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

Mouse Metabolic Phenotyping Centers Consortium (U2C)

Activity Code

U2C Resource-Related Research Multi-Component Projects and Centers

Announcement Type

Reissue of RFA-DK-10-006

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-DK-15-010

Companion Funding Opportunity

RFA-DK-15-011, U24 Resource-Related Research Projects – Cooperative Agreements  

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

93.847 

Funding Opportunity Purpose

This Funding Opportunity Announcement invites applications for Mouse Metabolic Phenotyping Centers (MMPC).  Member Centers of the MMPC consortium provide fee-for-service in-depth phenotyping tests for mouse models of diabetes, obesity, and related metabolic diseases or conditions.  Services are provided with equal priority to investigators inside and outside the home institution, at similar cost.  Mice and/or murine tissues can be shipped to MMPC facilities where standardized procedures are used to characterize metabolism, body composition, feeding behavior, physical activity, tissue pathology, brain and other organ function, microbiome, and other physiologic, anatomic or pathologic indices.  MMPCs may also provide special mouse models for study at the Center or for distribution, such as mice that have undergone bariatric surgery or are valuable for studying the effects of microbiota on host metabolism. 

Key Dates
Posted Date

July 17, 2015

Open Date (Earliest Submission Date)

October 3, 2015

Letter of Intent Due Date(s)

October 3, 2015

Application Due Date(s)

November 3, 2015, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

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

AIDS Application Due Date(s)

November 3, 2015, by 5:00 PM local time of applicant organization. All types of AIDS applications allowed for this funding opportunity announcement are due on this date.

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.

Scientific Merit Review

February/March 2016

Advisory Council Review

May 2016

Earliest Start Date

July 2016

Expiration Date

November 4, 2015

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

The Mouse Metabolic Phenotyping Centers (MMPC; http://www.mmpc.org) provide an array of sophisticated phenotyping services to the mouse research community. By broadening the availability and consistency of phenotyping technologies for mice, the MMPCs assist investigators in characterizing mouse models of human disease.

This is the fourth competition for the Mouse Metabolic Phenotyping Centers program (MMPC), which was established in 2001.  The current MMPC program is a consortium of six phenotyping Centers. The mission of the MMPC consortium is to advance medical and biological research by providing the scientific community with standardized, high quality metabolic and physiologic phenotyping services for mouse models of diabetes, diabetic complications, obesity and related disorders. The MMPCs have the following specific goals: 1) broaden the scope and availability of metabolic phenotyping tests for mice; 2) standardize key methodologies; 3) expedite the completion of research; 4) assist new investigators or established investigators from other scientific fields in diabetes and obesity research; and 5) work closely with the consortium’s Coordinating and Bioinformatics Unit (CBU) to compile a database of information relevant to mouse models of diabetes, obesity and diabetic complications. Information about the current MMPCs, including a catalog of services, policies and guidelines, can be found at http://www.mmpc.org.

The MMPCs are staffed by experts in state-of-the-art technologies and provide standardized assays to characterize physiologic, anatomic or pathological alterations that occur in mouse models of disease. The Centers work together to provide a broad range of phenotyping tests.  Strengths of the MMPC consortium include the many assays performed on living animals, and sophisticated technologies that are valuable for understanding metabolism and physiology, and are not widely available. Researchers ship mice or tissues to an MMPC where they are phenotyped on a fee-for-service basis.  Center clients are NIH grantees and other academic and non-academic researchers, from inside and outside the MMPC home institution, who wish to submit mice for detailed metabolic and physiologic phenotyping beyond what would be possible or cost-effective in individual laboratories.

In addition to the fee-for-service phenotyping Centers, the MMPC program supports an administrative infrastructure including a database for tracking business activity, a website for submission of electronic requests for services, a collaborative research database of test results, a pilot project funding program for which all US mouse researchers are eligible, opportunity funds for collaborative projects among Centers, and courses targeted at mouse physiology or technologies that are used to study mice.  The MMPC Coordinating and Bioinformatics Unit (CBU) houses the MMPC website and database, and is responsible for organization and oversight of collaborative activities. The MMPC CBU will be funded through a separate initiative (RFA-DK-15-011).

Research Topics

Phenotyping Centers may provide diagnostic services in one or many disease areas.  Successful Centers will be able to offer services immediately, and also be capable of developing new services.  Examples of disease areas that can be proposed for services include, but are not limited to:

  • Metabolic, signaling or endocrine disorders, such as those found in diabetes and obesity. Phenotypes to be measured may include changes in glucose, lipid and protein metabolism, insulin resistance, body composition, nutrient absorption, hormones, cytokines and adipokines, reactive oxygen species, insulin and other signaling pathway components, organ function;
  • Energy balance and thermogenesis, nutrient intake and expenditure;
  • Hypothalamic function or other aspects of nervous system activity, energy balance, thermoregulation, blood flow, and other physiologic parameters associated with obesity;
  • Brain functions, such as cognition, in diabetes and obesity;
  • Digestive system activity and function, including bariatric surgery procedures to dissect relationships between gut function and metabolic status;
  • Behaviors that affect diabetes and obesity, including feeding, physical activity, sleep and circadian rhythms;
  • Complications of diabetes, including assays to measure changes in multiple end-organ systems in the context of metabolic disease, such as defects in cardiovascular, kidney, nervous, urologic, and skin (wound healing);
  • Microbiome, particularly its impact on host metabolism and disease state.
Consortium Activities and Administrative Structure

The MMPC Consortium will consist of cooperating phenotyping Centers (MMPCs) and a Coordinating and Bioinformatics Unit (CBU), with guidance provided by an Executive Steering Committee and an External Scientific Panel (ESP). Individual MMPC phenotyping Centers will have a Center Director (PD/PI) and an Associate Director, who would become the Center Director if the original Director is unable to continue for any reason. The Center will be overseen by a Center Steering Committee, and will consist of an Administrative Core, an Animal Core (required if proposed tests are to be done on live mice), one or more Phenotyping Cores, and an optional Microbiome Research & Development project. These activities are described below. The MMPC CBU will provide administrative coordination and bioinformatics support for the consortium and will be competed through a separate FOA. CBU activities are also described briefly below.

