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 Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title
Coordinating Unit for the National Centers for Metabolic Phenotyping in Live Models of Obesity and Diabetes (MPMOD) (U24 - Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

  • January 07, 2021 - Notice of Change to Award Information for RFA-DK-21-035. See Notice NOT-DK-22-009.
  • October 28, 2021 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available. See Notice NOT-OD-22-018.
  • September 13, 2021 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients. See Notice NOT-OD-21-181.
  • August 5, 2021 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022. See Notice NOT-OD-21-169
  • August 5, 2021 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements. See Notice NOT-OD-21-170
  • April 20, 2021 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel. See Notice NOT-OD-21-109

Funding Opportunity Announcement (FOA) Number
RFA-DK-21-035
Companion Funding Opportunity
RFA-DK-21-027 , U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements
Assistance Listing Number(s)
93.847
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to establish a Coordinating Unit (CU) to support the National Centers for Metabolic Phenotyping in Live Models of Obesity and Diabetes (MPMOD). MPMOD Centers, solicited via RFA-DK-21-027, will provide complex metabolic, physiologic and behavioral phenotyping and consulting services to characterize living mouse models on a fair fee-for-service basis. Services are provided with equal priority to investigators inside and outside the home institution, at similar cost, to study the heterogeneity, pathogenesis, and metabolic and physiologic consequences of diabetes and obesity. The MPMOD Centers will work together as a consortium, supported by the Coordinating Unit, to improve access to high quality consultation and phenotyping for metabolic disease research conducted in mice. An important goal of this consortium will be to enable underrepresented PIs and those from small research institutions that traditionally have not received significant research funding and/or have historically served under-represented populations to produce outstanding results and better compete for funding.

Key Dates

Posted Date
November 29, 2021
Open Date (Earliest Submission Date)
February 08, 2022
Letter of Intent Due Date(s)

February 8, 2022

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
March 08, 2022 Not Applicable Not Applicable July 2022 October 2022 December 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
March 09, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in 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 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Study sections and journal editors typically require evidence that pathways under study in diabetes and obesity research affect function and health in the living animal, yet the required complex physiologic, metabolic and behavioral measurements are not available at all research institutions. The MPMOD is designed as an outwardly-facing consortium of service cores that collaborate to provide reduced-cost consultation and metabolic, physiologic and behavioral phenotyping tests on live animals to all US academic biomedical researchers. MPMOD will:

  1. Serve the US academic research community that uses mice to study diabetes and obesity by providing metabolic, physiologic and behavioral phenotyping on live mice, as well as expert advice in mouse models, experiment design, data analysis and interpretation. Centers will serve clients from outside as well as inside their home institution without bias and at similar cost, and collaborate to provide a wide array of tests and expert advice while avoiding unnecessary overlap.
  2. Work toward health equity and diversity in the US biomedical research enterprise by supporting underrepresented minority investigators to succeed in biomedical research in the areas of diabetes and obesity, via resources such as test services, pilot funding, expert advice on experimental design, and/or short internships at a MPMOD to learn test technologies. Together, these consortium activities constitute the MPMOD Vibrant program.
  3. Serve Rigor and Reproducibility in research by a) developing and sharing validated protocols for phenotyping live mice; b) providing difficult experimental tests conducted by experts with a high degree of standardization and quality control, to PIs who would otherwise not be able to conduct or afford them; c) sharing technologies and providing web-based tools for gold-standard approaches in experimental methods and data analysis. This will help train new physiologists and metabolic experts.
  4. Develop standardized data formats and storage guidelines for complex data, including metadata, for sharing with clients and the public as appropriate, and employ unique identifier Research Resource identifiers (RRID), Digital Object Identifiers (DOI), and other best practices directed by DKNet.

Consortium Structure

MPMOD will consist of cooperating Phenotyping Centers (PC) and a Coordinating Unit (CU), with guidance provided by a Steering Committee (SC) and External Scientific Panel (ESP). PCs will consist of an Administrative Core, an Animal Core, and one or more Phenotyping Cores. The CU will 1) provide logistical and administrative support, 2) distribute funds and overseeing financial management of the MPMOD Vibrant program, 3) provide and maintain the MPMOD website, which may contain web-based educational, data-storage, data-sharing, and business tools, and 4) promote the consortium via advertising/outreach. The CU may also share similar resources with other NIDDK-funded Centers programs as the CU budget allows, at the discretion of the NIDDK.

