIGMS MIDAS Centers are expected to provide national leadership in the field of infectiouis disease modeling. This includes the broadest possible dissemination of knowledge and technologies developed in the centers, peer training for scientists working in this field, and training a new generation of infectious disease modelers through a variety of approaches, as described in Section I above.

Specific plans for Training and Education of researchers, Outreach and Dissemination of center capabilities, and Recruitment and Retention to Enhance Diversity should be included in this section of the application. 

Training and education components may be conducted at multiple levels, as described. Component activities may include, but are not limited to, support for visiting investigators, fellowships, workshops, summer courses, internships, etc.  Centers’ education and outreach programs should serve a variety of communities, including public health, policy and decision makers. Applicants are expected to identify current educational needs and to propose well-reasoned and well-justified responses. 

Applicants should propose plans to support and nurture junior and new investigators, for example, by incorporating developmental research projects led by new investigators and/or by instituting career developmental programs. Outreach to individuals underrepresented in biomedical research is required (see Special Requirements heading in Section I).

Appendix for the Entire Application

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide, with the following modification:

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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.  

The MIDAS Network

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.

Data, Software, and Intellectual Property. Consistent with achieving the goals of this program, each research group are expected to propose a data and software release policy as described in Section IV.2, as well as 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 Director(s)/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(s)/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.

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

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

Overall Impact - Overall, Projects, and Cores

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).

Scored Review Criteria - Overall, Projects, and Cores

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?

Additional Review Criteria - Overall, Projects, and Cores

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. For Recruitment and Retention Plan to Enhance Diversity, is there evidence of success during the preceding project period?

Revisions

Not Applicable

Additional Review Considerations - Overall, Projects, and Cores

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.

Recruitment and Retention Plan to Enhance Diversity

Does the application offer a credible and compelling plan? In the case of Renewal applications, is there evidence of success during the preceding project period?

Applications from Foreign Organizations

Not Applicable

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.

2. Review and Selection Process

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:

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

Applications will be assigned to NIGMS and 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 Research Resources Council. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable 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:

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:

Areas of Joint Responsibility include:

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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

Scientific/Research Contact(s)

Douglas M. Sheeley, Sc.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email:sheeleyd@mail.nih.gov

Peer Review Contact(s)

Helen R. Sunshine, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email:sunshinh@mail.nih.gov

Financial/Grants Management Contact(s)

Ms. Lori Burge
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-3781
Email:BurgeL@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


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