The Program Director/Principal Investigator (PD/PI) of the MMPC must commit to active participation in consortium-wide activities as deemed necessary by appropriate oversight committees.

  • MMPC Pilot and Feasibility Program: This peer-reviewed funding program is run by MMPC staff and awards are administered through the MMPC CBU.   All US investigators, including post-doctoral fellows, are eligible to apply for up to $75,000 for one-year awards.  A description of the program can be found at http://www.mmpc.org/shared/microMouse.aspx.  Applications should not propose specific projects for this program, as they are submitted directly to the CBU during the funded period.
  • MMPC Collaborative Projects Program: MMPC staff can join MMPC working groups focused on research in emerging areas of science of interest to the MMPC consortium.  These working groups are allowed to compete for limited funding for collaborative research projects.  Current working groups focus on bariatric surgery models, brain imaging and cognition in metabolic disease, and energy balance, and future groups will be formed around emerging areas of opportunity.   Applications can propose scientific areas of interest for future working groups, but should not submit detailed project descriptions, as these will be devised by the Executive Steering Committee during the course of the funded period.
  • Database: The MMPC maintains a database of test data.  Center personnel must agree to submit to the database, in a timely manner, all test outcome data and experimental metadata.  Because these data belong to the client that has submitted his/her mice for testing, they will not be made public until data has been published, or two years after tests are completed (unless the client requests additional time).  Center staff should make an effort to obtain from the client sufficient experimental metadata to allow the test data to be interpreted.  The NIDDK feels strongly that these data, taken on a large variety of genetically manipulated mice using strong, consistent protocols, will be a valuable resource for the entire metabolic disease research community.
  • Technique Dissemination: The MMPC has a commitment to distribution of high quality phenotyping, whether that is by conducting tests at the Centers, by distribution of protocols and training individuals to conduct tests, or by conducting courses focused on specific tests or technologies of high value.  Therefore, applicants are encouraged to establish courses in conjunction with the MMPC, and to apply for funding through PAR-15-139 "NIDDK Research Education Program Grants for Courses for Skills Development (R25)".

Executive Steering Committee

The PD/PI of the MMPC must agree to participate in the MMPC Executive Steering Committee.  The Executive Steering Committee meets monthly by teleconference and once each year in person to encourage information exchange within the consortia. The MMPC Executive Steering Committee will consist of the MMPC Center Directors, the PD/PI of the Coordinating and Bioinformatics Unit, NIH Project Scientist and Project Officials, and other Core Directors and MMPC personnel as needed. The Chair of the steering committee will be elected from among the MMPC Center Directors and can serve for the duration of the five year award period, or may rotate annually. The role of the NIDDK Project Scientist is described under Cooperative Agreement Terms and Conditions of the Award, Section VI.2. The NIDDK Project Official is the NIDDK staff person responsible for reviewing annual progress and signing off on Grant Progress Reports. The purpose of the Executive Steering Committee will be to discuss and evaluate concerns and cooperative activities of the consortia. If voting is necessary for an action item, individual Center Directors and the NIDDK hold one vote each. The Executive Steering Committee will discuss and evaluate Subcommittee and Core activities and provide feedback to Subcommittee leaders at least bi-annually, implement changes in subcommittee membership or direction if needed, discuss and evaluate new projects, collaborative projects, and the MMPC pilot and feasibility program.

Expert Scientific Panel (ESP)

The PD/PI of the MMPC must indicate a commitment to be responsive to recommendations provided by an independent Expert Scientific Panel (ESP). The MMPC ESP will meet annually to review interim progress and will provide an annual report to the Executive Steering Committee on consortium activities. The MMPC CBU will be responsible for organizing and providing minutes of these meetings.

Members of the ESP will be nominated by the MMPC Executive Steering Committee, selected and invited by the NIH. A chairman will be chosen from among the ESP membership, who will be accomplished senior scientists from academia and industry with backgrounds in diabetes, diabetic complications, obesity, animal models, mouse genetics, and technologies associated with mouse phenotyping. If voting is necessary for an action item, members of the ESP and the ESP chair hold one vote each. The Executive Steering Committee will discuss implementation of ESP recommendations, and provide a timeline and action plan for making changes in a timely fashion. The action plan will be reported to the ESP.

Description of a Phenotyping Center (MMPC)

Phenotyping and Analysis Cores

The most important aspect to be considered in an MMPC application is the proposed Phenotyping and Analysis Cores.  These Cores will serve investigators from outside the recipient institution with the same priority as those from within.  Each Center will have one or more Phenotyping Cores, each headed by a Core Director, where tests will be performed on submitted mouse models or mouse tissues and fluids. Core personnel will design or adapt, standardize and validate a variety of tests to be conducted on living animals or tissue samples obtained from mice. These tests will be provided on a fee-for-service basis, and will constitute a phenotyping exam for mouse models of diabetes, diabetic complications, obesity and complex metabolic diseases.  Programmatic emphasis will be on Centers that have the capacity and expertise needed to provide tests of special and essential value to the diabetes and obesity mouse research community. Centers can have several Phenotyping Cores that provide a broad range of tests and expertise for the study of live animals, and/or provide unique and powerful tests that are difficult, require specialized equipment, or that are not widely available to the investigator community.   Centers could also be small, consisting of a single Phenotyping Core focused on a finite set of particularly valuable and rare services.  Centers may choose to provide either standard or customized 'exams' for various models, and should propose a method to provide advice to clients in order to determine the appropriate series of tests.  There can be a fee structure for time spent advising per se, but it cannot constitute an undue financial burden on the client.