Consortium Activities

The applicant must agree to active participation in consortium-wide activities as deemed necessary by appropriate oversight committees.  At the start of the award, these activities will include:

MPMOD Vibrant Program

The MPMOD Centers and CU will be expected to develop an MPMOD Vibrant program aimed at providing pilot funding, phenotyping services or other resources, and training and advice regarding experimental design to early career scientists, particularly those from underrepresented groups such as minorities, or from small research institutions that traditionally have not received significant research funding and/or have historically served under-represented populations. These resources are expected to improve the ability of these researchers to compete for independent funding. Vibrant activities should contribute to a diverse, high quality national biomedical research force, eventually helping to reduce US health disparities. Applications can describe activities that could comprise this program. Funding for pilot studies and outreach would be in the CU budget, and funding for other elements (waived test fees, structured or unstructured training at the centers, consultation, other mentoring) would be the responsibility of the Centers.

MPMOD Website and Web-based Tools

The CU will provide an MPMOD website, with web-based tools for outreach and to help manage the consortium's business, data, and other activities. At a minimum, information about each MPMOD PC, including contact information, a complete test catalog, and protocols for all tests will be posted on the website. PCs and the CU may post other information and tools developed to help clients and other researchers with metabolic research in mice.

MPMOD Consortium Support

The MPMOD CU will be responsible for providing organizational and logistical support for the MPMOD consortium, including steering committee and subcommittee meetings, and management of the ESP. It will also provide web-based business tools and data management for the Center Cores, and may also propose tools for scientific data management, storage and communication with clients. The CU will manage the MPMOD Vibrant program, which will be designed to provide support to early career researchers from underrepresented minorities and other underserved backgrounds in order to increase chances of obtaining funding for their research.

Support of other NIDDK-funded Centers programs

The NIDDK may choose to allow other of its funded Centers programs (such as Diabetes Research Centers, Centers for Diabetes Translation Research, Nutrition and Obesity Research Centers) to develop consortium activities, and to allow them access to limited services of the MPMOD CU, in order to support those consortial activities. Such services would be expected to be within the budget of the CU.

These may include but are not limited to the following:

  • Conducting nationally oriented funding programs, where pilot and feasibility research funds are contributed by NIDDK or non-MPMOD Centers, while solicitation, application receipt, review, award, records, etc. are overseen by the MPMOD CU;
  • Participation in the Vibrant program by providing tests, consulting and training experiences to early career researchers from underrepresented backgrounds and institutions;
  • Scientific workshops, where the CU could provide administrative, communication, and logistical support;
  • Logistical support for Centers Steering Committees and subcommittees with regular virtual or face-to-face meetings;
  • Websites or web-based tools.

A more detailed description of these CU activities is found in section IV.2.

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

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 scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $390,000 in FY 2023 to fund one award.

Award Budget

Application budgets are limited to $275,000 Direct Costs, but need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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)

Local 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)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
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 allowed. 

Required Registrations

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) – 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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.

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 SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. 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 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace 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.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in 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.

Letter of Intent

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

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

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

The letter of intent should be sent to:

John Connaughton, Ph.D.
Chief, Scientific Review Branch
Telephone: 301-594-7797
Email: NIDDKletterofintent@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

The CU should have a Director, and provide for administration and website production and maintenance with additional personnel as needed to support its proposed activities.