Applicants must carefully consider community needs and the methodologies, technologies, statistical tools, limitations and projected costs of any proposed tests. Centers will be required to establish 'normal' parameters for each test on the major wild type background strains typically used for creating genetic models of disease.  A quality control method for establishing, maintaining, and documenting the reliability of all tests should be proposed. Protocols for each test will be posted on the http://www.mmpc.org/site and detailed protocols should be made available upon request.  Data collected within an MMPC Phenotyping Core will be posted by Center Staff in the MMPC database.

Each MMPC will be expected to foster continuing evolution of offerings through the development and implementation of new technologies and tests for phenotyping mouse models of disease within the Phenotyping Cores.  It is expected that MMPC Research and Development activities will design or validate additional tests that may be adopted into the Center's existing services as deemed appropriate by Center and consortium Steering Committees. The plan might include developing novel imaging techniques for living animals, miniaturizing existing assays or tests for use in animals, or developing new or adopting existing assays used in other contexts for use in phenotyping mice.  It may be appropriate to propose projects that take advantage of data in the MMPC database as it is populated with publicly available test data from many animal models.  

Each funded Center will have unique strengths, either because of the technologies available to it, or because of specialized local expertise.  We encourage each application to focus on institutional strengths in selecting phenotyping cores.   It is expected that each Center will work closely with others in the consortium through the Executive Steering Committee to take full advantage of collective strengths to provide the best possible range of tests for customers. Ongoing research to provide new tests, with an emphasis on novel technologies and miniaturization, should also be coordinated through this body.

The list of current tests is found at http://www.mmpc.org/MMPC_Test_Selection.html.  Examples of phenotyping tests that can be proposed include, but are not limited to:

  • Microbiome analysis and influence of defined microbiota on host metabolism and physiology;
  • Whole animal or regional body composition measurements;
  • Whole body energy balance and activity measurements;
  • Appetite, food intake, eating behavior, nutrient absorption;
  • Glucose and insulin clamps;
  • PET, NMR, mass spectrometric, or other isotopic studies of metabolic pathway flux;
  • Whole body or organ balance tracer measurements of carbohydrate, protein, amino acid, or lipid uptake and production;
  • Assessment of mitochondrial function in vivo;
  • Organ-specific nutrient uptake or thermogenesis;
  • Assessment of hypothalamic activity and other neural substrates of eating behavior, energy balance and metabolism;
  • Anatomy and tissue pathology, or pathological changes associated with diabetic complications;  
  • Vulnerability of tissues to complications of diabetes;
  • Glomerular filtration rate, proteinuria, and renal hemodynamics;
  • Endothelial and cardiac function, or atherosclerotic lesions;
  • Cardiovascular stress paradigms such as aortic banding, coronary ligation, and telemetry (blood pressure, EKG);
  • Exercise or use of other stresses (exogenous hormones, altered diet) to uncover metabolic alterations;
  • Physiologic measurements, such as blood pressure, core temperature, cardiac output, regional blood flow, or nerve function;
  • Hormones, cytokines, adipokines, metabolites, ions, lipoprotein, enzyme etc. profiles in very small volumes of body fluids;
  • Immune parameters, especially those that are significant for development of type 1 diabetes and diabetic complications;
  • Pancreatic islet function, mass, etc
  • Surgical preparations, such as bariatric surgeries, placement of indwelling catheters, lymph fistula, etc.
Optional Microbiome Research and Development Project

For 2016-2020, there will be an additional opportunity within the MMPC program for studies aimed at definition or manipulation of the microbiome, and at interrogation of the interactions between the microbiota and host metabolism and physiology, especially in the context of metabolic disease.   In addition to the fee-for-service Microbiome Phenotyping Core, an application can also include a Microbiome Research and Development Project.  No topic other than microbiome research will be considered responsive for an independent Research and Development Project in this initiative, and only applications that include fee-for-service microbiome tests in the proposed Phenotyping Cores are eligible to include a Microbiome Research and Development Project.  The project must fit within the overall budget cap.  While the microbiome research opportunity reflects a new area of emphasis for the MMPC program, it is not anticipated that this be pursued at all Centers.  We encourage each application to focus on institutional strengths in selecting phenotyping cores.   

Leadership for the Microbiome Research and Development Project should have very high level of expertise.  The Project should describe significant, high quality research that explores the interaction between the microbiome and microbiome metabolites, and the host metabolism, physiology, function, diet and disease state.  Of particular interest would be the effects of defined microbiota and creative use of important mouse models.  It should be structured as a research project, but should have the dual goal of discovering new knowledge and providing information and new tests or test validation that would enhance the service goals of the Phenotyping Core.  Applicants that propose a Microbiome Research and Development Project should have access to appropriate facilities for manipulating and monitoring the microbiome, as well as the ability to phenotype important aspects of mammalian metabolism, immune system, circadian rhythms, energy balance, etc. 

There is likely to be considerable overlap between the Microbiome Phenotyping Core personnel and the participants in a Microbiome Research and Development Project.  However, it is hoped that by keeping them separate, the major goals of the two elements will remain distinct and undiluted.  The major goal of the Phenotyping Core is to provide fee-for-service tests to clients, to ensure that those tests are validated and of high quality, and to develop important new tests or testing paradigms for a large client base.  The major goals of the Research and Development Project are to uncover the roles of the microbiome in host metabolism, physiology and function, and the roles in disease prevention and pathobiology, as well as to provide information and technology that will enable and improve MMPC Phenotyping Core services.  The Research and Development Project is expected to take advantage of tests offered in the MMPC Phenotyping Cores.

Although there is an enhanced opportunity for the overall Consortium for microbiome research, there is no requirement for a microbiome element in an application for an MMPC award.  It is expected that only a subset of successful applications will include Microbiome Cores and/or Research and Development Projects. 

Animal Care Core

An MMPC application must propose an Animal Care Core if tests are to be done on live animals.  The Animal Care Core will receive, house, feed, monitor and maintain the health of submitted mice for the duration required for the phenotyping exam. In most cases animals received at an MMPC will not be returned to the originating institution.  However, applicants can propose to provide special animal models for shipment to client institutions, such as bariatric surgery models or mice with manipulated microbial populations.  