R&R Budget

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

Budgets are limited to $200,000 direct costs in each of years 1-5 to support CU personnel and their activities, travel, consortium meeting expenses, and supplies.  In addition, the applicant should request up to $90,000 in each of years 1-5 for pilot funds to be distributed as subawards as part of the Vibrant Program.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy:

The applicant should outline how the MPMOD CU plans to address the following required functions:

MPMOD Consortium Support

  • Organizing and supporting regular virtual and annual face-to-face meetings of the MPMOD investigators and other relevant stakeholders. This requires providing funding for 4 ESP members and CU staff to travel to face-to-face annual meetings.
  • Facilitate and support any SC subcommittees (website, Vibrant, etc.).
  • Develop and maintain minutes/other records of MPMOD meetings.
  • Provide support for the activities of the ESP. ESP members will be appointed by NIDDK. The application should not suggest specific ESP members.
  • Develop and maintain the MPMOD website. The website should have a public facing component for client interface, and a private component for MPMOD use (and potentially similar components for other Centers programs).
  • Curate the MPMOD catalog of services across Centers, ensure easy public access and enable clients to order services.
  • Curate the MPMOD list of procedures and protocols for all tests on the public-facing website.
  • Establish a procedure for obtaining client feedback.
  • Identify strategies to establish and promote the MPMOD program through outreach/advertising.
  • Develop and maintain metrics to assess the impact of the MPMOD.
  • Communicate with the NIDDK staff and ESP regarding all aspects of the MPMOD.

Vibrant Program

  • Manage the consortium to design the MPMOD Vibrant program, which would solicit applications for pilot research funding on a national level as well as seek to provide other services (tests, training, consulting) to early career researchers from backgrounds or at institutions underrepresented in US biomedical research.
  • Manage the solicitation, submission, review and selection of applications for pilot funding.
  • Coordinate the process for application submission, review and selection of projects to be funded, and provide appropriate web-based tools.
  • Award subcontracts and provide fiscal oversight for the Vibrant funding program.
  • Disseminate information and promote the Vibrant funding program, ensuring receipt of applications from researchers from underrepresented backgrounds and institutions.
  • Tracking outcomes of the projects and researchers supported by the Vibrant funding program.

Support of other NIDDK-funded Centers programs

The NIDDK may allow other of its funded Centers programs (such as Diabetes Research Centers, Centers for Diabetes Translation Research, Nutrition and Obesity Research Centers) to develop consortium activities, and to allow them to share the MPMOD CU via access to limited services to support those consortium activities.  The applicant can propose ways that the MPMOD CU could support such additional activities within the MPMOD CU budget.

These may include but are not limited to the following:

  • Conducting nationally oriented funding programs, where pilot and feasibility research funds are contributed by NIDDK or non-MPMOD Centers, while solicitation, application receipt, review, award, records, etc. are overseen by the MPMOD CU;
  • Participation in the Vibrant program by providing tests, consulting and training experiences to early career researchers from underrepresented backgrounds and institutions;
  • Scientific workshops, where the CU could provide administrative, communication, and logistical support;
  • Logistical support for Centers Steering Committees and subcommittees with regular virtual or face-to-face meetings;
  • Websites or web-based tools.

Data Storage and Bioinformatics Functions

The CU should propose a secure database for tracking MPMOD business, clients and publications. The CU may propose a database to house client data/experimental metadata, and for communication of that data to the client and the public. This database should employ appropriate FAIR principles. If proposed, this database should be compatible with the MMPC database (mmpc.org) and dkNET (dknet.org).

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.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

  • No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined 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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

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

3. Unique Entity Identifier and System for Award Management (SAM)

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

4. Submission Dates and Times

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.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. Other Submission Requirements and Information

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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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.

Use of Common Data Elements in NIH-funded Research

Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal" (https://cde.nlm.nih.gov/home) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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

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 proposed Coordinating Unit address the needs of the consortium that it will coordinate? Is the scope of activities proposed for the Coordinating Unit appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the consortium?

 

Are the PD(s)/PI(s) and other personnel well suited to their roles in the MPMOD Coordinating Unit? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing Center coordination? Do the investigators demonstrate significant experience with coordinating collaborative basic research? If the Coordinating Unit is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the MPMOD Coordinating Unit? Does the applicant have experience overseeing selection and management of subawards, if needed?

 

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research consortium the Coordinating Unit 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, management strategies or instrumentation proposed?

 


Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the Coordinating Unit will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: Did the applicant identify strategies to establish and promote the MPMOD and Vibrant programs through outreach/advertising to appropriate investigator communities? Will the applicant be able to manage and distribute funds via subcontracts for the MPMOD Vibrant program? Is the applicant able to provide a website and web-based tools to support the MPMOD Core business activities, including a client interface, test catalog, descriptions of protocols, business tracking tools, etc.? If proposed, is there evidence that a scientific database would be of high quality and follow appropriate standards?