There may be limited circumstances where all proposed tests will be done on isolated tissues.  If so, the applicant can collaborate with another applicant to use its Animal Care Core in the event that it becomes necessary to receive, ship or utilize live animals.  

Administrative Core

A well-organized Administrative Core is essential to ensure the efficiency and success of the Center. In consultation with the MMPC Coordinating and Bioinformatics Unit (CBU), the Administrative Core of each MMPC must use MMPC web-based business tools which are designed to facilitate client-provider interaction and help maintain Center budgetary and workflow records.  The Administrative Core will oversee the importation and workflow assignments for mice and mouse tissues submitted for services; establish, standardize, document and distribute phenotyping protocols; oversee communication between Center staff and clients, including data entry into the MMPC database; and provide for quality control and budgetary oversight. The Director of the Administrative Core would in most cases be the MMPC Center Director, and it is required that each MMPC have a Center Administrator with 6 person-months or greater time commitment. The Administrative Core must provide the following:

Administrative Plan: An administrative database has been established through the MMPC CBU for electronic submission of applications for phenotyping services, for maintaining records, and for communication with investigators.  This system ensures some uniformity in business practices among the MMPCs.  Applicants should be willing to use this system. Additional tracking systems should be implemented as necessary to measure service efficiency and workflow, as well as timely deposit of data in the MMPC database.  Investigator institutions who wish to use MMPC services must sign a Conditions of Use Statement (COU) (https://www.mmpc.org/shared/COU.aspx) and the Administrative Core is responsible for ensuring all necessary agreements are received and that records are maintained and up-to-date. All data produced in an MMPC on submitted mice and background strains are expected to be housed in the MMPC phenotype database, and the Administrative Core should work closely with the CBU to ensure that data which are deposited are deposited through an efficient process and in a timely manner, consistent with achieving the goals of this funding program. The Administrative Core is responsible for establishment and activities of the Center Steering Committee. It will also oversee the submission of yearly progress reports, including reports of program income and spending. The Center Administrator will participate in an administrative subcommittee of the Executive Steering Committee.

Service Plan: Applicants should consider their capacity to provide phenotyping services through each individual Core, and establish a plan for accepting and prioritizing strains for services. The same criteria should be applied to mice from investigators inside and outside the parent institution. Applicants should also plan to provide advice to submitting investigators regarding phenotyping protocols, and ensure efficient utilization of submitted strains by facilitating access and analysis through multiple Cores or by recommending the services of other MMPCs as appropriate.  

Business Plan: Applicants should strive to develop a costing model and business practices that are aligned with the stated mission of the MMPC program. Fee structures must allow for full or partial cost-recovery, with the same fee structure applied to academic investigators inside or outside the parent institution. Details are provided below under “Program Income”.

Web Site: Each MMPC can propose to have its own website, which would harmonize with the CBU-maintained central site (http://www.mmpc.org/).  It includes a description of Cores, contact information for Center personnel, lists of tests, detailed descriptions of all phenotypic assays, protocols and fees. The Administrative Core will be responsible for providing timely updates on phenotyping test availabilities, descriptions and protocols; and in addition submit any changes to the CBU for posting for informational purposes on the MMPC program intranet site.

Local Center Steering Committee: The Administrative Core will be expected to establish a local Center Steering Committee to provide scientific and administrative oversight of the Center. The committee will be composed of lead Center personnel (Center and Core Directors) and other technical or research personnel as deemed appropriate. At least one member should be a senior researcher at the institution who is not directly involved in the MMPC. The committee is expected to meet at least monthly, with minutes of the meetings made available to the MMPC CBU and NIH staff upon request. The Center Steering Committee will monitor workflow, customer service, and the uploading of test data into the MMPC database; assess market trends and emerging opportunities; oversee Center research and development as well as projects undertaken in collaboration with other MMPCs, and evaluate the impact of research on Center vitality; approve new tests; determine when collaborative arrangements are justified; and participate in other ways as necessary.

Program Income: Tests will be provided on a fee-for-service basis. Fees are charged to all users for all tests, whether Center personnel, non-Center personnel from the home institution, researchers from other Universities or businesses, or collaborators of Center personnel. Fees for academic users should be set so as to recover at least 40-60% of the actual cost of the test, and separate fee structures can be designed for users from for-profit and not-for-profit entities. Every effort should be made to treat internal and external academic clients equally.  Additional overhead costs are allowed, but it must be kept in mind that overhead costs charged to clients from outside the home institution are likely to come from funding targeted for research and should not constitute an undue burden or a barrier to Center use. Centers may have exemption programs where permission to waive fees is requested from the local MMPC Steering Committee. These might cover new investigators for small pilot studies.  Center personnel are expected to advise applicants for services regarding the best set of tests.  In the past, there has been no charge for planning and advice although applicants may propose a reasonable fee. Program income can be used to pay Core staff, purchase equipment or otherwise improve and expand Center operation.  Yearly progress reports must include detailed accounts of program income and expenditure. Program income will be considered as one indication of success of the MMPC, along with the number of external clients, completed tests, and published papers that cite the MMPC grant number.  

Data Ownership and Authorship

The MMPCs are designed to provide service at below cost to the research community, not to fund the personal or collaborative research programs of Center staff. Investigators who send their mice to an MMPC should be confident that phenotyping data subsequently provided by the MMPC belongs to them, and does not obligate them to any kind of collaboration, nor are they expected to share authorship with Center personnel when these phenotyping data are published. This is especially true for routine tests that are easily accomplished with minimal scientific or intellectual input from Center personnel, beyond the standard planning and advice needed to decide which tests are appropriate. In order to accomplish this, investigators seeking phenotyping services and Center personnel are required to sign a Conditions of Use Statement (COU) (https://www.mmpc.org/shared/COU.aspx) that verifies that phenotyping data generated by the MMPC belongs exclusively to the investigator that owns the mouse and his/her institution, and not to the Center. For routine tests, it should be very rare that Center personnel are listed as authors on resulting publications unless these are reports of their otherwise funded work. If a submitting investigator and an MMPC staff member decide to form a true collaboration based on equitably shared amounts of time, funds and scientific input, their collaborative work must be funded by non-MMPC funds, and the partnership should be documented by signed letters deposited in the MMPC Administrative Core.   Although the phenotypic data belongs to the MMPC client, he/she will be expected to allow it to be added to the MMPC database.  These data along with descriptive metadata will be released to the public either after publication or two years after completion of the tests unless the client requests additional time.