 

Will the institutional environment in which the Coordinating Unit will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Coordinating Unit proposed? Will the Coordinating Unit benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Additional Review Criteria

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

 

 

For research that involves human subjects but does not involve one of the  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  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 project 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 individuals of all ages (including children and older adults) 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

Additional Review Considerations

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

 

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

 

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDDK, 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 will receive a written critique.

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.

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 Diabetes and Digestive and Kidney Diseases Advisory Council (NDDKAC). 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.

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. 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.

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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 and 2 CFR Part 200.206 “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, 2 CFR 200 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 recipients 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:

  • Recipient(s) will be primarily responsible for defining the objectives and approaches, planning, conducting, analysis, and publication of results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award.
  • The Program Director/Principal Investigator (PD/PI) will assume responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research supported under this Funding Opportunity Announcement (FOA) in accordance with the terms and conditions of award, as well as all pertinent laws, regulations and policies.
  • Recipient(s) will retain custody of and have primary rights to the data and software developed under these awards, subject to Government policies regarding rights of access consistent with current DHHS, PHS, and NIH policies.
  • Recipients are responsible for their staff in maintaining the confidentiality of the information as developed by the consortium, including, without limitation, study protocols, data analysis, conclusions, etc. per policies approved by the Steering Committee (SC) as well as any confidential information received by third party collaborators.
  • Recipients must analyze, publish and/or publicly release and disseminate results, data, and other products of the study in a timely manner, concordant with the approved plan for making quality-assured data and materials available to the scientific community and the NIH, consistent with NIH policies and achieving the goals of the FOA.
  • Recipient(s) will be required to participate in a cooperative and interactive manner with members of the consortium including designated NIH staff (e.g., Program Official, Project Scientist).
  • Recipients must share data, materials, models, methods, information, and unique research resources that are generated by the projects in concordance with MPMOD Consortium policies in order to facilitate progress. When appropriate, and in accordance with NIH policies, as well as NIDDK policies, awardees will be expected to collaborate; share novel reagents, biomaterials, methods and models and resources; and share both positive and negative results that would help guide the research activities of other MPMOD members.
  • Recipient(s) agree to establish agreements amongst themselves that address the following issues: (1) procedures for data sharing among consortium members and data sharing with industry partners; (2) procedures for safeguarding confidential information, including without limitation, any data generated by the consortium as well as information and/or data received from external collaborators; (3) procedures for addressing ownership of intellectual property that result from aggregate multi-party data; (4) procedures for sharing bio-specimens under an overarching MTA amongst consortium members that operationalizes material transfer in an efficient and expeditious manner; (5) procedures for reviewing publications, determining authorship, and industry access to publications.
  • Any third-party collaboration (including but not limited to interactions with organizations from industry, academia, and nonprofit institutions) should be governed by a research collaboration agreement (e.g., Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, network policies, applicable NIH/NIDDK policies and procedures, and with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the network studies between the grantee and the third-party will be provided to the NIDDK Program staff and NIDDK Technology Advancement Office for review, comment, and approval to assure compliance with NIH/NIDDK policies and network policies. Further, at the request of the NIDDK Program staff, any other network-relevant third-party agreements must be shared with NIDDK. Failure to comply with this term may prompt action in accordance with NIH Grants Policy Statement, Section 8.5 titled: “Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions”, and Section 8.5.2, titled: “Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding Support”, noncompliance with the terms and conditions of award will be considered by the funding IC for future funding and support decisions and may result in termination of the award.
  • Recipients must agree to comply with the processes and goals as delineated within the FOA.
  • Upon completion or termination of the research project(s), the recipients are responsible for making all study materials and procedures broadly available (e.g., putting into the public domain) or making them accessible to the research community according to the NIH-approved plan submitted for each project, for making data and materials available to the scientific community and the NIH for the conduct of research. Data Management and Sharing Plan: In accordance with the NIH Policy for Data Management and Sharing (NIH NOT-OD-21-013), the NIDDK approved plan will become a term and condition of award, be routinely monitored during the award period, and compliance may factor into future funding decisions. By the end of the funding or proprietary period, an recipient or study group may not continue to use or share study-generated resources until those resources are available to the public via an NIDDK approved repository per the NIDDK approved sharing plan.
  • Recipient(s) agree to the governance of the study through a Steering Committee:
    • The PD/PI, or contact PD/PI in the case of multi-PD/PI awards, will serve as a voting member of the Steering Committee and will attend all meetings of the Steering Committee.
    • Each full member will have one vote.
    • The recipient will be responsible for accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the Steering Committee and Subcommittees.
    • Recipients must serve on MPMOD subcommittees as needed. Subcommittees will report progress at Steering Committee Meetings and/or lead discussions at the Annual Investigator’s Retreat.
  • Recipients may be asked to scientifically review applications for special opportunity pool funds, as it is deemed appropriate.