Terms and Agreements

Centers are expected to abide by the Guidelines and Policies found at http://www.mmpc.org/policies.html, to offer a set of phenotyping tests to mouse researchers, and to collaborate with other funded MMPCs to provide an optimum range and capacity of tests. If an MMPC proposes to carry out tests on live mice, the PD/PI must agree to accept, house and care for mice shipped from outside his/her home institution.  Otherwise, the PI must agree to accept tissues for analysis as appropriate for proposed tests.  The MMPC must conduct agreed upon tests, communicate resultant data to the client in a timely manner, and collect fees for those tests.   MMPC Directors will participate in the Executive Steering Committee. All data generated on submitted test strains belongs to the originating investigator and institution.  Phenotypic data from routine tests in test mice will be made available via the MMPC database to the public after publication or at an appropriate time after data was generated (typically 2 years). A Conditions of Use Statement (COU) (https://www.mmpc.org/shared/COU.aspx) to this effect must be signed for each set of mice to be studied.

Description of the MMPC Coordinating and Bioinformatics Unit (CBU)

The MMPC Coordinating and Bioinformatics Unit (CBU) will be shared with the NIDDK Diabetic Complications Consortium (DiaComp, http://www.diacomp.org/index.aspx) and will be competed through a separate RFA (RFA-DK-15-011). Activities to be undertaken by the CBU include: 1) providing clerical and administrative support, 2) maintaining and managing the central database, 3) distributing funds and overseeing financial management of the MMPC Pilot and Feasibility Program and the MMPC Collaborative Project Funds, 4) updating and maintaining the MMPC internet and intranet websites, 5) providing logistics and other support for consortium meetings, and 5) promoting the consortium via advertising and through facilitating collaborative efforts.

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.

Application Types Allowed

New
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIDDK intends to commit $5,430,000 in FY 2016 to fund 4-7 awards.  Of this total, $1,310,000 will be used for microbiome research, including Phenotyping Cores and Research and Development Projects.  Future year amounts will depend on annual appropriations.

Award Budget

Application budgets are limited to $750,000 per year in direct costs.  All award budgets should reflect the actual needs of the proposed project.

Award Project Period

The maximum project period may not exceed 5 years.     

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

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

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

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

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

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

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.  This means that the NIH will not accept:

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

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

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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:

Francisco O. Calvo, Ph.D
Chief, Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 
6707 Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone: 301-594-8897
Fax: 301-480-3505
Email: fc15y@mail.nih.gov

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

12 pages

Admin Core

12 pages

Core (Use for Animal Care Core and Phenotyping Cores)

12 pages

Project (Use for Microbiome Research and Development Project)

12 pages

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

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

  • Overall: Required
  • Administrative Core: Required
  • Animal Care Core: Required if any proposed test requires live mice
  • Phenotyping Core(s): Required
  • Microbiome Research and Development Project: Optional
Overall Component

When preparing your application in ASSIST, use Component Type ‘Overall’.

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.  

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims:   Please provide overall focus and goals of the proposed Center and describe its overall structure.     

Research Strategy:  Center Objectives and Strategic Plan: This narrative section identifies and describes the overall focus of the proposed Center and summarizes the general plan for its oversight, administration and workflow. This is an important section wherein the Center team can provide the rationale for development of the Center and then define the strategic plan that will be put in place to address identified compelling needs. This section should include a brief discussion of the central theme, goals, and objectives of the Center, the organizational structure, the participating institutions/organizations, and the role of all participants. The relationship between individual Cores and their interaction with the Administrative Core, as well as how proposed Cores contribute to the Center and to the overarching theme and goals of the national MMPC program should be defined. Summarize the special features in the environment and/or resources that make this application strong or unique.  It may also describe any special relationship between the applicant Center and another applicant Center, such as shared Cores.

Applicants must carefully justify the research community needs being uniquely addressed, and describe the methodologies, technologies, statistical tools, limitations of the approaches, and projected costs of the approaches. Applicants should estimate the number of animals that could be studied each year for each test, and how tests may be synchronized or sequenced to best take advantage of each model being evaluated. 

In addition, applicants should provide a detailed plan for how they will promote the identification, validation, and implementation of new technologies to ensure continuing evolution of Center offerings.

Progress Report: If the application is a Renewal, this section should also highlight past performance and the major accomplishments from resulting from the prior funding period.   These can include important publications that the MMPC contributed to, successful consortium research projects, research and development projects, successful Pilot and Feasibility projects, training elements, newly implemented tests, successful advertising campaigns, etc.  Data reflecting Center activities should be provided in narrative form with numbers of users and services  and key publications cited. In addition to discussing general progress of individual Cores, describe synergies and collaborations that occurred as a result of the program. For individual Cores that will be continued, additional details should be provided in the Progress Report section of the Research Strategy within each core.

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

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

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

Administrative Core

When preparing your application in ASSIST, use Component Type ‘Admin Core.’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)
  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Director’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   
Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package.  

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims:   List the broad, long-range objectives of the proposed Core.   

Research Strategy:  

Background and Significance: this section should describe how the proposed Core activities will contribute to meeting the goals of the Center and the national MMPC program.  Explain the strengths of key personnel and the environment.

Progress Report: this section is for renewal projects only, and will detail important activities of the Administrative Core in the last funding period which will impact on the assessment of the present Core, which were not detailed in the 'Overall' section.  These could include successful implementation of administrative practices, websites and database activities, etc.

Design and Methods: this section should describe the interaction between the Administrative Core and the other Center components, and any interaction between Core personnel and clients and their institutions.  It should address the administrative structure including a local Steering Committee, a succession plan if the PI should leave; the Administrative and Service Plans including workflow pipelines, prioritization of orders for tests; the Business Plan including billing, collection of fees and maintenance of records; general plan for use of program income from the Phenotyping Cores; website development plan including curation (optional); marketing approaches; plans to monitor and ensure timely data upload into the CBU administrative and phenotype databases; implementation and oversight; and any proposed training program or courses (if appropriate).  The PI should express a willingness to participate in MMPC consortium activities including monthly and annual meetings, courses and working groups, use the MMPC web-based business tools, reposit data in the MMPC database in a timely fashion, and follow MMPC guidelines and policies.

Describe any special relationships that exist between the applicant Center and any other applicant Center, such as shared Cores.

Service Plan: Applicants should provide capacity estimates for annual phenotyping services of individual Cores, and indicate a plan for establishing priorities for accepting strains for services. The same criteria should be applied to mice from investigators inside and outside the parent institution. Applicants should also plan to provide advice to submitting investigators regarding phenotyping protocols, and ensure efficient utilization of submitted strains by facilitating access and analysis through multiple Cores or by recommending the services of other MMPCs as appropriate.  Established Centers must show evidence of service through acknowledged support in peer-reviewed articles and grant applications, as well as contributions to the MMPC database. A majority of Center productivity should reflect support of non-Center investigators, as evidenced by peer-reviewed publications without Center personnel coauthorship.  

Business Plan: Applicants should strive to develop a costing model and business practices that are aligned with the stated mission of the MMPC program. Fee structures must allow for full or partial cost-recovery, with the same fee structure applied to academic investigators inside or outside the parent institution. Details are provided below under “Program Income”.  Renewal applications must show clear evidence of implementation of a cost-recovery plan that is appropriate, based on Center activity, and sufficient to allow for continued growth and evolution of the Center. A plan for regular and systematic review of workflow and utilization of Cores as well as recommended performance measures should be provided. This plan should include an annual assessment of market trends, with mechanisms put in place to facilitate redistribution and reallocation of resources as deemed appropriate by the MMPC Steering Committee based on emerging trends in research. Renewal applications should show evidence of consistent evaluation and evolution of Center services during the prior funding period.

Program Income: Applicants should incorporate tests as fee-for-service. Applications should incorporate charge structures that include charges for all users for all tests, whether Center personnel, non-Center personnel from the home institution, researchers from other Universities or businesses, or collaborators of Center personnel. Centers may include in the application the description of exemption programs where permission to waive fees is requested from the local MMPC Steering Committee, and this should be addressed in the application. These might cover new investigators for small pilot studies.  Applications should address how Center personnel will advise applicants for services regarding the best set of tests and any associated fees and whether Program income will be used to pay Core staff, purchase equipment or otherwise improve and expand Center operations. Applications should have a detailed plan for fee structure, cost recovery, and how program income will be used. 

Terms and Agreements: Applicants are instructed to include a plan for cost recovery through a fee-for-service structure, and should indicate how program income will be used to enhance Center activities and functions, consistent with achieving the goals of the program. MMPC funds, including program income, are meant to enhance services to the diabetes and obesity research community, and not to fund the personal or collaborative research of the Center personnel. 

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.

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

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

Planned Enrollment Report  (Administrative Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Administrative Core)

Not Applicable

Animal Care Core

When preparing your application in ASSIST, use Component Type ‘Core.’

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

SF424 (R&R) Cover (Animal Care Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Animal Care Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Animal Care Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Animal Care Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Animal Care Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Director’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (Animal Care Core)

Budget forms appropriate for the specific component will be included in the application package.  Funds should not be requested for per diem cage charges for client mice, as these should be paid by the client.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Animal Care Core)

Specific Aims:  List the broad, long-range objectives of the proposed Core.  

Research Strategy:

Background and Significance: this section should describe how the proposed Core activities will contribute to meeting the goals of the Center and the national MMPC program.  Explain the strengths of key personnel and the environment.

MMPC Animal Care Guidelines are posted at the MMPC website (http://www.mmpc.org/), and applicants should agree to follow these guidelines and provide details for any necessary deviations.  Applications must include germane institution policies including those regarding quarantine and assessment of animals upon arrival, documentation, procedures, and anticipated costs, as well as colony capacities. Institutional quarantine procedures should be clearly conducive for rapid and efficient evaluation of strains being shipped to the MMPC facility for phenotyping. Applicants must explain how the Animal Care Core will address program expectations for efficient animal importation and quarantine procedures by specifically responding to the existing MMPC animal importation and quarantine recommendations posted at the MMPC website.

There may be limited circumstances where all proposed tests will be done on isolated tissues.  If so, the applicant can collaborate with another applicant to use its Animal Care Core in the event that it becomes necessary to receive, ship or utilize live animals.  A plan must be presented to indicate logistical feasibility, and a letter from the collaborating applicant is required. 

Progress Report: this section is for renewal projects only, and will detail important activities of the Animal Care Core in the last funding period which will impact on the assessment of the present Core, which were not detailed in the 'Overall' section.  These could include successful implementation of new practices or infrastructure, etc.

Design and Methods: this section should describe the Core's structure, work flow, maintenance, health care, special services, any tests that can be done within the animal facility itself, etc.  It should describe importation and quarantine procedures with reference to the existing MMPC guidelines for animal importation, care and use (www.mmpc.org).   It should also describe fee structures for housing, feeding, pathogen testing, receipt of animals, shipping, etc.  A high quality Animal Care Core is an extremely important part of an MMPC that requires living animals for its phenotyping tests.

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

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

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

Planned Enrollment Report  (Animal Care Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Animal Care Core)

Not Applicable

Phenotyping Core(s)

When preparing your application in ASSIST, use Component Type ‘Core’ for each Phenotyping Core.