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

  • The NIDDK will designate program staff, including a Program Official and a Grants Management Specialist to provide normal program stewardship and administrative oversight of the cooperative agreement. The Program Official and Grants Management Specialist will be named in the Notice of Grant Award.
  • The NIDDK will invite External Consultants with relevant scientific expertise. The External Consultants [or External Experts] will meet to review the progress of the research projects and to advise NIH staff of scientific developments and opportunities that may enhance the achievement of the study goals.
  • An NIH IC Project Scientist [or Project Coordinator, or Project Collaborator] will be substantially involved in this project above and beyond the normal stewardship of an NIH IC Program Official as follows:
  • The NIH Project Scientist(s) will coordinate and facilitate the research projects, attend and participate in all meetings of the Consortium (Steering Committee), and act as (a) liaisons between the Recipient (Steering Committee) and the External Consultants [External Experts].
  • The NIH Project Scientist(s) will be a member(s) of the Steering Committee and, as determined by that committee, and its Subcommittees as needed. Only one NIH Project Scientist will vote on the Steering Committee. Other designated NIH program staff attending the steering committee meetings will be an ex officio (non-voting) member(s).
  • The NIH Project Scientist and other designated NIH program staff will help the Steering Committee develop and draft operating policies.
  • The NIH Project Scientist(s) and Program Official will review the scientific progress, cooperation in carrying out research, and maintenance of high-quality research in each of the individual research project(s), and review the project(s) for compliance with operating policies developed by the Consortium (Steering Committee), and may recommend to the NIH to continue funding; withhold support or restrict an award for lack of scientific progress or failure to adhere to policies established by the Consortium (Steering Committee). Review of progress may include regular communications with the PD/PI and NIH staff, periodic site visits for discussions with recipient research teams, fiscal review, and other relevant matters. The NIH retains the option of periodic external review of progress.
  • The NIDDK reserves the right to terminate or curtail any study or any individual award in the event of (a) substantial shortfall in data collection or submission, quality control, or other major breach or a study protocol or Consortium policy and procedure, (b) substantive changes in a study protocol that are not in keeping with the objectives of the FOA, and/or a human subject ethical issues that may dictate a premature termination.
  • The NIH Project Scientist(s) and Program Official will review and approve applications of the Special Opportunity Funds to ensure that they are within the scope of Consortium research as described in the FOA and NIH guidelines.
  • The NIH will name additional scientific consultants as necessary from within the NIH whose function will be to assist the Project Scientist(s) and the Steering Committee in carrying out the goals and aims of the approved studies. The NIH will have one vote for any key committees, regardless of the number of NIH personnel involved.
  • The Project Scientist(s) will have substantial scientific programmatic involvement in quality control, preparation of publications, research coordination and performance monitoring. The Project Scientist(s) will have the same access and privileges to any data generated by the grantee. The dominant role and primary responsibility for these activities reside with the recipients for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the recipients and the NIDDK Project Scientist(s).
  • The NIH Project Scientist(s) serve as a resource with respect to other ongoing NIH activities that may be relevant to the MPMOD studies to facilitate compatibility and avoid unnecessary duplication of effort.
  • The NIH Project Scientist(s) or designee may coordinate activities among recipients by assisting in the design, development, and coordination of (a) common research protocol(s) and statistical evaluations of data and in the publication of results.
  • The NIH Project Scientist(s) may review procedures for assessing data quality and monitor study performance.
  • The NIH Project Scientist(s) may be (a) co-author(s) on study publications. In general, to warrant co-authorship, the NIH staff must have contributed to one or more of the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.

Areas of Joint Responsibility include:

Through the Recipient, (Steering Committee) and NIH staff, the study members will cooperatively develop and implement processes to submit information and data to the Coordinating Unit (CU), determine criteria and processes for quality control of information and data to be posted for the research community, refine scientific objectives, and implement research advances to facilitate the goals of the study, consistent with NIH policies and achieving the goals of the program as described in the FOA.

  • Executive Committee (EC)
  • The EC will consist of: The Director of the MPMOD CU, the NIDDK Project Scientist(s), and representative PIs are chosen among the Recipients; the EC is not a governing body and does not cast votes.
  • The EC will review the progress of all NIH-funded special funding opportunity programs and make recommendations for improvement. Annual reports will be prepared for each special funding opportunity to coincide with one of the annual SC meetings;
  • The EC will be responsible for organizing the yearly MPMOD Scientific Retreat.
  • The EC will have meetings that will be organized by the Director of the MPMOD CU. Any EC member may place items on the agenda. These should be communicated in advance of the meeting to the Project Scientist(s) who will distribute these to all members. The designated NIDDK Program Official(s) of the U2C may be asked to participate in order to provide additional information and to summarize actions that are taken.
  • Steering Committee (SC)
  • The Steering Committee (SC) composed of each of the PD/PI(s) for each U2C or U24, or Contact PD/PI(s) in the case of multi-PD/PI grants, of the study (including research projects and Coordinating Center) and the NIH Project Scientist(s) will be the main governing board of the study (Consortium). Each full SC member will have one vote. All major scientific and policy decisions will be determined by (voting policies as established by the SC at the initial meeting). This committee will operate to develop collaborative protocols, identify impediments to success and strategies to overcome them, develop shared tools for disseminating information about the projects, and identify opportunities for sharing techniques, materials, information and tools developed within each individual project. The SC activities and decisions will consider the advice of the External Consultants.
  • NIDDK staff, in concert with the SC, will have the option to redirect research activities within the U2C grant(s) if it is considered beneficial to the overall program.
  • The SC may, as it deems necessary, invite additional, non-voting scientific consultants to meetings at which research priorities and opportunities are discussed. The NIH reserves the right to augment the expertise of the SC when necessary.
  • There will be one in person Steering Committee meeting annually, and regular virtual SC meetings as desired. These meetings will incorporate participation and recommendations of the External Consultants (External Experts) when determined by NIH staff (or as stipulated in the FOA).
  • An SC Chairperson will be chosen by the NIH. In collaboration with the CU and the NIH Project Scientists, the Chairperson is responsible for coordinating the SC activities, for preparing meeting agendas and for chairing meetings.
  • The SC, including the Project Scientist(s), is responsible for establishing and implementing processes and criteria for recommending special projects for consideration for special opportunity funds by NIH staff.
  • Each research project recipient and the CU recipient agree to the governance of the U2C or U24 through the SC.
  • The NIH Project Scientist(s) may work with recipients on issues coming before the Steering Committee and, as appropriate, other committees.
  • External Consultants
  • An independent panel of External Consultants will be established by the NIDDK. The External Experts will review periodically interim progress of the U2Cs and report to NIDDK staff. Members of the panel of External Experts may be asked, on an ad hoc basis, to participate in the peer review of applications for new research initiatives that utilize special “opportunity pool” funds.

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 recipient. This special dispute resolution procedure does not alter the recipient'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, recipients 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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 the threshold.  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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and 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)

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

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Kristin Abraham, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-8048
Email: kristin.abraham@nih.gov

Peer Review Contact(s)

Ann A. Jerkins, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-2242
Email: Ann.Jerkins@nih.gov

Financial/Grants Management Contact(s)

Christina Coriz
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8848
Email: corizc@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 Part 75 and 2 CFR Part 200.

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