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

SF424 (R&R) Cover (Phenotyping Core)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Phenotyping Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Phenotyping Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Phenotyping Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Phenotyping Core)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Director’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (Phenotyping Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Phenotyping Core)

Specific Aims:  List the broad, long-range objectives of the proposed Core.  

Research Strategy:    

Background and Significance: this section should describe how the proposed Core activities will contribute to meeting the goals of the Center and the national MMPC program.  Explain the strengths of key personnel and the environment, and rationale for selection of Core services.  Describe how the Core activities will address a compelling and unmet need for the research community.  Describe its interaction with other Cores in the proposed MMPC, and its relationship to similar Cores available in the institution or elsewhere in the US.

Preliminary Studies/Progress Report: Describe germane studies and preliminary data.  For renewals, provide historical data reflecting Core activities in the tabular form and format outlined below. Numbers of users and services should be provided as totals, and also broken down according to local versus customers from outside the parent institution. Numbers of publications citing the Core that contain Core or Center personnel as co-authors should be clearly indicated. In addition to the tabular data, provide information describing user funding sources and fraction of customers that are repeat users; the extent and timeliness of data uploads to CBU databases; how program income was used to advance Center goals; and any related research and development efforts undertaken during the prior funding period.

SAMPLE: Quantitative Assessment: Productivity and Program Income in the Prior Project Period

Diabetic Complications Phenotyping Core

Project Year 1

Project Year 2

Project Year 3

Project Year 4

Project Year 5

Project All Years

Clients served by Core (#local/#outside)

5 (1/4)

7 (1/6)

9 (2/7)

11 (3/8)

13 (3/10)

45 (10/35)

Services provided by Core (#local/#outside)

10 (2/8)

14 (2/12)

18 (4/14)

22 (6/16)

26 (6/20)

90 (20/70)

Publications citing MMPC: with Center co-authorship

1

2

3

4

5

15

Total Publications citing MMPC: no Center co-authorship

2

4

6

8

10

30

Program Income

$5000

$10,000

$15,000

$20,000

$25,000

$75,000

Phenotyping Tests: Describe the proposed Core activities and/or services, including quality control measures.  State the roles and responsibilities of the Core Director, roles of key personnel, and any special business plan of the proposed Core and the relationship to other existing Cores in the institution.  Describe the extent of interaction that will likely be needed between Core personnel and applicants.  Include an estimate of capacity (how many animals could be housed or studied, how many tests, etc.) and expected use by internal and external research communities.  Include plans for prioritizing services in response to orders.  Describe protocols to ensure timely data upload into the CBU phenotype database.

Applicants that propose microbiome phenotyping tests as a Phenotyping Core or part of a Phenotyping Core may also request funds for a Microbiome Research and Development Project (see below).

Test Development: Describe tests that are in development currently and planned for development during the project period, and plans for ensuring continued evolution of Core services based on emerging research needs.

Anticipated Core Usage and Program Income: describe anticipated Core usage and program income, and how income will be used to advance Core activities or functions.

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

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

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

Planned Enrollment Report  (Phenotyping Core)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Phenotyping Core)

Not Applicable

Microbiome Research and Development Project (optional)

When preparing your application in ASSIST, use Component Type ‘Project.’

Applicants requesting a Microbiome Research and Development Project must also propose microbiome phenotyping tests as part of a Phenotyping Core or as a Microbiome Phenotyping Core.

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

SF424 (R&R) Cover (Microbiome Research and Development Project)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Microbiome Research and Development Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Microbiome Research and Development Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Microbiome Research and Development Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Microbiome Research and Development Project)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (Microbiome Research and Development Project)

Budget forms appropriate for the specific component will be included in the application package.  The budget for this project is not capped, but must fit within the overall budget cap of $750,000.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Microbiome Research and Development Project)

Specific Aims: List the broad, long-range objectives of the proposed project, which should focus on the interaction between the microbiome and mammalian metabolism and physiology, especially as it pertains to diabetes and its complications, obesity, and other metabolic diseases. 

Research Strategy: This section should provide background information and address the significance of the project to the MMPC and/or the mouse research community; preliminary data germane to the study that demonstrates feasibility and the likelihood of success; thoroughly describe the proposed experimental design and methods; describe how this research will enrich the MMPC, either by providing additional tests or improving MMPC practices or the interpretation of MMPC tests.  It is likely that the proposed studies would utilize services proposed in the Phenotyping Cores, both microbiome analysis tests and tests focused on mammalian metabolism and physiology.  The project should serve to gain new understanding of the interaction between the microbiome and mammalian biology, and to inform and improve the services offered in the Phenotyping Cores.

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

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

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

Planned Enrollment Report  (Microbiome Research and Development Project)

Not Applicable

PHS 398 Cumulative Inclusion Enrollment Report (Microbiome Research and Development Project)

Not Applicable

3. Submission Dates and Times

See Part I. Section III.1 for information regarding the requirements for obtaining a Dun and Bradstreet Universal Numbering System (DUNS) Number and for completing and maintaining an active System for Award Management (SAM) registration. Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: https://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

All PD(s)/PI(s) and component Project Leads 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.

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 (SAM). 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.

In order to expedite review, applicants are requested to notify the NIDDK Referral Office by email at fc15y@mail.nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).

Scored Review Criteria - Overall

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 Center  that by its nature is not innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? If the aims of the Center 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 Center? 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 Center? 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 Center 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 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

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

Service

Do the proposed tests fill a need present in the diabetes and obesity research communities, and will they provide information that would otherwise be unavailable to most laboratories, or be more cost-effective to conduct centrally? Is the necessary technical and analytical expertise available?

Does the application demonstrate potential for in-house development of important new tests and technologies that will expand the scope and quality of the available tests? Do existing Centers show clear evidence of a charge-back structure that supports expanded and/or evolving Center activities? If proposed tests require live mice, does the institution have the capacity to efficiently receive, house and care for an adequate number of mice? Has the PI expressed a willingness to participate in consortium activities, to use the common web-based business tools and follow MMPC guidelines and policies, and to ensure that data is entered into the MMPC database?

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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 children to determine if it is justified in terms of the scientific goals and research strategy proposed.  For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

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

Revisions

Not Applicable

Additional Review Considerations - Overall

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

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; and 3) Genomic Data 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 the 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:

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

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

Applications will be assigned  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National 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

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 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.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

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

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial 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:
The Director of the Mouse Metabolic Phenotyping Center will have primary responsibility for all activities, including the planning, organizing and administering the Phenotyping, Administration and Animal Care Cores, optional Microbiome Research and Development Project, and a local Steering Committee.  The PD/PI will participate as a voting member of the MMPC Executive Steering Committee with NIH staff, the MMPC CBU PD/PI, and other MMPC Center Directors.  He/She will be ultimately be responsible for communicating with prospective clients, evaluating applications for phenotyping services, and will ensure that services are completed, that data is communicated back to the MMPC client, and placed in the MMPC database in a timely and satisfactory manner, and that appropriate fees are collected for completed services. The PI will ensure that Center personnel follow the MMPC guidelines and policies found on http://www.mmpc.org and participate in consortium activities as appropriate.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, unless these are assigned to the MMPC client according to the Conditions of Use Statement (COU) found at http://www.mmpc.org/shared/COU.aspx , subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
The NIH Project Scientist(s) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  The Project Scientist will serve as the contact point for all facets of the scientific interaction with the awardee (s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIDDK staff to provide advice to the awardee on specific scientific and/or analytic issues. Such staff may include another Project Scientist or Analyst, who will provide direct technical assistance to the awardees to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.

The NIDDK project scientist will participate in the Executive Steering Committee as a full participant and voting member of the Steering Committee and, if applicable, subcommittees.

The NIDDK project scientist will serve as a resource to study investigators with respect to other ongoing NIDDK activities that may be relevant to the study to facilitate compatibility with the NIDDK missions and avoid unnecessary duplication of effort.

The NIDDK project scientist will have substantial involvement assisting in the design and coordination of research activities for awardees as elaborated below:

  • Assisting by providing advice in the management and technical performance of the investigations, coordinating required regulatory clearances for investigational agents used in the study, which are held by NIDDK. The NIDDK may reserve the right to cross file or independently file an Investigational New Drug Application or an Investigational Device Exemption form with the FDA.
  • The NDDK Project Scientist or designee may coordinate activities among awardees by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results.
  • Reviewing procedures for assessing data quality and study performance monitoring.
  • The NIDDK Project Scientist or designee may be co-authors on study publications. In general, to warrant co-authorship, NIDDK staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participate in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.

In addition, a separate NIDDK Program Official identified in the Notice of Grant Award will be responsible for the normal stewardship and monitoring of the award including review and approval of all progress reports and all budgetary decisions. Additional responsibilities include interacting with the principal investigator(s) on a regular basis to monitor study progress. Monitoring may include: regular communications with the principal investigator and staff, periodic site visits, observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters; as well as attendance at Steering Committee, data safety and monitoring board, and related meetings. The NIDDK retains, as an option, periodic review of progress by researchers not involved with the study.

The NIDDK Program Official will review and approve protocols prior to implementation to insure they are within the scope of peer review, for safety considerations, as required by Federal regulations.

The NIDDK Program Official will make recommendations for continued funding based on: a) overall study progress, including sufficient data accrual; b) cooperation in carrying out the research (e.g., attendance at Steering Committee meetings, implementation of group decisions, compliance with the terms of award and reporting requirements); and/or c) maintenance of a high quality of research, which will allow pooling of data and comparisons across multiple cooperative agreement awards for common data elements.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

Consortium Activities and Responsibilities

The PD/PI of an MMPC must agree to be an active participant in consortium-wide activities as deemed necessary by the Executive Steering Committee and Expert Scientific Panel.

Executive Steering Committee

The PD/PI of the MMPC must agree to participate in the Executive Steering Committee of the MMPC consortium. The Executive Steering Committee meets monthly by teleconference and at least once each year in person to encourage information exchange within the consortia. The MMPC Executive Steering Committee will consist of the MMPC Center Directors, the PD/PI of the Coordinating and Bioinformatics Unit, NIH Project Scientists, the NIDDK Project Official, and other Core Directors and MMPC personnel as needed. The Chair will be chosen from among the MMPC Center Directors and may rotate annually.

The purpose of the Executive Steering Committee will be to discuss and evaluate concerns and cooperative activities of the consortia. If voting is necessary for an action item, individual PDs/PIs and/or Center Directors and the NIH institutes hold one vote each. The Executive Steering Committee will discuss and evaluate Subcommittee and Core activities and provide feedback to Subcommittee leaders at least bi-annually, implement changes in subcommittee membership or direction if needed, discuss and evaluate new projects, collaborative projects, and use of MMPC Opportunity Pool funds.

Expert Scientific Panel (ESP)

The MMPC Principal Investigator/Center Director must indicate his/her intention to be responsive to recommendations provided by an independent Expert Scientific Panel (ESP). ESPs will meet annually and will review interim progress and provide an annual report and recommendations to the Executive Steering Committee on consortium activities. The CBU will be responsible for organizing and providing minutes of these meetings.

Members of the ESP will be nominated by the Executive Steering Committee, selected and invited by the NIH staff. A chairman will be chosen from among the ESP membership, who will be accomplished senior scientists from academia and industry with backgrounds in diabetes, diabetic complications, obesity, animal models, mouse genetics, and technologies associated with mouse phenotyping. If voting is necessary for an action item, members of the ESP and the ESP chair hold one vote each. The Executive Steering Committee will discuss implementation of ESP recommendations, plan a strategy and timeline for making these changes in a timely fashion, and report an action plan back to the ESP.

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: 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 regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

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)

Francisco O. Calvo, Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8897
Email: calvof@mail.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.

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